Clinical trial NCT04392739
Conditions: Smallpox
Sponsor: SIGA Technologies
Start date: 2019-07-19; Completion date: 2019-12-05
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Safety and PK study in adults weighing more than 120 kg

Detailed description:
The primary objective of this study is to determine the pharmacokinetic (PK) profile of 600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing more than 120 kg to determine if a change in dosing regimen would be needed in these patients.

Secondary:

The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg.

Arms: arm 1: TPOXX 600 mg BID x 7 days
Interventions: intervention 1: Tpoxx
Intervention descriptions: intervention 1: oral antiviral

Protocol documents:
Prot_000.pdf: 


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SIGNATURE PAGE 
 
PROTOCOL TITLE: 
A Post Marketing Study of the Safety, Tolerability, and 
Pharmacokinetics of TPOXX® in Adult Subjects Weighing 
More Than 120 kg 
PROTOCOL NUMBER: 
SIGA-246-022 
 
Dennis E. Hruby, PhD 
Chief Scientific Officer 
SIGA Technologies, Inc. 
 
Date 
 




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TABLE OF CONTENTS 
TITLE PAGE .......................................................................................................................... 1 
SIGNATURE PAGE ............................................................................................................... 2 
INVESTIGATOR PROTOCOL AGREEMENT PAGE ..................................................... 3 
TABLE OF CONTENTS ........................................................................................................ 4 
LIST OF TABLES ................................................................................................................... 6 
PROTOCOL SYNOPSIS ....................................................................................................... 7 
1. 
INTRODUCTION ............................................................................................. 15 
1.1 
BACKGROUND ..............................................................................................15 
1.2 
RATIONALE FOR STUDY ............................................................................15 
1.3 
POTENTIAL RISKS AND BENEFITS ...........................................................15 
1.3.1 
Potential Risks ..............................................................................................15 
1.3.2 
Known Potential Benefits .............................................................................16 
2. 
STUDY OBJECTIVES ...................................................................................... 16 
2.1 
PRIMARY OBJECTIVE ..................................................................................16 
2.2 
SECONDARY OBJECTIVE ............................................................................16 
3. 
STUDY POPULATION..................................................................................... 16 
3.1 
INCLUSION CRITERIA .................................................................................16 
3.2 
EXCLUSION CRITERIA ................................................................................18 
3.3 
OTHER SCREENING CONSIDERATIONS ..................................................22 
3.3.1 
Subject Restrictions During the Study .........................................................22 
3.4 
WITHDRAWAL OF SUBJECTS FROM THE STUDY .................................22 
3.4.1 
Reasons for Withdrawal................................................................................22 
3.4.2 
Handling of Withdrawals ..............................................................................23 
3.4.3 
Halting Rules ................................................................................................23 
4. 
STUDY DESIGN ................................................................................................ 24 
4.1.1 
Replacements ................................................................................................25 
5. 
STUDY TREATMENT ..................................................................................... 25 
5.1 
TREATMENT ADMINISTERED....................................................................25 
5.2 
STUDY DRUG ................................................................................................26 
5.2.1 
Study Drug Packaging and Storage ..............................................................27 
5.2.2 
Study Drug Accountability ...........................................................................27 
5.3 
TREATMENT COMPLIANCE .......................................................................27 
5.3.1 
Prior and Concomitant Medications .............................................................28 
5.3.1.1 
Prior Medications ..................................................................................... 28 
5.3.1.2 
Concomitant Medications ........................................................................ 28 
6. 
STUDY PROCEDURES ................................................................................... 28 


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6.1 
PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS ......................29 
6.1.1 
Pharmacokinetic Sample Collection, Shipping, and Storage .......................30 
6.1.2 
Pharmacokinetic Sample Analysis................................................................31 
6.2 
SAFETY ASSESSMENTS AND ENDPOINTS ..............................................31 
6.2.1 
Adverse Events .............................................................................................31 
6.2.1.1 
Adverse Event Definitions ....................................................................... 31 
6.2.1.2 
Eliciting and Documenting Adverse Events ............................................ 33 
6.2.1.3 
Reporting Adverse Events ....................................................................... 34 
6.2.1.4 
Reporting of Serious Adverse Events ...................................................... 34 
6.2.1.5 
Assessment of Severity ............................................................................ 35 
6.2.1.6 
Assessment of Causality .......................................................................... 36 
6.2.1.7 
Follow-up of Adverse Events .................................................................. 37 
6.2.1.8 
Reactogenicity ......................................................................................... 37 
6.2.1.9 
Reporting of Pregnancy ........................................................................... 37 
6.2.2 
Clinical Laboratory Testing ..........................................................................38 
6.2.3 
Medical History ............................................................................................40 
6.2.4 
Vital Sign Measurements ..............................................................................40 
6.2.5 
Electrocardiograms .......................................................................................40 
6.2.6 
Physical Examinations ..................................................................................41 
6.2.7 
Unscheduled Visits .......................................................................................42 
7. 
STATISTICAL ANALYSIS PLANS ................................................................ 42 
7.1 
SAMPLE SIZE CALCULATIONS..................................................................42 
7.2 
ANALYSIS POPULATIONS ...........................................................................42 
7.3 
STATISTICAL ANALYSIS .............................................................................42 
7.3.1 
Pharmacokinetic Analyses ............................................................................43 
7.3.2 
Safety Analyses ............................................................................................43 
7.4 
HANDLING OF BELOW THE LIMIT OF QUANTIFICATION AND 
MISSING DATA ..............................................................................................44 
7.5 
INTERIM ANALYSES ....................................................................................44 
8. 
REFERENCE LIST........................................................................................... 45 
9. 
APPENDICES .................................................................................................... 46 
9.1 
APPENDIX 1: LIST OF ABBREVIATIONS ..................................................46 
9.2 
APPENDIX 2: SCHEDULE OF EVENTS ......................................................48 
9.3 
APPENDIX 3: STUDY GOVERNANCE .......................................................50 
9.3.1 
Data Quality Assurance ................................................................................50 
9.3.2 
Investigator Obligations ...............................................................................51 
9.3.2.1 
Confidentiality ......................................................................................... 51 
9.3.2.2 
Institutional Review ................................................................................. 51 


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9.3.2.3 
Subject Consent ....................................................................................... 52 
9.3.2.4 
Exclusion of Children .............................................................................. 52 
9.3.2.5 
Study Reporting Requirements ................................................................ 53 
9.3.2.6 
Financial Disclosure and Obligations ...................................................... 53 
9.3.2.7 
Investigator Documentation ..................................................................... 53 
9.3.2.8 
Study Conduct ......................................................................................... 54 
9.3.2.9 
Case Report Forms and Source Documents ............................................ 54 
9.3.2.10 
Adherence to Protocol ............................................................................. 55 
9.3.2.11 
Reporting Adverse Events ....................................................................... 55 
9.3.2.12 
Investigator’s Final Report ...................................................................... 55 
9.3.2.13 
Records Retention .................................................................................... 55 
9.3.2.14 
Publications .............................................................................................. 55 
9.3.3 
Study Management .......................................................................................56 
9.3.3.1 
Monitoring ............................................................................................... 56 
9.3.4 
Safety Monitoring Plan .................................................................................57 
9.3.5 
Medical Monitor ...........................................................................................57 
9.3.6 
Safety Oversite (Independent Safety Monitor) .............................................57 
9.3.6.1 
Inspection of Records .............................................................................. 57 
9.3.6.2 
Management of Protocol Amendments and Deviations .......................... 58 
9.3.6.3 
Study Termination .................................................................................... 59 
9.3.6.4 
Final Report ............................................................................................. 59 
9.4 
APPENDIX 4: CHANGE HISTORY ..............................................................60 
9.4.1 
Protocol Amendment 1 .................................................................................60 
9.4.2 
Protocol Amendment 2 .................................................................................61 
LIST OF TABLES 
Table 5-1 
Excipients of TPOXX Capsules ...................................................................... 26 
Table 9-1 
Schedule of Events .......................................................................................... 48 


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PROTOCOL SYNOPSIS 
PROTOCOL NO.: SIGA-246-022 
TITLE: A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of 
TPOXX® in Adult Subjects Weighing More Than 120 kg 
STUDY PHASE: 4 Post Marketing Study 
STUDY SITE: PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200, Austin, TX 78744, 
USA. 
OBJECTIVES: 
Primary: 
The primary objective of this study is to determine the pharmacokinetic (PK) profile of 
600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in 
adult subjects weighing more than 120 kg to determine if a change in dosing regimen would 
be needed in these patients. 
Secondary: 
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral 
TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg. 
STUDY DESIGN AND METHODOLOGY: 
This is an open-label, multiple-dose study to assess the safety, tolerability, and PK of TPOXX 
600 mg BID when administered orally for 7 days to adult subjects weighing more than 
120 kg. A total of 36 subjects, ages 18 to 50, inclusive, will be enrolled. The study will 
consist of a screening period (Day –28 to Day –2), a treatment and confinement period 
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]).  
Subjects will undergo screening evaluations to determine eligibility within 28 days before 
study drug administration. Subjects will be admitted to the study site on Day –1 to complete 
baseline assessments; results of these assessments must be reviewed by the investigator 
before dosing. Starting in the morning of Day 1, subjects will receive 600 mg oral TPOXX 
BID for 7 days (Days 1 through 7). 
All subjects will be provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration and subjects must fast for 2 hours after taking 
study drug. Subjects should eat this meal within 30 minutes or less of taking study drug. 
Study drug and meals must be taken with water only, and no other beverage except water 
should be ingested within 3 hours before or 3 hours after study drug administration. 
Subjects will remain confined to the study site for collection of PK samples and will be 
carefully monitored for safety and tolerability until discharge on Day 9. Subjects who have 
abnormal physical examination findings or an ongoing adverse event (AE)/serious adverse 
event (SAE) on Day 9 that is deemed related to study drug or per investigator or SIGA 
discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All other 
subjects will have the Day 14 (+2 days) follow-up via telephone. All subjects will have a 


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follow-up telephone call 30 days after administration of the last dose of study drug 
(Day 37 [+2 days]) to report any SAEs. At the time of discharge from the clinical research 
unit, subjects will be instructed to notify the investigator of any SAEs that occur within 
30 days after administration of the last dose of study drug. Serious AEs will be followed until 
the SAE is stable or until resolution as determined by the investigator and/or medical 
monitor. 
The total duration of the study for each subject, including the screening period, treatment 
period, and the Day 37 (+2 days) follow-up telephone call, will be approximately 65 days. 
STUDY POPULATION: 
Inclusion Criteria: 
Each subject must meet all the following criteria to be enrolled in this study: 
1. Subject is male or female between 18 and 50 years of age, inclusive. 
2. Subject has a body weight >120 kg at screening, at check-in on Day -1, and prior to 
dosing on Day 1. 
3. Women of childbearing potential, have a negative β human chorionic gonadotropin 
pregnancy test (serum) at the screening visit and a confirmatory negative serum 
pregnancy test on Day –1 before receipt of study drug, and meet 1 of the following 
criteria: 
a. The subject or their partner has undergone surgical sterilization 
b. The subject is postmenopausal, defined as 12 consecutive months with no menses 
without an alternative medical cause and has a documented plasma 
follicle-stimulating hormone level >40 IU/mL 
c. The subject agrees to be abstinent (ie, heterosexually inactive or women in a religious 
order) 
d. The subject agrees to consistently use 1 of the following methods of contraception 
from the beginning of screening (which they had been consistently using for at least 
30 days before the first dose of study drug) through 30 days after the last dose of 
study drug: 
i. 
Condoms, male or female, with a spermicide 
NOTE: For male subjects, condoms must be used for 90 days after the last dose 
of study drug. 
ii. 
Diaphragm or cervical cap with spermicide 
iii. 
Intrauterine device with spermicide 
iv. 
Oral contraceptives or other hormonal methods 
NOTE: Subject must agree to use an additional nonhormonal method of 
contraception in conjunction with oral contraceptives. 
v. 
Male sexual partner who had undergone a vasectomy at least 3 months before 
screening 
4. Male subjects must agree to not donate sperm from the first dose of study drug through 
90 days after the last dose of study drug. 


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5. Subject is considered by the investigator to be in good general health as determined by 
medical history (no hospitalizations for chronic medical conditions in the previous 
2 years), clinical laboratory results, vital sign measurements, 12-lead electrocardiogram 
(ECG) results, and physical examination findings at screening. 
6. Subject agrees to comply with all protocol requirements. 
7. Subject is able to provide written informed consent. 
8. Subject agrees to comply with the dietary requirements. 
9. Subject does not intend to lose weight (diet or weight loss) from the screening visit and 
throughout the study. 
EXCLUSION CRITERIA: 
Subjects meeting any of the following criteria will be excluded from the study: 
1. Subject is a female who is pregnant or breastfeeding or planning to become pregnant 
within 3 months after the last dose of study drug. 
2. Subject has a history of any clinically significant conditions including: 
• Asthma treated with oral systemic steroids within the past 6 months 
• Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes 
• Thyroidectomy or thyroid disease that required medication within the past 12 months 
• Serious angioedema episodes within the previous 3 years or requiring medication in 
the previous 2 years 
• Head trauma resulting in a diagnosis of traumatic brain injury other than concussion 
• Frequent episodes of headache. 
3. Subject has received treatment in another clinical study of an investigational drug (or 
medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose 
of study drug. 
4. Subject has been previously enrolled in any clinical study involving TPOXX 
(tecovirimat). 
5. Subject has a history of relevant drug and/or food allergies (ie, allergy to tecovirimat or 
excipients, or any significant food allergy that could preclude a standard diet in the study 
site). 
6. Subject has any condition possibly affecting drug absorption (eg, previous surgery on the 
gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder, 
or pancreas, with the exception of appendectomy). 
7. Subject has evidence or history of clinically significant allergic (except for untreated, 
asymptomatic, seasonal allergies at time of the first dose of study drug), hematological, 
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or 
neurological disease. Exceptions to these criteria (eg, stable, mild joint disease 
unassociated with collagen vascular disease) may be made following discussions with the 
medical monitor. 


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8. Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, 
syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia). 
9. Subject has a family history of sudden cardiac death, not clearly due to acute myocardial 
infarction. 
10. Subject has a seizure disorder or history of seizures (does not include childhood febrile 
seizures) or a past history that increases seizure risks such as significant head injury that 
caused loss of consciousness or other changes in the subject’s daily function, concussion, 
stroke, central nervous system infection or disease, or alcohol or drug abuse or family 
history of idiopathic seizures. 
11. Subject has a history of a peptic ulcer or significant gastrointestinal bleed. 
12. Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, 
coagulopathy, or platelet disorder requiring special precautions) or significant bruising or 
bleeding difficulties with blood draws. 
13. Subject has a malignancy that is active, or treated malignancy for which there is not 
reasonable assurance of sustained cure, or malignancy that is likely to recur during the 
period of the study (subject should be in complete remission for at least 5 years). 
14. Subject has neutropenia or other blood dyscrasia determined to be clinically significant 
by the investigator. 
15. Subject has used any of the following prohibited medications from within 7 days (or 
5 half-lives, whichever is longer) before the first dose of study drug: antidiabetic 
medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance 
protein transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, 
rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including repaglinide, 
paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of CYP2C19 
including S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole, 
and omeprazole. Medications not listed here that are known (or thought) to be CYP3A4 
substrates may be allowed at the investigator’s discretion, after consultation with the 
medical monitor, if administration poses little to no risk to the subject. 
16. Subject has a history of drug or alcohol abuse or dependency within the last year before 
screening. 
17. Subject has a history of an eating disorder. 
18. Subject has a current or recent (<30 days before screening) history of clinically 
significant bacterial, fungal, or mycobacterial infection. 
19. Subject has a current clinically significant viral infection. 
20. Subject has a known clinically significant chronic viral infection (eg, human T cell 
lymphotropic virus I or II). 
21. Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville 
orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products 
within 48 hours before the first dose of study drug or throughout the study. 
22. Subject has used any prescription (excluding hormonal birth control) or over-the-counter 
medication (including herbal or nutritional supplements) within 14 days before the first 
dose of study drug. 


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23. Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids including 
oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose 
inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the 
preceding 1 month (low-dose [≤800 mcg/day of beclomethasone dipropionate or 
equivalent] inhaled and topical steroids are allowed). 
24. Subject has donated >450 mL blood or blood components within 30 days before the first 
dose of study drug. The investigator should instruct subjects who participate in this study 
to not donate blood or blood components for 4 weeks after the completion of the study. 
25. Subject is a smoker or has used nicotine or nicotine-containing products (eg, cigarettes, 
electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine 
gum) within 6 months before the first dose of study drug. 
26. Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo juice, 
or alcohol within 72 hours before the first dose of study drug. 
27. Subject reports participation in strenuous activity or contact sports within 24 hours before 
the first dose of study drug. 
28. Subject has known hepatitis B or C infection or positive test for hepatitis B surface 
antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 
antibodies at screening. 
29. Subject has a positive test result for amphetamines (including methamphetamines and 
ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids 
(including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin, codeine, 
and oxycodone), or alcohol at screening or check-in. 
30. Subject has any of the following laboratory test results within 28 days before the first 
dose of study drug: 
• Estimated serum creatinine clearance (Cockcroft-Gault) <90 mL/min 
• Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper 
central laboratory reference range) 
• Hemoglobin ≤10% of the lower central laboratory reference range 
• White blood cell count not within the central laboratory reference range 
• Absolute neutrophil count <1000 cells/mm3 
• Platelets not within ±10% of central laboratory reference range 
• Alanine aminotransferase >1.5 times above the upper central laboratory reference 
range 
• Aspartate aminotransferase >1.5 times above the upper central laboratory reference 
range 
• Alkaline phosphatase >20% above the upper central laboratory reference range 
• Hemoglobin A1c ≥7.0% 
• Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL. 
31. Subject has a blood pressure considered to be clinically significant by the investigator. 
Blood pressure may be retested twice in the sitting position at 5-minute intervals. 


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32. Subject has a resting heart rate of <40 beats per minute or >100 beats per minute at 
screening. 
33. Subject has an abnormal ECG at screening that is determined by the investigator to be 
clinically significant. 
34. Male subject has a QTcF >450 ms or female subject has a QTcF >470 ms at screening or 
Day –1. 
35. In the opinion of the investigator, the subject is not suitable for entry into the study. 
EVALUATION PROCEDURES: 
Pharmacokinetic Assessments: 
Blood samples for PK analysis of TPOXX will be collected from all subjects on Day 1 before 
study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 
20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours 
after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the 
PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on 
Day 9 (48 hours after the AM dose on Day 7). 
For PK samples, the acceptable window for collection from the scheduled collection time 
point will be as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes 
for the 12- to 48-hour time points. 
The following plasma PK parameters will be calculated for TPOXX using actual sampling 
times rather than scheduled sampling times and will include but are not limited to:  
• Area under the plasma concentration-time curve (AUC) from time 0 to the last 
quantifiable measurement (AUC0-t) 
• AUC from time 0 extrapolated to infinity (AUC0-∞) 
• AUC from time 0 to 24 hours (AUC0-24) 
• AUC during the first dosing interval (tau = 12 hours) (AUC0-tau) 
• Maximum drug concentration in plasma (Cmax) 
• Time to Cmax (Tmax) 
• Apparent volume of distribution (Vd/F) 
• Apparent total body clearance (CL/F) 
• Concentration observed prior to the next dose administration (Ctrough) 
• Terminal elimination half-life (t1/2) 
• Terminal elimination rate constant (λz) 
• Percentage of AUC0-∞ extrapolated from the last quantifiable measurement to infinity 
(%AUCextrap). 


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Safety Assessments: 
Safety and tolerability will be assessed by monitoring and recording of AEs, clinical 
laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body 
temperature), 12-lead ECG results, and physical examination findings. 
STUDY DRUG, DOSAGE, AND ROUTE OF ADMINISTRATION: 
TPOXX, 600 mg (3 × 200-mg capsules), will be administered orally twice daily, 
approximately 12 hours (±30 minutes) apart, on Days 1 through 7. 
STATISTICAL METHODS: 
Complete, detailed statistical methods will be described in the statistical analysis plan. 
Sample Size: 
The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study is 
based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size is considered sufficient to effectively assess the PK and safety 
profiles of TPOXX. 
Analysis Populations: 
• The Safety Population will include all subjects who receive at least 1 dose of study drug. 
• The PK Population will include subjects who receive study drug and have sufficient 
concentration data to facilitate the calculation of PK variables. 
Pharmacokinetic Analyses: 
Individual plasma concentration and time deviation data will be presented in a data listing. 
Plasma concentration data will be listed and summarized using the following descriptive 
statistics: number of subjects, arithmetic mean, standard deviation (SD), coefficient of 
variation (CV), geometric mean, geometric CV, median, minimum, and maximum. Individual 
and mean plasma concentration versus time profiles will be presented in figures on both 
linear and semilogarithmic scales. 
The PK parameters of TPOXX will be analyzed based on the actual sampling times. All 
parameters will be determined using noncompartmental methods using Phoenix® 
WinNonlin® Version 8.0 or higher (Certara, L.P., Princeton, New Jersey) or SAS® Version 9.4 
or higher (SAS Institute Inc., Cary, North Carolina). 
The individual PK parameters and weight-normalized PK parameters will be presented in 
data listings and summarized using the following descriptive statistics: number of subjects, 
arithmetic mean, SD, CV, median, minimum, maximum, geometric mean, geometric SD, and 
geometric CV. 
Safety Analyses: 
Adverse events will be coded by preferred term and system organ class using the latest 
version of the Medical Dictionary for Regulatory Activities and summarized overall. All AE 
data will be presented in a data listing. Treatment-emergent AEs will be summarized overall, 
as well as by severity and relationship to study drug. Serious AEs and AEs leading to 


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discontinuation of study drug will also be presented in the data listings and summarized 
overall. 
Actual values and changes from baseline for clinical laboratory test results, vital sign 
measurements, and 12-lead ECG results will be summarized at each time point using 
descriptive statistics (number of subjects, mean, SD, median, minimum, and maximum). 
Shift tables will be generated for clinical laboratory test results. Clinical laboratory data, vital 
sign measurements, 12-lead ECG results, and physical examination findings will be 
presented in data listings. 
DATE OF PROTOCOL: 02 August 2019 


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1. 
INTRODUCTION 
1.1 
BACKGROUND 
Historically, variola virus (VARV), the etiologic agent of smallpox, has been one of the more 
important human pathogens. Smallpox is highly communicable and carries exceptionally 
high morbidity. Secondary attack rates from 30% to 80% have been reported among 
unvaccinated members of households.1 Mortality rates range from 1% for variola minor to 
30% for variola major.1 With the advent of biowarfare as an instrument of terrorism, 
smallpox can no longer be thought of as a disease only of historic impact.  
In July 2018, the FDA approved the oral formulation of TPOXX for the treatment of patients 
with human smallpox disease caused by VARV.  
1.2 
RATIONALE FOR STUDY 
This study is being conducted as an FDA post marketing commitment to the approved New 
Drug Application for TPOXX. SIGA is required to conduct a study to determine the 
pharmacokinetic (PK) profile of TPOXX in subjects with a body weight greater than 
120 kilograms (>120 kg) to determine if a change in dosing regimen would be needed in 
these patients. 
1.3 
POTENTIAL RISKS AND BENEFITS 
1.3.1 
Potential Risks 
The effect of TPOXX on a fetus or nursing baby is not yet known; therefore, women of 
childbearing potential participating in this study will be required to agree to use an acceptable 
means of birth control from 30 days before the first dose of study drug and continuing 
through 30 days after the last dose of study drug. Pregnancy testing will be performed at the 
screening visit and checked by the investigator for negative pregnancy before administration 
of study drug on Day –1. Women who are pregnant or lactating or plan to become pregnant 
within 3 months after study drug administration will be excluded from the study; if a female 
subject becomes pregnant during study participation, study drug dosing will be discontinued, 
and the subject will be withdrawn from the study (Section 6.2.1.9). 
As with all drugs, there is potential risk of an allergic reaction. At this time, there is no 
definitive information on the allergic activity of TPOXX. Headache and nausea have been 
the most common AEs in clinical studies completed to date. There may be other side effects 


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of TPOXX that are not yet known. Full details can be found in the TPOXX full prescribing 
information.2 
1.3.2 
Known Potential Benefits 
As this study will be conducted in subjects free from smallpox, no direct health benefits from 
taking the study drug are expected. Study subjects may benefit from receiving the laboratory 
testing, ECGs, and physical examinations. Others may benefit from knowledge gained in this 
study that may aid in the development of a drug for the treatment of smallpox.  
2. 
STUDY OBJECTIVES 
2.1 
PRIMARY OBJECTIVE 
The primary objective of this study is to determine the PK profile of 600 mg oral TPOXX 
(3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing 
more than 120 kg to determine if a change in dosing regimen would be needed in these 
patients. 
2.2 
SECONDARY OBJECTIVE 
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral 
TPOXX administered BID for 7 days in adult subjects weighing more than 120 kg. 
3. 
STUDY POPULATION 
Approximately 36 male and female subjects will be enrolled at a single center in the United 
States to achieve at least 32 evaluable enrolled subjects. 
3.1 
INCLUSION CRITERIA 
Each subject must meet all the following criteria to be enrolled in this study: 
 Subject is male or female between 18 and 50 years of age, inclusive. 
 Subject has a body weight >120 kg at screening, at check-in on Day -1, and prior to 
dosing on Day 1. 
 Women of childbearing potential, have a negative β human chorionic gonadotropin 
pregnancy test (serum) at the screening visit and a confirmatory negative serum 


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pregnancy test on Day –1 before receipt of study drug, and meet 1 of the following 
criteria: 
 The subject or their partner has undergone surgical sterilization 
 The subject is postmenopausal, defined as 12 consecutive months with no menses 
without an alternative medical cause and has a documented plasma 
follicle-stimulating hormone level >40 IU/mL 
 The subject agrees to be abstinent (ie, heterosexually inactive or women in a 
religious order) 
 The subject agrees to consistently use 1 of the following methods of contraception 
from the beginning of screening (which they had been consistently using for at 
least 30 days before the first dose of study drug) through 30 days after the last 
dose of study drug: 
i. 
Condoms, male or female, with a spermicide 
NOTE: For male subjects, condoms must be used for 90 days after the last 
dose of study drug. 
ii. 
Diaphragm or cervical cap with spermicide 
iii. 
Intrauterine device with spermicide 
iv. 
Oral contraceptives or other hormonal methods 
NOTE: Subject must agree to use an additional nonhormonal method of 
contraception in conjunction with oral contraceptives. 
v. 
Male sexual partner who had undergone a vasectomy at least 3 months before 
screening. 
 Male subjects must agree to not donate sperm from the first dose of study drug 
through 90 days after the last dose of study drug. 
 Subject is considered by the investigator to be in good general health as determined 
by medical history (no hospitalizations for chronic medical conditions in the 
previous 2 years), clinical laboratory results, vital sign measurements, 12-lead ECG 
results, and physical examination findings at screening. 
 Subject agrees to comply with all protocol requirements. 
 Subject is able to provide written informed consent. 
 Subject agrees to comply with the dietary requirements. 


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 Subject does not intend to lose weight (diet or weight loss) from the screening visit 
and throughout the study. 
3.2 
EXCLUSION CRITERIA 
Subjects meeting any of the following criteria will be excluded from the study: 
 Subject is a female who is pregnant or breastfeeding or planning to become 
pregnant within 3 months after the last dose of study drug. 
 Subject has a history of any clinically significant conditions including: 
• Asthma treated with oral systemic steroids within the past 6 months 
• Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes 
• Thyroidectomy or thyroid disease that required medication within the past 
12 months 
• Serious angioedema episodes within the previous 3 years or requiring medication 
in the previous 2 years 
• Head trauma resulting in a diagnosis of traumatic brain injury other than 
concussion 
• Frequent episodes of headache. 
 Subject has received treatment in another clinical study of an investigational drug 
(or medical device) within 30 days or 5 half-lives (whichever is longer) before the 
first dose of study drug. 
 Subject has been previously enrolled in any clinical study involving TPOXX 
(tecovirimat). 
 Subject has a history of relevant drug and/or food allergies (ie, allergy to 
tecovirimat or excipients, or any significant food allergy that could preclude a 
standard diet in the study site). 
 Subject has any condition possibly affecting drug absorption (eg, previous surgery 
on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, 
gallbladder, or pancreas, with the exception of appendectomy). 
 Subject has evidence or history of clinically significant allergic (except for 
untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), 
hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, 
psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild 


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joint disease unassociated with collagen vascular disease) may be made following 
discussions with the medical monitor. 
 Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, 
syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, 
hypokalemia). 
 Subject has a family history of sudden cardiac death not clearly due to acute 
myocardial infarction. 
 Subject has a seizure disorder or history of seizures (does not include childhood 
febrile seizures) or a past history that increases seizure risks such as significant 
head injury that caused loss of consciousness or other changes in the subject’s daily 
function, concussion, stroke, central nervous system infection or disease, or alcohol 
or drug abuse or family history of idiopathic seizures. 
 Subject has a history of a peptic ulcer or significant gastrointestinal bleed. 
 Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, 
coagulopathy, or platelet disorder requiring special precautions) or significant 
bruising or bleeding difficulties with blood draws. 
 Subject has a malignancy that is active, or treated malignancy for which there is not 
reasonable assurance of sustained cure, or malignancy that is likely to recur during 
the period of the study (subject should be in complete remission for at least 
5 years). 
 Subject has neutropenia or other blood dyscrasia determined to be clinically 
significant by the investigator. 
 Subject has used any of the following prohibited medications from within 7 days 
(or 5 half-lives, whichever is longer) before the first dose of study drug: 
antidiabetic medication; anticoagulants; anticonvulsants; substrates of the BCRP 
transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, 
rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including 
repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of 
CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, 
voriconazole, lansoprazole, and omeprazole. Medications not listed here that are 
known (or thought) to be CYP3A4 substrates may be allowed at the investigator’s 
discretion, after consultation with the medical monitor, if administration poses little 
to no risk to the subject. 


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 Subject has a history of drug or alcohol abuse or dependency within the last year 
before screening. 
 Subject has a history of an eating disorder. 
 Subject has a current or recent (<30 days before screening) history of clinically 
significant bacterial, fungal, or mycobacterial infection. 
 Subject has a current clinically significant viral infection. 
 Subject has a known clinically significant chronic viral infection (eg, human T cell 
lymphotropic virus I or II). 
 Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville 
orange-containing products (eg, marmalade), or caffeine- or xanthine-containing 
products within 48 hours before the first dose of study drug or throughout the study. 
 Subject has used any prescription (excluding hormonal birth control) or 
over-the-counter medication (including herbal or nutritional supplements) within 
14 days before the first dose of study drug. 
 Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids 
including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or 
high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or 
equivalent) within the preceding 1 month (low-dose [≤800 mcg/day of 
beclomethasone dipropionate or equivalent] inhaled and topical steroids are 
allowed). 
 Subject has donated >450 mL blood or blood components within 30 days before the 
first dose of study drug. The investigator should instruct subjects who participate in 
this study to not donate blood or blood components for 4 weeks after the 
completion of the study. 
 Subject is a smoker or has used nicotine or nicotine-containing products (eg, 
cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine 
patches, or nicotine gum) within 6 months before the first dose of study drug. 
 Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo 
juice, or alcohol within 72 hours before the first dose of study drug. 
 Subject reports participation in strenuous activity or contact sports within 24 hours 
before the first dose of study drug. 


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 Subject has known hepatitis B or C infection or positive test for hepatitis B surface 
antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 
antibodies at screening. 
 Subject has a positive test result for amphetamines (including methamphetamines 
and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, 
cannabinoids (including tetrahydrocannabinol), cocaine metabolites, opiates 
(including heroin, codeine, and oxycodone), or alcohol at screening or check-in. 
 Subject has any of the following laboratory test results within 28 days before the 
first dose of study drug: 
• Estimated serum creatinine clearance (Cockcroft-Gault) <90 mL/min 
• Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper 
central laboratory reference range) 
• Hemoglobin ≤10% of the lower central laboratory reference range 
• White blood cell count not within the central laboratory reference range 
• Absolute neutrophil count <1000 cells/mm3 
• Platelets not within ±10% of central laboratory reference range 
• Alanine aminotransferase >1.5 times above the upper central laboratory reference 
range 
• Aspartate aminotransferase >1.5 times above the upper central laboratory 
reference range 
• Alkaline phosphatase >20% above the upper central laboratory reference range 
• Hemoglobin A1c ≥7.0% 
• Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL. 
 Subject has a blood pressure considered to be clinically significant by the 
investigator. Blood pressure may be retested twice in the sitting position at 5-
minute intervals. 
 Subject has a resting heart rate of <40 beats per minute or >100 beats per minute at 
screening. 
 Subject has an abnormal ECG at screening that is determined by the investigator to 
be clinically significant. 
 Male subject has a QTcF >450 ms or female subject has a QTcF >470 ms at 
screening or Day –1. 
 In the opinion of the investigator, the subject is not suitable for entry into the study. 


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3.3 
OTHER SCREENING CONSIDERATIONS 
3.3.1 
Subject Restrictions During the Study 
• Subjects must be willing to remain confined at the study site from check-in (Day –1) until 
safety assessments are completed on Day 9. 
• Subjects who have abnormal physical examination findings or an ongoing AE/SAE on 
Day 9 that is deemed related to study drug or per investigator or SIGA discretion will 
return to the study site on Day 14 (+2 days) for a follow-up visit. 
3.4 
WITHDRAWAL OF SUBJECTS FROM THE STUDY 
3.4.1 
Reasons for Withdrawal 
Subjects can withdraw consent and discontinue from the study at any time, for any reason, 
without prejudice to further treatment. 
The investigator may withdraw a subject from the study for any of the following: 
• The subject is in violation of the protocol. 
• The subject experiences a serious or intolerable AE. 
• The subject becomes pregnant. 
• The subject is noncompliant. 
• The subject has laboratory abnormalities for assessments listed in 
Sections 4.1 or 4.2 that meet Grade 3 or Grade 4 on the Division of 
Acquired Immune Deficiency Syndrome (DAIDS) AE Grading Table 
Version 2.1 July 2017, any other Grade 3 or Grade 4 AE; or a Grade 2 or 
higher rash considered by the investigator to be possibly, probably, or 
definitely related to study drug. 
• The subject develops, during the course of the study, symptoms or conditions listed in 
the exclusion criteria. 
• The subject requires a medication prohibited by the protocol. 
• The subject requests an early discontinuation for any reason. 
• The subject’s primary care provider requests that the subject be withdrawn. 


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• The independent safety monitor (ISM), SIGA, or the FDA requests subject 
withdrawal based on study safety findings. 
The investigator can also withdraw a subject upon the request of SIGA or if SIGA terminates 
the study. Upon occurrence of a SAE or intolerable AE, the investigator will confer with 
SIGA. If a subject is discontinued because of an AE, the event will be followed until it is 
resolved or stabilized as determined by the investigator and/or the medical monitor. 
3.4.2 
Handling of Withdrawals 
Subjects are free to withdraw from the study at any time upon request. Subject participation 
in the study may be stopped at any time at the discretion of the investigator or at the request 
of SIGA. 
When a subject withdraws from the study, the reason(s) for withdrawal will be recorded by 
the investigator in the electronic case report form (eCRF). Whenever possible, any subject 
who withdraws from the study prematurely will undergo all Day 9/early discontinuation 
assessments (Table 9-1). Any subject who fails to return for final assessments will be 
contacted by the study site personnel in an attempt to have them comply with the protocol. 
The status of subjects who fail to complete final assessments will be documented in the 
eCRF. 
3.4.3 
Halting Rules 
The medical monitor, investigator, SIGA, and ISM will review all AEs. All AEs determined 
by the investigator to be severe and possibly, probably, or definitely related to study drug, as 
well as all clinical assessments, laboratory test results, ECG results, or vital sign 
measurements that meet Grade 3 criteria on the DAIDS AE Grading Table will be assessed 
by the medical monitor, who will make a recommendation as to whether or not halting of the 
study should occur. At the discretion of the medical monitor, depending on the assessment of 
the severity of the event, the recommendation to halt the study may be made after 
consultation with the investigator, SIGA, and the ISM. 
The study will be temporarily halted (no new enrollments and no further study drug 
administration) by the investigator and the medical monitor, SIGA, and the ISM will be 
promptly notified according to the following criteria: 
• One subject experiences a Grade 4 AE assessed as possibly, probably, or definitely 
related to study drug. 


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• There is a subject death assessed as possibly, probably, or definitely related to study 
drug. 
• One subject experiences a seizure assessed as possibly, probably, or definitely 
related to study drug. 
• Two or more subjects experience the same or similar SAEs that are possibly, 
probably, or definitely related to the study drug. 
• Three or more subjects experience the same or similar AEs that are Grade 3 or 
above and are possibly, probably, or definitely related to the study drug. 
Study enrollment and study drug administration would resume if review of the AEs that 
caused the halt resulted in a recommendation to permit further continuation. In such an 
instance, SIGA, with participation by the investigator and the medical monitor, would consult 
with the ISM to conduct the review of all AEs that meet the criteria for halting the study. The 
study would remain suspended until the events were reviewed by the ISM and a 
recommendation was made as to whether the study should be continued or stopped. This 
constitutes a minimum criterion, and the decision to halt the study may be made based on any 
other criteria that, in the judgment of the investigator, with agreement of the medical monitor 
and ISM, indicate a potentially serious safety concern. The investigator will advise SIGA 
immediately if any of the halting rules are met. 
4. 
STUDY DESIGN 
This is an open-label, multiple-dose study to assess the safety, tolerability, and PK of TPOXX 
600 mg BID when administered orally for 7 days to adult subjects weighing more than 
120 kg. A total of 36 subjects, ages 18 to 50, inclusive, will be enrolled. The study will 
consist of a screening period (Day –28 to Day –2), a treatment and confinement period 
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]).  
Subjects will undergo screening evaluations to determine eligibility within 28 days before 
study drug administration. Subjects will be admitted to the study site on Day –1 to complete 
baseline assessments; results of these assessments must be reviewed by the investigator 
before dosing. Starting in the morning of Day 1, subjects will receive 600 mg oral TPOXX 
BID for 7 days (Days 1 through 7). 
All subjects will be provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration and subjects must fast for 2 hours after taking 


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study drug. Subjects should eat this meal within 30 minutes or less of taking study drug. 
Study drug and meals must be taken with water only, and no other beverage except water 
should be ingested within 3 hours before or 3 hours after study drug administration. 
Subjects will remain confined to the study site for collection of PK samples and will be 
carefully monitored for safety and tolerability until discharge on Day 9. Subjects who have 
abnormal physical examination findings or an ongoing adverse event (AE)/serious adverse 
event (SAE) on Day 9 that is deemed related to study drug or per investigator or SIGA 
discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All other 
subjects will have the Day 14 (+2 days) follow-up via telephone. All subjects will have a 
follow-up telephone call 30 days after administration of the last dose of study drug 
(Day 37 [+2 days]) to report any SAEs. At the time of discharge from the clinical research 
unit, subjects will be instructed to notify the investigator of any SAEs that occur within 30 
days after administration of the last dose of study drug. Serious AEs will be followed until 
the SAE is stable or until resolution as determined by the investigator and/or medical 
monitor. 
The total duration of the study for each subject, including the screening period, treatment 
period, and the Day 37 (+2 days) follow-up telephone call, will be approximately 65 days. 
4.1.1 
Replacements 
At the discretion of the investigator, and after consultation with the medical monitor, any 
subject who withdraws before completing the study may be replaced to retain the target of 
32 evaluable enrolled subjects. 
5. 
STUDY TREATMENT 
5.1 
TREATMENT ADMINISTERED 
On Days 1 to 7, all subjects will receive an oral dose of TPOXX 600 mg (3 × 200-mg 
capsules) BID, approximately 12 hours (±30 minutes) apart, for 7 days. 
All subjects will be provided meals consisting of approximately 600 calories and 25 g fat, 
30 minutes before study drug administration. Subjects should eat this meal within 30 minutes 
or less of taking study drug. Study drug will be administered approximately 30 minutes after 
the start of the meal. All doses of study drug will be administered to subjects by study site 
personnel with approximately 240 mL of water. Subjects must fast 2 hours after taking study 


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drug. Study drug and meals must be taken with water only, and no other beverage except 
water should be ingested within 3 hours before or 3 hours after study drug administration. 
5.2 
STUDY DRUG 
TPOXX will be supplied as 200-mg capsules containing tecovirimat monohydrate as the 
active pharmaceutical ingredient. The TPOXX capsules are immediate release, size 0, orange 
and black, hard gelatin capsules containing white to off white powder. All inactive 
ingredients/excipients are generally recognized as safe and are United States 
Pharmacopeia/National Formulary grade. The TPOXX excipients are shown in Table 5-1. 
Table 5-1 
Excipients of TPOXX Capsules 
Component 
Quality Designation 
Microcrystalline cellulose 
NFa 
Lactose monohydrate 
NF 
Croscarmellose sodium 
NFa 
Colloidal silicon dioxide 
NF 
Hydroxypropyl methylcellulose 
USP 
Sodium lauryl sulfate 
NF 
Purified waterb 
USP 
Magnesium stearate 
NF 
Abbreviations: NF, National Formulary; USP, United States Pharmacopeia. 
a Microcrystalline cellulose and croscarmellose sodium are added as intragranular and extragranular excipients. 
b Removed during processing. 
Compendial components are tested and released in accordance with full compendial methods 
and specifications before their use in clinical formulations. TPOXX 200-mg capsules are 
manufactured and analyzed for clinical use in accordance with Current Good Manufacturing 
Practices. 
TPOXX capsules are manufactured by: 
Catalent Pharma Solutions 
1100 Enterprise Drive 
Winchester, KY 40391. 
Further information on TPOXX can be found in the TPOXX full prescribing information.2 


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5.2.1 
Study Drug Packaging and Storage 
TPOXX capsules are packaged, labeled, distributed, and placed on stability testing in 
accordance with Current Good Manufacturing Practice and International Council for 
Harmonisation (ICH) guidelines. 
The 200-mg TPOXX capsules are supplied in 75-mL high density polyethylene bottles fitted 
with a heat induction seal and child-resistant screw cap closure system. Each bottle of study 
drug will contain 42 capsules and will be labeled with the drug name, SIGA’s name, a space 
to fill in the protocol number, and a space to fill in the bottle number. 
SIGA (or designee) will provide the investigator and study site with adequate quantities of 
TPOXX.  
All study drug must be stored in a secure area (eg, a locked cabinet), protected from moisture 
and light, and stored at 15°C to 30°C (59°F to 86°F). Study drug should not be refrigerated or 
used beyond the expiration dates provided by the manufacturer. The study site will be 
required to keep a temperature log to establish a record of compliance with these study drug 
storage conditions. All study drug will be kept in a secure cabinet or room with access 
restricted to necessary study site personnel. 
5.2.2 
Study Drug Accountability 
The investigator will maintain accurate records of receipt of all study drug, including dates of 
receipt. Accurate records will be kept regarding when and how much study drug is dispensed 
and used by each subject in the study. Reasons for departure from the expected dispensing 
regimen must also be recorded. Study drug accountability will be recorded in the subject 
source documentation, entered into the eCRF, and should be reviewed by the monitor during 
each monitoring visit. On a regular basis and at the completion of the study, to satisfy 
regulatory requirements regarding drug accountability, all study drug will be reconciled and 
retained or destroyed according to applicable regulations. 
5.3 
TREATMENT COMPLIANCE 
All doses of the study drug will be administered in the study site under direct observation of 
study site personnel and recorded in the eCRF. Per standard clinic procedure, study site 
personnel will perform a mouth check and inspect all dose containers to ensure that the entire 
dose was administered. Following completion of dosing procedures and return of dosing 
containers to the pharmacy by team members, pharmacy staff will follow standard clinic 


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procedures for study drug reconciliation. SIGA will provide information to PPD for 
destruction of returned used and unused study drug and study drug bottles. 
The date and time of study drug dosing will be captured and recorded on the appropriate page 
of the eCRF. If a subject is not administered study drug, the reason for the missed dose will 
be recorded. 
5.3.1 
Prior and Concomitant Medications 
Restrictions for prior and concomitant medications and therapies are provided in Sections 4.1 
and 4.2. Prior and concomitant medications and therapies will be coded using the latest 
version of the World Health Organization Drug Dictionary. 
5.3.1.1 
Prior Medications 
Information regarding prior medications taken by the subject within the 30 days before 
signing the informed consent form (ICF) will be recorded in the subject’s eCRF. 
5.3.1.2 
Concomitant Medications 
Any concomitant medication deemed necessary for the welfare of the subject during the 
study may be given at the discretion of the investigator. If a concomitant medication listed in 
Section 4.2 is taken it will be documented as a protocol deviation and a joint decision will be 
made by the investigator and SIGA to continue or discontinue the subject based on the time 
the medication was administered, its pharmacology and PK, and whether the use of the 
medication will compromise the safety of the subject or the interpretation of the data. The 
investigator is responsible for ensuring that details regarding the medication are adequately 
recorded in both the subject’s source document and the eCRF. 
6. 
STUDY PROCEDURES 
Before performing any study procedures, all potential subjects will sign an ICF as outlined in 
Section 9.3.2.3. Subjects will undergo study procedures at the time points specified in the 
schedule of events (Table 9-1). 
The total amount of blood collected from each subject over the duration of the study, 
including any extra assessments that may be required, will not exceed 500 mL. 


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6.1 
PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS 
Blood samples for PK analysis of TPOXX will be collected from all subjects Day 1 before 
study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 
20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours 
after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the 
PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on 
Day 9 (48 hours after the AM dose on Day 7). 
For PK samples, the acceptable window for collection from the scheduled collection time 
point will be as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes 
for the 12- to 48-hour time points. 
The following plasma PK parameters will be calculated for TPOXX using actual sampling 
times rather than scheduled sampling times and will include but are not limited to:  
• Area under the plasma concentration-time curve (AUC) from time 0 to the last 
quantifiable measurement (AUC0-t) 
• AUC from time 0 extrapolated to infinity (AUC0-∞) 
• AUC from time 0 to 24 hour (AUC0-24) 
• AUC during the first dosing interval (tau = 12 hours) (AUC0-tau) 
• Maximum drug concentration in plasma (Cmax) 
• Time to Cmax (Tmax) 
• Apparent volume of distribution (Vd/F) 
• Apparent total body clearance (CL/F) 
• Concentration observed prior to the next dose administration (Ctrough) 
• Terminal elimination half-life (t1/2) 
• Terminal elimination rate constant (λz) 
• Percentage of AUC0-∞ extrapolated from the last quantifiable measurement to infinity 
(%AUCextrap). 


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6.1.1 
Pharmacokinetic Sample Collection, Shipping, and Storage 
Blood samples (approximately 5 mL) for the determination of plasma concentrations of 
TPOXX will be collected in 5-mL lavender-topped K3EDTA Vacutainer® tubes using a 
21 gauge or larger needle, or from an indwelling intravenous catheter using a vacutainer tube. 
Blood samples should be placed on wet ice or equivalent (approximately 4°C to 8°C) and 
kept at this temperature until processed to separate plasma.  
The exact time and date of sample collection will be recorded for each sample by the 
investigator or designee on the subject’s eCRF, the vacutainer and cryovial labels, and the 
specimen shipping log. In addition, the time of study drug administration before PK sampling 
will be recorded on the subject’s eCRF. Labels will be created by the site and should contain 
the protocol number, matrix (plasma), subject number, date, and time drawn. For information 
that is not preprinted on the label, a fine tipped indelible marking pen is to be used to 
complete the entry. 
The 5-mL blood sample will be centrifuged in a refrigerated centrifuge immediately, if 
possible, or within 60 minutes of collection at 1000 to 1200 × g (2000 to 3000 rpm) for 
10 minutes to separate plasma. Each plasma sample should be transferred via pipette into 
2 cryovials labeled as described previously and should be capped tightly. The second tube 
will be a duplicate and retained at the site as a backup sample. If red blood cells are 
inadvertently drawn into the plasma, the sample should be re-centrifuged as soon as possible. 
Adequate space between the solution and the tube cap should be allowed for expansion 
during freezing.  
Cryovial tubes containing plasma samples must be frozen at –70°C or below until shipment 
in a freezer equipped with a temperature monitor and temperature-activated alarm. 
Uncentrifuged specimens should not be frozen. 
The study site will batch ship sets of frozen plasma samples. A log sheet listing the samples 
being shipped will be included in each shipment. The samples will be sent on dry ice via 
courier to Alturas Analytics (Moscow, ID). The back-up sets will remain at the site until 
confirmation that the first sets have been received. After receipt confirmation is received 
from Alturas Analytics, the back-up sets should be shipped. The site will contact Alturas 
Analytics and coordinate the shipment prior to sending the samples. Shipments before 
weekends or holidays must be avoided. 


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The samples will be shipped for analysis to:  
Alturas Analytics 
1324 Alturas Drive 
Moscow, ID 83843 
The bioanalytical laboratory will store all plasma samples at –70°C until analysis for 
tecovirimat is complete. SIGA will advise Alturas to destroy any remaining plasma samples 
after regulatory review is complete or the samples have met their applicable length of 
stability, whichever comes sooner. 
6.1.2 
Pharmacokinetic Sample Analysis 
Pharmacokinetic samples will be analyzed by Alturas Analytics using a validated liquid 
chromatography coupled with tandem mass spectrometry assay for tecovirimat in human 
plasma method in accordance with the US FDA Guidance for Industry on Bioanalytical 
Method Validation.3 
6.2 
SAFETY ASSESSMENTS AND ENDPOINTS 
Safety and tolerability will be assessed by monitoring and recording of AEs, clinical 
laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body 
temperature), 12-lead ECG results, and physical examination findings. Adverse events will 
be assessed from the time of the first dose of study drug until the follow-up telephone call on 
Day 37 (+2 days). 
6.2.1 
Adverse Events 
6.2.1.1 
Adverse Event Definitions 
The investigator is responsible for reporting all AEs that are observed or reported during the 
study, regardless of their relationship to study drug or clinical significance. If there is any 
doubt as to whether a clinical observation is an AE, the event should be reported. 
An AE is any event or other untoward medical occurrence, including those AEs that result 
from dosing errors, which may present during administration of a study drug or during a 
reasonable follow-up period and which does not necessarily have a causal relationship with 
this treatment. An AE is any unfavorable and unintended sign (eg, a clinically significant 


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abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal product, whether or not considered to be related to the medicinal product. All AEs 
will be followed until the AE is resolved or stabilized as determined by the investigator 
and/or the medical monitor. 
A treatment-emergent AE (TEAE) is defined as any event not present before exposure to 
study drug or any event already present that worsens in intensity or frequency after exposure 
to study drug. 
An adverse reaction is any AE caused by a drug. Adverse reactions are a subset of all 
suspected adverse reactions for which there are reasons to conclude that the drug caused the 
event. 
A suspected adverse reaction is any AE for which there is a reasonable possibility that the 
study drug caused the AE. For the purposes of IND safety reporting, “reasonable possibility” 
means that there is evidence to suggest a causal relationship between the drug and the AE. A 
suspected adverse reaction implies a lesser degree of certainty about causality than adverse 
reaction, which means any AE caused by a study drug. 
An AE or suspected adverse reaction is considered “unexpected” if it is not listed in the 
TPOXX full prescribing information or at the specificity or severity that has been observed 
with the study drug being tested. For example, under this definition, hepatic necrosis would 
be unexpected (by virtue of greater severity) if the TPOXX full prescribing information 
referred only to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism 
and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the TPOXX 
full prescribing information listed only cerebral vascular accidents. “Unexpected,” as used in 
this definition, also refers to AEs or suspected adverse reactions that are mentioned in the 
TPOXX full prescribing information as occurring with a class of drugs or as anticipated from 
the pharmacological properties of the drug, but are not specifically mentioned as occurring 
with the particular drug under investigation. 
An AE or suspected adverse reaction is considered an SAE if, in the view of either the 
investigator or SIGA, it results in any of the following outcomes: 
• Results in death. 
• Is life threatening (subject is at immediate risk of death at the time of the event). 
• Requires inpatient hospitalization or prolongation of existing hospitalization, other than 
elective hospitalization, during the period of protocol defined surveillance. 


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• Results in congenital anomaly or birth defect. 
• Results in a persistent or significant disability/incapacity. 
• Any other important medical event that may not result in death, be life threatening, or 
requires hospitalization may be considered an SAE when, based on appropriate medical 
judgment, the event may jeopardize the subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition or is otherwise 
considered to be medically significant. 
Important medical events that may not result in death, be life threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgement, 
they may jeopardize the subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. Examples of such medical events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of 
drug dependency or drug abuse. 
An AE or suspected adverse reaction is considered “life-threatening” if, in the view of either 
the investigator or SIGA, its occurrence places the subject at immediate risk of death. It does 
not include an AE or suspected adverse reaction that, had it occurred in a more severe form, 
might have caused death. 
Serious AEs will be followed until the SAE is stable or until resolution as determined by the 
investigator and/or the medical monitor. 
6.2.1.2 
Eliciting and Documenting Adverse Events 
The investigator is responsible for ensuring that all AEs and SAEs are recorded in the eCRF 
and reported to SIGA by PPD. Adverse events and SAEs will be assessed from the first dose 
of study drug through the telephone call on Day 37 (+2 days).  
At every study visit or assessment, subjects will be asked a standard question to elicit any 
medically related changes in their well-being. They will also be asked if they have been 
hospitalized, had any accidents, used any new medications, or changed concomitant 
medication regimens (both prescription and over-the-counter medications). 
In addition to subject observations, AEs will be documented from any data collected on the 
AE page of the eCRF (eg, laboratory values, physical examination findings, and ECG 
changes) or other documents that are relevant to subject safety. 


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6.2.1.3 
Reporting Adverse Events 
All AEs reported or observed from the first dose of study drug through the follow-up 
telephone call on Day 37 (+2 days) will be recorded on the AE page of the eCRF. 
Information to be collected includes drug treatment, type of event, date and time of onset, 
investigator-specified assessment of severity and relationship to study drug, date and time of 
resolution of the event, seriousness, as well as any required treatment or evaluations, and 
outcome. Adverse events resulting from concurrent illnesses, reactions to concurrent 
illnesses, reactions to concurrent medications, or progression of disease states must also be 
reported. 
All AEs will be followed until they are resolved or stabilized as determined by the 
investigator and/or medical monitor. These data will be reviewed on an ongoing basis by the 
study coordinator, the investigator, the medical monitor, and the ISM. This requirement 
indicates that for some events, follow-up may be required after the subject has completed 
study participation. These events will be reported by SIGA, as required, to the FDA. 
Any medical condition that is present at the time that the subject is screened but does not 
deteriorate should not be reported as an AE. However, if it deteriorates at any time during the 
study, it should be recorded as an AE. Prior to this, medical conditions reported by subjects 
are considered medical history. 
6.2.1.4 
Reporting of Serious Adverse Events 
Any AE considered serious by the investigator or which meets SAE criteria (Section 6.2.1.1), 
or any other event or condition regardless of grade, which in their judgment represents a 
reportable event, must be reported to the medical monitor and SIGA as soon as the 
investigator becomes aware of the event. In addition, the event must be reported to PPD via 
the SAE hotline. The PPD SAE Report Form must be submitted within 24 hours of 
knowledge of the event. SIGA (or designee) will be responsible for notifying the relevant 
regulatory authorities of any SAE as outlined in US Title 21 Code of Federal Regulations 
(CFR) Parts 312 and 320. The investigator is responsible for notifying the institutional 
review board (IRB) directly. 
In addition, the investigator (or designee) must report any Grade 3 (severe) AE that they 
deem possibly, probably, or definitely related to study drug to the medical monitor and SIGA 
within 24 hours after becoming aware of the event. 




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• Grade 3 (Severe): Events interrupt a subject’s usual daily activity, may require systemic 
drug therapy or other treatment, and are usually incapacitating. 
• Grade 4 (Life-threatening): Event that, in the opinion of the investigator, places the 
subject at immediate risk of death from the reaction as it occurred (ie, it does not include 
a reaction that, had it occurred in a more severe form, might have caused death). 
• Grade 5 (Death). 
Changes in the severity of an AE should be documented to allow an assessment of the 
duration of the event at each level of intensity to be performed. An AE characterized as 
intermittent requires documentation of onset and duration of each episode.  
6.2.1.6 
Assessment of Causality 
Any occurrence of an AE will be assessed for relationship to the study drug. A causal 
relationship means that the study drug caused (or is reasonably likely to have caused) the AE. 
This usually implies a relationship in time between the drug and the AE; for example, the AE 
occurred shortly after the subject received the study drug. 
The investigator who examines and evaluates the subject will determine AE causality based 
on the temporal relationship to administration of the study drug, the pharmacology of the 
study drug, and their clinical judgment. Terms used to describe the degree of causality 
between a study drug and an AE are definitely related, probably related, possibly related, 
unlikely related, or not related. 
The best estimate at the time of reporting of an event and the degree of certainty about the 
causal relationship between the study drug administration and the AE will be graded as 
follows: 
Associated 
• Definitely Related: The AE and administration of study drug are related in time, and a 
direct association can be demonstrated (eg, the event disappears or decreases with 
reduction in dose or cessation of study drug and recurs with re-exposure). 
• Probably Related: The AE and administration of study drug are reasonably related in time 
and/or follow a known pattern of response, and the AE is more likely explained by study 
drug than other causes. 


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• Possibly Related: The AE and administration of study drug are reasonably related in time 
and/or follow a known pattern of response, but the AE can be explained equally well by 
causes other than study drug (eg, could readily have been produced by the subject’s 
clinical state or could have been due to environmental or other interventions). 
Not Associated 
• Unlikely Related: A potential relationship between study drug and the AE could exist 
(ie, the possibility cannot be excluded), but the AE is most likely explained by causes 
other than the study drug (eg, could readily have been produced by the subject’s clinical 
state or could have been due to environmental or other interventions). 
• Not Related: The AE is clearly due to extraneous causes (eg, underlying disease, 
environment) or exposure to the study drug has not occurred. Such events MUST have an 
alternative, definitive etiology documented in the subject’s medical record. 
6.2.1.7 
Follow-up of Adverse Events 
All AEs must be reported in detail on the appropriate page of the eCRF and followed until 
they are resolved or stabilized as determined by the investigator and/or medical monitor. 
6.2.1.8 
Reactogenicity 
At this time, there is no definitive information on allergic activity of TPOXX. Reactogenicity 
will be monitored in subjects during the study treatment period. 
6.2.1.9 
Reporting of Pregnancy 
Pregnant women are not eligible to participate in the study. Subjects must be counseled 
regarding prevention of pregnancy and encouraged to make every effort to avoid pregnancy 
during study participation. If a female subject becomes pregnant during study participation, 
study drug dosing will be discontinued, and the subject will be withdrawn from the study. 
The pregnancy itself is not considered an SAE. However, the investigator must complete the 
pregnancy report form and fax it to PPD Pharmacovigilance within 24 hours of knowledge of 
the pregnancy. After delivery or termination of pregnancy, the follow-up pregnancy report 
form should be completed and submitted via fax to PPD Pharmacovigilance. Spontaneous 
abortions should always be reported as SAEs. Pregnancy data will be captured and followed 
by PPD. All pregnancies and outcomes will be tracked. The case will not be closed until after 
the child is followed for 3 months. 


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If there are complications during the pregnancy, the complications will be recorded as AEs in 
the usual manner. The subject will be asked to report the outcome of the pregnancy. If there is 
a congenital anomaly in the infant, this will be recorded as an SAE in the data forms for the 
mother (ie, the study subject). 
If a subject becomes pregnant during the study after receiving the study drug, all safety 
evaluations will be collected as per protocol. In addition, at the time that the pregnancy is 
reported, consent will be requested to contact the subject and her physician in the postpartum 
period to assess delivery and health status of the neonate. 
If the partner of a male subject becomes pregnant, the partner will be asked for consent to 
allow her treating physician to provide SIGA or its designee with follow-up information 
regarding the pregnancy and its outcome. 
6.2.2 
Clinical Laboratory Testing 
Clinical laboratory tests will be performed by the PPD Central Laboratory. Blood samples 
will be collected at the time points indicated in the schedule of events (Table 9-1) and will be 
prepared using standard procedures.  
Repeat clinical laboratory tests may be performed at the discretion of the investigator, if 
necessary, to evaluate inclusion and exclusion criteria or clinical laboratory abnormalities. 
PPD central laboratory will provide the reference ranges for all clinical laboratory safety 
parameters. 
The following clinical laboratory assessments will be performed: 
Hematology 
Hematocrit, hemoglobin, mean corpuscular hemoglobin, mean 
corpuscular hemoglobin concentration, total and differential 
leukocyte count (basophils, eosinophils, lymphocytes, monocytes, 
neutrophils), mean corpuscular volume, platelet count, red blood 
cell count, and red cell distribution width 
Serum Chemistry 
Alanine aminotransferase, albumin, alkaline phosphatase, anion 
gap, aspartate aminotransferase, bilirubin (total), blood urea 
nitrogen, calcium, carbon dioxide, chloride, creatinine clearance 
(calculateda), gamma-glutamyltransferase, globulin, glucose, lactate 
dehydrogenase, phosphorus, potassium, sodium, total protein, and 
uric acid 


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Urinalysis 
Appearance, bilirubin, blood, color, glucose, ketones, leukocytes, 
microscopy (performed if dipstick is ≥1+; includes bacteria, cast, 
crystals, epithelial cells, red blood cells, and white blood cells), 
nitrates, pH, protein, specific gravity, turbidity, and urobilinogen  
a Creatinine clearance (CLcr) will be calculated using the Cockcroft-Gault formula:  
𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶 (𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚
⁄
) = [140 −𝑎𝑎𝑎𝑎𝑎𝑎(𝑦𝑦𝑦𝑦𝑦𝑦𝑦𝑦𝑦𝑦)] × 𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤ℎ𝑡𝑡 (𝑘𝑘𝑘𝑘)
72 × 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐 (𝑚𝑚𝑚𝑚𝑑𝑑𝑑𝑑
⁄
) {× 0.85 𝑖𝑖𝑖𝑖 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓} 
Glycosylated hemoglobin A1c and a fasting lipid panel including cholesterol (total, 
high-density lipoprotein, calculated low-density lipoprotein, and triglycerides) will be 
performed at screening. 
Serum pregnancy test (β human chorionic gonadotropin) for women of childbearing potential 
will be performed at screening and on Day –1. 
A serum follicle-stimulating hormone test for postmenopausal women will be performed at 
screening.  
Human immunodeficiency virus (type 1 and 2) antibodies, hepatitis B surface antigen, and 
hepatitis C virus antibody will be assessed at screening only.  
A urine drug screen for alcohol, amphetamines (including methamphetamines and 
ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids 
(including tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, 
codeine, and oxycodone) will be performed at screening and on Day –1. 
Abnormal clinical laboratory values will be flagged as either high or low (or normal or 
abnormal) based on the reference ranges for each laboratory parameter. The investigator will 
determine whether any of the abnormally high or low results are clinically significant or not 
clinically significant. Clinical significance is defined as any variation in results that has 
medical relevance and may result in an alteration in medical care (eg, active observation, 
diagnostic measures, or therapeutic measures). If a clinically significant change from the 
screening value is noted, the clinically significant value and reason for clinical significance 
will be documented on the AE page of the eCRF. The investigator will continue to monitor 
the subject with additional assessments until the values have reached the reference range or 
the values at screening or until the investigator determines that follow-up is no longer 
medically necessary. 


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6.2.3 
Medical History 
A complete medical history will be obtained, including a review of systems, recreational and 
prescription drug use, over-the-counter drug use, nicotine and alcohol use, and past 
hospitalizations.  
6.2.4 
Vital Sign Measurements 
Vital signs will be measured after the subject has been seated for at least 5 minutes at the 
time points indicated in the schedule of events (Table 9-1). 
Vital sign measurements will include systolic and diastolic blood pressures, heart rate, 
respiratory rate, and body temperature.  
When procedures are overlapping and occurring at the same time point, the order of 
procedures should be ECG, vital sign measurements, and then blood collection, with the 
blood collection scheduled to occur at the nominal time point, unless dictated by other study 
events happening at that time, such as dosing requirements. 
The investigator will determine whether any of the vital sign measurements are clinically 
significant or not clinically significant. Clinical significance is defined as any variation in 
results that has medical relevance and may result in an alteration in medical care (eg, active 
observation, diagnostic measures, or therapeutic measures). If a clinically significant change 
from the screening values is noted, the clinically significant value and reason for clinical 
significance will be documented on the AE page of the subject’s eCRF. The investigator will 
continue to monitor the subject with additional assessments until the value has reached the 
reference range or the value at screening or until the investigator determines that follow up is 
no longer medically necessary. 
6.2.5 
Electrocardiograms 
A 12-lead ECG will be obtained after the subject has been in the supine position for at least 
10 minutes at the time points indicated in the schedule of events (Table 9-1). On Days 1, 4, 
and 7, an ECG will be recorded 4 hours after the AM study drug administration. The 
acceptable window for collection from the scheduled collection time point will ±15 minutes. 
Electrocardiogram assessments will include comments on whether the tracings are normal or 
abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence 
of myocardial infarction, or ST segment, T wave, and U wave abnormalities. In addition, the 


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following parameters will be measured and reported: heart rate; PR, RR, and QT intervals; 
QTcF; QT interval corrected using Bazett’s formula; and QRS duration. All ECGs must be 
performed by an experienced ECG technician. 
The investigator will determine whether any of the 12-lead ECG results are clinically 
significant or not clinically significant. Clinical significance is defined as any variation in 
results that has medical relevance and may result in an alteration in medical care (eg, active 
observation, diagnostic measures, or therapeutic measures). If a clinically significant change 
from screening is noted, the clinically significant value and reason for clinical significance 
will be documented on the AE page of the subject’s eCRF. The investigator will continue to 
monitor the subject with additional assessments until either the values have reached reference 
range or the values at screening or until the investigator determines that follow-up is no 
longer medically necessary. 
6.2.6 
Physical Examinations 
A full physical examination will be performed at the time points indicated in the schedule of 
events (Table 9-1) and will include assessment of the following body systems: head, ears, 
eyes, nose, and throat; cardiac (including auscultation of heart); pulmonary (chest) 
auscultation of lungs; abdomen; skin; musculoskeletal system; lymphatic system; and 
neurologic system (cranial nerves, sensation, motor function, coordination, reflexes, and 
mental status). 
A symptom-directed physical examination will be performed at the time points indicated in 
the schedule of events (Table 9-1) (for those subjects who require it), and at unscheduled 
visits as necessary. This examination will include an assessment of the heart, lungs, abdomen, 
a neurologic review, and a review of symptoms for assessments and/or follow-up of reported 
or potential AEs. 
Weight will be measured without shoes and in light clothing at screening and without shoes 
and in hospital gowns at all other time points indicated in the schedule of events (Table 9-1). 
The scales should be calibrated, and the same weight scale should be used throughout the 
study starting with Screening through Day 9.  Weight measurements will be rounded to one 
decimal place. 
Height will be measured at Check-in on Day -1.  


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6.2.7 
Unscheduled Visits 
Subjects will be provided with the contact information for the study site personnel. Subjects 
are free to contact study site personnel at any time, and the site may require an unscheduled 
visit for the purpose of physical examinations, laboratory tests, etc. Unscheduled visits will 
be documented by the site personnel in the source documents. Unscheduled procedures and 
laboratory tests and results will also be recorded in the eCRF. 
7. 
STATISTICAL ANALYSIS PLANS 
7.1 
SAMPLE SIZE CALCULATIONS 
The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study is 
based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size is considered sufficient to effectively assess the PK and safety 
profiles of TPOXX. 
7.2 
ANALYSIS POPULATIONS 
The Safety Population will include all subjects who receive at least 1 dose of study drug. 
The PK Population will include subjects who receive study drug and have sufficient 
concentration data to facilitate the calculation of PK variables. 
7.3 
STATISTICAL ANALYSIS 
Details of all statistical analyses will be described in a statistical analysis plan. All data 
collected will be presented in data listings. Data from subjects excluded from an analysis 
population will be presented in the data listings, but not included in the calculation of 
summary statistics. 
For categorical variables, frequencies and percentages will be presented. Continuous 
variables will be summarized using descriptive statistics (number of subjects, mean, median, 
standard deviation [SD], minimum, and maximum). 
Baseline demographic and background variables will be summarized overall for all subjects. 
The number of subjects who enroll in the study and the number and percentage of subjects 
who complete the study will be presented. Frequency and percentage of subjects who 
withdraw or discontinue from the study, and the reason for withdrawal or discontinuation, 
will also be summarized. 


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7.3.1 
Pharmacokinetic Analyses 
Individual plasma concentration and time deviation data will be presented in a data listing. 
Plasma concentration data will be listed and summarized using the following descriptive 
statistics: number of subjects, arithmetic mean, SD, coefficient of variation (CV), geometric 
mean, geometric CV, median, minimum, and maximum. Individual and mean plasma 
concentration versus time profiles will be presented in figures on both linear and 
semilogarithmic scales. 
The PK parameters of TPOXX will be analyzed based on the actual sampling times. All 
parameters will be determined using noncompartmental methods using Phoenix® 
WinNonlin® Version 8.0 or higher (Certara, L.P., Princeton, New Jersey) or SAS® Version 9.4 
or higher (SAS Institute Inc., Cary, North Carolina). 
The individual PK parameters and body weight-normalized PK parameters will be presented 
in data listings and summarized using the following descriptive statistics: number of subjects, 
arithmetic mean, SD, CV, median, minimum, maximum, geometric mean, geometric SD, and 
geometric CV. 
7.3.2 
Safety Analyses 
Adverse events will be coded by preferred term and system organ class using the latest 
version of the Medical Dictionary for Regulatory Activities and summarized overall. All AE 
data will be presented in a data listing. Treatment-emergent AEs will be summarized overall, 
as well as by severity and relationship to study drug. Serious AEs and AEs leading to 
discontinuation of study drug will also be presented in the data listings and summarized 
overall. 
Actual values and changes from baseline for clinical laboratory test results, vital sign 
measurements, and 12-lead ECG results will be summarized at each time point using 
descriptive statistics (number of subjects, mean, SD, median, minimum, and maximum). 
Shift tables will be generated for clinical laboratory test results. Clinical laboratory data, vital 
sign measurements, 12-lead ECG results, and physical examination findings will be 
presented in data listings. 


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7.4 
HANDLING OF BELOW THE LIMIT OF 
QUANTIFICATION AND MISSING DATA 
Plasma concentrations that are below the limit of quantification (BLQ) will be treated as zero 
for descriptive statistics. Geometric mean values will not be calculated or displayed when 
zero is the minimal value. Mean BLQ concentrations will be presented as BLQ, and the SD 
and CV will be reported as not applicable. Missing concentrations will be excluded from the 
calculations. 
7.5 
INTERIM ANALYSES 
No formal interim safety analyses will be performed in this study. 


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8. 
REFERENCE LIST 
1. Breman JG, Henderson DA. Diagnosis and management of smallpox. N Engl J Med. 
2002;346(17):1300-8.  
2. TPOXX (tecovirimat) [full prescribing information]. SIGA Technologies, Inc. Corvallis 
(OR); 2018. 18 p. 
3. Department of Health and Human Services, Food and Drug Administration (US). 
Guidance for Industry. Bioanalytical Method Validation. May 2018. Available from: 
https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-
for-Industry.pdf. 


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9. 
APPENDICES 
9.1 
APPENDIX 1: LIST OF ABBREVIATIONS 
Abbreviation 
Term 
%AUCextrap 
percentage of AUC0-∞ extrapolated from the last quantifiable 
measurement to infinity 
λz 
terminal elimination rate constant 
AE 
adverse event 
AUC 
area under the plasma concentration-time curve 
AUC0-24 
area under the plasma concentration-time curve from time 0 to 
24 hours 
AUC0-∞ 
area under the plasma concentration-time curve from time 0 
extrapolated to infinity 
AUC0-t 
area under the plasma concentration-time curve from time 0 to the 
last quantifiable measurement 
AUC0-tau 
area under the plasma concentration-time curve during the first 
dosing interval 
BCRP 
breast cancer resistance protein 
BID 
twice daily 
BLQ 
below the limit of quantification 
CFR 
Code of Federal Regulations 
CL/F 
apparent total body clearance 
Cmax 
maximum drug concentration in plasma 
Ctrough 
concentration observed prior to the next dose administration 
CRA 
clinical research associate 
CV 
coefficient of variation 
CYP 
cytochrome P450 
DAIDS 
Division of Acquired Immune Deficiency Syndrome 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
FDA 
Food and Drug Administration 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IRB 
institutional review board 
ISM 
independent safety monitor  
MedDRA 
Medical Dictionary for Regulatory Activities 
PK 
pharmacokinetic(s) 
QTcF 
QT interval corrected using Fridericia’s formula 
SAE 
serious adverse event 
SD 
standard deviation 
SOP 
standard operating procedures 
t1/2 
terminal elimination half-life 
TEAE 
treatment-emergent adverse event 


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Abbreviation 
Term 
Tmax 
time to maximum drug concentration in plasma 
UGT 
uridine diphosphate-glucuronosyltransferase 
VARV 
variola virus 
Vd/F 
apparent volume of distribution 


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9.2 
APPENDIX 2: SCHEDULE OF EVENTS 
Table 9-1 
Schedule of Events 
 Screening Check-in 
Treatment Period 
Telephone Call 
or Follow-up 
Visit(a) 
Follow-up 
Telephone 
Call(b) 
Procedure(c) 
Day –28 to –2 
–1 
1 
2 
3 
4 
5 
6 
7 
8 
9 or Early 
Discontinuation  
14 (+2) 
  
37 (+2) 
Admission to clinic 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Discharge from clinic(d) 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical history(e) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Complete physical examination(f) 
X 
X 
 
 
 
 
 
 
X 
 
X 
 
 
Weight(g) 
X 
X 
X(h) 
 
 
 
 
 
 
 
X 
 
 
Height 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Vital sign measurements(i) 
X 
X 
X(j) 
 
 
X(j) 
 
 
X(j) 
X 
X 
X(k) 
 
Glycosylated hemoglobin (HbA1c) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Fasting lipid panel(l) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical laboratory testing(m) 
X(n) 
X 
 
 
 
X 
 
 
 
X(o) 
X(n) 
 
 
Serum follicle-stimulating 
hormone(p) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Serum pregnancy test(q) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Urine drug/alcohol screen(r) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Serology (HBsAg, HCV, and HIV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
12-Lead ECG(s) 
X 
X 
X 
 
 
X 
 
 
X 
 
X 
 
 
TPOXX administration(t) 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Pharmacokinetic sampling(u) 
 
 
X 
X 
 
 
 
X 
X 
X 
X 
 
 
Symptom-directed physical 
examination(v) 
 
 
 
X 
X 
X 
X 
X 
 
 
 
X(k) 
 
Adverse events 
 
 
X 
Prior/concomitant medications 
X 
Abbreviations: AE, adverse event; ECG, electrocardiogram; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; 
PK, pharmacokinetic; SAE, serious adverse event. 


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Notes: 
(a) The follow-up visit or telephone call will occur on Day 14 (+2 days), 7 days after the last dose of study drug. Subjects who have abnormal physical examination findings or an 
ongoing AE/SAE on Day 9 that is deemed related to study drug or per investigator or SIGA discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All 
other subjects will have the Day 14 (+2 days) follow-up via telephone.  
(b) The follow-up telephone call will be made 30 days after the last dose of study drug (Day 37 [+2 days]). 
(c) When procedures are overlapping and occurring at the same time point, the order of procedures should be ECG, vital sign measurements, and then blood collection, with the 
blood collection scheduled to occur at the nominal time point, unless dictated by other study events happening at that time, such as dosing requirements. 
(d) Discharge following collection of all safety assessments. 
(e) Including a review of systems; recreational, prescription, and over-the-counter drug use; nicotine and alcohol use; and past hospitalizations. 
(f) Including assessment of the following body systems: head, ears, eyes, nose, and throat; cardiac (including auscultation of heart); pulmonary (chest) auscultation of lungs; 
abdomen; skin; musculoskeletal system; lymphatic system; and neurologic system (cranial nerves, sensation, motor function, coordination, reflexes, and mental status). 
(g) Weight will be measured without shoes and in light clothing at screening and without shoes and in hospital gowns at all other time points. The scales should 
be calibrated and the same weight scale should be used throughout the study starting with Screening through Day 9.  Weight measurements will be rounded to 
one decimal place. 
(h) Weight will be collected prior to dosing. 
(i) Vital sign measurements will include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Vital signs will be measured after the subject has 
been seated for at least 5 minutes.  
(j) Vital sign measurements will be performed before dosing and 4 hours after the AM study drug administration on Days 1 and 7 and 4 hours after the AM study drug 
administration on Day 4. The acceptable window for collection from the scheduled collection time point is ±15 minutes. 
(k) Collected only if subjects are required to return to the study site on Day 14 (+2 days) for a follow-up visit. 
(l) Including cholesterol (total, high-density lipoprotein, calculated low-density lipoprotein, and triglycerides). 
(m) Clinical laboratory testing will include hematology and serum chemistry.  
(n) Clinical laboratory testing at screening and at Day 9 or early discontinuation will include hematology, serum chemistry, and urinalysis. 
(o) Collect 12 hours after the PM study drug administration on Day 7.  
(p) For postmenopausal women, a serum follicle-stimulating hormone test will be performed at screening. 
(q) Women of childbearing potential only. 
(r) Includes alcohol, amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids (including 
tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, codeine, and oxycodone). 
(s) A 12-lead ECG will be collected after the subject has been in the supine position for at least 10 minutes. On Days 1, 4, and 7, an ECG will be recorded 4 hours after the AM 
study drug administration. The acceptable window for collection from the scheduled collection time point is ±15 minutes. 
(t) TPOXX, 600 mg (3 × 200-mg capsules) will be administered orally twice daily, approximately 12 hours (± 30 minutes) apart on Days 1 through 7. All subjects will be 
provided meals consisting of approximately 600 calories and 25 g fat, which will start 30 minutes before study drug administration. Subjects should eat this meal within 30 
minutes or less of taking study drug. Study drug will be administered approximately 30 minutes after the start of the meal. All doses of study drug will be administered to 
subjects by study site personnel with approximately 240 mL of water. Subjects must fast 2 hours after taking study drug. Study drug and meals must be taken with water only, 
and no other beverage except water should be ingested within 3 hours before or 3 hours after study drug administration. 
(u) Blood samples for PK analysis of TPOXX will be collected from all subjects at the following tome points: on Day 1 before study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 
8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours after the AM dose), on Day 7 before the 
AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the 
AM dose on Day 7). For PK blood samples, the acceptable window for collection from the scheduled collection time point will be as follows: ±5 minutes for the time points 
from 1 to 8 hours and ±15 minutes for the 12- to 48-hour time points. 
(v) Including assessment of heart, lungs, abdomen, a neurologic review, and a review of symptoms for assessment and/or follow-up of reported or potential adverse events. 


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9.3 
APPENDIX 3: STUDY GOVERNANCE 
9.3.1 
Data Quality Assurance 
This study will be conducted using the quality processes described in applicable procedural 
documents. The quality management approach to be implemented will be documented and 
will comply with current ICH guidance on quality and risk management. All aspects of the 
study will be monitored for compliance with applicable government regulatory requirements, 
current Good Clinical Practice, the protocol, and standard operating procedures (SOPs). The 
monitor will maintain current personal knowledge of the study through observation, review 
of study records and source documentation, and discussion of the conduct of the study with 
the investigator and staff. Electronic CRFs and electronic data capture will be utilized. The 
electronic data capture system is validated and compliant with US Title 21 CFR Part 11. Each 
person involved with the study will have an individual identification code and password that 
allows for record traceability. There may be an internal quality review audit of the data and 
additional reviews by the clinical monitor. 
Steps to be taken to ensure the accuracy and reliability of data include, but are not limited to: 
selection of qualified investigator and appropriate study center, protocol training and review 
of protocol procedures with the investigator and study site personnel before the start of the 
study, site initiation and periodic interim monitoring visits by SIGA or PPD, and direct 
transmission of safety laboratory data into the PPD study database for all clinical safety 
laboratory tests performed. The eCRF will be reviewed for accuracy and completeness by 
PPD Clinical research associate (CRA) remotely and during on-site monitoring visits. 
Discrepancies will be resolved with the investigator or designees, as appropriate. The data 
will be entered into the clinical study database and validated for accuracy. During on-site 
monitoring visits, 100% of the data will be verified using source documentation. SIGA or 
Biomedical Advanced Research and Development Authority representatives may accompany 
the PPD CRA on any scheduled site visit. The investigator will be informed in advance of 
any visitors to the study site in addition to the PPD CRA.  
Representatives of SIGA’s Quality Assurance department (or designee) may visit the site to 
carry out an audit of the study in compliance with regulatory guidelines and PPD policy. 
Such audits will require access to all study records, including source documents, for 
inspection and source document verification with the eCRF. Subject privacy must, however, 
be respected. Sufficient prior notice will be provided to allow the investigator to prepare 
properly for the audit. Similar auditing procedures may also be conducted by any regulatory 
body reviewing the results of this study in support of a Licensing Application. The 


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investigator will immediately notify SIGA if they are contacted by a regulatory agency 
requesting a site inspection. 
9.3.2 
Investigator Obligations 
The following administrative items are meant to guide the investigator in the conduct of the 
study and may be subject to change based on industry and government SOPs, working 
practice documents, or guidelines. Changes will be reported to the IRB but will not result in 
protocol amendments. 
9.3.2.1 
Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain subject confidentiality. All records will be kept in a secure 
storage area with limited access. Subjects will not be identified by name in any reports in this 
study. All records will be kept confidential to the extent provided by federal, state, and local 
law. Medical records are made available for review when required by the FDA or other 
authorized users only under the guidelines set by the Federal Privacy Act. Direct access, as 
defined in the Federal Privacy Act, includes examining, analyzing, verifying, and 
reproducing any records and reports that are important to the evaluation of the study. The 
investigator is obligated to inform the subjects that these representatives may review their 
study-related records without violating the confidentiality of the subjects. The requirement to 
maintain subject confidentiality is included in the study informed consent document. 
The investigator and all employees and coworkers involved with this study may not disclose 
or use for any purpose other than performance of the study, any data, record, or other 
unpublished, confidential information disclosed to those individuals for the purpose of the 
study. Prior written agreement from SIGA or its designee must be obtained for the disclosure 
of any said confidential information to other parties. 
9.3.2.2 
Institutional Review 
Federal regulations and ICH guidelines require that approval be obtained from an IRB before 
participation of human subjects in research studies. Before study onset, the protocol, ICF, 
advertisements to be used for the recruitment of study subjects, and any other written 
information regarding this study to be provided to the subject or the subject’s legal guardian 
must be approved by the IRB. Documentation of all IRB approvals and of the IRB 


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compliance with the ICH harmonised tripartite guideline E6(R2): Good Clinical Practice will 
be maintained by the site and will be available for review by SIGA or its designee. 
All IRB approvals should be signed by the IRB chairman or designee and must identify the 
IRB name and address, the clinical protocol by title or protocol number or both, and the date 
approval or a favorable opinion was granted. 
9.3.2.3 
Subject Consent 
Written documentation of informed consent in compliance with US Title 21 CFR Part 50 
shall be obtained from each subject before any study-related procedures are performed and 
study drug is administered. If any institution-specific modifications to study-related 
procedures are proposed or made by the site, the consent should be reviewed by SIGA or its 
designee or both before IRB submission. Once reviewed, the investigator will submit the ICF 
to the IRB for review and approval before the start of the study. If the ICF is revised during 
the course of the study, all active participating subjects must sign the revised ICF. 
Before recruitment and enrollment, each prospective subject or his/her legal guardian will be 
given a full explanation of the study and will be asked to read and review the approved ICF. 
Once the investigator is assured that the subject/legal guardian understands the implications 
of participating in the study, the subject/legal guardian will be asked to give his or her 
consent to participate in the study by signing the ICF. A copy of the ICF will be provided to 
the subject/legal guardian. 
9.3.2.4 
Exclusion of Children 
Effort will be made to include women and minorities in proportions similar to that of the 
community from which they are recruited. Because this study is designed to establish safety 
of the study drug in adults, enrollment will be limited to persons at least 18 years of age, and 
no older than 50 years. Children are excluded from participation in this clinical study because 
it does not meet the Department of Health and Human Services’ guidelines (45 CFR 46, 
Subpart D, 401-409) for inclusion of children in research. These guidelines provide guidance 
for the protection of children in research. Generally, healthy children can be studied when the 
research is considered as “not greater than minimal risk.” Children can be involved in 
research with greater than minimal risk only when it presents the prospect of direct benefit to 
the individual child or is likely to yield generalizable knowledge about the child’s disorder or 
condition. 


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9.3.2.5 
Study Reporting Requirements 
By participating in this study, the investigator agrees to submit reports of SAEs according to 
the time line and method outlined in this protocol. In addition, the investigator agrees to 
submit annual reports to his or her IRB as appropriate. 
9.3.2.6 
Financial Disclosure and Obligations 
The investigator is required to provide financial disclosure information to allow SIGA to 
submit the complete and accurate certification or disclosure statements required under US 
Title 21 CFR Part 54. In addition, the investigator must provide to SIGA a commitment to 
promptly update this information if any relevant changes occur during the course of the 
investigation and for 1 year following the completion of the study. 
Neither SIGA nor PPD is financially responsible for further testing or treatment of any 
medical condition that may be detected during the screening process. In addition, in the 
absence of specific arrangements, neither SIGA nor PPD is financially responsible for further 
treatment of the disease under study. 
9.3.2.7 
Investigator Documentation 
Prior to beginning the study, the investigator will be asked to comply with ICH 
E6(R2) Section 8.2 and US Title 21 of the CFR by providing essential documents, including 
but not limited to, the following: 
• IRB approval. 
• An original investigator-signed investigator agreement page of the protocol. 
• Form FDA 1572, fully executed, and all updates on a new fully executed 
Form FDA 1572. 
• Curriculum vitae for the principal investigator and each subinvestigator listed on Form 
FDA 1572. Current licensure must be noted on the curriculum vitae. Curriculum vitae 
will be signed and dated by the principal investigators and subinvestigators at study 
start-up, indicating that they are accurate and current. 
• Financial disclosure information to allow SIGA to submit complete and accurate 
certification or disclosure statements required under US Title 21 CFR Part 54. In 
addition, the investigators must provide to SIGA a commitment to promptly update this 


SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
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information if any relevant changes occur during the course of the investigation and for 
1 year after the completion of the study. 
• An IRB-approved ICF, samples of site advertisements for recruitment for this study, and 
any other written information about this study that is to be provided to the subject or legal 
guardians. 
• Laboratory certifications and reference ranges for any local laboratories used by the site, 
in accordance with US Title 42 CFR Part 493. 
9.3.2.8 
Study Conduct 
The investigator agrees to perform all aspects of this study in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, ICH E6(R2): Good Clinical 
Practice; the protocol; and all national, state, and local laws or regulations. 
9.3.2.9 
Case Report Forms and Source Documents 
Site personnel will maintain source documentation, enter subject data into the eCRF as 
accurately as possible, and will rapidly respond to any reported discrepancies. 
Electronic CRFs and electronic data capture will be utilized. The electronic data capture 
system is validated and compliant with US Title 21 CFR Part 11. Each person involved with 
the study will have an individual identification code and password that allows for record 
traceability. Thus, the system, and any subsequent investigative reviews, can identify 
coordinators, investigators, and individuals who have entered or modified records, as well as 
the time and date of any modifications. There may be an internal quality review audit of the 
data and additional reviews by PPD’s CRA. 
Each eCRF is presented as an electronic copy, allowing data entry by site personnel, who can 
add and edit data, add new subjects, identify and resolve discrepancies, and view records. 
This system provides immediate direct data transfer to the database, as well as immediate 
detection of discrepancies, enabling site coordinators to resolve and manage discrepancies in 
a timely manner. 
Paper copies of the eCRFs and other database reports may be printed and signed by the 
investigator. This system provides site personnel, PPD CRAs, and reviewers with access to 
hardcopy audits, discrepancy reviews, and investigator comment information. 


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9.3.2.10 
Adherence to Protocol 
The investigator agrees to conduct the study as outlined in this protocol, in accordance with 
ICH E6(R2) and all applicable guidelines and regulations. 
9.3.2.11 
Reporting Adverse Events 
By participating in this study, the investigator agrees to submit reports of SAEs according to 
the timeline and method outlined in this protocol. In addition, the investigator agrees to 
submit annual reports to his or her IRB as appropriate. The investigator also agrees to 
provide SIGA with an adequate report, if applicable, shortly after completion of the 
investigator’s participation in the study. 
9.3.2.12 
Investigator’s Final Report 
Upon completion of the study, the investigator, where applicable, should inform the 
institution; the investigator/institution should provide the IRB with a summary of the study’s 
outcome and SIGA and regulatory authorities with any reports required. 
9.3.2.13 
Records Retention 
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study drug. These documents should be 
retained for a longer period, however, if required by applicable regulatory requirements or by 
an agreement with SIGA. SIGA is responsible for informing the investigator/institution when 
these documents no longer need to be retained. 
9.3.2.14 
Publications 
All information concerning TPOXX, SIGA operations, patent application, formulas, 
manufacturing processes, basic scientific data, and formula information, supplied by SIGA to 
the investigator and not previously published, is considered confidential and remains the sole 
property of SIGA. The investigator agrees to use this information only to accomplish this 
study and will not use it for other purposes without SIGA’s written consent. The investigator 
understands that the information developed in the clinical study will be used by SIGA, in 
connection with the continued development of TPOXX, and thus may be disclosed as 
required to other clinical investigators or government regulatory agencies. To permit the 


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information derived from the clinical studies to be used, the investigator is obligated to 
provide SIGA with all data obtained in the study. Any publication or other public 
presentation of results from this study, including manuscripts and materials for presentation 
at scientific meetings, should be provided to SIGA at least 30 working days before abstract or 
other relevant submission deadlines. Authorship of publications resulting from this study will 
be determined at the discretion of SIGA. 
9.3.3 
Study Management 
9.3.3.1 
Monitoring 
9.3.3.1.1 
Monitoring of the Study 
Site monitoring for safety is conducted to ensure that human subject protection, study 
procedures, and laboratory, study drug dosing, and data collection processes are of high 
quality and meet SIGA, GCP/ICH, and regulatory guidelines. PPD CRA(s) will conduct site 
monitoring visits as detailed in the monitoring plan. 
Site investigators will allow the CRA(s), the designated IRB, SIGA or its designee and the 
FDA to review, audit, and inspect study documents (eg, ICFs, drug accountability and 
distribution forms, eCRF), pertinent hospital and site records, and source documentation for 
verification of the study data.  
Clinical research associates will conduct site visits in accordance with PPD SOPs to monitor 
the following: study operations, the quality of data collected in the research records, the 
accuracy and timeliness of data entered in the database, and to determine that all process and 
regulatory requirements are met. Study monitoring visits will occur at initiation of the study 
site, at intervals determined by SIGA during conduct of the study, and at completion of the 
study.  
The CRA will maintain current personal knowledge of the study through observation, review 
of study records and source documentation, and discussion of the conduct of the study with 
the investigator and staff. During the routine monitoring visits, the CRA will perform a 100% 
source document verification of all subject data entered into the eCRF. Discrepancies, if any, 
will be clarified with the study site coordinator and investigator, and corrected at the site by 
the study coordinator. Any questions or required data clarifications will be sent to the study 
site electronically.  


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9.3.4 
Safety Monitoring Plan 
Close cooperation between the designated members of the study team will occur to evaluate 
and respond to individual AEs in a timely manner. Designated team members (investigator, 
subinvestigators, study coordinator, and other designated study clinicians) will review the 
subject safety information and data (laboratory test results, ECGs, AEs, and concomitant 
medications) and update the PPD project team and the ISM on the status of all enrolled 
subjects at their site on a weekly basis (or more frequently if required because of an 
unexpected safety issue) through completion of each subject’s final study visit. 
9.3.5 
Medical Monitor 
The medical monitor, or their qualified designee, will receive reports within 24 hours of 
study site awareness of all SAEs and within 7 days of study site awareness of all other AEs. 
The safety monitors will review all safety data and alert the medical monitor of SAEs and 
AEs of interest. The medical monitor may make a request for data to the investigator as 
necessary for safety evaluations.  
The medical monitor will review each significant AE in a timely fashion and ensure that 
appropriate management is initiated and completed. Drug safety representatives and the 
medical monitor will have direct contact with the investigators and follow all significant 
events as needed. 
9.3.6 
Safety Oversite (Independent Safety Monitor) 
In addition to the investigator’s ongoing review of the safety data, the ISM will review the 
protocol for any major concerns and will be involved in data review in coordination with the 
investigator. The primary role of the ISM will be to evaluate the study safety and tolerability 
data. The ISM will provide independent safety monitoring in a timely fashion, which will 
include reviewing individual SAE reports and a review of periodic cumulative AE reports. 
Clinical safety and laboratory data, clinical records, and other safety study-related records 
will be made available for the ISM to review. Based on review of this data, the ISM may 
make recommendations regarding the safe continuation of the study. Specific details will be 
outlined in the Safety and Medical Management Plan. 
9.3.6.1 
Inspection of Records 
The investigator and study site involved in the study will permit study-related monitoring, 
audits, IRB review, and regulatory inspections by providing direct access to all study records. 


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In the event of an audit, the investigator agrees to allow SIGA, their representatives, the 
FDA, or other regulatory agencies access to all study records. 
The investigator should promptly notify SIGA and study site of any audits scheduled by any 
regulatory authorities and promptly forward copies of any audit reports received to SIGA. 
9.3.6.2 
Management of Protocol Amendments and Deviations 
9.3.6.2.1 
Modification of the Protocol 
Any changes in this research activity, except those necessary to remove an apparent 
immediate hazard to the subject, must be reviewed and approved by SIGA or designee. 
Amendments to the protocol must be submitted in writing to the IRB for approval before 
subjects are enrolled into an amended protocol. 
9.3.6.2.2 
Protocol Deviations 
The investigator or designee must document and explain in the subject’s source 
documentation any deviation from the approved protocol. The investigator may implement a 
deviation from, or a change to, the protocol to eliminate an immediate hazard to study 
subjects without prior IRB approval. As soon as possible after such an occurrence, the 
implemented deviation or change, the reasons for it, and any proposed protocol amendments 
should be submitted to the IRB for review and approval, to SIGA for agreement, and to the 
regulatory authorities, if required. 
A protocol deviation is any change, divergence, or departure from the study design or 
procedures defined in the protocol. An important protocol deviation (sometimes referred to 
as a protocol violation or a major protocol deviation) is a subset of protocol deviations that 
might significantly affect the reliability of the study data or that might significantly affect a 
subject's safety. An important deviation can include nonadherence to inclusion or exclusion 
criteria or nonadherence to FDA regulations or ICH E6(R2) guidelines. 
Protocol deviations will be documented by the clinical monitor throughout the course of 
monitoring visits. The investigator will be notified in writing by the monitor of deviations. 
The IRB should be notified of all protocol deviations, if appropriate, in a timely manner. 


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9.3.6.3 
Study Termination 
Although SIGA has every intention of completing the study, they reserve the right to 
discontinue it at any time for clinical or administrative reasons. 
An initiative for closure of the clinical investigative site or termination of the study can be 
taken at any time either by SIGA, PPD, or the investigator provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. Reasons for such action 
include, but are not limited to: 
• Study site closure 
o Inadequate site recruitment/enrollment of subjects 
o Failure of an investigator to comply with the protocol, PPD SOPs, GCP guidelines, or 
applicable federal regulations 
• Termination of enrollment 
o Enrollment of the required estimated number of subjects for the study 
• Study termination 
o Completion of the study 
o Safety concerns 
In addition, the ISM and FDA have the prerogative to delay or terminate the study. 
The end of the study is defined as the date on which the last subject completes the last visit 
(includes the follow-up visit and the follow-up telephone call). Any additional long-term 
follow-up that is required for monitoring of the resolution of an AE or finding may be 
reported through an amendment to the clinical study report. 
9.3.6.4 
Final Report 
Whether the study is completed or prematurely terminated, SIGA will ensure that clinical 
study reports are prepared and provided to regulatory agency(ies) as required by the 
applicable regulatory requirement(s). SIGA will also ensure that clinical study reports in 
marketing applications meet the standards of the ICH harmonised tripartite guideline E3: 
Structure and content of clinical study reports. 


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Upon completion of the clinical study report, the investigator will be provided with the final 
approved clinical study report, as appropriate. 
9.4 
APPENDIX 4: CHANGE HISTORY 
9.4.1 
Protocol Amendment 1 
Protocol Amendment 1 was issued to clarify the weight requirements for qualified subjects 
on Day -1 and Day 1, clarify that the same scale will be used in Screening and how rounding 
procedures will be used, update Reference 3 to cite the current FDA Guidance, remove the 
±2 day window for the Day 9 / Early Discontinuation visit, and remove symptom-directed 
physical examination from Day 7.  The changes to Protocol Amendment 1 are outlined as 
follows: 
Protocol Section 
Change 
Rationale 
Synopsis and Section 
3.1 Inclusion Criteria 
Clarified subjects need to weigh 
>120 kg at check-in on Day -1, 
and prior to dosing on Day 1, in 
addition to weighing >120 kg at 
Screening. 
In order to obtain accurate 
pharmacokinetic data in 
subjects weighing >120 kg, 
subjects participating in this 
study need to meet the weight 
requirement during dosing. 
Section 6.2.6 
Physical 
Examinations and 
Section 9.2 Appendix 
2:  Schedule of 
Events 
Clarified the scale should be 
used throughout the entire study 
including Screening.  Clarified 
rounding should occur by adding 
the following text:  Weight 
measurements will be rounded to 
one decimal place. 
The same scale should be used 
for the screening of subjects as 
will be used in the study to 
ensure weight measurement 
consistency.  Scales at the site 
measure weight to two decimal 
places.   
Section 8 Reference 
List 
Updated reference 3 to cite the 
May 2018 Bioanalytical Method 
Validation Guidance for Industry 
An updated Guidance was 
published in May of 2018. 
Section 9.2 Appendix 
2:  Schedule of 
Events 
Removal of (±2) from Day 9 or 
Early Discontinuation visit 
header 
The ±2 day visit window was 
included in error.  Subjects will 
check out on day 9 or will 
undergo Early Discontinuation 
Procedures on the day they 
discontinue.  There is no 
window for these visits. 
Section 9.2 Appendix 
2:  Schedule of 
Events 
Removal of Day 7 symptom-
directed physical examination 
from schedule. 
A complete physical exam is 
already being conducted on 
Day 7. 


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9.4.2 
Protocol Amendment 2 
Protocol Amendment 2 was issued to revise Exclusion Criteria 31; to remove redundant 
Exclusion Criteria; to add the measurement of height to the Day -1 Check-in procedures; and 
to remove the one hour observation period for allergic reaction following dosing.  The 
changes to Protocol Amendment 2 are outlined as follows: 
Protocol Section 
Change 
Rationale 
Synopsis and 
Section 3.2 
Exclusion Criteria 
Removed bullet point 3 from Exclusion 
Criteria 2, which stated: Hypertension that 
is poorly controlled (repeat readings >140 
mm Hg systolic and/or >90 mm Hg 
diastolic) and revised Exclusion Criteria 
31 from Subject has a sustained sitting 
systolic blood pressure >140 mm Hg or 
<100 mm Hg or a diastolic blood pressure 
>90 mm Hg at screening. Blood pressure 
may be retested twice in the sitting 
position at 5-minute intervals. The 
pressure elevation is considered sustained 
if either the systolic or the diastolic 
pressure exceeds the stated limits on all 3 
assessments to Subject has a blood 
pressure considered to be clinically 
significant by the investigator. Blood 
pressure may be retested twice in the 
sitting position at 5-minute intervals.  
Bullet point 3 was 
removed as it was 
redundant with 
Exclusion Criteria 31.  
Exclusion Criteria 31 
was revised to allow 
the investigator to 
determine clinical 
significance of blood 
pressure for study 
inclusion or exclusion. 
Section 6.2.6 
Physical 
Examinations and 
Section 9.2 
Appendix 2:  
Schedule of Events 
Added height to Day -1 Check-in 
procedures 
This measurement was 
previously 
unintentionally 
omitted from the study 
assessments.   
Section 6.2.1.8 
Reactogenicity and 
Section 9.2 
Appendix 2:  
Schedule of Events 
Removed specific mention of a one hour 
observation period for allergic reaction 
following dosing from Section 6.2.1.8 and 
removed reactogenicity from the Schedule 
of Events. 
Subjects are  required 
to stay at the clinical 
site throughout the 
entire dosing period 
and are continually 
under observation by 
site staff.  
 

SAP_001.pdf: 
1.
TITLE PAGE
CLINICAL STUDY REPORT 
A POST MARKETING STUDY OF THE SAFETY, TOLERABILITY, 
AND PHARMACOKINETICS OF TPOXX® IN ADULT SUBJECTS 
WEIGHING MORE THAN 120 KG 
PROTOCOL NO. SIGA-246-022 
Name of Drug: 
TPOXX® 
Study Design: 
Multiple-dose, open-label, safety, tolerability, and PK 
study in adult subjects weighing more than 120 kg 
Sponsor: 
SIGA Technologies, Inc. 
4575 SW Research Way, Suite 110 
Corvallis, OR 97333 
Name of Sponsor Signatory: 
Dennis E. Hruby, PhD 
Chief Scientific Officer 
Telephone: 541-753-2000 
Drug Development Phase: 
4 
Study Initiation Date: 
First Subject First Visit: 19 July 2019 
Study Completion Date: 
Last Subject Last Visit: 05 December 2019 
Principal Investigator: 
 
 
 
 
Report Date: 
30 March 2020 
This study was conducted according to the International Council for Harmonisation 
Guideline E6(R2): Good Clinical Practice, including the archiving of essential documents 
at: 
 
CONFIDENTIAL 
Page 1


SlGA Tcchnologi~s. Inc. 
Prntocol No. SIGA-246-022 
SIGNATURE PAGE 
TPOXX' 
Chnu:al Study Report 
STUDY TITLE: 
A Post Mark.cting Study of I.he Safety. Tolerability, and 
Pharmacok.lncl1cs of rPOXX~ in Adi.111 Subjects Wc:iglting More: Than 
120kg 
PROTOCOt NUMHEU: 
SIGA-246-022 
I have read this repon and confinn thaL 10 lhe best of my knowledge it accurately describes 
the conduct and results of the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 2


SIGA Technologies, Inc. 
Protocol No. SIGA-246-022 
SIGNATURE PAGE 
TPOXX® 
Clinical Study Report 
STUDY TITLE: 
A Post Marketing Study of the Safety, Tolerability, and 
Pharmacokinetics ofTPOXX® in Adult Subjects Weighing More Than 
120kg 
PROTOCOL NUMBER: 
SIGA-246-022 
I have read this report and confirm that to the best of my knowledge it accurately describes 
the conduct and results of the study. 
APPROVED BY: 
Dennis E. Hruby, PhD 
Chief Scientific Officer 
SIGA Technologies, Inc. 
Date 
Page 3


SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
2.
SYNOPSIS
STUDY TITLE: A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of 
TPOXX® in Adult Subjects Weighing More Than 120 kg 
INVESTIGATOR: 
 
STUDY SITE: 
 
PUBLICATION (REFERENCE): None 
STUDY PERIOD: 
First Subject First Visit: 19 July 2019 
Last Subject Last Visit: 05 December 2019 
PHASE OF DEVELOPMENT: 4 
OBJECTIVES: 
The primary objective of this study was to determine the pharmacokinetic (PK) profile of 
600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in 
adult subjects weighing more than 120 kg to determine if a change in TPOXX dosing 
regimen would be needed in these patients. 
The secondary objective of this study was to evaluate the safety and tolerability of 600 mg 
oral TPOXX administered BID for 7 days in adult subjects weighing more than 120 kg. 
METHODOLOGY: 
This was an open-label, multiple-dose study to assess the safety, tolerability, and PK of 
TPOXX 600 mg BID when administered orally for 7 days to adult subjects weighing more 
than 120 kg. A total of 34 subjects, aged 20 to 50 years, inclusive, were enrolled. The study 
consisted of a screening period (Day –28 to –2), a treatment and confinement period  
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]). 
Subjects underwent screening evaluations to determine eligibility within 28 days before study 
drug administration. Subjects were admitted to the study site on Day –1 to complete baseline 
assessments, the results of which were reviewed by the investigator before dosing. Starting 
on the morning of Day 1, subjects received 600 mg oral TPOXX BID for 7 days (Days 1 
through 7). 
All subjects were provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration, and subjects fasted for 2 hours after taking 
study drug. Subjects ate this meal within 30 minutes or less of taking study drug. Study drug 
and meals were taken with water only, and no other beverage except water was ingested 
within 3 hours before and 3 hours after study drug administration. 
Subjects remained confined to the study site for collection of PK samples and were carefully 
monitored for safety and tolerability until discharge on Day 9. Subjects who had abnormal 
physical examination findings or an ongoing adverse event (AE)/serious AE (SAE) on Day 9 
that was deemed related to study drug or per investigator or SIGA discretion, returned to the 
study site on Day 14 (+2 days) for a follow-up visit. All other subjects had their Day 14 
(+2 days) follow-up via a telephone call. All subjects had a follow-up telephone call 30 days 
Page 4


SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
after administration of the last dose of study drug (Day 37 [+2 days]) to report any SAEs. At 
the time of discharge from the study site, subjects were instructed to notify the investigator of 
any SAEs that occurred within 30 days after administration of the last dose of study drug. 
Serious AEs were followed until the SAE was stable or until resolution, as determined by the 
investigator and/or medical monitor. 
Number of subjects: 
Up to 36 subjects were planned for this study to allow at least 32 enrolled subjects to 
complete. Thirty-four subjects were enrolled and completed the study. 
Diagnosis and main criteria for inclusion: 
Male and female subjects between 18 and 50 years of age, inclusive; who weighed more than 
120 kg at screening, at check-in on Day –1, and prior to dosing on Day 1; and who were 
assessed by the investigator to be in good general health as determined by medical history, 
clinical laboratory results, vital sign measurements, 12-lead electrocardiogram (ECG) results, 
and physical examination findings at screening. 
Test product, dose, and mode of administration, lot number: 
TPOXX 600 mg (3 × 200-mg capsules) oral BID on Days 1 to 7, 
. 
Reference therapy, dose, and mode of administration, lot number: 
Not applicable. 
Duration of treatment:  
The total duration of the study for each subject, including the screening period, treatment and 
confinement period, and the Day 37 (+2 days) follow-up telephone call, was approximately 
65 days. 
CRITERIA FOR EVALUATION: 
Pharmacokinetics: 
Blood samples for the PK analysis of TPOXX were collected from all subjects on Day 1 
before study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 
18, 20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 
4 hours after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 
(before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on 
Day 7), and on Day 9 (48 hours after the AM dose on Day 7). 
The individual plasma concentration versus actual time data for TPOXX were used to derive 
the PK parameters: 
•
Area under the plasma concentration versus time curve (AUC) from time 0 to the last
quantifiable measurement (AUC0-t).
•
AUC from time 0 to 24 hours postdose (AUC0-24).
•
AUC during the first dosing interval (AUC0-tau; tau = 12 hours).
•
AUC from time 0 extrapolated to infinity (AUC0-inf).
•
Percentage of AUC0-inf extrapolated from the last quantifiable measurement to infinity
(%AUCextrap).
Page 5


SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
•
Maximum observed plasma drug concentration (Cmax).
•
Time to reach Cmax (Tmax).
•
Terminal elimination rate constant (λz).
•
Terminal elimination half-life (t1/2).
•
Apparent total body clearance (CL/F).
•
Apparent volume of distribution (Vd/F).
•
Concentration observed prior to the next dose administration (Ctrough).
Safety: 
Safety and tolerability were assessed by monitoring and recording of AEs, clinical laboratory 
test results (hematology, serum chemistry, and urinalysis), vital sign measurements (systolic 
and diastolic blood pressures, heart rate, respiratory rate, and body temperature), 12-lead 
ECG results, and physical examination findings. 
STATISTICAL METHODS: 
Pharmacokinetics: 
Individual plasma concentrations, actual time, and deviation from the scheduled time are 
presented in a data listing by subject, study day, and nominal time point. Plasma 
concentration data are summarized by day and time point using the following descriptive 
statistics: sample size (n), arithmetic mean, geometric mean, SD, geometric SD, coefficient of 
variation (CV), geometric CV (calculated as sqrt [exp [variance for log transformed 
data] – 1] × 100), median, minimum, and maximum. 
Individual, mean (±SD), and trough (±SD) plasma TPOXX concentration versus time profiles 
are presented in figures on both linear and semilogarithmic scales. Mean plasma 
concentration versus time profiles are presented using nominal time and individual plasma 
concentration versus time profiles are presented using actual time. 
Actual sampling times, rather than scheduled sampling times, are used in the computation of 
PK parameters. However, for ease of presentation, scheduled sampling times are used to 
present results in summary tables. The individual PK parameters of TPOXX are presented in 
a data listing. The PK parameters are summarized by day using the following descriptive 
statistics: n, arithmetic mean, geometric mean, SD, CV, geometric SD, geometric CV, 
median, minimum, and maximum. For Tmax, only n, median, minimum, and maximum are 
included in descriptive statistics. Geometric mean, geometric SD, and geometric CV are 
included for the AUCs and Cmax. 
No formal statistical analysis of PK data was performed for this study. 
Safety: 
Adverse events were coded by preferred term (PT) and system organ class (SOC) using the 
Medical Dictionary for Regulatory Activities (MedDRA, Version 22.0). 
An overall summary of all AEs is presented. The number and percentage of subjects, as well 
as the number of AEs are presented for each of the following categories: any AE; any 
Grade 2, Grade 3, Grade 4, and Grade 5 AE; any treatment-related AE (TRAE); any Grade 2, 
Page 6


SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Grade 3, Grade 4, and Grade 5 TRAE; any SAE; any serious TRAE, and any AE leading to 
discontinuation of study drug. In addition, the table includes a summary of the time to first 
AE and the time to first AE of Grade 3 or higher. Adverse events are summarized by SOC 
and PT and by PT alone, including the total number of AEs and the number and percentage of 
subjects with at least one AE. 
Summaries of AEs by relationship to study drug and severity are presented in tables by 
incidence of occurrence. Treatment-related AEs are presented in a data listing. All AEs and 
SAEs are presented in a data listing. All AEs leading to study drug discontinuation are 
presented in a data listing. 
Observed values and changes from baseline are summarized for hematology, serum 
chemistry, and urinalysis laboratory tests with numeric values for subjects in the safety 
population. Changes from baseline to each scheduled postbaseline visit are presented. 
Changes in low, normal, high, and abnormal classifications are summarized in shift tables 
comparing the results at each scheduled postbaseline visit with those at the baseline visit. 
Shift tables are presented for subjects in the safety population. Where possible, abnormal 
clinical laboratory values were graded for severity according to the Division of Acquired 
Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and 
Pediatric Adverse Events. The maximum increase in DAIDS grade postbaseline (including 
both scheduled and unscheduled visits) is summarized and presented. 
Observed values and changes from baseline are summarized for vital sign data and 12-lead 
ECG parameters for subjects in the safety population. Changes from baseline to each 
scheduled postbaseline visit are presented. 
All clinical laboratory test results, vital sign measurements, 12-lead ECG data, and physical 
examination findings are presented in data listings. 
RESULTS: 
Pharmacokinetic Results: 
Following BID oral administration of TPOXX 600 mg, plasma concentrations of TPOXX 
were detected immediately after dosing and reached peak levels around 4 hours after dosing. 
Steady state was achieved by Day 6 following administration of TPOXX for 7 days. 
On Day 1, mean plasma exposure values for Cmax, AUC0-24, and AUC0-tau were 847 ng/mL, 
11900 ng*h/mL, and 5130 ng*h/mL, respectively. Mean plasma trough concentration, 
calculated prior to the third dose, was 517 ng/mL and median Tmax was 4 hours after dosing. 
The mean t1/2 was 8.46 hours (note that this could only be calculated in 32% of the total 
subjects due to having insufficient data in the terminal phase). 
On Day 7, steady-state mean plasma exposure values for Cmax, AUC0-24, and AUC from time 
0 to 12 hours postdose (AUC0-12) were 1350 ng/mL, 20000 ng*h/mL, and 9830 ng*h/mL, 
respectively. The mean steady-state t1/2 and CL/F values were 12.9 hours and 64.8 L/h, 
respectively. Mean plasma steady-state trough concentration, calculated prior to the second 
dose on Day 7, was 617 ng/mL. Median Tmax was 4 hours after dosing at steady state. 
The ratio (Day 7/Day 1) of mean plasma exposure Cmax, AUC0-24, and AUC0-tau ranged from 
1.6 to 1.9, suggesting plasma accumulation of TPOXX at steady-state. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Safety Results: 
A total of 9 of 34 subjects (26.5%) reported 12 AEs during the study. A total of 2 of 
34 subjects (5.9%) reported 2 TRAEs. The most commonly reported AEs were in the SOCs 
of gastrointestinal disorders (3 subjects, 8.8%) and nervous system disorders (2 subjects, 
5.9%). The most commonly reported AEs were nausea and headache (2 subjects, 5.9% each). 
All other AEs were reported by 1 subject (2.9%) each. No AEs above Grade 1 (mild; 
9 subjects) were reported in this study. All AEs were reported as recovered/resolved by the 
end of the study. There were no SAEs, serious TRAEs, or AEs leading to study drug or study 
discontinuation during the study. There were no notable safety signals in results from safety 
assessments. 
Mean clinical laboratory test results (hematology, serum chemistry, and urinalysis), vital sign 
measurements, physical examination findings, and 12-lead ECG values after dosing were 
generally similar to baseline values. No individual clinical laboratory test result, vital sign 
measurement, physical examination finding, or 12-lead ECG value was associated with an 
AE or considered clinically significant by the investigator. All clinical laboratory test results 
with toxicity grades were no higher than DAIDS Grade 1 or 2. 
CONCLUSIONS: 
Pharmacokinetics: 
•
Following BID oral administration of TPOXX 600 mg, plasma concentrations of
TPOXX were detected immediately after dosing and reached peak levels around
4 hours after dosing.
•
Steady state was achieved by Day 6 following administration of TPOXX for 7 days.
•
On Day 1, mean plasma exposure values for Cmax, AUC0-24, and AUC0-tau were
847 ng/mL, 11900 ng*h/mL, and 5130 ng*h/mL, respectively. Mean plasma trough
concentration, calculated prior to the third dose, was 517 ng/mL and median Tmax was
4 hours after dosing. The mean t1/2 was 8.46 hours (note that this could only be
calculated in 32% of the total subjects due to having insufficient data in the terminal
phase).
•
On Day 7, steady-state mean plasma exposure values for Cmax, AUC0-24, and AUC0-12
were 1350 ng/mL, 20000 ng*h/mL, and 9830 ng*h/mL, respectively. The mean
steady-state t1/2 and CL/F values were 12.9 hours and 64.8 L/h, respectively. Mean
plasma steady-state trough concentration, calculated prior to the second dose on
Day 7, was 617 ng/mL. Median Tmax was 4 hours after dosing at steady state.
•
The ratio (Day 7/Day 1) of mean plasma exposure Cmax, AUC0-24, and AUC0-tau ranged
from 1.6 to 1.9, suggesting plasma accumulation of TPOXX at steady-state.
•
SIGA will incorporate the PK data for the 34 subjects enrolled in this study into a
population PK model which is being developed outside of this clinical study to inform
if a change in dosing regimen would be needed in these patients.
Page 8


SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Safety: 
TPOXX was considered safe and generally well tolerated when administered orally at a dose 
of 600 mg BID for 7 days in adult subjects weighing more than 120 kg. 
DATE OF REPORT: 30 March 2020 
Page 9


SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
3.
TABLE OF CONTENTS
1.
TITLE PAGE ........................................................................................................ 1 
2.
SYNOPSIS ............................................................................................................. 4 
3.
TABLE OF CONTENTS ................................................................................... 10 
4.
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .................... 16 
5.
ETHICS ............................................................................................................... 18 
5.1 
INSTITUTIONAL REVIEW BOARD ............................................................ 18 
5.2 
ETHICAL CONDUCT OF THE STUDY........................................................ 18 
5.3 
SUBJECT INFORMATION AND CONSENT ................................................ 18 
6.
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE ....... 19 
7.
INTRODUCTION .............................................................................................. 21 
8.
STUDY OBJECTIVES ...................................................................................... 21 
8.1 
PRIMARY OBJECTIVE .................................................................................. 21 
8.2 
SECONDARY OBJECTIVE ........................................................................... 21 
9.
INVESTIGATIONAL PLAN ............................................................................. 21 
9.1 
OVERALL STUDY DESIGN AND PLAN ..................................................... 21 
9.2 
DISCUSSION OF STUDY DESIGN, INCLUDING THE CHOICE OF 
CONTROL GROUPS ...................................................................................... 22 
9.3 
SELECTION OF STUDY POPULATION ...................................................... 23 
9.3.1 
Inclusion Criteria .......................................................................................... 23 
9.3.2 
Exclusion Criteria ......................................................................................... 24 
9.3.3 
Subject Restrictions During the Study ......................................................... 28 
9.3.4 
Removal of Subjects From the Study ........................................................... 28 
9.4 
TREATMENT .................................................................................................. 30 
9.4.1 
Treatment Administered ............................................................................... 30 
9.4.2 
Identity of Investigational Product ............................................................... 30 
9.4.3 
Method of Assigning Subjects to Treatment Group ..................................... 31 
9.4.4 
Selection of Doses in the Study .................................................................... 31 
9.4.5 
Selection and Timing of Dose for Each Subject ........................................... 31 
9.4.6 
Blinding ........................................................................................................ 32 
9.4.7 
Prior and Concomitant Therapy ................................................................... 32 
9.4.8 
Treatment Compliance ................................................................................. 32 
9.5 
PHARMACOKINETIC AND SAFETY VARIABLES ................................... 33 
9.5.1 
Pharmacokinetic and Safety Measurements Assessed and Schedule of 
Events ........................................................................................................... 33 
9.5.1.1 
Pharmacokinetic Assessments .................................................................. 33 
9.5.1.2 
Safety Assessments ................................................................................... 33 
9.5.1.3 
Schedule of Events ................................................................................... 37 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
9.5.2 
Appropriateness of Measurements ............................................................... 40 
9.5.3 
Pharmacokinetic Variables ........................................................................... 40 
9.5.3.1 
Pharmacokinetic Variables ....................................................................... 40 
9.5.4 
Drug Concentration Measurements .............................................................. 41 
9.6 
DATA QUALITY ASSURANCE ..................................................................... 41 
9.7 
STATISTICAL METHODS PLANNED IN THE PROTOCOL AND 
DETERMINATION OF SAMPLE SIZE ......................................................... 42 
9.7.1 
Statistical and Analytical Plans .................................................................... 42 
9.7.1.1 
Analysis Populations ................................................................................ 42 
9.7.1.2 
Analysis of Subject Disposition and Demographics ................................ 42 
9.7.1.3 
Analysis of Pharmacokinetic Data ........................................................... 43 
9.7.1.4 
Analysis of Safety Data ............................................................................ 44 
9.7.2 
Determination of Sample Size ...................................................................... 47 
9.8 
CHANGES IN THE CONDUCT OF THE STUDY OR PLANNED 
ANALYSES ..................................................................................................... 47 
10.
STUDY SUBJECTS ............................................................................................ 48 
10.1 
DISPOSITION OF SUBJECTS ....................................................................... 48 
10.2 
PROTOCOL DEVIATIONS ............................................................................ 49 
10.3 
DATASETS ANALYZED ................................................................................ 49 
10.4 
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS ........... 49 
10.4.1 
Demographics and Baseline Characteristics ................................................ 49 
10.4.2 
Other Baseline Characteristics ..................................................................... 50 
10.5 
PRIOR AND CONCOMITANT MEDICATIONS .......................................... 51 
10.6 
EXPOSURE AND COMPLIANCE ................................................................. 51 
10.6.1 
Extent of Exposure ....................................................................................... 51 
10.6.2 
Measures of Treatment Compliance ............................................................. 52 
11.
PHARMACOKINETIC EVALUATION .......................................................... 52 
11.1 
ANALYSIS OF PHARMACOKINETICS ...................................................... 52 
11.1.1 
Plasma Concentrations of TPOXX ............................................................... 52 
11.1.2 
Plasma Pharmacokinetic Parameters of TPOXX ......................................... 56 
11.2 
STATISTICAL/ANALYTICAL ISSUES ......................................................... 57 
11.2.1 
Adjustments for Covariates .......................................................................... 57 
11.2.2 
Handling of Dropouts or Missing Data ........................................................ 57 
11.2.3 
Interim Analyses and Data Monitoring ........................................................ 57 
11.2.4 
Multicenter Studies ....................................................................................... 57 
11.2.5 
Multiple Comparison/Multiplicity ............................................................... 58 
11.2.6 
Use of an “Efficacy Subset” of Subjects ...................................................... 58 
11.2.7 
Active-Control Studies Intended to Show Equivalence ............................... 58 
11.2.8 
Examination of Subgroups ........................................................................... 58 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
11.3 
TABULATION OF INDIVIDUAL RESPONSE DATA .................................. 58 
11.4 
DRUG DOSE, DRUG CONCENTRATION, AND RELATIONSHIPS TO 
RESPONSE ...................................................................................................... 58 
11.5 
DRUG-DRUG AND DRUG-DISEASE INTERACTIONS ............................ 58 
11.6 
BY-SUBJECT DISPLAYS ............................................................................... 58 
11.7 
PHARMACOKINETIC CONCLUSIONS ...................................................... 58 
12.
SAFETY EVALUATION ................................................................................... 59 
12.1 
ADVERSE EVENTS ....................................................................................... 59 
12.1.1 
Brief Summary of Adverse Events ............................................................... 59 
12.1.2 
Display of Adverse Events ........................................................................... 59 
12.1.3 
Analysis of Adverse Events .......................................................................... 61 
12.1.4 
Listing of Adverse Events by Subject .......................................................... 62 
12.2 
DEATHS, OTHER SERIOUS ADVERSE EVENTS, AND OTHER 
SIGNIFICANT ADVERSE EVENTS ............................................................. 62 
12.2.1 
Listing of Deaths, Other Serious Adverse Events and Other Significant 
Adverse Events ............................................................................................. 62 
12.2.1.1 
Deaths ....................................................................................................... 62 
12.2.1.2 
Other Serious Adverse Events .................................................................. 62 
12.2.1.3 
Other Significant Adverse Events ............................................................. 62 
12.2.2 
Narratives of Deaths, Other Serious Adverse Events, and Certain Other 
Significant Adverse Events .......................................................................... 62 
12.2.3 
Analysis and Discussion of Deaths, Serious Adverse Events, and Other 
Significant Adverse Events .......................................................................... 62 
12.3 
CLINICAL LABORATORY EVALUATION .................................................. 62 
12.3.1 
Listing of Individual Laboratory Measurements by Subject and Each 
Abnormal Laboratory Value ......................................................................... 62 
12.3.2 
Evaluation of Each Laboratory Parameter ................................................... 63 
12.3.2.1 
Laboratory Values Over Time ................................................................... 63 
12.3.2.2 
Individual Subject Changes ...................................................................... 63 
12.3.2.3 
Individual Clinically Significant Abnormalities ....................................... 64 
12.4 
VITAL SIGNS, PHYSICAL FINDINGS, AND OTHER OBSERVATIONS 
RELATED TO SAFETY .................................................................................. 65 
12.4.1 
Vital Sign Measurements .............................................................................. 65 
12.4.2 
Twelve-Lead Electrocardiograms ................................................................. 65 
12.4.3 
Physical Measurements ................................................................................ 65 
12.4.4 
Physical Examinations ................................................................................. 65 
12.4.5 
Follow-up Visit or Telephone Call ............................................................... 65 
12.4.6 
Pregnancies ................................................................................................... 65 
12.5 
SAFETY CONCLUSIONS .............................................................................. 66 
13.
DISCUSSION AND OVERALL CONCLUSIONS ......................................... 66 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
13.1 
DISCUSSION .................................................................................................. 66 
13.2 
OVERALL CONCLUSIONS .......................................................................... 67 
14.
TABLES AND FIGURES REFERRED TO BUT NOT INCLUDED IN THE
TEXT ................................................................................................................... 68 
14.1 
DEMOGRAPHIC DATA ................................................................................. 68 
14.2 
PHARMACOKINETIC DATA ........................................................................ 68 
14.3 
SAFETY DATA ................................................................................................ 68 
14.3.1 
Displays of Adverse Events .......................................................................... 68 
14.3.2 
Listings of Deaths, Other Serious and Significant Adverse Events ............. 69 
14.3.3 
Narratives of Deaths, Other Serious and Certain Other Significant 
Adverse Events ............................................................................................. 69 
14.3.4 
Laboratory and Other Safety Data ................................................................ 69 
15.
REFERENCE LIST ......................................................................................... 187 
16. 
APPENDICES ................................................................................................... 188 
16.1
STUDY INFORMATION .............................................................................. 189
16.1.1
Protocol and Protocol Amendments ........................................................... 190
16.1.2 
Sample Case Report Form (Unique Pages Only) ....................................... 373 
16.1.3 
IRB (Plus the Name of the Committee Chair if Required by the Regulatory 
Authority) and Representative Written Information for Subject and Sample 
Consent Forms ............................................................................................ 495 
16.1.4 
List and Description of Investigators and Other Important Participants in the 
Study, Including Brief Curriculum Vitae or Equivalent Summaries of 
Training and Experience Relevant to the Performance of the Study ......... 544 
16.1.5 
Signature of Principal Investigator ............................................................. 548 
16.1.6 
Listing of Subjects Receiving Test Drug/Investigational Product(s) From 
Specific Batches, Where More Than 1 Batch was Used ............................ 549 
16.1.7 
Randomization Scheme and Codes (Subject Identification and Treatment 
Assigned) .................................................................................................... 550 
16.1.8
Audit Certificates ....................................................................................... 551
16.1.9 
Documentation of Statistical Methods ....................................................... 552 
16.1.10 
Documentation of Interlaboratory Standardization Methods and Quality 
Assurance Procedures if Used .................................................................... 577 
16.1.11 
Publications Based on the Study ................................................................ 578 
16.1.12 
Important Publications Referenced in the Report ...................................... 579 
16.2
DATA LISTINGS ........................................................................................... 580
16.2.1
Discontinued Subjects ................................................................................ 581
16.2.2
Protocol Deviations .................................................................................... 590
16.2.3 
Subjects Excluded From the Analyses ....................................................... 610 
16.2.4 
Demographic Data ...................................................................................... 611 
16.2.5 
Compliance and/or Drug Concentration Data ............................................ 631 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.2.6
Individual Pharmacokinetic Response Data ............................................... 679 
16.2.7 
Adverse Event Listings (Each Subject) ...................................................... 786 
16.2.8 
Listing of Individual Laboratory Measurements by Subject ...................... 797 
16.3
CASE REPORT FORM S .............................................................................1697 
16.3.1 
Case Report Forms for Deaths, Serious Adverse Events, and Withdrawals 
for Adverse Events ................................................................................... 1698 
16.3.2 
Other Case Report Forms Submitted ........................................................ 1699 
16.4 
INDIVIDUAL SUBJECT DATA LISTINGS ............................................... 1700 
16.5
BIOANALYTICAL REPOR T ......................................................................1701 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
LIST OF IN-TEXT TABLES 
Table 6-1 
Individuals Responsible for Study Conduct .................................................... 20 
Table 9-1 
Investigational Products Used in the Study ..................................................... 30 
Table 9-2 
Excipients of TPOXX® Capsule ...................................................................... 31 
Table 9-3 
Schedule of Events........................................................................................... 38 
Table 10-1 
Summary of Subject Disposition (Enrolled Population) ................................. 48 
Table 10-2 
Summary of Subject Demographics and Baseline Characteristics (Safety 
Population) ....................................................................................................... 50 
Table 10-3 
Study Drug Administration (Enrolled Population) .......................................... 52 
Table 11-1 
Mean (CV) Plasma Pharmacokinetic Parameters of TPOXX (Pharmacokinetic 
Population) ....................................................................................................... 56 
Table 12-1 
Overall Summary of Adverse Events (Safety Population) .............................. 60 
Table 12-2 
Adverse Events by System Organ Class and Preferred Term (Safety 
Population) ....................................................................................................... 61 
LIST OF IN-TEXT FIGURES 
Figure 11-1 
Mean Plasma Concentrations of TPOXX Versus Time: Day 1 (Linear and 
Semilogarithmic Scales) (Pharmacokinetic Population) ................................. 53 
Figure 11-2 
Mean Plasma Concentrations of TPOXX Versus Time: Day 7 (Linear and 
Semilogarithmic Scales) (Pharmacokinetic Population) ................................. 54 
Figure 11-3 
Mean (±SD) Plasma Trough Concentrations of TPOXX Versus Time (Linear 
and Semilogarithmic Scales) (Pharmacokinetic Population) ........................... 55 
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4.
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
ABBREVIATION 
TERM 
AE 
adverse event 
AUC0-12 
area under the plasma concentration versus time curve from time 0 
to 12 hours postdose 
AUC0-24 
area under the plasma concentration versus time curve from time 0 
to 24 hours postdose 
AUC0-inf 
area under the plasma concentration versus time curve from time 0 
extrapolated to infinity 
AUC0-t 
area under the plasma concentration versus time curve from 
time 0 to the last quantifiable measurement 
AUC0-tau 
area under the plasma concentration versus time curve during the 
first dosing interval 
BCRP 
breast cancer resistance protein 
BID 
twice daily 
BLQ 
below the limit of quantification 
CFR 
Code of Federal Regulations 
CL/F 
apparent total body clearance 
Cmax 
maximum observed plasma drug concentration 
Ctrough 
concentration observed prior to the next dose administration 
CV 
coefficient of variation 
CYP 
cytochrome P450 
DAIDS 
Division of Acquired Immune Deficiency Syndrome 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
ED 
early discontinuation 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
HBsAg 
hepatitis B surface antigen 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IRB 
institutional review board 
ISM 
independent safety monitor 
MedDRA 
Medical Dictionary for Regulatory Activities 
NDA 
New Drug Application 
PK 
pharmacokinetic(s) 
PT 
preferred term 
QTcB 
QT interval corrected using Bazett’s formula 
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ABBREVIATION 
TERM 
QTcF 
QT interval corrected using Fridericia’s formula 
SAE 
serious adverse event 
SOC 
system organ class 
t1/2 
terminal elimination half-life 
Tmax 
time to reach Cmax 
TRAE 
treatment-related adverse event 
US 
United States 
Vd/F 
apparent volume of distribution 
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5.
ETHICS
5.1
INSTITUTIONAL REVIEW BOARD 
The original study protocol, dated 19 February 2019, Amendment 1, dated 27 June 2019, and 
Amendment 2, dated 02 August 2019, were submitted to the institutional review board (IRB; 
ADVARRA) for ethical review. Approval was obtained in writing before the study began. All 
changes to the protocol were approved by the IRB before implementation. 
The original protocol and Amendments 1 and 2 are presented in Appendix 16.1.1. A sample 
electronic case report form (eCRF) is presented in Appendix 16.1.2. The IRB information is 
presented in Appendix 16.1.3. 
5.2 
ETHICAL CONDUCT OF THE STUDY 
The investigator agreed to conduct the study according to the principles of the International 
Council for Harmonisation (ICH) harmonised tripartite guideline E6(R2): Good Clinical 
Practice. The investigator performed all aspects of this study in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, the protocol, and all national, 
state, and local laws or regulations. 
5.3 
SUBJECT INFORMATION AND CONSENT 
A written informed consent in compliance with United States (US) Title 21 Code of Federal 
Regulations (CFR) Part 50 was obtained from each subject before entering the study and 
before any study-related assessment or procedure was performed. The informed consent form 
(ICF) was submitted by the investigator to the IRB for review and approval before the start of 
the study. 
Subjects that enrolled and completed the study before 23 Sep 2019, signed the original ICF, 
dated 13 Jun 2019 and a second version of the ICF, dated 23 Jul 2019. Subjects that were 
enrolled in the study prior to 23 Sep 2019 but were still actively participating in the study on 
23 Sep 2019, signed the second version of the ICF, dated 23 Jul 2019, and also signed the 
new ICF, dated 23 Sep 2019. Subjects that were enrolled in the study on or after 23 Sep 2019 
only signed the new ICF, dated 23 Sep 2019. 
Before recruitment and enrollment, each prospective subject was given a full explanation of 
the study and was required to read the approved ICF. Once the investigator was assured that 
the subject understood the implications of participating in the study, the subject was asked to 
give consent to participate in the study by signing the ICF and received a signed and dated 
copy. A copy of the ICF is provided in Appendix 16.1.3. 
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6.
INVESTIGATORS AND STUDY ADMINISTRATIVE
STRUCTURE
This was a single-center study conducted by the principal investigator, 
 
 
The investigator’s curriculum vitae is presented in Appendix 16.1.4. 
The following laboratories were used: 
Clinical Laboratory: 
PPD Central Laboratory 
7551 Metro Center Drive, Suite 200 
Austin, TX 78744. 
Bioanalytical Laboratory: 
Alturas Analytics, Inc. 
1324 Alturas Drive 
Moscow, ID 83843. 
PPD served as the contract research organization for this study and was responsible for 
program and project management, clinical and pharmacovigilance for safety reporting, 
clinical monitoring, medical monitoring, medical writing, clinical data management, 
pharmacokinetic (PK) and biostatistical plan and analysis, and final reporting. The 
individuals involved either in coordination of the study or in analysis and reporting of results 
are presented in Table 6-1. 
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Table 6-1 
Individuals Responsible for Study Conduct 
Name 
Title 
Duties 
 
Principal Investigator 
Responsible for study conduct and 
supervision of study staff and subjects 
 
 
Medical Monitor 
Medical monitoring 
 
 
Senior Project Manager 
Overall management of the study 
 
 
Project Manager 
Management of the study conduct and 
liaison with biostatistics, medical writing, 
and clinical laboratory personnel 
 
Biostatistician 
Development of statistical analysis plan 
and analysis of statistical data 
 
Pharmacokineticist 
Analysis of pharmacokinetic data 
 
Clinical Data Manager 
Responsible for data management 
 
Senior Clinical Research 
Associate 
Responsible for clinical research associate 
and monitoring activities 
 
Medical Writer 
Preparation of clinical study protocol 
 
Medical Writer 
Preparation of clinical study report 
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7.
INTRODUCTION
Historically, variola virus (VARV), the etiologic agent of smallpox, has been one of the more 
important human pathogens. Smallpox is highly communicable and carries exceptionally 
high morbidity. Secondary attack rates from 30% to 80% have been reported among 
unvaccinated members of households.1 Mortality rates range from 1% for variola minor to 
30% for variola major.1 With the advent of biowarfare as an instrument of terrorism, 
smallpox can no longer be thought of as a disease only of historic impact. 
In July 2018, the US Food and Drug Administration (FDA) approved the oral formulation of 
TPOXX for the treatment of patients with smallpox disease caused by VARV. 
This study was conducted as an FDA post marketing commitment to the approved New Drug 
Application (NDA) for TPOXX (NDA 208,627). SIGA was required to conduct a study to 
determine the PK profile of TPOXX in subjects with a body weight greater than 120 kg to 
determine if a change in TPOXX dosing regimen would be needed in these patients. 
8.
STUDY OBJECTIVES
8.1 
PRIMARY OBJECTIVE 
The primary objective of this study was to determine the PK profile of 600 mg oral TPOXX 
(3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing 
more than 120 kg to determine if a change in TPOXX dosing regimen would be needed in 
these patients. 
8.2 
SECONDARY OBJECTIVE 
The secondary objective of this study was to evaluate the safety and tolerability of 600 mg 
oral TPOXX administered BID for 7 days in adult subjects weighing more than 120 kg. 
9.
INVESTIGATIONAL PLAN
9.1 
OVERALL STUDY DESIGN AND PLAN 
This was an open-label, multiple-dose study to assess the safety, tolerability, and PK of 
TPOXX 600 mg BID when administered orally for 7 days to adult subjects weighing more 
than 120 kg. A total of 34 subjects, aged 20 to 50 years, inclusive, were enrolled. The study 
consisted of a screening period (Day –28 to –2), a treatment and confinement period  
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]). 
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Subjects underwent screening evaluations to determine eligibility within 28 days before study 
drug administration. Subjects were admitted to the study site on Day –1 to complete baseline 
assessments, the results of which were reviewed by the investigator before dosing. Starting 
on the morning of Day 1, subjects received 600 mg oral TPOXX BID for 7 days (Days 1 
through 7). 
All subjects were provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration, and subjects fasted for 2 hours after taking 
study drug. Subjects ate this meal within 30 minutes or less of taking study drug. Study drug 
and meals were taken with water only, and no other beverage except water was ingested 
within 3 hours before and 3 hours after study drug administration. 
Subjects remained confined to the study site for collection of PK samples and were carefully 
monitored for safety and tolerability until discharge on Day 9. Subjects who had abnormal 
physical examination findings or an ongoing adverse event (AE)/serious AE (SAE) on Day 9 
that was deemed related to study drug or per investigator or SIGA discretion, returned to the 
study site on Day 14 (+2 days) for a follow-up visit. All other subjects had their Day 14 
(+2 days) follow-up via a telephone call. All subjects had a follow-up telephone call 30 days 
after administration of the last dose of study drug (Day 37 [+2 days]) to report any SAEs. At 
the time of discharge from the study site, subjects were instructed to notify the investigator of 
any SAEs that occurred within 30 days after administration of the last dose of study drug. 
Serious AEs were followed until the SAE was stable or until resolution, as determined by the 
investigator and/or medical monitor. 
The total duration of the study for each subject, including the screening period, treatment and 
confinement period, and the Day 37 (+2 days) follow-up telephone call, was approximately 
65 days. 
9.2 
DISCUSSION OF STUDY DESIGN, INCLUDING THE 
CHOICE OF CONTROL GROUPS 
This study included the recognized elements of a well-controlled nonrandomized clinical 
study. 
This study was being conducted as an FDA post marketing commitment to the approved 
NDA for TPOXX (NDA 208,627). SIGA was required to conduct a study to determine the 
PK profile of TPOXX in subjects with a body weight greater than 120 kg to determine if a 
change in TPOXX dosing regimen would be needed in these patients. 
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9.3 
SELECTION OF STUDY POPULATION 
9.3.1 
Inclusion Criteria 
For inclusion in the study, each subject was required to meet all of the following criteria: 
1. Subject was male or female between 18 and 50 years of age, inclusive.
2. Subject had a body weight >120 kg at screening, at check-in on Day –1, and prior to
dosing on Day 1.
3. Women of childbearing potential had a negative β human chorionic gonadotropin
pregnancy test (serum) at the screening visit and a confirmatory negative serum
pregnancy test on Day –1 before receipt of study drug, and met at least 1 of the following
criteria:
a.
The subject and their partner had undergone surgical sterilization.
b. The subject was postmenopausal, defined as 12 consecutive months with no menses
without an alternative medical cause and had a documented plasma
follicle-stimulating hormone (FSH) level >40 IU/mL.
c.
The subject agreed to be abstinent (i.e., heterosexually inactive or women in a
religious order).
d. The subject agreed to consistently use 1 of the following methods of contraception
from the beginning of screening (which they had been consistently using for at least
30 days before the first dose of study drug) through 30 days after the last dose of
study drug:
i.
Condoms, male or female, with a spermicide.
NOTE: For male subjects, condoms must have been used for 90 days after the last
dose of study drug.
ii. Diaphragm or cervical cap with spermicide.
iii. Intrauterine device with spermicide.
iv. Oral contraceptives or other hormonal methods.
NOTE: Subject must have agreed to use an additional nonhormonal method of
contraception in conjunction with oral contraceptives.
v. Male sexual partner who had undergone a vasectomy at least 3 months before
screening.
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4. If male, subject agreed not to donate sperm from the first dose of study drug through
90 days after the last dose of study drug.
5. Subject was considered by the investigator to be in good general health as determined by
medical history (no hospitalizations for chronic medical conditions in the previous
2 years), clinical laboratory results, vital sign measurements, 12-lead electrocardiogram
(ECG) results, and physical examination findings at screening.
6. Subject agreed to comply with all protocol requirements.
7. Subject was able to provide written informed consent.
8. Subject agreed to comply with the dietary requirements.
9. Subject did not intend to lose weight (diet or weight loss) from the screening visit and
throughout the study.
9.3.2 
Exclusion Criteria 
Any of the following was regarded as a criterion for exclusion of a subject from the study: 
1. Subject was a female who was pregnant or breastfeeding or planning to become pregnant
within 3 months after the last dose of study drug.
2. Subject had a history of any clinically significant conditions including:
•
Asthma treated with oral systemic steroids within the past 6 months.
•
Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes.
•
Thyroidectomy or thyroid disease that required medication within the past 12 months.
•
Serious angioedema episodes within the previous 3 years or required medication in
the previous 2 years.
•
Head trauma resulting in a diagnosis of traumatic brain injury other than concussion.
•
Frequent episodes of headache.
3. Subject had received treatment in another clinical study of an investigational drug (or
medical device) within 30 days or 5 half-lives (whichever was longer) before the first
dose of study drug.
4. Subject had been previously enrolled in any clinical study involving TPOXX
(tecovirimat).
5. Subject had a history of relevant drug and/or food allergies (i.e., allergy to tecovirimat or
excipients, or any significant food allergy that could have precluded a standard diet at the
study site).
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6. Subject had any condition that could have possibly affected drug absorption
(e.g., previous surgery on the gastrointestinal tract, including removal of parts of the
stomach, bowel, liver, gallbladder, or pancreas, with the exception of appendectomy).
7. Subject had evidence or history of clinically significant allergic (except for untreated,
asymptomatic, seasonal allergies at the time of the first dose of study drug)
hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
psychiatric, or neurological disease. An exception to this criterion (e.g., stable, mild joint
disease unassociated with collagen vascular disease) could have been made following
discussions with the medical monitor.
8. Subject had a history of cardiac disease, symptomatic or asymptomatic arrhythmias,
syncopal episodes, or risk factors for torsades de pointes (e.g., heart failure,
hypokalemia).
9. Subject had a family history of sudden cardiac death not clearly due to acute myocardial
infarction.
10. Subject had a seizure disorder or history of seizures (not including childhood febrile
seizures) or a past history that increased seizure risks such as significant head injury that
caused loss of consciousness or other changes in the subject’s daily function, concussion,
stroke, central nervous system infection or disease, or alcohol or drug abuse, or family
history or idiopathic seizures.
11. Subject had a history of a peptic ulcer or significant gastrointestinal bleed.
12. Subject had a bleeding disorder diagnosed by a doctor (e.g., factor deficiency,
coagulopathy, or platelet disorder requiring special precautions) or significant bruising or
bleeding difficulties with blood draws.
13. Subject had a malignancy that was active, or treated malignancy for which there was not
a reasonable assurance of sustained cure, or malignancy that was likely to recur during
the period of the study (subject should have been in complete remission for at least
5 years).
14. Subject had neutropenia or other blood dyscrasia determined to be clinically significant
by the investigator.
15. Subject had used any of the following prohibited medications from within 7 days (or
5 half-lives; whichever was longer) before the first dose of study drug: antidiabetic
medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance
protein (BCRP) transporter including methotrexate, mitoxantrone, imatinib, irinotecan,
lapatinib, rosuvastatin, sulfasalazine, and topotecan; substrates of cytochrome P450
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(CYP) 2C8 including repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; 
and substrates of CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, 
voriconazole, lansoprazole, and omeprazole. Medications not listed here that were known 
(or thought) to be CYP3A4 substrates may have been allowed at the investigator’s 
discretion, after consultation with the medical monitor, if administration posed little to no 
risk to the subject. 
16. Subject had a history of drug or alcohol abuse or dependency within the last year before
screening.
17. Subject had a history of an eating disorder.
18. Subject had a current or recent (<30 days before screening) history of clinically
significant bacterial, fungal, or mycobacterial infection.
19. Subject had a current clinically significant viral infection.
20. Subject had a known clinically significant chronic viral infection (e.g., human T cell
lymphotropic virus I or II).
21. Subject had consumed grapefruit or grapefruit juice, Seville orange or Seville
orange-containing products (e.g., marmalade), or caffeine- or xanthine-containing
products within 48 hours before the first dose of study drug or throughout the study.
22. Subject had used any prescription (excluding hormonal birth control) or over-the-counter
medication (including herbal or nutritional supplements) within 14 days before the first
dose of study drug.
23. Subject demonstrated long-term use (≥14 consecutive days) of glucocorticoids including
oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose
inhaled steroids (>800 mcg/day or beclomethasone dipropionate or equivalent) within the
preceding 1 month (low dose [≤800 mcg/day of beclomethasone dipropionate or
equivalent] inhaled and topical steroids were allowed).
24. Subject had donated >450 mL blood or blood components within 30 days before the first
dose of study drug. The investigator instructed subjects who participated in this study not
to donate blood or blood components for 4 weeks after the completion of the study.
25. Subject was a smoker or had used nicotine or nicotine-containing products
(e.g., cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine
patches, or nicotine gum) within 6 months before the first dose of study drug.
26. Subject had consumed pomegranate or pomegranate juice, pomelo fruits or pomelo juice,
or alcohol within 72 hours before the first dose of study drug.
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27. Subject reported participation in strenuous activity or contact sports within 24 hours
before the first dose of study drug.
28. Subject had known hepatitis B or C infection or positive test for hepatitis B surface
antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus
(HIV) type 1 or 2 antibodies at screening.
29. Subject had a positive test result for amphetamines (including methamphetamines and
ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids
(including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin, codeine,
and oxycodone), or alcohol at screening or check-in.
30. Subject had any of the following laboratory test results within 28 days before the first
dose of study drug:
•
Estimated serum creatinine clearance (Cockcroft-Gault) <90 mL/min.
•
Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper
central laboratory reference range).
•
Hemoglobin ≤10% of the lower central laboratory reference range.
•
White blood cell count not within the central laboratory reference range.
•
Absolute neutrophil count <1000 cells/mm3.
•
Platelets not within ±10% of central laboratory reference range.
•
Alanine aminotransferase >1.5 times above the upper central laboratory reference
range.
•
Aspartate aminotransferase >1.5 times above the upper central laboratory reference
range.
•
Alkaline phosphatase >20% above the upper central laboratory reference range.
•
Hemoglobin A1c ≥7.0%.
•
Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL.
31. Subject had a blood pressure considered to be clinically significant by the investigator.
Blood pressure could have been retested twice in the sitting position at 5-minute intervals.
32. Subject had a resting heart rate of <40 beats per minute or >100 beats per minute at
screening.
33. Subject had an abnormal ECG at screening that was determined by the investigator to be
clinically significant.
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34. Male subject had a QT interval corrected using Fridericia’s formula (QTcF) >450 ms or
female subject had a QTcF >470 ms at screening or Day –1.
35. In the opinion of the investigator, the subject was not suitable for entry into the study.
9.3.3 
Subject Restrictions During the Study 
Subject must have been willing to remain confined at the study site from check-in (Day –1) 
until safety assessments were completed on Day 9. Subjects who had abnormal physical 
examination findings or an ongoing AE/SAE on Day 9 that was deemed related to study drug 
or per investigator or SIGA discretion, returned to the study site on Day 14 (+2 days) for a 
follow-up visit. 
9.3.4 
Removal of Subjects From the Study 
Reasons for Withdrawal 
Subject could withdraw consent and discontinue from the study at any time, for any reason, 
without prejudice to further treatment. 
The investigator may have withdrawn a subject from the study for any of the following: 
•
The subject was in violation of the protocol.
•
The subject experienced a serious or intolerable AE.
•
The subject became pregnant.
•
The subject was noncompliant.
•
The subject had laboratory abnormalities for assessments listed in Sections 9.3.1 or
9.3.2 that met Grade 3 or 4 on the Division of Acquired Immune Deficiency
Syndrome (DAIDS) AE Grading Table, version 2.1 July 2017; or any other Grade 3
or 4 AE; or a Grade 2 or higher rash considered by the investigator to be possibly,
probably, or definitely related to study drug.
•
The subject developed, during the course of the study, symptoms or conditions listed
in the exclusion criteria (Section 9.3.2).
•
The subject required a medication prohibited by the protocol.
•
The subject requested an early discontinuation for any reason.
•
The subject’s primary care provider requested that the subject be withdrawn.
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•
The independent safety monitor (ISM), SIGA, or the FDA requested subject
withdrawal based on study safety findings.
Handling of Withdrawals 
Subjects were free to withdraw from the study at any time upon request. Subject participation 
in the study may have been stopped at any time at the discretion of the investigator or at the 
request of SIGA. 
In the event that a subject withdrew from the study, the reason(s) for withdrawal were to be 
recorded by the investigator in the eCRF. Wherever possible, any subject who withdrew from 
the study were to prematurely undergo all Day 9/early discontinuation assessments 
(Table 9-3). Any subject who failed to return for final assessments was to be contacted by the 
study site personnel in an attempt to have them comply with the protocol. The status of 
subject who failed to complete final assessments was to be documented in the eCRF. 
Halting Rules 
The medical monitor, investigator, SIGA, and ISM reviewed all AEs. All AEs determined by 
the investigator to be severe and possibly, probably, or definitely related to study drug, as 
well as all clinical assessments, laboratory test results, ECG results, or vital sign 
measurements that met Grade 3 criteria based on the DAIDS AE Grading Table were 
assessed by the medical monitor, who made a recommendation as to whether or not halting of 
the study should have occurred. At the discretion of the medical monitor, depending on the 
assessment of the severity of the event, the recommendation to halt the study may have been 
made after consultation with the investigator, SIGA, and the ISM. 
The study was to be temporarily halted (no new enrollments and no further study drug 
administration) by the investigator and the medical monitor, SIGA, and the ISM were 
promptly notified according to the following criteria: 
•
One subject experienced a Grade 4 AE assessed as possibly, probably, or definitely
related to study drug.
•
There was a subject death assessed as possibly, probably, or definitely related to study
drug.
•
One subject experienced a seizure assessed as possibly, probably, or definitely related
to study drug.
•
Two or more subjects experienced the same or similar SAEs that were assessed as
possibly, probably, or definitely related to study drug.
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•
Three or more subjects experienced the same or similar AEs that were Grade 3 or
above and were assessed as possibly, probably, or definitely related to study drug.
Study enrollment and study drug administration were only to resume if the review of the AEs 
that caused the halt, resulted in the recommendation to permit further continuation. In such an 
instance, SIGA, with participation by the investigator and the medical monitor, were to 
consult with the ISM to conduct the review of all AEs that met the criteria for halting the 
study. The study was to remain suspended until the events were reviewed by the ISM and a 
recommendation was made as to whether the study should have been continued or stopped. 
This constituted a minimum criterion, and the decision to halt the study may have been made 
based on any other criteria that, in the judgment of the investigator with agreement of the 
medical monitor and ISM, indicated a potentially serious safety concern. The investigator 
advised SIGA immediately if any of the halting rules had been met. 
This study was not halted. 
Replacements 
At the discretion of the investigator, and after consultation with the medical monitor, any 
subject who withdrew before completing the study may have been replaced to retain the 
target of 32 evaluable enrolled subjects. 
9.4 
TREATMENT 
9.4.1 
Treatment Administered 
On Days 1 to 7, all subjects received an oral dose of TPOXX 600 mg (3 × 200-mg capsules) 
BID, approximately 12 hours (±30 minutes) apart, for 7 days within 30 minutes of 
completing a meal consisting of approximately 600 calories and 25 g of fat. 
9.4.2 
Identity of Investigational Product 
The investigational product used in the study is presented in Table 9-1. 
Table 9-1 
Investigational Products Used in the Study 
Product 
Formulation 
Lot Number 
TPOXX® 
200-mg capsule
 
TPOXX was supplied as 200-mg capsules containing tecovirimat monohydrate as the active 
pharmaceutical ingredient. The TPOXX capsules were immediate release, size 0, orange and 
black, hard gelatin capsules containing white to off white powder. All inactive 
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ingredients/excipients are generally recognized as safe and were US Pharmacopeia/National 
Formulary grade. The TPOXX excipients are presented in Table 9-2. 
Table 9-2 
Excipients of TPOXX® Capsule 
Component 
Quality Designation 
 
 
 
 
 
 
 
 
USP
 
. 
(a) Microcrystalline cellulose and croscarmellose sodium were added as intragranular and extragranular
excipients.
(b) Removed during processing.
Compendial components were tested and released in accordance with full compendial 
methods and specifications before their use in clinical formulations. TPOXX 200-mg 
capsules were manufactured and analyzed for clinical use in accordance with Current Good 
Manufacturing Practices by Catalent Pharma Solutions (Winchester, KY). Further 
information on TPOXX can be found in the TPOXX full prescribing information.2 
9.4.3 
Method of Assigning Subjects to Treatment Group 
This was an open-label, nonrandomized study. All subjects who fulfilled the eligibility 
criteria and provided written informed consent were enrolled in the study and received an 
oral dose of TPOXX 600 mg (3 × 200-mg capsules) BID for 7 days. 
9.4.4 
Selection of Doses in the Study 
The rationale for selection of the TPOXX dose used in this study was based on a strong 
safety profile observed with 600 mg tecovirimat BID oral dosing. This dose was considered 
appropriate for evaluation of tecovirimat PK profiles in subjects weighing at least 120 kg. 
9.4.5 
Selection and Timing of Dose for Each Subject 
All subjects were provided meals consisting of approximately 600 calories and 25 g fat, 
30 minutes before oral TPOXX administration. Subjects were to eat this meal within 
30 minutes or less of taking TPOXX. TPOXX was administered approximately 30 minutes 
after the start of the meal. All doses were administered to subjects by study site personnel 
with approximately 240 mL of water. Subjects fasted for 2 hours after taking TPOXX. 
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Protocol No. SIGA-246-022 
Clinical Study Report 
TPOXX and meals were taken with water only, and no other beverage except water was 
ingested within 3 hours before or 3 hours after TPOXX administration. 
9.4.6 
Blinding 
This was an open-label study. 
9.4.7 
Prior and Concomitant Therapy 
Restrictions for prior and concomitant medications are provided in Sections 9.3.1 and 9.3.2. 
Information regarding prior medications taken by the subjects within the 30 days before 
signing the ICF were recorded in the subject’s eCRF. 
Any concomitant medication deemed necessary for the welfare of the subject during the 
study was given at the discretion of the investigator. If a concomitant medication listed in 
Section 9.3.2 was taken, it was documented as a protocol deviation and a joint decision was 
made by the investigator and SIGA to continue or discontinue the subject based on the time 
the medication was administered, its pharmacology and PK, and whether the use of the 
medication compromised the safety of the subject or the interpretation of the data. The 
investigator was responsible for ensuring that details regarding the medication were 
adequately recorded in both the subject’s source document and the eCRF. 
Prior and concomitant medications and therapies were coded using the World Health 
Organization Drug Dictionary (WHODrug, version March 2019 Global B3). 
9.4.8 
Treatment Compliance 
All doses of study drug were administered at the study site under direct observation of study 
site personnel and recorded in the eCRF. Per standard clinic procedure, study site personnel 
performed a mouth check and inspected all dose containers to ensure that the entire dose was 
administered. Following completion of dosing procedures and return of dosing containers to 
the pharmacy by team members, pharmacy staff followed standard clinic procedures for 
study drug reconciliation. SIGA provided information to PPD for destruction of returned used 
and unused study drug and study drug bottles. 
The date and time of study drug dosing was captured and recorded on the appropriate page of 
the eCRF. If a subject was not administered study drug, the reason for the missed dose was 
recorded. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
9.5 
PHARMACOKINETIC AND SAFETY VARIABLES 
9.5.1 
Pharmacokinetic and Safety Measurements Assessed and 
Schedule of Events 
9.5.1.1 
Pharmacokinetic Assessments 
Blood samples for the PK analysis of TPOXX were collected from all subjects on Day 1 
before study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 
18, 20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 
4 hours after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 
(before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on 
Day 7), and on Day 9 (48 hours after the AM dose on Day 7). 
For PK samples, the acceptable window for collection from the scheduled collection time 
point was as follows: ±5 minutes for the time points from 1 to 8 hours, and ±15 minutes for 
the 12- to 48-hour time points. 
9.5.1.2 
Safety Assessments 
Safety and tolerability were assessed by monitoring and recording of AEs, clinical laboratory 
test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body 
temperature), 12-lead ECG results, and physical examination findings. 
9.5.1.2.1 
Adverse Events 
The investigator was responsible for reporting all AEs observed or reported during the study 
from the first dose of study drug through the follow-up telephone call on Day 37 (+2 days), 
regardless of the relationship to study drug or clinical significance. If there was any doubt as 
to whether a clinical observation was an AE, the event was to be reported. All AEs were 
recorded on the AE page of the eCRF. 
The AE definitions, assignment of severity and causality, procedures for reporting SAEs, and 
follow-up of AEs are provided in the protocol (Appendix 16.1.1). 
9.5.1.2.2 
Clinical Laboratory Tests 
The PPD Central Laboratory performed clinical laboratory tests. Blood and urine samples for 
hematology, serum chemistry, pregnancy, urinalysis, and drug screen tests were collected at 
the time points indicated in the schedule of events (Table 9-3) and were prepared using 
standard procedures. Repeat clinical laboratory tests may have been performed at the 
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Protocol No. SIGA-246-022 
Clinical Study Report 
discretion of the investigator, if necessary, to evaluate inclusion and exclusion criteria or 
clinical laboratory abnormalities. The clinical laboratory that performed the tests provided the 
reference ranges for all clinical laboratory parameters. 
The following clinical laboratory tests were performed: 
Hematology 
Hematocrit, hemoglobin, mean corpuscular hemoglobin, mean 
corpuscular hemoglobin concentration, total and differential 
leukocyte count (basophils, eosinophils, lymphocytes, monocytes, 
neutrophils), mean corpuscular volume, platelet count, red blood cell 
count, and red blood cell distribution width 
Serum chemistry 
Alanine aminotransferase, albumin, alkaline phosphatase, anion gap, 
aspartate aminotransferase, bilirubin (total), blood urea nitrogen, 
calcium, carbon dioxide, chloride, creatinine clearance (calculated(a)), 
gamma-glutamyltransferase, globulin, glucose, lactate 
dehydrogenase, phosphorus, potassium, sodium, total protein, and 
uric acid 
Urinalysis 
Appearance, bilirubin, blood, color, glucose, ketones, leukocytes 
microscopy (performed if dipstick was ≥1+ and included bacteria, 
casts, crystals, epithelial cells, red blood cells, and white blood cells), 
nitrites, pH, protein, specific gravity, turbidity, and urobilinogen 
Serology
HBsAg, HCV antibody, and HIV types 1 and 2 (screening only) 
Other analyses 
Urine drug screen (alcohol, amphetamines [including 
methamphetamines and ecstasy/methylenedioxymethamphetamine], 
barbiturates, benzodiazepines, cannabinoids [including 
tetrahydrocannabinol], cocaine metabolites, and opiates [including 
heroin, codeine, and oxycodone]) 
(a) Creatinine clearance (CLcr) was calculated using the Cockcroft-Gault formula:
𝐶𝐿𝑐𝑟 ሺ𝑚𝐿𝑚𝑖𝑛
⁄
ሻ= [140 −𝑎𝑔𝑒ሺ𝑦𝑒𝑎𝑟𝑠ሻ] × 𝑤𝑒𝑖𝑔ℎ𝑡 ሺ𝑘𝑔ሻ
72 × 𝑠𝑒𝑟𝑢𝑚 𝑐𝑟𝑒𝑎𝑡𝑖𝑛𝑖𝑛𝑒 ሺ𝑚𝑔𝑑𝐿
⁄
ሻ{× 0.85 𝑖𝑓 𝑓𝑒𝑚𝑎𝑙𝑒} 
Glycosylated hemoglobin A1c and a fasting lipid panel including cholesterol (total, 
high-density lipoprotein, calculated low-density lipoprotein, and triglycerides) were 
performed at screening. 
A serum pregnancy test (β human chorionic gonadotropin) for women of childbearing 
potential was performed at screening and on Day –1. 
A serum FSH test for postmenopausal women was to be performed at screening. 
Human immunodeficiency virus (types 1 and 2) antibodies, HBsAg, and HCV antibody were 
assessed at screening only. 
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SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
Clinical Study Report 
Abnormal clinical laboratory values were flagged as either high or low (or normal or 
abnormal) based on the reference ranges for each laboratory parameter. The investigator 
determined whether any of the abnormally high or low results were clinically significant or 
not clinically significant. Clinical significance was defined as any variation in results that had 
medical relevance and may have resulted in an alteration in medical care (e.g., active 
observation, diagnostic measures, or therapeutic measures). If a clinically significant change 
from screening was noted, the clinically significant value and the reason for clinical 
significance was documented on the AE page of the eCRF. The investigator continued to 
monitor the subject with additional assessments until the values had reached the reference 
range or the values at screening or until the investigator determined that follow-up was no 
longer medically necessary. 
9.5.1.2.3 
Vital Sign Measurements 
Vital sign measurements included systolic and diastolic blood pressures, heart rate, 
respiratory rate, and body temperature. The subject was seated for at least 5 minutes before 
all measurements were taken. Vital sign measurements were measured at the time points 
indicated in the schedule of events (Table 9-3). 
When procedures overlapped and occurred at the same time point, the order of the procedures 
was ECG, vital sign measurements, then blood collection, with the blood collection 
scheduled to occur at the nominal time point, unless dictated by other study events happening 
at the same time, such as dosing requirements. 
The investigator determined whether any of the vital sign measurements were clinically 
significant or not clinically significant. Clinical significance was defined as any variation in 
results that had medical relevance and may have resulted in an alteration in medical care 
(e.g., active observation, diagnostic measures, or therapeutic measures). If a clinically 
significant change from screening was noted, the clinically significant value and the reason 
for clinical significance was documented on the AE page of the eCRF. The investigator 
continued to monitor the subject with additional assessments until the values had reached the 
reference range or the values at screening or until the investigator determined that follow-up 
was no longer medically necessary. 
9.5.1.2.4 
Twelve-Lead Electrocardiogram 
Single 12-lead ECGs were obtained after the subject had been in the supine position for at 
least 10 minutes at the time points indicated in the schedule of events (Table 9-3). On Days 1, 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
4, and 7, an ECG was recorded 4 hours after the AM study drug administration. The 
acceptable window for collection from the scheduled collection time point was ±15 minutes.  
Electrocardiogram assessments included comments on whether the tracings were normal or 
abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence 
of myocardial infarction, or ST-segment, T-wave, and U-wave abnormalities. In addition, the 
following parameters were measured and reported: heart rate, PR, RR, and QT intervals; 
QTcF; QT interval corrected using Bazett’s formula (QTcB); and QRS durations. All ECGs 
were performed by an experienced ECG technician. 
The investigator determined whether any of the 12-lead ECG results were clinically 
significant or not clinically significant. Clinical significance was defined as any variation in 
results that had medical relevance and may have resulted in an alteration in medical care 
(e.g., active observation, diagnostic measures, or therapeutic measures). If a clinically 
significant change from screening was noted, the clinically significant value and the reason 
for clinical significance was documented on the AE page of the eCRF. The investigator 
continued to monitor the subject with additional assessments until the values had reached the 
reference range or the values at screening or until the investigator determined that follow-up 
was no longer medically necessary. 
9.5.1.2.5 
Physical Examination 
A full physical examination was performed at the time points indicated in the schedule of 
events (Table 9-3). The examination included assessment of the following body systems: 
head, ears, eyes, nose, throat; cardiac (including auscultation of heart); pulmonary (chest) 
auscultation of lungs; abdomen; skin; musculoskeletal system; lymphatic system; and 
neurologic system (cranial nerves, sensation, motor function, coordination, reflexes, and 
mental status). 
A symptom-directed physical examination was performed at the time points indicated in the 
schedule of events (Table 9-3) for those subjects who required it, and at unscheduled visits, as 
necessary. This examination included an assessment of the heart, lungs, abdomen, a 
neurologic review, and a review of symptoms for assessments and/or follow-up of reported or 
potential AEs. 
Weight was measured without shoes and in light clothing at screening and without shoes and 
in hospital gowns at all other time points indicated in the schedule of events (Table 9-3). The 
scale was calibrated prior to the start of the study and did not require recalibration during use 
in the study (per the manufacturer, the scale was recommended for recalibration twice 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
yearly). The same weight scale was used throughout the study starting with screening and 
through Day 9. Weight measurements were rounded to 1 decimal place. Height was measured 
at check-in on Day –1. 
9.5.1.2.6 
Other Safety Measures 
At this time, there is no definitive information on allergic activity of TPOXX. Reactogenicity 
was monitored in subjects during the study treatment and confinement period. 
Pregnant women were not eligible to participate in the study. Pregnancy reporting 
procedures, follow-up of pregnancy in female subjects, and procedures for events wherein the 
partner of male subjects become pregnant are provided in the protocol (Appendix 16.1.1). 
There were no pregnancies reported during the study. 
A complete medical history was obtained, including a review of systems, recreational drug 
use, prescription drug use, over-the-counter drug use, nicotine and alcohol use, and past 
hospitalizations. 
9.5.1.3 
Schedule of Events 
The schedule of events is presented in Table 9-3.
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Table 9-3 
Schedule of Events 
Screening 
Check-in 
Treatment and Confinement Period 
Telephone 
Call or 
Follow-up 
Visit(a) 
Follow-up 
Telephone 
Call(b) 
Procedure(c) 
Day 
–28 to –2
–1
1 
2 
3 
4 
5 
6 
7 
8 
9 or Early 
Discontinuation 
14 (+2) 
37 (+2) 
Admission to the clinic 
X 
Discharge from the clinic(d)
 
X
Informed consent
X
Inclusion/exclusion criteria 
X 
X 
Medical history(e)
X
X
Complete physical examination(f) 
X 
X 
 
X 
X 
Weight(g)
X 
X
X(h) 
 
X 
Height
X
Vital sign measurements(i)
X 
X
X(j) 
 
 
X(j) 
 
 
X(j) 
X 
X 
X(k)
Glycosylated hemoglobin (HbA1c) 
X 
Fasting lipid panel(l)
X
Clinical laboratory testing(m)
X(n) 
X 
X 
 
X(o)
X(n)
Serum FSH test(p)
X
Serum pregnancy test(q)
X 
X
Urine drug/alcohol screen(r)
X 
X
Serology (HBsAg, HCV, and HIV) 
X 
12-lead ECG(s)
X 
X 
X
 
X
 
X 
X 
TPOXX administration(t) 
X 
X 
X 
X 
X 
X 
X 
Pharmacokinetic sampling(u) 
X 
X 
X 
X 
X 
X 
Symptom-directed physical 
examination(v) 
X 
X 
X 
X 
X 
X(k)
Adverse events 
X 
Prior/concomitant medications 
X 
Abbreviations: AE, adverse event; BID, twice daily; ECG, electrocardiogram; FSH, follicle-stimulating hormone; HbA1c, glycosylated hemoglobin; HBsAg, 
hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; PK, pharmacokinetic; SAE, serious adverse event. 
(a) The follow-up visit or telephone call occurred on Day 14 (+2 days), 7 days after the last dose of study drug. Subjects who had abnormal physical examination
findings or an ongoing AE/SAE at Day 9 that was deemed related to study drug or per the investigator or SIGA discretion, returned to the study site on Day 14
(+2 days) for a follow-up visit. All other subjects had the Day 14 (+2 days) follow-up via a telephone call.
(b) The follow-up telephone call was made 30 days after the last dose of study drug (Day 37 [+2 days]).
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
(c) When procedures overlapped and occurred at the same time point, the order of procedures was ECG, vital sign measurements, and then blood collection, with
the blood collection scheduled to occur at the nominal time point, unless dictated by other study events happening at that time, such as dosing requirements.
(d) Discharge occurred following collection of all safety assessments.
(e) Included a review of systems; recreational drug use, prescription drug use, and over-the-counter drug use; nicotine and alcohol use; and past hospitalizations.
(f) Included an assessment of the following body systems: head, ears, eyes, nose, and throat; cardiac (including auscultation of heart); pulmonary (chest)
auscultation of the lungs; abdomen; skin; musculoskeletal system; lymphatic system; and neurologic system (cranial nerves, sensation, motor function,
coordination, reflexes, and mental status).
(g) Weight was measured without shoes and in light clothing at screening and without shoes and in hospital gowns at all other time points. The scale was
calibrated prior to the start of the study and did not require recalibration during use in the study (per the manufacturer, the scale was recommended for
recalibration twice yearly). The same weight scale was used throughout the study starting with screening and through Day 9. Weight measurements were
rounded to 1 decimal place.
(h) Weight was collected prior to dosing.
(i) Vital sign measurements included systolic and diastolic blood pressures, heart rate, respiratory rates, and body temperature. Vital signs were measured after
the subject had been seated for at least 5 minutes.
(j) Vital sign measurements were performed before dosing and 4 hours after the AM study drug administration on Days 1 and 7, and 4 hours after the AM study
drug administration on Day 4. The acceptable window for collection from the scheduled collection time point was ±15 minutes.
(k) Collected only if subjects were required to return to the study site on Day 14 (+2 days) for a follow-up visit.
(l) Included cholesterol (total, high-density lipoprotein, calculated low-density lipoprotein, and triglycerides).
(m) Clinical laboratory testing included hematology and serum chemistry.
(n) Clinical laboratory testing at screening and at Day 9 or early discontinuation included hematology, serum chemistry, and urinalysis.
(o) Collected 12 hours after the PM study drug administration on Day 7.
(p) For postmenopausal women, a serum FSH test was performed at screening.
(q) Women of childbearing potential only.
(r) Included alcohol, amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids
(including tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, codeine, and oxycodone).
(s) A 12-lead ECG was collected after the subject had been in the supine position for at least 10 minutes. On Days 1, 4, and 7, an ECG was recorded 4 hours after
the AM study drug administration. The acceptable window for collection from the scheduled collection time point was ±15 minutes.
(t) TPOXX, 600 mg (3 × 200-mg capsules) was administered orally BID, approximately 12 hours (±30 minutes) apart on Days 1 through 7. All subjects were
provided meals consisting of approximately 600 calories and 25 g fat, which started 30 minutes before study drug administration. Subjects ate this meal
within 30 minutes or less of taking study drug. Study drug was administered approximately 30 minutes after the start of the meal. All doses of study drug were
administered to subjects by study site personnel with approximately 240 mL of water. Subjects fasted 2 hours after taking study drug. Study drug and meals
were taken with water only, and no other beverage except water was ingested within 3 hours before or 3 hours after study drug administration.
(u) Blood samples for the PK analysis of TPOXX were collected from all subjects at the following time points: on Day 1 before study drug administration
(0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours
after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the
AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7). For PK blood samples, the acceptable window for collection from the scheduled
collection time point was as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes for the 12- to 48-hour time points.
(v) Included an assessment of heart, lungs, abdomen, a neurologic review, and a review of symptoms for assessment and/or follow-up of reported or potential
AEs.
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SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
Clinical Study Report 
9.5.2 
Appropriateness of Measurements 
The PK evaluation in this study used the standard accepted methods to describe the PK 
profile of a drug in plasma in accordance with US FDA Guidance for Industry on 
Bioanalytical Method Validation.3 The safety assessments performed were standard and are 
recognized as reliable, accurate, and relevant. 
9.5.3 
Pharmacokinetic Variables 
9.5.3.1 
Pharmacokinetic Variables 
The individual plasma concentration versus actual time data for TPOXX were used to derive 
the PK parameters, by noncompartmental methods using Phoenix® WinNonlin® Version 8.0 
(Certara USA, Inc., Princeton, NJ): 
Parameter 
Day(s) 
Definition 
AUC0-t 
1, 7 
Area under the plasma concentration versus time curve (AUC) from 
time 0 to the last quantifiable measurement, calculated using the 
linear trapezoidal rule. 
AUC0-t = 
, where Ci and Ci-1 was the 
plasma concentration at ti and ti-1, respectively, and ti-ti-1 was the 
time interval.
 
AUC0-24 
1, 7 
AUC from time 0 to 24 hours postdose, calculated using the linear 
trapezoidal rule. 
AUC0-tau 
1, 7 
AUC during the first dosing interval (tau = 12 hours). 
AUC0-inf 
7 
AUC from time 0 extrapolated to infinity, calculated using the linear 
trapezoidal rule,  
AUC0-inf= AUC0-t + Clast/λz, where Clast was the last quantifiable 
plasma drug concentration and λz was the terminal elimination rate 
constant. 
%AUCextrap 
7 
Percentage of AUC0-inf extrapolated from the last quantifiable 
measurement to infinity. 
Cmax 
1, 7 
Maximum observed plasma drug concentration. 
Tmax 
1, 7 
Time to reach Cmax. 
λz 
1, 7 
Terminal elimination rate constant. 
t1/2 
1, 7 
Terminal elimination half-life, calculated as t1/2 = ln2/λz. 
CL/F 
7 
Apparent total body clearance, calculated as: Dose/AUC0-tau. 
Vd/F 
7 
Apparent volume of distribution, calculated as: CL/F/λz. 
Ctrough 
1, 2, 6, 7 
Concentration observed prior to the next dose administration 

=
−
−
−
+
n
i
i
i
i
i
t
t
C
C
1
1
1
)
(
2
)
(
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
9.5.4 
Drug Concentration Measurements 
Blood samples (approximately 5 mL) for the determination of plasma concentrations of 
TPOXX were collected in 5-mL lavender-topped K3EDTA Vacutainer® tubes using a 
21 gauge or larger needle, or from an indwelling intravenous catheter using a vacutainer tube. 
Blood samples were placed on wet ice or equivalent (approximately 4ºC to 8ºC) and kept at 
this temperature until processed to separate plasma. 
The exact time and date of sample collection was recorded for each sample by the 
investigator or designee in the subject’s eCRF, the vacutainer and cryovial labels, and the 
specimen shipping log. In addition, the time of study drug administration before PK sampling 
was recorded in the subject’s eCRF. Labels were created by the site which contained the 
protocol number, matrix (plasma), subject number, date, and time drawn. For information that 
was not preprinted on the label, a fine tipped indelible marking pen was used to complete the 
entry. 
The 5-mL blood sample was centrifuged in a refrigerated centrifuge immediately, if possible, 
or within 60 minutes of collection at 1000 to 1200 × g (2000 to 3000 rpm) for 10 minutes to 
separate plasma. Each plasma sample was transferred via pipette into 2 cryovials labeled as 
previously described and were capped tightly. The second tube was a duplicate and was 
retained at the study site as a backup sample. If red blood cells were inadvertently drawn into 
the plasma, the sample was recentrifuged as soon as possible. Adequate space between the 
solution and the tube cap was allowed for expansion during freezing. 
Cryovial tubes containing plasma samples were stored frozen in a freezer equipped with a 
temperature monitor and temperature alarm at –70ºC or below until shipment. Uncentrifuged 
specimens were not frozen. All plasma samples were shipped frozen to the bioanalytical 
laboratory (Alturas Analytics, Inc.) using dry ice. 
9.6 
DATA QUALITY ASSURANCE 
This study was conducted using quality processes described in applicable procedural 
documents. The quality management approach implemented was documented and complied 
with the current ICH guidance on quality and risk management. All aspects of the study were 
monitored for compliance with applicable government regulatory requirements, current Good 
Clinical Practice, the protocol, and standard operating procedures. The monitor maintained 
current personal knowledge of the study through observation, review of study records and 
source documentation, and discussion of the conduct of the study with the investigator and 
staff. Electronic CRFs and electronic data capture were utilized. The electronic data capture 
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SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
Clinical Study Report 
system is validated and compliant with US Title 21 CFR Part 11. Each person involved with 
the study had an individual identification code and password that allowed for record 
traceability. Data were continuously monitored for quality and compliance at every 
monitoring visit throughout the study. Additional reviews performed by the clinical monitor 
included query review and resolution, and protocol deviation review. Protocol deviations are 
presented in Section 10.2. 
9.7 
STATISTICAL METHODS PLANNED IN THE PROTOCOL 
AND DETERMINATION OF SAMPLE SIZE 
9.7.1 
Statistical and Analytical Plans 
All analyses were performed using SAS® Version 9.4 (SAS Institute, Cary, NC). 
All data collected are presented in data listings. Data from subjects excluded from an analysis 
population are presented in the data listings but not included in the calculation of summary 
statistics. 
For categorical variables, frequencies and percentages are presented. Continuous variables 
are summarized using descriptive statistics (number of subjects, mean, median, SD, 
minimum, and maximum). 
Unless specified otherwise, baseline is defined as the last nonmissing assessment prior to 
dosing. Unscheduled visits were used in determining baseline. 
The statistical analysis plan for this study is provided in Appendix 16.1.9. 
9.7.1.1 
Analysis Populations 
The safety population included all subjects who received at least 1 dose of study drug. 
The PK population included subjects who received study drug and had sufficient 
concentration data to facilitate the calculation of PK variables. 
9.7.1.2 
Analysis of Subject Disposition and Demographics 
Subject disposition is summarized overall for all subjects. 
The number of subjects who enrolled in the study and the number and percentage of subjects 
who completed the study are presented. The frequency and percentage of subjects who 
withdrew or discontinued from the study and the reason for withdrawal or discontinuation are 
also summarized. 
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Protocol No. SIGA-246-022 
Clinical Study Report 
Subject disposition data and analysis populations are presented in data listings. 
Baseline demographic and background variables are summarized overall for all subjects and 
presented in a data listing. 
The demographic characteristics consist of age (years), sex, race, and ethnicity. The baseline 
characteristics consist of baseline weight (kg) and height (cm). A subject’s age in years was 
calculated using the date of informed consent and date of birth. Age (years) and baseline 
weight (kg) are summarized using descriptive statistics. The number and percentage of 
subjects by race (American Indian or Alaska Native, Asian, black or African American, 
Native Hawaiian or Other Pacific Islander, and white), ethnicity (Hispanic or Latino, Not 
Hispanic or Latino), and reproductive status (for females only; Sterile, Post-Menopausal, 
Potentially Able to Bear Children) are also reported. Percentages are based on the total 
number of subjects in the safety population. 
Subject demographic and baseline characteristics are presented in a data listing. 
9.7.1.3 
Analysis of Pharmacokinetic Data 
9.7.1.3.1 
Plasma Drug Concentrations 
Individual plasma concentrations, actual time, and deviation from the scheduled time are 
presented in a data listing by subject, study day, and nominal time point. Plasma 
concentration data are summarized by day and time point using the following descriptive 
statistics: sample size (n), arithmetic mean, geometric mean, SD, geometric SD, coefficient of 
variation (CV), geometric CV (calculated as sqrt [exp [variance for log transformed 
data] – 1] × 100), median, minimum, and maximum. 
If the minimum value was zero, the geometric mean was not calculated and displayed. If the 
mean concentration values were below the limit of quantification (BLQ), they are displayed 
as BLQ; in this case the SD and CV are reported as not applicable. 
Plasma concentrations that were BLQ are treated as zero for descriptive statistics. Missing 
concentrations were excluded from the calculations. 
Individual, mean (±SD), and trough (±SD) plasma TPOXX concentration versus time profiles 
are presented in figures on both linear and semilogarithmic scales. Mean plasma 
concentration versus time profiles are presented using nominal time and individual plasma 
concentration versus time profiles are presented using actual time. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
9.7.1.3.2 
Plasma Pharmacokinetic Parameters 
Actual sampling times, rather than scheduled sampling times, are used in the computation of 
PK parameters. However, for ease of presentation, scheduled sampling time are used to 
present results in summary tables. The individual PK parameters of TPOXX are presented in 
a data listing. The PK parameters are summarized by day using the following descriptive 
statistics: n, arithmetic mean, geometric mean, SD, CV, geometric SD, geometric CV, 
median, minimum, and maximum. For Tmax, only n, median, minimum, and maximum are 
included in descriptive statistics. Geometric mean, geometric SD, and geometric CV are 
included for the AUCs and Cmax. 
9.7.1.3.3 
Statistical Analysis of Pharmacokinetic Data 
No formal statistical analysis of PK data was performed for this study. Key PK parameters 
are summarized with descriptive statistics. 
9.7.1.4 
Analysis of Safety Data 
All safety summaries and analyses were conducted for the safety population. Safety data are 
presented in data listings. 
9.7.1.4.1 
Adverse Events 
Adverse events were coded by preferred term (PT) and system organ class (SOC) using the 
Medical Dictionary for Regulatory Activities (MedDRA, Version 22.0). 
An overall summary of all AEs is presented. The number and percentage of subjects, as well 
as the number of AEs are presented for each of the following categories: any AE; any 
Grade 2, Grade 3, Grade 4, and Grade 5 AE; any treatment-related AE (TRAE); any Grade 2, 
Grade 3, Grade 4, and Grade 5 TRAE; any SAE; any serious TRAE, and any AE leading to 
discontinuation of study drug. In addition, the table includes a summary of the time to first 
AE and the time to first AE of Grade 3 or higher. Time to first AE was calculated for each 
period of the study in days as the date of the first AE in the period – the date of first dose of 
study drug in the period + 1. Time to first AE of Grade 3 or higher was computed similarly. 
These times were summarized overall. 
Adverse events were summarized by SOC and PT and by PT alone, including the total 
number of AEs and the number and percentage of subjects with at least one AE. At each level 
of subject summarization, a subject was counted once if the subject reported one or more 
events. Percentages were calculated out of the number of subjects in the safety population. 
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Protocol No. SIGA-246-022 
Clinical Study Report 
A summary of AEs by relationship to study drug is presented in a table by incidence of 
occurrence. The investigator provided an assessment of the relationship of the event to the 
study drug. The possible relationships were: not related, unlikely related, possibly related, 
probably related, and definitely related. In the summary of AEs by relationship, if a subject 
reported multiple occurrence of the same AE, only the most closely related occurrence is 
presented. Adverse events that were missing a relationship are presented in the summary 
table as definitely related but are presented in the data listing with a missing relationship. 
Percentages were calculated based on the number of subjects in the safety population. 
An AE was considered treatment-related if it was assessed as probably, possibly, or definitely 
related by the investigator. Treatment-related AEs are presented in a data listing. 
A summary of AEs by severity is presented in a table. The severity that is presented 
represents the most extreme severity captured on the eCRF page. In this summary, if a 
subject reported multiple occurrences of the same AE, only the most severe is presented. 
Adverse events that were missing severity are presented in tables as Grade 3 but are 
presented in the data listing with a missing severity. Percentages were calculated out of the 
number of subjects in the safety population. 
All AEs and SAEs are presented in a data listing. All AEs leading to study drug 
discontinuation are presented in a data listing. 
9.7.1.4.2 
Clinical Laboratory Tests 
Observed values and changes from baseline are summarized for hematology, serum 
chemistry, and urinalysis laboratory tests with numeric values for subjects in the safety 
population. Changes from baseline to each scheduled postbaseline visit are presented. 
Changes in low, normal, high, and abnormal classifications are summarized in shift tables 
comparing the results at each scheduled postbaseline visit with those at the baseline visit. 
Shift tables are presented for subjects in the safety population. 
Where possible, abnormal clinical laboratory values were graded for severity according to the 
DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. The maximum 
increase in DAIDS grade postbaseline (including both scheduled and unscheduled visits) is 
summarized and presented. 
Microscopy data are not included in the summaries. 
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SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
Clinical Study Report 
All hematology, serum chemistry, and urinalysis laboratory data are presented in data listings. 
The results of glycosylated hemoglobin A1c, serum pregnancy test, serum FSH (for 
postmenopausal women only), HIV, HBsAg, HCV, and urine drug and alcohol screen 
assessments are presented in a data listing. 
9.7.1.4.3 
Vital Sign Measurements 
Observed values and changes from baseline are summarized for vital sign data for subjects in 
the safety population. Changes from baseline to each scheduled postbaseline visit are 
presented. All vital sign data are presented in a data listing. 
9.7.1.4.4 
Twelve-Lead Electrocardiogram 
Observed values and changes from baseline are summarized for ECG numeric results for 
subjects in the safety population. Changes from baseline to each scheduled postbaseline visit 
are presented. All ECG data are presented in a data listing. 
9.7.1.4.5 
Physical Examination 
Physical examination results are presented in a data listing. 
9.7.1.4.6 
Physical Measurements 
Physical measurements are presented in a data listing. 
9.7.1.4.7 
Ancillary Data 
A protocol deviation was any change, divergence, or departure from the study design or 
procedures defined in the protocol. An important protocol deviation (sometimes referred to as 
a protocol violation or a major protocol deviation) was a subset of protocol deviations that 
might have significantly affected the reliability of the study data or that might have 
significantly affected a subject's safety. An important deviation could have included 
nonadherence to inclusion or exclusion criteria or nonadherence to FDA regulations or ICH 
E6(R2) guidelines. 
Protocol deviations were documented by the clinical monitor throughout the course of 
monitoring visits. The investigator was notified in writing by the monitor of deviations. The 
IRB was notified of all protocol deviations, if appropriate, in a timely manner. 
Major protocol deviations are summarized overall. All protocol deviations are presented in a 
data listing, including the categorization of the deviation as major or minor. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
A complete medical history was obtained from subjects, including recreational drug use, 
prescription drug use, over-the-counter drug use, nicotine and alcohol use, and past 
hospitalizations. Medical history was coded using MedDRA (Version 22.0) and is presented 
in a data listing. 
All inclusion/exclusion criteria deviations recorded in the eCRF are presented in a data 
listing. 
A prior medication was defined as any medication that was taken within 30 days before 
signing the ICF. A concomitant medication was defined as any medication that had a start 
date on or after date of the first dose of study drug. Prior and concomitant medications and 
therapies were coded using WHODrug (Version March 21019 Global B3) and are presented 
in a data listing. 
All medical and surgical treatment procedures were coded using MedDRA (Version 22.0) and 
are presented in a data listing. 
A summary of study drug administration data is presented. The summary includes the number 
and percentage of subjects dosed, as well as summary statistics of the number of complete 
doses received and the number and percentage of subjects who received all 14 planned doses. 
All study drug administration data are presented in a data listing. 
Meal data, height and weight data and follow-up visit/call data are presented in data listings. 
9.7.2 
Determination of Sample Size 
The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study is 
based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size was considered sufficient to effectively assess the PK and safety 
profiles of TPOXX. 
9.8 
CHANGES IN THE CONDUCT OF THE STUDY OR 
PLANNED ANALYSES 
There were 2 amendments to the original study protocol dated 19 February 2019 
(Appendix 16.1.1). 
Amendment 1, dated 27 June 2019, was issued to: 
•
Clarify the weight requirements for qualified subjects on Days –1 and 1.
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
•
Clarify that the same scale would be used in screening and how rounding procedures
would be applied.
•
Update Reference 3 to cite the current FDA Guidance.
•
Remove the ±2-day window for the Day 9/Early Discontinuation visit.
•
Remove the symptom-directed physical examination from Day 7.
Amendment 2, dated 02 August 2019, was issued to: 
•
Revise exclusion criterion 31.
•
Remove redundant exclusion criteria.
•
Add the measurement of height to the Day –1 check-in procedures.
•
Remove the 1-hour observation period for allergic reaction following dosing.
10.
STUDY SUBJECTS
10.1 
DISPOSITION OF SUBJECTS 
Subject disposition is summarized in Table 10-1. 
Table 10-1 
Summary of Subject Disposition (Enrolled Population) 
Total 
(N=34) 
n (%) 
Total number of subjects 
Completed 
34 (100.0) 
Discontinued
0
Analysis populations 
Safety population 
34 (100.0) 
PK population 
34 (100.0) 
Abbreviation: PK, pharmacokinetic. 
Notes: The safety population included all subjects who received at least 1 dose of study drug. 
The PK population included all subjects who received study drug and had sufficient concentration data to 
facilitate the calculation of PK variables. 
All percentages were based on the enrolled subjects. 
TPOXX 600 mg (3 × 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 
12 hours (±30 minutes) apart. 
Source: End-of-Text Table 14.1.1.1. 
A total of 34 subjects were enrolled, and all 34 subjects (100.0%) completed the study. All 
34 subjects (100.0%) were included in the safety and PK populations. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Subject disposition and reasons for discontinuation are summarized in End-of-Text 
Table 14.1.1.1 and presented by subject in Data Listing 16.2.1.1. Analysis sets are presented 
by subject in Data Listing 16.2.1.2. 
10.2 
PROTOCOL DEVIATIONS 
Information on the monitoring and documenting of protocol deviations is presented in 
Section 9.6. 
There were no inclusion/exclusion criteria deviations. Overall, 6 subjects (17.6%) 
experienced major protocol deviations in the category of missing endpoint assessments, and 
1 subject (2.9%) experienced a major protocol deviation in the category of study procedures 
and/or assessments. The majority of protocol deviations were assessed as minor, and none of 
the protocol deviations were deemed likely to affect the results of the study or the integrity of 
the data. 
Major protocol deviations are summarized in End-of-Text Table 14.1.1.2. All protocol 
deviations are presented by subject in Data Listing 16.2.2.1. Inclusion/exclusion criteria 
deviations are presented in Data Listing 16.2.2.2. 
10.3 
DATASETS ANALYZED 
The safety population included 34 subjects who received at least 1 dose of study drug  
The PK population included 34 subjects who received study drug and had sufficient 
concentration data to facilitate the calculation of PK variables. 
10.4 
DEMOGRAPHIC AND OTHER BASELINE 
CHARACTERISTICS  
10.4.1 
Demographics and Baseline Characteristics 
Subject demographic and baseline characteristics are summarized in Table 10-2. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Table 10-2 
Summary of Subject Demographics and Baseline Characteristics 
(Safety Population) 
Total 
(N=34) 
Age (years) 
Mean (SD) 
35.5 (8.31) 
Median 
34.5 
Minimum, maximum 
20, 50 
Sex, n (%) 
Male 
23 (67.6) 
Female 
11 (32.4) 
Reproductive Status, n (%)(a)
Potentially able to bear children 
8 (72.7) 
Sterile 
3 (27.3) 
Race, n (%) 
White 
12 (35.3) 
Black or African American 
22 (64.7) 
Ethnicity, n (%) 
Hispanic or Latino 
5 (14.7) 
Not Hispanic or Latino 
29 (85.3) 
Weight (kg) 
Mean (SD) 
138.13 (20.881) 
Median 
131.15 
Minimum, maximum 
120.3, 220.4 
Height (cm) 
Mean (SD) 
176.40 (9.649) 
Median 
176.55 
Minimum, maximum 
151.2, 195.3 
Note: TPOXX 600 mg (3 × 200-mg capsules) was administered orally twice a day on Days 1 to 7, 
approximately 12 hours (±30 minutes) apart. 
(a) Reproductive status is presented for female subjects only, and percentages were computed based on the
total number of females.
Source: End-of-Text Table 14.1.2. 
The majority of subjects were black or African American (22 subjects, 64.7%). There were 
more male (23 subjects, 67.6%) than female subjects (11 subjects, 32.4%). More female 
subjects were of childbearing potential (8 subjects, 72.7%) than sterile (3 subjects, 27.3%). 
The mean age was 35.5 years (range: 20 to 50 years), and all subjects weighed more than 
120 kg with a mean weight of 138.13 kg (range: 120.3 to 220.4 kg). 
Demographics characteristics are summarized for the safety population in End-of-Text 
Table 14.1.2. Demographics are presented by subject in Data Listing 16.2.4.1. 
10.4.2 
Other Baseline Characteristics 
None of the medical history findings precluded any subject from participating in the study. 
All HIV, HBsAg, and HCV test results were negative or nonreactive at screening. Serum FSH 
testing was not performed because none of the female subjects were postmenopausal. At 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
screening and on Day –1, all subjects tested negative for drugs and alcohol, and all female 
subjects tested negative for pregnancy (β human chorionic gonadotropin less than 5.0 IU/L). 
Two subjects had a high hemoglobin A1c value at screening, which were assessed as 
abnormal but not clinically significant in both cases. 
Medical history is presented by subject in Data Listing 16.2.4.2. Laboratory test results for 
HIV, HBsAg, HCV, hemoglobin A1c, drugs and alcohol, and serum pregnancy tests are 
presented by subject in Data Listing 16.2.8.4. 
10.5 
PRIOR AND CONCOMITANT MEDICATIONS 
Several subjects reported prior medications, including biotin, cholecalciferol, ibuprofen, 
lysine, chlorphenamine maleate, finasteride, paracetamol, tramadol, and vitamins and 
minerals not otherwise specified that were not ongoing during the study. Concomitant 
medications were received by the following subjects: 
•
Subject 9021 received prune juice to treat the AE of infrequent bowel movements.
•
Subject 9025 received chlorphenamine maleate to manage the medical history of
seasonal allergies.
•
Subject 9061 received nitrofurantoin to treat the AE of urinary tract infection.
•
Subject 9095 received loratadine to manage the medical history of seasonal allergies.
The only medical or surgical treatment procedures included ad hoc safety observations 
(18 September 2019 to 19 September 2019) and rhythm strips (18 September 2019) for 
Subject 9025 to assess frequent premature ventricular contractions, which were not assessed 
as an AE by the investigator and were not ongoing at the end of the study. No other subjects 
reported medical or surgical treatment procedures. 
Prior and concomitant medications are presented by subject in Data Listing 16.2.4.3. Medical 
and surgical treatment procedures are presented by subject in Data Listing 16.2.4.4. 
10.6 
EXPOSURE AND COMPLIANCE 
10.6.1 
Extent of Exposure 
Study drug administration is presented in Table 10-3. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Table 10-3 
Study Drug Administration (Enrolled Population) 
Total 
(N=34) 
Subjects enrolled
Dosed, n (%) 
34 (100.0) 
Number of complete doses received (maximum of 14) 
Mean (SD) 
14.0 (0.00) 
Median 
14.0 
Minimum, maximum 
14, 14 
Number of subjects completing all 14 doses of study drug, n (%) 
34 (100.0) 
Notes: Percentages were based on the number of subjects in the safety population. 
TPOXX 600 mg (3 × 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 
12 hours (±30 minutes) apart. 
Source: End-of-Text Table 14.1.3. 
All 34 subjects received all 14 planned doses (100.0%) of oral TPOXX in this study. 
Study drug administration data are summarized for the safety population in End-of-Text 
Table 14.1.3 and presented by subject in Data Listing 16.2.5.1. 
Meal data are presented by subject in Data Listing 16.2.5.2. 
10.6.2 
Measures of Treatment Compliance 
All doses of study drug were administered at the study site under direct observation of study 
site personnel and recorded in the eCRF. Per standard clinic procedure, study site personnel 
performed a mouth check and inspected all dose containers to ensure that the entire dose was 
administered. The date and time of study drug dosing were captured and recorded on the 
appropriate page of the eCRF. If a subject was not administered study drug, the reason for the 
missed dose was recorded. 
Study drug administration data are presented by subject in Data Listing 16.2.5.1. 
11.
PHARMACOKINETIC EVALUATION
11.1 
ANALYSIS OF PHARMACOKINETICS 
11.1.1 
Plasma Concentrations of TPOXX 
Mean plasma concentrations of TPOXX are presented in Figure 11-1 (Day 1) and Figure 11-2 
(Day 7). Mean plasma trough concentrations of TPOXX are presented in Figure 11-3. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Figure 11-1 
Mean Plasma Concentrations of TPOXX Versus Time: Day 1 
(Linear and Semilogarithmic Scales) (Pharmacokinetic 
Population) 
Abbreviation: BID, twice daily. 
Treatment: TPOXX 600 mg (3 × 200-mg capsules) was administered orally BID on Days 1 to 7, approximately 
12 hours (±30 minutes) apart. 
Source: End-of-Text Figure 14.2.1. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Figure 11-2 
Mean Plasma Concentrations of TPOXX Versus Time: Day 7 
(Linear and Semilogarithmic Scales) (Pharmacokinetic 
Population) 
Abbreviation: BID, twice daily. 
Treatment: TPOXX 600 mg (3 × 200-mg capsules) was administered orally BID on Days 1 to 7, approximately 
12 hours (±30 minutes) apart. 
Source: End-of-Text Figure 14.2.1. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Figure 11-3 
Mean (±SD) Plasma Trough Concentrations of TPOXX Versus 
Time (Linear and Semilogarithmic Scales) (Pharmacokinetic 
Population) 
Abbreviation: BID, twice daily. 
Treatment: TPOXX 600 mg (3 × 200-mg capsules) was administered orally BID on Days 1 to 7, approximately 
12 hours (±30 minutes) apart. 
Source: End-of-Text Figure 14.2.2. 
Following BID oral administration of TPOXX 600 mg, plasma concentrations of TPOXX 
were detected immediately after dosing and reached peak levels around 4 hours after dosing. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Mean plasma concentrations of TPOXX achieved steady state by Day 6 after administration 
of TPOXX for 7 days. 
Mean plasma concentrations of TPOXX are presented in End-of-Text Figure 14.2.1. Mean 
plasma trough concentrations of TPOXX are presented in End-of-Text Figure 14.2.2. 
Individual plasma concentrations (as an overlay plot) of TPOXX are presented in 
End-of-Text Figure 14.2.3. Individual plasma collection times and concentrations of TPOXX 
are presented in Data Listing 16.2.6.1. A summary of plasma concentrations of TPOXX is 
presented in End-of-Text Table 14.2.1. 
11.1.2 
Plasma Pharmacokinetic Parameters of TPOXX 
Plasma PK parameters of TPOXX for Day 1 and Day 7 are summarized in Table 11-1.  
Table 11-1 
Mean (CV) Plasma Pharmacokinetic Parameters of TPOXX 
(Pharmacokinetic Population) 
Parameter (unit) 
Day 1 
N=34 
Day 7 
N=34 
Cmax (ng/mL) 
847 (24.9) 
1350 (29.0) 
AUC0-24 (ng•h/mL) 
11900 (23.8) 
20000 (23.0) 
AUC0-t (ng•h/mL) 
11900 (23.8) 
29500 (26.0) 
AUC0-tau (ng•h/mL) 
5130 (22.6) 
9830 (23.9) 
AUC0-inf (ng•h/mL) 
– 
33200 (27.8)(b) 
Tmax (h)(a) 
4.00 (2.00, 8.02) 
4.00 (2.00, 11.95) 
t1/2 (h) 
8.46 (45.5)(c) 
12.9 (19.3)(b) 
CL/F (L/h) 
– 
64.8 (26.0) 
Vd/F (L) 
– 
1180 (29.9)(b) 
Ctrough (ng/mL) 
517 (39.8)(d)
617 (35.6)(e) 
Abbreviations: AUC0-24, area under the plasma concentration versus time curve from time 0 to 24 hours 
postdose; AUC0-inf, area under the plasma concentration versus time curve from time 0 extrapolated to 
infinity; AUC0-t, area under the plasma concentration versus time curve from time 0 to the last quantifiable 
measurement; AUC0-tau, area under the plasma concentration versus time curve during the first dosing 
interval; CL/F, apparent total body clearance; Cmax, maximum observed plasma drug concentration; 
Ctrough, concentration observed prior to the next dose administration; CV, coefficient of variation; 
t1/2, terminal elimination half-life; Tmax, time to reach Cmax; Vd/F, apparent volume of distribution. 
(a) For Tmax, the median (minimum, maximum) values are presented.
(b) n = 33.
(c) n = 11.
(d) Prior to the third dose.
(e) Prior to the second dose on Day 7.
Source: End-of-Text Tables 14.2.2, 14.2.3, and 14.2.4.
Pharmacokinetic parameters were calculated using the 24-hour concentration profile for 
Days 1 and 7. 
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SIGA Technologies, Inc. 
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Clinical Study Report 
Following BID oral administration of TPOXX 600 mg, mean plasma exposure values for 
Cmax, AUC0-24, and AUC0-tau were 847 ng/mL, 11900 ng*h/mL, and 5130 ng*h/mL, 
respectively, on Day 1. Mean t1/2 was 8.46 hours on Day 1, although half-life for most of the 
Day 1 concentration profiles could not be calculated due to not having at least 3 time points 
excluding Cmax in the elimination phase. Mean plasma trough concentration, calculated prior 
to the third dose, was 517 ng/mL. Median Tmax was 4 hours after dosing on Day 1. 
The steady-state mean plasma exposure values for Cmax, AUC0-24, and AUC from time 0 to 
12 hours postdose (AUC0-12) were 1350 ng/mL, 20000 ng*h/mL, and 9830 ng*h/mL, 
respectively, on Day 7. The mean steady-state t1/2 and CL/F values were 12.9 h and 64.8 L/h, 
respectively. Mean plasma steady-state trough concentration, calculated prior to the second 
dose on Day 7, was 617 ng/mL. Median Tmax was 4 hours after dosing at steady state. 
The ratio (Day 7/Day 1) of mean plasma exposure Cmax, AUC0-24, and AUC0-tau were 1.6, 1.7, 
and 1.9, respectively, suggesting plasma accumulation of TPOXX at a steady-state. 
A summary of plasma PK parameters of TPOXX is presented in End-of-Text Table 14.2.2 
(Day 1) and End-of-Text Table 14.2.3 (Day 7). A summary of plasma trough concentrations 
of TPOXX is presented in End-of-Text Table 14.2.4. Individual plasma PK parameters of 
TPOXX are presented in Data Listing 16.2.6.2 (Day 1) and Data Listing 16.2.6.3 (Day 7). 
11.2 
STATISTICAL/ANALYTICAL ISSUES 
11.2.1 
Adjustments for Covariates 
Not applicable. 
11.2.2 
Handling of Dropouts or Missing Data 
For the calculation of PK parameters, all plasma concentrations that were BLQ prior to the 
first measurable concentration were set to zero and treated as missing thereafter. No 
concentration estimates were imputed for missing sample values. Any sample with a missing 
value was treated as if the sample had not been scheduled for collection and was ignored 
when calculating mean concentrations or PK parameters. 
11.2.3 
Interim Analyses and Data Monitoring 
No interim analysis was performed. 
11.2.4 
Multicenter Studies 
This was a single-center study. 
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SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
Clinical Study Report 
11.2.5 
Multiple Comparison/Multiplicity 
Not applicable. 
11.2.6 
Use of an “Efficacy Subset” of Subjects 
Not applicable. 
11.2.7 
Active-Control Studies Intended to Show Equivalence 
Not applicable. 
11.2.8 
Examination of Subgroups 
Not applicable. 
11.3 
TABULATION OF INDIVIDUAL RESPONSE DATA 
Individual plasma concentrations of TPOXX are presented in Data Listing 16.2.6.1. 
Individual plasma PK parameters of TPOXX on Days 1 and 7 are presented in 
Data Listings 16.2.6.2 and 16.2.6.3, respectively. 
11.4 
DRUG DOSE, DRUG CONCENTRATION, AND 
RELATIONSHIPS TO RESPONSE 
Not applicable. 
11.5 
DRUG-DRUG AND DRUG-DISEASE INTERACTIONS 
Not applicable. 
11.6 
BY-SUBJECT DISPLAYS 
Individual plasma concentrations of TPOXX are presented in End-of-Text Figure 14.2.3. 
11.7 
PHARMACOKINETIC CONCLUSIONS 
•
Following BID oral administration of TPOXX 600 mg, plasma concentrations of
TPOXX were detected immediately after dosing and reached peak levels around
4 hours after dosing.
•
Steady state was achieved by Day 6 following administration of TPOXX for 7 days.
•
On Day 1, mean plasma exposure values for Cmax, AUC0-24, and AUC0-tau were
847 ng/mL, 11900 ng*h/mL, and 5130 ng*h/mL, respectively. Mean plasma trough
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
concentration, calculated prior to the third dose, was 517 ng/mL and median Tmax was 
4 hours after dosing. The mean t1/2 was 8.46 hours (note that this could only be 
calculated in 32% of the total subjects due to having insufficient data in the terminal 
phase). 
•
On Day 7, steady-state mean plasma exposure values for Cmax, AUC0-24, and AUC0-12
were 1350 ng/mL, 20000 ng*h/mL, and 9830 ng*h/mL, respectively. The mean
steady-state t1/2 and CL/F values were 12.9 hours and 64.8 L/h, respectively. Mean
plasma steady-state trough concentration, calculated prior to the second dose on
Day 7, was 617 ng/mL. Median Tmax was 4 hours after dosing at steady state.
•
The ratio (Day 7/Day 1) of mean plasma exposure Cmax, AUC0-24, and AUC0-tau ranged
from 1.6 to 1.9, suggesting plasma accumulation of TPOXX at steady-state.
12.
SAFETY EVALUATION
12.1 
ADVERSE EVENTS 
12.1.1 
Brief Summary of Adverse Events 
A total of 9 of 34 subjects (26.5%) reported 12 AEs during the study. A total of 2 of 
34 subjects (5.9%) reported 2 TRAEs. The most commonly reported AEs were in the SOCs 
of gastrointestinal disorders (3 subjects, 8.8%) and nervous system disorders (2 subjects, 
5.9%). The most commonly reported AEs were nausea and headache (2 subjects, 5.9% each). 
All other AEs were reported by 1 subject (2.9%) each. No AEs above Grade 1 (mild; 
9 subjects) were reported in this study. All AEs were reported as recovered/resolved by the 
end of the study. There were no SAEs, serious TRAEs, or AEs leading to study drug or study 
discontinuation during the study. 
12.1.2 
Display of Adverse Events 
An overall summary of AEs is presented in Table 12-1. A summary of AEs by SOC and PT is 
presented in Table 12-2. 
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TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Table 12-1 
Overall Summary of Adverse Events (Safety Population) 
Category 
Total 
(N=34) 
n (%) [E] 
Any AE 
9 (26.5) [12] 
Time to first AE (days) 
n
9
Mean (SD) 
5.0 (5.45) 
Median
3.0
Minimum, maximum 
2, 19 
Any Grade 2 (moderate) AE 
0 
Any Grade 3 (severe) AE 
0 
Any Grade 4 (life-threatening) AE 
0 
Any Grade 5 (death) AE 
0 
Any TRAE 
2 (5.9) [2] 
Any Grade 2 (moderate) TRAE 
0 
Any Grade 3 (severe) TRAE 
0 
Any Grade 4 (life-threatening) TRAE 
0 
Any Grade 5 (death) TRAE 
0 
Any serious AE 
0 
Any serious TRAE 
0 
Any AE leading to study drug discontinuation
0
Any AE leading to study discontinuation
0
Abbreviations: AE, adverse event; BID, twice daily; [E], the number of events at each level of 
summarization; n, the number of subjects at each level of summarization; TRAE, treatment-related 
adverse event. 
Notes: An AE was considered a TRAE if it was assessed as probably, possibly, or definitely related. 
At each level of subject summarization, a subject was counted once if the subject reported one or more 
events. 
If the relationship of an AE was missing, the AE was considered related; if the severity of an AE was missing, 
the AE was considered Grade 3 (severe) in severity. 
Time to first AE was calculated in days as the date of the first AE — the date of first dose of study drug + 1. 
Only treatment-emergent AEs were considered. 
TPOXX 600 mg (3 × 200-mg capsules) was administered orally BID on Days 1 to 7, approximately 12 hours 
(±30 minutes) apart. 
Percentages were based on the number of subjects in the safety population. 
Source: End-of-Text Table 14.3.1.1. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Table 12-2 
Adverse Events by System Organ Class and Preferred Term 
(Safety Population) 
System Organ Class 
Preferred Term 
Total 
(N=34) 
n (%) 
Total number of AEs 
12 
Number of subjects with at least 1 AE 
9 (26.5) 
Gastrointestinal disorders 
3 (8.8) 
Nausea 
2 (5.9) 
Infrequent bowel movements 
1 (2.9) 
Lip dry 
1 (2.9) 
Nervous system disorders 
2 (5.9) 
Headache 
2 (5.9) 
Eye disorders 
1 (2.9) 
Scleral hyperaemia 
1 (2.9) 
Infections and infestations 
1 (2.9) 
Urinary tract infection 
1 (2.9) 
Injury, poisoning and procedural complications 
1 (2.9) 
Palate injury 
1 (2.9) 
Musculoskeletal and connective tissue disorders 
1 (2.9) 
Back pain 
1 (2.9) 
Renal and urinary disorders 
1 (2.9) 
Dysuria 
1 (2.9) 
Skin and subcutaneous tissue disorders 
1 (2.9) 
Dermatitis contact 
1 (2.9) 
Abbreviations: AE, adverse event; n, the number of subjects at each level of summarization. 
Notes: The total number of AEs counts all AEs for subjects. 
At each level of summarization, a subject was counted once if the subject counted 1 or more events. 
Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 22.0. 
TPOXX 600 mg (3 × 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 
12 hours (±30 minutes) apart. 
Source: End-of-Text Table 14.3.1.2. 
12.1.3 
Analysis of Adverse Events 
A total of 9 of 34 subjects (26.5%) reported 12 AEs during the study. A total of 2 of 
34 subjects (5.9%) reported 2 TRAEs (nausea and headache, reported by 1 subject [2.9%] 
each). The most commonly reported AEs were in the SOCs of gastrointestinal disorders 
(3 subjects, 8.8%) and nervous system disorders (2 subjects, 5.9%). The most commonly 
reported AEs were nausea and headache (2 subjects, 5.9% each). All other AEs were reported 
by 1 subject (2.9%) each. No AEs above Grade 1 (mild; 9 subjects) were reported in this 
study. All AEs were reported as recovered/resolved by the end of the study. There were no 
SAEs, serious TRAEs, or AEs leading to study drug or study discontinuation during the 
study. 
An overall summary of AEs is presented in End-of-Text Table 14.3.1.1. Adverse events are 
summarized by SOC and PT in End-of-Text Table 14.3.1.2, by PT in End-of-Text 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Table 14.3.1.3, by relationship to study drug in End-of-Text Table 14.3.1.4, and by severity in 
End-of Text Table 14.3.1.5. 
12.1.4 
Listing of Adverse Events by Subject 
Details of all AEs and TRAEs are presented by subject in Data Listings 16.2.7.1 and 16.2.7.2, 
respectively. 
12.2 
DEATHS, OTHER SERIOUS ADVERSE EVENTS, AND 
OTHER SIGNIFICANT ADVERSE EVENTS 
12.2.1 
Listing of Deaths, Other Serious Adverse Events and Other 
Significant Adverse Events 
12.2.1.1 
Deaths 
There were no deaths in this study (Data Listing 16.2.7.3). 
12.2.1.2 
Other Serious Adverse Events 
There were no SAEs in this study (Data Listing 16.2.7.3). 
12.2.1.3 
Other Significant Adverse Events 
No subject discontinued study drug because of an AE (Data Listing 16.2.7.4). 
12.2.2 
Narratives of Deaths, Other Serious Adverse Events, and 
Certain Other Significant Adverse Events 
Not applicable. 
12.2.3 
Analysis and Discussion of Deaths, Serious Adverse Events, 
and Other Significant Adverse Events 
Not applicable. 
12.3 
CLINICAL LABORATORY EVALUATION 
12.3.1 
Listing of Individual Laboratory Measurements by Subject 
and Each Abnormal Laboratory Value 
Individual hematology, serum chemistry, and urinalysis results are presented by subject in 
Data Listings 16.2.8.1, 16.2.8.2, and 16.2.8.3, respectively. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
12.3.2 
Evaluation of Each Laboratory Parameter 
12.3.2.1 
Laboratory Values Over Time 
Hematology 
Mean hematology results were within the reference ranges at the time points assessed and the 
mean values observed after dosing were generally similar to those observed at baseline. None 
of the postbaseline hematology results increased in DAIDS grade. 
Serum Chemistry 
Mean serum chemistry results were within the reference ranges at the time points assessed 
and the mean values observed after dosing were generally similar to those observed at 
baseline. 
Several subjects had postbaseline serum chemistry results that increased in DAIDS grade. 
None of the postbaseline increases in DAIDS grade were higher than a maximum of Grade 1. 
Overall, 2 subjects (5.9%) each had low albumin and high glucose values assessed as DAIDS 
Grade 1 postbaseline and 3 subjects (8.8%) each had low sodium and high urate values 
assessed as DAIDS Grade 1 postbaseline. 
Urinalysis 
Mean urinalysis results were within the reference ranges at the time points assessed, and the 
mean values observed after dosing were generally similar to those observed at baseline. None 
of the postbaseline urinalysis results increased in DAIDS grade. 
Summary statistics and change from baseline in mean hematology, serum chemistry, and 
urinalysis values are provided in End-of-Text Tables 14.3.2.1.1, 14.3.2.2.1, and 14.3.2.3.1, 
respectively. Summary statistics of hematology, serum chemistry, and urinalysis results by 
maximum grade increase postbaseline relative to baseline are provided in End-of-Text 
Tables 14.3.2.1.3, 14.3.2.2.3, and 14.3.2.3.3, respectively. 
12.3.2.2 
Individual Subject Changes 
Shifts in hematology values from normal at baseline to low or high after dosing were only 
observed in more than 1 subject for basophils. Overall, 2 subjects (5.9%) shifted to high on 
Days 8 and 9/early discontinuation (ED). 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Shifts in serum chemistry values from normal at baseline to low or high after dosing in more 
than 1 subject were as follows: 
•
Lactate dehydrogenase: 2 subjects (5.9%) shifted to high on Days 8 and 9/ED.
•
Urate: 3 subjects (8.8%) shifted to high on Day 4, and 6 subjects (17.6%) shifted to
high on Days 8 and 9/ED.
Shifts in urinalysis values from normal at baseline to low, high, or abnormal after dosing in 
more than 1 subject were as follows: 
•
Clarity: 3 subjects (8.8%) shifted to abnormal on Day 9/ED.
•
Leukocyte esterase: 2 subjects (5.9%) shifted to abnormal on Day 9/ED.
•
Occult blood: 3 subjects (8.8%) shifted to abnormal on Day 9/ED.
•
Urine protein: 2 subjects (5.9%) shifted to abnormal on Day 9/ED.
Shifts from baseline in hematology, serum chemistry, and urinalysis values are presented in 
End-of-Text Tables 14.3.2.1.2, 14.3.2.2.2, and 14.3.2.3.2, respectively. 
12.3.2.3 
Individual Clinically Significant Abnormalities 
No individual hematology, serum chemistry, or urinalysis abnormality was considered 
clinically significant or reported as an AE by the investigator. 
Laboratory results meeting DAIDS toxicity Grade 1 or higher are presented by subject in 
Data Listing 16.2.8.5. All clinical laboratory test results with toxicity grades were no higher 
than DAIDS Grade 1 or 2. 
Of note, 3 subjects had negative urine protein and urine glucose test results for the Day 9 
urinalysis sample, which were within the normal range for this study; however, a limitation 
within the Lab Trend View system used in this study forced an assessment code to be 
assigned to these laboratory values by the investigator in order for the laboratory results to be 
signed. The investigator assessed these values as not clinically significant. The Lab Trend 
View system will soon be decommissioned, and no fix has been planned for the system. This 
limitation was identified and is characterized in a note to file dated 30 January 2020. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
12.4 
VITAL SIGNS, PHYSICAL FINDINGS, AND OTHER 
OBSERVATIONS RELATED TO SAFETY 
12.4.1 
Vital Sign Measurements 
Mean vital sign measurements were generally similar at the time points assessed. No 
individual vital sign measurement was reported as an AE by the investigator. 
Summary statistics and change from baseline in vital sign measurements are presented in 
End-of-Text Table 14.3.3.1.1. Individual vital sign measurements are presented by subject in 
Data Listing 16.2.8.6. 
12.4.2 
Twelve-Lead Electrocardiograms 
Mean 12-lead ECG values were generally similar at the time points assessed. No individual 
12-lead ECG value was reported as an AE, and none of the abnormal 12-lead ECG values
were assessed as clinically significant by the investigator.
Summary statistics and change from baseline in 12-lead ECG parameters are presented in 
End-of-Text Table 14.3.4.1.1. Individual 12-lead ECG parameters are presented by subject in 
Data Listing 16.2.8.7. 
12.4.3 
Physical Measurements 
Individual physical measurements are presented by subject in Data Listing 16.2.8.9. 
12.4.4 
Physical Examinations 
None of the subjects had abnormal postbaseline physical examination findings that had not 
been previously observed at screening and none of the physical examination findings were 
associated with AEs or reported as clinically significant by the investigator. 
Individual physical examination findings are presented by subject in Data Listing 16.2.8.8. 
12.4.5 
Follow-up Visit or Telephone Call 
Individual follow-up visit/telephone call information is presented by subject in Data 
Listing 16.2.8.10. 
12.4.6 
Pregnancies 
There were no pregnancies reported during this study. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
12.5 
SAFETY CONCLUSIONS 
•
TPOXX was considered safe and generally well tolerated when administered orally at
a dose of 600 mg BID for 7 days in adult subjects weighing more than 120 kg.
•
A total of 9 subjects (26.5%) reported 12 AEs during the study. A total of 2 of
34 subjects (5.9%) reported 2 TRAEs.
•
The most commonly reported AEs were in the SOCs of gastrointestinal disorders
(3 subjects, 8.8%) and nervous system disorders (2 subjects, 5.9%). The most
commonly reported AEs were nausea and headache (2 subjects, 5.9% each).
•
No AEs above Grade 1 (mild; 9 subjects) were reported in this study.
•
There were no SAEs, serious TRAEs, or AEs leading to study drug or study
discontinuation during the study.
•
Mean clinical laboratory test results (hematology, serum chemistry, and urinalysis),
vital sign measurements, physical examination findings, and 12-lead ECG values after
dosing were generally similar to baseline values.
•
No individual clinical laboratory test result, vital sign measurement, physical
examination finding, or 12-lead ECG value was associated with an AE or considered
clinically significant by the investigator. All clinical laboratory test results with
toxicity grades were no higher than DAIDS Grade 1 or 2.
13.
DISCUSSION AND OVERALL CONCLUSIONS
13.1 
DISCUSSION
This was an open-label, multiple-dose study to assess the safety, tolerability, and PK of 
TPOXX 600 mg BID when administered orally for 7 days to adult subjects weighing more 
than 120 kg. A total of 34 subjects, aged 20 to 50 years, inclusive, were enrolled. The study 
consisted of a screening period (Day –28 to –2), a treatment and confinement period 
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]). 
The primary objective of this study was to determine the PK profile of 600 mg oral TPOXX 
(3 × 200-mg capsules) administered BID for 7 days in adult subjects weighing more than 
120 kg to determine if a change in TPOXX dosing regimen would be needed in these 
patients. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
Following BID oral administration of TPOXX 600 mg, plasma concentrations of TPOXX 
were detected immediately after dosing and reached peak levels around 4 hours after dosing. 
Steady state was achieved by Day 6 following administration of TPOXX for 7 days. The 
ratios of mean plasma exposure Cmax, AUC0-24, and AUC0-tau on Day 7/Day 1 ranged from 1.6 
to 1.9, suggesting plasma accumulation of TPOXX at steady-state. 
The secondary objective of this study was to evaluate the safety and tolerability of 600 mg 
oral TPOXX administered BID for 7 days in adult subjects weighing more than 120 kg. 
A total of 9 subjects (26.5%) reported 12 AEs during the study. A total of 2 of 34 subjects 
(5.9%) reported 2 TRAEs. The most commonly reported AEs were in the SOCs of 
gastrointestinal disorders (3 subjects, 8.8%) and nervous system disorders (2 subjects, 5.9%). 
The most commonly reported AEs were nausea and headache (2 subjects, 5.9% each). All 
other AEs were reported by 1 subject (2.9%) each. No AEs above Grade 1 (mild; 9 subjects) 
were reported in this study. There were no SAEs, serious TRAEs, or AEs leading to study 
drug or study discontinuation during the study. There were no notable safety signals in results 
from safety assessments. 
Mean clinical laboratory test results (hematology, serum chemistry, and urinalysis), vital sign 
measurements, physical examination findings, and 12-lead ECG values after dosing were 
generally similar to baseline values. No individual clinical laboratory test result, vital sign 
measurement, physical examination finding, or 12-lead ECG value was associated with an 
AE or considered clinically significant by the investigator. All clinical laboratory test results 
with toxicity grades were no higher than DAIDS Grade 1 or 2. 
13.2 
OVERALL CONCLUSIONS 
Pharmacokinetics: 
SIGA will incorporate the PK data for the 34 subjects enrolled in this study into a population 
PK model which is being developed outside of this clinical study to inform if a change in 
dosing regimen would be needed in these patients. 
Safety: 
TPOXX was considered safe and generally well tolerated when administered orally at a dose 
of 600 mg BID for 7 days in adult subjects weighing more than 120 kg. 
Page 67


SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
14.
TABLES AND FIGURES REFERRED TO BUT NOT
INCLUDED IN THE TEXT
14.1 
DEMOGRAPHIC DATA 
Table 14.1.1.1 
Subject Disposition (Enrolled Population) 
Table 14.1.1.2 
Major Protocol Deviations (Safety Population) 
Table 14.1.2 
Demographics (Safety Population) 
Table 14.1.3 
Study Drug Administration (Enrolled Population) 
14.2 
PHARMACOKINETIC DATA 
Table 14.2.1 
Summary of Plasma Concentrations (ng/mL) of TPOXX 
(Pharmacokinetic Population) 
Table 14.2.2 
Summary of Plasma Pharmacokinetic Parameters of TPOXX – 
Day 1 (Pharmacokinetic Population) 
Table 14.2.3 
Summary of Plasma Pharmacokinetic Parameters of TPOXX – 
Day 7 (Pharmacokinetic Population) 
Table 14.2.4 
Summary of Trough Concentration (ng/mL) of TPOXX 
(Pharmacokinetic Population) 
Figure 14.2.1 
Mean (±SD) Plasma Concentrations of TPOXX Versus Time 
(Pharmacokinetic Population) 
Figure 14.2.2 
Mean (±SD) Plasma Trough Concentrations of TPOXX Versus Time 
(Pharmacokinetic Population) 
Figure 14.2.3 
Individual Plasma Concentrations of TPOSS Versus Time 
(Pharmacokinetic Population) 
14.3 
SAFETY DATA 
14.3.1 
Displays of Adverse Events 
Table 14.3.1.1 
Overall Summary of Adverse Events (Safety Population) 
Table 14.3.1.2 
Adverse Events by System Organ Class and Preferred Term (Safety 
Population) 
Table 14.3.1.3 
Adverse Events by Preferred Term (Safety Population) 
Table 14.3.1.4 
Adverse Events by Relationship to Study Drug (Safety Population) 
Table 14.3.1.5 
Adverse Events by Severity (Safety Population) 
Page 68


SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
14.3.2 
Listings of Deaths, Other Serious and Significant Adverse 
Events 
Not applicable. 
14.3.3 
Narratives of Deaths, Other Serious and Certain Other 
Significant Adverse Events 
There were no deaths, SAEs, or other significant AEs during the study (Section 12.2). 
14.3.4 
Laboratory and Other Safety Data 
Table 14.3.2.1.1 
Summary of Actual Value and Change From Baseline in Hematology 
(Safety Population) 
Table 14.3.2.1.2 
Shift From Baseline in Hematology (Safety Population) 
Table 14.3.2.1.3 
Summary of Hematology Results by Maximum Grade Increase 
Post-Baseline Relative to Baseline (Safety Population) 
Table 14.3.2.2.1 
Summary of Actual Value and Change From Baseline in Serum 
Chemistry (Safety Population) 
Table 14.3.2.2.2 
Shift From Baseline in Serum Chemistry (Safety Population) 
Table 14.3.2.2.3 
Summary of Serum Chemistry Results by Maximum Grade Increase 
Post-Baseline Relative to Baseline (Safety Population) 
Table 14.3.2.3.1 
Summary of Actual Value and Change From Baseline in Urinalysis 
(Safety Population) 
Table14.3.2.3.2 
Shift From Baseline in Urinalysis (Safety Population) 
Table 14.3.2.3.3 
Summary of Urinalysis Results by Maximum Grade Increase 
Post-Baseline Relative to Baseline (Safety Population) 
Table 14.3.3.1.1 
Summary of Actual Value and Change From Baseline in Vital Signs 
(Safety Population) 
Table 14.3.4.1.1 
Summary of Actual Value and Change From Baseline in 
Electrocardiogram Results (Safety Population) 
Page 69


SIGA TECHNOLOGIES, INC.
Page 1 of 1 
SIGA-246-022
Table 14.1.1.1
Subject Disposition
Enrolled Population
Note: The Safety population includes all subjects who receive at least 1 dose of study drug.
The PK population includes all subjects who receive study drug and have sufficient concentration data to facilitate the calculation 
of PK variables. 
All percentages are based on the Enrolled population.
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.
Source Data: Listing 16.2.1.1
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T14010101.SAS  Executed: 21JAN2020 22:54
Total 
(N=34) 
n (%)
Total Number of Subjects
Completed
34 (100.0)
Discontinued
0
Analysis Populations
Safety Population
34 (100.0)
PK Population
34 (100.0)
Primary Reason for Discontinuation
Adverse Event
0
Death
0
Lost to Follow-up
0
Physician Decision
0
Protocol Deviation
0
Screen Failure
0
Withdrawal by Subject
0
Other
0
Page 70


SIGA TECHNOLOGIES, INC.  
Page 1 of 1 
SIGA-246-022  
Table 14.1.1.2  
Major Protocol Deviations  
Safety Population  
 
 
Note: Subjects could have more than one major protocol deviation, but are counted once for each level of summarization.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.2.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14010102.SAS  Executed: 21JAN2020 22:54  
Category 
Total 
(N=34) 
n (%) 
Missing Endpoint Assessments 
6  (17.6) 
Study Procedures/Assessments 
1   (2.9) 
 
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SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Table 14.1.2  
Demographics  
Safety Population  
 
 
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] Reproductive status is presented for female subjects only and percentages are computed based on the total number of females.  
Source Data: Listing 16.2.4.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T140102.SAS  Executed: 21JAN2020 22:55  
Total 
(N=34) 
Age (Years) 
 n 
34 
 Mean (SD) 
35.5 (8.31) 
 Median 
34.5 
 Min, Max 
20, 50 
Sex, n (%) 
 MALE 
23  (67.6) 
 FEMALE 
11  (32.4) 
Reproductive Status, n (%) [1] 
 POTENTIALLY ABLE TO BEAR CHILDREN 
8 (72.7) 
 STERILE 
3 (27.3) 
Race, n (%) 
 WHITE 
12  (35.3) 
 BLACK OR AFRICAN AMERICAN 
22  (64.7) 
 ASIAN 
0 
 AMERICAN INDIAN OR ALASKA NATIVE 
0 
 NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER 
0 
Ethnicity, n (%) 
 HISPANIC OR LATINO 
5  (14.7) 
 NOT HISPANIC OR LATINO 
29  (85.3) 
Page 72


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Table 14.1.2  
Demographics  
Safety Population  
 
 
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] Reproductive status is presented for female subjects only and percentages are computed based on the total number of females.  
Source Data: Listing 16.2.4.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T140102.SAS  Executed: 21JAN2020 22:55  
Total 
(N=34) 
Weight (kg) 
 n 
34 
 Mean (SD) 
138.13 (20.881) 
 Median 
131.15 
 Min, Max 
120.3, 220.4 
Height (cm) 
 n 
34 
 Mean (SD) 
176.40 (9.649) 
 Median 
176.55 
 Min, Max 
151.2, 195.3 
 
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SIGA TECHNOLOGIES, INC.  
Page 1 of 1 
SIGA-246-022  
Table 14.1.3  
Study Drug Administration  
Enrolled Population  
 
 
Note: Percentages are based on the number of subjects in the safety population.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.5.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t140103.SAS  Executed: 21JAN2020 22:55  
Total 
(N=34) 
Subjects Enrolled 
34 
 Dosed n (%) 
34 (100.0) 
 Number of complete doses received (maximum of 14)
  Mean (SD) 
14.0 (0.00) 
  Median 
14.0 
  Min, Max 
14, 14 
Number of subjects completing all 14 doses of study
drug 
34 (100.0) 
 
Page 74


SIGA TECHNOLOGIES, INC.  
Page 1 of 3 
SIGA-246-022  
Table 14.2.1  
Summary of Plasma Concentrations (ng/mL) of TPOXX  
Pharmacokinetic Population  
Day = Day 1 
 
 
NA = Not applicable.  
Note: Concentrations below the limit of quantification (BLQ) were treated as zero for descriptive statistics.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours 
(±30 minutes) apart.  
Source Data: Listing 16.2.6.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\t140201.SAS  Executed: 24JAN2020 08:06  
 
Scheduled Time (hours)  
Statistics 
PREDOSE 
0.5 
1 
2 
4 
6 
8 
12 
14 
16 
18 
20 
24 
n 
34 
34 
34 
34 
34 
34 
33 
33 
34 
34 
33 
33 
34 
Mean 
BLQ 
8.26 
74.0 
436 
773 
568 
401 
267 
339 
640 
711 
714 
517 
Geometric Mean 
. 
. 
. 
342 
728 
538 
360 
246 
304 
597 
673 
687 
484 
SD 
NA 
14.3 
80.4 
251 
246 
182 
223 
123 
172 
248 
257 
200 
206 
CV% 
NA 
172.9 
108.7 
57.6 
31.9 
32.0 
55.6 
46.2 
50.8 
38.8 
36.1 
28.0 
39.8 
Geometric SD 
. 
. 
. 
2.30 
1.46 
1.42 
1.58 
1.48 
1.59 
1.45 
1.39 
1.34 
1.43 
Geometric CV% 
. 
. 
. 
99.8 
39.5 
36.1 
48.2 
41.0 
48.7 
38.8 
33.9 
29.6 
37.0 
Median 
0 
0 
43.5 
454 
760 
564 
361 
241 
269 
541 
642 
704 
471 
Min 
0 
0 
0 
25.6 
192 
232 
136 
121 
148 
240 
382 
395 
215 
Max 
0 
73.2 
355 
940 
1310 
941 
1330 
758 
745 
1220 
1520 
1100 
1170 
Page 75


SIGA TECHNOLOGIES, INC.  
Page 2 of 3 
SIGA-246-022  
Table 14.2.1  
Summary of Plasma Concentrations (ng/mL) of TPOXX  
Pharmacokinetic Population  
Day = Day 6 
 
 
NA = Not applicable.  
Note: Concentrations below the limit of quantification (BLQ) were treated as zero for descriptive statistics.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours 
(±30 minutes) apart.  
Source Data: Listing 16.2.6.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\t140201.SAS  Executed: 24JAN2020 08:06  
 
Scheduled Time (hours)  
Statistics 
PREDOSE 
4 
n 
34 
34 
Mean 
620 
1280 
Geometric Mean 
584 
1230 
SD 
213 
337 
CV% 
34.3 
26.4 
Geometric SD 
1.44 
1.31 
Geometric CV% 
37.6 
27.6 
Median 
586 
1220 
Min 
227 
633 
Max 
1200 
2000 
Page 76


SIGA TECHNOLOGIES, INC.  
Page 3 of 3 
SIGA-246-022  
Table 14.2.1  
Summary of Plasma Concentrations (ng/mL) of TPOXX  
Pharmacokinetic Population  
Day = Day 7 
 
 
NA = Not applicable.  
Note: Concentrations below the limit of quantification (BLQ) were treated as zero for descriptive statistics.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours 
(±30 minutes) apart.  
Source Data: Listing 16.2.6.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\t140201.SAS  Executed: 24JAN2020 08:06  
 
Scheduled Time (hours)  
Statistics 
PREDOSE 
0.5 
1 
2 
4 
6 
8 
12 
14 
16 
18 
20 
24 
48 
n 
34 
34 
34 
34 
34 
34 
34 
34 
34 
34 
33 
34 
34 
34 
Mean 
615 
487 
476 
768 
1280 
1030 
686 
617 
806 
1080 
991 
856 
610 
182 
Geometric Mean 
585 
462 
453 
694 
1210 
996 
652 
584 
772 
1030 
963 
819 
573 
165 
SD 
190 
158 
151 
376 
427 
270 
206 
219 
236 
314 
239 
243 
212 
75.0 
CV% 
30.9 
32.4 
31.8 
48.9 
33.4 
26.1 
30.0 
35.6 
29.3 
29.1 
24.2 
28.4 
34.8 
41.2 
Geometric SD 
1.39 
1.40 
1.38 
1.57 
1.39 
1.34 
1.41 
1.39 
1.35 
1.34 
1.28 
1.37 
1.45 
1.65 
Geometric CV% 
34.0 
34.8 
33.4 
47.3 
34.2 
29.6 
35.1 
34.2 
30.9 
29.5 
25.4 
32.6 
38.2 
53.1 
Median 
605 
455 
446 
697 
1200 
1030 
685 
562 
841 
1000 
979 
874 
592 
171 
Min 
247 
192 
157 
291 
516 
459 
285 
265 
439 
641 
539 
322 
263 
27.9 
Max 
1090 
978 
897 
1860 
2270 
1480 
1210 
1280 
1330 
1850 
1490 
1300 
1090 
381 
 
Page 77


SIGA TECHNOLOGIES, INC.  
Page 1 of 1 
SIGA-246-022  
Table 14.2.2  
Summary of Plasma Pharmacokinetic Parameters of TPOXX — Day 1  
Pharmacokinetic Population  
 
 
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours 
(±30 minutes) apart.  
Source Data: Listing 16.2.6.2  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\t140202.SAS  Executed: 24JAN2020 08:07  
 
Scheduled Time (hours)  
Statistics 
Cmax 
(ng/mL) 
AUC0-24 
(h*ng/mL) 
AUC0-t 
(h*ng/mL) 
AUC0-tau 
(h*ng/mL) 
Tmax 
(h) 
t1/2 
(h) 
Lambda_z 
(1/h) 
n 
34 
34 
34 
34 
34 
11 
11 
Mean 
847 
11900 
11900 
5130 
. 
8.46 
0.0938 
Geometric Mean 
823 
11600 
11600 
5000 
. 
. 
. 
SD 
211 
2820 
2820 
1160 
. 
3.85 
0.0309 
CV% 
24.9 
23.8 
23.8 
22.6 
. 
45.5 
32.9 
Geometric SD 
1.28 
1.28 
1.28 
1.26 
. 
. 
. 
Geometric CV% 
25.0 
24.7 
24.7 
23.6 
. 
. 
. 
Median 
848 
11800 
11800 
5070 
4.00 
6.49 
0.1069 
Min 
523 
6210 
6210 
2960 
2.00 
5.09 
0.0380 
Max 
1330 
19000 
19000 
7270 
8.02 
18.2 
0.1362 
 
Page 78


SIGA TECHNOLOGIES, INC.  
Page 1 of 1 
SIGA-246-022  
Table 14.2.3  
Summary of Plasma Pharmacokinetic Parameters of TPOXX — Day 7  
Pharmacokinetic Population  
 
 
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours 
(±30 minutes) apart.  
Note: CL/F is calculated as Dose/AUC0-12. Vz/F is calculated as Dose/(AUC0-12*Lambda_z).  
Source Data: Listing 16.2.6.3  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\t140203.SAS  Executed: 24JAN2020 08:07  
 
Scheduled Time (hours)  
Statistics 
Cmax 
(ng/mL) 
AUC0-24 
(h*ng/mL) 
AUC0-t 
(h*ng/mL) 
AUC0-tau 
(h*ng/mL) 
AUC0-inf 
(h*ng/mL) 
Tmax 
(h) 
t1/2 
(h) 
Lambda_z 
(1/h) 
CL/F 
(L/h) 
Vz/F 
(L) 
%AUCextrap 
(%) 
n 
34 
34 
34 
34 
33 
34 
33 
33 
34 
33 
33 
Mean 
1350 
20000 
29500 
9830 
33200 
. 
12.9 
0.0559 
64.8 
1180 
10.4 
Geometric Mean 
1300 
19500 
28500 
9550 
31900 
. 
. 
. 
. 
. 
. 
SD 
393 
4590 
7670 
2350 
9240 
. 
2.48 
0.0113 
16.8 
355 
4.06 
CV% 
29.0 
23.0 
26.0 
23.9 
27.8 
. 
19.3 
20.3 
26.0 
29.9 
39.2 
Geometric SD 
1.33 
1.27 
1.31 
1.28 
1.34 
. 
. 
. 
. 
. 
. 
Geometric CV% 
29.1 
24.3 
27.8 
25.1 
30.2 
. 
. 
. 
. 
. 
. 
Median 
1280 
19200 
29000 
9510 
33000 
4.00 
12.5 
0.0552 
63.1 
1170 
9.78 
Min 
690 
10900 
15500 
5280 
15900 
2.00 
7.65 
0.0379 
40.6 
698 
1.94 
Max 
2270 
27600 
45300 
14800 
54500 
11.95 
18.3 
0.0906 
114 
2430 
19.1 
 
Page 79


SIGA TECHNOLOGIES, INC.  
Page 1 of 1 
SIGA-246-022  
Table 14.2.4  
Summary of Trough Concentration (ng/mL) of TPOXX  
Pharmacokinetic Population  
 
 
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours 
(±30 minutes) apart.  
Source Data: Listing 16.2.6.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\t140204.SAS  Executed: 24JAN2020 08:07  
 
Scheduled Time (hours)  
Statistics 
Day 1 
Before PM Dose 
Day 2 
Before AM Dose 
Day 6 
Before AM Dose 
Day 7 
Before AM Dose 
Day 7 
Before PM Dose 
n 
33 
34 
34 
34 
34 
Mean 
267 
517 
620 
615 
617 
Geometric Mean 
246 
484 
584 
585 
584 
SD 
123 
206 
213 
190 
219 
CV% 
46.2 
39.8 
34.3 
30.9 
35.6 
Geometric SD 
1.48 
1.43 
1.44 
1.39 
1.39 
Geometric CV% 
41.0 
37.0 
37.6 
34.0 
34.2 
Median 
241 
471 
586 
605 
562 
Min 
121 
215 
227 
247 
265 
Max 
758 
1170 
1200 
1090 
1280 
 
Page 80


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Figure 14.2.1  
Mean (±SD) Plasma Concentrations of TPOXX versus Time  
Pharmacokinetic Population  
 
 
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 
1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Table 14.2.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\f140201.SAS  
Executed: 24JAN2020 08:03  
 
Page 81


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Figure 14.2.1  
Mean (±SD) Plasma Concentrations of TPOXX versus Time  
Pharmacokinetic Population  
 
 
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 
1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Table 14.2.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\f140201.SAS  
Executed: 24JAN2020 08:03  
 
Page 82


SIGA TECHNOLOGIES, INC.  
Page 1 of 1 
SIGA-246-022  
Figure 14.2.2  
Mean (±SD) Plasma Trough Concentrations of TPOXX versus Time  
Pharmacokinetic Population  
 
 
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 
1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Table 14.2.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\f140202.SAS  
Executed: 24JAN2020 08:04  
 
Page 83


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Figure 14.2.3  
Individual Plasma Concentrations of TPOXX versus Time  
Safety Population  
 
 
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 
1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.6.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\f140203.SAS  
Executed: 24JAN2020 08:04  
 
Page 84


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Figure 14.2.3  
Individual Plasma Concentrations of TPOXX versus Time  
Safety Population  
 
 
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 
1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.6.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\f140203.SAS  
Executed: 24JAN2020 08:04  
 
Page 85


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Table 14.3.1.1  
Overall Summary of Adverse Events  
Safety Population  
 
 
Note: An AE is considered a treatment-related AE (TRAE) if it is assessed as probably, possibly, or definitely related.  
At each level of subject summarization, a subject is counted once if the subject reported one or more events. n represents the 
number of subjects at each level of summarization. Percentages are based on the number of subjects in the safety population. [E] 
represents the number of events at each level of summarization.  
If the relationship of an AE is missing, the AE will be considered 'Related'; if the severity of an AE is missing, the AE will 
be considerd 'Grade 3 (Severe)'.  
Time to first AE is calculated in days as the date of the first AE — the date of first dose of study drug + 1. Time to first AE 
of grade 3 or higher is calculated similarly. Only treatment-emergent AEs are considered.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030101.SAS  Executed: 21JAN2020 22:56  
Total 
(N=34) 
n (%) [E] 
Any AE 
9  (26.5)  [12] 
Time to first TEAE (days) 
 n 
9 
 Mean (SD) 
5.0 (5.45) 
 Median 
3.0 
 Min, Max 
2, 19 
Any Grade 2 (Moderate) AE 
0 
Any Grade 3 (Severe) AE 
0 
Any Grade 4 (Life-Threatening) AE 
0 
Any Grade 5 (Death) AE 
0 
Time to first TEAE of Grade 3 or higher (days) 
 n 
0 
 Mean (SD) 
 Median 
 Min, Max 
Page 86


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Table 14.3.1.1  
Overall Summary of Adverse Events  
Safety Population  
 
 
Note: An AE is considered a treatment-related AE (TRAE) if it is assessed as probably, possibly, or definitely related.  
At each level of subject summarization, a subject is counted once if the subject reported one or more events. n represents the 
number of subjects at each level of summarization. Percentages are based on the number of subjects in the safety population. [E] 
represents the number of events at each level of summarization.  
If the relationship of an AE is missing, the AE will be considered 'Related'; if the severity of an AE is missing, the AE will 
be considerd 'Grade 3 (Severe)'.  
Time to first AE is calculated in days as the date of the first AE — the date of first dose of study drug + 1. Time to first AE 
of grade 3 or higher is calculated similarly. Only treatment-emergent AEs are considered.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030101.SAS  Executed: 21JAN2020 22:56  
Total 
(N=34) 
n (%) [E] 
Any Treatment-Related AE (TRAE) 
2   (5.9)  [2] 
Any Grade 2 (Moderate) TRAE 
0 
Any Grade 3 (Severe) TRAE 
0 
Any Grade 4 (Life-Threatening) TRAE 
0 
Any Grade 5 (Death) TRAE 
0 
Any Serious AE 
0 
Any Serious TRAE 
0 
Any AE leading to study drug 
discontinuation 
0 
Any AE leading to study 
discontinuation 
0 
 
Page 87


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Table 14.3.1.2  
Adverse Events by System Organ Class and Preferred Term  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once if 
the subject reported one or more events.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030102.SAS  Executed: 21JAN2020 22:56  
System Organ Class 
 Preferred Term 
Total 
(N=34) 
n (%) 
Total number of adverse events 
12 
Number of subjects with at least one adverse event 
9  (26.5) 
Gastrointestinal disorders 
3   (8.8) 
 Nausea 
2   (5.9) 
 Infrequent bowel movements 
1   (2.9) 
 Lip dry 
1   (2.9) 
Nervous system disorders 
2   (5.9) 
 Headache 
2   (5.9) 
Eye disorders 
1   (2.9) 
 Scleral hyperaemia 
1   (2.9) 
Infections and infestations 
1   (2.9) 
 Urinary tract infection 
1   (2.9) 
Injury, poisoning and procedural complications 
1   (2.9) 
 Palate injury 
1   (2.9) 
Musculoskeletal and connective tissue disorders 
1   (2.9) 
 Back pain 
1   (2.9) 
Renal and urinary disorders 
1   (2.9) 
 Dysuria 
1   (2.9) 
Page 88


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Table 14.3.1.2  
Adverse Events by System Organ Class and Preferred Term  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once if 
the subject reported one or more events.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030102.SAS  Executed: 21JAN2020 22:56  
System Organ Class 
 Preferred Term 
Total 
(N=34) 
n (%) 
Skin and subcutaneous tissue disorders 
1   (2.9) 
 Dermatitis contact 
1   (2.9) 
 
Page 89


SIGA TECHNOLOGIES, INC.  
Page 1 of 1 
SIGA-246-022  
  
Table 14.3.1.3  
Adverse Events by Preferred Term  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once if 
the subject reported one or more events.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data : Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030103.SAS  Executed: 21JAN2020 22:57  
Preferred Term 
Total 
(N=34) 
n (%) 
Total number of adverse events 
12 
Number of subjects with at least one adverse event 
9  (26.5) 
Headache 
2   (5.9) 
Nausea 
2   (5.9) 
Back pain 
1   (2.9) 
Dermatitis contact 
1   (2.9) 
Dysuria 
1   (2.9) 
Infrequent bowel movements 
1   (2.9) 
Lip dry 
1   (2.9) 
Palate injury 
1   (2.9) 
Scleral hyperaemia 
1   (2.9) 
Urinary tract infection 
1   (2.9) 
 
Page 90


SIGA TECHNOLOGIES, INC.  
Page 1 of 7 
SIGA-246-022  
  
Table 14.3.1.4  
Adverse Events by Relationship to Study Drug  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most related event if the subject reported one or more events.  
If the relationship of an AE is missing, the AE is reported as 'DEFINITELY RELATED'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030104.SAS  Executed: 21JAN2020 22:57  
System Organ Class 
 Preferred Term 
   Relationship 
Total 
(N=34) 
n (%) 
Total number of adverse events 
12 
   NOT RELATED 
4 
   UNLIKELY RELATED 
6 
   POSSIBLY RELATED 
2 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Number of subjects with at least one adverse event 
9  (26.5) 
   NOT RELATED 
3   (8.8) 
   UNLIKELY RELATED 
4  (11.8) 
   POSSIBLY RELATED 
2   (5.9) 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Gastrointestinal disorders 
3   (8.8) 
   NOT RELATED 
1   (2.9) 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
1   (2.9) 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Page 91


SIGA TECHNOLOGIES, INC.  
Page 2 of 7 
SIGA-246-022  
  
Table 14.3.1.4  
Adverse Events by Relationship to Study Drug  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most related event if the subject reported one or more events.  
If the relationship of an AE is missing, the AE is reported as 'DEFINITELY RELATED'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030104.SAS  Executed: 21JAN2020 22:57  
System Organ Class 
 Preferred Term 
   Relationship 
Total 
(N=34) 
n (%) 
Gastrointestinal disorders (cont.) 
 Nausea 
2   (5.9) 
   NOT RELATED 
0 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
1   (2.9) 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
 Infrequent bowel movements 
1   (2.9) 
   NOT RELATED 
0 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
 Lip dry 
1   (2.9) 
   NOT RELATED 
1   (2.9) 
   UNLIKELY RELATED 
0 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Page 92


SIGA TECHNOLOGIES, INC.  
Page 3 of 7 
SIGA-246-022  
  
Table 14.3.1.4  
Adverse Events by Relationship to Study Drug  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most related event if the subject reported one or more events.  
If the relationship of an AE is missing, the AE is reported as 'DEFINITELY RELATED'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030104.SAS  Executed: 21JAN2020 22:57  
System Organ Class 
 Preferred Term 
   Relationship 
Total 
(N=34) 
n (%) 
Nervous system disorders 
2   (5.9) 
   NOT RELATED 
0 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
1   (2.9) 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
 Headache 
2   (5.9) 
   NOT RELATED 
0 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
1   (2.9) 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Eye disorders 
1   (2.9) 
   NOT RELATED 
0 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Page 93


SIGA TECHNOLOGIES, INC.  
Page 4 of 7 
SIGA-246-022  
  
Table 14.3.1.4  
Adverse Events by Relationship to Study Drug  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most related event if the subject reported one or more events.  
If the relationship of an AE is missing, the AE is reported as 'DEFINITELY RELATED'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030104.SAS  Executed: 21JAN2020 22:57  
System Organ Class 
 Preferred Term 
   Relationship 
Total 
(N=34) 
n (%) 
Eye disorders (cont.) 
 Scleral hyperaemia 
1   (2.9) 
   NOT RELATED 
0 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Infections and infestations 
1   (2.9) 
   NOT RELATED 
1   (2.9) 
   UNLIKELY RELATED 
0 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
 Urinary tract infection 
1   (2.9) 
   NOT RELATED 
1   (2.9) 
   UNLIKELY RELATED 
0 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Page 94


SIGA TECHNOLOGIES, INC.  
Page 5 of 7 
SIGA-246-022  
  
Table 14.3.1.4  
Adverse Events by Relationship to Study Drug  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most related event if the subject reported one or more events.  
If the relationship of an AE is missing, the AE is reported as 'DEFINITELY RELATED'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030104.SAS  Executed: 21JAN2020 22:57  
System Organ Class 
 Preferred Term 
   Relationship 
Total 
(N=34) 
n (%) 
Injury, poisoning and procedural complications 
1   (2.9) 
   NOT RELATED 
1   (2.9) 
   UNLIKELY RELATED 
0 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
 Palate injury 
1   (2.9) 
   NOT RELATED 
1   (2.9) 
   UNLIKELY RELATED 
0 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Musculoskeletal and connective tissue disorders 
1   (2.9) 
   NOT RELATED 
1   (2.9) 
   UNLIKELY RELATED 
0 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Page 95


SIGA TECHNOLOGIES, INC.  
Page 6 of 7 
SIGA-246-022  
  
Table 14.3.1.4  
Adverse Events by Relationship to Study Drug  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most related event if the subject reported one or more events.  
If the relationship of an AE is missing, the AE is reported as 'DEFINITELY RELATED'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030104.SAS  Executed: 21JAN2020 22:57  
System Organ Class 
 Preferred Term 
   Relationship 
Total 
(N=34) 
n (%) 
Musculoskeletal and connective tissue disorders 
(cont.) 
 Back pain 
1   (2.9) 
   NOT RELATED 
1   (2.9) 
   UNLIKELY RELATED 
0 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Renal and urinary disorders 
1   (2.9) 
   NOT RELATED 
0 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
 Dysuria 
1   (2.9) 
   NOT RELATED 
0 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
Page 96


SIGA TECHNOLOGIES, INC.  
Page 7 of 7 
SIGA-246-022  
  
Table 14.3.1.4  
Adverse Events by Relationship to Study Drug  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most related event if the subject reported one or more events.  
If the relationship of an AE is missing, the AE is reported as 'DEFINITELY RELATED'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030104.SAS  Executed: 21JAN2020 22:57  
System Organ Class 
 Preferred Term 
   Relationship 
Total 
(N=34) 
n (%) 
Skin and subcutaneous tissue disorders 
1   (2.9) 
   NOT RELATED 
0 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
 Dermatitis contact 
1   (2.9) 
   NOT RELATED 
0 
   UNLIKELY RELATED 
1   (2.9) 
   POSSIBLY RELATED 
0 
   PROBABLY RELATED 
0 
   DEFINITELY RELATED 
0 
 
Page 97


SIGA TECHNOLOGIES, INC.  
Page 1 of 7 
SIGA-246-022  
Table 14.3.1.5  
Adverse Events by Severity  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most severe event if the subject reported one or more events.  
If the severity of an AE is missing, the AE is reported as 'Grade 3 (SEVERE)'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030105.SAS  Executed: 21JAN2020 22:58  
System Organ Class 
 Preferred Term 
   Severity 
Total 
(N=34) 
n (%) 
Total number of adverse events 
12 
   Grade 1 (MILD) 
12 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Number of subjects with at least one adverse 
event 
9  (26.5) 
   Grade 1 (MILD) 
9  (26.5) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Gastrointestinal disorders 
3   (8.8) 
   Grade 1 (MILD) 
3   (8.8) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Page 98


SIGA TECHNOLOGIES, INC.  
Page 2 of 7 
SIGA-246-022  
Table 14.3.1.5  
Adverse Events by Severity  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most severe event if the subject reported one or more events.  
If the severity of an AE is missing, the AE is reported as 'Grade 3 (SEVERE)'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030105.SAS  Executed: 21JAN2020 22:58  
System Organ Class 
 Preferred Term 
   Severity 
Total 
(N=34) 
n (%) 
Gastrointestinal disorders (cont.) 
 Nausea 
2   (5.9) 
   Grade 1 (MILD) 
2   (5.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
 Infrequent bowel movements 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
 Lip dry 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Page 99


SIGA TECHNOLOGIES, INC.  
Page 3 of 7 
SIGA-246-022  
Table 14.3.1.5  
Adverse Events by Severity  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most severe event if the subject reported one or more events.  
If the severity of an AE is missing, the AE is reported as 'Grade 3 (SEVERE)'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030105.SAS  Executed: 21JAN2020 22:58  
System Organ Class 
 Preferred Term 
   Severity 
Total 
(N=34) 
n (%) 
Nervous system disorders 
2   (5.9) 
   Grade 1 (MILD) 
2   (5.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
 Headache 
2   (5.9) 
   Grade 1 (MILD) 
2   (5.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Eye disorders 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Page 100


SIGA TECHNOLOGIES, INC.  
Page 4 of 7 
SIGA-246-022  
Table 14.3.1.5  
Adverse Events by Severity  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most severe event if the subject reported one or more events.  
If the severity of an AE is missing, the AE is reported as 'Grade 3 (SEVERE)'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030105.SAS  Executed: 21JAN2020 22:58  
System Organ Class 
 Preferred Term 
   Severity 
Total 
(N=34) 
n (%) 
Eye disorders (cont.) 
 Scleral hyperaemia 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Infections and infestations 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
 Urinary tract infection 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Page 101


SIGA TECHNOLOGIES, INC.  
Page 5 of 7 
SIGA-246-022  
Table 14.3.1.5  
Adverse Events by Severity  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most severe event if the subject reported one or more events.  
If the severity of an AE is missing, the AE is reported as 'Grade 3 (SEVERE)'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030105.SAS  Executed: 21JAN2020 22:58  
System Organ Class 
 Preferred Term 
   Severity 
Total 
(N=34) 
n (%) 
Injury, poisoning and procedural complications 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
 Palate injury 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Musculoskeletal and connective tissue disorders 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Page 102


SIGA TECHNOLOGIES, INC.  
Page 6 of 7 
SIGA-246-022  
Table 14.3.1.5  
Adverse Events by Severity  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most severe event if the subject reported one or more events.  
If the severity of an AE is missing, the AE is reported as 'Grade 3 (SEVERE)'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030105.SAS  Executed: 21JAN2020 22:58  
System Organ Class 
 Preferred Term 
   Severity 
Total 
(N=34) 
n (%) 
Musculoskeletal and connective tissue disorders (cont.)
 Back pain 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Renal and urinary disorders 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
 Dysuria 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
Page 103


SIGA TECHNOLOGIES, INC.  
Page 7 of 7 
SIGA-246-022  
Table 14.3.1.5  
Adverse Events by Severity  
Safety Population  
 
 
Note: The total number of AEs counts all AEs for subjects.  At each level of subject summarization, a subject is counted once for 
the most severe event if the subject reported one or more events.  
If the severity of an AE is missing, the AE is reported as 'Grade 3 (SEVERE)'.  
Adverse Events were coded using MedDRA, Version 22.0.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.7.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t14030105.SAS  Executed: 21JAN2020 22:58  
System Organ Class 
 Preferred Term 
   Severity 
Total 
(N=34) 
n (%) 
Skin and subcutaneous tissue disorders 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
 Dermatitis contact 
1   (2.9) 
   Grade 1 (MILD) 
1   (2.9) 
   Grade 2 (MODERATE) 
0 
   Grade 3 (SEVERE) 
0 
   Grade 4 (LIFE-THREATENING) 
0 
   Grade 5 (DEATH) 
0 
 
Page 104


SIGA TECHNOLOGIES, INC.  
Page 1 of 5 
SIGA-246-022  
Table 14.3.2.1.1  
Summary of Actual Value and Change from Baseline in Hematology  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020101.SAS  Executed: 21JAN2020 22:58  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Basophils (10^9/L) 
 Baseline 
34 
0.044 0.0197
0.040
0.01 
0.09
 Day 4 
34 
0.046 0.0187
0.040
0.02 
0.09
34 
0.003 0.0124
0.000
-0.03
0.03
 Day 8 
34 
0.045 0.0160
0.040
0.02 
0.08
34 
0.001 0.0113
0.000
-0.02
0.03
 Day 9/ED 
34 
0.043 0.0193
0.040
0.01 
0.09
34 
-0.001 0.0098
0.000
-0.02
0.02
Basophils/Leukocytes (%) 
 Baseline 
34 
0.68
0.424
0.60
0.2 
2.8 
 Day 4 
34 
0.70
0.405
0.60
0.3 
2.6 
34 
0.02
0.180
0.00
-0.3 
0.4 
 Day 8 
34 
0.74
0.366
0.60
0.3 
2.4 
34 
0.06
0.196
0.00
-0.4 
0.6 
 Day 9/ED 
34 
0.71
0.365
0.60
0.3 
2.2 
34 
0.02
0.219
0.00
-0.6 
0.5 
Eosinophils (10^9/L) 
 Baseline 
34 
0.159 0.0907
0.135
0.03 
0.44
 Day 4 
34 
0.156 0.0687
0.160
0.03 
0.34
34 
-0.003 0.0606
0.010
-0.19
0.14
 Day 8 
34 
0.147 0.0532
0.140
0.04 
0.26
34 
-0.011 0.0673
0.000
-0.23
0.12
 Day 9/ED 
34 
0.131 0.0501
0.125
0.04 
0.27
34 
-0.028 0.0711 -0.005
-0.26
0.08
Eosinophils/Leukocytes (%) 
 Baseline 
34 
2.36
1.235
2.30
0.6 
6.7 
 Day 4 
34 
2.32
0.948
2.20
0.7 
4.2 
34 
-0.03
0.841
0.10
-2.8 
1.6 
 Day 8 
34 
2.31
0.872
2.20
0.8 
4.0 
34 
-0.05
1.008
0.10
-3.5 
2.1 
 Day 9/ED 
34 
2.21
0.870
2.10
1.0 
4.3 
34 
-0.15
1.086
0.10
-3.7 
1.9 
Page 105


SIGA TECHNOLOGIES, INC.  
Page 2 of 5 
SIGA-246-022  
Table 14.3.2.1.1  
Summary of Actual Value and Change from Baseline in Hematology  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020101.SAS  Executed: 21JAN2020 22:58  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Ery. Mean Corpuscular HGB Concentration
(g/L) 
 Baseline 
34 
334.3 
9.82
336.0 309 
351 
 Day 4 
34 
334.8 
9.26
335.0 307 
351 
34 
0.5 
3.31
0.0 
-5 
9 
 Day 8 
34 
335.1 
9.54
336.0 311 
352 
34 
0.9 
4.02
0.5 
-7 
8 
 Day 9/ED 
34 
334.8 
10.10
337.5 308 
349 
34 
0.5 
3.98
1.0 
-8 
8 
Ery. Mean Corpuscular Hemoglobin (pg) 
 Baseline 
34 
28.54
2.854
29.05
19.0 
32.8 
 Day 4 
34 
28.57
2.776
29.00
19.4 
32.6 
34 
0.03
0.296
0.00
-0.4 
0.7 
 Day 8 
34 
28.64
2.771
29.35
19.2 
32.3 
34 
0.11
0.356
0.15
-0.6 
0.9 
 Day 9/ED 
34 
28.60
2.817
29.10
18.9 
32.3 
34 
0.06
0.374
0.05
-0.5 
0.8 
Ery. Mean Corpuscular Volume (fL) 
 Baseline 
34 
85.28
7.025
86.85
60.9 
97.4 
 Day 4 
34 
85.24
6.908
86.30
61.5 
97.7 
34 
-0.04
0.576
-0.10
-1.2 
1.0 
 Day 8 
34 
85.34
6.865
86.50
60.8 
97.7 
34 
0.06
0.757
-0.05
-1.1 
1.7 
 Day 9/ED 
34 
85.27
6.804
86.30
61.4 
97.5 
34 
0.00
0.728
0.00
-1.7 
1.7 
Erythrocytes (10^12/L) 
 Baseline 
34 
4.857 0.4635
4.830
3.76 
6.66
 Day 4 
34 
5.014 0.4500
4.985
3.79 
6.60
34 
0.156 0.2066
0.120
-0.15
0.62
 Day 8 
34 
4.981 0.4635
4.985
3.80 
6.59
34 
0.124 0.1743
0.080
-0.24
0.47
 Day 9/ED 
34 
4.942 0.4907
4.880
3.78 
6.82
34 
0.085 0.1558
0.100
-0.21
0.38
Page 106


SIGA TECHNOLOGIES, INC.  
Page 3 of 5 
SIGA-246-022  
Table 14.3.2.1.1  
Summary of Actual Value and Change from Baseline in Hematology  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020101.SAS  Executed: 21JAN2020 22:58  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Erythrocytes Distribution Width (%) 
 Baseline 
34 
14.36
1.697
14.00
12.4 
20.4 
 Day 4 
34 
14.37
1.778
13.90
12.3 
20.9 
34 
0.01
0.299
0.00
-0.6 
0.6 
 Day 8 
34 
14.26
1.728
13.85
12.1 
21.1 
34 
-0.11
0.311
-0.10
-1.0 
0.7 
 Day 9/ED 
34 
14.24
1.736
13.90
12.4 
21.2 
34 
-0.12
0.358
-0.10
-1.2 
0.8 
Hematocrit (fraction of 1) 
 Baseline 
34 
0.41210.03127 0.4140
0.336 0.460
 Day 4 
34 
0.42560.03540 0.4340
0.334 0.483
34 
0.01350.01866 0.0110 -0.014
0.058
 Day 8 
34 
0.42340.03446 0.4350
0.342 0.476
34 
0.01120.01517 0.0095 -0.025
0.037
 Day 9/ED 
34 
0.41930.03250 0.4280
0.334 0.467
34 
0.00720.01419 0.0110 -0.022
0.035
Hemoglobin (g/L) 
 Baseline 
34 
138.0 
12.45
138.0 104 
160 
 Day 4 
34 
142.6 
14.43
145.0 102 
164 
34 
4.6 
5.95
4.0 
-4 
17 
 Day 8 
34 
142.0 
13.40
144.5 107 
162 
34 
4.0 
5.39
3.5 
-7 
15 
 Day 9/ED 
34 
140.6 
13.35
144.0 104 
161 
34 
2.6 
5.06
4.0 
-9 
12 
Leukocytes (10^9/L) 
 Baseline 
34 
6.72
1.653
6.70
3.2 
9.7 
 Day 4 
34 
6.84
1.620
6.85
3.3 
10.4 
34 
0.12
0.845
0.10
-1.7 
1.6 
 Day 8 
34 
6.54
1.389
6.70
3.2 
9.3 
34 
-0.18
0.911
-0.20
-2.4 
1.9 
 Day 9/ED 
34 
6.18
1.379
6.35
3.1 
9.0 
34 
-0.54
0.807
-0.45
-2.3 
1.0 
Page 107


SIGA TECHNOLOGIES, INC.  
Page 4 of 5 
SIGA-246-022  
Table 14.3.2.1.1  
Summary of Actual Value and Change from Baseline in Hematology  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020101.SAS  Executed: 21JAN2020 22:58  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Lymphocytes (10^9/L) 
 Baseline 
34 
2.075 0.6190
1.970
1.09 
3.83
 Day 4 
34 
2.280 0.5440
2.330
1.32 
3.68
34 
0.205 0.3087
0.205
-0.58
0.79
 Day 8 
34 
2.134 0.5743
2.110
1.12 
4.05
34 
0.059 0.4129
0.055
-1.35
0.85
 Day 9/ED 
34 
1.945 0.4578
1.885
0.84 
3.01
34 
-0.129 0.3883 -0.110
-1.63
0.44
Lymphocytes/Leukocytes (%) 
 Baseline 
34 
31.32
6.777
30.85
18.8 
47.0 
 Day 4 
34 
34.14
7.154
33.55
20.2 
46.2 
34 
2.82
3.361
3.15
-4.8 
10.6 
 Day 8 
34 
33.11
7.374
32.50
20.3 
48.2 
34 
1.79
4.492
2.25
-12.2 
9.7 
 Day 9/ED 
34 
32.03
6.485
31.10
19.9 
47.4 
34 
0.71
3.898
1.40
-9.7 
8.9 
Monocytes (10^9/L) 
 Baseline 
34 
0.527 0.1372
0.515
0.30 
0.82
 Day 4 
34 
0.535 0.1273
0.510
0.27 
0.91
34 
0.008 0.1064
0.000
-0.24
0.20
 Day 8 
34 
0.520 0.1081
0.510
0.37 
0.81
34 
-0.007 0.1031 -0.005
-0.23
0.20
 Day 9/ED 
34 
0.497 0.1128
0.475
0.30 
0.84
34 
-0.030 0.1029 -0.015
-0.30
0.16
Monocytes/Leukocytes (%) 
 Baseline 
34 
8.03
1.908
8.05
5.0 
13.9 
 Day 4 
34 
8.05
1.891
8.10
5.2 
13.9 
34 
0.02
1.255
0.05
-2.2 
3.1 
 Day 8 
34 
8.19
1.995
7.85
5.0 
14.3 
34 
0.16
1.179
0.20
-1.8 
2.5 
 Day 9/ED 
34 
8.33
2.433
8.25
5.3 
17.1 
34 
0.30
1.542
0.40
-3.2 
5.7 
Page 108


SIGA TECHNOLOGIES, INC.  
Page 5 of 5 
SIGA-246-022  
Table 14.3.2.1.1  
Summary of Actual Value and Change from Baseline in Hematology  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020101.SAS  Executed: 21JAN2020 22:58  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Neutrophils (10^9/L) 
 Baseline 
34 
3.925 1.2035
4.065
1.54 
5.97
 Day 4 
34 
3.827 1.2783
3.750
1.35 
6.91
34 
-0.098 0.6657 -0.120
-1.43
1.35
 Day 8 
34 
3.697 1.1210
3.645
1.48 
6.30
34 
-0.227 0.6436 -0.260
-2.03
1.32
 Day 9/ED 
34 
3.561 1.0839
3.500
1.50 
5.70
34 
-0.363 0.6039 -0.280
-1.97
0.67
Neutrophils/Leukocytes (%) 
 Baseline 
34 
57.64
7.321
58.30
43.6 
73.4 
 Day 4 
34 
54.82
7.979
55.00
40.8 
71.6 
34 
-2.82
4.369
-2.95
-12.2 
6.8 
 Day 8 
34 
55.73
8.191
55.75
40.3 
72.1 
34 
-1.91
4.971
-2.45
-12.9 
7.7 
 Day 9/ED 
34 
56.76
7.259
56.60
41.6 
71.3 
34 
-0.88
4.346
-0.65
-10.9 
10.0 
Platelets (10^9/L) 
 Baseline 
34 
267.1 
58.58
253.0 184 
403 
 Day 4 
34 
281.6 
62.14
268.5 197 
432 
34 
14.6 
14.68
15.0 -14 
42 
 Day 8 
34 
280.5 
60.67
269.0 195 
437 
34 
13.5 
18.11
11.5 -24 
50 
 Day 9/ED 
34 
279.9 
59.59
274.0 196 
420 
34 
12.9 
13.90
13.5 -21 
40 
 
Page 109


SIGA TECHNOLOGIES, INC.  
Page 1 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Basophils (10^9/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
31  (91.2) 
1   (2.9) 
 High 
0 
1   (2.9) 
1   (2.9) 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
2   (5.9) 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
31  (91.2) 
1   (2.9) 
 High 
0 
2   (5.9) 
0 
Page 110


SIGA TECHNOLOGIES, INC.  
Page 2 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Basophils/Leukocytes (%) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
0 
1   (2.9) 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
0 
1   (2.9) 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
0 
1   (2.9) 
Page 111


SIGA TECHNOLOGIES, INC.  
Page 3 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Eosinophils (10^9/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
1   (2.9) 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
1   (2.9) 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
1   (2.9) 
0 
Page 112


SIGA TECHNOLOGIES, INC.  
Page 4 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Eosinophils/Leukocytes (%) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
1   (2.9) 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
1   (2.9) 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
1   (2.9) 
0 
Page 113


SIGA TECHNOLOGIES, INC.  
Page 5 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Ery. Mean Corpuscular HGB Concentration (g/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
2   (5.9) 
0 
0 
 Normal 
0 
31  (91.2) 
0 
 High 
0 
1   (2.9) 
0 
Day 8 
 Low 
2   (5.9) 
0 
0 
 Normal 
0 
31  (91.2) 
0 
 High 
0 
0 
1   (2.9) 
Day 9/ED 
 Low 
2   (5.9) 
0 
0 
 Normal 
0 
31  (91.2) 
0 
 High 
0 
1   (2.9) 
0 
Page 114


SIGA TECHNOLOGIES, INC.  
Page 6 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Ery. Mean Corpuscular Hemoglobin (pg) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
2   (5.9) 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
2   (5.9) 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
2   (5.9) 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
0 
Page 115


SIGA TECHNOLOGIES, INC.  
Page 7 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Ery. Mean Corpuscular Volume (fL) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
2   (5.9) 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
2   (5.9) 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
2   (5.9) 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
0 
Page 116


SIGA TECHNOLOGIES, INC.  
Page 8 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Erythrocytes (10^12/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
1   (2.9) 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
1   (2.9) 
Day 8 
 Low 
1   (2.9) 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
1   (2.9) 
Day 9/ED 
 Low 
1   (2.9) 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
1   (2.9) 
Page 117


SIGA TECHNOLOGIES, INC.  
Page 9 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Erythrocytes Distribution Width (%) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
28  (82.4) 
1   (2.9) 
 High 
0 
1   (2.9) 
4  (11.8) 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
28  (82.4) 
1   (2.9) 
 High 
0 
1   (2.9) 
4  (11.8) 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
28  (82.4) 
1   (2.9) 
 High 
0 
1   (2.9) 
4  (11.8) 
Page 118


SIGA TECHNOLOGIES, INC.  
Page 10 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Hematocrit (fraction of 1) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
1   (2.9) 
0 
 Normal 
1   (2.9) 
31  (91.2) 
1   (2.9) 
 High 
0 
0 
0 
Day 8 
 Low 
0 
1   (2.9) 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
1   (2.9) 
0 
 Normal 
1   (2.9) 
32  (94.1) 
0 
 High 
0 
0 
0 
Page 119


SIGA TECHNOLOGIES, INC.  
Page 11 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Hemoglobin (g/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
1   (2.9) 
1   (2.9) 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
2   (5.9) 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
1   (2.9) 
1   (2.9) 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
0 
Page 120


SIGA TECHNOLOGIES, INC.  
Page 12 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Leukocytes (10^9/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
2   (5.9) 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 121


SIGA TECHNOLOGIES, INC.  
Page 13 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Lymphocytes (10^9/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
30  (88.2) 
2   (5.9) 
 High 
0 
0 
2   (5.9) 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
1   (2.9) 
1   (2.9) 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
1   (2.9) 
1   (2.9) 
Page 122


SIGA TECHNOLOGIES, INC.  
Page 14 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Lymphocytes/Leukocytes (%) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 123


SIGA TECHNOLOGIES, INC.  
Page 15 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Monocytes (10^9/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
2   (5.9) 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
1   (2.9) 
1   (2.9) 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
1   (2.9) 
1   (2.9) 
Page 124


SIGA TECHNOLOGIES, INC.  
Page 16 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Monocytes/Leukocytes (%) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
1   (2.9) 
 High 
0 
0 
1   (2.9) 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
1   (2.9) 
 High 
0 
0 
1   (2.9) 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
1   (2.9) 
 High 
0 
0 
1   (2.9) 
Page 125


SIGA TECHNOLOGIES, INC.  
Page 17 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Neutrophils (10^9/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
1   (2.9) 
32  (94.1) 
1   (2.9) 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
1   (2.9) 
33  (97.1) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 126


SIGA TECHNOLOGIES, INC.  
Page 18 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Neutrophils/Leukocytes (%) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 127


SIGA TECHNOLOGIES, INC.  
Page 19 of 19 
SIGA-246-022  
Table 14.3.2.1.2  
Shift from Baseline in Hematology  
Safety Population  
 
 
Parameter: Platelets (10^9/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020102.SAS  Executed: 21JAN2020 22:58  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
1   (2.9) 
 High 
0 
0 
1   (2.9) 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
1   (2.9) 
 High 
0 
1   (2.9) 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
1   (2.9) 
 High 
0 
1   (2.9) 
0 
 
Page 128


SIGA TECHNOLOGIES, INC.  
Page 1 of 3 
SIGA-246-022  
Table 14.3.2.1.3  
Summary of Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020103.SAS  Executed: 21JAN2020 22:59  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Hemoglobin (g/L)/ 
n 
34 
Low 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Leukocytes (10^9/L)/ 
n 
34 
Low 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 129


SIGA TECHNOLOGIES, INC.  
Page 2 of 3 
SIGA-246-022  
Table 14.3.2.1.3  
Summary of Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020103.SAS  Executed: 21JAN2020 22:59  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Lymphocytes (10^9/L)/ 
n 
34 
Low 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Neutrophils (10^9/L)/ 
n 
34 
Low 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 130


SIGA TECHNOLOGIES, INC.  
Page 3 of 3 
SIGA-246-022  
Table 14.3.2.1.3  
Summary of Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.1  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020103.SAS  Executed: 21JAN2020 22:59  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Platelets (10^9/L)/ 
n 
34 
Low 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
 
Page 131


SIGA TECHNOLOGIES, INC.  
Page 1 of 6 
SIGA-246-022  
Table 14.3.2.2.1  
Summary of Actual Value and Change from Baseline in Serum Chemistry  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020201.SAS  Executed: 21JAN2020 22:59  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Alanine Aminotransferase (IU/L) 
 Baseline 
34 
21.8 
8.87
20.0 
11 
45 
 Day 4 
34 
23.5 
11.84
20.5 
10 
61 
34 
1.7 
6.11
1.0 
-7 
22 
 Day 8 
34 
25.0 
11.70
22.5 
10 
56 
34 
3.2 
7.66
2.0 
-9 
36 
 Day 9/ED 
34 
25.6 
12.21
23.0 
11 
56 
34 
3.9 
7.77
2.5 -10 
34 
Albumin (g/L) 
 Baseline 
34 
42.4 
2.78
43.0 
37 
47 
 Day 4 
34 
43.4 
3.35
44.0 
37 
49 
34 
0.9 
2.26
1.0 
-4 
7 
 Day 8 
34 
43.5 
2.61
44.0 
37 
48 
34 
1.1 
1.95
1.0 
-3 
5 
 Day 9/ED 
34 
44.2 
2.73
44.0 
38 
50 
34 
1.8 
2.29
2.0 
-2 
7 
Alkaline Phosphatase (IU/L) 
 Baseline 
34 
64.9 
20.51
63.5 
30 
108 
 Day 4 
34 
61.0 
19.42
58.5 
29 
121 
34 
-3.9 
6.77
-3.0 -20 
15 
 Day 8 
34 
66.9 
20.90
66.0 
33 
124 
34 
2.0 
6.31
3.0 -14 
18 
 Day 9/ED 
34 
67.4 
20.56
64.0 
30 
127 
34 
2.5 
6.33
3.0 -16 
21 
Anion Gap (mmol/L) 
 Baseline 
34 
10.6 
1.50
10.5 
8 
15 
 Day 4 
34 
10.4 
2.15
11.0 
6 
15 
34 
-0.2 
2.47
0.0 
-6 
4 
 Day 8 
34 
10.6 
1.65
11.0 
6 
13 
34 
0.0 
2.04
0.0 
-5 
5 
 Day 9/ED 
34 
10.3 
1.38
10.0 
8 
14 
34 
-0.3 
1.96
0.0 
-5 
4 
Page 132


SIGA TECHNOLOGIES, INC.  
Page 2 of 6 
SIGA-246-022  
Table 14.3.2.2.1  
Summary of Actual Value and Change from Baseline in Serum Chemistry  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020201.SAS  Executed: 21JAN2020 22:59  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Aspartate Aminotransferase (IU/L) 
 Baseline 
34 
17.6 
4.63
18.0 
11 
33 
 Day 4 
34 
18.2 
5.69
17.0 
11 
37 
34 
0.6 
3.62
0.5 
-8 
13 
 Day 8 
34 
17.9 
4.49
17.5 
11 
29 
34 
0.3 
3.37
1.0 
-7 
13 
 Day 9/ED 
34 
18.3 
4.46
18.0 
11 
28 
34 
0.7 
2.94
0.0 
-6 
9 
Bilirubin (umol/L) 
 Baseline 
34 
7.96
3.339
7.20
3.2 
21.2 
 Day 4 
34 
10.24
3.760
10.00
5.5 
23.6 
34 
2.28
1.833
2.15
-1.1 
6.4 
 Day 8 
34 
10.25
3.393
10.10
6.0 
20.5 
34 
2.29
2.057
2.10
-0.7 
7.7 
 Day 9/ED 
34 
9.04
2.881
9.00
5.1 
17.1 
34 
1.08
2.236
0.50
-5.1 
6.7 
Blood Urea Nitrogen (mmol/L) 
 Baseline 
34 
4.415 1.0537
4.445
2.25 
6.46
 Day 4 
34 
4.231 0.7147
4.180
2.82 
6.18
34 
-0.184 0.9306 -0.145
-2.18
1.40
 Day 8 
34 
4.091 0.6397
4.230
3.00 
5.39
34 
-0.325 0.9451 -0.195
-2.29
2.07
 Day 9/ED 
34 
4.346 0.6745
4.285
3.11 
6.46
34 
-0.069 0.9951 -0.035
-1.82
2.18
Calcium (mmol/L) 
 Baseline 
34 
2.304 0.0980
2.315
2.10 
2.53
 Day 4 
34 
2.360 0.0921
2.350
2.15 
2.58
34 
0.056 0.0750
0.060
-0.10
0.20
 Day 8 
34 
2.397 0.0755
2.400
2.23 
2.58
34 
0.092 0.0752
0.100
-0.08
0.20
 Day 9/ED 
34 
2.348 0.0852
2.350
2.18 
2.50
34 
0.043 0.0887
0.050
-0.13
0.18
Page 133


SIGA TECHNOLOGIES, INC.  
Page 3 of 6 
SIGA-246-022  
Table 14.3.2.2.1  
Summary of Actual Value and Change from Baseline in Serum Chemistry  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020201.SAS  Executed: 21JAN2020 22:59  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Carbon Dioxide (mmol/L) 
 Baseline 
34 
29.2 
1.47
29.0 
26 
31 
 Day 4 
34 
29.5 
2.02
29.5 
24 
33 
34 
0.3 
1.89
0.0 
-4 
4 
 Day 8 
34 
29.8 
1.55
30.0 
27 
33 
34 
0.6 
1.46
1.0 
-3 
3 
 Day 9/ED 
34 
29.4 
1.78
30.0 
26 
33 
34 
0.2 
1.67
0.0 
-4 
3 
Chloride (mmol/L) 
 Baseline 
34 
102.6 
1.48
102.5 100 
105 
 Day 4 
34 
103.0 
1.55
103.0 100 
106 
34 
0.4 
1.99
0.5 
-3 
6 
 Day 8 
34 
102.2 
1.68
102.0 
99 
107 
34 
-0.4 
1.87
0.0 
-3 
5 
 Day 9/ED 
34 
101.9 
1.56
102.0 
98 
105 
34 
-0.7 
1.99
-1.0 
-5 
5 
Cholesterol (mmol/L) 
 Baseline 
34 
4.815 0.9557
4.660
3.24 
6.84
Creatinine (umol/L) 
 Baseline 
34 
80.26 16.181
80.00
46.0 109.6 
 Day 4 
34 
80.60 15.558
77.80
47.7 108.7 
34 
0.34
5.090
0.85
-12.3 
10.6 
 Day 8 
34 
82.52 16.787
81.30
49.5 118.5 
34 
2.27
6.553
0.85
-12.4 
21.2 
 Day 9/ED 
34 
83.07 15.678
83.10
52.2 114.9 
34 
2.82
6.208
3.10
-12.4 
13.3 
Creatinine Clearance (mL/min) 
 Baseline 
34 
224.69 50.724 223.30
131.8 338.3 
Page 134


SIGA TECHNOLOGIES, INC.  
Page 4 of 6 
SIGA-246-022  
Table 14.3.2.2.1  
Summary of Actual Value and Change from Baseline in Serum Chemistry  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020201.SAS  Executed: 21JAN2020 22:59  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Gamma Glutamyl Transferase (IU/L) 
 Baseline 
34 
27.4 
12.89
25.5 
13 
64 
 Day 4 
34 
27.6 
12.81
26.0 
12 
69 
34 
0.2 
3.44
0.0 
-9 
13 
 Day 8 
34 
28.6 
12.91
26.0 
13 
65 
34 
1.2 
5.68
1.0 -14 
21 
 Day 9/ED 
34 
28.6 
13.01
25.5 
12 
66 
34 
1.2 
6.07
1.0 -13 
23 
Globulin (g/L) 
 Baseline 
34 
27.3 
3.87
27.5 
19 
35 
 Day 4 
34 
29.1 
3.53
29.0 
21 
36 
34 
1.7 
1.56
2.0 
-2 
5 
 Day 8 
34 
28.6 
3.78
29.0 
18 
35 
34 
1.3 
2.26
2.0 
-5 
6 
 Day 9/ED 
34 
28.9 
3.81
29.0 
19 
36 
34 
1.6 
1.84
1.0 
-2 
5 
Glucose (mmol/L) 
 Baseline 
34 
5.401 0.4533
5.465
4.38 
6.33
 Day 4 
34 
5.276 0.4118
5.245
4.61 
6.11
34 
-0.125 0.4346 -0.135
-1.06
1.06
 Day 8 
34 
5.088 0.4252
5.025
4.44 
6.33
34 
-0.314 0.4706 -0.300
-1.39
0.61
 Day 9/ED 
34 
5.169 0.3683
5.160
4.61 
6.11
34 
-0.232 0.4249 -0.135
-1.27
0.45
HDL Cholesterol (mmol/L) 
 Baseline 
34 
1.130 0.2600
1.110
0.73 
1.81
LDL Cholesterol (mmol/L) 
 Baseline 
34 
2.982 0.8138
2.695
1.79 
4.77
Page 135


SIGA TECHNOLOGIES, INC.  
Page 5 of 6 
SIGA-246-022  
Table 14.3.2.2.1  
Summary of Actual Value and Change from Baseline in Serum Chemistry  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020201.SAS  Executed: 21JAN2020 22:59  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Lactate Dehydrogenase (IU/L) 
 Baseline 
34 
159.2 
33.00
159.5 
82 
233 
 Day 4 
34 
147.8 
34.86
146.5 
82 
226 
34 
-11.4 
12.16
-11.0 -40 
14 
 Day 8 
34 
142.9 
33.20
136.5 
75 
222 
34 
-16.3 
12.78
-17.5 -40 
20 
 Day 9/ED 
34 
148.1 
31.10
144.0 
85 
223 
34 
-11.1 
13.93
-12.0 -33 
22 
Phosphate (mmol/L) 
 Baseline 
34 
1.115 0.1642
1.100
0.78 
1.71
 Day 4 
34 
1.246 0.1668
1.230
0.94 
1.65
34 
0.130 0.1376
0.115
-0.10
0.42
 Day 8 
34 
1.282 0.1600
1.260
1.03 
1.81
34 
0.167 0.1115
0.160
0.00
0.52
 Day 9/ED 
34 
1.104 0.1363
1.100
0.84 
1.42
34 
-0.011 0.1259 -0.030
-0.29
0.32
Potassium (mmol/L) 
 Baseline 
34 
4.12
0.263
4.10
3.7 
4.6 
 Day 4 
34 
4.15
0.230
4.15
3.6 
4.8 
34 
0.03
0.275
0.00
-0.6 
0.5 
 Day 8 
34 
4.17
0.244
4.20
3.7 
4.7 
34 
0.05
0.256
0.10
-0.6 
0.5 
 Day 9/ED 
34 
4.13
0.303
4.10
3.5 
5.1 
34 
0.01
0.282
0.00
-0.8 
0.8 
Protein (g/L) 
 Baseline 
34 
69.7 
5.13
70.0 
58 
79 
 Day 4 
34 
72.4 
5.16
73.5 
60 
83 
34 
2.7 
3.52
2.0 
-5 
12 
 Day 8 
34 
72.1 
4.46
72.5 
59 
79 
34 
2.4 
3.69
2.5 
-8 
11 
 Day 9/ED 
34 
73.1 
4.90
72.5 
60 
83 
34 
3.4 
3.53
3.0 
-4 
11 
Page 136


SIGA TECHNOLOGIES, INC.  
Page 6 of 6 
SIGA-246-022  
Table 14.3.2.2.1  
Summary of Actual Value and Change from Baseline in Serum Chemistry  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020201.SAS  Executed: 21JAN2020 22:59  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Sodium (mmol/L) 
 Baseline 
34 
138.2 
1.57
138.5 135 
142 
 Day 4 
34 
138.9 
1.62
139.0 136 
144 
34 
0.6 
1.57
1.0 
-2 
5 
 Day 8 
34 
138.5 
1.69
138.0 135 
142 
34 
0.3 
1.78
0.0 
-4 
4 
 Day 9/ED 
34 
137.4 
1.88
138.0 133 
140 
34 
-0.8 
2.04
-0.5 
-6 
3 
Triglycerides (mmol/L) 
 Baseline 
34 
1.537 0.9103
1.265
0.41 
4.19
Urate (umol/L) 
 Baseline 
34 
386.6 
68.53
384.0 274 
535 
 Day 4 
34 
406.0 
66.99
404.0 309 
589 
34 
19.4 
42.17
18.0 -71 
125 
 Day 8 
34 
391.2 
65.17
393.0 280 
571 
34 
4.6 
44.21
6.0 -107 
107 
 Day 9/ED 
34 
391.5 
62.74
390.0 286 
577 
34 
4.9 
43.70
6.0 -101 
113 
 
Page 137


SIGA TECHNOLOGIES, INC.  
Page 1 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Alanine Aminotransferase (IU/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
1   (2.9) 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 138


SIGA TECHNOLOGIES, INC.  
Page 2 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Albumin (g/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
2   (5.9) 
32  (94.1) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
1   (2.9) 
33  (97.1) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 139


SIGA TECHNOLOGIES, INC.  
Page 3 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Alkaline Phosphatase (IU/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
1   (2.9) 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
1   (2.9) 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
1   (2.9) 
 High 
0 
0 
0 
Page 140


SIGA TECHNOLOGIES, INC.  
Page 4 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Anion Gap (mmol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 141


SIGA TECHNOLOGIES, INC.  
Page 5 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Aspartate Aminotransferase (IU/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 142


SIGA TECHNOLOGIES, INC.  
Page 6 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Bilirubin (umol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 143


SIGA TECHNOLOGIES, INC.  
Page 7 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Blood Urea Nitrogen (mmol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 144


SIGA TECHNOLOGIES, INC.  
Page 8 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Calcium (mmol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
1   (2.9) 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
1   (2.9) 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
1   (2.9) 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
0 
0 
Page 145


SIGA TECHNOLOGIES, INC.  
Page 9 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Carbon Dioxide (mmol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 146


SIGA TECHNOLOGIES, INC.  
Page 10 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Chloride (mmol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 147


SIGA TECHNOLOGIES, INC.  
Page 11 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Creatinine (umol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
1   (2.9) 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 148


SIGA TECHNOLOGIES, INC.  
Page 12 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Gamma Glutamyl Transferase (IU/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 149


SIGA TECHNOLOGIES, INC.  
Page 13 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Globulin (g/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
1   (2.9) 
33  (97.1) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 150


SIGA TECHNOLOGIES, INC.  
Page 14 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Glucose (mmol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 151


SIGA TECHNOLOGIES, INC.  
Page 15 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Lactate Dehydrogenase (IU/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
32  (94.1) 
0 
 High 
0 
0 
2   (5.9) 
Day 8 
 Low 
0 
0 
0 
 Normal 
1   (2.9) 
30  (88.2) 
1   (2.9) 
 High 
0 
2   (5.9) 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
31  (91.2) 
1   (2.9) 
 High 
0 
2   (5.9) 
0 
Page 152


SIGA TECHNOLOGIES, INC.  
Page 16 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Phosphate (mmol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
0 
1   (2.9) 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
0 
1   (2.9) 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
1   (2.9) 
0 
Page 153


SIGA TECHNOLOGIES, INC.  
Page 17 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Potassium (mmol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
1   (2.9) 
 High 
0 
0 
0 
Page 154


SIGA TECHNOLOGIES, INC.  
Page 18 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Protein (g/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 155


SIGA TECHNOLOGIES, INC.  
Page 19 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Sodium (mmol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 156


SIGA TECHNOLOGIES, INC.  
Page 20 of 20 
SIGA-246-022  
Table 14.3.2.2.2  
Shift from Baseline in Serum Chemistry  
Safety Population  
 
 
Parameter: Urate (umol/L) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. Baseline is defined as the last 
non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020202.SAS  Executed: 21JAN2020 23:00  
 
Baseline 
Post-Baseline Visit 
Low 
Normal 
High 
Day 4 
 Low 
0 
0 
0 
 Normal 
0 
21  (61.8) 
4  (11.8) 
 High 
0 
3   (8.8) 
6  (17.6) 
Day 8 
 Low 
0 
0 
0 
 Normal 
0 
23  (67.6) 
2   (5.9) 
 High 
0 
6  (17.6) 
3   (8.8) 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
22  (64.7) 
3   (8.8) 
 High 
0 
6  (17.6) 
3   (8.8) 
 
Page 157


SIGA TECHNOLOGIES, INC.  
Page 1 of 9 
SIGA-246-022  
Table 14.3.2.2.3  
Summary of Serum Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020203.SAS  Executed: 21JAN2020 23:01  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Alanine Aminotransferase 
(IU/L)/ 
n 
34 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Albumin (g/L)/ 
n 
34 
Low 
 Increase to Grade 1 
2  (5.9) 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
2  (5.9) 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 158


SIGA TECHNOLOGIES, INC.  
Page 2 of 9 
SIGA-246-022  
Table 14.3.2.2.3  
Summary of Serum Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020203.SAS  Executed: 21JAN2020 23:01  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Alkaline Phosphatase 
(IU/L)/ 
n 
34 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Aspartate Aminotransferase 
(IU/L)/ 
n 
34 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 159


SIGA TECHNOLOGIES, INC.  
Page 3 of 9 
SIGA-246-022  
Table 14.3.2.2.3  
Summary of Serum Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020203.SAS  Executed: 21JAN2020 23:01  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Bilirubin (umol/L)/ 
n 
34 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Calcium (mmol/L)/ 
n 
34 
Low 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 160


SIGA TECHNOLOGIES, INC.  
Page 4 of 9 
SIGA-246-022  
Table 14.3.2.2.3  
Summary of Serum Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020203.SAS  Executed: 21JAN2020 23:01  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Calcium (mmol/L)/ 
n 
34 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Carbon Dioxide (mmol/L)/ 
n 
34 
Low 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 161


SIGA TECHNOLOGIES, INC.  
Page 5 of 9 
SIGA-246-022  
Table 14.3.2.2.3  
Summary of Serum Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020203.SAS  Executed: 21JAN2020 23:01  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Creatinine (umol/L)/ 
n 
34 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Glucose (mmol/L)/ 
n 
34 
Low 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 162


SIGA TECHNOLOGIES, INC.  
Page 6 of 9 
SIGA-246-022  
Table 14.3.2.2.3  
Summary of Serum Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020203.SAS  Executed: 21JAN2020 23:01  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Glucose (mmol/L)/ 
n 
34 
High 
 Increase to Grade 1 
2  (5.9) 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
2  (5.9) 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Phosphate (mmol/L)/ 
n 
34 
Low 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 163


SIGA TECHNOLOGIES, INC.  
Page 7 of 9 
SIGA-246-022  
Table 14.3.2.2.3  
Summary of Serum Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020203.SAS  Executed: 21JAN2020 23:01  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Potassium (mmol/L)/ 
n 
34 
Low 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Potassium (mmol/L)/ 
n 
34 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 164


SIGA TECHNOLOGIES, INC.  
Page 8 of 9 
SIGA-246-022  
Table 14.3.2.2.3  
Summary of Serum Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020203.SAS  Executed: 21JAN2020 23:01  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Sodium (mmol/L)/ 
n 
34 
Low 
 Increase to Grade 1 
3  (8.8) 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
3  (8.8) 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Sodium (mmol/L)/ 
n 
34 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 165


SIGA TECHNOLOGIES, INC.  
Page 9 of 9 
SIGA-246-022  
Table 14.3.2.2.3  
Summary of Serum Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.2  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020203.SAS  Executed: 21JAN2020 23:01  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Urate (umol/L)/ 
n 
34 
High 
 Increase to Grade 1 
3  (8.8) 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
3  (8.8) 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
 
Page 166


SIGA TECHNOLOGIES, INC.  
Page 1 of 1 
SIGA-246-022  
Table 14.3.2.3.1  
Summary of Actual Value and Change from Baseline in Urinalysis  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403020301.SAS  Executed: 21JAN2020 23:01  
 
Actual Value 
Change From Baseline [1] 
Lab Parameter 
 Visit 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Specific Gravity 
 Baseline 
34 
1.01680.00807 1.0185
1.003 1.029
 Day 9/ED 
34 
1.01960.00640 1.0205
1.006 1.034
34 
0.00280.00903 0.0010 -0.016
0.022
Urobilinogen (umol/dL) 
 Baseline 
34 
0.697 0.6045
0.340
0.34 
1.69
 Day 9/ED 
34 
0.499 0.4415
0.340
0.34 
1.69
34 
-0.199 0.6756
0.000
-1.35
1.35
pH 
 Baseline 
34 
5.97
0.550
6.00
5.0 
7.0 
 Day 9/ED 
34 
5.93
0.566
6.00
5.0 
7.0 
34 
-0.04
0.711
0.00
-2.0 
1.5 
 
Page 167


SIGA TECHNOLOGIES, INC.  
Page 1 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Specific Gravity 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Low 
Normal 
High 
Screening 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
33  (97.1) 
0 
 High 
0 
1   (2.9) 
0 
Page 168


SIGA TECHNOLOGIES, INC.  
Page 2 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Urobilinogen (umol/dL) 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Low 
Normal 
High 
Screening 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 169


SIGA TECHNOLOGIES, INC.  
Page 3 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): pH 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Low 
Normal 
High 
Screening 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Day 9/ED 
 Low 
0 
0 
0 
 Normal 
0 
34 (100.0) 
0 
 High 
0 
0 
0 
Page 170


SIGA TECHNOLOGIES, INC.  
Page 4 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Clarity 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Normal 
Abnormal 
Screening 
 Normal 
34 (100.0) 
0 
 Abnormal 
0 
0 
Day 9/ED 
 Normal 
31  (91.2) 
0 
 Abnormal 
3   (8.8) 
0 
Page 171


SIGA TECHNOLOGIES, INC.  
Page 5 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Color 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Normal 
Abnormal 
Screening 
 Normal 
34 (100.0) 
0 
 Abnormal 
0 
0 
Day 9/ED 
 Normal 
34 (100.0) 
0 
 Abnormal 
0 
0 
Page 172


SIGA TECHNOLOGIES, INC.  
Page 6 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Ketones 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Normal 
Abnormal 
Screening 
 Normal 
34 (100.0) 
0 
 Abnormal 
0 
0 
Day 9/ED 
 Normal 
34 (100.0) 
0 
 Abnormal 
0 
0 
Page 173


SIGA TECHNOLOGIES, INC.  
Page 7 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Leukocyte Esterase 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Normal 
Abnormal 
Screening 
 Normal 
32  (94.1) 
0 
 Abnormal 
0 
2   (5.9) 
Day 9/ED 
 Normal 
30  (88.2) 
0 
 Abnormal 
2   (5.9) 
2   (5.9) 
Page 174


SIGA TECHNOLOGIES, INC.  
Page 8 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Nitrite 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Normal 
Abnormal 
Screening 
 Normal 
33  (97.1) 
0 
 Abnormal 
0 
1   (2.9) 
Day 9/ED 
 Normal 
32  (94.1) 
1   (2.9) 
 Abnormal 
1   (2.9) 
0 
Page 175


SIGA TECHNOLOGIES, INC.  
Page 9 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Occult Blood 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Normal 
Abnormal 
Screening 
 Normal 
32  (94.1) 
0 
 Abnormal 
0 
2   (5.9) 
Day 9/ED 
 Normal 
29  (85.3) 
1   (2.9) 
 Abnormal 
3   (8.8) 
1   (2.9) 
Page 176


SIGA TECHNOLOGIES, INC.  
Page 10 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Urine Bilirubin 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Normal 
Abnormal 
Screening 
 Normal 
34 (100.0) 
0 
 Abnormal 
0 
0 
Day 9/ED 
 Normal 
34 (100.0) 
0 
 Abnormal 
0 
0 
Page 177


SIGA TECHNOLOGIES, INC.  
Page 11 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Urine Glucose 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Normal 
Abnormal 
Screening 
 Normal 
34 (100.0) 
0 
 Abnormal 
0 
0 
Day 9/ED 
 Normal 
34 (100.0) 
0 
 Abnormal 
0 
0 
Page 178


SIGA TECHNOLOGIES, INC.  
Page 12 of 12 
SIGA-246-022  
Table 14.3.2.3.2  
Shift from Baseline in Urinalysis  
Safety Population  
 
 
Parameter (Unit): Urine Protein 
 
 
Note: Counts represent subjects with a baseline value in addition to having a value at each post-baseline visit summarized. 'Low' 
denotes a value below the reference range. 'High' denotes a value above the reference range. 'Abnormal' denotes a value outside 
the reference range. Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020302.SAS  Executed: 21JAN2020 23:02  
 
Baseline  
Post-Baseline Visit 
Normal 
Abnormal 
Screening 
 Normal 
34 (100.0) 
0 
 Abnormal 
0 
0 
Day 9/ED 
 Normal 
32  (94.1) 
0 
 Abnormal 
2   (5.9) 
0 
 
Page 179


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Table 14.3.2.3.3  
Summary of Urinalysis Results by Maximum Grade Increase Post -Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020303.SAS  Executed: 21JAN2020 23:02  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Urine Erythrocytes (/HPF)/ 
n 
10 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Urine Glucose/ 
n 
34 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
Page 180


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Table 14.3.2.3.3  
Summary of Urinalysis Results by Maximum Grade Increase Post -Baseline Relative to Baseline  
Safety Population  
 
 
Note: Counts represent subjects with a baseline value in addition to having at least one post-baseline value, including unscheduled 
visits. Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
Source Data: Listing 16.2.8.3  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\T1403020303.SAS  Executed: 21JAN2020 23:02  
Test (units)/ 
Term 
Total 
(N=34) 
n (%) 
Urine Protein/ 
n 
34 
High 
 Increase to Grade 1 
0 
 
 Increase to Grade 2 
0 
 
 Increase to Grade 3 
0 
 
 Increase to Grade 4 
0 
 
 Increase to Grades 1 to 4 
0 
 
 Increase to Grades 2 to 4 
0 
 
 Increase to Grades 3 to 4 
0 
 
Page 181


SIGA TECHNOLOGIES, INC.  
Page 1 of 3 
SIGA-246-022  
Table 14.3.3.1.1  
Summary of Actual Value and Change from Baseline in Vital Signs  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.5  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403030101.SAS  Executed: 21JAN2020 23:03  
 
Actual Value 
Change From Baseline [1] 
Parameter 
 Visit – Time Point 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Systolic Blood Pressure (mmHg) 
 Baseline 
34 
124.9 
11.55
123.0 100 
150 
 Day 1 – 4 hr after AM dose 
34 
126.5 
15.84
124.0 
98 
182 
34 
1.6 
13.49
-3.0 -23 
44 
 Day 4 – 4 hr after AM dose 
34 
125.8 
14.03
125.5 
84 
166 
34 
0.9 
12.06
1.5 -32 
28 
 Day 7 – before dosing 
34 
122.6 
13.17
122.0 100 
162 
34 
-2.3 
10.72
-3.0 -23 
28 
 Day 7 – 4 hr after AM dose 
34 
126.9 
13.18
122.5 106 
154 
34 
2.0 
9.84
2.0 -19 
21 
 Day 8 
34 
123.0 
13.52
123.0 102 
172 
34 
-1.9 
12.12
-2.5 -20 
34 
 Day 9/ED 
34 
122.9 
11.41
121.0 101 
149 
34 
-2.1 
11.52
-1.0 -22 
31 
Diastolic Blood Pressure (mmHg) 
 Baseline 
34 
71.8 
10.03
70.0 
57 
100 
 Day 1 – 4 hr after AM dose 
34 
71.0 
8.84
71.0 
56 
87 
34 
-0.7 
9.21
-0.5 -18 
19 
 Day 4 – 4 hr after AM dose 
34 
69.5 
9.91
68.5 
47 
100 
34 
-2.3 
7.44
-0.5 -20 
9 
 Day 7 – before dosing 
34 
67.6 
10.60
68.0 
50 
95 
34 
-4.2 
10.41
-2.5 -32 
20 
 Day 7 – 4 hr after AM dose 
34 
69.2 
9.51
69.0 
50 
90 
34 
-2.6 
8.14
-2.5 -23 
10 
 Day 8 
34 
70.2 
7.65
70.0 
56 
91 
34 
-1.5 
8.27
-0.5 -16 
19 
 Day 9/ED 
34 
67.1 
8.91
66.5 
54 
88 
34 
-4.6 
6.76
-5.0 -18 
9 
Page 182


SIGA TECHNOLOGIES, INC.  
Page 2 of 3 
SIGA-246-022  
Table 14.3.3.1.1  
Summary of Actual Value and Change from Baseline in Vital Signs  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.5  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403030101.SAS  Executed: 21JAN2020 23:03  
 
Actual Value 
Change From Baseline [1] 
Parameter 
 Visit – Time Point 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Heart Rate (beats/min) 
 Baseline 
34 
73.1 
10.90
72.5 
44 
93 
 Day 1 – 4 hr after AM dose 
34 
70.4 
9.60
73.5 
46 
83 
34 
-2.7 
6.24
-3.5 -15 
10 
 Day 4 – 4 hr after AM dose 
34 
70.5 
9.03
71.0 
50 
84 
34 
-2.6 
7.82
-2.5 -20 
14 
 Day 7 – before dosing 
34 
75.1 
11.19
75.0 
44 
107 
34 
2.0 
7.53
1.0 -11 
22 
 Day 7 – 4 hr after AM dose 
34 
69.6 
8.95
70.0 
47 
91 
34 
-3.6 
7.48
-4.0 -22 
11 
 Day 8 
34 
76.0 
10.46
77.5 
57 
101 
34 
2.9 
8.21
3.0 -16 
20 
 Day 9/ED 
34 
77.0 
9.96
79.0 
49 
92 
34 
3.9 
9.23
3.0 -12 
25 
Respiratory Rate (breaths/min) 
 Baseline 
34 
14.4 
2.23
14.0 
10 
20 
 Day 1 – 4 hr after AM dose 
34 
14.4 
2.13
14.0 
12 
18 
34 
0.1 
2.67
0.0 
-6 
6 
 Day 4 – 4 hr after AM dose 
34 
14.9 
2.57
16.0 
8 
18 
34 
0.5 
3.16
2.0 
-6 
6 
 Day 7 – before dosing 
34 
15.5 
1.97
16.0 
10 
20 
34 
1.2 
2.61
2.0 
-4 
6 
 Day 7 – 4 hr after AM dose 
34 
14.7 
2.20
15.0 
10 
18 
34 
0.4 
2.53
0.0 
-6 
4 
 Day 8 
34 
13.6 
1.87
14.0 
10 
18 
34 
-0.7 
3.19
0.0 -10 
4 
 Day 9/ED 
34 
14.8 
2.15
14.0 
12 
18 
34 
0.4 
2.73
0.0 
-6 
4 
Page 183


SIGA TECHNOLOGIES, INC.  
Page 3 of 3 
SIGA-246-022  
Table 14.3.3.1.1  
Summary of Actual Value and Change from Baseline in Vital Signs  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.5  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403030101.SAS  Executed: 21JAN2020 23:03  
 
Actual Value 
Change From Baseline [1] 
Parameter 
 Visit – Time Point 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
Temperature (C) 
 Baseline 
34 
36.37
0.319
36.40
35.7 
36.9 
 Day 1 – 4 hr after AM dose 
34 
36.18
0.303
36.20
35.2 
36.7 
34 
-0.19
0.404
-0.20
-1.3 
0.7 
 Day 4 – 4 hr after AM dose 
34 
36.40
0.330
36.40
35.7 
37.2 
34 
0.03
0.427
0.00
-1.0 
1.0 
 Day 7 – before dosing 
34 
36.35
0.345
36.35
35.7 
37.1 
34 
-0.02
0.288
0.00
-0.6 
0.7 
 Day 7 – 4 hr after AM dose 
34 
36.41
0.378
36.40
35.7 
37.2 
34 
0.04
0.427
0.00
-1.0 
1.0 
 Day 8 
34 
36.30
0.416
36.40
35.1 
37.2 
34 
-0.07
0.384
-0.10
-1.4 
0.7 
 Day 9/ED 
34 
36.50
0.281
36.45
35.9 
37.2 
34 
0.13
0.324
0.10
-0.6 
0.8 
 
Page 184


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Table 14.3.4.1.1  
Summary of Actual Value and Change from Baseline in Electrocardiogram Results  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.7  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403040101.SAS  Executed: 21JAN2020 23:04  
 
Actual Value 
Change From Baseline [1] 
Parameter 
 Visit – Time Point 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
ECG Mean Heart Rate (beats/min) 
 Baseline 
34 
71.9 
11.13
74.0 
47 
93 
 Day 1 – 4 hr after AM dose 
34 
64.6 
8.77
66.0 
48 
78 
34 
-7.3 
7.16
-4.5 -27 
2 
 Day 4 – 4 hr after AM dose 
34 
67.0 
8.33
67.5 
50 
84 
34 
-4.9 
7.39
-4.0 -23 
14 
 Day 7 – 4 hr after AM dose 
34 
66.2 
8.92
66.0 
50 
86 
34 
-5.7 
7.91
-6.0 -21 
9 
 Day 9/ED 
34 
71.0 
9.66
71.0 
48 
92 
34 
-0.9 
7.64
0.0 -21 
14 
PR Interval, Aggregate (msec) 
 Baseline 
34 
168.1 
22.50
162.0 130 
219 
 Day 1 – 4 hr after AM dose 
34 
169.1 
21.34
168.0 134 
217 
34 
0.9 
9.25
1.0 -20 
26 
 Day 4 – 4 hr after AM dose 
34 
170.0 
21.53
166.0 136 
220 
34 
1.9 
8.96
0.5 -14 
26 
 Day 7 – 4 hr after AM dose 
34 
170.1 
22.29
168.0 126 
217 
34 
1.9 
9.27
1.0 -18 
26 
 Day 9/ED 
34 
171.1 
20.43
167.0 128 
221 
34 
2.9 
16.19
5.0 -56 
34 
QRS Duration, Aggregate (msec) 
 Baseline 
34 
96.1 
10.10
93.5 
75 
124 
 Day 1 – 4 hr after AM dose 
34 
95.8 
9.63
93.0 
74 
114 
34 
-0.3 
6.11
-0.5 -15 
13 
 Day 4 – 4 hr after AM dose 
34 
94.4 
9.43
92.5 
79 
113 
34 
-1.7 
5.60
-1.0 -19 
11 
 Day 7 – 4 hr after AM dose 
34 
95.6 
10.37
93.5 
77 
121 
34 
-0.5 
5.94
0.0 -20 
10 
 Day 9/ED 
34 
95.9 
10.38
97.0 
73 
116 
34 
-0.2 
5.92
-1.0 -16 
13 
Page 185


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Table 14.3.4.1.1  
Summary of Actual Value and Change from Baseline in Electrocardiogram Results  
Safety Population  
 
 
Note: Baseline is defined as the last non-missing measurement prior to first dosing.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
ED = Early Discontinuation.  
[1] Change from baseline: post-baseline value — baseline value.  
Source Data: Listing 16.2.8.7  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\t1403040101.SAS  Executed: 21JAN2020 23:04  
 
Actual Value 
Change From Baseline [1] 
Parameter 
 Visit – Time Point 
n 
Mean 
SD 
Median 
Min 
Max 
n 
Mean 
SD 
Median 
Min 
Max 
QTcB Interval, Aggregate (msec) 
 Baseline 
34 
420.1 
22.21
418.5 367 
464 
 Day 1 – 4 hr after AM dose 
34 
417.4 
23.81
420.0 364 
463 
34 
-2.7 
11.79
-1.0 -31 
16 
 Day 4 – 4 hr after AM dose 
34 
411.9 
21.68
411.5 363 
454 
34 
-8.3 
13.53
-4.0 -37 
17 
 Day 7 – 4 hr after AM dose 
34 
411.9 
21.32
419.5 365 
444 
34 
-8.2 
14.60
-9.0 -36 
21 
 Day 9/ED 
34 
412.1 
20.31
411.5 366 
454 
34 
-8.0 
9.68
-8.0 -28 
12 
QTcF Interval, Aggregate (msec) 
 Baseline 
34 
407.8 
17.17
408.5 372 
446 
 Day 1 – 4 hr after AM dose 
34 
412.2 
19.03
414.5 378 
462 
34 
4.4 
9.68
4.0 -16 
23 
 Day 4 – 4 hr after AM dose 
34 
405.3 
19.11
402.5 371 
445 
34 
-2.6 
12.34
-2.0 -27 
19 
 Day 7 – 4 hr after AM dose 
34 
405.3 
18.82
411.0 372 
438 
34 
-2.5 
11.70
-1.5 -24 
18 
 Day 9/ED 
34 
400.9 
16.49
399.0 373 
429 
34 
-6.9 
9.53
-7.0 -29 
13 
RR Interval, Aggregate (msec) 
 Baseline 
34 
846.7 143.52
809.0 645 
1272 
 Day 1 – 4 hr after AM dose 
34 
939.5 138.35
902.0 764 
1239 
34 
92.7 
84.53
80.5 -35 
287 
 Day 4 – 4 hr after AM dose 
34 
901.8 114.18
885.0 708 
1185 
34 
55.1 
90.43
52.0 -159 
244 
 Day 7 – 4 hr after AM dose 
34 
916.1 125.13
900.5 697 
1198 
34 
69.4 
95.47
82.0 -117 
263 
 Day 9/ED 
34 
855.9 122.72
840.0 647 
1230 
34 
9.2 
85.47
7.0 -179 
208 
 
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Clinical Study Report 
15.
REFERENCE LIST
1. Breman JG, Henderson DA. Diagnosis and management of smallpox. N Engl J Med.
2002;346(17):1300-8.
2. TPOXX (tecovirimat) [full prescribing information]. SIGA Technologies, Inc. Corvallis
(OR); 2018. 18 p.
3. Department of Health and Human Services, Food and Drug Administration (US).
Guidance for Industry. Bioanalytical Method Validation. May 2018. Available from:
https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-
for-Industry.pdf.
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16.  
APPENDICES 
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Protocol No. SIGA-246-022 
Clinical Study Report 
 
16.1 
STUDY INFORMATION 
 
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TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.1 
Protocol and Protocol Amendments 
This section contains the following documents: 
Protocol Original dated 19 February 2019 
Protocol Amendment 1.0 dated 27 June 2019 
Protocol Administrative Letter dated 19 July 2019 
Protocol Amendment 2.0 dated 02 August 2019 
Page 190


 
 
 
Title Page 
CLINICAL STUDY PROTOCOL 
IND 69,019 
 
A POST MARKETING STUDY OF THE SAFETY, TOLERABILITY, 
AND PHARMACOKINETICS OF TPOXX® IN ADULT SUBJECTS 
WEIGHING MORE THAN 120 KG 
Post Marketing Commitment: 3417-4 
SIGA-246-022 
Sponsor: 
SIGA Technologies, Inc. 
4575 SW Research Way, Suite 110 
Corvallis, OR 97333 
Sponsor Contact: 
Candace Lovejoy, CPCM, PMP 
SIGA Technologies, Inc. 
4575 SW Research Way, Suite 110 
Corvallis, OR 97333 
Medical Monitor: 
Rahul Bhatnagar, MD 
PPD Phase I Clinic 
7551 Metro Center Drive, Suite 300 
Austin, TX 78744 
Version of Protocol: 
Final 1.0 
Date of Protocol:  
19 February 2019 
 
CONFIDENTIAL 
The concepts and information contained in this document or generated during the study are 
considered proprietary and may not be disclosed in whole or in part without the expressed, 
written consent of SIGA Technologies, Inc. 
The study will be conducted according to the International Council for Harmonisation 
Guideline E6(R2): Good Clinical Practice. 
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SIGA Technologies, Inc. 
Protocol No. SIGA-246-022 
PROTOCOL TITLE: 
PROTOCOL NUMBER: 
Dennis E. Hruby, PhD 
Chief Scientific Officer 
SIGA Technologies, Inc. 
SIGNATURE PAGE 
TPOXX 
Clinical Study Protocol 
A Post Marketing Study of the Safety, Tolerability, and 
Pharmacokinetics ofTPOXX® in Adult Subjects Weighing 
More Than 120 kg 
SIGA-246-022 
Date 
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SIGA Technologies, Inc. 
Protocol No. SIGA-246-022 
TPOXX 
Clinical Study Protocol 
INVESTIGATOR PROTOCOL AGREEMENT PAGE 
I agree to conduct the study as outlined in the protocol titled "A Post Marketing Study of the 
Safety, Tolerability, and Pharmacokinetics of TPOXX® in Adult Subjects Weighing More 
Than 120 kg" in accordance with the guidelines and all applicable government regulations, 
including US Title 21 of the Code of Federal Regulations Part 54. I have read and understand 
Rebecca N. Wood­
Principal Investigator 
PPD 
Date 
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SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
Clinical Study Protocol 
TABLE OF CONTENTS 
TITLE PAGE .......................................................................................................................1 
SIGNATURE PAGE ............................................................................................................2 
INVESTIGATOR PROTOCOL AGREEMENT PAGE ....................................................3 
TABLE OF CONTENTS .....................................................................................................4 
LIST OF TABLES ...............................................................................................................6 
PROTOCOL SYNOPSIS ....................................................................................................7 
1.
INTRODUCTION .......................................................................................... 15 
1.1
BACKGROUND .......................................................................................... 15
1.2
RATIONALE FOR STUDY ......................................................................... 15
1.3
POTENTIAL RISKS AND BENEFITS ........................................................ 15
1.3.1
Potential Risks .......................................................................................... 15
1.3.2
Known Potential Benefits .......................................................................... 16
2.
STUDY OBJECTIVES ................................................................................... 16 
2.1
PRIMARY OBJECTIVE .............................................................................. 16
2.2
SECONDARY OBJECTIVE ........................................................................ 16
3.
STUDY DESIGN ............................................................................................. 16 
4.
STUDY POPULATION .................................................................................. 17 
4.1
INCLUSION CRITERIA .............................................................................. 17
4.2
EXCLUSION CRITERIA ............................................................................. 19
4.3
OTHER SCREENING CONSIDERATIONS ................................................ 23
4.3.1
Subject Restrictions During the Study ....................................................... 23
4.4
WITHDRAWAL OF SUBJECTS FROM THE STUDY ................................ 23
4.4.1
Reasons for Withdrawal ............................................................................ 23
4.4.2
Handling of Withdrawals........................................................................... 24
4.4.3
Halting Rules ............................................................................................ 24
4.4.4
Replacements ............................................................................................ 25
5.
STUDY TREATMENT ................................................................................... 25 
5.1
TREATMENT ADMINISTERED ................................................................. 25
5.2
STUDY DRUG............................................................................................. 26
5.2.1
Study Drug Packaging and Storage ........................................................... 27
5.2.2
Study Drug Accountability ........................................................................ 27
5.3
TREATMENT COMPLIANCE .................................................................... 27
5.3.1
Prior and Concomitant Medications .......................................................... 28
5.3.1.1
Prior Medications .................................................................................. 28
5.3.1.2
Concomitant Medications ...................................................................... 28
6.
STUDY PROCEDURES ................................................................................. 28 
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Clinical Study Protocol 
6.1
PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS ..................... 29
6.1.1
Pharmacokinetic Sample Collection, Shipping, and Storage ...................... 30
6.1.2
Pharmacokinetic Sample Analysis ............................................................. 31
6.2
SAFETY ASSESSMENTS AND ENDPOINTS ............................................ 31
6.2.1
Adverse Events ......................................................................................... 31
6.2.1.1
Adverse Event Definitions ..................................................................... 31
6.2.1.2
Eliciting and Documenting Adverse Events ........................................... 33
6.2.1.3
Reporting Adverse Events ..................................................................... 34
6.2.1.4
Reporting of Serious Adverse Events ..................................................... 34
6.2.1.5
Assessment of Severity .......................................................................... 35
6.2.1.6
Assessment of Causality ........................................................................ 36
6.2.1.7
Follow-up of Adverse Events................................................................. 37
6.2.1.8
Reactogenicity ....................................................................................... 37
6.2.1.9
Reporting of Pregnancy ......................................................................... 37
6.2.2
Clinical Laboratory Testing ....................................................................... 38
6.2.3
Medical History ........................................................................................ 40
6.2.4
Vital Sign Measurements........................................................................... 40
6.2.5
Electrocardiograms ................................................................................... 40
6.2.6
Physical Examinations .............................................................................. 41
6.2.7
Unscheduled Visits .................................................................................... 41
7.
STATISTICAL ANALYSIS PLANS ............................................................... 42 
7.1
SAMPLE SIZE CALCULATIONS ............................................................... 42
7.2
ANALYSIS POPULATIONS ........................................................................ 42
7.3
STATISTICAL ANALYSIS .......................................................................... 42
7.3.1
Pharmacokinetic Analyses ......................................................................... 42
7.3.2
Safety Analyses ......................................................................................... 43
7.4
HANDLING OF BELOW THE LIMIT OF QUANTIFICATION AND 
MISSING DATA .......................................................................................... 43
7.5
INTERIM ANALYSES ................................................................................. 44
8.
REFERENCE LIST ........................................................................................ 45 
9.
APPENDICES ................................................................................................. 46 
9.1
APPENDIX 1: LIST OF ABBREVIATIONS ................................................ 46
9.2
APPENDIX 2: SCHEDULE OF EVENTS ................................................... 48
9.3
APPENDIX 3: STUDY GOVERNANCE ..................................................... 50
9.3.1
Data Quality Assurance ............................................................................. 50
9.3.2
Investigator Obligations ............................................................................ 51
9.3.2.1
Confidentiality ...................................................................................... 51
9.3.2.2
Institutional Review .............................................................................. 51
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Clinical Study Protocol 
9.3.2.3
Subject Consent ..................................................................................... 52
9.3.2.4
Exclusion of Children ............................................................................ 52
9.3.2.5
Study Reporting Requirements .............................................................. 53
9.3.2.6
Financial Disclosure and Obligations..................................................... 53
9.3.2.7
Investigator Documentation ................................................................... 53
9.3.2.8
Study Conduct ....................................................................................... 54
9.3.2.9
Case Report Forms and Source Documents ........................................... 54
9.3.2.10
Adherence to Protocol ........................................................................... 55
9.3.2.11
Reporting Adverse Events ..................................................................... 55
9.3.2.12
Investigator’s Final Report .................................................................... 55
9.3.2.13
Records Retention ................................................................................. 55
9.3.2.14
Publications ........................................................................................... 55
9.3.3
Study Management ................................................................................... 56
9.3.3.1
Monitoring ............................................................................................ 56
9.3.4
Safety Monitoring Plan ............................................................................. 57
9.3.5
Medical Monitor ....................................................................................... 57
9.3.6
Safety Oversite (Independent Safety Monitor) ........................................... 57
9.3.6.1
Inspection of Records ............................................................................ 57
9.3.6.2
Management of Protocol Amendments and Deviations .......................... 58
9.3.6.3
Study Termination ................................................................................. 59
9.3.6.4
Final Report .......................................................................................... 59
LIST OF TABLES 
Table 5-1
Excipients of TPOXX Capsules .................................................................... 26
Table 9-1
Schedule of Events ....................................................................................... 48
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Clinical Study Protocol 
PROTOCOL SYNOPSIS 
PROTOCOL NO.: SIGA-246-022 
TITLE: A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of 
TPOXX® in Adult Subjects Weighing More Than 120 kg 
STUDY PHASE: 4 Post Marketing Study 
STUDY SITE: PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200, Austin, TX 78744, 
USA. 
OBJECTIVES: 
Primary: 
The primary objective of this study is to determine the pharmacokinetic (PK) profile of 
600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in 
adult subjects weighing more than 120 kg to determine if a change in dosing regimen would 
be needed in these patients. 
Secondary: 
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral 
TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg. 
STUDY DESIGN AND METHODOLOGY: 
This is an open-label, multiple-dose study to assess the safety, tolerability, and PK of TPOXX 
600 mg BID when administered orally for 7 days to adult subjects weighing more than 
120 kg. A total of 36 subjects, ages 18 to 50, inclusive, will be enrolled. The study will 
consist of a screening period (Day –28 to Day –2), a treatment and confinement period 
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]). 
Subjects will undergo screening evaluations to determine eligibility within 28 days before 
study drug administration. Subjects will be admitted to the study site on Day –1 to complete 
baseline assessments; results of these assessments must be reviewed by the investigator 
before dosing. Starting in the morning of Day 1, subjects will receive 600 mg oral TPOXX 
BID for 7 days (Days 1 through 7). 
All subjects will be provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration and subjects must fast for 2 hours after taking 
study drug. Subjects should eat this meal within 30 minutes or less of taking study drug. 
Study drug and meals must be taken with water only, and no other beverage except water 
should be ingested within 3 hours before or 3 hours after study drug administration. 
Subjects will remain confined to the study site for collection of PK samples and will be 
carefully monitored for safety and tolerability until discharge on Day 9. Subjects who have 
abnormal physical examination findings or an ongoing adverse event (AE)/serious adverse 
event (SAE) on Day 9 that is deemed related to study drug or per investigator or SIGA 
discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All other 
subjects will have the Day 14 (+2 days) follow-up via telephone. All subjects will have a 
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SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
Clinical Study Protocol 
follow-up telephone call 30 days after administration of the last dose of study drug 
(Day 37 [+2 days]) to report any SAEs. At the time of discharge from the clinical research 
unit, subjects will be instructed to notify the investigator of any SAEs that occur within 
30 days after administration of the last dose of study drug. Serious AEs will be followed until 
the SAE is stable or until resolution as determined by the investigator and/or medical 
monitor. 
The total duration of the study for each subject, including the screening period, treatment 
period, and the Day 37 (+2 days) follow-up telephone call, will be approximately 65 days. 
STUDY POPULATION: 
Inclusion Criteria: 
Each subject must meet all the following criteria to be enrolled in this study: 
1. Subject is male or female between 18 and 50 years of age, inclusive.
2. Subject has a body weight >120 kg at screening.
3. Women of childbearing potential, have a negative  human chorionic gonadotropin
pregnancy test (serum) at the screening visit and a confirmatory negative serum
pregnancy test on Day –1 before receipt of study drug, and meet 1 of the following
criteria:
a.
The subject or their partner has undergone surgical sterilization
b. The subject is postmenopausal, defined as 12 consecutive months with no menses
without an alternative medical cause and has a documented plasma
follicle-stimulating hormone level >40 IU/mL
c.
The subject agrees to be abstinent (ie, heterosexually inactive or women in a religious
order)
d. The subject agrees to consistently use 1 of the following methods of contraception
from the beginning of screening (which they had been consistently using for at least
30 days before the first dose of study drug) through 30 days after the last dose of
study drug:
i.
Condoms, male or female, with a spermicide
NOTE: For male subjects, condoms must be used for 90 days after the last dose
of study drug.
ii.
Diaphragm or cervical cap with spermicide
iii.
Intrauterine device with spermicide
iv.
Oral contraceptives or other hormonal methods
NOTE: Subject must agree to use an additional nonhormonal method of
contraception in conjunction with oral contraceptives.
v.
Male sexual partner who had undergone a vasectomy at least 3 months before
screening
4. Male subjects must agree to not donate sperm from the first dose of study drug through
90 days after the last dose of study drug.
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5. Subject is considered by the investigator to be in good general health as determined by
medical history (no hospitalizations for chronic medical conditions in the previous
2 years), clinical laboratory results, vital sign measurements, 12-lead electrocardiogram
(ECG) results, and physical examination findings at screening.
6. Subject agrees to comply with all protocol requirements.
7. Subject is able to provide written informed consent.
8. Subject agrees to comply with the dietary requirements.
9. Subject does not intend to lose weight (diet or weight loss) from the screening visit and
throughout the study.
EXCLUSION CRITERIA: 
Subjects meeting any of the following criteria will be excluded from the study: 
1. Subject is a female who is pregnant or breastfeeding or planning to become pregnant
within 3 months after the last dose of study drug.
2. Subject has a history of any clinically significant conditions including:
•
Asthma treated with oral systemic steroids within the past 6 months
•
Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
•
Hypertension that is poorly controlled (repeat readings >140 mm Hg systolic and/or
>90 mm Hg diastolic)
•
Thyroidectomy or thyroid disease that required medication within the past 12 months
•
Serious angioedema episodes within the previous 3 years or requiring medication in
the previous 2 years
•
Head trauma resulting in a diagnosis of traumatic brain injury other than concussion
•
Frequent episodes of headache.
3. Subject has received treatment in another clinical study of an investigational drug (or
medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose
of study drug.
4. Subject has been previously enrolled in any clinical study involving TPOXX
(tecovirimat).
5. Subject has a history of relevant drug and/or food allergies (ie, allergy to tecovirimat or
excipients, or any significant food allergy that could preclude a standard diet in the study
site).
6. Subject has any condition possibly affecting drug absorption (eg, previous surgery on the
gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder,
or pancreas, with the exception of appendectomy).
7. Subject has evidence or history of clinically significant allergic (except for untreated,
asymptomatic, seasonal allergies at time of the first dose of study drug), hematological,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or
neurological disease. Exceptions to these criteria (eg, stable, mild joint disease
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Protocol No. SIGA-246-022 
Clinical Study Protocol 
unassociated with collagen vascular disease) may be made following discussions with the 
medical monitor. 
8. Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias,
syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia).
9. Subject has a family history of sudden cardiac death, not clearly due to acute myocardial
infarction.
10. Subject has a seizure disorder or history of seizures (does not include childhood febrile
seizures) or a past history that increases seizure risks such as significant head injury that
caused loss of consciousness or other changes in the subject’s daily function, concussion,
stroke, central nervous system infection or disease, or alcohol or drug abuse or family
history of idiopathic seizures.
11. Subject has a history of a peptic ulcer or significant gastrointestinal bleed.
12. Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency,
coagulopathy, or platelet disorder requiring special precautions) or significant bruising or
bleeding difficulties with blood draws.
13. Subject has a malignancy that is active, or treated malignancy for which there is not
reasonable assurance of sustained cure, or malignancy that is likely to recur during the
period of the study (subject should be in complete remission for at least 5 years).
14. Subject has neutropenia or other blood dyscrasia determined to be clinically significant
by the investigator.
15. Subject has used any of the following prohibited medications from within 7 days (or
5 half-lives, whichever is longer) before the first dose of study drug: antidiabetic
medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance
protein transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib,
rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including repaglinide,
paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of CYP2C19
including S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole,
and omeprazole. Medications not listed here that are known (or thought) to be CYP3A4
substrates may be allowed at the investigator’s discretion, after consultation with the
medical monitor, if administration poses little to no risk to the subject.
16. Subject has a history of drug or alcohol abuse or dependency within the last year before
screening.
17. Subject has a history of an eating disorder.
18. Subject has a current or recent (<30 days before screening) history of clinically
significant bacterial, fungal, or mycobacterial infection.
19. Subject has a current clinically significant viral infection.
20. Subject has a known clinically significant chronic viral infection (eg, human T cell
lymphotropic virus I or II).
21. Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville
orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products
within 48 hours before the first dose of study drug or throughout the study.
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22. Subject has used any prescription (excluding hormonal birth control) or over-the-counter
medication (including herbal or nutritional supplements) within 14 days before the first
dose of study drug.
23. Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids including
oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose
inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the
preceding 1 month (low-dose [≤800 mcg/day of beclomethasone dipropionate or
equivalent] inhaled and topical steroids are allowed).
24. Subject has donated >450 mL blood or blood components within 30 days before the first
dose of study drug. The investigator should instruct subjects who participate in this study
to not donate blood or blood components for 4 weeks after the completion of the study.
25. Subject is a smoker or has used nicotine or nicotine-containing products (eg, cigarettes,
electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine
gum) within 6 months before the first dose of study drug.
26. Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo juice,
or alcohol within 72 hours before the first dose of study drug.
27. Subject reports participation in strenuous activity or contact sports within 24 hours before
the first dose of study drug.
28. Subject has known hepatitis B or C infection or positive test for hepatitis B surface
antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2
antibodies at screening.
29. Subject has a positive test result for amphetamines (including methamphetamines and
ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids
(including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin, codeine,
and oxycodone), or alcohol at screening or check-in.
30. Subject has any of the following laboratory test results within 28 days before the first
dose of study drug:
•
Estimated serum creatinine clearance (Cockcroft-Gault) <90 mL/min
•
Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper
central laboratory reference range)
•
Hemoglobin ≤10% of the lower central laboratory reference range
•
White blood cell count not within the central laboratory reference range
•
Absolute neutrophil count <1000 cells/mm3
•
Platelets not within ±10% of central laboratory reference range
•
Alanine aminotransferase >1.5 times above the upper central laboratory reference
range
•
Aspartate aminotransferase >1.5 times above the upper central laboratory reference
range
•
Alkaline phosphatase >20% above the upper central laboratory reference range
•
Hemoglobin A1c ≥7.0%
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•
Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL.
31. Subject has a sustained sitting systolic blood pressure >140 mm Hg or <100 mm Hg or a
diastolic blood pressure >90 mm Hg at screening. Blood pressure may be retested twice
in the sitting position at 5-minute intervals. The pressure elevation is considered sustained
if either the systolic or the diastolic pressure exceeds the stated limits on all
3 assessments.
32. Subject has a resting heart rate of <40 beats per minute or >100 beats per minute at
screening.
33. Subject has an abnormal ECG at screening that is determined by the investigator to be
clinically significant.
34. Male subject has a QTcF >450 ms or female subject has a QTcF >470 ms at screening or
Day –1.
35. In the opinion of the investigator, the subject is not suitable for entry into the study.
EVALUATION PROCEDURES: 
Pharmacokinetic Assessments: 
Blood samples for PK analysis of TPOXX will be collected from all subjects on Day 1 before 
study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 
20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours 
after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the 
PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on 
Day 9 (48 hours after the AM dose on Day 7). 
For PK samples, the acceptable window for collection from the scheduled collection time 
point will be as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes 
for the 12- to 48-hour time points. 
The following plasma PK parameters will be calculated for TPOXX using actual sampling 
times rather than scheduled sampling times and will include but are not limited to:  
•
Area under the plasma concentration-time curve (AUC) from time 0 to the last
quantifiable measurement (AUC0-t)
•
AUC from time 0 extrapolated to infinity (AUC0-∞)
•
AUC from time 0 to 24 hours (AUC0-24)
•
AUC during the first dosing interval (tau = 12 hours) (AUC0-tau)
•
Maximum drug concentration in plasma (Cmax)
•
Time to Cmax (Tmax)
•
Apparent volume of distribution (Vd/F)
•
Apparent total body clearance (CL/F)
•
Concentration observed prior to the next dose administration (Ctrough)
•
Terminal elimination half-life (t1/2)
•
Terminal elimination rate constant (λz)
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•
Percentage of AUC0-∞ extrapolated from the last quantifiable measurement to infinity
(%AUCextrap).
Safety Assessments: 
Safety and tolerability will be assessed by monitoring and recording of AEs, clinical 
laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body 
temperature), 12-lead ECG results, and physical examination findings. 
STUDY DRUG, DOSAGE, AND ROUTE OF ADMINISTRATION: 
TPOXX, 600 mg (3 × 200-mg capsules), will be administered orally twice daily, 
approximately 12 hours (±30 minutes) apart, on Days 1 through 7. 
STATISTICAL METHODS: 
Complete, detailed statistical methods will be described in the statistical analysis plan. 
Sample Size: 
The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study is 
based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size is considered sufficient to effectively assess the PK and safety 
profiles of TPOXX. 
Analysis Populations: 
•
The Safety Population will include all subjects who receive at least 1 dose of study drug.
•
The PK Population will include subjects who receive study drug and have sufficient
concentration data to facilitate the calculation of PK variables.
Pharmacokinetic Analyses: 
Individual plasma concentration and time deviation data will be presented in a data listing. 
Plasma concentration data will be listed and summarized using the following descriptive 
statistics: number of subjects, arithmetic mean, standard deviation (SD), coefficient of 
variation (CV), geometric mean, geometric CV, median, minimum, and maximum. Individual 
and mean plasma concentration versus time profiles will be presented in figures on both 
linear and semilogarithmic scales. 
The PK parameters of TPOXX will be analyzed based on the actual sampling times. All 
parameters will be determined using noncompartmental methods using Phoenix® 
WinNonlin® Version 6.4 or higher (Certara, L.P., Princeton, New Jersey) or SAS® Version 9.4 
or higher (SAS Institute Inc., Cary, North Carolina). 
The individual PK parameters and weight-normalized PK parameters will be presented in 
data listings and summarized using the following descriptive statistics: number of subjects, 
arithmetic mean, SD, CV, median, minimum, maximum, geometric mean, geometric SD, and 
geometric CV. 
Safety Analyses: 
Adverse events will be coded by preferred term and system organ class using the latest 
version of the Medical Dictionary for Regulatory Activities and summarized overall. All AE 
data will be presented in a data listing. Treatment-emergent AEs will be summarized overall, 
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as well as by severity and relationship to study drug. Serious AEs and AEs leading to 
discontinuation of study drug will also be presented in the data listings and summarized 
overall. 
Actual values and changes from baseline for clinical laboratory test results, vital sign 
measurements, and 12-lead ECG results will be summarized at each time point using 
descriptive statistics (number of subjects, mean, SD, median, minimum, and maximum). 
Shift tables will be generated for clinical laboratory test results. Clinical laboratory data, vital 
sign measurements, 12-lead ECG results, and physical examination findings will be 
presented in data listings. 
DATE OF PROTOCOL: 19 February 2019 
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1.
INTRODUCTION
1.1
BACKGROUND 
Historically, variola virus (VARV), the etiologic agent of smallpox, has been one of the more 
important human pathogens. Smallpox is highly communicable and carries exceptionally 
high morbidity. Secondary attack rates from 30% to 80% have been reported among 
unvaccinated members of households.1 Mortality rates range from 1% for variola minor to 
30% for variola major.1 With the advent of biowarfare as an instrument of terrorism, 
smallpox can no longer be thought of as a disease only of historic impact.  
In July 2018, the FDA approved the oral formulation of TPOXX for the treatment of patients 
with human smallpox disease caused by VARV.  
1.2
RATIONALE FOR STUDY 
This study is being conducted as an FDA post marketing commitment to the approved New 
Drug Application for TPOXX. SIGA is required to conduct a study to determine the 
pharmacokinetic (PK) profile of TPOXX in subjects with a body weight greater than 
120 kilograms (>120 kg) to determine if a change in dosing regimen would be needed in 
these patients. 
1.3
POTENTIAL RISKS AND BENEFITS 
1.3.1 
Potential Risks 
The effect of TPOXX on a fetus or nursing baby is not yet known; therefore, women of 
childbearing potential participating in this study will be required to agree to use an acceptable 
means of birth control from 30 days before the first dose of study drug and continuing 
through 30 days after the last dose of study drug. Pregnancy testing will be performed at the 
screening visit and checked by the investigator for negative pregnancy before administration 
of study drug on Day –1. Women who are pregnant or lactating or plan to become pregnant 
within 3 months after study drug administration will be excluded from the study; if a female 
subject becomes pregnant during study participation, study drug dosing will be discontinued, 
and the subject will be withdrawn from the study (Section 6.2.1.9). 
As with all drugs, there is potential risk of an allergic reaction. At this time, there is no 
definitive information on the allergic activity of TPOXX. Headache and nausea have been 
the most common AEs in clinical studies completed to date. There may be other side effects 
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of TPOXX that are not yet known. Full details can be found in the TPOXX full prescribing 
information.2 
1.3.2 
Known Potential Benefits 
As this study will be conducted in subjects free from smallpox, no direct health benefits from 
taking the study drug are expected. Study subjects may benefit from receiving the laboratory 
testing, ECGs, and physical examinations. Others may benefit from knowledge gained in this 
study that may aid in the development of a drug for the treatment of smallpox.  
2.
STUDY OBJECTIVES
2.1
PRIMARY OBJECTIVE 
The primary objective of this study is to determine the PK profile of 600 mg oral TPOXX 
(3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing 
more than 120 kg to determine if a change in dosing regimen would be needed in these 
patients. 
2.2
SECONDARY OBJECTIVE 
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral 
TPOXX administered BID for 7 days in adult subjects weighing more than 120 kg. 
3.
STUDY DESIGN
This is an open-label, multiple-dose study to assess the safety, tolerability, and PK of TPOXX 
600 mg BID when administered orally for 7 days to adult subjects weighing more than 
120 kg. A total of 36 subjects, ages 18 to 50, inclusive, will be enrolled. The study will 
consist of a screening period (Day –28 to Day –2), a treatment and confinement period 
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]). 
Subjects will undergo screening evaluations to determine eligibility within 28 days before 
study drug administration. Subjects will be admitted to the study site on Day –1 to complete 
baseline assessments; results of these assessments must be reviewed by the investigator 
before dosing. Starting in the morning of Day 1, subjects will receive 600 mg oral TPOXX 
BID for 7 days (Days 1 through 7). 
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All subjects will be provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration and subjects must fast for 2 hours after taking 
study drug. Subjects should eat this meal within 30 minutes or less of taking study drug. 
Study drug and meals must be taken with water only, and no other beverage except water 
should be ingested within 3 hours before or 3 hours after study drug administration. 
Subjects will remain confined to the study site for collection of PK samples and will be 
carefully monitored for safety and tolerability until discharge on Day 9. Subjects who have 
abnormal physical examination findings or an ongoing adverse event (AE)/serious adverse 
event (SAE) on Day 9 that is deemed related to study drug or per investigator or SIGA 
discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All other 
subjects will have the Day 14 (+2 days) follow-up via telephone. All subjects will have a 
follow-up telephone call 30 days after administration of the last dose of study drug 
(Day 37 [+2 days]) to report any SAEs. At the time of discharge from the clinical research 
unit, subjects will be instructed to notify the investigator of any SAEs that occur within 30 
days after administration of the last dose of study drug. Serious AEs will be followed until 
the SAE is stable or until resolution as determined by the investigator and/or medical 
monitor. 
The total duration of the study for each subject, including the screening period, treatment 
period, and the Day 37 (+2 days) follow-up telephone call, will be approximately 65 days. 
4.
STUDY POPULATION
Approximately 36 male and female subjects will be enrolled at a single center in the United 
States to achieve at least 32 evaluable enrolled subjects. 
4.1
INCLUSION CRITERIA 
Each subject must meet all the following criteria to be enrolled in this study: 
Subject is male or female between 18 and 50 years of age, inclusive. 
Subject has a body weight >120 kg at screening. 
Women of childbearing potential, have a negative  human chorionic gonadotropin 
pregnancy test (serum) at the screening visit and a confirmatory negative serum 
pregnancy test on Day –1 before receipt of study drug, and meet 1 of the following 
criteria: 
The subject or their partner has undergone surgical sterilization 
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The subject is postmenopausal, defined as 12 consecutive months with no menses 
without an alternative medical cause and has a documented plasma 
follicle-stimulating hormone level >40 IU/mL 
The subject agrees to be abstinent (ie, heterosexually inactive or women in a 
religious order) 
The subject agrees to consistently use 1 of the following methods of contraception 
from the beginning of screening (which they had been consistently using for at 
least 30 days before the first dose of study drug) through 30 days after the last 
dose of study drug: 
i.
Condoms, male or female, with a spermicide
NOTE: For male subjects, condoms must be used for 90 days after the last
dose of study drug.
ii.
Diaphragm or cervical cap with spermicide
iii.
Intrauterine device with spermicide
iv.
Oral contraceptives or other hormonal methods
NOTE: Subject must agree to use an additional nonhormonal method of
contraception in conjunction with oral contraceptives.
v.
Male sexual partner who had undergone a vasectomy at least 3 months before
screening.
Male subjects must agree to not donate sperm from the first dose of study drug 
through 90 days after the last dose of study drug. 
Subject is considered by the investigator to be in good general health as determined 
by medical history (no hospitalizations for chronic medical conditions in the 
previous 2 years), clinical laboratory results, vital sign measurements, 12-lead ECG 
results, and physical examination findings at screening. 
Subject agrees to comply with all protocol requirements. 
Subject is able to provide written informed consent. 
Subject agrees to comply with the dietary requirements. 
Subject does not intend to lose weight (diet or weight loss) from the screening visit 
and throughout the study. 
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4.2 
EXCLUSION CRITERIA 
Subjects meeting any of the following criteria will be excluded from the study: 
Subject is a female who is pregnant or breastfeeding or planning to become 
pregnant within 3 months after the last dose of study drug. 
Subject has a history of any clinically significant conditions including: 
•
Asthma treated with oral systemic steroids within the past 6 months
•
Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
•
Hypertension that is poorly controlled (repeat readings >140 mm Hg systolic
and/or >90 mm Hg diastolic)
•
Thyroidectomy or thyroid disease that required medication within the past
12 months
•
Serious angioedema episodes within the previous 3 years or requiring medication
in the previous 2 years
•
Head trauma resulting in a diagnosis of traumatic brain injury other than
concussion
•
Frequent episodes of headache.
Subject has received treatment in another clinical study of an investigational drug
(or medical device) within 30 days or 5 half-lives (whichever is longer) before the
first dose of study drug.
Subject has been previously enrolled in any clinical study involving TPOXX 
(tecovirimat). 
Subject has a history of relevant drug and/or food allergies (ie, allergy to 
tecovirimat or excipients, or any significant food allergy that could preclude a 
standard diet in the study site). 
Subject has any condition possibly affecting drug absorption (eg, previous surgery 
on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, 
gallbladder, or pancreas, with the exception of appendectomy). 
Subject has evidence or history of clinically significant allergic (except for 
untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), 
hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, 
psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild 
joint disease unassociated with collagen vascular disease) may be made following 
discussions with the medical monitor. 
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Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, 
syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, 
hypokalemia). 
Subject has a family history of sudden cardiac death not clearly due to acute 
myocardial infarction. 
 Subject has a seizure disorder or history of seizures (does not include childhood 
febrile seizures) or a past history that increases seizure risks such as significant 
head injury that caused loss of consciousness or other changes in the subject’s daily 
function, concussion, stroke, central nervous system infection or disease, or alcohol 
or drug abuse or family history of idiopathic seizures. 
 Subject has a history of a peptic ulcer or significant gastrointestinal bleed. 
 Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, 
coagulopathy, or platelet disorder requiring special precautions) or significant 
bruising or bleeding difficulties with blood draws. 
 Subject has a malignancy that is active, or treated malignancy for which there is not 
reasonable assurance of sustained cure, or malignancy that is likely to recur during 
the period of the study (subject should be in complete remission for at least 
5 years). 
 Subject has neutropenia or other blood dyscrasia determined to be clinically 
significant by the investigator. 
 Subject has used any of the following prohibited medications from within 7 days 
(or 5 half-lives, whichever is longer) before the first dose of study drug: 
antidiabetic medication; anticoagulants; anticonvulsants; substrates of the BCRP 
transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, 
rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including 
repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of 
CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, 
voriconazole, lansoprazole, and omeprazole. Medications not listed here that are 
known (or thought) to be CYP3A4 substrates may be allowed at the investigator’s 
discretion, after consultation with the medical monitor, if administration poses little 
to no risk to the subject. 
 Subject has a history of drug or alcohol abuse or dependency within the last year 
before screening. 
 Subject has a history of an eating disorder. 
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 Subject has a current or recent (<30 days before screening) history of clinically 
significant bacterial, fungal, or mycobacterial infection. 
 Subject has a current clinically significant viral infection. 
 Subject has a known clinically significant chronic viral infection (eg, human T cell 
lymphotropic virus I or II). 
 Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville 
orange-containing products (eg, marmalade), or caffeine- or xanthine-containing 
products within 48 hours before the first dose of study drug or throughout the study. 
 Subject has used any prescription (excluding hormonal birth control) or 
over-the-counter medication (including herbal or nutritional supplements) within 
14 days before the first dose of study drug. 
 Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids 
including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or 
high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or 
equivalent) within the preceding 1 month (low-dose [≤800 mcg/day of 
beclomethasone dipropionate or equivalent] inhaled and topical steroids are 
allowed). 
 Subject has donated >450 mL blood or blood components within 30 days before the 
first dose of study drug. The investigator should instruct subjects who participate in 
this study to not donate blood or blood components for 4 weeks after the 
completion of the study. 
 Subject is a smoker or has used nicotine or nicotine-containing products (eg, 
cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine 
patches, or nicotine gum) within 6 months before the first dose of study drug. 
 Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo 
juice, or alcohol within 72 hours before the first dose of study drug. 
 Subject reports participation in strenuous activity or contact sports within 24 hours 
before the first dose of study drug. 
 Subject has known hepatitis B or C infection or positive test for hepatitis B surface 
antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 
antibodies at screening. 
 Subject has a positive test result for amphetamines (including methamphetamines 
and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, 
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cannabinoids (including tetrahydrocannabinol), cocaine metabolites, opiates 
(including heroin, codeine, and oxycodone), or alcohol at screening or check-in. 
 Subject has any of the following laboratory test results within 28 days before the 
first dose of study drug: 
•
Estimated serum creatinine clearance (Cockcroft-Gault) <90 mL/min
•
Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper
central laboratory reference range)
•
Hemoglobin ≤10% of the lower central laboratory reference range
•
White blood cell count not within the central laboratory reference range
•
Absolute neutrophil count <1000 cells/mm3
•
Platelets not within ±10% of central laboratory reference range
•
Alanine aminotransferase >1.5 times above the upper central laboratory reference
range
•
Aspartate aminotransferase >1.5 times above the upper central laboratory
reference range
•
Alkaline phosphatase >20% above the upper central laboratory reference range
•
Hemoglobin A1c ≥7.0%
•
Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL.
Subject has a sustained sitting systolic blood pressure >140 mm Hg or
<100 mm Hg or a diastolic blood pressure >90 mm Hg at screening. Blood pressure
may be retested twice in the sitting position at 5-minute intervals. The pressure
elevation is considered sustained if either the systolic or the diastolic pressure
exceeds the stated limits on all 3 assessments.
 Subject has a resting heart rate of <40 beats per minute or >100 beats per minute at 
screening. 
 Subject has an abnormal ECG at screening that is determined by the investigator to 
be clinically significant. 
 Male subject has a QTcF >450 ms or female subject has a QTcF >470 ms at 
screening or Day –1. 
 In the opinion of the investigator, the subject is not suitable for entry into the study. 
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4.3
OTHER SCREENING CONSIDERATIONS 
4.3.1 
Subject Restrictions During the Study 
•
Subjects must be willing to remain confined at the study site from Check-in (Day –1)
until safety assessments are completed on Day 9.
•
Subjects who have abnormal physical examination findings or an ongoing AE/SAE on Day 9
that is deemed related to study drug or per investigator or SIGA discretion will return to the
study site on Day 14 (+2 days) for a follow-up visit.
4.4
WITHDRAWAL OF SUBJECTS FROM THE STUDY 
4.4.1 
Reasons for Withdrawal 
Subjects can withdraw consent and discontinue from the study at any time, for any reason, 
without prejudice to further treatment. 
The investigator may withdraw a subject from the study for any of the following: 
•
The subject is in violation of the protocol.
•
The subject experiences a serious or intolerable AE.
•
The subject becomes pregnant.
•
The subject is noncompliant.
•
The subject has laboratory abnormalities for assessments listed in
Sections 4.1 or 4.2 that meet Grade 3 or Grade 4 on the Division of
Acquired Immune Deficiency Syndrome (DAIDS) AE Grading Table
(https://rsc.tech-res.com/docs/default-source/safety/division-of-aids-
(daids)-table-for-grading-the-severity-of-adult-and-pediatric-adverse-
events-corrected-v-2-1.pdf?sfvrsn=2), any other Grade 3 or Grade 4 AE; or
a Grade 2 or higher rash considered by the investigator to be possibly,
probably, or definitely related to study drug.
•
The subject develops, during the course of the study, symptoms or conditions listed in
the exclusion criteria.
•
The subject requires a medication prohibited by the protocol.
•
The subject requests an early discontinuation for any reason.
•
The subject’s primary care provider requests that the subject be withdrawn.
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•
The independent safety monitor (ISM), SIGA, or the FDA requests subject
withdrawal based on study safety findings.
The investigator can also withdraw a subject upon the request of SIGA or if SIGA terminates 
the study. Upon occurrence of a SAE or intolerable AE, the investigator will confer with 
SIGA. If a subject is discontinued because of an AE, the event will be followed until it is 
resolved or stabilized as determined by the investigator and/or the medical monitor. 
4.4.2 
Handling of Withdrawals 
Subjects are free to withdraw from the study at any time upon request. Subject participation 
in the study may be stopped at any time at the discretion of the investigator or at the request 
of SIGA. 
When a subject withdraws from the study, the reason(s) for withdrawal will be recorded by 
the investigator in the electronic case report form (eCRF). Whenever possible, any subject 
who withdraws from the study prematurely will undergo all Day 9/early discontinuation 
assessments (±2 days) (Table 9-1). Any subject who fails to return for final assessments will 
be contacted by the study site personnel in an attempt to have them comply with the protocol. 
The status of subjects who fail to complete final assessments will be documented in the 
eCRF. 
4.4.3 
Halting Rules 
The medical monitor, investigator, SIGA, and ISM will review all AEs. All AEs determined 
by the investigator to be severe and possibly, probably, or definitely related to study drug, as 
well as all clinical assessments, laboratory test results, ECG results, or vital sign 
measurements that meet Grade 3 criteria on the DAIDS AE Grading Table will be assessed 
by the medical monitor, who will make a recommendation as to whether or not halting of the 
study should occur. At the discretion of the medical monitor, depending on the assessment of 
the severity of the event, the recommendation to halt the study may be made after 
consultation with the investigator, SIGA, and the ISM. 
The study will be temporarily halted (no new enrollments and no further study drug 
administration) by the investigator and the medical monitor, SIGA, and the ISM will be 
promptly notified according to the following criteria: 
•
One subject experiences a Grade 4 AE assessed as possibly, probably, or definitely
related to study drug.
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•
There is a subject death assessed as possibly, probably, or definitely related to study
drug.
•
One subject experiences a seizure assessed as possibly, probably, or definitely
related to study drug.
•
Two or more subjects experience the same or similar SAEs that are possibly,
probably, or definitely related to the study drug.
•
Three or more subjects experience the same or similar AEs that are Grade 3 or
above and are possibly, probably, or definitely related to the study drug.
Study enrollment and study drug administration would resume if review of the AEs that 
caused the halt resulted in a recommendation to permit further continuation. In such an 
instance, SIGA, with participation by the investigator and the medical monitor, would consult 
with the ISM to conduct the review of all AEs that meet the criteria for halting the study. The 
study would remain suspended until the events were reviewed by the ISM and a 
recommendation was made as to whether the study should be continued or stopped. This 
constitutes a minimum criterion, and the decision to halt the study may be made based on any 
other criteria that, in the judgment of the investigator, with agreement of the medical monitor 
and ISM, indicate a potentially serious safety concern. The investigator will advise SIGA 
immediately if any of the halting rules are met. 
4.4.4 
Replacements 
At the discretion of the investigator, and after consultation with the medical monitor, any 
subject who withdraws before completing the study may be replaced to retain the target of 
32 evaluable enrolled subjects. 
5.
STUDY TREATMENT
5.1
TREATMENT ADMINISTERED 
On Days 1 to 7, all subjects will receive an oral dose of TPOXX 600 mg (3 × 200-mg 
capsules) BID, approximately 12 hours (±30 minutes) apart, for 7 days. 
All subjects will be provided meals consisting of approximately 600 calories and 25 g fat, 
30 minutes before study drug administration. Subjects should eat this meal within 30 minutes 
or less of taking study drug. Study drug will be administered approximately 30 minutes after 
the start of the meal. All doses of study drug will be administered to subjects by study site 
personnel with approximately 240 mL of water. Subjects must fast 2 hours after taking study 
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drug. Study drug and meals must be taken with water only, and no other beverage except 
water should be ingested within 3 hours before or 3 hours after study drug administration. 
5.2
STUDY DRUG 
TPOXX will be supplied as 200-mg capsules containing tecovirimat monohydrate as the 
active pharmaceutical ingredient. The TPOXX capsules are immediate release, size 0, orange 
and black, hard gelatin capsules containing white to off white powder. All inactive 
ingredients/excipients are generally recognized as safe and are United States 
Pharmacopeia/National Formulary grade. The TPOXX excipients are shown in Table 5-1. 
Table 5-1 
Excipients of TPOXX Capsules 
Component 
Quality Designation 
Microcrystalline cellulose 
NFa 
Lactose monohydrate 
NF 
Croscarmellose sodium 
NFa 
Colloidal silicon dioxide 
NF 
Hydroxypropyl methylcellulose 
USP 
Sodium lauryl sulfate 
NF 
Purified waterb 
USP 
Magnesium stearate 
NF 
Abbreviations: NF, National Formulary; USP, United States Pharmacopeia. 
a Microcrystalline cellulose and croscarmellose sodium are added as intragranular and extragranular excipients. 
b Removed during processing. 
Compendial components are tested and released in accordance with full compendial methods 
and specifications before their use in clinical formulations. TPOXX 200-mg capsules are 
manufactured and analyzed for clinical use in accordance with Current Good Manufacturing 
Practices. 
TPOXX capsules are manufactured by: 
Catalent Pharma Solutions 
1100 Enterprise Drive 
Winchester, KY 40391. 
Further information on TPOXX can be found in the TPOXX full prescribing information.2 
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5.2.1 
Study Drug Packaging and Storage 
TPOXX capsules are packaged, labeled, distributed, and placed on stability testing in 
accordance with Current Good Manufacturing Practice and International Council for 
Harmonisation (ICH) guidelines. 
The 200-mg TPOXX capsules are supplied in 75-mL high density polyethylene bottles fitted 
with a heat induction seal and child-resistant screw cap closure system. Each bottle of study 
drug will contain 42 capsules and will be labeled with the drug name, SIGA’s name, a space 
to fill in the protocol number, and a space to fill in the bottle number. 
SIGA (or designee) will provide the investigator and study site with adequate quantities of 
TPOXX.  
All study drug must be stored in a secure area (eg, a locked cabinet), protected from moisture 
and light, and stored at 15°C to 30°C (59°F to 86°F). Study drug should not be refrigerated or 
used beyond the expiration dates provided by the manufacturer. The study site will be 
required to keep a temperature log to establish a record of compliance with these study drug 
storage conditions. All study drug will be kept in a secure cabinet or room with access 
restricted to necessary study site personnel. 
5.2.2 
Study Drug Accountability 
The investigator will maintain accurate records of receipt of all study drug, including dates of 
receipt. Accurate records will be kept regarding when and how much study drug is dispensed 
and used by each subject in the study. Reasons for departure from the expected dispensing 
regimen must also be recorded. Study drug accountability will be recorded in the subject 
source documentation, entered into the eCRF, and should be reviewed by the monitor during 
each monitoring visit. On a regular basis and at the completion of the study, to satisfy 
regulatory requirements regarding drug accountability, all study drug will be reconciled and 
retained or destroyed according to applicable regulations. 
5.3
TREATMENT COMPLIANCE 
All doses of the study drug will be administered in the study site under direct observation of 
study site personnel and recorded in the eCRF. Per standard clinic procedure, study site 
personnel will perform a mouth check and inspect all dose containers to ensure that the entire 
dose was administered. Following completion of dosing procedures and return of dosing 
containers to the pharmacy by team members, pharmacy staff will follow standard clinic 
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procedures for study drug reconciliation. SIGA will provide information to PPD for 
destruction of returned used and unused study drug and study drug bottles. 
The date and time of study drug dosing will be captured and recorded on the appropriate page 
of the eCRF. If a subject is not administered study drug, the reason for the missed dose will 
be recorded. 
5.3.1 
Prior and Concomitant Medications 
Restrictions for prior and concomitant medications and therapies are provided in Sections 4.1 
and 4.2. Prior and concomitant medications and therapies will be coded using the latest 
version of the World Health Organization Drug Dictionary. 
5.3.1.1 
Prior Medications 
Information regarding prior medications taken by the subject within the 30 days before 
signing the informed consent form (ICF) will be recorded in the subject’s eCRF. 
5.3.1.2 
Concomitant Medications 
Any concomitant medication deemed necessary for the welfare of the subject during the 
study may be given at the discretion of the investigator. If a concomitant medication listed in 
Section 4.2 is taken it will be documented as a protocol deviation and a joint decision will be 
made by the investigator and SIGA to continue or discontinue the subject based on the time 
the medication was administered, its pharmacology and PK, and whether the use of the 
medication will compromise the safety of the subject or the interpretation of the data. The 
investigator is responsible for ensuring that details regarding the medication are adequately 
recorded in both the subject’s source document and the eCRF. 
6.
STUDY PROCEDURES
Before performing any study procedures, all potential subjects will sign an ICF as outlined in 
Section 9.3.2.3. Subjects will undergo study procedures at the time points specified in the 
schedule of events (Table 9-1). 
The total amount of blood collected from each subject over the duration of the study, 
including any extra assessments that may be required, will not exceed 500 mL. 
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6.1
PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS 
Blood samples for PK analysis of TPOXX will be collected from all subjects Day 1 before 
study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 
20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours 
after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the 
PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on 
Day 9 (48 hours after the AM dose on Day 7). 
For PK samples, the acceptable window for collection from the scheduled collection time 
point will be as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes 
for the 12- to 48-hour time points. 
The following plasma PK parameters will be calculated for TPOXX using actual sampling 
times rather than scheduled sampling times and will include but are not limited to:  
•
Area under the plasma concentration-time curve (AUC) from time 0 to the last
quantifiable measurement (AUC0-t)
•
AUC from time 0 extrapolated to infinity (AUC0-∞)
•
AUC from time 0 to 24 hour (AUC0-24)
•
AUC during the first dosing interval (tau = 12 hours) (AUC0-tau)
•
Maximum drug concentration in plasma (Cmax)
•
Time to Cmax (Tmax)
•
Apparent volume of distribution (Vd/F)
•
Apparent total body clearance (CL/F)
•
Concentration observed prior to the next dose administration (Ctrough)
•
Terminal elimination half-life (t1/2)
•
Terminal elimination rate constant (λz)
•
Percentage of AUC0-∞ extrapolated from the last quantifiable measurement to infinity
(%AUCextrap).
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6.1.1 
Pharmacokinetic Sample Collection, Shipping, and Storage 
Blood samples (approximately 5 mL) for the determination of plasma concentrations of 
TPOXX will be collected in 5-mL lavender-topped K3EDTA Vacutainer® tubes using a 
21 gauge or larger needle, or from an indwelling intravenous catheter using a vacutainer tube. 
Blood samples should be placed on wet ice or equivalent (approximately 4°C to 8°C) and 
kept at this temperature until processed to separate plasma.  
The exact time and date of sample collection will be recorded for each sample by the 
investigator or designee on the subject’s eCRF, the vacutainer and cryovial labels, and the 
specimen shipping log. In addition, the time of study drug administration before PK sampling 
will be recorded on the subject’s eCRF. Labels will be created by the site and should contain 
the protocol number, matrix (plasma), subject number, date, and time drawn. For information 
that is not preprinted on the label, a fine tipped indelible marking pen is to be used to 
complete the entry. 
The 5-mL blood sample will be centrifuged in a refrigerated centrifuge immediately, if 
possible, or within 60 minutes of collection at 1000 to 1200 × g (2000 to 3000 rpm) for 
10 minutes to separate plasma. Each plasma sample should be transferred via pipette into 
2 cryovials labeled as described previously and should be capped tightly. The second tube 
will be a duplicate and retained at the site as a backup sample. If red blood cells are 
inadvertently drawn into the plasma, the sample should be re-centrifuged as soon as possible. 
Adequate space between the solution and the tube cap should be allowed for expansion 
during freezing.  
Cryovial tubes containing plasma samples must be frozen at –70°C or below until shipment 
in a freezer equipped with a temperature monitor and temperature-activated alarm. 
Uncentrifuged specimens should not be frozen. 
The study site will batch ship sets of frozen plasma samples. A log sheet listing the samples 
being shipped will be included in each shipment. The samples will be sent on dry ice via 
courier to Alturas Analytics (Moscow, ID). The back-up sets will remain at the site until 
confirmation that the first sets have been received. After receipt confirmation is received 
from Alturas Analytics, the back-up sets should be shipped. The site will contact Alturas 
Analytics and coordinate the shipment prior to sending the samples. Shipments before 
weekends or holidays must be avoided. 
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The samples will be shipped for analysis to: 
Alturas Analytics 
1324 Alturas Drive 
Moscow, ID 83843 
The bioanalytical laboratory will store all plasma samples at –70°C until analysis for 
tecovirimat is complete. SIGA will advise Alturas to destroy any remaining plasma samples 
after regulatory review is complete or the samples have met their applicable length of 
stability, whichever comes sooner. 
6.1.2 
Pharmacokinetic Sample Analysis 
Pharmacokinetic samples will be analyzed by Alturas Analytics using a validated liquid 
chromatography coupled with tandem mass spectrometry assay for tecovirimat in human 
plasma method in accordance with the US FDA Guidance for Industry on Bioanalytical 
Method Validation.3 
6.2
SAFETY ASSESSMENTS AND ENDPOINTS 
Safety and tolerability will be assessed by monitoring and recording of AEs, clinical 
laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body 
temperature), 12-lead ECG results, and physical examination findings. Adverse events will 
be assessed from the time of the first dose of study drug until the follow-up telephone call on 
Day 37 (+2 days). 
6.2.1 
Adverse Events 
6.2.1.1 
Adverse Event Definitions 
The investigator is responsible for reporting all AEs that are observed or reported during the 
study, regardless of their relationship to study drug or clinical significance. If there is any 
doubt as to whether a clinical observation is an AE, the event should be reported. 
An AE is any event or other untoward medical occurrence, including those AEs that result 
from dosing errors, which may present during administration of a study drug or during a 
reasonable follow-up period and which does not necessarily have a causal relationship with 
this treatment. An AE is any unfavorable and unintended sign (eg, a clinically significant 
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abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal product, whether or not considered to be related to the medicinal product. All AEs 
will be followed until the AE is resolved or stabilized as determined by the investigator 
and/or the medical monitor. 
A treatment-emergent AE (TEAE) is defined as any event not present before exposure to 
study drug or any event already present that worsens in intensity or frequency after exposure 
to study drug. 
An adverse reaction is any AE caused by a drug. Adverse reactions are a subset of all 
suspected adverse reactions for which there are reasons to conclude that the drug caused the 
event. 
A suspected adverse reaction is any AE for which there is a reasonable possibility that the 
study drug caused the AE. For the purposes of IND safety reporting, “reasonable possibility” 
means that there is evidence to suggest a causal relationship between the drug and the AE. A 
suspected adverse reaction implies a lesser degree of certainty about causality than adverse 
reaction, which means any AE caused by a study drug. 
An AE or suspected adverse reaction is considered “unexpected” if it is not listed in the 
TPOXX full prescribing information or at the specificity or severity that has been observed 
with the study drug being tested. For example, under this definition, hepatic necrosis would 
be unexpected (by virtue of greater severity) if the TPOXX full prescribing information 
referred only to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism 
and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the TPOXX 
full prescribing information listed only cerebral vascular accidents. “Unexpected,” as used in 
this definition, also refers to AEs or suspected adverse reactions that are mentioned in the 
TPOXX full prescribing information as occurring with a class of drugs or as anticipated from 
the pharmacological properties of the drug, but are not specifically mentioned as occurring 
with the particular drug under investigation. 
An AE or suspected adverse reaction is considered an SAE if, in the view of either the 
investigator or SIGA, it results in any of the following outcomes: 
•
Results in death.
•
Is life threatening (subject is at immediate risk of death at the time of the event).
•
Requires inpatient hospitalization or prolongation of existing hospitalization, other than
elective hospitalization, during the period of protocol defined surveillance.
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•
Results in congenital anomaly or birth defect.
•
Results in a persistent or significant disability/incapacity.
•
Any other important medical event that may not result in death, be life threatening, or
requires hospitalization may be considered an SAE when, based on appropriate medical
judgment, the event may jeopardize the subject and may require medical or surgical
intervention to prevent one of the outcomes listed in this definition or is otherwise
considered to be medically significant.
Important medical events that may not result in death, be life threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgement, 
they may jeopardize the subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. Examples of such medical events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of 
drug dependency or drug abuse. 
An AE or suspected adverse reaction is considered “life-threatening” if, in the view of either 
the investigator or SIGA, its occurrence places the subject at immediate risk of death. It does 
not include an AE or suspected adverse reaction that, had it occurred in a more severe form, 
might have caused death. 
Serious AEs will be followed until the SAE is stable or until resolution as determined by the 
investigator and/or the medical monitor. 
6.2.1.2 
Eliciting and Documenting Adverse Events 
The investigator is responsible for ensuring that all AEs and SAEs are recorded in the eCRF 
and reported to SIGA by PPD. Adverse events and SAEs will be assessed from the first dose 
of study drug through the telephone call on Day 37 (+2 days).  
At every study visit or assessment, subjects will be asked a standard question to elicit any 
medically related changes in their well-being. They will also be asked if they have been 
hospitalized, had any accidents, used any new medications, or changed concomitant 
medication regimens (both prescription and over-the-counter medications). 
In addition to subject observations, AEs will be documented from any data collected on the 
AE page of the eCRF (eg, laboratory values, physical examination findings, and ECG 
changes) or other documents that are relevant to subject safety. 
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6.2.1.3 
Reporting Adverse Events 
All AEs reported or observed from the first dose of study drug through the follow-up 
telephone call on Day 37 (+2 days) will be recorded on the AE page of the eCRF. 
Information to be collected includes drug treatment, type of event, date and time of onset, 
investigator-specified assessment of severity and relationship to study drug, date and time of 
resolution of the event, seriousness, as well as any required treatment or evaluations, and 
outcome. Adverse events resulting from concurrent illnesses, reactions to concurrent 
illnesses, reactions to concurrent medications, or progression of disease states must also be 
reported. 
All AEs will be followed until they are resolved or stabilized as determined by the 
investigator and/or medical monitor. These data will be reviewed on an ongoing basis by the 
study coordinator, the investigator, the medical monitor, and the ISM. This requirement 
indicates that for some events, follow-up may be required after the subject has completed 
study participation. These events will be reported by SIGA, as required, to the FDA. 
Any medical condition that is present at the time that the subject is screened but does not 
deteriorate should not be reported as an AE. However, if it deteriorates at any time during the 
study, it should be recorded as an AE. Prior to this, medical conditions reported by subjects 
are considered medical history. 
6.2.1.4 
Reporting of Serious Adverse Events 
Any AE considered serious by the investigator or which meets SAE criteria (Section 6.2.1.1), 
or any other event or condition regardless of grade, which in their judgment represents a 
reportable event, must be reported to the medical monitor and SIGA as soon as the 
investigator becomes aware of the event. In addition, the event must be reported to PPD via 
the SAE hotline. The PPD SAE Report Form must be submitted within 24 hours of 
knowledge of the event. SIGA (or designee) will be responsible for notifying the relevant 
regulatory authorities of any SAE as outlined in US Title 21 Code of Federal Regulations 
(CFR) Parts 312 and 320. The investigator is responsible for notifying the institutional 
review board (IRB) directly. 
In addition, the investigator (or designee) must report any Grade 3 (severe) AE that they 
deem possibly, probably, or definitely related to study drug to the medical monitor and SIGA 
within 24 hours after becoming aware of the event. 
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After notification from the investigator, SIGA will report all study drug-related and 
unexpected SAEs (those not listed in the TPOXX full prescribing information) to the FDA 
within 15 calendar days of first knowledge. Fatalities or life-threatening events assessed as 
related and unexpected will be reported to the FDA within 7 calendar days of first 
knowledge. The ISM will also receive these reports. 
The following contact information is to be used for SAE reporting: 
PPD Medical Monitor: 
Rahul Bhatnagar, MD 
PPD Phase I Clinic 
7551 Metro Center Drive, Suite 300 
Austin, TX 78744 
Telephone: 888-483-7729 
PPD SAE Hotline: 888-483-7729 
PPD SAE Fax line: 888-529-3580 
The collection and monitoring period for SAEs is 30 days after administration of the last 
dose of study drug. At the time of discharge or early termination from the study site, the 
subject will be instructed to notify the investigator of any SAEs that occur within 30 days 
after the last dose of study drug. 
All subjects will have a follow-up telephone call 30 days after administration of the last dose 
of study drug (Day 37 [+2 days]) to report any SAEs. 
6.2.1.5 
Assessment of Severity 
All AEs will be graded for intensity according to the current DAIDS Table for Grading the 
Severity of Adult and Pediatric Adverse Events. The table may be accessed at the following 
link: https://rsc.tech-res.com/docs/default-source/safety/division-of-aids-(daids)-table-for-
grading-the-severity-of-adult-and-pediatric-adverse-events-corrected-v-2-1.pdf?sfvrsn=2. 
Any laboratory or clinical AE that is not listed on the DAIDS Table will be assessed for 
severity and classified into 1 of 5 clearly defined categories as follows: 
•
Grade 1 (Mild): Events require minimal or no treatment and do not interfere with the
subject’s daily activities.
•
Grade 2 (Moderate): Events result in a low level of inconvenience or concern with the
therapeutic measures and may cause some interference with normal functioning.
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•
Grade 3 (Severe): Events interrupt a subject’s usual daily activity, may require systemic
drug therapy or other treatment, and are usually incapacitating.
•
Grade 4 (Life-threatening): Event that, in the opinion of the investigator, places the
subject at immediate risk of death from the reaction as it occurred (ie, it does not include
a reaction that, had it occurred in a more severe form, might have caused death).
•
Grade 5 (Death).
Changes in the severity of an AE should be documented to allow an assessment of the 
duration of the event at each level of intensity to be performed. An AE characterized as 
intermittent requires documentation of onset and duration of each episode.  
6.2.1.6 
Assessment of Causality 
Any occurrence of an AE will be assessed for relationship to the study drug. A causal 
relationship means that the study drug caused (or is reasonably likely to have caused) the AE. 
This usually implies a relationship in time between the drug and the AE; for example, the AE 
occurred shortly after the subject received the study drug. 
The investigator who examines and evaluates the subject will determine AE causality based 
on the temporal relationship to administration of the study drug, the pharmacology of the 
study drug, and their clinical judgment. Terms used to describe the degree of causality 
between a study drug and an AE are definitely related, probably related, possibly related, 
unlikely related, or not related. 
The best estimate at the time of reporting of an event and the degree of certainty about the 
causal relationship between the study drug administration and the AE will be graded as 
follows: 
Associated 
•
Definitely Related: The AE and administration of study drug are related in time, and a
direct association can be demonstrated (eg, the event disappears or decreases with
reduction in dose or cessation of study drug and recurs with re-exposure).
•
Probably Related: The AE and administration of study drug are reasonably related in time
and/or follow a known pattern of response, and the AE is more likely explained by study
drug than other causes.
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•
Possibly Related: The AE and administration of study drug are reasonably related in time
and/or follow a known pattern of response, but the AE can be explained equally well by
causes other than study drug (eg, could readily have been produced by the subject’s
clinical state or could have been due to environmental or other interventions).
Not Associated 
•
Unlikely Related: A potential relationship between study drug and the AE could exist
(ie, the possibility cannot be excluded), but the AE is most likely explained by causes
other than the study drug (eg, could readily have been produced by the subject’s clinical
state or could have been due to environmental or other interventions).
•
Not Related: The AE is clearly due to extraneous causes (eg, underlying disease,
environment) or exposure to the study drug has not occurred. Such events MUST have an
alternative, definitive etiology documented in the subject’s medical record.
6.2.1.7 
Follow-up of Adverse Events 
All AEs must be reported in detail on the appropriate page of the eCRF and followed until 
they are resolved or stabilized as determined by the investigator and/or medical monitor. 
6.2.1.8 
Reactogenicity 
At this time, there is no definitive information on allergic activity of TPOXX. Reactogenicity 
will be monitored in subjects during the study treatment period. The study site personnel will 
observe the subjects for signs of allergic reaction for at least 1 hour after the study drug is 
ingested. 
6.2.1.9 
Reporting of Pregnancy 
Pregnant women are not eligible to participate in the study. Subjects must be counseled 
regarding prevention of pregnancy and encouraged to make every effort to avoid pregnancy 
during study participation. If a female subject becomes pregnant during study participation, 
study drug dosing will be discontinued, and the subject will be withdrawn from the study. 
The pregnancy itself is not considered an SAE. However, the investigator must complete the 
pregnancy report form and fax it to PPD Pharmacovigilance within 24 hours of knowledge of 
the pregnancy. After delivery or termination of pregnancy, the follow-up pregnancy report 
form should be completed and submitted via fax to PPD Pharmacovigilance. Spontaneous 
abortions should always be reported as SAEs. Pregnancy data will be captured and followed 
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by PPD. All pregnancies and outcomes will be tracked. The case will not be closed until after 
the child is followed for 3 months. 
If there are complications during the pregnancy, the complications will be recorded as AEs in 
the usual manner. The subject will be asked to report the outcome of the pregnancy. If there is 
a congenital anomaly in the infant, this will be recorded as an SAE in the data forms for the 
mother (ie, the study subject). 
If a subject becomes pregnant during the study after receiving the study drug, all safety 
evaluations will be collected as per protocol. In addition, at the time that the pregnancy is 
reported, consent will be requested to contact the subject and her physician in the postpartum 
period to assess delivery and health status of the neonate. 
If the partner of a male subject becomes pregnant, the partner will be asked for consent to 
allow her treating physician to provide SIGA or its designee with follow-up information 
regarding the pregnancy and its outcome. 
6.2.2 
Clinical Laboratory Testing 
Clinical laboratory tests will be performed by the PPD Central Laboratory. Blood samples 
will be collected at the time points indicated in the schedule of events (Table 9-1) and will be 
prepared using standard procedures.  
Repeat clinical laboratory tests may be performed at the discretion of the investigator, if 
necessary, to evaluate inclusion and exclusion criteria or clinical laboratory abnormalities. 
PPD central laboratory will provide the reference ranges for all clinical laboratory safety 
parameters. 
The following clinical laboratory assessments will be performed: 
Hematology 
Hematocrit, hemoglobin, mean corpuscular hemoglobin, mean 
corpuscular hemoglobin concentration, total and differential 
leukocyte count (basophils, eosinophils, lymphocytes, monocytes, 
neutrophils), mean corpuscular volume, platelet count, red blood 
cell count, and red cell distribution width 
Serum Chemistry 
Alanine aminotransferase, albumin, alkaline phosphatase, anion 
gap, aspartate aminotransferase, bilirubin (total), blood urea 
nitrogen, calcium, carbon dioxide, chloride, creatinine clearance 
(calculateda), gamma-glutamyltransferase, globulin, glucose, lactate 
dehydrogenase, phosphorus, potassium, sodium, total protein, and 
uric acid 
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Urinalysis 
Appearance, bilirubin, blood, color, glucose, ketones, leukocytes, 
microscopy (performed if dipstick is ≥1+; includes bacteria, cast, 
crystals, epithelial cells, red blood cells, and white blood cells), 
nitrates, pH, protein, specific gravity, turbidity, and urobilinogen  
a Creatinine clearance (CLcr) will be calculated using the Cockcroft-Gault formula: 
𝐶𝐿𝑐𝑟 (𝑚𝐿𝑚𝑖𝑛
⁄
) = [140 −𝑎𝑔𝑒(𝑦𝑒𝑎𝑟𝑠)] × 𝑤𝑒𝑖𝑔ℎ𝑡 (𝑘𝑔)
72 × 𝑠𝑒𝑟𝑢𝑚 𝑐𝑟𝑒𝑎𝑡𝑖𝑛𝑖𝑛𝑒 (𝑚𝑔𝑑𝐿
⁄
) {× 0.85 𝑖𝑓 𝑓𝑒𝑚𝑎𝑙𝑒}
Glycosylated hemoglobin A1c and a fasting lipid panel including cholesterol (total, 
high-density lipoprotein, calculated low-density lipoprotein, and triglycerides) will be 
performed at screening. 
Serum pregnancy test ( human chorionic gonadotropin) for women of childbearing potential 
will be performed at screening and on Day –1. 
A serum follicle-stimulating hormone test for postmenopausal women will be performed at 
screening.  
Human immunodeficiency virus (type 1 and 2) antibodies, hepatitis B surface antigen, and 
hepatitis C virus antibody will be assessed at screening only.  
A urine drug screen for alcohol, amphetamines (including methamphetamines and 
ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids 
(including tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, 
codeine, and oxycodone) will be performed at screening and on Day –1. 
Abnormal clinical laboratory values will be flagged as either high or low (or normal or 
abnormal) based on the reference ranges for each laboratory parameter. The investigator will 
determine whether any of the abnormally high or low results are clinically significant or not 
clinically significant. Clinical significance is defined as any variation in results that has 
medical relevance and may result in an alteration in medical care (eg, active observation, 
diagnostic measures, or therapeutic measures). If a clinically significant change from the 
screening value is noted, the clinically significant value and reason for clinical significance 
will be documented on the AE page of the eCRF. The investigator will continue to monitor 
the subject with additional assessments until the values have reached the reference range or 
the values at screening or until the investigator determines that follow-up is no longer 
medically necessary. 
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6.2.3 
Medical History 
A complete medical history will be obtained, including a review of systems, recreational and 
prescription drug use, over-the-counter drug use, nicotine and alcohol use, and past 
hospitalizations.  
6.2.4 
Vital Sign Measurements 
Vital signs will be measured after the subject has been seated for at least 5 minutes at the 
time points indicated in the schedule of events (Table 9-1). 
Vital sign measurements will include systolic and diastolic blood pressures, heart rate, 
respiratory rate, and body temperature.  
When procedures are overlapping and occurring at the same time point, the order of 
procedures should be ECG, vital sign measurements, and then blood collection, with the 
blood collection scheduled to occur at the nominal time point, unless dictated by other study 
events happening at that time, such as dosing requirements. 
The investigator will determine whether any of the vital sign measurements are clinically 
significant or not clinically significant. Clinical significance is defined as any variation in 
results that has medical relevance and may result in an alteration in medical care (eg, active 
observation, diagnostic measures, or therapeutic measures). If a clinically significant change 
from the screening values is noted, the clinically significant value and reason for clinical 
significance will be documented on the AE page of the subject’s eCRF. The investigator will 
continue to monitor the subject with additional assessments until the value has reached the 
reference range or the value at screening or until the investigator determines that follow up is 
no longer medically necessary. 
6.2.5 
Electrocardiograms 
A 12-lead ECG will be obtained after the subject has been in the supine position for at least 
10 minutes at the time points indicated in the schedule of events (Table 9-1). On Days 1, 4, 
and 7, an ECG will be recorded 4 hours after the AM study drug administration. The 
acceptable window for collection from the scheduled collection time point will ±15 minutes. 
Electrocardiogram assessments will include comments on whether the tracings are normal or 
abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence 
of myocardial infarction, or ST segment, T wave, and U wave abnormalities. In addition, the 
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following parameters will be measured and reported: heart rate; PR, RR, and QT intervals; 
QTcF; QT interval corrected using Bazett’s formula; and QRS duration. All ECGs must be 
performed by an experienced ECG technician. 
The investigator will determine whether any of the 12-lead ECG results are clinically 
significant or not clinically significant. Clinical significance is defined as any variation in 
results that has medical relevance and may result in an alteration in medical care (eg, active 
observation, diagnostic measures, or therapeutic measures). If a clinically significant change 
from screening is noted, the clinically significant value and reason for clinical significance 
will be documented on the AE page of the subject’s eCRF. The investigator will continue to 
monitor the subject with additional assessments until either the values have reached reference 
range or the values at screening or until the investigator determines that follow-up is no 
longer medically necessary. 
6.2.6 
Physical Examinations 
A full physical examination will be performed at the time points indicated in the schedule of 
events (Table 9-1) and will include assessment of the following body systems: head, ears, 
eyes, nose, and throat; cardiac (including auscultation of heart); pulmonary (chest) 
auscultation of lungs; abdomen; skin; musculoskeletal system; lymphatic system; and 
neurologic system (cranial nerves, sensation, motor function, coordination, reflexes, and 
mental status). 
A symptom-directed physical examination will be performed at the time points indicated in 
the schedule of events (Table 9-1) (for those subjects who require it), and at unscheduled 
visits as necessary. This examination will include an assessment of the heart, lungs, abdomen, 
a neurologic review, and a review of symptoms for assessments and/or follow-up of reported 
or potential AEs. 
Weight will be measured without shoes and in light clothing at screening and without shoes 
and in hospital gowns at all other time points indicated in the schedule of events (Table 9-1). 
The scales should be calibrated, and the same weight scale should be used throughout the 
study starting on Day –1. 
6.2.7 
Unscheduled Visits 
Subjects will be provided with the contact information for the study site personnel. Subjects 
are free to contact study site personnel at any time, and the site may require an unscheduled 
visit for the purpose of physical examinations, laboratory tests, etc. Unscheduled visits will 
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be documented by the site personnel in the source documents. Unscheduled procedures and 
laboratory tests and results will also be recorded in the eCRF. 
7.
STATISTICAL ANALYSIS PLANS
7.1
SAMPLE SIZE CALCULATIONS 
The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study is 
based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size is considered sufficient to effectively assess the PK and safety 
profiles of TPOXX. 
7.2
ANALYSIS POPULATIONS 
The Safety Population will include all subjects who receive at least 1 dose of study drug. 
The PK Population will include subjects who receive study drug and have sufficient 
concentration data to facilitate the calculation of PK variables. 
7.3
STATISTICAL ANALYSIS 
Details of all statistical analyses will be described in a statistical analysis plan. All data 
collected will be presented in data listings. Data from subjects excluded from an analysis 
population will be presented in the data listings, but not included in the calculation of 
summary statistics. 
For categorical variables, frequencies and percentages will be presented. Continuous 
variables will be summarized using descriptive statistics (number of subjects, mean, median, 
standard deviation [SD], minimum, and maximum). 
Baseline demographic and background variables will be summarized overall for all subjects. 
The number of subjects who enroll in the study and the number and percentage of subjects 
who complete the study will be presented. Frequency and percentage of subjects who 
withdraw or discontinue from the study, and the reason for withdrawal or discontinuation, 
will also be summarized. 
7.3.1 
Pharmacokinetic Analyses 
Individual plasma concentration and time deviation data will be presented in a data listing. 
Plasma concentration data will be listed and summarized using the following descriptive 
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statistics: number of subjects, arithmetic mean, SD, coefficient of variation (CV), geometric 
mean, geometric CV, median, minimum, and maximum. Individual and mean plasma 
concentration versus time profiles will be presented in figures on both linear and 
semilogarithmic scales. 
The PK parameters of TPOXX will be analyzed based on the actual sampling times. All 
parameters will be determined using noncompartmental methods using Phoenix® 
WinNonlin® Version 6.4 or higher (Certara, L.P., Princeton, New Jersey) or SAS® Version 9.4 
or higher (SAS Institute Inc., Cary, North Carolina). 
The individual PK parameters and body weight-normalized PK parameters will be presented 
in data listings and summarized using the following descriptive statistics: number of subjects, 
arithmetic mean, SD, CV, median, minimum, maximum, geometric mean, geometric SD, and 
geometric CV. 
7.3.2 
Safety Analyses 
Adverse events will be coded by preferred term and system organ class using the latest 
version of the Medical Dictionary for Regulatory Activities and summarized overall. All AE 
data will be presented in a data listing. Treatment-emergent AEs will be summarized overall, 
as well as by severity and relationship to study drug. Serious AEs and AEs leading to 
discontinuation of study drug will also be presented in the data listings and summarized 
overall. 
Actual values and changes from baseline for clinical laboratory test results, vital sign 
measurements, and 12-lead ECG results will be summarized at each time point using 
descriptive statistics (number of subjects, mean, SD, median, minimum, and maximum). 
Shift tables will be generated for clinical laboratory test results. Clinical laboratory data, vital 
sign measurements, 12-lead ECG results, and physical examination findings will be 
presented in data listings. 
7.4
HANDLING OF BELOW THE LIMIT OF 
QUANTIFICATION AND MISSING DATA 
Plasma concentrations that are below the limit of quantification (BLQ) will be treated as zero 
for descriptive statistics. Geometric mean values will not be calculated or displayed when 
zero is the minimal value. Mean BLQ concentrations will be presented as BLQ, and the SD 
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and CV will be reported as not applicable. Missing concentrations will be excluded from the 
calculations. 
7.5
INTERIM ANALYSES 
No formal interim safety analyses will be performed in this study. 
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8.
REFERENCE LIST
1. Breman JG, Henderson DA. Diagnosis and management of smallpox. N Engl J Med.
2002;346(17):1300-8.
2. TPOXX (tecovirimat) [full prescribing information]. SIGA Technologies, Inc. Corvallis
(OR); 2018. 18 p.
3. Department of Health and Human Services, Food and Drug Administration (US).
Guidance for Industry. Bioanalytical Method Validation. May 2001. Available from:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid
ances/ucm070107.pdf.
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9.
APPENDICES
9.1
APPENDIX 1: LIST OF ABBREVIATIONS 
Abbreviation 
Term 
%AUCextrap 
percentage of AUC0-∞ extrapolated from the last quantifiable 
measurement to infinity 
λz 
terminal elimination rate constant 
AE 
adverse event 
AUC 
area under the plasma concentration-time curve 
AUC0-24 
area under the plasma concentration-time curve from time 0 to 
24 hours 
AUC0-∞ 
area under the plasma concentration-time curve from time 0 
extrapolated to infinity 
AUC0-t 
area under the plasma concentration-time curve from time 0 to the 
last quantifiable measurement 
AUC0-tau 
area under the plasma concentration-time curve during the first 
dosing interval 
BCRP 
breast cancer resistance protein 
BID 
twice daily 
BLQ 
below the limit of quantification 
CFR 
Code of Federal Regulations 
CL/F 
apparent total body clearance 
Cmax 
maximum drug concentration in plasma 
Ctrough 
concentration observed prior to the next dose administration 
CRA 
clinical research associate 
CV 
coefficient of variation 
CYP 
cytochrome P450 
DAIDS 
Division of Acquired Immune Deficiency Syndrome 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
FDA 
Food and Drug Administration 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IRB 
institutional review board 
ISM 
independent safety monitor  
MedDRA 
Medical Dictionary for Regulatory Activities 
PK 
pharmacokinetic(s) 
QTcF 
QT interval corrected using Fridericia’s formula 
SAE 
serious adverse event 
SD 
standard deviation 
SOP 
standard operating procedures 
t1/2 
terminal elimination half-life 
TEAE 
treatment-emergent adverse event 
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Abbreviation 
Term 
Tmax 
time to maximum drug concentration in plasma 
UGT 
uridine diphosphate-glucuronosyltransferase 
VARV 
variola virus 
Vd/F 
apparent volume of distribution 
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9.2
APPENDIX 2: SCHEDULE OF EVENTS 
Table 9-1 
Schedule of Events 
Screening Check-in 
Treatment Period 
Telephone Call 
or Follow-up 
Visit(a) 
Follow-up 
Telephone 
Call(b) 
Procedure(c)
Day –28 to –2
–1
1 
2 
3 
4 
5 
6 
7 
8 
9 or Early 
Discontinuation (±2) 
14 (+2) 
37 (+2) 
Admission to clinic 
X 
Discharge from clinic(d) 
X 
Informed consent 
X 
Inclusion/exclusion criteria 
X 
X 
Medical history(e) 
X 
X 
Complete physical examination(f) 
X 
X 
X 
X 
Weight(g) 
X 
X 
X(h) 
X 
Vital sign measurements(i) 
X 
X 
X(j) 
X(j) 
X(j) 
X 
X 
X(k) 
Glycosylated hemoglobin (HbA1c) 
X 
Fasting lipid panel(l) 
X 
Clinical laboratory testing(m) 
X(n) 
X 
X 
X(o) 
X(n) 
Serum follicle-stimulating 
hormone(p)
X 
Serum pregnancy test(q) 
X 
X 
Urine drug/alcohol screen(r) 
X 
X 
Serology (HBsAg, HCV, and HIV) 
X 
12-Lead ECG(s)
X 
X 
X 
X 
X 
X 
TPOXX administration(t) 
X 
X 
X 
X 
X 
X 
X 
Pharmacokinetic sampling(u) 
X 
X 
X 
X 
X 
X 
Symptom-directed physical 
examination(v)
X 
X 
X 
X 
X 
X 
X(k) 
Reactogenicity(w) 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
X 
Prior/concomitant medications 
X 
Abbreviations: AE, adverse event; ECG, electrocardiogram; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; 
PK, pharmacokinetic; SAE, serious adverse event. 
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Notes: 
(a) The follow-up visit or telephone call will occur on Day 14 (+2 days), 7 days after the last dose of study drug. Subjects who have abnormal physical examination findings or an
ongoing AE/SAE on Day 9 that is deemed related to study drug or per investigator or SIGA discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All
other subjects will have the Day 14 (+2 days) follow-up via telephone.
(b) The follow-up telephone call will be made 30 days after the last dose of study drug (Day 37 [+2 days]).
(c) When procedures are overlapping and occurring at the same time point, the order of procedures should be ECG, vital sign measurements, and then blood collection, with the
blood collection scheduled to occur at the nominal time point, unless dictated by other study events happening at that time, such as dosing requirements.
(d) Discharge following collection of all safety assessments.
(e) Including a review of systems; recreational, prescription, and over-the-counter drug use; nicotine and alcohol use; and past hospitalizations.
(f) Including assessment of the following body systems: head, ears, eyes, nose, and throat; cardiac (including auscultation of heart); pulmonary (chest) auscultation of lungs;
abdomen; skin; musculoskeletal system; lymphatic system; and neurologic system (cranial nerves, sensation, motor function, coordination, reflexes, and mental status).
(g) Weight will be measured without shoes and in light clothing at screening and without shoes and in hospital gowns at all other time points. The scales should be calibrated and
the same weight scale should be used throughout the study starting on Day –1.
(h) Weight will be collected prior to dosing.
(i)
Vital sign measurements will include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Vital signs will be measured after the subject has
been seated for at least 5 minutes.
(j)
Vital sign measurements will be performed before dosing and 4 hours after the AM study drug administration on Days 1 and 7 and 4 hours after the AM study drug
administration on Day 4. The acceptable window for collection from the scheduled collection time point is ±15 minutes.
(k) Collected only if subjects are required to return to the study site on Day 14 (+2 days) for a follow-up visit.
(l)
Including cholesterol (total, high-density lipoprotein, calculated low-density lipoprotein, and triglycerides).
(m) Clinical laboratory testing will include hematology and serum chemistry.
(n) Clinical laboratory testing at screening and at Day 9 or early discontinuation will include hematology, serum chemistry, and urinalysis.
(o) Collect 12 hours after the PM study drug administration on Day 7.
(p) For postmenopausal women, a serum follicle-stimulating hormone test will be performed at screening.
(q) Women of childbearing potential only.
(r) Includes alcohol, amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids (including
tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, codeine, and oxycodone).
(s) A 12-lead ECG will be collected after the subject has been in the supine position for at least 10 minutes. On Days 1, 4, and 7, an ECG will be recorded 4 hours after the AM
study drug administration. The acceptable window for collection from the scheduled collection time point is ±15 minutes.
(t)
TPOXX, 600 mg (3 × 200-mg capsules) will be administered orally twice daily, approximately 12 hours (± 30 minutes) apart on Days 1 through 7. All subjects will be
provided meals consisting of approximately 600 calories and 25 g fat, which will start 30 minutes before study drug administration. Subjects should eat this meal within 30
minutes or less of taking study drug. Study drug will be administered approximately 30 minutes after the start of the meal. All doses of study drug will be administered to
subjects by study site personnel with approximately 240 mL of water. Subjects must fast 2 hours after taking study drug. Study drug and meals must be taken with water only,
and no other beverage except water should be ingested within 3 hours before or 3 hours after study drug administration.
(u) Blood samples for PK analysis of TPOXX will be collected from all subjects at the following tome points: on Day 1 before study drug administration (0 hour), at 0.5, 1, 2, 4, 6,
8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours after the AM dose), on Day 7 before the
AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the
AM dose on Day 7). For PK blood samples, the acceptable window for collection from the scheduled collection time point will be as follows: ±5 minutes for the time points
from 1 to 8 hours and ±15 minutes for the 12- to 48-hour time points.
(v) Including assessment of heart, lungs, abdomen, a neurologic review, and a review of symptoms for assessment and/or follow-up of reported or potential adverse events.
(w) The study site personnel will observe the subjects for signs of allergic reaction for at least 1 hour after the study drug is ingested.
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9.3
APPENDIX 3: STUDY GOVERNANCE 
9.3.1 
Data Quality Assurance 
This study will be conducted using the quality processes described in applicable procedural 
documents. The quality management approach to be implemented will be documented and 
will comply with current ICH guidance on quality and risk management. All aspects of the 
study will be monitored for compliance with applicable government regulatory requirements, 
current Good Clinical Practice, the protocol, and standard operating procedures (SOPs). The 
monitor will maintain current personal knowledge of the study through observation, review 
of study records and source documentation, and discussion of the conduct of the study with 
the investigator and staff. Electronic CRFs and electronic data capture will be utilized. The 
electronic data capture system is validated and compliant with US Title 21 CFR Part 11. Each 
person involved with the study will have an individual identification code and password that 
allows for record traceability. There may be an internal quality review audit of the data and 
additional reviews by the clinical monitor. 
Steps to be taken to ensure the accuracy and reliability of data include, but are not limited to: 
selection of qualified investigator and appropriate study center, protocol training and review 
of protocol procedures with the investigator and study site personnel before the start of the 
study, site initiation and periodic interim monitoring visits by SIGA or PPD, and direct 
transmission of safety laboratory data into the PPD study database for all clinical safety 
laboratory tests performed. The eCRF will be reviewed for accuracy and completeness by 
PPD Clinical research associate (CRA) remotely and during on-site monitoring visits. 
Discrepancies will be resolved with the investigator or designees, as appropriate. The data 
will be entered into the clinical study database and validated for accuracy. During on-site 
monitoring visits, 100% of the data will be verified using source documentation. SIGA or 
Biomedical Advanced Research and Development Authority representatives may accompany 
the PPD CRA on any scheduled site visit. The investigator will be informed in advance of 
any visitors to the study site in addition to the PPD CRA.  
Representatives of SIGA’s Quality Assurance department (or designee) may visit the site to 
carry out an audit of the study in compliance with regulatory guidelines and PPD policy. 
Such audits will require access to all study records, including source documents, for 
inspection and source document verification with the eCRF. Subject privacy must, however, 
be respected. Sufficient prior notice will be provided to allow the investigator to prepare 
properly for the audit. Similar auditing procedures may also be conducted by any regulatory 
body reviewing the results of this study in support of a Licensing Application. The 
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investigator will immediately notify SIGA if they are contacted by a regulatory agency 
requesting a site inspection. 
9.3.2 
Investigator Obligations 
The following administrative items are meant to guide the investigator in the conduct of the 
study and may be subject to change based on industry and government SOPs, working 
practice documents, or guidelines. Changes will be reported to the IRB but will not result in 
protocol amendments. 
9.3.2.1 
Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain subject confidentiality. All records will be kept in a secure 
storage area with limited access. Subjects will not be identified by name in any reports in this 
study. All records will be kept confidential to the extent provided by federal, state, and local 
law. Medical records are made available for review when required by the FDA or other 
authorized users only under the guidelines set by the Federal Privacy Act. Direct access, as 
defined in the Federal Privacy Act, includes examining, analyzing, verifying, and 
reproducing any records and reports that are important to the evaluation of the study. The 
investigator is obligated to inform the subjects that these representatives may review their 
study-related records without violating the confidentiality of the subjects. The requirement to 
maintain subject confidentiality is included in the study informed consent document. 
The investigator and all employees and coworkers involved with this study may not disclose 
or use for any purpose other than performance of the study, any data, record, or other 
unpublished, confidential information disclosed to those individuals for the purpose of the 
study. Prior written agreement from SIGA or its designee must be obtained for the disclosure 
of any said confidential information to other parties. 
9.3.2.2 
Institutional Review 
Federal regulations and ICH guidelines require that approval be obtained from an IRB before 
participation of human subjects in research studies. Before study onset, the protocol, ICF, 
advertisements to be used for the recruitment of study subjects, and any other written 
information regarding this study to be provided to the subject or the subject’s legal guardian 
must be approved by the IRB. Documentation of all IRB approvals and of the IRB 
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compliance with the ICH harmonised tripartite guideline E6(R2): Good Clinical Practice will 
be maintained by the site and will be available for review by SIGA or its designee. 
All IRB approvals should be signed by the IRB chairman or designee and must identify the 
IRB name and address, the clinical protocol by title or protocol number or both, and the date 
approval or a favorable opinion was granted. 
9.3.2.3 
Subject Consent 
Written documentation of informed consent in compliance with US Title 21 CFR Part 50 
shall be obtained from each subject before any study-related procedures are performed and 
study drug is administered. If any institution-specific modifications to study-related 
procedures are proposed or made by the site, the consent should be reviewed by SIGA or its 
designee or both before IRB submission. Once reviewed, the investigator will submit the ICF 
to the IRB for review and approval before the start of the study. If the ICF is revised during 
the course of the study, all active participating subjects must sign the revised ICF. 
Before recruitment and enrollment, each prospective subject or his/her legal guardian will be 
given a full explanation of the study and will be asked to read and review the approved ICF. 
Once the investigator is assured that the subject/legal guardian understands the implications 
of participating in the study, the subject/legal guardian will be asked to give his or her 
consent to participate in the study by signing the ICF. A copy of the ICF will be provided to 
the subject/legal guardian. 
9.3.2.4 
Exclusion of Children 
Effort will be made to include women and minorities in proportions similar to that of the 
community from which they are recruited. Because this study is designed to establish safety 
of the study drug in adults, enrollment will be limited to persons at least 18 years of age, and 
no older than 50 years. Children are excluded from participation in this clinical study because 
it does not meet the Department of Health and Human Services’ guidelines (45 CFR 46, 
Subpart D, 401-409) for inclusion of children in research. These guidelines provide guidance 
for the protection of children in research. Generally, healthy children can be studied when the 
research is considered as “not greater than minimal risk.” Children can be involved in 
research with greater than minimal risk only when it presents the prospect of direct benefit to 
the individual child or is likely to yield generalizable knowledge about the child’s disorder or 
condition. 
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9.3.2.5 
Study Reporting Requirements 
By participating in this study, the investigator agrees to submit reports of SAEs according to 
the time line and method outlined in this protocol. In addition, the investigator agrees to 
submit annual reports to his or her IRB as appropriate. 
9.3.2.6 
Financial Disclosure and Obligations 
The investigator is required to provide financial disclosure information to allow SIGA to 
submit the complete and accurate certification or disclosure statements required under US 
Title 21 CFR Part 54. In addition, the investigator must provide to SIGA a commitment to 
promptly update this information if any relevant changes occur during the course of the 
investigation and for 1 year following the completion of the study. 
Neither SIGA nor PPD is financially responsible for further testing or treatment of any 
medical condition that may be detected during the screening process. In addition, in the 
absence of specific arrangements, neither SIGA nor PPD is financially responsible for further 
treatment of the disease under study. 
9.3.2.7 
Investigator Documentation 
Prior to beginning the study, the investigator will be asked to comply with ICH 
E6(R2) Section 8.2 and US Title 21 of the CFR by providing essential documents, including 
but not limited to, the following: 
•
IRB approval.
•
An original investigator-signed investigator agreement page of the protocol.
•
Form FDA 1572, fully executed, and all updates on a new fully executed
Form FDA 1572.
•
Curriculum vitae for the principal investigator and each subinvestigator listed on Form
FDA 1572. Current licensure must be noted on the curriculum vitae. Curriculum vitae
will be signed and dated by the principal investigators and subinvestigators at study
start-up, indicating that they are accurate and current.
•
Financial disclosure information to allow SIGA to submit complete and accurate
certification or disclosure statements required under US Title 21 CFR Part 54. In
addition, the investigators must provide to SIGA a commitment to promptly update this
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information if any relevant changes occur during the course of the investigation and for 
1 year after the completion of the study. 
•
An IRB-approved ICF, samples of site advertisements for recruitment for this study, and
any other written information about this study that is to be provided to the subject or legal
guardians.
•
Laboratory certifications and reference ranges for any local laboratories used by the site,
in accordance with US Title 42 CFR Part 493.
9.3.2.8 
Study Conduct 
The investigator agrees to perform all aspects of this study in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, ICH E6(R2): Good Clinical 
Practice; the protocol; and all national, state, and local laws or regulations. 
9.3.2.9 
Case Report Forms and Source Documents 
Site personnel will maintain source documentation, enter subject data into the eCRF as 
accurately as possible, and will rapidly respond to any reported discrepancies. 
Electronic CRFs and electronic data capture will be utilized. The electronic data capture 
system is validated and compliant with US Title 21 CFR Part 11. Each person involved with 
the study will have an individual identification code and password that allows for record 
traceability. Thus, the system, and any subsequent investigative reviews, can identify 
coordinators, investigators, and individuals who have entered or modified records, as well as 
the time and date of any modifications. There may be an internal quality review audit of the 
data and additional reviews by PPD’s CRA. 
Each eCRF is presented as an electronic copy, allowing data entry by site personnel, who can 
add and edit data, add new subjects, identify and resolve discrepancies, and view records. 
This system provides immediate direct data transfer to the database, as well as immediate 
detection of discrepancies, enabling site coordinators to resolve and manage discrepancies in 
a timely manner. 
Paper copies of the eCRFs and other database reports may be printed and signed by the 
investigator. This system provides site personnel, PPD CRAs, and reviewers with access to 
hardcopy audits, discrepancy reviews, and investigator comment information. 
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9.3.2.10 
Adherence to Protocol 
The investigator agrees to conduct the study as outlined in this protocol, in accordance with 
ICH E6(R2) and all applicable guidelines and regulations. 
9.3.2.11 
Reporting Adverse Events 
By participating in this study, the investigator agrees to submit reports of SAEs according to 
the timeline and method outlined in this protocol. In addition, the investigator agrees to 
submit annual reports to his or her IRB as appropriate. The investigator also agrees to 
provide SIGA with an adequate report, if applicable, shortly after completion of the 
investigator’s participation in the study. 
9.3.2.12 
Investigator’s Final Report 
Upon completion of the study, the investigator, where applicable, should inform the 
institution; the investigator/institution should provide the IRB with a summary of the study’s 
outcome and SIGA and regulatory authorities with any reports required. 
9.3.2.13 
Records Retention 
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study drug. These documents should be 
retained for a longer period, however, if required by applicable regulatory requirements or by 
an agreement with SIGA. SIGA is responsible for informing the investigator/institution when 
these documents no longer need to be retained. 
9.3.2.14 
Publications 
All information concerning TPOXX, SIGA operations, patent application, formulas, 
manufacturing processes, basic scientific data, and formula information, supplied by SIGA to 
the investigator and not previously published, is considered confidential and remains the sole 
property of SIGA. The investigator agrees to use this information only to accomplish this 
study and will not use it for other purposes without SIGA’s written consent. The investigator 
understands that the information developed in the clinical study will be used by SIGA, in 
connection with the continued development of TPOXX, and thus may be disclosed as 
required to other clinical investigators or government regulatory agencies. To permit the 
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information derived from the clinical studies to be used, the investigator is obligated to 
provide SIGA with all data obtained in the study. Any publication or other public 
presentation of results from this study, including manuscripts and materials for presentation 
at scientific meetings, should be provided to SIGA at least 30 working days before abstract or 
other relevant submission deadlines. Authorship of publications resulting from this study will 
be determined at the discretion of SIGA. 
9.3.3 
Study Management 
9.3.3.1 
Monitoring 
9.3.3.1.1 
Monitoring of the Study 
Site monitoring for safety is conducted to ensure that human subject protection, study 
procedures, and laboratory, study drug dosing, and data collection processes are of high 
quality and meet SIGA, GCP/ICH, and regulatory guidelines. PPD CRA(s) will conduct site 
monitoring visits as detailed in the monitoring plan. 
Site investigators will allow the CRA(s), the designated IRB, SIGA or its designee and the 
FDA to review, audit, and inspect study documents (eg, ICFs, drug accountability and 
distribution forms, eCRF), pertinent hospital and site records, and source documentation for 
verification of the study data.  
Clinical research associates will conduct site visits in accordance with PPD SOPs to monitor 
the following: study operations, the quality of data collected in the research records, the 
accuracy and timeliness of data entered in the database, and to determine that all process and 
regulatory requirements are met. Study monitoring visits will occur at initiation of the study 
site, at intervals determined by SIGA during conduct of the study, and at completion of the 
study.  
The CRA will maintain current personal knowledge of the study through observation, review 
of study records and source documentation, and discussion of the conduct of the study with 
the investigator and staff. During the routine monitoring visits, the CRA will perform a 100% 
source document verification of all subject data entered into the eCRF. Discrepancies, if any, 
will be clarified with the study site coordinator and investigator, and corrected at the site by 
the study coordinator. Any questions or required data clarifications will be sent to the study 
site electronically.  
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9.3.4 
Safety Monitoring Plan 
Close cooperation between the designated members of the study team will occur to evaluate 
and respond to individual AEs in a timely manner. Designated team members (investigator, 
subinvestigators, study coordinator, and other designated study clinicians) will review the 
subject safety information and data (laboratory test results, ECGs, AEs, and concomitant 
medications) and update the PPD project team and the ISM on the status of all enrolled 
subjects at their site on a weekly basis (or more frequently if required because of an 
unexpected safety issue) through completion of each subject’s final study visit. 
9.3.5 
Medical Monitor 
The medical monitor, or their qualified designee, will receive reports within 24 hours of 
study site awareness of all SAEs and within 7 days of study site awareness of all other AEs. 
The safety monitors will review all safety data and alert the medical monitor of SAEs and 
AEs of interest. The medical monitor may make a request for data to the investigator as 
necessary for safety evaluations.  
The medical monitor will review each significant AE in a timely fashion and ensure that 
appropriate management is initiated and completed. Drug safety representatives and the 
medical monitor will have direct contact with the investigators and follow all significant 
events as needed. 
9.3.6 
Safety Oversite (Independent Safety Monitor) 
In addition to the investigator’s ongoing review of the safety data, the ISM will review the 
protocol for any major concerns and will be involved in data review in coordination with the 
investigator. The primary role of the ISM will be to evaluate the study safety and tolerability 
data. The ISM will provide independent safety monitoring in a timely fashion, which will 
include reviewing individual SAE reports and a review of periodic cumulative AE reports. 
Clinical safety and laboratory data, clinical records, and other safety study-related records 
will be made available for the ISM to review. Based on review of this data, the ISM may 
make recommendations regarding the safe continuation of the study. Specific details will be 
outlined in the Safety and Medical Management Plan. 
9.3.6.1 
Inspection of Records 
The investigator and study site involved in the study will permit study-related monitoring, 
audits, IRB review, and regulatory inspections by providing direct access to all study records. 
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In the event of an audit, the investigator agrees to allow SIGA, their representatives, the 
FDA, or other regulatory agencies access to all study records. 
The investigator should promptly notify SIGA and study site of any audits scheduled by any 
regulatory authorities and promptly forward copies of any audit reports received to SIGA. 
9.3.6.2 
Management of Protocol Amendments and Deviations 
9.3.6.2.1 
Modification of the Protocol 
Any changes in this research activity, except those necessary to remove an apparent 
immediate hazard to the subject, must be reviewed and approved by SIGA or designee. 
Amendments to the protocol must be submitted in writing to the IRB for approval before 
subjects are enrolled into an amended protocol. 
9.3.6.2.2 
Protocol Deviations 
The investigator or designee must document and explain in the subject’s source 
documentation any deviation from the approved protocol. The investigator may implement a 
deviation from, or a change to, the protocol to eliminate an immediate hazard to study 
subjects without prior IRB approval. As soon as possible after such an occurrence, the 
implemented deviation or change, the reasons for it, and any proposed protocol amendments 
should be submitted to the IRB for review and approval, to SIGA for agreement, and to the 
regulatory authorities, if required. 
A protocol deviation is any change, divergence, or departure from the study design or 
procedures defined in the protocol. An important protocol deviation (sometimes referred to 
as a protocol violation or a major protocol deviation) is a subset of protocol deviations that 
might significantly affect the reliability of the study data or that might significantly affect a 
subject's safety. An important deviation can include nonadherence to inclusion or exclusion 
criteria or nonadherence to FDA regulations or ICH E6(R2) guidelines. 
Protocol deviations will be documented by the clinical monitor throughout the course of 
monitoring visits. The investigator will be notified in writing by the monitor of deviations. 
The IRB should be notified of all protocol deviations, if appropriate, in a timely manner. 
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9.3.6.3 
Study Termination 
Although SIGA has every intention of completing the study, they reserve the right to 
discontinue it at any time for clinical or administrative reasons. 
An initiative for closure of the clinical investigative site or termination of the study can be 
taken at any time either by SIGA, PPD, or the investigator provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. Reasons for such action 
include, but are not limited to: 
•
Study site closure
o
Inadequate site recruitment/enrollment of subjects
o
Failure of an investigator to comply with the protocol, PPD SOPs, GCP guidelines, or
applicable federal regulations
•
Termination of enrollment
o
Enrollment of the required estimated number of subjects for the study
•
Study termination
o
Completion of the study
o
Safety concerns
In addition, the ISM and FDA have the prerogative to delay or terminate the study. 
The end of the study is defined as the date on which the last subject completes the last visit 
(includes the follow-up visit and the follow-up telephone call). Any additional long-term 
follow-up that is required for monitoring of the resolution of an AE or finding may be 
reported through an amendment to the clinical study report. 
9.3.6.4 
Final Report 
Whether the study is completed or prematurely terminated, SIGA will ensure that clinical 
study reports are prepared and provided to regulatory agency(ies) as required by the 
applicable regulatory requirement(s). SIGA will also ensure that clinical study reports in 
marketing applications meet the standards of the ICH harmonised tripartite guideline E3: 
Structure and content of clinical study reports. 
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Upon completion of the clinical study report, the investigator will be provided with the final 
approved clinical study report, as appropriate. 
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Title Page 
CLINICAL STUDY PROTOCOL AMENDMENT 1 
IND 69,019 
A POST MARKETING STUDY OF THE SAFETY, TOLERABILITY, 
AND PHARMACOKINETICS OF TPOXX® IN ADULT SUBJECTS 
WEIGHING MORE THAN 120 KG 
Post Marketing Commitment: 3417-4 
SIGA-246-022 
Sponsor: 
SIGA Technologies, Inc. 
4575 SW Research Way, Suite 110 
Corvallis, OR 97333 
Sponsor Contact: 
Kady Honeychurch, PhD, PMP 
SIGA Technologies, Inc. 
4575 SW Research Way, Suite 110 
Corvallis, OR 97333 
Medical Monitor: 
Rahul Bhatnagar, MD 
PPD Phase I Clinic 
7551 Metro Center Drive, Suite 300 
Austin, TX 78744 
Version of Protocol: 
Final 2.0 
Date of Protocol:  
27 June 2019 
CONFIDENTIAL 
The concepts and information contained in this document or generated during the study are 
considered proprietary and may not be disclosed in whole or in part without the expressed, 
written consent of SIGA Technologies, Inc. 
The study will be conducted according to the International Council for Harmonisation 
Guideline E6(R2): Good Clinical Practice. 
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SIGA Technologies, Inc. 
Protocol No. SIGA-246-022 
SIGNATURE PAGE 
TPOXX 
Clinical Study Protocol 
PROTOCOL TITLE: 
A Post Marketing Study of the Safety, Tolerability, and 
Pharmacokinetics ofTPOXX® in Adult Subjects Weighing 
More Than 120 kg 
PROTOCOL NUMBER: 
SIGA-246-022 
(j] t_ '-/Jl/VLX.)L/\ , 
O I -J  2019 
Dennis E. Hruby, PhD 
---+--
Date 
Chief Scientific Officer 
SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
TPOXX 
Clinical Study Protocol 
INVESTIGATOR PROTOCOL AGREEMENT PAGE 
I agree to conduct the study as outlined in the protocol titled "A Post Marketing Study of the 
Safety, Tolerability, and Pharmacokinetics ofTPOXX® in Adult Subjects Weighing More 
Than 120 kg" in accordance with the guidelines and all applicable government regulations, 
including US Title 21 of the Code of Federal Regulations Part 54. I have read and understand 
all sections of the protocol. 
Date 
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Clinical Study Protocol 
TABLE OF CONTENTS 
TITLE PAGE .......................................................................................................................... 1 
SIGNATURE PAGE ............................................................................................................... 2 
INVESTIGATOR PROTOCOL AGREEMENT PAGE ..................................................... 3 
TABLE OF CONTENTS ........................................................................................................ 4 
LIST OF TABLES ................................................................................................................... 6 
PROTOCOL SYNOPSIS ....................................................................................................... 7 
1.
INTRODUCTION ............................................................................................. 15 
1.1 
BACKGROUND ..............................................................................................15 
1.2 
RATIONALE FOR STUDY ............................................................................15 
1.3 
POTENTIAL RISKS AND BENEFITS ...........................................................15 
1.3.1 
Potential Risks ..............................................................................................15 
1.3.2 
Known Potential Benefits .............................................................................16 
2.
STUDY OBJECTIVES ...................................................................................... 16 
2.1 
PRIMARY OBJECTIVE ..................................................................................16 
2.2 
SECONDARY OBJECTIVE ............................................................................16 
3.
STUDY DESIGN ................................................................................................ 16 
4.
STUDY POPULATION..................................................................................... 17 
4.1 
INCLUSION CRITERIA .................................................................................17 
4.2 
EXCLUSION CRITERIA ................................................................................19 
4.3 
OTHER SCREENING CONSIDERATIONS ..................................................23 
4.3.1 
Subject Restrictions During the Study .........................................................23 
4.4 
WITHDRAWAL OF SUBJECTS FROM THE STUDY .................................23 
4.4.1 
Reasons for Withdrawal................................................................................23 
4.4.2 
Handling of Withdrawals ..............................................................................24 
4.4.3 
Halting Rules ................................................................................................24 
4.4.4 
Replacements ................................................................................................25 
5.
STUDY TREATMENT ..................................................................................... 25 
5.1 
TREATMENT ADMINISTERED....................................................................25 
5.2 
STUDY DRUG ................................................................................................26 
5.2.1 
Study Drug Packaging and Storage ..............................................................27 
5.2.2 
Study Drug Accountability ...........................................................................27 
5.3 
TREATMENT COMPLIANCE .......................................................................27 
5.3.1 
Prior and Concomitant Medications .............................................................28 
5.3.1.1 
Prior Medications ..................................................................................... 28 
5.3.1.2 
Concomitant Medications ........................................................................ 28 
6.
STUDY PROCEDURES ................................................................................... 28 
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6.1 
PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS ......................29 
6.1.1 
Pharmacokinetic Sample Collection, Shipping, and Storage .......................30 
6.1.2 
Pharmacokinetic Sample Analysis................................................................31 
6.2 
SAFETY ASSESSMENTS AND ENDPOINTS ..............................................31 
6.2.1 
Adverse Events .............................................................................................31 
6.2.1.1 
Adverse Event Definitions ....................................................................... 31 
6.2.1.2 
Eliciting and Documenting Adverse Events ............................................ 33 
6.2.1.3 
Reporting Adverse Events ....................................................................... 34 
6.2.1.4 
Reporting of Serious Adverse Events ...................................................... 34 
6.2.1.5 
Assessment of Severity ............................................................................ 35 
6.2.1.6 
Assessment of Causality .......................................................................... 36 
6.2.1.7 
Follow-up of Adverse Events .................................................................. 37 
6.2.1.8 
Reactogenicity ......................................................................................... 37 
6.2.1.9 
Reporting of Pregnancy ........................................................................... 37 
6.2.2 
Clinical Laboratory Testing ..........................................................................38 
6.2.3 
Medical History ............................................................................................40 
6.2.4 
Vital Sign Measurements ..............................................................................40 
6.2.5 
Electrocardiograms .......................................................................................40 
6.2.6 
Physical Examinations ..................................................................................41 
6.2.7 
Unscheduled Visits .......................................................................................41 
7.
STATISTICAL ANALYSIS PLANS ................................................................ 42 
7.1 
SAMPLE SIZE CALCULATIONS..................................................................42 
7.2 
ANALYSIS POPULATIONS ...........................................................................42 
7.3 
STATISTICAL ANALYSIS .............................................................................42 
7.3.1 
Pharmacokinetic Analyses ............................................................................43 
7.3.2 
Safety Analyses ............................................................................................43 
7.4 
HANDLING OF BELOW THE LIMIT OF QUANTIFICATION AND 
MISSING DATA ..............................................................................................44 
7.5 
INTERIM ANALYSES ....................................................................................44 
8.
REFERENCE LIST........................................................................................... 45 
9.
APPENDICES .................................................................................................... 46
9.1 
APPENDIX 1: LIST OF ABBREVIATIONS ..................................................46 
9.2 
APPENDIX 2: SCHEDULE OF EVENTS ......................................................48 
9.3 
APPENDIX 3: STUDY GOVERNANCE .......................................................51 
9.3.1 
Data Quality Assurance ................................................................................51 
9.3.2 
Investigator Obligations ...............................................................................52 
9.3.2.1 
Confidentiality ......................................................................................... 52 
9.3.2.2 
Institutional Review ................................................................................. 52 
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9.3.2.3 
Subject Consent ....................................................................................... 53 
9.3.2.4 
Exclusion of Children .............................................................................. 53 
9.3.2.5 
Study Reporting Requirements ................................................................ 54 
9.3.2.6 
Financial Disclosure and Obligations ...................................................... 54 
9.3.2.7 
Investigator Documentation ..................................................................... 54 
9.3.2.8 
Study Conduct ......................................................................................... 55 
9.3.2.9 
Case Report Forms and Source Documents ............................................ 55 
9.3.2.10 
Adherence to Protocol ............................................................................. 56 
9.3.2.11 
Reporting Adverse Events ....................................................................... 56 
9.3.2.12 
Investigator’s Final Report ...................................................................... 56 
9.3.2.13 
Records Retention .................................................................................... 56 
9.3.2.14 
Publications .............................................................................................. 56 
9.3.3 
Study Management .......................................................................................57 
9.3.3.1 
Monitoring ............................................................................................... 57 
9.3.4 
Safety Monitoring Plan .................................................................................58 
9.3.5 
Medical Monitor ...........................................................................................58 
9.3.6 
Safety Oversite (Independent Safety Monitor) .............................................58 
9.3.6.1 
Inspection of Records .............................................................................. 58 
9.3.6.2 
Management of Protocol Amendments and Deviations .......................... 59 
9.3.6.3 
Study Termination .................................................................................... 60 
9.3.6.4 
Final Report ............................................................................................. 60 
9.4 
APPENDIX 4: CHANGE HISTORY ..............................................................61 
9.4.1 
Protocol Amendment 1 .................................................................................61 
LIST OF TABLES 
Table 5-1 
Excipients of TPOXX Capsules ...................................................................... 26 
Table 9-1 
Schedule of Events .......................................................................................... 48 
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PROTOCOL SYNOPSIS 
PROTOCOL NO.: SIGA-246-022 
TITLE: A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of 
TPOXX® in Adult Subjects Weighing More Than 120 kg 
STUDY PHASE: 4 Post Marketing Study 
STUDY SITE: PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200, Austin, TX 78744, 
USA. 
OBJECTIVES: 
Primary: 
The primary objective of this study is to determine the pharmacokinetic (PK) profile of 
600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in 
adult subjects weighing more than 120 kg to determine if a change in dosing regimen would 
be needed in these patients. 
Secondary: 
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral 
TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg. 
STUDY DESIGN AND METHODOLOGY: 
This is an open-label, multiple-dose study to assess the safety, tolerability, and PK of TPOXX 
600 mg BID when administered orally for 7 days to adult subjects weighing more than 
120 kg. A total of 36 subjects, ages 18 to 50, inclusive, will be enrolled. The study will 
consist of a screening period (Day –28 to Day –2), a treatment and confinement period 
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]). 
Subjects will undergo screening evaluations to determine eligibility within 28 days before 
study drug administration. Subjects will be admitted to the study site on Day –1 to complete 
baseline assessments; results of these assessments must be reviewed by the investigator 
before dosing. Starting in the morning of Day 1, subjects will receive 600 mg oral TPOXX 
BID for 7 days (Days 1 through 7). 
All subjects will be provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration and subjects must fast for 2 hours after taking 
study drug. Subjects should eat this meal within 30 minutes or less of taking study drug. 
Study drug and meals must be taken with water only, and no other beverage except water 
should be ingested within 3 hours before or 3 hours after study drug administration. 
Subjects will remain confined to the study site for collection of PK samples and will be 
carefully monitored for safety and tolerability until discharge on Day 9. Subjects who have 
abnormal physical examination findings or an ongoing adverse event (AE)/serious adverse 
event (SAE) on Day 9 that is deemed related to study drug or per investigator or SIGA 
discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All other 
subjects will have the Day 14 (+2 days) follow-up via telephone. All subjects will have a 
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Clinical Study Protocol 
follow-up telephone call 30 days after administration of the last dose of study drug 
(Day 37 [+2 days]) to report any SAEs. At the time of discharge from the clinical research 
unit, subjects will be instructed to notify the investigator of any SAEs that occur within 
30 days after administration of the last dose of study drug. Serious AEs will be followed until 
the SAE is stable or until resolution as determined by the investigator and/or medical 
monitor. 
The total duration of the study for each subject, including the screening period, treatment 
period, and the Day 37 (+2 days) follow-up telephone call, will be approximately 65 days. 
STUDY POPULATION: 
Inclusion Criteria: 
Each subject must meet all the following criteria to be enrolled in this study: 
1. Subject is male or female between 18 and 50 years of age, inclusive.
2. Subject has a body weight >120 kg at screening, at check-in on Day -1, and prior to
dosing on Day 1.
3. Women of childbearing potential, have a negative β human chorionic gonadotropin
pregnancy test (serum) at the screening visit and a confirmatory negative serum
pregnancy test on Day –1 before receipt of study drug, and meet 1 of the following
criteria:
a.
The subject or their partner has undergone surgical sterilization
b. The subject is postmenopausal, defined as 12 consecutive months with no menses
without an alternative medical cause and has a documented plasma
follicle-stimulating hormone level >40 IU/mL
c.
The subject agrees to be abstinent (ie, heterosexually inactive or women in a religious
order)
d. The subject agrees to consistently use 1 of the following methods of contraception
from the beginning of screening (which they had been consistently using for at least
30 days before the first dose of study drug) through 30 days after the last dose of
study drug:
i.
Condoms, male or female, with a spermicide
NOTE: For male subjects, condoms must be used for 90 days after the last dose
of study drug.
ii.
Diaphragm or cervical cap with spermicide
iii.
Intrauterine device with spermicide
iv.
Oral contraceptives or other hormonal methods
NOTE: Subject must agree to use an additional nonhormonal method of
contraception in conjunction with oral contraceptives.
v.
Male sexual partner who had undergone a vasectomy at least 3 months before
screening
4. Male subjects must agree to not donate sperm from the first dose of study drug through
90 days after the last dose of study drug.
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5. Subject is considered by the investigator to be in good general health as determined by
medical history (no hospitalizations for chronic medical conditions in the previous
2 years), clinical laboratory results, vital sign measurements, 12-lead electrocardiogram
(ECG) results, and physical examination findings at screening.
6. Subject agrees to comply with all protocol requirements.
7. Subject is able to provide written informed consent.
8. Subject agrees to comply with the dietary requirements.
9. Subject does not intend to lose weight (diet or weight loss) from the screening visit and
throughout the study.
EXCLUSION CRITERIA: 
Subjects meeting any of the following criteria will be excluded from the study: 
1. Subject is a female who is pregnant or breastfeeding or planning to become pregnant
within 3 months after the last dose of study drug.
2. Subject has a history of any clinically significant conditions including:
•
Asthma treated with oral systemic steroids within the past 6 months
•
Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
•
Hypertension that is poorly controlled (repeat readings >140 mm Hg systolic and/or
>90 mm Hg diastolic)
•
Thyroidectomy or thyroid disease that required medication within the past 12 months
•
Serious angioedema episodes within the previous 3 years or requiring medication in
the previous 2 years
•
Head trauma resulting in a diagnosis of traumatic brain injury other than concussion
•
Frequent episodes of headache.
3. Subject has received treatment in another clinical study of an investigational drug (or
medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose
of study drug.
4. Subject has been previously enrolled in any clinical study involving TPOXX
(tecovirimat).
5. Subject has a history of relevant drug and/or food allergies (ie, allergy to tecovirimat or
excipients, or any significant food allergy that could preclude a standard diet in the study
site).
6. Subject has any condition possibly affecting drug absorption (eg, previous surgery on the
gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder,
or pancreas, with the exception of appendectomy).
7. Subject has evidence or history of clinically significant allergic (except for untreated,
asymptomatic, seasonal allergies at time of the first dose of study drug), hematological,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or
neurological disease. Exceptions to these criteria (eg, stable, mild joint disease
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unassociated with collagen vascular disease) may be made following discussions with the 
medical monitor. 
8. Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias,
syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia).
9. Subject has a family history of sudden cardiac death, not clearly due to acute myocardial
infarction.
10. Subject has a seizure disorder or history of seizures (does not include childhood febrile
seizures) or a past history that increases seizure risks such as significant head injury that
caused loss of consciousness or other changes in the subject’s daily function, concussion,
stroke, central nervous system infection or disease, or alcohol or drug abuse or family
history of idiopathic seizures.
11. Subject has a history of a peptic ulcer or significant gastrointestinal bleed.
12. Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency,
coagulopathy, or platelet disorder requiring special precautions) or significant bruising or
bleeding difficulties with blood draws.
13. Subject has a malignancy that is active, or treated malignancy for which there is not
reasonable assurance of sustained cure, or malignancy that is likely to recur during the
period of the study (subject should be in complete remission for at least 5 years).
14. Subject has neutropenia or other blood dyscrasia determined to be clinically significant
by the investigator.
15. Subject has used any of the following prohibited medications from within 7 days (or
5 half-lives, whichever is longer) before the first dose of study drug: antidiabetic
medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance
protein transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib,
rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including repaglinide,
paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of CYP2C19
including S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole,
and omeprazole. Medications not listed here that are known (or thought) to be CYP3A4
substrates may be allowed at the investigator’s discretion, after consultation with the
medical monitor, if administration poses little to no risk to the subject.
16. Subject has a history of drug or alcohol abuse or dependency within the last year before
screening.
17. Subject has a history of an eating disorder.
18. Subject has a current or recent (<30 days before screening) history of clinically
significant bacterial, fungal, or mycobacterial infection.
19. Subject has a current clinically significant viral infection.
20. Subject has a known clinically significant chronic viral infection (eg, human T cell
lymphotropic virus I or II).
21. Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville
orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products
within 48 hours before the first dose of study drug or throughout the study.
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22. Subject has used any prescription (excluding hormonal birth control) or over-the-counter
medication (including herbal or nutritional supplements) within 14 days before the first
dose of study drug.
23. Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids including
oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose
inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the
preceding 1 month (low-dose [≤800 mcg/day of beclomethasone dipropionate or
equivalent] inhaled and topical steroids are allowed).
24. Subject has donated >450 mL blood or blood components within 30 days before the first
dose of study drug. The investigator should instruct subjects who participate in this study
to not donate blood or blood components for 4 weeks after the completion of the study.
25. Subject is a smoker or has used nicotine or nicotine-containing products (eg, cigarettes,
electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine
gum) within 6 months before the first dose of study drug.
26. Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo juice,
or alcohol within 72 hours before the first dose of study drug.
27. Subject reports participation in strenuous activity or contact sports within 24 hours before
the first dose of study drug.
28. Subject has known hepatitis B or C infection or positive test for hepatitis B surface
antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2
antibodies at screening.
29. Subject has a positive test result for amphetamines (including methamphetamines and
ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids
(including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin, codeine,
and oxycodone), or alcohol at screening or check-in.
30. Subject has any of the following laboratory test results within 28 days before the first
dose of study drug:
•
Estimated serum creatinine clearance (Cockcroft-Gault) <90 mL/min
•
Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper
central laboratory reference range)
•
Hemoglobin ≤10% of the lower central laboratory reference range
•
White blood cell count not within the central laboratory reference range
•
Absolute neutrophil count <1000 cells/mm3
•
Platelets not within ±10% of central laboratory reference range
•
Alanine aminotransferase >1.5 times above the upper central laboratory reference
range
•
Aspartate aminotransferase >1.5 times above the upper central laboratory reference
range
•
Alkaline phosphatase >20% above the upper central laboratory reference range
•
Hemoglobin A1c ≥7.0%
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•
Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL.
31. Subject has a sustained sitting systolic blood pressure >140 mm Hg or <100 mm Hg or a
diastolic blood pressure >90 mm Hg at screening. Blood pressure may be retested twice
in the sitting position at 5-minute intervals. The pressure elevation is considered sustained
if either the systolic or the diastolic pressure exceeds the stated limits on all
3 assessments.
32. Subject has a resting heart rate of <40 beats per minute or >100 beats per minute at
screening.
33. Subject has an abnormal ECG at screening that is determined by the investigator to be
clinically significant.
34. Male subject has a QTcF >450 ms or female subject has a QTcF >470 ms at screening or
Day –1.
35. In the opinion of the investigator, the subject is not suitable for entry into the study.
EVALUATION PROCEDURES: 
Pharmacokinetic Assessments: 
Blood samples for PK analysis of TPOXX will be collected from all subjects on Day 1 before 
study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 
20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours 
after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the 
PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on 
Day 9 (48 hours after the AM dose on Day 7). 
For PK samples, the acceptable window for collection from the scheduled collection time 
point will be as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes 
for the 12- to 48-hour time points. 
The following plasma PK parameters will be calculated for TPOXX using actual sampling 
times rather than scheduled sampling times and will include but are not limited to:  
•
Area under the plasma concentration-time curve (AUC) from time 0 to the last
quantifiable measurement (AUC0-t)
•
AUC from time 0 extrapolated to infinity (AUC0-∞)
•
AUC from time 0 to 24 hours (AUC0-24)
•
AUC during the first dosing interval (tau = 12 hours) (AUC0-tau)
•
Maximum drug concentration in plasma (Cmax)
•
Time to Cmax (Tmax)
•
Apparent volume of distribution (Vd/F)
•
Apparent total body clearance (CL/F)
•
Concentration observed prior to the next dose administration (Ctrough)
•
Terminal elimination half-life (t1/2)
•
Terminal elimination rate constant (λz)
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•
Percentage of AUC0-∞ extrapolated from the last quantifiable measurement to infinity
(%AUCextrap).
Safety Assessments: 
Safety and tolerability will be assessed by monitoring and recording of AEs, clinical 
laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body 
temperature), 12-lead ECG results, and physical examination findings. 
STUDY DRUG, DOSAGE, AND ROUTE OF ADMINISTRATION: 
TPOXX, 600 mg (3 × 200-mg capsules), will be administered orally twice daily, 
approximately 12 hours (±30 minutes) apart, on Days 1 through 7. 
STATISTICAL METHODS: 
Complete, detailed statistical methods will be described in the statistical analysis plan. 
Sample Size: 
The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study is 
based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size is considered sufficient to effectively assess the PK and safety 
profiles of TPOXX. 
Analysis Populations: 
•
The Safety Population will include all subjects who receive at least 1 dose of study drug.
•
The PK Population will include subjects who receive study drug and have sufficient
concentration data to facilitate the calculation of PK variables.
Pharmacokinetic Analyses: 
Individual plasma concentration and time deviation data will be presented in a data listing. 
Plasma concentration data will be listed and summarized using the following descriptive 
statistics: number of subjects, arithmetic mean, standard deviation (SD), coefficient of 
variation (CV), geometric mean, geometric CV, median, minimum, and maximum. Individual 
and mean plasma concentration versus time profiles will be presented in figures on both 
linear and semilogarithmic scales. 
The PK parameters of TPOXX will be analyzed based on the actual sampling times. All 
parameters will be determined using noncompartmental methods using Phoenix® 
WinNonlin® Version 8.0 or higher (Certara, L.P., Princeton, New Jersey) or SAS® Version 9.4 
or higher (SAS Institute Inc., Cary, North Carolina). 
The individual PK parameters and weight-normalized PK parameters will be presented in 
data listings and summarized using the following descriptive statistics: number of subjects, 
arithmetic mean, SD, CV, median, minimum, maximum, geometric mean, geometric SD, and 
geometric CV. 
Safety Analyses: 
Adverse events will be coded by preferred term and system organ class using the latest 
version of the Medical Dictionary for Regulatory Activities and summarized overall. All AE 
data will be presented in a data listing. Treatment-emergent AEs will be summarized overall, 
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as well as by severity and relationship to study drug. Serious AEs and AEs leading to 
discontinuation of study drug will also be presented in the data listings and summarized 
overall. 
Actual values and changes from baseline for clinical laboratory test results, vital sign 
measurements, and 12-lead ECG results will be summarized at each time point using 
descriptive statistics (number of subjects, mean, SD, median, minimum, and maximum). 
Shift tables will be generated for clinical laboratory test results. Clinical laboratory data, vital 
sign measurements, 12-lead ECG results, and physical examination findings will be 
presented in data listings. 
DATE OF PROTOCOL: 19 February 2019 
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1.
INTRODUCTION
1.1 
BACKGROUND 
Historically, variola virus (VARV), the etiologic agent of smallpox, has been one of the more 
important human pathogens. Smallpox is highly communicable and carries exceptionally 
high morbidity. Secondary attack rates from 30% to 80% have been reported among 
unvaccinated members of households.1 Mortality rates range from 1% for variola minor to 
30% for variola major.1 With the advent of biowarfare as an instrument of terrorism, 
smallpox can no longer be thought of as a disease only of historic impact.  
In July 2018, the FDA approved the oral formulation of TPOXX for the treatment of patients 
with human smallpox disease caused by VARV.  
1.2 
RATIONALE FOR STUDY 
This study is being conducted as an FDA post marketing commitment to the approved New 
Drug Application for TPOXX. SIGA is required to conduct a study to determine the 
pharmacokinetic (PK) profile of TPOXX in subjects with a body weight greater than 
120 kilograms (>120 kg) to determine if a change in dosing regimen would be needed in 
these patients. 
1.3 
POTENTIAL RISKS AND BENEFITS 
1.3.1 
Potential Risks 
The effect of TPOXX on a fetus or nursing baby is not yet known; therefore, women of 
childbearing potential participating in this study will be required to agree to use an acceptable 
means of birth control from 30 days before the first dose of study drug and continuing 
through 30 days after the last dose of study drug. Pregnancy testing will be performed at the 
screening visit and checked by the investigator for negative pregnancy before administration 
of study drug on Day –1. Women who are pregnant or lactating or plan to become pregnant 
within 3 months after study drug administration will be excluded from the study; if a female 
subject becomes pregnant during study participation, study drug dosing will be discontinued, 
and the subject will be withdrawn from the study (Section 6.2.1.9). 
As with all drugs, there is potential risk of an allergic reaction. At this time, there is no 
definitive information on the allergic activity of TPOXX. Headache and nausea have been 
the most common AEs in clinical studies completed to date. There may be other side effects 
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of TPOXX that are not yet known. Full details can be found in the TPOXX full prescribing 
information.2 
1.3.2 
Known Potential Benefits 
As this study will be conducted in subjects free from smallpox, no direct health benefits from 
taking the study drug are expected. Study subjects may benefit from receiving the laboratory 
testing, ECGs, and physical examinations. Others may benefit from knowledge gained in this 
study that may aid in the development of a drug for the treatment of smallpox.  
2.
STUDY OBJECTIVES
2.1 
PRIMARY OBJECTIVE 
The primary objective of this study is to determine the PK profile of 600 mg oral TPOXX 
(3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing 
more than 120 kg to determine if a change in dosing regimen would be needed in these 
patients. 
2.2 
SECONDARY OBJECTIVE 
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral 
TPOXX administered BID for 7 days in adult subjects weighing more than 120 kg. 
3.
STUDY DESIGN
This is an open-label, multiple-dose study to assess the safety, tolerability, and PK of TPOXX 
600 mg BID when administered orally for 7 days to adult subjects weighing more than 
120 kg. A total of 36 subjects, ages 18 to 50, inclusive, will be enrolled. The study will 
consist of a screening period (Day –28 to Day –2), a treatment and confinement period 
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]). 
Subjects will undergo screening evaluations to determine eligibility within 28 days before 
study drug administration. Subjects will be admitted to the study site on Day –1 to complete 
baseline assessments; results of these assessments must be reviewed by the investigator 
before dosing. Starting in the morning of Day 1, subjects will receive 600 mg oral TPOXX 
BID for 7 days (Days 1 through 7). 
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All subjects will be provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration and subjects must fast for 2 hours after taking 
study drug. Subjects should eat this meal within 30 minutes or less of taking study drug. 
Study drug and meals must be taken with water only, and no other beverage except water 
should be ingested within 3 hours before or 3 hours after study drug administration. 
Subjects will remain confined to the study site for collection of PK samples and will be 
carefully monitored for safety and tolerability until discharge on Day 9. Subjects who have 
abnormal physical examination findings or an ongoing adverse event (AE)/serious adverse 
event (SAE) on Day 9 that is deemed related to study drug or per investigator or SIGA 
discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All other 
subjects will have the Day 14 (+2 days) follow-up via telephone. All subjects will have a 
follow-up telephone call 30 days after administration of the last dose of study drug 
(Day 37 [+2 days]) to report any SAEs. At the time of discharge from the clinical research 
unit, subjects will be instructed to notify the investigator of any SAEs that occur within 30 
days after administration of the last dose of study drug. Serious AEs will be followed until 
the SAE is stable or until resolution as determined by the investigator and/or medical 
monitor. 
The total duration of the study for each subject, including the screening period, treatment 
period, and the Day 37 (+2 days) follow-up telephone call, will be approximately 65 days. 
4.
STUDY POPULATION
Approximately 36 male and female subjects will be enrolled at a single center in the United 
States to achieve at least 32 evaluable enrolled subjects. 
4.1 
INCLUSION CRITERIA 
Each subject must meet all the following criteria to be enrolled in this study: 
Subject is male or female between 18 and 50 years of age, inclusive. 
Subject has a body weight >120 kg at screening, at check-in on Day -1, and prior to 
dosing on Day 1. 
Women of childbearing potential, have a negative β human chorionic gonadotropin 
pregnancy test (serum) at the screening visit and a confirmatory negative serum 
pregnancy test on Day –1 before receipt of study drug, and meet 1 of the following 
criteria: 
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The subject or their partner has undergone surgical sterilization 
The subject is postmenopausal, defined as 12 consecutive months with no menses 
without an alternative medical cause and has a documented plasma 
follicle-stimulating hormone level >40 IU/mL 
The subject agrees to be abstinent (ie, heterosexually inactive or women in a 
religious order) 
The subject agrees to consistently use 1 of the following methods of contraception 
from the beginning of screening (which they had been consistently using for at 
least 30 days before the first dose of study drug) through 30 days after the last 
dose of study drug: 
i.
Condoms, male or female, with a spermicide
NOTE: For male subjects, condoms must be used for 90 days after the last
dose of study drug.
ii.
Diaphragm or cervical cap with spermicide
iii.
Intrauterine device with spermicide
iv.
Oral contraceptives or other hormonal methods
NOTE: Subject must agree to use an additional nonhormonal method of
contraception in conjunction with oral contraceptives.
v.
Male sexual partner who had undergone a vasectomy at least 3 months before
screening.
Male subjects must agree to not donate sperm from the first dose of study drug 
through 90 days after the last dose of study drug. 
Subject is considered by the investigator to be in good general health as determined 
by medical history (no hospitalizations for chronic medical conditions in the 
previous 2 years), clinical laboratory results, vital sign measurements, 12-lead ECG 
results, and physical examination findings at screening. 
Subject agrees to comply with all protocol requirements. 
Subject is able to provide written informed consent. 
Subject agrees to comply with the dietary requirements. 
Subject does not intend to lose weight (diet or weight loss) from the screening visit 
and throughout the study. 
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4.2 
EXCLUSION CRITERIA 
Subjects meeting any of the following criteria will be excluded from the study: 
Subject is a female who is pregnant or breastfeeding or planning to become 
pregnant within 3 months after the last dose of study drug. 
Subject has a history of any clinically significant conditions including: 
•
Asthma treated with oral systemic steroids within the past 6 months
•
Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
•
Hypertension that is poorly controlled (repeat readings >140 mm Hg systolic
and/or >90 mm Hg diastolic)
•
Thyroidectomy or thyroid disease that required medication within the past
12 months
•
Serious angioedema episodes within the previous 3 years or requiring medication
in the previous 2 years
•
Head trauma resulting in a diagnosis of traumatic brain injury other than
concussion
•
Frequent episodes of headache.
Subject has received treatment in another clinical study of an investigational drug
(or medical device) within 30 days or 5 half-lives (whichever is longer) before the
first dose of study drug.
Subject has been previously enrolled in any clinical study involving TPOXX 
(tecovirimat). 
Subject has a history of relevant drug and/or food allergies (ie, allergy to 
tecovirimat or excipients, or any significant food allergy that could preclude a 
standard diet in the study site). 
Subject has any condition possibly affecting drug absorption (eg, previous surgery 
on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, 
gallbladder, or pancreas, with the exception of appendectomy). 
Subject has evidence or history of clinically significant allergic (except for 
untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), 
hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, 
psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild 
joint disease unassociated with collagen vascular disease) may be made following 
discussions with the medical monitor. 
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Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, 
syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, 
hypokalemia). 
Subject has a family history of sudden cardiac death not clearly due to acute 
myocardial infarction. 
 Subject has a seizure disorder or history of seizures (does not include childhood 
febrile seizures) or a past history that increases seizure risks such as significant 
head injury that caused loss of consciousness or other changes in the subject’s daily 
function, concussion, stroke, central nervous system infection or disease, or alcohol 
or drug abuse or family history of idiopathic seizures. 
 Subject has a history of a peptic ulcer or significant gastrointestinal bleed. 
 Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, 
coagulopathy, or platelet disorder requiring special precautions) or significant 
bruising or bleeding difficulties with blood draws. 
 Subject has a malignancy that is active, or treated malignancy for which there is not 
reasonable assurance of sustained cure, or malignancy that is likely to recur during 
the period of the study (subject should be in complete remission for at least 
5 years). 
 Subject has neutropenia or other blood dyscrasia determined to be clinically 
significant by the investigator. 
 Subject has used any of the following prohibited medications from within 7 days 
(or 5 half-lives, whichever is longer) before the first dose of study drug: 
antidiabetic medication; anticoagulants; anticonvulsants; substrates of the BCRP 
transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, 
rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including 
repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of 
CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, 
voriconazole, lansoprazole, and omeprazole. Medications not listed here that are 
known (or thought) to be CYP3A4 substrates may be allowed at the investigator’s 
discretion, after consultation with the medical monitor, if administration poses little 
to no risk to the subject. 
 Subject has a history of drug or alcohol abuse or dependency within the last year 
before screening. 
 Subject has a history of an eating disorder. 
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 Subject has a current or recent (<30 days before screening) history of clinically 
significant bacterial, fungal, or mycobacterial infection. 
 Subject has a current clinically significant viral infection. 
 Subject has a known clinically significant chronic viral infection (eg, human T cell 
lymphotropic virus I or II). 
 Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville 
orange-containing products (eg, marmalade), or caffeine- or xanthine-containing 
products within 48 hours before the first dose of study drug or throughout the study. 
 Subject has used any prescription (excluding hormonal birth control) or 
over-the-counter medication (including herbal or nutritional supplements) within 
14 days before the first dose of study drug. 
 Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids 
including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or 
high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or 
equivalent) within the preceding 1 month (low-dose [≤800 mcg/day of 
beclomethasone dipropionate or equivalent] inhaled and topical steroids are 
allowed). 
 Subject has donated >450 mL blood or blood components within 30 days before the 
first dose of study drug. The investigator should instruct subjects who participate in 
this study to not donate blood or blood components for 4 weeks after the 
completion of the study. 
 Subject is a smoker or has used nicotine or nicotine-containing products (eg, 
cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine 
patches, or nicotine gum) within 6 months before the first dose of study drug. 
 Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo 
juice, or alcohol within 72 hours before the first dose of study drug. 
 Subject reports participation in strenuous activity or contact sports within 24 hours 
before the first dose of study drug. 
 Subject has known hepatitis B or C infection or positive test for hepatitis B surface 
antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 
antibodies at screening. 
 Subject has a positive test result for amphetamines (including methamphetamines 
and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, 
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cannabinoids (including tetrahydrocannabinol), cocaine metabolites, opiates 
(including heroin, codeine, and oxycodone), or alcohol at screening or check-in. 
 Subject has any of the following laboratory test results within 28 days before the 
first dose of study drug: 
•
Estimated serum creatinine clearance (Cockcroft-Gault) <90 mL/min
•
Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper
central laboratory reference range)
•
Hemoglobin ≤10% of the lower central laboratory reference range
•
White blood cell count not within the central laboratory reference range
•
Absolute neutrophil count <1000 cells/mm3
•
Platelets not within ±10% of central laboratory reference range
•
Alanine aminotransferase >1.5 times above the upper central laboratory reference
range
•
Aspartate aminotransferase >1.5 times above the upper central laboratory
reference range
•
Alkaline phosphatase >20% above the upper central laboratory reference range
•
Hemoglobin A1c ≥7.0%
•
Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL.
Subject has a sustained sitting systolic blood pressure >140 mm Hg or
<100 mm Hg or a diastolic blood pressure >90 mm Hg at screening. Blood pressure
may be retested twice in the sitting position at 5-minute intervals. The pressure
elevation is considered sustained if either the systolic or the diastolic pressure
exceeds the stated limits on all 3 assessments.
 Subject has a resting heart rate of <40 beats per minute or >100 beats per minute at 
screening. 
 Subject has an abnormal ECG at screening that is determined by the investigator to 
be clinically significant. 
 Male subject has a QTcF >450 ms or female subject has a QTcF >470 ms at 
screening or Day –1. 
 In the opinion of the investigator, the subject is not suitable for entry into the study. 
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4.3 
OTHER SCREENING CONSIDERATIONS 
4.3.1 
Subject Restrictions During the Study 
•
Subjects must be willing to remain confined at the study site from check-in (Day –1) until
safety assessments are completed on Day 9.
•
Subjects who have abnormal physical examination findings or an ongoing AE/SAE on
Day 9 that is deemed related to study drug or per investigator or SIGA discretion will
return to the study site on Day 14 (+2 days) for a follow-up visit.
4.4 
WITHDRAWAL OF SUBJECTS FROM THE STUDY 
4.4.1 
Reasons for Withdrawal 
Subjects can withdraw consent and discontinue from the study at any time, for any reason, 
without prejudice to further treatment. 
The investigator may withdraw a subject from the study for any of the following: 
•
The subject is in violation of the protocol.
•
The subject experiences a serious or intolerable AE.
•
The subject becomes pregnant.
•
The subject is noncompliant.
•
The subject has laboratory abnormalities for assessments listed in
Sections 4.1 or 4.2 that meet Grade 3 or Grade 4 on the Division of
Acquired Immune Deficiency Syndrome (DAIDS) AE Grading Table
Version 2.1 July 2017, any other Grade 3 or Grade 4 AE; or a Grade 2 or
higher rash considered by the investigator to be possibly, probably, or
definitely related to study drug.
•
The subject develops, during the course of the study, symptoms or conditions listed in
the exclusion criteria.
•
The subject requires a medication prohibited by the protocol.
•
The subject requests an early discontinuation for any reason.
•
The subject’s primary care provider requests that the subject be withdrawn.
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•
The independent safety monitor (ISM), SIGA, or the FDA requests subject
withdrawal based on study safety findings.
The investigator can also withdraw a subject upon the request of SIGA or if SIGA terminates 
the study. Upon occurrence of a SAE or intolerable AE, the investigator will confer with 
SIGA. If a subject is discontinued because of an AE, the event will be followed until it is 
resolved or stabilized as determined by the investigator and/or the medical monitor. 
4.4.2 
Handling of Withdrawals 
Subjects are free to withdraw from the study at any time upon request. Subject participation 
in the study may be stopped at any time at the discretion of the investigator or at the request 
of SIGA. 
When a subject withdraws from the study, the reason(s) for withdrawal will be recorded by 
the investigator in the electronic case report form (eCRF). Whenever possible, any subject 
who withdraws from the study prematurely will undergo all Day 9/early discontinuation 
assessments (Table 9-1). Any subject who fails to return for final assessments will be 
contacted by the study site personnel in an attempt to have them comply with the protocol. 
The status of subjects who fail to complete final assessments will be documented in the 
eCRF. 
4.4.3 
Halting Rules 
The medical monitor, investigator, SIGA, and ISM will review all AEs. All AEs determined 
by the investigator to be severe and possibly, probably, or definitely related to study drug, as 
well as all clinical assessments, laboratory test results, ECG results, or vital sign 
measurements that meet Grade 3 criteria on the DAIDS AE Grading Table will be assessed 
by the medical monitor, who will make a recommendation as to whether or not halting of the 
study should occur. At the discretion of the medical monitor, depending on the assessment of 
the severity of the event, the recommendation to halt the study may be made after 
consultation with the investigator, SIGA, and the ISM. 
The study will be temporarily halted (no new enrollments and no further study drug 
administration) by the investigator and the medical monitor, SIGA, and the ISM will be 
promptly notified according to the following criteria: 
•
One subject experiences a Grade 4 AE assessed as possibly, probably, or definitely
related to study drug.
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•
There is a subject death assessed as possibly, probably, or definitely related to study
drug.
•
One subject experiences a seizure assessed as possibly, probably, or definitely
related to study drug.
•
Two or more subjects experience the same or similar SAEs that are possibly,
probably, or definitely related to the study drug.
•
Three or more subjects experience the same or similar AEs that are Grade 3 or
above and are possibly, probably, or definitely related to the study drug.
Study enrollment and study drug administration would resume if review of the AEs that 
caused the halt resulted in a recommendation to permit further continuation. In such an 
instance, SIGA, with participation by the investigator and the medical monitor, would consult 
with the ISM to conduct the review of all AEs that meet the criteria for halting the study. The 
study would remain suspended until the events were reviewed by the ISM and a 
recommendation was made as to whether the study should be continued or stopped. This 
constitutes a minimum criterion, and the decision to halt the study may be made based on any 
other criteria that, in the judgment of the investigator, with agreement of the medical monitor 
and ISM, indicate a potentially serious safety concern. The investigator will advise SIGA 
immediately if any of the halting rules are met. 
4.4.4 
Replacements 
At the discretion of the investigator, and after consultation with the medical monitor, any 
subject who withdraws before completing the study may be replaced to retain the target of 
32 evaluable enrolled subjects. 
5.
STUDY TREATMENT
5.1 
TREATMENT ADMINISTERED 
On Days 1 to 7, all subjects will receive an oral dose of TPOXX 600 mg (3 × 200-mg 
capsules) BID, approximately 12 hours (±30 minutes) apart, for 7 days. 
All subjects will be provided meals consisting of approximately 600 calories and 25 g fat, 
30 minutes before study drug administration. Subjects should eat this meal within 30 minutes 
or less of taking study drug. Study drug will be administered approximately 30 minutes after 
the start of the meal. All doses of study drug will be administered to subjects by study site 
personnel with approximately 240 mL of water. Subjects must fast 2 hours after taking study 
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drug. Study drug and meals must be taken with water only, and no other beverage except 
water should be ingested within 3 hours before or 3 hours after study drug administration. 
5.2 
STUDY DRUG 
TPOXX will be supplied as 200-mg capsules containing tecovirimat monohydrate as the 
active pharmaceutical ingredient. The TPOXX capsules are immediate release, size 0, orange 
and black, hard gelatin capsules containing white to off white powder. All inactive 
ingredients/excipients are generally recognized as safe and are United States 
Pharmacopeia/National Formulary grade. The TPOXX excipients are shown in Table 5-1. 
Table 5-1 
Excipients of TPOXX Capsules 
Component 
Quality Designation 
Microcrystalline cellulose 
NFa 
Lactose monohydrate 
NF 
Croscarmellose sodium 
NFa 
Colloidal silicon dioxide 
NF 
Hydroxypropyl methylcellulose 
USP 
Sodium lauryl sulfate 
NF 
Purified waterb 
USP 
Magnesium stearate 
NF 
Abbreviations: NF, National Formulary; USP, United States Pharmacopeia. 
a Microcrystalline cellulose and croscarmellose sodium are added as intragranular and extragranular excipients. 
b Removed during processing. 
Compendial components are tested and released in accordance with full compendial methods 
and specifications before their use in clinical formulations. TPOXX 200-mg capsules are 
manufactured and analyzed for clinical use in accordance with Current Good Manufacturing 
Practices. 
TPOXX capsules are manufactured by: 
Catalent Pharma Solutions 
1100 Enterprise Drive 
Winchester, KY 40391. 
Further information on TPOXX can be found in the TPOXX full prescribing information.2 
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5.2.1 
Study Drug Packaging and Storage 
TPOXX capsules are packaged, labeled, distributed, and placed on stability testing in 
accordance with Current Good Manufacturing Practice and International Council for 
Harmonisation (ICH) guidelines. 
The 200-mg TPOXX capsules are supplied in 75-mL high density polyethylene bottles fitted 
with a heat induction seal and child-resistant screw cap closure system. Each bottle of study 
drug will contain 42 capsules and will be labeled with the drug name, SIGA’s name, a space 
to fill in the protocol number, and a space to fill in the bottle number. 
SIGA (or designee) will provide the investigator and study site with adequate quantities of 
TPOXX.  
All study drug must be stored in a secure area (eg, a locked cabinet), protected from moisture 
and light, and stored at 15°C to 30°C (59°F to 86°F). Study drug should not be refrigerated or 
used beyond the expiration dates provided by the manufacturer. The study site will be 
required to keep a temperature log to establish a record of compliance with these study drug 
storage conditions. All study drug will be kept in a secure cabinet or room with access 
restricted to necessary study site personnel. 
5.2.2 
Study Drug Accountability 
The investigator will maintain accurate records of receipt of all study drug, including dates of 
receipt. Accurate records will be kept regarding when and how much study drug is dispensed 
and used by each subject in the study. Reasons for departure from the expected dispensing 
regimen must also be recorded. Study drug accountability will be recorded in the subject 
source documentation, entered into the eCRF, and should be reviewed by the monitor during 
each monitoring visit. On a regular basis and at the completion of the study, to satisfy 
regulatory requirements regarding drug accountability, all study drug will be reconciled and 
retained or destroyed according to applicable regulations. 
5.3 
TREATMENT COMPLIANCE 
All doses of the study drug will be administered in the study site under direct observation of 
study site personnel and recorded in the eCRF. Per standard clinic procedure, study site 
personnel will perform a mouth check and inspect all dose containers to ensure that the entire 
dose was administered. Following completion of dosing procedures and return of dosing 
containers to the pharmacy by team members, pharmacy staff will follow standard clinic 
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procedures for study drug reconciliation. SIGA will provide information to PPD for 
destruction of returned used and unused study drug and study drug bottles. 
The date and time of study drug dosing will be captured and recorded on the appropriate page 
of the eCRF. If a subject is not administered study drug, the reason for the missed dose will 
be recorded. 
5.3.1 
Prior and Concomitant Medications 
Restrictions for prior and concomitant medications and therapies are provided in Sections 4.1 
and 4.2. Prior and concomitant medications and therapies will be coded using the latest 
version of the World Health Organization Drug Dictionary. 
5.3.1.1 
Prior Medications 
Information regarding prior medications taken by the subject within the 30 days before 
signing the informed consent form (ICF) will be recorded in the subject’s eCRF. 
5.3.1.2 
Concomitant Medications 
Any concomitant medication deemed necessary for the welfare of the subject during the 
study may be given at the discretion of the investigator. If a concomitant medication listed in 
Section 4.2 is taken it will be documented as a protocol deviation and a joint decision will be 
made by the investigator and SIGA to continue or discontinue the subject based on the time 
the medication was administered, its pharmacology and PK, and whether the use of the 
medication will compromise the safety of the subject or the interpretation of the data. The 
investigator is responsible for ensuring that details regarding the medication are adequately 
recorded in both the subject’s source document and the eCRF. 
6.
STUDY PROCEDURES
Before performing any study procedures, all potential subjects will sign an ICF as outlined in 
Section 9.3.2.3. Subjects will undergo study procedures at the time points specified in the 
schedule of events (Table 9-1). 
The total amount of blood collected from each subject over the duration of the study, 
including any extra assessments that may be required, will not exceed 500 mL. 
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6.1 
PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS 
Blood samples for PK analysis of TPOXX will be collected from all subjects Day 1 before 
study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 
20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours 
after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the 
PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on 
Day 9 (48 hours after the AM dose on Day 7). 
For PK samples, the acceptable window for collection from the scheduled collection time 
point will be as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes 
for the 12- to 48-hour time points. 
The following plasma PK parameters will be calculated for TPOXX using actual sampling 
times rather than scheduled sampling times and will include but are not limited to:  
•
Area under the plasma concentration-time curve (AUC) from time 0 to the last
quantifiable measurement (AUC0-t)
•
AUC from time 0 extrapolated to infinity (AUC0-∞)
•
AUC from time 0 to 24 hour (AUC0-24)
•
AUC during the first dosing interval (tau = 12 hours) (AUC0-tau)
•
Maximum drug concentration in plasma (Cmax)
•
Time to Cmax (Tmax)
•
Apparent volume of distribution (Vd/F)
•
Apparent total body clearance (CL/F)
•
Concentration observed prior to the next dose administration (Ctrough)
•
Terminal elimination half-life (t1/2)
•
Terminal elimination rate constant (λz)
•
Percentage of AUC0-∞ extrapolated from the last quantifiable measurement to infinity
(%AUCextrap).
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6.1.1 
Pharmacokinetic Sample Collection, Shipping, and Storage 
Blood samples (approximately 5 mL) for the determination of plasma concentrations of 
TPOXX will be collected in 5-mL lavender-topped K3EDTA Vacutainer® tubes using a 
21 gauge or larger needle, or from an indwelling intravenous catheter using a vacutainer tube. 
Blood samples should be placed on wet ice or equivalent (approximately 4°C to 8°C) and 
kept at this temperature until processed to separate plasma.  
The exact time and date of sample collection will be recorded for each sample by the 
investigator or designee on the subject’s eCRF, the vacutainer and cryovial labels, and the 
specimen shipping log. In addition, the time of study drug administration before PK sampling 
will be recorded on the subject’s eCRF. Labels will be created by the site and should contain 
the protocol number, matrix (plasma), subject number, date, and time drawn. For information 
that is not preprinted on the label, a fine tipped indelible marking pen is to be used to 
complete the entry. 
The 5-mL blood sample will be centrifuged in a refrigerated centrifuge immediately, if 
possible, or within 60 minutes of collection at 1000 to 1200 × g (2000 to 3000 rpm) for 
10 minutes to separate plasma. Each plasma sample should be transferred via pipette into 
2 cryovials labeled as described previously and should be capped tightly. The second tube 
will be a duplicate and retained at the site as a backup sample. If red blood cells are 
inadvertently drawn into the plasma, the sample should be re-centrifuged as soon as possible. 
Adequate space between the solution and the tube cap should be allowed for expansion 
during freezing.  
Cryovial tubes containing plasma samples must be frozen at –70°C or below until shipment 
in a freezer equipped with a temperature monitor and temperature-activated alarm. 
Uncentrifuged specimens should not be frozen. 
The study site will batch ship sets of frozen plasma samples. A log sheet listing the samples 
being shipped will be included in each shipment. The samples will be sent on dry ice via 
courier to Alturas Analytics (Moscow, ID). The back-up sets will remain at the site until 
confirmation that the first sets have been received. After receipt confirmation is received 
from Alturas Analytics, the back-up sets should be shipped. The site will contact Alturas 
Analytics and coordinate the shipment prior to sending the samples. Shipments before 
weekends or holidays must be avoided. 
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Clinical Study Protocol 
The samples will be shipped for analysis to: 
Alturas Analytics 
1324 Alturas Drive 
Moscow, ID 83843 
The bioanalytical laboratory will store all plasma samples at –70°C until analysis for 
tecovirimat is complete. SIGA will advise Alturas to destroy any remaining plasma samples 
after regulatory review is complete or the samples have met their applicable length of 
stability, whichever comes sooner. 
6.1.2 
Pharmacokinetic Sample Analysis 
Pharmacokinetic samples will be analyzed by Alturas Analytics using a validated liquid 
chromatography coupled with tandem mass spectrometry assay for tecovirimat in human 
plasma method in accordance with the US FDA Guidance for Industry on Bioanalytical 
Method Validation.3 
6.2 
SAFETY ASSESSMENTS AND ENDPOINTS 
Safety and tolerability will be assessed by monitoring and recording of AEs, clinical 
laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body 
temperature), 12-lead ECG results, and physical examination findings. Adverse events will 
be assessed from the time of the first dose of study drug until the follow-up telephone call on 
Day 37 (+2 days). 
6.2.1 
Adverse Events 
6.2.1.1 
Adverse Event Definitions 
The investigator is responsible for reporting all AEs that are observed or reported during the 
study, regardless of their relationship to study drug or clinical significance. If there is any 
doubt as to whether a clinical observation is an AE, the event should be reported. 
An AE is any event or other untoward medical occurrence, including those AEs that result 
from dosing errors, which may present during administration of a study drug or during a 
reasonable follow-up period and which does not necessarily have a causal relationship with 
this treatment. An AE is any unfavorable and unintended sign (eg, a clinically significant 
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Clinical Study Protocol 
abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal product, whether or not considered to be related to the medicinal product. All AEs 
will be followed until the AE is resolved or stabilized as determined by the investigator 
and/or the medical monitor. 
A treatment-emergent AE (TEAE) is defined as any event not present before exposure to 
study drug or any event already present that worsens in intensity or frequency after exposure 
to study drug. 
An adverse reaction is any AE caused by a drug. Adverse reactions are a subset of all 
suspected adverse reactions for which there are reasons to conclude that the drug caused the 
event. 
A suspected adverse reaction is any AE for which there is a reasonable possibility that the 
study drug caused the AE. For the purposes of IND safety reporting, “reasonable possibility” 
means that there is evidence to suggest a causal relationship between the drug and the AE. A 
suspected adverse reaction implies a lesser degree of certainty about causality than adverse 
reaction, which means any AE caused by a study drug. 
An AE or suspected adverse reaction is considered “unexpected” if it is not listed in the 
TPOXX full prescribing information or at the specificity or severity that has been observed 
with the study drug being tested. For example, under this definition, hepatic necrosis would 
be unexpected (by virtue of greater severity) if the TPOXX full prescribing information 
referred only to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism 
and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the TPOXX 
full prescribing information listed only cerebral vascular accidents. “Unexpected,” as used in 
this definition, also refers to AEs or suspected adverse reactions that are mentioned in the 
TPOXX full prescribing information as occurring with a class of drugs or as anticipated from 
the pharmacological properties of the drug, but are not specifically mentioned as occurring 
with the particular drug under investigation. 
An AE or suspected adverse reaction is considered an SAE if, in the view of either the 
investigator or SIGA, it results in any of the following outcomes: 
•
Results in death.
•
Is life threatening (subject is at immediate risk of death at the time of the event).
•
Requires inpatient hospitalization or prolongation of existing hospitalization, other than
elective hospitalization, during the period of protocol defined surveillance.
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•
Results in congenital anomaly or birth defect.
•
Results in a persistent or significant disability/incapacity.
•
Any other important medical event that may not result in death, be life threatening, or
requires hospitalization may be considered an SAE when, based on appropriate medical
judgment, the event may jeopardize the subject and may require medical or surgical
intervention to prevent one of the outcomes listed in this definition or is otherwise
considered to be medically significant.
Important medical events that may not result in death, be life threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgement, 
they may jeopardize the subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. Examples of such medical events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of 
drug dependency or drug abuse. 
An AE or suspected adverse reaction is considered “life-threatening” if, in the view of either 
the investigator or SIGA, its occurrence places the subject at immediate risk of death. It does 
not include an AE or suspected adverse reaction that, had it occurred in a more severe form, 
might have caused death. 
Serious AEs will be followed until the SAE is stable or until resolution as determined by the 
investigator and/or the medical monitor. 
6.2.1.2 
Eliciting and Documenting Adverse Events 
The investigator is responsible for ensuring that all AEs and SAEs are recorded in the eCRF 
and reported to SIGA by PPD. Adverse events and SAEs will be assessed from the first dose 
of study drug through the telephone call on Day 37 (+2 days).  
At every study visit or assessment, subjects will be asked a standard question to elicit any 
medically related changes in their well-being. They will also be asked if they have been 
hospitalized, had any accidents, used any new medications, or changed concomitant 
medication regimens (both prescription and over-the-counter medications). 
In addition to subject observations, AEs will be documented from any data collected on the 
AE page of the eCRF (eg, laboratory values, physical examination findings, and ECG 
changes) or other documents that are relevant to subject safety. 
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Clinical Study Protocol 
6.2.1.3 
Reporting Adverse Events 
All AEs reported or observed from the first dose of study drug through the follow-up 
telephone call on Day 37 (+2 days) will be recorded on the AE page of the eCRF. 
Information to be collected includes drug treatment, type of event, date and time of onset, 
investigator-specified assessment of severity and relationship to study drug, date and time of 
resolution of the event, seriousness, as well as any required treatment or evaluations, and 
outcome. Adverse events resulting from concurrent illnesses, reactions to concurrent 
illnesses, reactions to concurrent medications, or progression of disease states must also be 
reported. 
All AEs will be followed until they are resolved or stabilized as determined by the 
investigator and/or medical monitor. These data will be reviewed on an ongoing basis by the 
study coordinator, the investigator, the medical monitor, and the ISM. This requirement 
indicates that for some events, follow-up may be required after the subject has completed 
study participation. These events will be reported by SIGA, as required, to the FDA. 
Any medical condition that is present at the time that the subject is screened but does not 
deteriorate should not be reported as an AE. However, if it deteriorates at any time during the 
study, it should be recorded as an AE. Prior to this, medical conditions reported by subjects 
are considered medical history. 
6.2.1.4 
Reporting of Serious Adverse Events 
Any AE considered serious by the investigator or which meets SAE criteria (Section 6.2.1.1), 
or any other event or condition regardless of grade, which in their judgment represents a 
reportable event, must be reported to the medical monitor and SIGA as soon as the 
investigator becomes aware of the event. In addition, the event must be reported to PPD via 
the SAE hotline. The PPD SAE Report Form must be submitted within 24 hours of 
knowledge of the event. SIGA (or designee) will be responsible for notifying the relevant 
regulatory authorities of any SAE as outlined in US Title 21 Code of Federal Regulations 
(CFR) Parts 312 and 320. The investigator is responsible for notifying the institutional 
review board (IRB) directly. 
In addition, the investigator (or designee) must report any Grade 3 (severe) AE that they 
deem possibly, probably, or definitely related to study drug to the medical monitor and SIGA 
within 24 hours after becoming aware of the event. 
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Clinical Study Protocol 
After notification from the investigator, SIGA will report all study drug-related and 
unexpected SAEs (those not listed in the TPOXX full prescribing information) to the FDA 
within 15 calendar days of first knowledge. Fatalities or life-threatening events assessed as 
related and unexpected will be reported to the FDA within 7 calendar days of first 
knowledge. The ISM will also receive these reports. 
The following contact information is to be used for SAE reporting: 
PPD Medical Monitor: 
Rahul Bhatnagar, MD 
PPD Phase I Clinic 
7551 Metro Center Drive, Suite 300 
Austin, TX 78744 
Telephone: 888-483-7729 
PPD SAE Hotline: 888-483-7729 
PPD SAE Fax line: 888-529-3580 
The collection and monitoring period for SAEs is 30 days after administration of the last 
dose of study drug. At the time of discharge or early termination from the study site, the 
subject will be instructed to notify the investigator of any SAEs that occur within 30 days 
after the last dose of study drug. 
All subjects will have a follow-up telephone call 30 days after administration of the last dose 
of study drug (Day 37 [+2 days]) to report any SAEs. 
6.2.1.5 
Assessment of Severity 
All AEs will be graded for intensity according to the current DAIDS Table for Grading the 
Severity of Adult and Pediatric Adverse Events Version 2.1 July 2017.  
Any laboratory or clinical AE that is not listed on the DAIDS Table will be assessed for 
severity and classified into 1 of 5 clearly defined categories as follows: 
•
Grade 1 (Mild): Events require minimal or no treatment and do not interfere with the
subject’s daily activities.
•
Grade 2 (Moderate): Events result in a low level of inconvenience or concern with the
therapeutic measures and may cause some interference with normal functioning.
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•
Grade 3 (Severe): Events interrupt a subject’s usual daily activity, may require systemic
drug therapy or other treatment, and are usually incapacitating.
•
Grade 4 (Life-threatening): Event that, in the opinion of the investigator, places the
subject at immediate risk of death from the reaction as it occurred (ie, it does not include
a reaction that, had it occurred in a more severe form, might have caused death).
•
Grade 5 (Death).
Changes in the severity of an AE should be documented to allow an assessment of the 
duration of the event at each level of intensity to be performed. An AE characterized as 
intermittent requires documentation of onset and duration of each episode.  
6.2.1.6 
Assessment of Causality 
Any occurrence of an AE will be assessed for relationship to the study drug. A causal 
relationship means that the study drug caused (or is reasonably likely to have caused) the AE. 
This usually implies a relationship in time between the drug and the AE; for example, the AE 
occurred shortly after the subject received the study drug. 
The investigator who examines and evaluates the subject will determine AE causality based 
on the temporal relationship to administration of the study drug, the pharmacology of the 
study drug, and their clinical judgment. Terms used to describe the degree of causality 
between a study drug and an AE are definitely related, probably related, possibly related, 
unlikely related, or not related. 
The best estimate at the time of reporting of an event and the degree of certainty about the 
causal relationship between the study drug administration and the AE will be graded as 
follows: 
Associated 
•
Definitely Related: The AE and administration of study drug are related in time, and a
direct association can be demonstrated (eg, the event disappears or decreases with
reduction in dose or cessation of study drug and recurs with re-exposure).
•
Probably Related: The AE and administration of study drug are reasonably related in time
and/or follow a known pattern of response, and the AE is more likely explained by study
drug than other causes.
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Clinical Study Protocol 
•
Possibly Related: The AE and administration of study drug are reasonably related in time
and/or follow a known pattern of response, but the AE can be explained equally well by
causes other than study drug (eg, could readily have been produced by the subject’s
clinical state or could have been due to environmental or other interventions).
Not Associated 
•
Unlikely Related: A potential relationship between study drug and the AE could exist
(ie, the possibility cannot be excluded), but the AE is most likely explained by causes
other than the study drug (eg, could readily have been produced by the subject’s clinical
state or could have been due to environmental or other interventions).
•
Not Related: The AE is clearly due to extraneous causes (eg, underlying disease,
environment) or exposure to the study drug has not occurred. Such events MUST have an
alternative, definitive etiology documented in the subject’s medical record.
6.2.1.7 
Follow-up of Adverse Events 
All AEs must be reported in detail on the appropriate page of the eCRF and followed until 
they are resolved or stabilized as determined by the investigator and/or medical monitor. 
6.2.1.8 
Reactogenicity 
At this time, there is no definitive information on allergic activity of TPOXX. Reactogenicity 
will be monitored in subjects during the study treatment period. The study site personnel will 
observe the subjects for signs of allergic reaction for at least 1 hour after the study drug is 
ingested. 
6.2.1.9 
Reporting of Pregnancy 
Pregnant women are not eligible to participate in the study. Subjects must be counseled 
regarding prevention of pregnancy and encouraged to make every effort to avoid pregnancy 
during study participation. If a female subject becomes pregnant during study participation, 
study drug dosing will be discontinued, and the subject will be withdrawn from the study. 
The pregnancy itself is not considered an SAE. However, the investigator must complete the 
pregnancy report form and fax it to PPD Pharmacovigilance within 24 hours of knowledge of 
the pregnancy. After delivery or termination of pregnancy, the follow-up pregnancy report 
form should be completed and submitted via fax to PPD Pharmacovigilance. Spontaneous 
abortions should always be reported as SAEs. Pregnancy data will be captured and followed 
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Clinical Study Protocol 
by PPD. All pregnancies and outcomes will be tracked. The case will not be closed until after 
the child is followed for 3 months. 
If there are complications during the pregnancy, the complications will be recorded as AEs in 
the usual manner. The subject will be asked to report the outcome of the pregnancy. If there is 
a congenital anomaly in the infant, this will be recorded as an SAE in the data forms for the 
mother (ie, the study subject). 
If a subject becomes pregnant during the study after receiving the study drug, all safety 
evaluations will be collected as per protocol. In addition, at the time that the pregnancy is 
reported, consent will be requested to contact the subject and her physician in the postpartum 
period to assess delivery and health status of the neonate. 
If the partner of a male subject becomes pregnant, the partner will be asked for consent to 
allow her treating physician to provide SIGA or its designee with follow-up information 
regarding the pregnancy and its outcome. 
6.2.2 
Clinical Laboratory Testing 
Clinical laboratory tests will be performed by the PPD Central Laboratory. Blood samples 
will be collected at the time points indicated in the schedule of events (Table 9-1) and will be 
prepared using standard procedures.  
Repeat clinical laboratory tests may be performed at the discretion of the investigator, if 
necessary, to evaluate inclusion and exclusion criteria or clinical laboratory abnormalities. 
PPD central laboratory will provide the reference ranges for all clinical laboratory safety 
parameters. 
The following clinical laboratory assessments will be performed: 
Hematology 
Hematocrit, hemoglobin, mean corpuscular hemoglobin, mean 
corpuscular hemoglobin concentration, total and differential 
leukocyte count (basophils, eosinophils, lymphocytes, monocytes, 
neutrophils), mean corpuscular volume, platelet count, red blood 
cell count, and red cell distribution width 
Serum Chemistry 
Alanine aminotransferase, albumin, alkaline phosphatase, anion 
gap, aspartate aminotransferase, bilirubin (total), blood urea 
nitrogen, calcium, carbon dioxide, chloride, creatinine clearance 
(calculateda), gamma-glutamyltransferase, globulin, glucose, lactate 
dehydrogenase, phosphorus, potassium, sodium, total protein, and 
uric acid 
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Clinical Study Protocol 
Urinalysis 
Appearance, bilirubin, blood, color, glucose, ketones, leukocytes, 
microscopy (performed if dipstick is ≥1+; includes bacteria, cast, 
crystals, epithelial cells, red blood cells, and white blood cells), 
nitrates, pH, protein, specific gravity, turbidity, and urobilinogen  
a Creatinine clearance (CLcr) will be calculated using the Cockcroft-Gault formula: 
𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶 (𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚
⁄
) = [140 −𝑎𝑎𝑎𝑎𝑎𝑎(𝑦𝑦𝑦𝑦𝑦𝑦𝑦𝑦𝑦𝑦)] × 𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤ℎ𝑡𝑡 (𝑘𝑘𝑘𝑘)
72 × 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐(𝑚𝑚𝑚𝑚𝑑𝑑𝑑𝑑
⁄
) {× 0.85 𝑖𝑖𝑖𝑖 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓} 
Glycosylated hemoglobin A1c and a fasting lipid panel including cholesterol (total, 
high-density lipoprotein, calculated low-density lipoprotein, and triglycerides) will be 
performed at screening. 
Serum pregnancy test (β human chorionic gonadotropin) for women of childbearing potential 
will be performed at screening and on Day –1. 
A serum follicle-stimulating hormone test for postmenopausal women will be performed at 
screening.  
Human immunodeficiency virus (type 1 and 2) antibodies, hepatitis B surface antigen, and 
hepatitis C virus antibody will be assessed at screening only.  
A urine drug screen for alcohol, amphetamines (including methamphetamines and 
ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids 
(including tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, 
codeine, and oxycodone) will be performed at screening and on Day –1. 
Abnormal clinical laboratory values will be flagged as either high or low (or normal or 
abnormal) based on the reference ranges for each laboratory parameter. The investigator will 
determine whether any of the abnormally high or low results are clinically significant or not 
clinically significant. Clinical significance is defined as any variation in results that has 
medical relevance and may result in an alteration in medical care (eg, active observation, 
diagnostic measures, or therapeutic measures). If a clinically significant change from the 
screening value is noted, the clinically significant value and reason for clinical significance 
will be documented on the AE page of the eCRF. The investigator will continue to monitor 
the subject with additional assessments until the values have reached the reference range or 
the values at screening or until the investigator determines that follow-up is no longer 
medically necessary. 
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Clinical Study Protocol 
6.2.3 
Medical History 
A complete medical history will be obtained, including a review of systems, recreational and 
prescription drug use, over-the-counter drug use, nicotine and alcohol use, and past 
hospitalizations.  
6.2.4 
Vital Sign Measurements 
Vital signs will be measured after the subject has been seated for at least 5 minutes at the 
time points indicated in the schedule of events (Table 9-1). 
Vital sign measurements will include systolic and diastolic blood pressures, heart rate, 
respiratory rate, and body temperature.  
When procedures are overlapping and occurring at the same time point, the order of 
procedures should be ECG, vital sign measurements, and then blood collection, with the 
blood collection scheduled to occur at the nominal time point, unless dictated by other study 
events happening at that time, such as dosing requirements. 
The investigator will determine whether any of the vital sign measurements are clinically 
significant or not clinically significant. Clinical significance is defined as any variation in 
results that has medical relevance and may result in an alteration in medical care (eg, active 
observation, diagnostic measures, or therapeutic measures). If a clinically significant change 
from the screening values is noted, the clinically significant value and reason for clinical 
significance will be documented on the AE page of the subject’s eCRF. The investigator will 
continue to monitor the subject with additional assessments until the value has reached the 
reference range or the value at screening or until the investigator determines that follow up is 
no longer medically necessary. 
6.2.5 
Electrocardiograms 
A 12-lead ECG will be obtained after the subject has been in the supine position for at least 
10 minutes at the time points indicated in the schedule of events (Table 9-1). On Days 1, 4, 
and 7, an ECG will be recorded 4 hours after the AM study drug administration. The 
acceptable window for collection from the scheduled collection time point will ±15 minutes. 
Electrocardiogram assessments will include comments on whether the tracings are normal or 
abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence 
of myocardial infarction, or ST segment, T wave, and U wave abnormalities. In addition, the 
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Clinical Study Protocol 
following parameters will be measured and reported: heart rate; PR, RR, and QT intervals; 
QTcF; QT interval corrected using Bazett’s formula; and QRS duration. All ECGs must be 
performed by an experienced ECG technician. 
The investigator will determine whether any of the 12-lead ECG results are clinically 
significant or not clinically significant. Clinical significance is defined as any variation in 
results that has medical relevance and may result in an alteration in medical care (eg, active 
observation, diagnostic measures, or therapeutic measures). If a clinically significant change 
from screening is noted, the clinically significant value and reason for clinical significance 
will be documented on the AE page of the subject’s eCRF. The investigator will continue to 
monitor the subject with additional assessments until either the values have reached reference 
range or the values at screening or until the investigator determines that follow-up is no 
longer medically necessary. 
6.2.6 
Physical Examinations 
A full physical examination will be performed at the time points indicated in the schedule of 
events (Table 9-1) and will include assessment of the following body systems: head, ears, 
eyes, nose, and throat; cardiac (including auscultation of heart); pulmonary (chest) 
auscultation of lungs; abdomen; skin; musculoskeletal system; lymphatic system; and 
neurologic system (cranial nerves, sensation, motor function, coordination, reflexes, and 
mental status). 
A symptom-directed physical examination will be performed at the time points indicated in 
the schedule of events (Table 9-1) (for those subjects who require it), and at unscheduled 
visits as necessary. This examination will include an assessment of the heart, lungs, abdomen, 
a neurologic review, and a review of symptoms for assessments and/or follow-up of reported 
or potential AEs. 
Weight will be measured without shoes and in light clothing at screening and without shoes 
and in hospital gowns at all other time points indicated in the schedule of events (Table 9-1). 
The scales should be calibrated, and the same weight scale should be used throughout the 
study starting with Screening through Day 9.  Weight measurements will be rounded to one 
decimal place.  
6.2.7 
Unscheduled Visits 
Subjects will be provided with the contact information for the study site personnel. Subjects 
are free to contact study site personnel at any time, and the site may require an unscheduled 
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visit for the purpose of physical examinations, laboratory tests, etc. Unscheduled visits will 
be documented by the site personnel in the source documents. Unscheduled procedures and 
laboratory tests and results will also be recorded in the eCRF. 
7.
STATISTICAL ANALYSIS PLANS
7.1 
SAMPLE SIZE CALCULATIONS 
The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study is 
based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size is considered sufficient to effectively assess the PK and safety 
profiles of TPOXX. 
7.2 
ANALYSIS POPULATIONS 
The Safety Population will include all subjects who receive at least 1 dose of study drug. 
The PK Population will include subjects who receive study drug and have sufficient 
concentration data to facilitate the calculation of PK variables. 
7.3 
STATISTICAL ANALYSIS 
Details of all statistical analyses will be described in a statistical analysis plan. All data 
collected will be presented in data listings. Data from subjects excluded from an analysis 
population will be presented in the data listings, but not included in the calculation of 
summary statistics. 
For categorical variables, frequencies and percentages will be presented. Continuous 
variables will be summarized using descriptive statistics (number of subjects, mean, median, 
standard deviation [SD], minimum, and maximum). 
Baseline demographic and background variables will be summarized overall for all subjects. 
The number of subjects who enroll in the study and the number and percentage of subjects 
who complete the study will be presented. Frequency and percentage of subjects who 
withdraw or discontinue from the study, and the reason for withdrawal or discontinuation, 
will also be summarized. 
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7.3.1 
Pharmacokinetic Analyses 
Individual plasma concentration and time deviation data will be presented in a data listing. 
Plasma concentration data will be listed and summarized using the following descriptive 
statistics: number of subjects, arithmetic mean, SD, coefficient of variation (CV), geometric 
mean, geometric CV, median, minimum, and maximum. Individual and mean plasma 
concentration versus time profiles will be presented in figures on both linear and 
semilogarithmic scales. 
The PK parameters of TPOXX will be analyzed based on the actual sampling times. All 
parameters will be determined using noncompartmental methods using Phoenix® 
WinNonlin® Version 8.0 or higher (Certara, L.P., Princeton, New Jersey) or SAS® Version 9.4 
or higher (SAS Institute Inc., Cary, North Carolina). 
The individual PK parameters and body weight-normalized PK parameters will be presented 
in data listings and summarized using the following descriptive statistics: number of subjects, 
arithmetic mean, SD, CV, median, minimum, maximum, geometric mean, geometric SD, and 
geometric CV. 
7.3.2 
Safety Analyses 
Adverse events will be coded by preferred term and system organ class using the latest 
version of the Medical Dictionary for Regulatory Activities and summarized overall. All AE 
data will be presented in a data listing. Treatment-emergent AEs will be summarized overall, 
as well as by severity and relationship to study drug. Serious AEs and AEs leading to 
discontinuation of study drug will also be presented in the data listings and summarized 
overall. 
Actual values and changes from baseline for clinical laboratory test results, vital sign 
measurements, and 12-lead ECG results will be summarized at each time point using 
descriptive statistics (number of subjects, mean, SD, median, minimum, and maximum). 
Shift tables will be generated for clinical laboratory test results. Clinical laboratory data, vital 
sign measurements, 12-lead ECG results, and physical examination findings will be 
presented in data listings. 
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7.4 
HANDLING OF BELOW THE LIMIT OF 
QUANTIFICATION AND MISSING DATA 
Plasma concentrations that are below the limit of quantification (BLQ) will be treated as zero 
for descriptive statistics. Geometric mean values will not be calculated or displayed when 
zero is the minimal value. Mean BLQ concentrations will be presented as BLQ, and the SD 
and CV will be reported as not applicable. Missing concentrations will be excluded from the 
calculations. 
7.5 
INTERIM ANALYSES 
No formal interim safety analyses will be performed in this study. 
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8.
REFERENCE LIST
1. Breman JG, Henderson DA. Diagnosis and management of smallpox. N Engl J Med.
2002;346(17):1300-8.
2. TPOXX (tecovirimat) [full prescribing information]. SIGA Technologies, Inc. Corvallis
(OR); 2018. 18 p.
3. Department of Health and Human Services, Food and Drug Administration (US).
Guidance for Industry. Bioanalytical Method Validation. May 2018. Available from:
https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-
for-Industry.pdf.
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9.
APPENDICES
9.1 
APPENDIX 1: LIST OF ABBREVIATIONS 
Abbreviation 
Term 
%AUCextrap 
percentage of AUC0-∞ extrapolated from the last quantifiable 
measurement to infinity 
λz 
terminal elimination rate constant 
AE 
adverse event 
AUC 
area under the plasma concentration-time curve 
AUC0-24 
area under the plasma concentration-time curve from time 0 to 
24 hours 
AUC0-∞ 
area under the plasma concentration-time curve from time 0 
extrapolated to infinity 
AUC0-t 
area under the plasma concentration-time curve from time 0 to the 
last quantifiable measurement 
AUC0-tau 
area under the plasma concentration-time curve during the first 
dosing interval 
BCRP 
breast cancer resistance protein 
BID 
twice daily 
BLQ 
below the limit of quantification 
CFR 
Code of Federal Regulations 
CL/F 
apparent total body clearance 
Cmax 
maximum drug concentration in plasma 
Ctrough 
concentration observed prior to the next dose administration 
CRA 
clinical research associate 
CV 
coefficient of variation 
CYP 
cytochrome P450 
DAIDS 
Division of Acquired Immune Deficiency Syndrome 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
FDA 
Food and Drug Administration 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IRB 
institutional review board 
ISM 
independent safety monitor  
MedDRA 
Medical Dictionary for Regulatory Activities 
PK 
pharmacokinetic(s) 
QTcF 
QT interval corrected using Fridericia’s formula 
SAE 
serious adverse event 
SD 
standard deviation 
SOP 
standard operating procedures 
t1/2 
terminal elimination half-life 
TEAE 
treatment-emergent adverse event 
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Abbreviation 
Term 
Tmax 
time to maximum drug concentration in plasma 
UGT 
uridine diphosphate-glucuronosyltransferase 
VARV 
variola virus 
Vd/F 
apparent volume of distribution 
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9.2 
APPENDIX 2: SCHEDULE OF EVENTS 
Table 9-1 
Schedule of Events 
Screening Check-in 
Treatment Period 
Telephone Call 
or Follow-up 
Visit(a) 
Follow-up 
Telephone 
Call(b) 
Procedure(c) 
Day –28 to –2
–1
1 
2 
3 
4 
5 
6 
7 
8 
9 or Early 
Discontinuation 
14 (+2) 
37 (+2) 
Admission to clinic 
X 
Discharge from clinic(d) 
X 
Informed consent 
X 
Inclusion/exclusion criteria 
X 
X 
Medical history(e) 
X 
X 
Complete physical examination(f) 
X 
X 
X 
X 
Weight(g) 
X 
X 
X(h) 
X 
Vital sign measurements(i) 
X 
X 
X(j) 
X(j) 
X(j) 
X 
X 
X(k) 
Glycosylated hemoglobin (HbA1c) 
X 
Fasting lipid panel(l) 
X 
Clinical laboratory testing(m) 
X(n) 
X 
X 
X(o) 
X(n) 
Serum follicle-stimulating 
hormone(p)
X 
Serum pregnancy test(q) 
X 
X 
Urine drug/alcohol screen(r) 
X 
X 
Serology (HBsAg, HCV, and HIV) 
X 
12-Lead ECG(s)
X 
X 
X 
X 
X 
X 
TPOXX administration(t) 
X 
X 
X 
X 
X 
X 
X 
Pharmacokinetic sampling(u)
X 
X 
X 
X 
X 
X 
Symptom-directed physical 
examination(v)
X 
X 
X 
X 
X 
X(k) 
Reactogenicity(w) 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
X 
Prior/concomitant medications 
X 
Abbreviations: AE, adverse event; ECG, electrocardiogram; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; 
PK, pharmacokinetic; SAE, serious adverse event. 
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Notes: 
(a) The follow-up visit or telephone call will occur on Day 14 (+2 days), 7 days after the last dose of study drug. Subjects who have abnormal physical examination findings or an
ongoing AE/SAE on Day 9 that is deemed related to study drug or per investigator or SIGA discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All
other subjects will have the Day 14 (+2 days) follow-up via telephone.
(b) The follow-up telephone call will be made 30 days after the last dose of study drug (Day 37 [+2 days]).
(c) When procedures are overlapping and occurring at the same time point, the order of procedures should be ECG, vital sign measurements, and then blood collection, with the
blood collection scheduled to occur at the nominal time point, unless dictated by other study events happening at that time, such as dosing requirements.
(d) Discharge following collection of all safety assessments.
(e) Including a review of systems; recreational, prescription, and over-the-counter drug use; nicotine and alcohol use; and past hospitalizations.
(f) Including assessment of the following body systems: head, ears, eyes, nose, and throat; cardiac (including auscultation of heart); pulmonary (chest) auscultation of lungs;
abdomen; skin; musculoskeletal system; lymphatic system; and neurologic system (cranial nerves, sensation, motor function, coordination, reflexes, and mental status).
(g) Weight will be measured without shoes and in light clothing at screening and without shoes and in hospital gowns at all other time points. The scales should
be calibrated and the same weight scale should be used throughout the study starting with Screening through Day 9.  Weight measurements will be rounded to
one decimal place.
(h) Weight will be collected prior to dosing.
(i)
Vital sign measurements will include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Vital signs will be measured after the subject has
been seated for at least 5 minutes.
(j)
Vital sign measurements will be performed before dosing and 4 hours after the AM study drug administration on Days 1 and 7 and 4 hours after the AM study drug
administration on Day 4. The acceptable window for collection from the scheduled collection time point is ±15 minutes.
(k) Collected only if subjects are required to return to the study site on Day 14 (+2 days) for a follow-up visit.
(l)
Including cholesterol (total, high-density lipoprotein, calculated low-density lipoprotein, and triglycerides).
(m) Clinical laboratory testing will include hematology and serum chemistry.
(n) Clinical laboratory testing at screening and at Day 9 or early discontinuation will include hematology, serum chemistry, and urinalysis.
(o) Collect 12 hours after the PM study drug administration on Day 7.
(p) For postmenopausal women, a serum follicle-stimulating hormone test will be performed at screening.
(q) Women of childbearing potential only.
(r) Includes alcohol, amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids (including
tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, codeine, and oxycodone).
(s) A 12-lead ECG will be collected after the subject has been in the supine position for at least 10 minutes. On Days 1, 4, and 7, an ECG will be recorded 4 hours after the AM
study drug administration. The acceptable window for collection from the scheduled collection time point is ±15 minutes.
(t)
TPOXX, 600 mg (3 × 200-mg capsules) will be administered orally twice daily, approximately 12 hours (± 30 minutes) apart on Days 1 through 7. All subjects will be
provided meals consisting of approximately 600 calories and 25 g fat, which will start 30 minutes before study drug administration. Subjects should eat this meal within 30
minutes or less of taking study drug. Study drug will be administered approximately 30 minutes after the start of the meal. All doses of study drug will be administered to
subjects by study site personnel with approximately 240 mL of water. Subjects must fast 2 hours after taking study drug. Study drug and meals must be taken with water only,
and no other beverage except water should be ingested within 3 hours before or 3 hours after study drug administration.
(u) Blood samples for PK analysis of TPOXX will be collected from all subjects at the following tome points: on Day 1 before study drug administration (0 hour), at 0.5, 1, 2, 4, 6,
8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours after the AM dose), on Day 7 before the
AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the
AM dose on Day 7). For PK blood samples, the acceptable window for collection from the scheduled collection time point will be as follows: ±5 minutes for the time points
from 1 to 8 hours and ±15 minutes for the 12- to 48-hour time points.
(v) Including assessment of heart, lungs, abdomen, a neurologic review, and a review of symptoms for assessment and/or follow-up of reported or potential adverse events.
(w) The study site personnel will observe the subjects for signs of allergic reaction for at least 1 hour after the study drug is ingested.
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9.3 
APPENDIX 3: STUDY GOVERNANCE 
9.3.1 
Data Quality Assurance 
This study will be conducted using the quality processes described in applicable procedural 
documents. The quality management approach to be implemented will be documented and 
will comply with current ICH guidance on quality and risk management. All aspects of the 
study will be monitored for compliance with applicable government regulatory requirements, 
current Good Clinical Practice, the protocol, and standard operating procedures (SOPs). The 
monitor will maintain current personal knowledge of the study through observation, review 
of study records and source documentation, and discussion of the conduct of the study with 
the investigator and staff. Electronic CRFs and electronic data capture will be utilized. The 
electronic data capture system is validated and compliant with US Title 21 CFR Part 11. Each 
person involved with the study will have an individual identification code and password that 
allows for record traceability. There may be an internal quality review audit of the data and 
additional reviews by the clinical monitor. 
Steps to be taken to ensure the accuracy and reliability of data include, but are not limited to: 
selection of qualified investigator and appropriate study center, protocol training and review 
of protocol procedures with the investigator and study site personnel before the start of the 
study, site initiation and periodic interim monitoring visits by SIGA or PPD, and direct 
transmission of safety laboratory data into the PPD study database for all clinical safety 
laboratory tests performed. The eCRF will be reviewed for accuracy and completeness by 
PPD Clinical research associate (CRA) remotely and during on-site monitoring visits. 
Discrepancies will be resolved with the investigator or designees, as appropriate. The data 
will be entered into the clinical study database and validated for accuracy. During on-site 
monitoring visits, 100% of the data will be verified using source documentation. SIGA or 
Biomedical Advanced Research and Development Authority representatives may accompany 
the PPD CRA on any scheduled site visit. The investigator will be informed in advance of 
any visitors to the study site in addition to the PPD CRA.  
Representatives of SIGA’s Quality Assurance department (or designee) may visit the site to 
carry out an audit of the study in compliance with regulatory guidelines and PPD policy. 
Such audits will require access to all study records, including source documents, for 
inspection and source document verification with the eCRF. Subject privacy must, however, 
be respected. Sufficient prior notice will be provided to allow the investigator to prepare 
properly for the audit. Similar auditing procedures may also be conducted by any regulatory 
body reviewing the results of this study in support of a Licensing Application. The 
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investigator will immediately notify SIGA if they are contacted by a regulatory agency 
requesting a site inspection. 
9.3.2 
Investigator Obligations 
The following administrative items are meant to guide the investigator in the conduct of the 
study and may be subject to change based on industry and government SOPs, working 
practice documents, or guidelines. Changes will be reported to the IRB but will not result in 
protocol amendments. 
9.3.2.1 
Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain subject confidentiality. All records will be kept in a secure 
storage area with limited access. Subjects will not be identified by name in any reports in this 
study. All records will be kept confidential to the extent provided by federal, state, and local 
law. Medical records are made available for review when required by the FDA or other 
authorized users only under the guidelines set by the Federal Privacy Act. Direct access, as 
defined in the Federal Privacy Act, includes examining, analyzing, verifying, and 
reproducing any records and reports that are important to the evaluation of the study. The 
investigator is obligated to inform the subjects that these representatives may review their 
study-related records without violating the confidentiality of the subjects. The requirement to 
maintain subject confidentiality is included in the study informed consent document. 
The investigator and all employees and coworkers involved with this study may not disclose 
or use for any purpose other than performance of the study, any data, record, or other 
unpublished, confidential information disclosed to those individuals for the purpose of the 
study. Prior written agreement from SIGA or its designee must be obtained for the disclosure 
of any said confidential information to other parties. 
9.3.2.2 
Institutional Review 
Federal regulations and ICH guidelines require that approval be obtained from an IRB before 
participation of human subjects in research studies. Before study onset, the protocol, ICF, 
advertisements to be used for the recruitment of study subjects, and any other written 
information regarding this study to be provided to the subject or the subject’s legal guardian 
must be approved by the IRB. Documentation of all IRB approvals and of the IRB 
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compliance with the ICH harmonised tripartite guideline E6(R2): Good Clinical Practice will 
be maintained by the site and will be available for review by SIGA or its designee. 
All IRB approvals should be signed by the IRB chairman or designee and must identify the 
IRB name and address, the clinical protocol by title or protocol number or both, and the date 
approval or a favorable opinion was granted. 
9.3.2.3 
Subject Consent 
Written documentation of informed consent in compliance with US Title 21 CFR Part 50 
shall be obtained from each subject before any study-related procedures are performed and 
study drug is administered. If any institution-specific modifications to study-related 
procedures are proposed or made by the site, the consent should be reviewed by SIGA or its 
designee or both before IRB submission. Once reviewed, the investigator will submit the ICF 
to the IRB for review and approval before the start of the study. If the ICF is revised during 
the course of the study, all active participating subjects must sign the revised ICF. 
Before recruitment and enrollment, each prospective subject or his/her legal guardian will be 
given a full explanation of the study and will be asked to read and review the approved ICF. 
Once the investigator is assured that the subject/legal guardian understands the implications 
of participating in the study, the subject/legal guardian will be asked to give his or her 
consent to participate in the study by signing the ICF. A copy of the ICF will be provided to 
the subject/legal guardian. 
9.3.2.4 
Exclusion of Children 
Effort will be made to include women and minorities in proportions similar to that of the 
community from which they are recruited. Because this study is designed to establish safety 
of the study drug in adults, enrollment will be limited to persons at least 18 years of age, and 
no older than 50 years. Children are excluded from participation in this clinical study because 
it does not meet the Department of Health and Human Services’ guidelines (45 CFR 46, 
Subpart D, 401-409) for inclusion of children in research. These guidelines provide guidance 
for the protection of children in research. Generally, healthy children can be studied when the 
research is considered as “not greater than minimal risk.” Children can be involved in 
research with greater than minimal risk only when it presents the prospect of direct benefit to 
the individual child or is likely to yield generalizable knowledge about the child’s disorder or 
condition. 
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9.3.2.5 
Study Reporting Requirements 
By participating in this study, the investigator agrees to submit reports of SAEs according to 
the time line and method outlined in this protocol. In addition, the investigator agrees to 
submit annual reports to his or her IRB as appropriate. 
9.3.2.6 
Financial Disclosure and Obligations 
The investigator is required to provide financial disclosure information to allow SIGA to 
submit the complete and accurate certification or disclosure statements required under US 
Title 21 CFR Part 54. In addition, the investigator must provide to SIGA a commitment to 
promptly update this information if any relevant changes occur during the course of the 
investigation and for 1 year following the completion of the study. 
Neither SIGA nor PPD is financially responsible for further testing or treatment of any 
medical condition that may be detected during the screening process. In addition, in the 
absence of specific arrangements, neither SIGA nor PPD is financially responsible for further 
treatment of the disease under study. 
9.3.2.7 
Investigator Documentation 
Prior to beginning the study, the investigator will be asked to comply with ICH 
E6(R2) Section 8.2 and US Title 21 of the CFR by providing essential documents, including 
but not limited to, the following: 
•
IRB approval.
•
An original investigator-signed investigator agreement page of the protocol.
•
Form FDA 1572, fully executed, and all updates on a new fully executed
Form FDA 1572.
•
Curriculum vitae for the principal investigator and each subinvestigator listed on Form
FDA 1572. Current licensure must be noted on the curriculum vitae. Curriculum vitae
will be signed and dated by the principal investigators and subinvestigators at study
start-up, indicating that they are accurate and current.
•
Financial disclosure information to allow SIGA to submit complete and accurate
certification or disclosure statements required under US Title 21 CFR Part 54. In
addition, the investigators must provide to SIGA a commitment to promptly update this
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information if any relevant changes occur during the course of the investigation and for 
1 year after the completion of the study. 
•
An IRB-approved ICF, samples of site advertisements for recruitment for this study, and
any other written information about this study that is to be provided to the subject or legal
guardians.
•
Laboratory certifications and reference ranges for any local laboratories used by the site,
in accordance with US Title 42 CFR Part 493.
9.3.2.8 
Study Conduct 
The investigator agrees to perform all aspects of this study in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, ICH E6(R2): Good Clinical 
Practice; the protocol; and all national, state, and local laws or regulations. 
9.3.2.9 
Case Report Forms and Source Documents 
Site personnel will maintain source documentation, enter subject data into the eCRF as 
accurately as possible, and will rapidly respond to any reported discrepancies. 
Electronic CRFs and electronic data capture will be utilized. The electronic data capture 
system is validated and compliant with US Title 21 CFR Part 11. Each person involved with 
the study will have an individual identification code and password that allows for record 
traceability. Thus, the system, and any subsequent investigative reviews, can identify 
coordinators, investigators, and individuals who have entered or modified records, as well as 
the time and date of any modifications. There may be an internal quality review audit of the 
data and additional reviews by PPD’s CRA. 
Each eCRF is presented as an electronic copy, allowing data entry by site personnel, who can 
add and edit data, add new subjects, identify and resolve discrepancies, and view records. 
This system provides immediate direct data transfer to the database, as well as immediate 
detection of discrepancies, enabling site coordinators to resolve and manage discrepancies in 
a timely manner. 
Paper copies of the eCRFs and other database reports may be printed and signed by the 
investigator. This system provides site personnel, PPD CRAs, and reviewers with access to 
hardcopy audits, discrepancy reviews, and investigator comment information. 
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9.3.2.10 
Adherence to Protocol 
The investigator agrees to conduct the study as outlined in this protocol, in accordance with 
ICH E6(R2) and all applicable guidelines and regulations. 
9.3.2.11 
Reporting Adverse Events 
By participating in this study, the investigator agrees to submit reports of SAEs according to 
the timeline and method outlined in this protocol. In addition, the investigator agrees to 
submit annual reports to his or her IRB as appropriate. The investigator also agrees to 
provide SIGA with an adequate report, if applicable, shortly after completion of the 
investigator’s participation in the study. 
9.3.2.12 
Investigator’s Final Report 
Upon completion of the study, the investigator, where applicable, should inform the 
institution; the investigator/institution should provide the IRB with a summary of the study’s 
outcome and SIGA and regulatory authorities with any reports required. 
9.3.2.13 
Records Retention 
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study drug. These documents should be 
retained for a longer period, however, if required by applicable regulatory requirements or by 
an agreement with SIGA. SIGA is responsible for informing the investigator/institution when 
these documents no longer need to be retained. 
9.3.2.14 
Publications 
All information concerning TPOXX, SIGA operations, patent application, formulas, 
manufacturing processes, basic scientific data, and formula information, supplied by SIGA to 
the investigator and not previously published, is considered confidential and remains the sole 
property of SIGA. The investigator agrees to use this information only to accomplish this 
study and will not use it for other purposes without SIGA’s written consent. The investigator 
understands that the information developed in the clinical study will be used by SIGA, in 
connection with the continued development of TPOXX, and thus may be disclosed as 
required to other clinical investigators or government regulatory agencies. To permit the 
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information derived from the clinical studies to be used, the investigator is obligated to 
provide SIGA with all data obtained in the study. Any publication or other public 
presentation of results from this study, including manuscripts and materials for presentation 
at scientific meetings, should be provided to SIGA at least 30 working days before abstract or 
other relevant submission deadlines. Authorship of publications resulting from this study will 
be determined at the discretion of SIGA. 
9.3.3 
Study Management 
9.3.3.1 
Monitoring 
9.3.3.1.1 
Monitoring of the Study 
Site monitoring for safety is conducted to ensure that human subject protection, study 
procedures, and laboratory, study drug dosing, and data collection processes are of high 
quality and meet SIGA, GCP/ICH, and regulatory guidelines. PPD CRA(s) will conduct site 
monitoring visits as detailed in the monitoring plan. 
Site investigators will allow the CRA(s), the designated IRB, SIGA or its designee and the 
FDA to review, audit, and inspect study documents (eg, ICFs, drug accountability and 
distribution forms, eCRF), pertinent hospital and site records, and source documentation for 
verification of the study data.  
Clinical research associates will conduct site visits in accordance with PPD SOPs to monitor 
the following: study operations, the quality of data collected in the research records, the 
accuracy and timeliness of data entered in the database, and to determine that all process and 
regulatory requirements are met. Study monitoring visits will occur at initiation of the study 
site, at intervals determined by SIGA during conduct of the study, and at completion of the 
study.  
The CRA will maintain current personal knowledge of the study through observation, review 
of study records and source documentation, and discussion of the conduct of the study with 
the investigator and staff. During the routine monitoring visits, the CRA will perform a 100% 
source document verification of all subject data entered into the eCRF. Discrepancies, if any, 
will be clarified with the study site coordinator and investigator, and corrected at the site by 
the study coordinator. Any questions or required data clarifications will be sent to the study 
site electronically.  
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9.3.4 
Safety Monitoring Plan 
Close cooperation between the designated members of the study team will occur to evaluate 
and respond to individual AEs in a timely manner. Designated team members (investigator, 
subinvestigators, study coordinator, and other designated study clinicians) will review the 
subject safety information and data (laboratory test results, ECGs, AEs, and concomitant 
medications) and update the PPD project team and the ISM on the status of all enrolled 
subjects at their site on a weekly basis (or more frequently if required because of an 
unexpected safety issue) through completion of each subject’s final study visit. 
9.3.5 
Medical Monitor 
The medical monitor, or their qualified designee, will receive reports within 24 hours of 
study site awareness of all SAEs and within 7 days of study site awareness of all other AEs. 
The safety monitors will review all safety data and alert the medical monitor of SAEs and 
AEs of interest. The medical monitor may make a request for data to the investigator as 
necessary for safety evaluations.  
The medical monitor will review each significant AE in a timely fashion and ensure that 
appropriate management is initiated and completed. Drug safety representatives and the 
medical monitor will have direct contact with the investigators and follow all significant 
events as needed. 
9.3.6 
Safety Oversite (Independent Safety Monitor) 
In addition to the investigator’s ongoing review of the safety data, the ISM will review the 
protocol for any major concerns and will be involved in data review in coordination with the 
investigator. The primary role of the ISM will be to evaluate the study safety and tolerability 
data. The ISM will provide independent safety monitoring in a timely fashion, which will 
include reviewing individual SAE reports and a review of periodic cumulative AE reports. 
Clinical safety and laboratory data, clinical records, and other safety study-related records 
will be made available for the ISM to review. Based on review of this data, the ISM may 
make recommendations regarding the safe continuation of the study. Specific details will be 
outlined in the Safety and Medical Management Plan. 
9.3.6.1 
Inspection of Records 
The investigator and study site involved in the study will permit study-related monitoring, 
audits, IRB review, and regulatory inspections by providing direct access to all study records. 
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In the event of an audit, the investigator agrees to allow SIGA, their representatives, the 
FDA, or other regulatory agencies access to all study records. 
The investigator should promptly notify SIGA and study site of any audits scheduled by any 
regulatory authorities and promptly forward copies of any audit reports received to SIGA. 
9.3.6.2 
Management of Protocol Amendments and Deviations 
9.3.6.2.1 
Modification of the Protocol 
Any changes in this research activity, except those necessary to remove an apparent 
immediate hazard to the subject, must be reviewed and approved by SIGA or designee. 
Amendments to the protocol must be submitted in writing to the IRB for approval before 
subjects are enrolled into an amended protocol. 
9.3.6.2.2 
Protocol Deviations 
The investigator or designee must document and explain in the subject’s source 
documentation any deviation from the approved protocol. The investigator may implement a 
deviation from, or a change to, the protocol to eliminate an immediate hazard to study 
subjects without prior IRB approval. As soon as possible after such an occurrence, the 
implemented deviation or change, the reasons for it, and any proposed protocol amendments 
should be submitted to the IRB for review and approval, to SIGA for agreement, and to the 
regulatory authorities, if required. 
A protocol deviation is any change, divergence, or departure from the study design or 
procedures defined in the protocol. An important protocol deviation (sometimes referred to 
as a protocol violation or a major protocol deviation) is a subset of protocol deviations that 
might significantly affect the reliability of the study data or that might significantly affect a 
subject's safety. An important deviation can include nonadherence to inclusion or exclusion 
criteria or nonadherence to FDA regulations or ICH E6(R2) guidelines. 
Protocol deviations will be documented by the clinical monitor throughout the course of 
monitoring visits. The investigator will be notified in writing by the monitor of deviations. 
The IRB should be notified of all protocol deviations, if appropriate, in a timely manner. 
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SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
Clinical Study Protocol 
9.3.6.3 
Study Termination 
Although SIGA has every intention of completing the study, they reserve the right to 
discontinue it at any time for clinical or administrative reasons. 
An initiative for closure of the clinical investigative site or termination of the study can be 
taken at any time either by SIGA, PPD, or the investigator provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. Reasons for such action 
include, but are not limited to: 
•
Study site closure
o
Inadequate site recruitment/enrollment of subjects
o
Failure of an investigator to comply with the protocol, PPD SOPs, GCP guidelines, or
applicable federal regulations
•
Termination of enrollment
o
Enrollment of the required estimated number of subjects for the study
•
Study termination
o
Completion of the study
o
Safety concerns
In addition, the ISM and FDA have the prerogative to delay or terminate the study. 
The end of the study is defined as the date on which the last subject completes the last visit 
(includes the follow-up visit and the follow-up telephone call). Any additional long-term 
follow-up that is required for monitoring of the resolution of an AE or finding may be 
reported through an amendment to the clinical study report. 
9.3.6.4 
Final Report 
Whether the study is completed or prematurely terminated, SIGA will ensure that clinical 
study reports are prepared and provided to regulatory agency(ies) as required by the 
applicable regulatory requirement(s). SIGA will also ensure that clinical study reports in 
marketing applications meet the standards of the ICH harmonised tripartite guideline E3: 
Structure and content of clinical study reports. 
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Protocol No. SIGA-246-022 
Clinical Study Protocol 
Upon completion of the clinical study report, the investigator will be provided with the final 
approved clinical study report, as appropriate. 
9.4 
APPENDIX 4: CHANGE HISTORY 
9.4.1 
Protocol Amendment 1 
Protocol Amendment 1 was issued to clarify the weight requirements for qualified subjects 
on Day -1 and Day 1, clarify that the same scale will be used in Screening and how rounding 
procedures will be used, update Reference 3 to cite the current FDA Guidance, remove the 
±2 day window for the Day 9 / Early Discontinuation visit, and remove symptom-directed 
physical examination from Day 7.  The changes to Protocol Amendment 1 are outlined as 
follows: 
Protocol Section 
Change 
Rationale 
Synopsis and Section 
4.1 Inclusion Criteria 
Clarified subjects need to weigh 
>120 kg at check-in on Day -1,
and prior to dosing on Day 1, in
addition to weighing >120 kg at
Screening.
In order to obtain accurate 
pharmacokinetic data in 
subjects weighing >120 kg, 
subjects participating in this 
study need to meet the weight 
requirement during dosing. 
Section 6.2.6 
Physical 
Examinations and 
Section 9.2 Appendix 
2:  Schedule of 
Events 
Clarified the scale should be 
used throughout the entire study 
including Screening.  Clarified 
rounding should occur by adding 
the following text:  Weight 
measurements will be rounded to 
one decimal place. 
The same scale should be used 
for the screening of subjects as 
will be used in the study to 
ensure weight measurement 
consistency.  Scales at the site 
measure weight to two decimal 
places.   
Section 8 Reference 
List 
Updated reference 3 to cite the 
May 2018 Bioanalytical Method 
Validation Guidance for Industry 
An updated Guidance was 
published in May of 2018. 
Section 9.2 Appendix 
2:  Schedule of 
Events 
Removal of (±2) from Day 9 or 
Early Discontinuation visit 
header 
The ±2 day visit window was 
included in error.  Subjects will 
check out on day 9 or will 
undergo Early Discontinuation 
Procedures on the day they 
discontinue.  There is no 
window for these visits. 
Section 9.2 Appendix 
2:  Schedule of 
Events 
Removal of Day 7 symptom-
directed physical examination 
from schedule. 
A complete physical exam is 
already being conducted on 
Day 7. 
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TO: 
FROM: 
STUDY: 
PROTOCOL ADMINISTRATIVE LETTER 
Rebecca Wood-Horrall, MD - Principal Investigator 
SIGA Technologies, Inc. 
SIGA-246-022 
"A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetic 
of TPOXX in Adult Subjects Weighing More Than 120 kg" 
RE: 
Collection of "Height" data point for all subjects on Study Day -1 Check-in 
Visit 
DATE: 
CC: 
19 July 2019 
SIGA-246-022 Trial Master File 
ADVARRA IRB 
Dear Dr. Wood and Staff: 
Per our discussion at the SIGA-246-022 study site initiation visit with the PPD team on 
16 July 2019, please add "Height" to the Study Day -1 Check-in Visit procedures. 
The protocol will not be amended at this time; however, per ADVARRA's request, 
should the protocol be amended in the future, this change will be included. 
Kady M. H 
eye urch 
Associate Direc r, Project Management 
SIGA Technologies, Inc. 
SIGA-246-022 Protocol Administrative Leiter 19 July 2019 
19 July 2019 
Date 
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Title Page 
CLINICAL STUDY PROTOCOL AMENDMENT 2 
IND 69,019 
A POST MARKETING STUDY OF THE SAFETY, TOLERABILITY, 
AND PHARMACOKINETICS OF TPOXX® IN ADULT SUBJECTS 
WEIGHING MORE THAN 120 KG 
Post Marketing Commitment: 3417-4 
SIGA-246-022 
Sponsor: 
SIGA Technologies, Inc. 
4575 SW Research Way, Suite 110 
Corvallis, OR 97333 
Sponsor Contact: 
Kady Honeychurch, PhD, PMP 
SIGA Technologies, Inc. 
4575 SW Research Way, Suite 110 
Corvallis, OR 97333 
Medical Monitor: 
Rahul Bhatnagar, MD 
PPD Phase I Clinic 
7551 Metro Center Drive, Suite 300 
Austin, TX 78744 
Version of Protocol: 
Final 3.0 
Date of Protocol:  
02 August 2019 
CONFIDENTIAL 
The concepts and information contained in this document or generated during the study are 
considered proprietary and may not be disclosed in whole or in part without the expressed, 
written consent of SIGA Technologies, Inc. 
The study will be conducted according to the International Council for Harmonisation 
Guideline E6(R2): Good Clinical Practice. 
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SIGA Technologies, Inc. 
Protocol No. SIGA-246-022 
SIGNATURE PAGE 
TPOXX 
Clinical Study Protocol 
PROTOCOL TITLE: 
A Post Marketing Study of the Safety, Tolerability, and 
Phannacokinetics ofTPOXX® in Adult Subjects Weighing 
More Than 120 kg 
PROTOCOL NUMBER: 
SIGA-246-022 
g:f	
y ok! 
SIGA Technologies, Inc. 
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SIGA Technologies, Inc. 
Protocol No. SIGA-246-022 
TPOXX 
Clinical Study Protocol 
INVESTIGATOR PROTOCOL AGREEMENT PAGE 
I agree to conduct the study as outlined in the protocol titled "A Post Marketing Study of the 
Safety, Tolerability, and Phannacokinetics ofTPOXX® in Adult Subjects Weighing More 
Than 120 kg" in accordance with the guidelines and all applicable government regulations, 
including US Title 21 of the Code of F eral Regulations Part 54. I have read and understand 
Principal Investigator 
PPD 
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SIGA Technologies, Inc. 
TPOXX 
Protocol No. SIGA-246-022 
Clinical Study Protocol 
TABLE OF CONTENTS 
TITLE PAGE .......................................................................................................................... 1 
SIGNATURE PAGE ............................................................................................................... 2 
INVESTIGATOR PROTOCOL AGREEMENT PAGE ..................................................... 3 
TABLE OF CONTENTS ........................................................................................................ 4 
LIST OF TABLES ................................................................................................................... 6 
PROTOCOL SYNOPSIS ....................................................................................................... 7 
1.
INTRODUCTION ............................................................................................. 15 
1.1 
BACKGROUND ..............................................................................................15 
1.2 
RATIONALE FOR STUDY ............................................................................15 
1.3 
POTENTIAL RISKS AND BENEFITS ...........................................................15 
1.3.1 
Potential Risks ..............................................................................................15 
1.3.2 
Known Potential Benefits .............................................................................16 
2.
STUDY OBJECTIVES ...................................................................................... 16 
2.1 
PRIMARY OBJECTIVE ..................................................................................16 
2.2 
SECONDARY OBJECTIVE ............................................................................16 
3.
STUDY POPULATION..................................................................................... 16 
3.1 
INCLUSION CRITERIA .................................................................................16 
3.2 
EXCLUSION CRITERIA ................................................................................18 
3.3 
OTHER SCREENING CONSIDERATIONS ..................................................22 
3.3.1 
Subject Restrictions During the Study .........................................................22 
3.4 
WITHDRAWAL OF SUBJECTS FROM THE STUDY .................................22 
3.4.1 
Reasons for Withdrawal................................................................................22 
3.4.2 
Handling of Withdrawals ..............................................................................23 
3.4.3 
Halting Rules ................................................................................................23 
4.
STUDY DESIGN ................................................................................................ 24 
4.1.1 
Replacements ................................................................................................25 
5.
STUDY TREATMENT ..................................................................................... 25 
5.1 
TREATMENT ADMINISTERED....................................................................25 
5.2 
STUDY DRUG ................................................................................................26 
5.2.1 
Study Drug Packaging and Storage ..............................................................27 
5.2.2 
Study Drug Accountability ...........................................................................27 
5.3 
TREATMENT COMPLIANCE .......................................................................27 
5.3.1 
Prior and Concomitant Medications .............................................................28 
5.3.1.1 
Prior Medications ..................................................................................... 28 
5.3.1.2 
Concomitant Medications ........................................................................ 28 
6.
STUDY PROCEDURES ................................................................................... 28 
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Protocol No. SIGA-246-022 
Clinical Study Protocol 
6.1 
PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS ......................29 
6.1.1 
Pharmacokinetic Sample Collection, Shipping, and Storage .......................30 
6.1.2 
Pharmacokinetic Sample Analysis................................................................31 
6.2 
SAFETY ASSESSMENTS AND ENDPOINTS ..............................................31 
6.2.1 
Adverse Events .............................................................................................31 
6.2.1.1 
Adverse Event Definitions ....................................................................... 31 
6.2.1.2 
Eliciting and Documenting Adverse Events ............................................ 33 
6.2.1.3 
Reporting Adverse Events ....................................................................... 34 
6.2.1.4 
Reporting of Serious Adverse Events ...................................................... 34 
6.2.1.5 
Assessment of Severity ............................................................................ 35 
6.2.1.6 
Assessment of Causality .......................................................................... 36 
6.2.1.7 
Follow-up of Adverse Events .................................................................. 37 
6.2.1.8 
Reactogenicity ......................................................................................... 37 
6.2.1.9 
Reporting of Pregnancy ........................................................................... 37 
6.2.2 
Clinical Laboratory Testing ..........................................................................38 
6.2.3 
Medical History ............................................................................................40 
6.2.4 
Vital Sign Measurements ..............................................................................40 
6.2.5 
Electrocardiograms .......................................................................................40 
6.2.6 
Physical Examinations ..................................................................................41 
6.2.7 
Unscheduled Visits .......................................................................................42 
7.
STATISTICAL ANALYSIS PLANS ................................................................ 42 
7.1 
SAMPLE SIZE CALCULATIONS..................................................................42 
7.2 
ANALYSIS POPULATIONS ...........................................................................42 
7.3 
STATISTICAL ANALYSIS .............................................................................42 
7.3.1 
Pharmacokinetic Analyses ............................................................................43 
7.3.2 
Safety Analyses ............................................................................................43 
7.4 
HANDLING OF BELOW THE LIMIT OF QUANTIFICATION AND 
MISSING DATA ..............................................................................................44 
7.5 
INTERIM ANALYSES ....................................................................................44 
8.
REFERENCE LIST........................................................................................... 45 
9.
APPENDICES .................................................................................................... 46 
9.1 
APPENDIX 1: LIST OF ABBREVIATIONS ..................................................46 
9.2 
APPENDIX 2: SCHEDULE OF EVENTS ......................................................48 
9.3 
APPENDIX 3: STUDY GOVERNANCE .......................................................50 
9.3.1 
Data Quality Assurance ................................................................................50 
9.3.2 
Investigator Obligations ...............................................................................51 
9.3.2.1 
Confidentiality ......................................................................................... 51 
9.3.2.2 
Institutional Review ................................................................................. 51 
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SIGA Technologies, Inc. 
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Protocol No. SIGA-246-022 
Clinical Study Protocol 
9.3.2.3 
Subject Consent ....................................................................................... 52 
9.3.2.4 
Exclusion of Children .............................................................................. 52 
9.3.2.5 
Study Reporting Requirements ................................................................ 53 
9.3.2.6 
Financial Disclosure and Obligations ...................................................... 53 
9.3.2.7 
Investigator Documentation ..................................................................... 53 
9.3.2.8 
Study Conduct ......................................................................................... 54 
9.3.2.9 
Case Report Forms and Source Documents ............................................ 54 
9.3.2.10 
Adherence to Protocol ............................................................................. 55 
9.3.2.11 
Reporting Adverse Events ....................................................................... 55 
9.3.2.12 
Investigator’s Final Report ...................................................................... 55 
9.3.2.13 
Records Retention .................................................................................... 55 
9.3.2.14 
Publications .............................................................................................. 55 
9.3.3 
Study Management .......................................................................................56 
9.3.3.1 
Monitoring ............................................................................................... 56 
9.3.4 
Safety Monitoring Plan .................................................................................57 
9.3.5 
Medical Monitor ...........................................................................................57 
9.3.6 
Safety Oversite (Independent Safety Monitor) .............................................57 
9.3.6.1 
Inspection of Records .............................................................................. 57 
9.3.6.2 
Management of Protocol Amendments and Deviations .......................... 58 
9.3.6.3 
Study Termination .................................................................................... 59 
9.3.6.4 
Final Report ............................................................................................. 59 
9.4 
APPENDIX 4: CHANGE HISTORY ..............................................................60 
9.4.1 
Protocol Amendment 1 .................................................................................60 
9.4.2 
Protocol Amendment 2 .................................................................................61 
LIST OF TABLES 
Table 5-1 
Excipients of TPOXX Capsules ...................................................................... 26 
Table 9-1 
Schedule of Events .......................................................................................... 48 
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Clinical Study Protocol 
PROTOCOL SYNOPSIS 
PROTOCOL NO.: SIGA-246-022 
TITLE: A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of 
TPOXX® in Adult Subjects Weighing More Than 120 kg 
STUDY PHASE: 4 Post Marketing Study 
STUDY SITE: PPD Phase I Clinic, 7551 Metro Center Drive, Suite 200, Austin, TX 78744, 
USA. 
OBJECTIVES: 
Primary: 
The primary objective of this study is to determine the pharmacokinetic (PK) profile of 
600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in 
adult subjects weighing more than 120 kg to determine if a change in dosing regimen would 
be needed in these patients. 
Secondary: 
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral 
TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg. 
STUDY DESIGN AND METHODOLOGY: 
This is an open-label, multiple-dose study to assess the safety, tolerability, and PK of TPOXX 
600 mg BID when administered orally for 7 days to adult subjects weighing more than 
120 kg. A total of 36 subjects, ages 18 to 50, inclusive, will be enrolled. The study will 
consist of a screening period (Day –28 to Day –2), a treatment and confinement period 
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]). 
Subjects will undergo screening evaluations to determine eligibility within 28 days before 
study drug administration. Subjects will be admitted to the study site on Day –1 to complete 
baseline assessments; results of these assessments must be reviewed by the investigator 
before dosing. Starting in the morning of Day 1, subjects will receive 600 mg oral TPOXX 
BID for 7 days (Days 1 through 7). 
All subjects will be provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration and subjects must fast for 2 hours after taking 
study drug. Subjects should eat this meal within 30 minutes or less of taking study drug. 
Study drug and meals must be taken with water only, and no other beverage except water 
should be ingested within 3 hours before or 3 hours after study drug administration. 
Subjects will remain confined to the study site for collection of PK samples and will be 
carefully monitored for safety and tolerability until discharge on Day 9. Subjects who have 
abnormal physical examination findings or an ongoing adverse event (AE)/serious adverse 
event (SAE) on Day 9 that is deemed related to study drug or per investigator or SIGA 
discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All other 
subjects will have the Day 14 (+2 days) follow-up via telephone. All subjects will have a 
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Clinical Study Protocol 
follow-up telephone call 30 days after administration of the last dose of study drug 
(Day 37 [+2 days]) to report any SAEs. At the time of discharge from the clinical research 
unit, subjects will be instructed to notify the investigator of any SAEs that occur within 
30 days after administration of the last dose of study drug. Serious AEs will be followed until 
the SAE is stable or until resolution as determined by the investigator and/or medical 
monitor. 
The total duration of the study for each subject, including the screening period, treatment 
period, and the Day 37 (+2 days) follow-up telephone call, will be approximately 65 days. 
STUDY POPULATION: 
Inclusion Criteria: 
Each subject must meet all the following criteria to be enrolled in this study: 
1. Subject is male or female between 18 and 50 years of age, inclusive.
2. Subject has a body weight >120 kg at screening, at check-in on Day -1, and prior to
dosing on Day 1.
3. Women of childbearing potential, have a negative β human chorionic gonadotropin
pregnancy test (serum) at the screening visit and a confirmatory negative serum
pregnancy test on Day –1 before receipt of study drug, and meet 1 of the following
criteria:
a.
The subject or their partner has undergone surgical sterilization
b. The subject is postmenopausal, defined as 12 consecutive months with no menses
without an alternative medical cause and has a documented plasma
follicle-stimulating hormone level >40 IU/mL
c.
The subject agrees to be abstinent (ie, heterosexually inactive or women in a religious
order)
d. The subject agrees to consistently use 1 of the following methods of contraception
from the beginning of screening (which they had been consistently using for at least
30 days before the first dose of study drug) through 30 days after the last dose of
study drug:
i.
Condoms, male or female, with a spermicide
NOTE: For male subjects, condoms must be used for 90 days after the last dose
of study drug.
ii.
Diaphragm or cervical cap with spermicide
iii.
Intrauterine device with spermicide
iv.
Oral contraceptives or other hormonal methods
NOTE: Subject must agree to use an additional nonhormonal method of
contraception in conjunction with oral contraceptives.
v.
Male sexual partner who had undergone a vasectomy at least 3 months before
screening
4. Male subjects must agree to not donate sperm from the first dose of study drug through
90 days after the last dose of study drug.
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5. Subject is considered by the investigator to be in good general health as determined by
medical history (no hospitalizations for chronic medical conditions in the previous
2 years), clinical laboratory results, vital sign measurements, 12-lead electrocardiogram
(ECG) results, and physical examination findings at screening.
6. Subject agrees to comply with all protocol requirements.
7. Subject is able to provide written informed consent.
8. Subject agrees to comply with the dietary requirements.
9. Subject does not intend to lose weight (diet or weight loss) from the screening visit and
throughout the study.
EXCLUSION CRITERIA: 
Subjects meeting any of the following criteria will be excluded from the study: 
1. Subject is a female who is pregnant or breastfeeding or planning to become pregnant
within 3 months after the last dose of study drug.
2. Subject has a history of any clinically significant conditions including:
•
Asthma treated with oral systemic steroids within the past 6 months
•
Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
•
Thyroidectomy or thyroid disease that required medication within the past 12 months
•
Serious angioedema episodes within the previous 3 years or requiring medication in
the previous 2 years
•
Head trauma resulting in a diagnosis of traumatic brain injury other than concussion
•
Frequent episodes of headache.
3. Subject has received treatment in another clinical study of an investigational drug (or
medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose
of study drug.
4. Subject has been previously enrolled in any clinical study involving TPOXX
(tecovirimat).
5. Subject has a history of relevant drug and/or food allergies (ie, allergy to tecovirimat or
excipients, or any significant food allergy that could preclude a standard diet in the study
site).
6. Subject has any condition possibly affecting drug absorption (eg, previous surgery on the
gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder,
or pancreas, with the exception of appendectomy).
7. Subject has evidence or history of clinically significant allergic (except for untreated,
asymptomatic, seasonal allergies at time of the first dose of study drug), hematological,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or
neurological disease. Exceptions to these criteria (eg, stable, mild joint disease
unassociated with collagen vascular disease) may be made following discussions with the
medical monitor.
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8. Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias,
syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia).
9. Subject has a family history of sudden cardiac death, not clearly due to acute myocardial
infarction.
10. Subject has a seizure disorder or history of seizures (does not include childhood febrile
seizures) or a past history that increases seizure risks such as significant head injury that
caused loss of consciousness or other changes in the subject’s daily function, concussion,
stroke, central nervous system infection or disease, or alcohol or drug abuse or family
history of idiopathic seizures.
11. Subject has a history of a peptic ulcer or significant gastrointestinal bleed.
12. Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency,
coagulopathy, or platelet disorder requiring special precautions) or significant bruising or
bleeding difficulties with blood draws.
13. Subject has a malignancy that is active, or treated malignancy for which there is not
reasonable assurance of sustained cure, or malignancy that is likely to recur during the
period of the study (subject should be in complete remission for at least 5 years).
14. Subject has neutropenia or other blood dyscrasia determined to be clinically significant
by the investigator.
15. Subject has used any of the following prohibited medications from within 7 days (or
5 half-lives, whichever is longer) before the first dose of study drug: antidiabetic
medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance
protein transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib,
rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including repaglinide,
paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of CYP2C19
including S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole,
and omeprazole. Medications not listed here that are known (or thought) to be CYP3A4
substrates may be allowed at the investigator’s discretion, after consultation with the
medical monitor, if administration poses little to no risk to the subject.
16. Subject has a history of drug or alcohol abuse or dependency within the last year before
screening.
17. Subject has a history of an eating disorder.
18. Subject has a current or recent (<30 days before screening) history of clinically
significant bacterial, fungal, or mycobacterial infection.
19. Subject has a current clinically significant viral infection.
20. Subject has a known clinically significant chronic viral infection (eg, human T cell
lymphotropic virus I or II).
21. Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville
orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products
within 48 hours before the first dose of study drug or throughout the study.
22. Subject has used any prescription (excluding hormonal birth control) or over-the-counter
medication (including herbal or nutritional supplements) within 14 days before the first
dose of study drug.
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23. Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids including
oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose
inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the
preceding 1 month (low-dose [≤800 mcg/day of beclomethasone dipropionate or
equivalent] inhaled and topical steroids are allowed).
24. Subject has donated >450 mL blood or blood components within 30 days before the first
dose of study drug. The investigator should instruct subjects who participate in this study
to not donate blood or blood components for 4 weeks after the completion of the study.
25. Subject is a smoker or has used nicotine or nicotine-containing products (eg, cigarettes,
electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine
gum) within 6 months before the first dose of study drug.
26. Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo juice,
or alcohol within 72 hours before the first dose of study drug.
27. Subject reports participation in strenuous activity or contact sports within 24 hours before
the first dose of study drug.
28. Subject has known hepatitis B or C infection or positive test for hepatitis B surface
antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2
antibodies at screening.
29. Subject has a positive test result for amphetamines (including methamphetamines and
ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids
(including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin, codeine,
and oxycodone), or alcohol at screening or check-in.
30. Subject has any of the following laboratory test results within 28 days before the first
dose of study drug:
•
Estimated serum creatinine clearance (Cockcroft-Gault) <90 mL/min
•
Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper
central laboratory reference range)
•
Hemoglobin ≤10% of the lower central laboratory reference range
•
White blood cell count not within the central laboratory reference range
•
Absolute neutrophil count <1000 cells/mm3
•
Platelets not within ±10% of central laboratory reference range
•
Alanine aminotransferase >1.5 times above the upper central laboratory reference
range
•
Aspartate aminotransferase >1.5 times above the upper central laboratory reference
range
•
Alkaline phosphatase >20% above the upper central laboratory reference range
•
Hemoglobin A1c ≥7.0%
•
Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL.
31. Subject has a blood pressure considered to be clinically significant by the investigator.
Blood pressure may be retested twice in the sitting position at 5-minute intervals.
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32. Subject has a resting heart rate of <40 beats per minute or >100 beats per minute at
screening.
33. Subject has an abnormal ECG at screening that is determined by the investigator to be
clinically significant.
34. Male subject has a QTcF >450 ms or female subject has a QTcF >470 ms at screening or
Day –1.
35. In the opinion of the investigator, the subject is not suitable for entry into the study.
EVALUATION PROCEDURES: 
Pharmacokinetic Assessments: 
Blood samples for PK analysis of TPOXX will be collected from all subjects on Day 1 before 
study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 
20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours 
after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the 
PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on 
Day 9 (48 hours after the AM dose on Day 7). 
For PK samples, the acceptable window for collection from the scheduled collection time 
point will be as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes 
for the 12- to 48-hour time points. 
The following plasma PK parameters will be calculated for TPOXX using actual sampling 
times rather than scheduled sampling times and will include but are not limited to:  
•
Area under the plasma concentration-time curve (AUC) from time 0 to the last
quantifiable measurement (AUC0-t)
•
AUC from time 0 extrapolated to infinity (AUC0-∞)
•
AUC from time 0 to 24 hours (AUC0-24)
•
AUC during the first dosing interval (tau = 12 hours) (AUC0-tau)
•
Maximum drug concentration in plasma (Cmax)
•
Time to Cmax (Tmax)
•
Apparent volume of distribution (Vd/F)
•
Apparent total body clearance (CL/F)
•
Concentration observed prior to the next dose administration (Ctrough)
•
Terminal elimination half-life (t1/2)
•
Terminal elimination rate constant (λz)
•
Percentage of AUC0-∞ extrapolated from the last quantifiable measurement to infinity
(%AUCextrap).
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Safety Assessments: 
Safety and tolerability will be assessed by monitoring and recording of AEs, clinical 
laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body 
temperature), 12-lead ECG results, and physical examination findings. 
STUDY DRUG, DOSAGE, AND ROUTE OF ADMINISTRATION: 
TPOXX, 600 mg (3 × 200-mg capsules), will be administered orally twice daily, 
approximately 12 hours (±30 minutes) apart, on Days 1 through 7. 
STATISTICAL METHODS: 
Complete, detailed statistical methods will be described in the statistical analysis plan. 
Sample Size: 
The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study is 
based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size is considered sufficient to effectively assess the PK and safety 
profiles of TPOXX. 
Analysis Populations: 
•
The Safety Population will include all subjects who receive at least 1 dose of study drug.
•
The PK Population will include subjects who receive study drug and have sufficient
concentration data to facilitate the calculation of PK variables.
Pharmacokinetic Analyses: 
Individual plasma concentration and time deviation data will be presented in a data listing. 
Plasma concentration data will be listed and summarized using the following descriptive 
statistics: number of subjects, arithmetic mean, standard deviation (SD), coefficient of 
variation (CV), geometric mean, geometric CV, median, minimum, and maximum. Individual 
and mean plasma concentration versus time profiles will be presented in figures on both 
linear and semilogarithmic scales. 
The PK parameters of TPOXX will be analyzed based on the actual sampling times. All 
parameters will be determined using noncompartmental methods using Phoenix® 
WinNonlin® Version 8.0 or higher (Certara, L.P., Princeton, New Jersey) or SAS® Version 9.4 
or higher (SAS Institute Inc., Cary, North Carolina). 
The individual PK parameters and weight-normalized PK parameters will be presented in 
data listings and summarized using the following descriptive statistics: number of subjects, 
arithmetic mean, SD, CV, median, minimum, maximum, geometric mean, geometric SD, and 
geometric CV. 
Safety Analyses: 
Adverse events will be coded by preferred term and system organ class using the latest 
version of the Medical Dictionary for Regulatory Activities and summarized overall. All AE 
data will be presented in a data listing. Treatment-emergent AEs will be summarized overall, 
as well as by severity and relationship to study drug. Serious AEs and AEs leading to 
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discontinuation of study drug will also be presented in the data listings and summarized 
overall. 
Actual values and changes from baseline for clinical laboratory test results, vital sign 
measurements, and 12-lead ECG results will be summarized at each time point using 
descriptive statistics (number of subjects, mean, SD, median, minimum, and maximum). 
Shift tables will be generated for clinical laboratory test results. Clinical laboratory data, vital 
sign measurements, 12-lead ECG results, and physical examination findings will be 
presented in data listings. 
DATE OF PROTOCOL: 02 August 2019 
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1.
INTRODUCTION
1.1 
BACKGROUND 
Historically, variola virus (VARV), the etiologic agent of smallpox, has been one of the more 
important human pathogens. Smallpox is highly communicable and carries exceptionally 
high morbidity. Secondary attack rates from 30% to 80% have been reported among 
unvaccinated members of households.1 Mortality rates range from 1% for variola minor to 
30% for variola major.1 With the advent of biowarfare as an instrument of terrorism, 
smallpox can no longer be thought of as a disease only of historic impact.  
In July 2018, the FDA approved the oral formulation of TPOXX for the treatment of patients 
with human smallpox disease caused by VARV.  
1.2 
RATIONALE FOR STUDY 
This study is being conducted as an FDA post marketing commitment to the approved New 
Drug Application for TPOXX. SIGA is required to conduct a study to determine the 
pharmacokinetic (PK) profile of TPOXX in subjects with a body weight greater than 
120 kilograms (>120 kg) to determine if a change in dosing regimen would be needed in 
these patients. 
1.3 
POTENTIAL RISKS AND BENEFITS 
1.3.1 
Potential Risks 
The effect of TPOXX on a fetus or nursing baby is not yet known; therefore, women of 
childbearing potential participating in this study will be required to agree to use an acceptable 
means of birth control from 30 days before the first dose of study drug and continuing 
through 30 days after the last dose of study drug. Pregnancy testing will be performed at the 
screening visit and checked by the investigator for negative pregnancy before administration 
of study drug on Day –1. Women who are pregnant or lactating or plan to become pregnant 
within 3 months after study drug administration will be excluded from the study; if a female 
subject becomes pregnant during study participation, study drug dosing will be discontinued, 
and the subject will be withdrawn from the study (Section 6.2.1.9). 
As with all drugs, there is potential risk of an allergic reaction. At this time, there is no 
definitive information on the allergic activity of TPOXX. Headache and nausea have been 
the most common AEs in clinical studies completed to date. There may be other side effects 
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of TPOXX that are not yet known. Full details can be found in the TPOXX full prescribing 
information.2 
1.3.2 
Known Potential Benefits 
As this study will be conducted in subjects free from smallpox, no direct health benefits from 
taking the study drug are expected. Study subjects may benefit from receiving the laboratory 
testing, ECGs, and physical examinations. Others may benefit from knowledge gained in this 
study that may aid in the development of a drug for the treatment of smallpox.  
2.
STUDY OBJECTIVES
2.1 
PRIMARY OBJECTIVE 
The primary objective of this study is to determine the PK profile of 600 mg oral TPOXX 
(3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing 
more than 120 kg to determine if a change in dosing regimen would be needed in these 
patients. 
2.2 
SECONDARY OBJECTIVE 
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral 
TPOXX administered BID for 7 days in adult subjects weighing more than 120 kg. 
3.
STUDY POPULATION
Approximately 36 male and female subjects will be enrolled at a single center in the United 
States to achieve at least 32 evaluable enrolled subjects. 
3.1 
INCLUSION CRITERIA 
Each subject must meet all the following criteria to be enrolled in this study: 
Subject is male or female between 18 and 50 years of age, inclusive. 
Subject has a body weight >120 kg at screening, at check-in on Day -1, and prior to 
dosing on Day 1. 
Women of childbearing potential, have a negative β human chorionic gonadotropin 
pregnancy test (serum) at the screening visit and a confirmatory negative serum 
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pregnancy test on Day –1 before receipt of study drug, and meet 1 of the following 
criteria: 
The subject or their partner has undergone surgical sterilization 
The subject is postmenopausal, defined as 12 consecutive months with no menses 
without an alternative medical cause and has a documented plasma 
follicle-stimulating hormone level >40 IU/mL 
The subject agrees to be abstinent (ie, heterosexually inactive or women in a 
religious order) 
The subject agrees to consistently use 1 of the following methods of contraception 
from the beginning of screening (which they had been consistently using for at 
least 30 days before the first dose of study drug) through 30 days after the last 
dose of study drug: 
i.
Condoms, male or female, with a spermicide
NOTE: For male subjects, condoms must be used for 90 days after the last
dose of study drug.
ii.
Diaphragm or cervical cap with spermicide
iii.
Intrauterine device with spermicide
iv.
Oral contraceptives or other hormonal methods
NOTE: Subject must agree to use an additional nonhormonal method of
contraception in conjunction with oral contraceptives.
v.
Male sexual partner who had undergone a vasectomy at least 3 months before
screening.
Male subjects must agree to not donate sperm from the first dose of study drug 
through 90 days after the last dose of study drug. 
Subject is considered by the investigator to be in good general health as determined 
by medical history (no hospitalizations for chronic medical conditions in the 
previous 2 years), clinical laboratory results, vital sign measurements, 12-lead ECG 
results, and physical examination findings at screening. 
Subject agrees to comply with all protocol requirements. 
Subject is able to provide written informed consent. 
Subject agrees to comply with the dietary requirements. 
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Subject does not intend to lose weight (diet or weight loss) from the screening visit 
and throughout the study. 
3.2 
EXCLUSION CRITERIA 
Subjects meeting any of the following criteria will be excluded from the study: 
Subject is a female who is pregnant or breastfeeding or planning to become 
pregnant within 3 months after the last dose of study drug. 
Subject has a history of any clinically significant conditions including: 
•
Asthma treated with oral systemic steroids within the past 6 months
•
Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
•
Thyroidectomy or thyroid disease that required medication within the past
12 months
•
Serious angioedema episodes within the previous 3 years or requiring medication
in the previous 2 years
•
Head trauma resulting in a diagnosis of traumatic brain injury other than
concussion
•
Frequent episodes of headache.
Subject has received treatment in another clinical study of an investigational drug
(or medical device) within 30 days or 5 half-lives (whichever is longer) before the
first dose of study drug.
Subject has been previously enrolled in any clinical study involving TPOXX 
(tecovirimat). 
Subject has a history of relevant drug and/or food allergies (ie, allergy to 
tecovirimat or excipients, or any significant food allergy that could preclude a 
standard diet in the study site). 
Subject has any condition possibly affecting drug absorption (eg, previous surgery 
on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, 
gallbladder, or pancreas, with the exception of appendectomy). 
Subject has evidence or history of clinically significant allergic (except for 
untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), 
hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, 
psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild 
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joint disease unassociated with collagen vascular disease) may be made following 
discussions with the medical monitor. 
Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, 
syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, 
hypokalemia). 
Subject has a family history of sudden cardiac death not clearly due to acute 
myocardial infarction. 
 Subject has a seizure disorder or history of seizures (does not include childhood 
febrile seizures) or a past history that increases seizure risks such as significant 
head injury that caused loss of consciousness or other changes in the subject’s daily 
function, concussion, stroke, central nervous system infection or disease, or alcohol 
or drug abuse or family history of idiopathic seizures. 
 Subject has a history of a peptic ulcer or significant gastrointestinal bleed. 
 Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, 
coagulopathy, or platelet disorder requiring special precautions) or significant 
bruising or bleeding difficulties with blood draws. 
 Subject has a malignancy that is active, or treated malignancy for which there is not 
reasonable assurance of sustained cure, or malignancy that is likely to recur during 
the period of the study (subject should be in complete remission for at least 
5 years). 
 Subject has neutropenia or other blood dyscrasia determined to be clinically 
significant by the investigator. 
 Subject has used any of the following prohibited medications from within 7 days 
(or 5 half-lives, whichever is longer) before the first dose of study drug: 
antidiabetic medication; anticoagulants; anticonvulsants; substrates of the BCRP 
transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, 
rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including 
repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of 
CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, 
voriconazole, lansoprazole, and omeprazole. Medications not listed here that are 
known (or thought) to be CYP3A4 substrates may be allowed at the investigator’s 
discretion, after consultation with the medical monitor, if administration poses little 
to no risk to the subject. 
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 Subject has a history of drug or alcohol abuse or dependency within the last year 
before screening. 
 Subject has a history of an eating disorder. 
 Subject has a current or recent (<30 days before screening) history of clinically 
significant bacterial, fungal, or mycobacterial infection. 
 Subject has a current clinically significant viral infection. 
 Subject has a known clinically significant chronic viral infection (eg, human T cell 
lymphotropic virus I or II). 
 Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville 
orange-containing products (eg, marmalade), or caffeine- or xanthine-containing 
products within 48 hours before the first dose of study drug or throughout the study. 
 Subject has used any prescription (excluding hormonal birth control) or 
over-the-counter medication (including herbal or nutritional supplements) within 
14 days before the first dose of study drug. 
 Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids 
including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or 
high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or 
equivalent) within the preceding 1 month (low-dose [≤800 mcg/day of 
beclomethasone dipropionate or equivalent] inhaled and topical steroids are 
allowed). 
 Subject has donated >450 mL blood or blood components within 30 days before the 
first dose of study drug. The investigator should instruct subjects who participate in 
this study to not donate blood or blood components for 4 weeks after the 
completion of the study. 
 Subject is a smoker or has used nicotine or nicotine-containing products (eg, 
cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine 
patches, or nicotine gum) within 6 months before the first dose of study drug. 
 Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo 
juice, or alcohol within 72 hours before the first dose of study drug. 
 Subject reports participation in strenuous activity or contact sports within 24 hours 
before the first dose of study drug. 
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 Subject has known hepatitis B or C infection or positive test for hepatitis B surface 
antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 
antibodies at screening. 
 Subject has a positive test result for amphetamines (including methamphetamines 
and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, 
cannabinoids (including tetrahydrocannabinol), cocaine metabolites, opiates 
(including heroin, codeine, and oxycodone), or alcohol at screening or check-in. 
 Subject has any of the following laboratory test results within 28 days before the 
first dose of study drug: 
•
Estimated serum creatinine clearance (Cockcroft-Gault) <90 mL/min
•
Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper
central laboratory reference range)
•
Hemoglobin ≤10% of the lower central laboratory reference range
•
White blood cell count not within the central laboratory reference range
•
Absolute neutrophil count <1000 cells/mm3
•
Platelets not within ±10% of central laboratory reference range
•
Alanine aminotransferase >1.5 times above the upper central laboratory reference
range
•
Aspartate aminotransferase >1.5 times above the upper central laboratory
reference range
•
Alkaline phosphatase >20% above the upper central laboratory reference range
•
Hemoglobin A1c ≥7.0%
•
Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL.
Subject has a blood pressure considered to be clinically significant by the
investigator. Blood pressure may be retested twice in the sitting position at 5-
minute intervals.
 Subject has a resting heart rate of <40 beats per minute or >100 beats per minute at 
screening. 
 Subject has an abnormal ECG at screening that is determined by the investigator to 
be clinically significant. 
 Male subject has a QTcF >450 ms or female subject has a QTcF >470 ms at 
screening or Day –1. 
 In the opinion of the investigator, the subject is not suitable for entry into the study. 
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3.3 
OTHER SCREENING CONSIDERATIONS 
3.3.1 
Subject Restrictions During the Study 
•
Subjects must be willing to remain confined at the study site from check-in (Day –1) until
safety assessments are completed on Day 9.
•
Subjects who have abnormal physical examination findings or an ongoing AE/SAE on
Day 9 that is deemed related to study drug or per investigator or SIGA discretion will
return to the study site on Day 14 (+2 days) for a follow-up visit.
3.4 
WITHDRAWAL OF SUBJECTS FROM THE STUDY 
3.4.1 
Reasons for Withdrawal 
Subjects can withdraw consent and discontinue from the study at any time, for any reason, 
without prejudice to further treatment. 
The investigator may withdraw a subject from the study for any of the following: 
•
The subject is in violation of the protocol.
•
The subject experiences a serious or intolerable AE.
•
The subject becomes pregnant.
•
The subject is noncompliant.
•
The subject has laboratory abnormalities for assessments listed in
Sections 4.1 or 4.2 that meet Grade 3 or Grade 4 on the Division of
Acquired Immune Deficiency Syndrome (DAIDS) AE Grading Table
Version 2.1 July 2017, any other Grade 3 or Grade 4 AE; or a Grade 2 or
higher rash considered by the investigator to be possibly, probably, or
definitely related to study drug.
•
The subject develops, during the course of the study, symptoms or conditions listed in
the exclusion criteria.
•
The subject requires a medication prohibited by the protocol.
•
The subject requests an early discontinuation for any reason.
•
The subject’s primary care provider requests that the subject be withdrawn.
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•
The independent safety monitor (ISM), SIGA, or the FDA requests subject
withdrawal based on study safety findings.
 
3.4.2 
Handling of Withdrawals 
 
When a subject withdraws from the study, the reason(s) for withdrawal will be recorded by 
the investigator in the electronic case report form (eCRF). Whenever possible, any subject 
who withdraws from the study prematurely will undergo all Day 9/early discontinuation 
assessments (Table 9-1). Any subject who fails to return for final assessments will be 
contacted by the study site personnel in an attempt to have them comply with the protocol. 
The status of subjects who fail to complete final assessments will be documented in the 
eCRF. 
3.4.3 
Halting Rules 
The medical monitor, investigator, SIGA, and ISM will review all AEs. All AEs determined 
by the investigator to be severe and possibly, probably, or definitely related to study drug, as 
well as all clinical assessments, laboratory test results, ECG results, or vital sign 
measurements that meet Grade 3 criteria on the DAIDS AE Grading Table will be assessed 
by the medical monitor, who will make a recommendation as to whether or not halting of the 
study should occur. At the discretion of the medical monitor, depending on the assessment of 
the severity of the event, the recommendation to halt the study may be made after 
consultation with the investigator, SIGA, and the ISM. 
The study will be temporarily halted (no new enrollments and no further study drug 
administration) by the investigator and the medical monitor, SIGA, and the ISM will be 
promptly notified according to the following criteria: 
•
One subject experiences a Grade 4 AE assessed as possibly, probably, or definitely
related to study drug.
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•
There is a subject death assessed as possibly, probably, or definitely related to study
drug.
•
One subject experiences a seizure assessed as possibly, probably, or definitely
related to study drug.
•
Two or more subjects experience the same or similar SAEs that are possibly,
probably, or definitely related to the study drug.
•
Three or more subjects experience the same or similar AEs that are Grade 3 or
above and are possibly, probably, or definitely related to the study drug.
Study enrollment and study drug administration would resume if review of the AEs that 
caused the halt resulted in a recommendation to permit further continuation. In such an 
instance, SIGA, with participation by the investigator and the medical monitor, would consult 
with the ISM to conduct the review of all AEs that meet the criteria for halting the study. The 
study would remain suspended until the events were reviewed by the ISM and a 
recommendation was made as to whether the study should be continued or stopped. This 
constitutes a minimum criterion, and the decision to halt the study may be made based on any 
other criteria that, in the judgment of the investigator, with agreement of the medical monitor 
and ISM, indicate a potentially serious safety concern. The investigator will advise SIGA 
immediately if any of the halting rules are met. 
4.
STUDY DESIGN
This is an open-label, multiple-dose study to assess the safety, tolerability, and PK of TPOXX 
600 mg BID when administered orally for 7 days to adult subjects weighing more than 
120 kg. A total of 36 subjects, ages 18 to 50, inclusive, will be enrolled. The study will 
consist of a screening period (Day –28 to Day –2), a treatment and confinement period 
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]). 
Subjects will undergo screening evaluations to determine eligibility within 28 days before 
study drug administration. Subjects will be admitted to the study site on Day –1 to complete 
baseline assessments; results of these assessments must be reviewed by the investigator 
before dosing. Starting in the morning of Day 1, subjects will receive 600 mg oral TPOXX 
BID for 7 days (Days 1 through 7). 
All subjects will be provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration and subjects must fast for 2 hours after taking 
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study drug. Subjects should eat this meal within 30 minutes or less of taking study drug. 
Study drug and meals must be taken with water only, and no other beverage except water 
should be ingested within 3 hours before or 3 hours after study drug administration. 
Subjects will remain confined to the study site for collection of PK samples and will be 
carefully monitored for safety and tolerability until discharge on Day 9. Subjects who have 
abnormal physical examination findings or an ongoing adverse event (AE)/serious adverse 
event (SAE) on Day 9 that is deemed related to study drug or per investigator or SIGA 
discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All other 
subjects will have the Day 14 (+2 days) follow-up via telephone. All subjects will have a 
follow-up telephone call 30 days after administration of the last dose of study drug 
(Day 37 [+2 days]) to report any SAEs. At the time of discharge from the clinical research 
unit, subjects will be instructed to notify the investigator of any SAEs that occur within 30 
days after administration of the last dose of study drug. Serious AEs will be followed until 
the SAE is stable or until resolution as determined by the investigator and/or medical 
monitor. 
The total duration of the study for each subject, including the screening period, treatment 
period, and the Day 37 (+2 days) follow-up telephone call, will be approximately 65 days. 
4.1.1 
Replacements 
At the discretion of the investigator, and after consultation with the medical monitor, any 
subject who withdraws before completing the study may be replaced to retain the target of 
32 evaluable enrolled subjects. 
5.
STUDY TREATMENT
5.1 
TREATMENT ADMINISTERED 
On Days 1 to 7, all subjects will receive an oral dose of TPOXX 600 mg (3 × 200-mg 
capsules) BID, approximately 12 hours (±30 minutes) apart, for 7 days. 
All subjects will be provided meals consisting of approximately 600 calories and 25 g fat, 
30 minutes before study drug administration. Subjects should eat this meal within 30 minutes 
or less of taking study drug. Study drug will be administered approximately 30 minutes after 
the start of the meal. All doses of study drug will be administered to subjects by study site 
personnel with approximately 240 mL of water. Subjects must fast 2 hours after taking study 
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drug. Study drug and meals must be taken with water only, and no other beverage except 
water should be ingested within 3 hours before or 3 hours after study drug administration. 
5.2 
STUDY DRUG 
TPOXX will be supplied as 200-mg capsules containing tecovirimat monohydrate as the 
active pharmaceutical ingredient. The TPOXX capsules are immediate release, size 0, orange 
and black, hard gelatin capsules containing white to off white powder. All inactive 
ingredients/excipients are generally recognized as safe and are United States 
Pharmacopeia/National Formulary grade. The TPOXX excipients are shown in Table 5-1. 
Table 5-1 
Excipients of TPOXX Capsules 
Component 
Quality Designation 
Microcrystalline cellulose 
NFa 
Lactose monohydrate 
NF 
Croscarmellose sodium 
NFa 
Colloidal silicon dioxide 
NF 
Hydroxypropyl methylcellulose 
USP 
Sodium lauryl sulfate 
NF 
Purified waterb 
USP 
Magnesium stearate 
NF 
Abbreviations: NF, National Formulary; USP, United States Pharmacopeia. 
a Microcrystalline cellulose and croscarmellose sodium are added as intragranular and extragranular excipients. 
b Removed during processing. 
Compendial components are tested and released in accordance with full compendial methods 
and specifications before their use in clinical formulations. TPOXX 200-mg capsules are 
manufactured and analyzed for clinical use in accordance with Current Good Manufacturing 
Practices. 
TPOXX capsules are manufactured by: 
Catalent Pharma Solutions 
1100 Enterprise Drive 
Winchester, KY 40391. 
Further information on TPOXX can be found in the TPOXX full prescribing information.2 
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5.2.1 
Study Drug Packaging and Storage 
TPOXX capsules are packaged, labeled, distributed, and placed on stability testing in 
accordance with Current Good Manufacturing Practice and International Council for 
Harmonisation (ICH) guidelines. 
The 200-mg TPOXX capsules are supplied in 75-mL high density polyethylene bottles fitted 
with a heat induction seal and child-resistant screw cap closure system. Each bottle of study 
drug will contain 42 capsules and will be labeled with the drug name, SIGA’s name, a space 
to fill in the protocol number, and a space to fill in the bottle number. 
SIGA (or designee) will provide the investigator and study site with adequate quantities of 
TPOXX.  
All study drug must be stored in a secure area (eg, a locked cabinet), protected from moisture 
and light, and stored at 15°C to 30°C (59°F to 86°F). Study drug should not be refrigerated or 
used beyond the expiration dates provided by the manufacturer. The study site will be 
required to keep a temperature log to establish a record of compliance with these study drug 
storage conditions. All study drug will be kept in a secure cabinet or room with access 
restricted to necessary study site personnel. 
5.2.2 
Study Drug Accountability 
The investigator will maintain accurate records of receipt of all study drug, including dates of 
receipt. Accurate records will be kept regarding when and how much study drug is dispensed 
and used by each subject in the study. Reasons for departure from the expected dispensing 
regimen must also be recorded. Study drug accountability will be recorded in the subject 
source documentation, entered into the eCRF, and should be reviewed by the monitor during 
each monitoring visit. On a regular basis and at the completion of the study, to satisfy 
regulatory requirements regarding drug accountability, all study drug will be reconciled and 
retained or destroyed according to applicable regulations. 
5.3 
TREATMENT COMPLIANCE 
All doses of the study drug will be administered in the study site under direct observation of 
study site personnel and recorded in the eCRF. Per standard clinic procedure, study site 
personnel will perform a mouth check and inspect all dose containers to ensure that the entire 
dose was administered. Following completion of dosing procedures and return of dosing 
containers to the pharmacy by team members, pharmacy staff will follow standard clinic 
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procedures for study drug reconciliation. SIGA will provide information to PPD for 
destruction of returned used and unused study drug and study drug bottles. 
The date and time of study drug dosing will be captured and recorded on the appropriate page 
of the eCRF. If a subject is not administered study drug, the reason for the missed dose will 
be recorded. 
5.3.1 
Prior and Concomitant Medications 
Restrictions for prior and concomitant medications and therapies are provided in Sections 4.1 
and 4.2. Prior and concomitant medications and therapies will be coded using the latest 
version of the World Health Organization Drug Dictionary. 
5.3.1.1 
Prior Medications 
Information regarding prior medications taken by the subject within the 30 days before 
signing the informed consent form (ICF) will be recorded in the subject’s eCRF. 
5.3.1.2 
Concomitant Medications 
Any concomitant medication deemed necessary for the welfare of the subject during the 
study may be given at the discretion of the investigator. If a concomitant medication listed in 
Section 4.2 is taken it will be documented as a protocol deviation and a joint decision will be 
made by the investigator and SIGA to continue or discontinue the subject based on the time 
the medication was administered, its pharmacology and PK, and whether the use of the 
medication will compromise the safety of the subject or the interpretation of the data. The 
investigator is responsible for ensuring that details regarding the medication are adequately 
recorded in both the subject’s source document and the eCRF. 
6.
STUDY PROCEDURES
Before performing any study procedures, all potential subjects will sign an ICF as outlined in 
Section 9.3.2.3. Subjects will undergo study procedures at the time points specified in the 
schedule of events (Table 9-1). 
The total amount of blood collected from each subject over the duration of the study, 
including any extra assessments that may be required, will not exceed 500 mL. 
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6.1 
PHARMACOKINETIC ASSESSMENTS AND ENDPOINTS 
Blood samples for PK analysis of TPOXX will be collected from all subjects Day 1 before 
study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 
20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours 
after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the 
PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on 
Day 9 (48 hours after the AM dose on Day 7). 
For PK samples, the acceptable window for collection from the scheduled collection time 
point will be as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes 
for the 12- to 48-hour time points. 
The following plasma PK parameters will be calculated for TPOXX using actual sampling 
times rather than scheduled sampling times and will include but are not limited to:  
•
Area under the plasma concentration-time curve (AUC) from time 0 to the last
quantifiable measurement (AUC0-t)
•
AUC from time 0 extrapolated to infinity (AUC0-∞)
•
AUC from time 0 to 24 hour (AUC0-24)
•
AUC during the first dosing interval (tau = 12 hours) (AUC0-tau)
•
Maximum drug concentration in plasma (Cmax)
•
Time to Cmax (Tmax)
•
Apparent volume of distribution (Vd/F)
•
Apparent total body clearance (CL/F)
•
Concentration observed prior to the next dose administration (Ctrough)
•
Terminal elimination half-life (t1/2)
•
Terminal elimination rate constant (λz)
•
Percentage of AUC0-∞ extrapolated from the last quantifiable measurement to infinity
(%AUCextrap).
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6.1.1 
Pharmacokinetic Sample Collection, Shipping, and Storage 
Blood samples (approximately 5 mL) for the determination of plasma concentrations of 
TPOXX will be collected in 5-mL lavender-topped K3EDTA Vacutainer® tubes using a 
21 gauge or larger needle, or from an indwelling intravenous catheter using a vacutainer tube. 
Blood samples should be placed on wet ice or equivalent (approximately 4°C to 8°C) and 
kept at this temperature until processed to separate plasma.  
The exact time and date of sample collection will be recorded for each sample by the 
investigator or designee on the subject’s eCRF, the vacutainer and cryovial labels, and the 
specimen shipping log. In addition, the time of study drug administration before PK sampling 
will be recorded on the subject’s eCRF. Labels will be created by the site and should contain 
the protocol number, matrix (plasma), subject number, date, and time drawn. For information 
that is not preprinted on the label, a fine tipped indelible marking pen is to be used to 
complete the entry. 
The 5-mL blood sample will be centrifuged in a refrigerated centrifuge immediately, if 
possible, or within 60 minutes of collection at 1000 to 1200 × g (2000 to 3000 rpm) for 
10 minutes to separate plasma. Each plasma sample should be transferred via pipette into 
2 cryovials labeled as described previously and should be capped tightly. The second tube 
will be a duplicate and retained at the site as a backup sample. If red blood cells are 
inadvertently drawn into the plasma, the sample should be re-centrifuged as soon as possible. 
Adequate space between the solution and the tube cap should be allowed for expansion 
during freezing.  
Cryovial tubes containing plasma samples must be frozen at –70°C or below until shipment 
in a freezer equipped with a temperature monitor and temperature-activated alarm. 
Uncentrifuged specimens should not be frozen. 
The study site will batch ship sets of frozen plasma samples. A log sheet listing the samples 
being shipped will be included in each shipment. The samples will be sent on dry ice via 
courier to Alturas Analytics (Moscow, ID). The back-up sets will remain at the site until 
confirmation that the first sets have been received. After receipt confirmation is received 
from Alturas Analytics, the back-up sets should be shipped. The site will contact Alturas 
Analytics and coordinate the shipment prior to sending the samples. Shipments before 
weekends or holidays must be avoided. 
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The samples will be shipped for analysis to: 
Alturas Analytics 
1324 Alturas Drive 
Moscow, ID 83843 
The bioanalytical laboratory will store all plasma samples at –70°C until analysis for 
tecovirimat is complete. SIGA will advise Alturas to destroy any remaining plasma samples 
after regulatory review is complete or the samples have met their applicable length of 
stability, whichever comes sooner. 
6.1.2 
Pharmacokinetic Sample Analysis 
Pharmacokinetic samples will be analyzed by Alturas Analytics using a validated liquid 
chromatography coupled with tandem mass spectrometry assay for tecovirimat in human 
plasma method in accordance with the US FDA Guidance for Industry on Bioanalytical 
Method Validation.3 
6.2 
SAFETY ASSESSMENTS AND ENDPOINTS 
Safety and tolerability will be assessed by monitoring and recording of AEs, clinical 
laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body 
temperature), 12-lead ECG results, and physical examination findings. Adverse events will 
be assessed from the time of the first dose of study drug until the follow-up telephone call on 
Day 37 (+2 days). 
6.2.1 
Adverse Events 
6.2.1.1 
Adverse Event Definitions 
The investigator is responsible for reporting all AEs that are observed or reported during the 
study, regardless of their relationship to study drug or clinical significance. If there is any 
doubt as to whether a clinical observation is an AE, the event should be reported. 
An AE is any event or other untoward medical occurrence, including those AEs that result 
from dosing errors, which may present during administration of a study drug or during a 
reasonable follow-up period and which does not necessarily have a causal relationship with 
this treatment. An AE is any unfavorable and unintended sign (eg, a clinically significant 
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abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal product, whether or not considered to be related to the medicinal product. All AEs 
will be followed until the AE is resolved or stabilized as determined by the investigator 
and/or the medical monitor. 
A treatment-emergent AE (TEAE) is defined as any event not present before exposure to 
study drug or any event already present that worsens in intensity or frequency after exposure 
to study drug. 
An adverse reaction is any AE caused by a drug. Adverse reactions are a subset of all 
suspected adverse reactions for which there are reasons to conclude that the drug caused the 
event. 
A suspected adverse reaction is any AE for which there is a reasonable possibility that the 
study drug caused the AE. For the purposes of IND safety reporting, “reasonable possibility” 
means that there is evidence to suggest a causal relationship between the drug and the AE. A 
suspected adverse reaction implies a lesser degree of certainty about causality than adverse 
reaction, which means any AE caused by a study drug. 
An AE or suspected adverse reaction is considered “unexpected” if it is not listed in the 
TPOXX full prescribing information or at the specificity or severity that has been observed 
with the study drug being tested. For example, under this definition, hepatic necrosis would 
be unexpected (by virtue of greater severity) if the TPOXX full prescribing information 
referred only to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism 
and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the TPOXX 
full prescribing information listed only cerebral vascular accidents. “Unexpected,” as used in 
this definition, also refers to AEs or suspected adverse reactions that are mentioned in the 
TPOXX full prescribing information as occurring with a class of drugs or as anticipated from 
the pharmacological properties of the drug, but are not specifically mentioned as occurring 
with the particular drug under investigation. 
An AE or suspected adverse reaction is considered an SAE if, in the view of either the 
investigator or SIGA, it results in any of the following outcomes: 
•
Results in death.
•
Is life threatening (subject is at immediate risk of death at the time of the event).
•
Requires inpatient hospitalization or prolongation of existing hospitalization, other than
elective hospitalization, during the period of protocol defined surveillance.
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•
Results in congenital anomaly or birth defect.
•
Results in a persistent or significant disability/incapacity.
•
Any other important medical event that may not result in death, be life threatening, or
requires hospitalization may be considered an SAE when, based on appropriate medical
judgment, the event may jeopardize the subject and may require medical or surgical
intervention to prevent one of the outcomes listed in this definition or is otherwise
considered to be medically significant.
Important medical events that may not result in death, be life threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgement, 
they may jeopardize the subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. Examples of such medical events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of 
drug dependency or drug abuse. 
An AE or suspected adverse reaction is considered “life-threatening” if, in the view of either 
the investigator or SIGA, its occurrence places the subject at immediate risk of death. It does 
not include an AE or suspected adverse reaction that, had it occurred in a more severe form, 
might have caused death. 
Serious AEs will be followed until the SAE is stable or until resolution as determined by the 
investigator and/or the medical monitor. 
6.2.1.2 
Eliciting and Documenting Adverse Events 
The investigator is responsible for ensuring that all AEs and SAEs are recorded in the eCRF 
and reported to SIGA by PPD. Adverse events and SAEs will be assessed from the first dose 
of study drug through the telephone call on Day 37 (+2 days).  
At every study visit or assessment, subjects will be asked a standard question to elicit any 
medically related changes in their well-being. They will also be asked if they have been 
hospitalized, had any accidents, used any new medications, or changed concomitant 
medication regimens (both prescription and over-the-counter medications). 
In addition to subject observations, AEs will be documented from any data collected on the 
AE page of the eCRF (eg, laboratory values, physical examination findings, and ECG 
changes) or other documents that are relevant to subject safety. 
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6.2.1.3 
Reporting Adverse Events 
All AEs reported or observed from the first dose of study drug through the follow-up 
telephone call on Day 37 (+2 days) will be recorded on the AE page of the eCRF. 
Information to be collected includes drug treatment, type of event, date and time of onset, 
investigator-specified assessment of severity and relationship to study drug, date and time of 
resolution of the event, seriousness, as well as any required treatment or evaluations, and 
outcome. Adverse events resulting from concurrent illnesses, reactions to concurrent 
illnesses, reactions to concurrent medications, or progression of disease states must also be 
reported. 
All AEs will be followed until they are resolved or stabilized as determined by the 
investigator and/or medical monitor. These data will be reviewed on an ongoing basis by the 
study coordinator, the investigator, the medical monitor, and the ISM. This requirement 
indicates that for some events, follow-up may be required after the subject has completed 
study participation. These events will be reported by SIGA, as required, to the FDA. 
Any medical condition that is present at the time that the subject is screened but does not 
deteriorate should not be reported as an AE. However, if it deteriorates at any time during the 
study, it should be recorded as an AE. Prior to this, medical conditions reported by subjects 
are considered medical history. 
6.2.1.4 
Reporting of Serious Adverse Events 
Any AE considered serious by the investigator or which meets SAE criteria (Section 6.2.1.1), 
or any other event or condition regardless of grade, which in their judgment represents a 
reportable event, must be reported to the medical monitor and SIGA as soon as the 
investigator becomes aware of the event. In addition, the event must be reported to PPD via 
the SAE hotline. The PPD SAE Report Form must be submitted within 24 hours of 
knowledge of the event. SIGA (or designee) will be responsible for notifying the relevant 
regulatory authorities of any SAE as outlined in US Title 21 Code of Federal Regulations 
(CFR) Parts 312 and 320. The investigator is responsible for notifying the institutional 
review board (IRB) directly. 
In addition, the investigator (or designee) must report any Grade 3 (severe) AE that they 
deem possibly, probably, or definitely related to study drug to the medical monitor and SIGA 
within 24 hours after becoming aware of the event. 
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After notification from the investigator, SIGA will report all study drug-related and 
unexpected SAEs (those not listed in the TPOXX full prescribing information) to the FDA 
within 15 calendar days of first knowledge. Fatalities or life-threatening events assessed as 
related and unexpected will be reported to the FDA within 7 calendar days of first 
knowledge. The ISM will also receive these reports. 
The following contact information is to be used for SAE reporting: 
PPD Medical Monitor: 
Rahul Bhatnagar, MD 
PPD Phase I Clinic 
7551 Metro Center Drive, Suite 300 
Austin, TX 78744 
Telephone: 888-483-7729 
PPD SAE Hotline: 888-483-7729 
PPD SAE Fax line: 888-529-3580 
The collection and monitoring period for SAEs is 30 days after administration of the last 
dose of study drug. At the time of discharge or early termination from the study site, the 
subject will be instructed to notify the investigator of any SAEs that occur within 30 days 
after the last dose of study drug. 
All subjects will have a follow-up telephone call 30 days after administration of the last dose 
of study drug (Day 37 [+2 days]) to report any SAEs. 
6.2.1.5 
Assessment of Severity 
All AEs will be graded for intensity according to the current DAIDS Table for Grading the 
Severity of Adult and Pediatric Adverse Events Version 2.1 July 2017.  
Any laboratory or clinical AE that is not listed on the DAIDS Table will be assessed for 
severity and classified into 1 of 5 clearly defined categories as follows: 
•
Grade 1 (Mild): Events require minimal or no treatment and do not interfere with the
subject’s daily activities.
•
Grade 2 (Moderate): Events result in a low level of inconvenience or concern with the
therapeutic measures and may cause some interference with normal functioning.
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•
Grade 3 (Severe): Events interrupt a subject’s usual daily activity, may require systemic
drug therapy or other treatment, and are usually incapacitating.
•
Grade 4 (Life-threatening): Event that, in the opinion of the investigator, places the
subject at immediate risk of death from the reaction as it occurred (ie, it does not include
a reaction that, had it occurred in a more severe form, might have caused death).
•
Grade 5 (Death).
Changes in the severity of an AE should be documented to allow an assessment of the 
duration of the event at each level of intensity to be performed. An AE characterized as 
intermittent requires documentation of onset and duration of each episode.  
6.2.1.6 
Assessment of Causality 
Any occurrence of an AE will be assessed for relationship to the study drug. A causal 
relationship means that the study drug caused (or is reasonably likely to have caused) the AE. 
This usually implies a relationship in time between the drug and the AE; for example, the AE 
occurred shortly after the subject received the study drug. 
The investigator who examines and evaluates the subject will determine AE causality based 
on the temporal relationship to administration of the study drug, the pharmacology of the 
study drug, and their clinical judgment. Terms used to describe the degree of causality 
between a study drug and an AE are definitely related, probably related, possibly related, 
unlikely related, or not related. 
The best estimate at the time of reporting of an event and the degree of certainty about the 
causal relationship between the study drug administration and the AE will be graded as 
follows: 
Associated 
•
Definitely Related: The AE and administration of study drug are related in time, and a
direct association can be demonstrated (eg, the event disappears or decreases with
reduction in dose or cessation of study drug and recurs with re-exposure).
•
Probably Related: The AE and administration of study drug are reasonably related in time
and/or follow a known pattern of response, and the AE is more likely explained by study
drug than other causes.
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•
Possibly Related: The AE and administration of study drug are reasonably related in time
and/or follow a known pattern of response, but the AE can be explained equally well by
causes other than study drug (eg, could readily have been produced by the subject’s
clinical state or could have been due to environmental or other interventions).
Not Associated 
•
Unlikely Related: A potential relationship between study drug and the AE could exist
(ie, the possibility cannot be excluded), but the AE is most likely explained by causes
other than the study drug (eg, could readily have been produced by the subject’s clinical
state or could have been due to environmental or other interventions).
•
Not Related: The AE is clearly due to extraneous causes (eg, underlying disease,
environment) or exposure to the study drug has not occurred. Such events MUST have an
alternative, definitive etiology documented in the subject’s medical record.
6.2.1.7 
Follow-up of Adverse Events 
All AEs must be reported in detail on the appropriate page of the eCRF and followed until 
they are resolved or stabilized as determined by the investigator and/or medical monitor. 
6.2.1.8 
Reactogenicity 
At this time, there is no definitive information on allergic activity of TPOXX. Reactogenicity 
will be monitored in subjects during the study treatment period. 
6.2.1.9 
Reporting of Pregnancy 
Pregnant women are not eligible to participate in the study. Subjects must be counseled 
regarding prevention of pregnancy and encouraged to make every effort to avoid pregnancy 
during study participation. If a female subject becomes pregnant during study participation, 
study drug dosing will be discontinued, and the subject will be withdrawn from the study. 
The pregnancy itself is not considered an SAE. However, the investigator must complete the 
pregnancy report form and fax it to PPD Pharmacovigilance within 24 hours of knowledge of 
the pregnancy. After delivery or termination of pregnancy, the follow-up pregnancy report 
form should be completed and submitted via fax to PPD Pharmacovigilance. Spontaneous 
abortions should always be reported as SAEs. Pregnancy data will be captured and followed 
by PPD. All pregnancies and outcomes will be tracked. The case will not be closed until after 
the child is followed for 3 months. 
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If there are complications during the pregnancy, the complications will be recorded as AEs in 
the usual manner. The subject will be asked to report the outcome of the pregnancy. If there is 
a congenital anomaly in the infant, this will be recorded as an SAE in the data forms for the 
mother (ie, the study subject). 
If a subject becomes pregnant during the study after receiving the study drug, all safety 
evaluations will be collected as per protocol. In addition, at the time that the pregnancy is 
reported, consent will be requested to contact the subject and her physician in the postpartum 
period to assess delivery and health status of the neonate. 
If the partner of a male subject becomes pregnant, the partner will be asked for consent to 
allow her treating physician to provide SIGA or its designee with follow-up information 
regarding the pregnancy and its outcome. 
6.2.2 
Clinical Laboratory Testing 
Clinical laboratory tests will be performed by the PPD Central Laboratory. Blood samples 
will be collected at the time points indicated in the schedule of events (Table 9-1) and will be 
prepared using standard procedures.  
Repeat clinical laboratory tests may be performed at the discretion of the investigator, if 
necessary, to evaluate inclusion and exclusion criteria or clinical laboratory abnormalities. 
PPD central laboratory will provide the reference ranges for all clinical laboratory safety 
parameters. 
The following clinical laboratory assessments will be performed: 
Hematology 
Hematocrit, hemoglobin, mean corpuscular hemoglobin, mean 
corpuscular hemoglobin concentration, total and differential 
leukocyte count (basophils, eosinophils, lymphocytes, monocytes, 
neutrophils), mean corpuscular volume, platelet count, red blood 
cell count, and red cell distribution width 
Serum Chemistry 
Alanine aminotransferase, albumin, alkaline phosphatase, anion 
gap, aspartate aminotransferase, bilirubin (total), blood urea 
nitrogen, calcium, carbon dioxide, chloride, creatinine clearance 
(calculateda), gamma-glutamyltransferase, globulin, glucose, lactate 
dehydrogenase, phosphorus, potassium, sodium, total protein, and 
uric acid 
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Urinalysis 
Appearance, bilirubin, blood, color, glucose, ketones, leukocytes, 
microscopy (performed if dipstick is ≥1+; includes bacteria, cast, 
crystals, epithelial cells, red blood cells, and white blood cells), 
nitrates, pH, protein, specific gravity, turbidity, and urobilinogen  
a Creatinine clearance (CLcr) will be calculated using the Cockcroft-Gault formula: 
𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶 (𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚𝑚
⁄
) = [140 −𝑎𝑎𝑎𝑎𝑎𝑎(𝑦𝑦𝑦𝑦𝑦𝑦𝑦𝑦𝑦𝑦)] × 𝑤𝑤𝑤𝑤𝑤𝑤𝑤𝑤ℎ𝑡𝑡 (𝑘𝑘𝑘𝑘)
72 × 𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠 𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐(𝑚𝑚𝑚𝑚𝑑𝑑𝑑𝑑
⁄
) {× 0.85 𝑖𝑖𝑖𝑖 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑒𝑒} 
Glycosylated hemoglobin A1c and a fasting lipid panel including cholesterol (total, 
high-density lipoprotein, calculated low-density lipoprotein, and triglycerides) will be 
performed at screening. 
Serum pregnancy test (β human chorionic gonadotropin) for women of childbearing potential 
will be performed at screening and on Day –1. 
A serum follicle-stimulating hormone test for postmenopausal women will be performed at 
screening.  
Human immunodeficiency virus (type 1 and 2) antibodies, hepatitis B surface antigen, and 
hepatitis C virus antibody will be assessed at screening only.  
A urine drug screen for alcohol, amphetamines (including methamphetamines and 
ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids 
(including tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, 
codeine, and oxycodone) will be performed at screening and on Day –1. 
Abnormal clinical laboratory values will be flagged as either high or low (or normal or 
abnormal) based on the reference ranges for each laboratory parameter. The investigator will 
determine whether any of the abnormally high or low results are clinically significant or not 
clinically significant. Clinical significance is defined as any variation in results that has 
medical relevance and may result in an alteration in medical care (eg, active observation, 
diagnostic measures, or therapeutic measures). If a clinically significant change from the 
screening value is noted, the clinically significant value and reason for clinical significance 
will be documented on the AE page of the eCRF. The investigator will continue to monitor 
the subject with additional assessments until the values have reached the reference range or 
the values at screening or until the investigator determines that follow-up is no longer 
medically necessary. 
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6.2.3 
Medical History 
A complete medical history will be obtained, including a review of systems, recreational and 
prescription drug use, over-the-counter drug use, nicotine and alcohol use, and past 
hospitalizations.  
6.2.4 
Vital Sign Measurements 
Vital signs will be measured after the subject has been seated for at least 5 minutes at the 
time points indicated in the schedule of events (Table 9-1). 
Vital sign measurements will include systolic and diastolic blood pressures, heart rate, 
respiratory rate, and body temperature.  
When procedures are overlapping and occurring at the same time point, the order of 
procedures should be ECG, vital sign measurements, and then blood collection, with the 
blood collection scheduled to occur at the nominal time point, unless dictated by other study 
events happening at that time, such as dosing requirements. 
The investigator will determine whether any of the vital sign measurements are clinically 
significant or not clinically significant. Clinical significance is defined as any variation in 
results that has medical relevance and may result in an alteration in medical care (eg, active 
observation, diagnostic measures, or therapeutic measures). If a clinically significant change 
from the screening values is noted, the clinically significant value and reason for clinical 
significance will be documented on the AE page of the subject’s eCRF. The investigator will 
continue to monitor the subject with additional assessments until the value has reached the 
reference range or the value at screening or until the investigator determines that follow up is 
no longer medically necessary. 
6.2.5 
Electrocardiograms 
A 12-lead ECG will be obtained after the subject has been in the supine position for at least 
10 minutes at the time points indicated in the schedule of events (Table 9-1). On Days 1, 4, 
and 7, an ECG will be recorded 4 hours after the AM study drug administration. The 
acceptable window for collection from the scheduled collection time point will ±15 minutes. 
Electrocardiogram assessments will include comments on whether the tracings are normal or 
abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence 
of myocardial infarction, or ST segment, T wave, and U wave abnormalities. In addition, the 
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following parameters will be measured and reported: heart rate; PR, RR, and QT intervals; 
QTcF; QT interval corrected using Bazett’s formula; and QRS duration. All ECGs must be 
performed by an experienced ECG technician. 
The investigator will determine whether any of the 12-lead ECG results are clinically 
significant or not clinically significant. Clinical significance is defined as any variation in 
results that has medical relevance and may result in an alteration in medical care (eg, active 
observation, diagnostic measures, or therapeutic measures). If a clinically significant change 
from screening is noted, the clinically significant value and reason for clinical significance 
will be documented on the AE page of the subject’s eCRF. The investigator will continue to 
monitor the subject with additional assessments until either the values have reached reference 
range or the values at screening or until the investigator determines that follow-up is no 
longer medically necessary. 
6.2.6 
Physical Examinations 
A full physical examination will be performed at the time points indicated in the schedule of 
events (Table 9-1) and will include assessment of the following body systems: head, ears, 
eyes, nose, and throat; cardiac (including auscultation of heart); pulmonary (chest) 
auscultation of lungs; abdomen; skin; musculoskeletal system; lymphatic system; and 
neurologic system (cranial nerves, sensation, motor function, coordination, reflexes, and 
mental status). 
A symptom-directed physical examination will be performed at the time points indicated in 
the schedule of events (Table 9-1) (for those subjects who require it), and at unscheduled 
visits as necessary. This examination will include an assessment of the heart, lungs, abdomen, 
a neurologic review, and a review of symptoms for assessments and/or follow-up of reported 
or potential AEs. 
Weight will be measured without shoes and in light clothing at screening and without shoes 
and in hospital gowns at all other time points indicated in the schedule of events (Table 9-1). 
The scales should be calibrated, and the same weight scale should be used throughout the 
study starting with Screening through Day 9.  Weight measurements will be rounded to one 
decimal place. 
Height will be measured at Check-in on Day -1. 
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6.2.7 
Unscheduled Visits 
Subjects will be provided with the contact information for the study site personnel. Subjects 
are free to contact study site personnel at any time, and the site may require an unscheduled 
visit for the purpose of physical examinations, laboratory tests, etc. Unscheduled visits will 
be documented by the site personnel in the source documents. Unscheduled procedures and 
laboratory tests and results will also be recorded in the eCRF. 
7.
STATISTICAL ANALYSIS PLANS
7.1 
SAMPLE SIZE CALCULATIONS 
The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study is 
based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size is considered sufficient to effectively assess the PK and safety 
profiles of TPOXX. 
7.2 
ANALYSIS POPULATIONS 
The Safety Population will include all subjects who receive at least 1 dose of study drug. 
The PK Population will include subjects who receive study drug and have sufficient 
concentration data to facilitate the calculation of PK variables. 
7.3 
STATISTICAL ANALYSIS 
Details of all statistical analyses will be described in a statistical analysis plan. All data 
collected will be presented in data listings. Data from subjects excluded from an analysis 
population will be presented in the data listings, but not included in the calculation of 
summary statistics. 
For categorical variables, frequencies and percentages will be presented. Continuous 
variables will be summarized using descriptive statistics (number of subjects, mean, median, 
standard deviation [SD], minimum, and maximum). 
Baseline demographic and background variables will be summarized overall for all subjects. 
The number of subjects who enroll in the study and the number and percentage of subjects 
who complete the study will be presented. Frequency and percentage of subjects who 
withdraw or discontinue from the study, and the reason for withdrawal or discontinuation, 
will also be summarized. 
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7.3.1 
Pharmacokinetic Analyses 
Individual plasma concentration and time deviation data will be presented in a data listing. 
Plasma concentration data will be listed and summarized using the following descriptive 
statistics: number of subjects, arithmetic mean, SD, coefficient of variation (CV), geometric 
mean, geometric CV, median, minimum, and maximum. Individual and mean plasma 
concentration versus time profiles will be presented in figures on both linear and 
semilogarithmic scales. 
The PK parameters of TPOXX will be analyzed based on the actual sampling times. All 
parameters will be determined using noncompartmental methods using Phoenix® 
WinNonlin® Version 8.0 or higher (Certara, L.P., Princeton, New Jersey) or SAS® Version 9.4 
or higher (SAS Institute Inc., Cary, North Carolina). 
The individual PK parameters and body weight-normalized PK parameters will be presented 
in data listings and summarized using the following descriptive statistics: number of subjects, 
arithmetic mean, SD, CV, median, minimum, maximum, geometric mean, geometric SD, and 
geometric CV. 
7.3.2 
Safety Analyses 
Adverse events will be coded by preferred term and system organ class using the latest 
version of the Medical Dictionary for Regulatory Activities and summarized overall. All AE 
data will be presented in a data listing. Treatment-emergent AEs will be summarized overall, 
as well as by severity and relationship to study drug. Serious AEs and AEs leading to 
discontinuation of study drug will also be presented in the data listings and summarized 
overall. 
Actual values and changes from baseline for clinical laboratory test results, vital sign 
measurements, and 12-lead ECG results will be summarized at each time point using 
descriptive statistics (number of subjects, mean, SD, median, minimum, and maximum). 
Shift tables will be generated for clinical laboratory test results. Clinical laboratory data, vital 
sign measurements, 12-lead ECG results, and physical examination findings will be 
presented in data listings. 
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7.4 
HANDLING OF BELOW THE LIMIT OF 
QUANTIFICATION AND MISSING DATA 
Plasma concentrations that are below the limit of quantification (BLQ) will be treated as zero 
for descriptive statistics. Geometric mean values will not be calculated or displayed when 
zero is the minimal value. Mean BLQ concentrations will be presented as BLQ, and the SD 
and CV will be reported as not applicable. Missing concentrations will be excluded from the 
calculations. 
7.5 
INTERIM ANALYSES 
No formal interim safety analyses will be performed in this study. 
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8.
REFERENCE LIST
1. Breman JG, Henderson DA. Diagnosis and management of smallpox. N Engl J Med.
2002;346(17):1300-8.
2. TPOXX (tecovirimat) [full prescribing information]. SIGA Technologies, Inc. Corvallis
(OR); 2018. 18 p.
3. Department of Health and Human Services, Food and Drug Administration (US).
Guidance for Industry. Bioanalytical Method Validation. May 2018. Available from:
https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-
for-Industry.pdf.
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9.
APPENDICES
9.1 
APPENDIX 1: LIST OF ABBREVIATIONS 
Abbreviation 
Term 
%AUCextrap 
percentage of AUC0-∞ extrapolated from the last quantifiable 
measurement to infinity 
λz 
terminal elimination rate constant 
AE 
adverse event 
AUC 
area under the plasma concentration-time curve 
AUC0-24 
area under the plasma concentration-time curve from time 0 to 
24 hours 
AUC0-∞ 
area under the plasma concentration-time curve from time 0 
extrapolated to infinity 
AUC0-t 
area under the plasma concentration-time curve from time 0 to the 
last quantifiable measurement 
AUC0-tau 
area under the plasma concentration-time curve during the first 
dosing interval 
BCRP 
breast cancer resistance protein 
BID 
twice daily 
BLQ 
below the limit of quantification 
CFR 
Code of Federal Regulations 
CL/F 
apparent total body clearance 
Cmax 
maximum drug concentration in plasma 
Ctrough 
concentration observed prior to the next dose administration 
CRA 
clinical research associate 
CV 
coefficient of variation 
CYP 
cytochrome P450 
DAIDS 
Division of Acquired Immune Deficiency Syndrome 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
FDA 
Food and Drug Administration 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IRB 
institutional review board 
ISM 
independent safety monitor  
MedDRA 
Medical Dictionary for Regulatory Activities 
PK 
pharmacokinetic(s) 
QTcF 
QT interval corrected using Fridericia’s formula 
SAE 
serious adverse event 
SD 
standard deviation 
SOP 
standard operating procedures 
t1/2 
terminal elimination half-life 
TEAE 
treatment-emergent adverse event 
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Abbreviation 
Term 
Tmax 
time to maximum drug concentration in plasma 
UGT 
uridine diphosphate-glucuronosyltransferase 
VARV 
variola virus 
Vd/F 
apparent volume of distribution 
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9.2 
APPENDIX 2: SCHEDULE OF EVENTS 
Table 9-1 
Schedule of Events 
Screening Check-in 
Treatment Period 
Telephone Call 
or Follow-up 
Visit(a) 
Follow-up 
Telephone 
Call(b) 
Procedure(c) 
Day –28 to –2
–1
1 
2 
3 
4 
5 
6 
7 
8 
9 or Early 
Discontinuation 
14 (+2) 
37 (+2) 
Admission to clinic 
X 
Discharge from clinic(d) 
X 
Informed consent 
X 
Inclusion/exclusion criteria 
X 
X 
Medical history(e) 
X 
X 
Complete physical examination(f) 
X 
X 
X 
X 
Weight(g) 
X 
X 
X(h) 
X 
Height 
X 
Vital sign measurements(i) 
X 
X 
X(j) 
X(j) 
X(j) 
X 
X 
X(k) 
Glycosylated hemoglobin (HbA1c) 
X 
Fasting lipid panel(l) 
X 
Clinical laboratory testing(m) 
X(n) 
X 
X 
X(o) 
X(n) 
Serum follicle-stimulating 
hormone(p)
X 
Serum pregnancy test(q) 
X 
X 
Urine drug/alcohol screen(r) 
X 
X 
Serology (HBsAg, HCV, and HIV) 
X 
12-Lead ECG(s)
X 
X 
X 
X 
X 
X 
TPOXX administration(t) 
X 
X 
X 
X 
X 
X 
X 
Pharmacokinetic sampling(u)
X 
X 
X 
X 
X 
X 
Symptom-directed physical 
examination(v)
X 
X 
X 
X 
X 
X(k) 
Adverse events 
X 
Prior/concomitant medications 
X 
Abbreviations: AE, adverse event; ECG, electrocardiogram; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; 
PK, pharmacokinetic; SAE, serious adverse event. 
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Notes: 
(a) The follow-up visit or telephone call will occur on Day 14 (+2 days), 7 days after the last dose of study drug. Subjects who have abnormal physical examination findings or an
ongoing AE/SAE on Day 9 that is deemed related to study drug or per investigator or SIGA discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All
other subjects will have the Day 14 (+2 days) follow-up via telephone.
(b) The follow-up telephone call will be made 30 days after the last dose of study drug (Day 37 [+2 days]).
(c) When procedures are overlapping and occurring at the same time point, the order of procedures should be ECG, vital sign measurements, and then blood collection, with the
blood collection scheduled to occur at the nominal time point, unless dictated by other study events happening at that time, such as dosing requirements.
(d) Discharge following collection of all safety assessments.
(e) Including a review of systems; recreational, prescription, and over-the-counter drug use; nicotine and alcohol use; and past hospitalizations.
(f) Including assessment of the following body systems: head, ears, eyes, nose, and throat; cardiac (including auscultation of heart); pulmonary (chest) auscultation of lungs;
abdomen; skin; musculoskeletal system; lymphatic system; and neurologic system (cranial nerves, sensation, motor function, coordination, reflexes, and mental status).
(g) Weight will be measured without shoes and in light clothing at screening and without shoes and in hospital gowns at all other time points. The scales should
be calibrated and the same weight scale should be used throughout the study starting with Screening through Day 9.  Weight measurements will be rounded to
one decimal place.
(h) Weight will be collected prior to dosing.
(i)
Vital sign measurements will include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Vital signs will be measured after the subject has
been seated for at least 5 minutes.
(j)
Vital sign measurements will be performed before dosing and 4 hours after the AM study drug administration on Days 1 and 7 and 4 hours after the AM study drug
administration on Day 4. The acceptable window for collection from the scheduled collection time point is ±15 minutes.
(k) Collected only if subjects are required to return to the study site on Day 14 (+2 days) for a follow-up visit.
(l)
Including cholesterol (total, high-density lipoprotein, calculated low-density lipoprotein, and triglycerides).
(m) Clinical laboratory testing will include hematology and serum chemistry.
(n) Clinical laboratory testing at screening and at Day 9 or early discontinuation will include hematology, serum chemistry, and urinalysis.
(o) Collect 12 hours after the PM study drug administration on Day 7.
(p) For postmenopausal women, a serum follicle-stimulating hormone test will be performed at screening.
(q) Women of childbearing potential only.
(r) Includes alcohol, amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids (including
tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, codeine, and oxycodone).
(s) A 12-lead ECG will be collected after the subject has been in the supine position for at least 10 minutes. On Days 1, 4, and 7, an ECG will be recorded 4 hours after the AM
study drug administration. The acceptable window for collection from the scheduled collection time point is ±15 minutes.
(t)
TPOXX, 600 mg (3 × 200-mg capsules) will be administered orally twice daily, approximately 12 hours (± 30 minutes) apart on Days 1 through 7. All subjects will be
provided meals consisting of approximately 600 calories and 25 g fat, which will start 30 minutes before study drug administration. Subjects should eat this meal within 30
minutes or less of taking study drug. Study drug will be administered approximately 30 minutes after the start of the meal. All doses of study drug will be administered to
subjects by study site personnel with approximately 240 mL of water. Subjects must fast 2 hours after taking study drug. Study drug and meals must be taken with water only,
and no other beverage except water should be ingested within 3 hours before or 3 hours after study drug administration.
(u) Blood samples for PK analysis of TPOXX will be collected from all subjects at the following tome points: on Day 1 before study drug administration (0 hour), at 0.5, 1, 2, 4, 6,
8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours after the AM dose), on Day 7 before the
AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the
AM dose on Day 7). For PK blood samples, the acceptable window for collection from the scheduled collection time point will be as follows: ±5 minutes for the time points
from 1 to 8 hours and ±15 minutes for the 12- to 48-hour time points.
(v) Including assessment of heart, lungs, abdomen, a neurologic review, and a review of symptoms for assessment and/or follow-up of reported or potential adverse events.
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9.3 
APPENDIX 3: STUDY GOVERNANCE 
9.3.1 
Data Quality Assurance 
This study will be conducted using the quality processes described in applicable procedural 
documents. The quality management approach to be implemented will be documented and 
will comply with current ICH guidance on quality and risk management. All aspects of the 
study will be monitored for compliance with applicable government regulatory requirements, 
current Good Clinical Practice, the protocol, and standard operating procedures (SOPs). The 
monitor will maintain current personal knowledge of the study through observation, review 
of study records and source documentation, and discussion of the conduct of the study with 
the investigator and staff. Electronic CRFs and electronic data capture will be utilized. The 
electronic data capture system is validated and compliant with US Title 21 CFR Part 11. Each 
person involved with the study will have an individual identification code and password that 
allows for record traceability. There may be an internal quality review audit of the data and 
additional reviews by the clinical monitor. 
Steps to be taken to ensure the accuracy and reliability of data include, but are not limited to: 
selection of qualified investigator and appropriate study center, protocol training and review 
of protocol procedures with the investigator and study site personnel before the start of the 
study, site initiation and periodic interim monitoring visits by SIGA or PPD, and direct 
transmission of safety laboratory data into the PPD study database for all clinical safety 
laboratory tests performed. The eCRF will be reviewed for accuracy and completeness by 
PPD Clinical research associate (CRA) remotely and during on-site monitoring visits. 
Discrepancies will be resolved with the investigator or designees, as appropriate. The data 
will be entered into the clinical study database and validated for accuracy. During on-site 
monitoring visits, 100% of the data will be verified using source documentation. SIGA or 
Biomedical Advanced Research and Development Authority representatives may accompany 
the PPD CRA on any scheduled site visit. The investigator will be informed in advance of 
any visitors to the study site in addition to the PPD CRA.  
Representatives of SIGA’s Quality Assurance department (or designee) may visit the site to 
carry out an audit of the study in compliance with regulatory guidelines and PPD policy. 
Such audits will require access to all study records, including source documents, for 
inspection and source document verification with the eCRF. Subject privacy must, however, 
be respected. Sufficient prior notice will be provided to allow the investigator to prepare 
properly for the audit. Similar auditing procedures may also be conducted by any regulatory 
body reviewing the results of this study in support of a Licensing Application. The 
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investigator will immediately notify SIGA if they are contacted by a regulatory agency 
requesting a site inspection. 
9.3.2 
Investigator Obligations 
The following administrative items are meant to guide the investigator in the conduct of the 
study and may be subject to change based on industry and government SOPs, working 
practice documents, or guidelines. Changes will be reported to the IRB but will not result in 
protocol amendments. 
9.3.2.1 
Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain subject confidentiality. All records will be kept in a secure 
storage area with limited access. Subjects will not be identified by name in any reports in this 
study. All records will be kept confidential to the extent provided by federal, state, and local 
law. Medical records are made available for review when required by the FDA or other 
authorized users only under the guidelines set by the Federal Privacy Act. Direct access, as 
defined in the Federal Privacy Act, includes examining, analyzing, verifying, and 
reproducing any records and reports that are important to the evaluation of the study. The 
investigator is obligated to inform the subjects that these representatives may review their 
study-related records without violating the confidentiality of the subjects. The requirement to 
maintain subject confidentiality is included in the study informed consent document. 
The investigator and all employees and coworkers involved with this study may not disclose 
or use for any purpose other than performance of the study, any data, record, or other 
unpublished, confidential information disclosed to those individuals for the purpose of the 
study. Prior written agreement from SIGA or its designee must be obtained for the disclosure 
of any said confidential information to other parties. 
9.3.2.2 
Institutional Review 
Federal regulations and ICH guidelines require that approval be obtained from an IRB before 
participation of human subjects in research studies. Before study onset, the protocol, ICF, 
advertisements to be used for the recruitment of study subjects, and any other written 
information regarding this study to be provided to the subject or the subject’s legal guardian 
must be approved by the IRB. Documentation of all IRB approvals and of the IRB 
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compliance with the ICH harmonised tripartite guideline E6(R2): Good Clinical Practice will 
be maintained by the site and will be available for review by SIGA or its designee. 
All IRB approvals should be signed by the IRB chairman or designee and must identify the 
IRB name and address, the clinical protocol by title or protocol number or both, and the date 
approval or a favorable opinion was granted. 
9.3.2.3 
Subject Consent 
Written documentation of informed consent in compliance with US Title 21 CFR Part 50 
shall be obtained from each subject before any study-related procedures are performed and 
study drug is administered. If any institution-specific modifications to study-related 
procedures are proposed or made by the site, the consent should be reviewed by SIGA or its 
designee or both before IRB submission. Once reviewed, the investigator will submit the ICF 
to the IRB for review and approval before the start of the study. If the ICF is revised during 
the course of the study, all active participating subjects must sign the revised ICF. 
Before recruitment and enrollment, each prospective subject or his/her legal guardian will be 
given a full explanation of the study and will be asked to read and review the approved ICF. 
Once the investigator is assured that the subject/legal guardian understands the implications 
of participating in the study, the subject/legal guardian will be asked to give his or her 
consent to participate in the study by signing the ICF. A copy of the ICF will be provided to 
the subject/legal guardian. 
9.3.2.4 
Exclusion of Children 
Effort will be made to include women and minorities in proportions similar to that of the 
community from which they are recruited. Because this study is designed to establish safety 
of the study drug in adults, enrollment will be limited to persons at least 18 years of age, and 
no older than 50 years. Children are excluded from participation in this clinical study because 
it does not meet the Department of Health and Human Services’ guidelines (45 CFR 46, 
Subpart D, 401-409) for inclusion of children in research. These guidelines provide guidance 
for the protection of children in research. Generally, healthy children can be studied when the 
research is considered as “not greater than minimal risk.” Children can be involved in 
research with greater than minimal risk only when it presents the prospect of direct benefit to 
the individual child or is likely to yield generalizable knowledge about the child’s disorder or 
condition. 
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9.3.2.5 
Study Reporting Requirements 
By participating in this study, the investigator agrees to submit reports of SAEs according to 
the time line and method outlined in this protocol. In addition, the investigator agrees to 
submit annual reports to his or her IRB as appropriate. 
9.3.2.6 
Financial Disclosure and Obligations 
The investigator is required to provide financial disclosure information to allow SIGA to 
submit the complete and accurate certification or disclosure statements required under US 
Title 21 CFR Part 54. In addition, the investigator must provide to SIGA a commitment to 
promptly update this information if any relevant changes occur during the course of the 
investigation and for 1 year following the completion of the study. 
Neither SIGA nor PPD is financially responsible for further testing or treatment of any 
medical condition that may be detected during the screening process. In addition, in the 
absence of specific arrangements, neither SIGA nor PPD is financially responsible for further 
treatment of the disease under study. 
9.3.2.7 
Investigator Documentation 
Prior to beginning the study, the investigator will be asked to comply with ICH 
E6(R2) Section 8.2 and US Title 21 of the CFR by providing essential documents, including 
but not limited to, the following: 
•
IRB approval.
•
An original investigator-signed investigator agreement page of the protocol.
•
Form FDA 1572, fully executed, and all updates on a new fully executed
Form FDA 1572.
•
Curriculum vitae for the principal investigator and each subinvestigator listed on Form
FDA 1572. Current licensure must be noted on the curriculum vitae. Curriculum vitae
will be signed and dated by the principal investigators and subinvestigators at study
start-up, indicating that they are accurate and current.
•
Financial disclosure information to allow SIGA to submit complete and accurate
certification or disclosure statements required under US Title 21 CFR Part 54. In
addition, the investigators must provide to SIGA a commitment to promptly update this
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information if any relevant changes occur during the course of the investigation and for 
1 year after the completion of the study. 
•
An IRB-approved ICF, samples of site advertisements for recruitment for this study, and
any other written information about this study that is to be provided to the subject or legal
guardians.
•
Laboratory certifications and reference ranges for any local laboratories used by the site,
in accordance with US Title 42 CFR Part 493.
9.3.2.8 
Study Conduct 
The investigator agrees to perform all aspects of this study in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, ICH E6(R2): Good Clinical 
Practice; the protocol; and all national, state, and local laws or regulations. 
9.3.2.9 
Case Report Forms and Source Documents 
Site personnel will maintain source documentation, enter subject data into the eCRF as 
accurately as possible, and will rapidly respond to any reported discrepancies. 
Electronic CRFs and electronic data capture will be utilized. The electronic data capture 
system is validated and compliant with US Title 21 CFR Part 11. Each person involved with 
the study will have an individual identification code and password that allows for record 
traceability. Thus, the system, and any subsequent investigative reviews, can identify 
coordinators, investigators, and individuals who have entered or modified records, as well as 
the time and date of any modifications. There may be an internal quality review audit of the 
data and additional reviews by PPD’s CRA. 
Each eCRF is presented as an electronic copy, allowing data entry by site personnel, who can 
add and edit data, add new subjects, identify and resolve discrepancies, and view records. 
This system provides immediate direct data transfer to the database, as well as immediate 
detection of discrepancies, enabling site coordinators to resolve and manage discrepancies in 
a timely manner. 
Paper copies of the eCRFs and other database reports may be printed and signed by the 
investigator. This system provides site personnel, PPD CRAs, and reviewers with access to 
hardcopy audits, discrepancy reviews, and investigator comment information. 
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9.3.2.10 
Adherence to Protocol 
The investigator agrees to conduct the study as outlined in this protocol, in accordance with 
ICH E6(R2) and all applicable guidelines and regulations. 
9.3.2.11 
Reporting Adverse Events 
By participating in this study, the investigator agrees to submit reports of SAEs according to 
the timeline and method outlined in this protocol. In addition, the investigator agrees to 
submit annual reports to his or her IRB as appropriate. The investigator also agrees to 
provide SIGA with an adequate report, if applicable, shortly after completion of the 
investigator’s participation in the study. 
9.3.2.12 
Investigator’s Final Report 
Upon completion of the study, the investigator, where applicable, should inform the 
institution; the investigator/institution should provide the IRB with a summary of the study’s 
outcome and SIGA and regulatory authorities with any reports required. 
9.3.2.13 
Records Retention 
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study drug. These documents should be 
retained for a longer period, however, if required by applicable regulatory requirements or by 
an agreement with SIGA. SIGA is responsible for informing the investigator/institution when 
these documents no longer need to be retained. 
9.3.2.14 
Publications 
All information concerning TPOXX, SIGA operations, patent application, formulas, 
manufacturing processes, basic scientific data, and formula information, supplied by SIGA to 
the investigator and not previously published, is considered confidential and remains the sole 
property of SIGA. The investigator agrees to use this information only to accomplish this 
study and will not use it for other purposes without SIGA’s written consent. The investigator 
understands that the information developed in the clinical study will be used by SIGA, in 
connection with the continued development of TPOXX, and thus may be disclosed as 
required to other clinical investigators or government regulatory agencies. To permit the 
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information derived from the clinical studies to be used, the investigator is obligated to 
provide SIGA with all data obtained in the study. Any publication or other public 
presentation of results from this study, including manuscripts and materials for presentation 
at scientific meetings, should be provided to SIGA at least 30 working days before abstract or 
other relevant submission deadlines. Authorship of publications resulting from this study will 
be determined at the discretion of SIGA. 
9.3.3 
Study Management 
9.3.3.1 
Monitoring 
9.3.3.1.1 
Monitoring of the Study 
Site monitoring for safety is conducted to ensure that human subject protection, study 
procedures, and laboratory, study drug dosing, and data collection processes are of high 
quality and meet SIGA, GCP/ICH, and regulatory guidelines. PPD CRA(s) will conduct site 
monitoring visits as detailed in the monitoring plan. 
Site investigators will allow the CRA(s), the designated IRB, SIGA or its designee and the 
FDA to review, audit, and inspect study documents (eg, ICFs, drug accountability and 
distribution forms, eCRF), pertinent hospital and site records, and source documentation for 
verification of the study data.  
Clinical research associates will conduct site visits in accordance with PPD SOPs to monitor 
the following: study operations, the quality of data collected in the research records, the 
accuracy and timeliness of data entered in the database, and to determine that all process and 
regulatory requirements are met. Study monitoring visits will occur at initiation of the study 
site, at intervals determined by SIGA during conduct of the study, and at completion of the 
study.  
The CRA will maintain current personal knowledge of the study through observation, review 
of study records and source documentation, and discussion of the conduct of the study with 
the investigator and staff. During the routine monitoring visits, the CRA will perform a 100% 
source document verification of all subject data entered into the eCRF. Discrepancies, if any, 
will be clarified with the study site coordinator and investigator, and corrected at the site by 
the study coordinator. Any questions or required data clarifications will be sent to the study 
site electronically.  
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9.3.4 
Safety Monitoring Plan 
Close cooperation between the designated members of the study team will occur to evaluate 
and respond to individual AEs in a timely manner. Designated team members (investigator, 
subinvestigators, study coordinator, and other designated study clinicians) will review the 
subject safety information and data (laboratory test results, ECGs, AEs, and concomitant 
medications) and update the PPD project team and the ISM on the status of all enrolled 
subjects at their site on a weekly basis (or more frequently if required because of an 
unexpected safety issue) through completion of each subject’s final study visit. 
9.3.5 
Medical Monitor 
The medical monitor, or their qualified designee, will receive reports within 24 hours of 
study site awareness of all SAEs and within 7 days of study site awareness of all other AEs. 
The safety monitors will review all safety data and alert the medical monitor of SAEs and 
AEs of interest. The medical monitor may make a request for data to the investigator as 
necessary for safety evaluations.  
The medical monitor will review each significant AE in a timely fashion and ensure that 
appropriate management is initiated and completed. Drug safety representatives and the 
medical monitor will have direct contact with the investigators and follow all significant 
events as needed. 
9.3.6 
Safety Oversite (Independent Safety Monitor) 
In addition to the investigator’s ongoing review of the safety data, the ISM will review the 
protocol for any major concerns and will be involved in data review in coordination with the 
investigator. The primary role of the ISM will be to evaluate the study safety and tolerability 
data. The ISM will provide independent safety monitoring in a timely fashion, which will 
include reviewing individual SAE reports and a review of periodic cumulative AE reports. 
Clinical safety and laboratory data, clinical records, and other safety study-related records 
will be made available for the ISM to review. Based on review of this data, the ISM may 
make recommendations regarding the safe continuation of the study. Specific details will be 
outlined in the Safety and Medical Management Plan. 
9.3.6.1 
Inspection of Records 
The investigator and study site involved in the study will permit study-related monitoring, 
audits, IRB review, and regulatory inspections by providing direct access to all study records. 
Page 368


SIGA Technologies, Inc. 
TPOXX 
Protocol No. SIGA-246-022 
Clinical Study Protocol 
In the event of an audit, the investigator agrees to allow SIGA, their representatives, the 
FDA, or other regulatory agencies access to all study records. 
The investigator should promptly notify SIGA and study site of any audits scheduled by any 
regulatory authorities and promptly forward copies of any audit reports received to SIGA. 
9.3.6.2 
Management of Protocol Amendments and Deviations 
9.3.6.2.1 
Modification of the Protocol 
Any changes in this research activity, except those necessary to remove an apparent 
immediate hazard to the subject, must be reviewed and approved by SIGA or designee. 
Amendments to the protocol must be submitted in writing to the IRB for approval before 
subjects are enrolled into an amended protocol. 
9.3.6.2.2 
Protocol Deviations 
The investigator or designee must document and explain in the subject’s source 
documentation any deviation from the approved protocol. The investigator may implement a 
deviation from, or a change to, the protocol to eliminate an immediate hazard to study 
subjects without prior IRB approval. As soon as possible after such an occurrence, the 
implemented deviation or change, the reasons for it, and any proposed protocol amendments 
should be submitted to the IRB for review and approval, to SIGA for agreement, and to the 
regulatory authorities, if required. 
A protocol deviation is any change, divergence, or departure from the study design or 
procedures defined in the protocol. An important protocol deviation (sometimes referred to 
as a protocol violation or a major protocol deviation) is a subset of protocol deviations that 
might significantly affect the reliability of the study data or that might significantly affect a 
subject's safety. An important deviation can include nonadherence to inclusion or exclusion 
criteria or nonadherence to FDA regulations or ICH E6(R2) guidelines. 
Protocol deviations will be documented by the clinical monitor throughout the course of 
monitoring visits. The investigator will be notified in writing by the monitor of deviations. 
The IRB should be notified of all protocol deviations, if appropriate, in a timely manner. 
Page 369


SIGA Technologies, Inc. 
TPOXX 
Protocol No. SIGA-246-022 
Clinical Study Protocol 
9.3.6.3 
Study Termination 
Although SIGA has every intention of completing the study, they reserve the right to 
discontinue it at any time for clinical or administrative reasons. 
An initiative for closure of the clinical investigative site or termination of the study can be 
taken at any time either by SIGA, PPD, or the investigator provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. Reasons for such action 
include, but are not limited to: 
•
Study site closure
o
Inadequate site recruitment/enrollment of subjects
o
Failure of an investigator to comply with the protocol, PPD SOPs, GCP guidelines, or
applicable federal regulations
•
Termination of enrollment
o
Enrollment of the required estimated number of subjects for the study
•
Study termination
o
Completion of the study
o
Safety concerns
In addition, the ISM and FDA have the prerogative to delay or terminate the study. 
The end of the study is defined as the date on which the last subject completes the last visit 
(includes the follow-up visit and the follow-up telephone call). Any additional long-term 
follow-up that is required for monitoring of the resolution of an AE or finding may be 
reported through an amendment to the clinical study report. 
9.3.6.4 
Final Report 
Whether the study is completed or prematurely terminated, SIGA will ensure that clinical 
study reports are prepared and provided to regulatory agency(ies) as required by the 
applicable regulatory requirement(s). SIGA will also ensure that clinical study reports in 
marketing applications meet the standards of the ICH harmonised tripartite guideline E3: 
Structure and content of clinical study reports. 
Page 370


SIGA Technologies, Inc. 
TPOXX 
Protocol No. SIGA-246-022 
Clinical Study Protocol 
Upon completion of the clinical study report, the investigator will be provided with the final 
approved clinical study report, as appropriate. 
9.4 
APPENDIX 4: CHANGE HISTORY 
9.4.1 
Protocol Amendment 1 
Protocol Amendment 1 was issued to clarify the weight requirements for qualified subjects 
on Day -1 and Day 1, clarify that the same scale will be used in Screening and how rounding 
procedures will be used, update Reference 3 to cite the current FDA Guidance, remove the 
±2 day window for the Day 9 / Early Discontinuation visit, and remove symptom-directed 
physical examination from Day 7.  The changes to Protocol Amendment 1 are outlined as 
follows: 
Protocol Section 
Change 
Rationale 
Synopsis and Section 
3.1 Inclusion Criteria 
Clarified subjects need to weigh 
>120 kg at check-in on Day -1,
and prior to dosing on Day 1, in
addition to weighing >120 kg at
Screening.
In order to obtain accurate 
pharmacokinetic data in 
subjects weighing >120 kg, 
subjects participating in this 
study need to meet the weight 
requirement during dosing. 
Section 6.2.6 
Physical 
Examinations and 
Section 9.2 Appendix 
2:  Schedule of 
Events 
Clarified the scale should be 
used throughout the entire study 
including Screening.  Clarified 
rounding should occur by adding 
the following text:  Weight 
measurements will be rounded to 
one decimal place. 
The same scale should be used 
for the screening of subjects as 
will be used in the study to 
ensure weight measurement 
consistency.  Scales at the site 
measure weight to two decimal 
places.   
Section 8 Reference 
List 
Updated reference 3 to cite the 
May 2018 Bioanalytical Method 
Validation Guidance for Industry 
An updated Guidance was 
published in May of 2018. 
Section 9.2 Appendix 
2:  Schedule of 
Events 
Removal of (±2) from Day 9 or 
Early Discontinuation visit 
header 
The ±2 day visit window was 
included in error.  Subjects will 
check out on day 9 or will 
undergo Early Discontinuation 
Procedures on the day they 
discontinue.  There is no 
window for these visits. 
Section 9.2 Appendix 
2:  Schedule of 
Events 
Removal of Day 7 symptom-
directed physical examination 
from schedule. 
A complete physical exam is 
already being conducted on 
Day 7. 
Page 371


SIGA Technologies, Inc. 
TPOXX 
Protocol No. SIGA-246-022 
Clinical Study Protocol 
9.4.2 
Protocol Amendment 2 
Protocol Amendment 2 was issued to revise Exclusion Criteria 31; to remove redundant 
Exclusion Criteria; to add the measurement of height to the Day -1 Check-in procedures; and 
to remove the one hour observation period for allergic reaction following dosing.  The 
changes to Protocol Amendment 2 are outlined as follows: 
Protocol Section 
Change 
Rationale 
Synopsis and 
Section 3.2 
Exclusion Criteria 
Removed bullet point 3 from Exclusion 
Criteria 2, which stated: Hypertension that 
is poorly controlled (repeat readings >140 
mm Hg systolic and/or >90 mm Hg 
diastolic) and revised Exclusion Criteria 
31 from Subject has a sustained sitting 
systolic blood pressure >140 mm Hg or 
<100 mm Hg or a diastolic blood pressure 
>90 mm Hg at screening. Blood pressure
may be retested twice in the sitting
position at 5-minute intervals. The
pressure elevation is considered sustained
if either the systolic or the diastolic
pressure exceeds the stated limits on all 3
assessments to Subject has a blood
pressure considered to be clinically
significant by the investigator. Blood
pressure may be retested twice in the
sitting position at 5-minute intervals.
Bullet point 3 was 
removed as it was 
redundant with 
Exclusion Criteria 31.  
Exclusion Criteria 31 
was revised to allow 
the investigator to 
determine clinical 
significance of blood 
pressure for study 
inclusion or exclusion. 
Section 6.2.6 
Physical 
Examinations and 
Section 9.2 
Appendix 2:  
Schedule of Events 
Added height to Day -1 Check-in 
procedures 
This measurement was 
previously 
unintentionally 
omitted from the study 
assessments.   
Section 6.2.1.8 
Reactogenicity and 
Section 9.2 
Appendix 2:  
Schedule of Events 
Removed specific mention of a one hour 
observation period for allergic reaction 
following dosing from Section 6.2.1.8 and 
removed reactogenicity from the Schedule 
of Events. 
Subjects are  required 
to stay at the clinical 
site throughout the 
entire dosing period 
and are continually 
under observation by 
site staff.  
Page 372


SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.2 
Sample Case Report Form (Unique Pages Only) 
This section contains the following document: 
Sample case report form dated 16 December 2019 
Page 373


Subject Case Report Forms
PROD_16DEC2019_3.00 - UNIQUE
Generated On: 31 Jan 2020 12:45:03
Page 374


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Subject Enrollment
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What is the site identifier?
What is the subject identifier?
1 of 120
Page 375


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Visit Date
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What is the Visit Date? (dd-mon-yyyy)
2 of 120
Page 376


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Unscheduled Checklist
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Select all assessments performed at the Unscheduled Visit.
Vital Signs
Electrocardiogram
Central Laboratory
Physical Examination
Pharmacokinetic Blood Collection
3 of 120
Page 377


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Informed Consent
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
To which period of the trial does this disposition refer?
SCREENING
BASELINE
FOLLOW-UP
Protocol Milestone
INFORMED CONSENT
OBTAINED
ELIGIBILITY CRITERIA MET
What is the date informed consent was signed? (dd-mon-yyyy)
4 of 120
Page 378


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Demographics
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What is the subject's date of birth? (dd-mon-yyyy)
What is the sex of the subject?
MALE
FEMALE
What is the ethnicity of the subject?
HISPANIC OR LATINO
NOT HISPANIC OR LATINO
NOT REPORTED
UNKNOWN
Race Not Reported
NOT
REPORTED.................................
.................
Race: Choose all that apply
AMERICAN INDIAN OR ALASKA NATIVE: A person having
origins in any of the original peoples of North and South America
(including Central America), and who maintains tribal affiliation or
community attachment. (FDA)
AMERICAN INDIAN OR
ALASKA NATIVE................
ASIAN:  A person having origins in any of the original peoples of
the Far East, Southeast Asia, or the Indian subcontinent including,
for example, Cambodia, China, India, Japan, Korea, Malaysia,
Pakistan, the Philippine Islands, Thailand, and Vietnam. (FDA)
ASIAN.........................................
..........................
BLACK OR AFRICAN AMERICAN: A person having origins in
any of the black racial groups of Africa. Terms such as "Haitian" or
"Negro" can be used in addition to "Black or African American."
(FDA)
BLACK OR AFRICAN
AMERICAN...........................
5 of 120
Page 379


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Demographics
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER: Denotes
a person having origins in any of the original peoples of Hawaii,
Guam, Samoa, or other Pacific Islands. The term covers particularly
people who identify themselves as part-Hawaiian, Native Hawaiian,
Guamanian or Chamorro, Carolinian, Samoan, Chuu. (FDA)
NATIVE HAWAIIAN OR
OTHER PACIFIC ISLANDER
WHITE: Denotes a person with European, Middle Eastern, or North
African ancestral origin who identifies, or is identified, as White.
(FDA)
WHITE.........................................
.........................
6 of 120
Page 380


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Inclusion/Exclusion Criteria
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Protocol Milestone
INFORMED CONSENT
OBTAINED
ELIGIBILITY CRITERIA MET
What is the protocol version and date?
AMENDMENT 1, VERSION
2.0, 27-JUN-2019
AMENDMENT 2, VERSION
3.0, 02-AUG-2019
Did the subject meet all eligibility criteria?
YES
NO
If the subject did not meet all eligibility criteria, please specify criterion type and number below.
What was the category of the criterion?
INCLUSION
EXCLUSION
What is the identifier of the criterion the subject did not meet?
IN01
IN02
IN03
IN04
IN05
IN06
IN07
IN08
IN09
EX01
EX02
EX03
EX04
7 of 120
Page 381


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Inclusion/Exclusion Criteria
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
EX05
EX06
EX07
EX08
EX09
EX10
EX11
EX12
EX13
EX14
EX15
EX16
EX17
EX18
EX19
EX20
EX21
EX22
EX23
EX24
EX25
EX26
EX27
EX28
EX29
EX30
EX31
EX32
EX33
EX34
EX35
8 of 120
Page 382


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Inclusion/Exclusion Criteria-Check-in
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Protocol Milestone
INFORMED CONSENT
OBTAINED
ELIGIBILITY CRITERIA MET
What is the protocol version and date?
AMENDMENT 1, VERSION
2.0, 27-JUN-2019
AMENDMENT 2, VERSION
3.0, 02-AUG-2019
Did the subject meet all eligibility criteria?
YES
NO
9 of 120
Page 383


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - Screening
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
On what date were the measurements performed? (dd-mon-yyyy)
Any collections: DERIVED
YES
NO
Current Date/Time (Hidden field for CF use)
In what position was the subject during the measurement?
SITTING
Were Vital Signs collected?
YES
NO
If No, provide reason
At what time were the measurements performed? (00:00-23:59)
Systolic Blood Pressure
mmHg
Diastolic Blood Pressure
mmHg
Heart Rate
beats/min
Respiratory Rate
breaths/min
Temperature
C
10 of 120
Page 384


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - Screening
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Vital Date/Time: DERIVED (dd-mon-yyyy 00:00-23:59)
11 of 120
Page 385


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - Check-in, Day 9 and Early Term
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
On what date were the measurements performed? (dd-mon-yyyy)
Any collections: DERIVED
YES
NO
Current Date/Time (Hidden field for CF use)
In what position was the subject during the measurement?
SITTING
Were Vital Signs collected?
YES
NO
If No, provide reason
At what time were the measurements performed? (00:00-23:59)
Systolic Blood Pressure
mmHg
Diastolic Blood Pressure
mmHg
Heart Rate
beats/min
Respiratory Rate
breaths/min
Temperature
C
12 of 120
Page 386


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - Check-in, Day 9 and Early Term
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Vital Date/Time: DERIVED (dd-mon-yyyy 00:00-23:59)
13 of 120
Page 387


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - D1
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
On what date were the measurements performed? (dd-mon-yyyy)
Any collections: DERIVED
YES
NO
Current Date/Time (Hidden field for CF use)
What is the planned time point for this measurement?
PREDOSE
4 HOUR POSTDOSE
In what position was the subject during the measurement?
SITTING
Were Vital Signs collected?
YES
NO
If No, provide reason
At what time were the measurements performed? (00:00-23:59)
Systolic Blood Pressure
mmHg
Diastolic Blood Pressure
mmHg
Heart Rate
beats/min
14 of 120
Page 388


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - D1
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Respiratory Rate
breaths/min
Temperature
C
Vital Date/Time: DERIVED (dd-mon-yyyy 00:00-23:59)
What is the planned time point for this measurement?
PREDOSE
4 HOUR POSTDOSE
In what position was the subject during the measurement?
SITTING
Were Vital Signs collected?
YES
NO
If No, provide reason
At what time were the measurements performed? (00:00-23:59)
Systolic Blood Pressure
mmHg
Diastolic Blood Pressure
mmHg
Heart Rate
beats/min
Respiratory Rate
breaths/min
15 of 120
Page 389


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - D1
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Temperature
C
Vital Date/Time: DERIVED (dd-mon-yyyy 00:00-23:59)
16 of 120
Page 390


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - D4
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
On what date were the measurements performed? (dd-mon-yyyy)
Any collections: DERIVED
YES
NO
Current Date/Time (Hidden field for CF use)
What is the planned time point for this measurement?
PREDOSE
4 HOUR POSTDOSE
In what position was the subject during the measurement?
SITTING
Were Vital Signs collected?
YES
NO
If No, provide reason
At what time were the measurements performed? (00:00-23:59)
Systolic Blood Pressure
mmHg
Diastolic Blood Pressure
mmHg
Heart Rate
beats/min
17 of 120
Page 391


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - D4
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Respiratory Rate
breaths/min
Temperature
C
Vital Date/Time: DERIVED (dd-mon-yyyy 00:00-23:59)
18 of 120
Page 392


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - D7
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
On what date were the measurements performed? (dd-mon-yyyy)
Any collections: DERIVED
YES
NO
Current Date/Time (Hidden field for CF use)
What is the planned time point for this measurement?
PREDOSE
4 HOUR POSTDOSE
In what position was the subject during the measurement?
SITTING
Were Vital Signs collected?
YES
NO
If No, provide reason
At what time were the measurements performed? (00:00-23:59)
Systolic Blood Pressure
mmHg
Diastolic Blood Pressure
mmHg
Heart Rate
beats/min
19 of 120
Page 393


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - D7
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Respiratory Rate
breaths/min
Temperature
C
Vital Date/Time: DERIVED (dd-mon-yyyy 00:00-23:59)
What is the planned time point for this measurement?
PREDOSE
4 HOUR POSTDOSE
In what position was the subject during the measurement?
SITTING
Were Vital Signs collected?
YES
NO
If No, provide reason
At what time were the measurements performed? (00:00-23:59)
Systolic Blood Pressure
mmHg
Diastolic Blood Pressure
mmHg
Heart Rate
beats/min
Respiratory Rate
breaths/min
20 of 120
Page 394


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - D7
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Temperature
C
Vital Date/Time: DERIVED (dd-mon-yyyy 00:00-23:59)
21 of 120
Page 395


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - D8 and D14
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
On what date were the measurements performed? (dd-mon-yyyy)
Any collections: DERIVED
YES
NO
Current Date/Time (Hidden field for CF use)
In what position was the subject during the measurement?
SITTING
Were Vital Signs collected?
YES
NO
If No, provide reason
At what time were the measurements performed? (00:00-23:59)
Systolic Blood Pressure
mmHg
Diastolic Blood Pressure
mmHg
Heart Rate
beats/min
Respiratory Rate
breaths/min
Temperature
C
22 of 120
Page 396


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - D8 and D14
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Vital Date/Time: DERIVED (dd-mon-yyyy 00:00-23:59)
23 of 120
Page 397


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Measurements
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
On what date were the measurements performed? (dd-mon-yyyy)
At what time were the measurements performed? (00:00-23:59)
Height
cm
Weight
kg
24 of 120
Page 398


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Measurements - Weight only
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
On what date were the measurements performed? (dd-mon-yyyy)
At what time were the measurements performed? (00:00-23:59)
Weight
kg
25 of 120
Page 399


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the method used to measure ECG?
10 LEAD STANDARD
12 LEAD 1 LEAD MISSING
12 LEAD CABRERA
12 LEAD CONTINUOUS ECG
12 LEAD EASI DOWER
TRANSFORMATION
12 LEAD ECG EXTRACTED
FROM 12 LEAD
CONTINUOUS ECG
RECORDING
12 LEAD MASON LIKAR
12 LEAD MODIFIED MASON
LIKAR
12 LEAD NON-STANDARD
12 LEAD RIGHT-SIDED
PRECORDIAL LEADS
12 LEAD SINGLE PAD
12 LEAD STANDARD
12 LEAD UNSPECIFIED
6 LEAD NEHB-SPORI
6 LEAD STANDARD
8 LEAD STANDARD
BIPOLAR UNCORRECTED
XYZ LEAD SYSTEM
CONTINUOUS
AMBULATORY ECG
CUBE LEAD SYSTEM
FRANK LEAD SYSTEM
HOLTER CONTINUOUS ECG
RECORDING
MCFEE-PARUNGAO LEAD
SYSTEM
PSEUDO-ORTHOGONAL XYZ
LEAD SYSTEM
STANDARD 12-LEAD AND
CC5-CM5-ML
26 of 120
Page 400


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
STANDARD 12-LEAD AND
CM5-CC5-CH5
STANDARD 12-LEAD
EXTENDED LEFT
STANDARD 12-LEAD
EXTENDED RIGHT
STANDARD LEADS FOR
BICYCLE EXERCISE
STANDARD LEADS ONE
INTERCOSTAL SPACE
HIGHER
VECTORCARDIOGRAPH
CORRECTED
VECTORCARDIOGRAPH
UNCORRECTED
What was the ECG date? (dd-mon-yyyy)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the position of the subject during ECG measurement?
DECUBITUS
FOWLERS
LATERAL DECUBITUS
LEFT LATERAL DECUBITUS
PRONE
REVERSE TRENDELENBURG
RIGHT LATERAL
DECUBITUS
SEMI-FOWLERS
SEMI-RECUMBENT
SITTING
27 of 120
Page 401


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
SLING
STANDING
SUPINE
TRENDELENBURG
UNCONSTRAINED
Was an ECG performed?
YES
NO
If No, provide reason
What was the ECG time? (00:00-23:59)
Heart Rate
beats/min
PR Interval
msec
QRS Duration
msec
QTcB Interval
msec
QTcF Interval
msec
RR Interval
msec
Interpretation
NORMAL
ABNORMAL
28 of 120
Page 402


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
INDETERMINATE
NOT EVALUABLE
UNKNOWN
If abnormal, was the interpretation considered clinically significant?
YES
NO
Abnormal findings
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
29 of 120
Page 403


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram_4Hrs
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the method used to measure ECG?
10 LEAD STANDARD
12 LEAD 1 LEAD MISSING
12 LEAD CABRERA
12 LEAD CONTINUOUS ECG
12 LEAD EASI DOWER
TRANSFORMATION
12 LEAD ECG EXTRACTED
FROM 12 LEAD
CONTINUOUS ECG
RECORDING
12 LEAD MASON LIKAR
12 LEAD MODIFIED MASON
LIKAR
12 LEAD NON-STANDARD
12 LEAD RIGHT-SIDED
PRECORDIAL LEADS
12 LEAD SINGLE PAD
12 LEAD STANDARD
12 LEAD UNSPECIFIED
6 LEAD NEHB-SPORI
6 LEAD STANDARD
8 LEAD STANDARD
BIPOLAR UNCORRECTED
XYZ LEAD SYSTEM
CONTINUOUS
AMBULATORY ECG
CUBE LEAD SYSTEM
FRANK LEAD SYSTEM
HOLTER CONTINUOUS ECG
RECORDING
MCFEE-PARUNGAO LEAD
SYSTEM
PSEUDO-ORTHOGONAL XYZ
LEAD SYSTEM
STANDARD 12-LEAD AND
CC5-CM5-ML
30 of 120
Page 404


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram_4Hrs
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
STANDARD 12-LEAD AND
CM5-CC5-CH5
STANDARD 12-LEAD
EXTENDED LEFT
STANDARD 12-LEAD
EXTENDED RIGHT
STANDARD LEADS FOR
BICYCLE EXERCISE
STANDARD LEADS ONE
INTERCOSTAL SPACE
HIGHER
VECTORCARDIOGRAPH
CORRECTED
VECTORCARDIOGRAPH
UNCORRECTED
What was the ECG date? (dd-mon-yyyy)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the planned time point of the measurement?
4 HOUR POSTDOSE
What was the position of the subject during ECG measurement?
DECUBITUS
FOWLERS
LATERAL DECUBITUS
LEFT LATERAL DECUBITUS
PRONE
REVERSE TRENDELENBURG
RIGHT LATERAL
DECUBITUS
31 of 120
Page 405


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram_4Hrs
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
SEMI-FOWLERS
SEMI-RECUMBENT
SITTING
SLING
STANDING
SUPINE
TRENDELENBURG
UNCONSTRAINED
Was an ECG performed?
YES
NO
If No, provide reason
What was the ECG time? (00:00-23:59)
Heart Rate
beats/min
PR Interval
msec
QRS Duration
msec
QTcB Interval
msec
QTcF Interval
msec
RR Interval
msec
32 of 120
Page 406


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram_4Hrs
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Interpretation
NORMAL
ABNORMAL
INDETERMINATE
NOT EVALUABLE
UNKNOWN
If abnormal, was the interpretation considered clinically significant?
YES
NO
Abnormal findings
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
33 of 120
Page 407


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Screening
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection date?  (dd-mon-yyyy)
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
34 of 120
Page 408


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Screening
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection date?  (dd-mon-yyyy)
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
35 of 120
Page 409


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Screening
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection date?  (dd-mon-yyyy)
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
36 of 120
Page 410


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Screening
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection date?  (dd-mon-yyyy)
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection date?  (dd-mon-yyyy)
37 of 120
Page 411


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Screening
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection date?  (dd-mon-yyyy)
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
38 of 120
Page 412


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Screening
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection date?  (dd-mon-yyyy)
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
39 of 120
Page 413


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Screening
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection date?  (dd-mon-yyyy)
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
40 of 120
Page 414


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Check-in
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab specimen collection date?  (dd-mon-yyyy)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
41 of 120
Page 415


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Check-in
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
42 of 120
Page 416


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Check-in
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
43 of 120
Page 417


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Check-in
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
44 of 120
Page 418


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Day 4
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab specimen collection date?  (dd-mon-yyyy)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
45 of 120
Page 419


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Day 4
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
46 of 120
Page 420


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Day 8
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab specimen collection date?  (dd-mon-yyyy)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
What was the planned time point of the lab?
12 HOURS POSTDOSE
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
47 of 120
Page 421


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Day 8
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
What was the planned time point of the lab?
12 HOURS POSTDOSE
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
48 of 120
Page 422


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Day9/ET
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab specimen collection date?  (dd-mon-yyyy)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
49 of 120
Page 423


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Day9/ET
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
50 of 120
Page 424


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory-Day9/ET
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Was the sample collected?
YES
NO
NOT APPLICABLE
If No, provide reason
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
51 of 120
Page 425


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Medical History YN
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Has the subject experienced any past and/or concomitant diseases or
past surgeries?
YES
NO
If yes, record all significant findings on the Medical History form.
52 of 120
Page 426


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Medical History YN-Check-in
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Has the subject reported any additional past medical history or
concomitant medications since screening visit?
YES
NO
53 of 120
Page 427


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Medical History
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Please record any past or present medical conditions.
Medical History Category
GENERAL MEDICAL
HISTORY
What is the verbatim term of the medical history condition/event?
What was the date the medical history event or condition started?
(dd-mon-yyyy)
Is the medical history disease/condition or event still ongoing?
YES
NO
What was the date the medical history event or condition ended?
(dd-mon-yyyy)
MH Key Items: DERIVED
54 of 120
Page 428


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination YN
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Was the physical examination performed?
YES
NO
If yes, record all significant findings on the Physical Examination form.
55 of 120
Page 429


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the physical examination date? (dd-mon-yyyy)
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
56 of 120
Page 430


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
57 of 120
Page 431


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
58 of 120
Page 432


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
59 of 120
Page 433


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
60 of 120
Page 434


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
61 of 120
Page 435


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
62 of 120
Page 436


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Female Reproductive System
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What is the subject's child bearing potential?
STERILE
POST-MENOPAUSAL
POTENTIALLY ABLE TO
BEAR CHILDREN
Birth Control Test
BIRTH CONTROL METHOD
Birth Control Test Code
BCMETHOD
Select all methods of birth control used.
What kind of birth control was used?
BARRIER WITH SPERMICIDE
ORAL CONTRACEPTIVES
DEPOT CONTRACEPTIVES
(IMPLANTS/ INJECTABLES)
IUD
OTHER
Other, specify
63 of 120
Page 437


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Exposure YN
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Is treatment data available?
YES
NO
If yes, record dosing information on Exposure form.
64 of 120
Page 438


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Exposure - Oral
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the study treatment?
TPOXX
What was the planned time point for the study treatment?
AM
PM
What was the treatment date? (dd-mon-yyyy)
What was the treatment time? (00:00-23:59)
What was the planned dose per administration?
600
What were the units for the dose?
mg
ug
mL
IU
TABLET
g
CAPSULE
PUFF
What was the total amount administered?
200
400
600
What were the units for the amount administered?
mg
What was the frequency of the study treatment dosing?
QD
65 of 120
Page 439


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Exposure - Oral
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
QOD
BID
TID
QID
PRN
QM
ONCE
UNKNOWN
What was the route of administration for the study treatment?
INTRALESIONAL
INTRAOCULAR
INTRAPERITONEAL
RESPIRATORY
(INHALATION)
ORAL
TOPICAL
SUBCUTANEOUS
INTRAMUSCULAR
RECTAL
VAGINAL
NASAL
TRANSDERMAL
Was the dose adjusted from planned?
YES
NO
What was the reason the dose was adjusted?
ADVERSE EVENT
DOSING ERROR
OTHER
66 of 120
Page 440


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Exposure - Oral
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Specify other reason
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the study treatment?
TPOXX
What was the planned time point for the study treatment?
AM
PM
What was the treatment date? (dd-mon-yyyy)
What was the treatment time? (00:00-23:59)
What was the planned dose per administration?
600
What were the units for the dose?
mg
ug
mL
IU
TABLET
g
CAPSULE
PUFF
What was the total amount administered?
200
400
600
67 of 120
Page 441


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Exposure - Oral
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What were the units for the amount administered?
mg
What was the frequency of the study treatment dosing?
QD
QOD
BID
TID
QID
PRN
QM
ONCE
UNKNOWN
What was the route of administration for the study treatment?
INTRALESIONAL
INTRAOCULAR
INTRAPERITONEAL
RESPIRATORY
(INHALATION)
ORAL
TOPICAL
SUBCUTANEOUS
INTRAMUSCULAR
RECTAL
VAGINAL
NASAL
TRANSDERMAL
Was the dose adjusted from planned?
YES
NO
68 of 120
Page 442


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Exposure - Oral
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the reason the dose was adjusted?
ADVERSE EVENT
DOSING ERROR
OTHER
Specify other reason
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
69 of 120
Page 443


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Meal
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the planned time point for the meal?
PREDOSE
What was the meal type?
BREAKFAST
DINNER
What was the date of the meal? (dd-mon-yyyy)
What was the start time of the meal? (00:00-23:59)
What was the end time of the meal? (00:00-23:59)
What was the percentage (%) of meal eaten?
0
25
50
75
100
Start Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
End Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the planned time point for the meal?
PREDOSE
What was the meal type?
BREAKFAST
DINNER
70 of 120
Page 444


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Meal
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the date of the meal? (dd-mon-yyyy)
What was the start time of the meal? (00:00-23:59)
What was the end time of the meal? (00:00-23:59)
What was the percentage (%) of meal eaten?
0
25
50
75
100
Start Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
End Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
71 of 120
Page 445


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Predose-14hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
72 of 120
Page 446


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Predose-14hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
73 of 120
Page 447


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Predose-14hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the sample date? (dd-mon-yyyy)
74 of 120
Page 448


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Predose-14hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
75 of 120
Page 449


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Predose-14hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
76 of 120
Page 450


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Predose-14hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
77 of 120
Page 451


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Predose-14hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
78 of 120
Page 452


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Predose-14hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
79 of 120
Page 453


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Predose-14hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
80 of 120
Page 454


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - 16-24hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
81 of 120
Page 455


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - 16-24hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
82 of 120
Page 456


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - 16-24hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the sample date? (dd-mon-yyyy)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the sample date? (dd-mon-yyyy)
83 of 120
Page 457


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - 16-24hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
84 of 120
Page 458


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - 48Hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the sample date? (dd-mon-yyyy)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
85 of 120
Page 459


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - 48Hr
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
86 of 120
Page 460


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Day 6
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the sample date? (dd-mon-yyyy)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
87 of 120
Page 461


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - Day 6
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
What was the planned time point of the sample?
PREDOSE
0.5 HOUR POSTDOSE
1 HOUR POSTDOSE
2 HOUR POSTDOSE
4 HOUR POSTDOSE
6 HOUR POSTDOSE
8 HOUR POSTDOSE
12 HOUR POSTDOSE
14 HOUR POSTDOSE
16 HOUR POSTDOSE
18 HOUR POSTDOSE
20 HOUR POSTDOSE
24 HOUR POSTDOSE
48 HOUR POSTDOSE
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
88 of 120
Page 462


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - ET
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the sample date? (dd-mon-yyyy)
Was the sample collected?
YES
NO
If No, provide reason
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
Any Collections: DERIVED
Current Date/Time (Hidden field for CF use)
89 of 120
Page 463


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Follow-up Visit
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Was the visit performed?
YES
NO
Was the visit completed in-person or remotely?
Remotely
In-Person
If Site Visit, what is the reason?
ABNORMAL PE
ABNORMAL RESULT
ONGOING AE/SAE
INVESTIGATOR DISCRETION
SIGA DISCRETION
Did the subject experience any adverse events since the last visit?
YES
NO
Did the subject use any medications related to an AE?
YES
NO
90 of 120
Page 464


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Follow-up Call
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Please select one status for the follow-up contact
CONTACT MADE
CONTACT NOT MADE
If contact was not made, what was the reason?
Date of Contact or Contact Attempt (dd-mon-yyyy)
Did the subject experience any adverse events since the last visit?
YES
NO
Did the subject use any medications related to an AE?
YES
NO
91 of 120
Page 465


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Adverse Events YN
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Were any adverse events experienced?
YES
NO
If yes, please complete Adverse Events form.
92 of 120
Page 466


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Adverse Events
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What is the adverse event term?
What is the date the adverse event started? (dd-mon-yyyy)
At what time did the adverse event start? (00:00-23:59)
Check if start time is unknown
Is the adverse event still ongoing?
YES
NO
What date did the adverse event end? (dd-mon-yyyy)
At what time did the adverse event end? (00:00-23:59)
Check if end time is unknown
What was the severity of the adverse event?
Grade 1 (MILD)
Grade 2 (MODERATE)
Grade 3 (SEVERE)
Grade 4 (LIFE THREATENING)
Grade 5 (DEATH)
What was the outcome of this adverse event?
FATAL
NOT RECOVERED/NOT
RESOLVED
RECOVERED/RESOLVED
RECOVERED/RESOLVED
WITH SEQUELAE
RECOVERING/RESOLVING
93 of 120
Page 467


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Adverse Events
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
UNKNOWN
What was the frequency of the adverse event?
CONTINUOUS
INTERMITTENT
Did the adverse event cause the subject to be discontinued from the
study?
YES
NO
Is this event related to study treatment XXXX?
NOT RELATED
UNLIKELY RELATED
POSSIBLY RELATED
PROBABLY RELATED
DEFINITELY RELATED
What action was taken with study treatment?
DOSE NOT CHANGED
DRUG WITHDRAWN
NOT APPLICABLE
What other action was taken in response to the adverse event?
Was the adverse event serious?
YES
NO
What was the ID of the medication/therapy that was taken for the
adverse event? (If applicable)
What was the ID of second medication/therapy that was taken for the
adverse event? (If applicable)
94 of 120
Page 468


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Adverse Events
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the ID of third medication/therapy that was taken for the
adverse event? (If applicable)
Start Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
End Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
AE Key Items: DERIVED
95 of 120
Page 469


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Prior/Concomitant Medications YN
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Were any medications taken?
YES
NO
If yes, please complete Prior/Concomitant Medications form.
96 of 120
Page 470


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Prior/Concomitant Medications
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the term for the medication/therapy taken?
For what indication was the medication/therapy taken?
What was the individual dose of the medication/therapy?
What was the total daily dose of the medication/therapy?
What was the unit of the medication/therapy?
APPLICATION
CALORIES
CAPSULES
Centigram (cg)
Dram (dr)
GTT (DROPS)
Femtogram (fg)
Grain (gr)
GRAMS
RING, HORMONAL
CONTRACEPTIVE
I.U. (INTERNATIONAL
UNITS)
KG (KILOGRAMS)
LITERS
MCG (MICROGRAMS)
mEq (Milliequivalent)
MG (MILLIGRAMS)
ML (MILLILITERS)
Moles (mol)
Nanograms (ng)
OZ (OUNCES)
PATCH
97 of 120
Page 471


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Prior/Concomitant Medications
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Picograms (pg)
PUFF
SPRAY
TBS (TABLESPOON)
TABLETS
TSP (TEASPOON)
OTHER
UNKNOWN
Specify other dose unit
What was the frequency of the medication/therapy?
ONCE
PRN (AS NEEDED)
CONTINUOUS
QD (DAILY)
QOD (EVERY OTHER DAY)
BID (TWICE PER DAY)
TID (THREE TIMES PER
DAY)
QID (FOUR TIMES PER DAY)
QH (EVERY HOUR)
Q2H (EVERY TWO HOURS)
Q3H (EVERY THREE HOURS)
Q4H (EVERY FOUR HOURS)
Q5H (EVERY FIVE HOURS)
Q6H (EVERY SIX HOURS)
Q8H (EVERY EIGHT HOURS)
Q12H (EVERY TWELVE
HOURS)
Q18H (EVERY EIGHTEEN
HOURS)
98 of 120
Page 472


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Prior/Concomitant Medications
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
1XWK (ONE TIME PER
WEEK)
2XWK (TWICE PER WEEK)
3XWK (THREE TIMES PER
WEEK)
Q1WK (EVERY WEEK)
Q2WK (EVERY TWO WEEKS)
Q3WK (EVERY THREE
WEEKS)
Q4WK (EVERY FOUR
WEEKS)
Q5WK (EVERY FIVE WEEKS)
QM (MONTHLY)
6 TIMES PER YEAR (EVERY
TWO MONTHS)
4 TIMES PER YEAR (EVERY
THREE MONTHS)
OTHER
Specify other dose frequency
What was the route of administration of the medication/therapy?
ORAL
TOPICAL
SUBCUTANEOUS
INTRAMUSCULAR
INTRAVENOUS
RECTAL
AURICULAR (OTIC)
INTRADERMAL
RESPIRATORY
(INHALATION)
INTRAUTERINE
TRANSDERMAL
OTHER
99 of 120
Page 473


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Prior/Concomitant Medications
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Specify other dose route
What was the start date of the medication/therapy? (dd-mon-yyyy)
What was the start time of the medication/therapy? (00:00-23:59)
Check if start time is unknown
Is the medication/therapy still ongoing?
YES
NO
What was the end date of the medication/therapy? (dd-mon-yyyy)
What was the end time of the medication/therapy? (00:00-23:59)
Check if end time is unknown
Was the medication/therapy taken prior to the study?
YES
NO
What was the ID for the adverse event for which the medication was
taken? (If applicable)
What was the ID for the second adverse event for which the
medication was taken? (If applicable)
What was the ID for the third adverse event for which the medication
was taken? (If applicable)
100 of 120
Page 474


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Prior/Concomitant Medications
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the ID of the medical history condition(s) for which the
medication was taken? (If applicable)
What was the ID of the second medical history condition(s) for which
the medication was taken? (If applicable)
What was the ID of the third medical history condition(s) for which
the medication was taken? (If applicable)
Start Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
End Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
CM Key Items: DERIVED
101 of 120
Page 475


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Medical Surgical Treatment Procedures YN
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Has the subject had any medical or surgical treatment procedures?
YES
NO
If yes, please complete the Medical/Surgical Treatment procedure form.
102 of 120
Page 476


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Medical or Surgical Treatment Procedures
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the medical or surgical treatment procedure?
For what indication was the medical or surgical treatment procedure
taken?
Adverse Event
Other
Other, specify
What was the ID for the adverse event for which the treatment was
taken?
What was the start date of the treatment/procedure? (dd-mon-yyyy)
Is the treatment/procedure still ongoing?
YES
NO
What was the end date of the treatment/procedure? (dd-mon-yyyy)
103 of 120
Page 477


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
On what date were the measurements performed? (dd-mon-yyyy)
Status (If Repeat, please specify original period/day/visit)
REPEAT
UNSCHEDULED
Original Period/Day/Visit
Screening
Check-in
Day 1
Day 4
Day 7
Day 8
Day 9
Early Term
Follow-up (D14)
Follow-up (D37)
What is the planned time point for this measurement?
PREDOSE
4 HOUR POSTDOSE
In what position was the subject during the measurement?
SITTING
At what time were the measurements performed? (00:00-23:59)
Systolic Blood Pressure
mmHg
Diastolic Blood Pressure
mmHg
104 of 120
Page 478


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Vital Signs - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Heart Rate
beats/min
Respiratory Rate
breaths/min
Temperature
C
Vital Date/Time: DERIVED (dd-mon-yyyy 00:00-23:59)
105 of 120
Page 479


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Status (If Repeat, please specify original period/day/visit)
REPEAT
UNSCHEDULED
Original Period/Day/Visit
Screening
Check-in
Day 1
Day 4
Day 7
Day 9
Early Term
What was the method used to measure ECG?
10 LEAD STANDARD
12 LEAD 1 LEAD MISSING
12 LEAD CABRERA
12 LEAD CONTINUOUS ECG
12 LEAD EASI DOWER
TRANSFORMATION
12 LEAD ECG EXTRACTED
FROM 12 LEAD
CONTINUOUS ECG
RECORDING
12 LEAD MASON LIKAR
12 LEAD MODIFIED MASON
LIKAR
12 LEAD NON-STANDARD
12 LEAD RIGHT-SIDED
PRECORDIAL LEADS
12 LEAD SINGLE PAD
12 LEAD STANDARD
12 LEAD UNSPECIFIED
6 LEAD NEHB-SPORI
6 LEAD STANDARD
106 of 120
Page 480


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
8 LEAD STANDARD
BIPOLAR UNCORRECTED
XYZ LEAD SYSTEM
CONTINUOUS
AMBULATORY ECG
CUBE LEAD SYSTEM
FRANK LEAD SYSTEM
HOLTER CONTINUOUS ECG
RECORDING
MCFEE-PARUNGAO LEAD
SYSTEM
PSEUDO-ORTHOGONAL XYZ
LEAD SYSTEM
STANDARD 12-LEAD AND
CC5-CM5-ML
STANDARD 12-LEAD AND
CM5-CC5-CH5
STANDARD 12-LEAD
EXTENDED LEFT
STANDARD 12-LEAD
EXTENDED RIGHT
STANDARD LEADS FOR
BICYCLE EXERCISE
STANDARD LEADS ONE
INTERCOSTAL SPACE
HIGHER
VECTORCARDIOGRAPH
CORRECTED
VECTORCARDIOGRAPH
UNCORRECTED
What was the ECG date? (dd-mon-yyyy)
What was the planned time point of the measurement?
4 HOUR POSTDOSE
107 of 120
Page 481


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the position of the subject during ECG measurement?
DECUBITUS
FOWLERS
LATERAL DECUBITUS
LEFT LATERAL DECUBITUS
PRONE
REVERSE TRENDELENBURG
RIGHT LATERAL
DECUBITUS
SEMI-FOWLERS
SEMI-RECUMBENT
SITTING
SLING
STANDING
SUPINE
TRENDELENBURG
UNCONSTRAINED
What was the ECG time? (00:00-23:59)
Heart Rate
beats/min
PR Interval
msec
QRS Duration
msec
QTcB Interval
msec
QTcF Interval
msec
108 of 120
Page 482


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Electrocardiogram - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
RR Interval
msec
Interpretation
NORMAL
ABNORMAL
INDETERMINATE
NOT EVALUABLE
UNKNOWN
If abnormal, was the interpretation considered clinically significant?
YES
NO
Abnormal findings
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
109 of 120
Page 483


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab specimen collection date?  (dd-mon-yyyy)
Status (If Repeat, please specify original period/day/visit)
REPEAT
UNSCHEDULED
Original Period/Day/Visit
Screening
Check-in
Day 4
Day 8
Day 9
Early Term
Follow-up (D14)
Follow-up (D37)
What was the lab panel name?
HEMATOLOGY
CHEMISTRY
SEROLOGY
SPECIAL CHEMISTRY
URINALYSIS
URINE DRUG SCREEN
SERUM HUMAN CHORIONIC
GONADOTROPIN
SERUM CHEMISTRY
Was the sample collected?
YES
NO
NOT APPLICABLE
What was the planned time point of the lab?
12 HOURS POSTDOSE
110 of 120
Page 484


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Central Laboratory - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the lab specimen collection time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
111 of 120
Page 485


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
Status (If Repeat, please specify original period/day/visit)
REPEAT
UNSCHEDULED
Original Period/Day/Visit
Screening
Check-in
Day 7
Day 9
Early Term
What was the physical examination date? (dd-mon-yyyy)
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
112 of 120
Page 486


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
113 of 120
Page 487


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
114 of 120
Page 488


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
115 of 120
Page 489


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
116 of 120
Page 490


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
117 of 120
Page 491


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Physical Examination - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the body system examined?
SKIN
HEENT
PULMONARY
CARDIOVASCULAR
ABDOMEN
LYMPH NODES
MUSCULOSKELETAL
NEUROLOGIC SYSTEM
OTHER
What was the overall interpretation?
NORMAL
ABNORMAL
NOT DONE
If the result was abnormal, what were the findings?
If abnormal, was the interpretation considered clinically significant?
YES
NO
118 of 120
Page 492


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Pharmacokinetic Blood Collection - UNSCH
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
What was the sample date? (dd-mon-yyyy)
What was the sample time? (00:00-23:59)
Date/Time DERIVED (dd-mon-yyyy 00:00-23:59)
119 of 120
Page 493


PROD_16DEC2019_3.00: UNIQUE
Project Name: SGSIGA246022
Form: Study Completion
Generated On: 31 Jan 2020 12:45:03
PROD_16DEC2019_3.00 (4472)
To which period of the trial does this disposition refer?
SCREENING
BASELINE
FOLLOW-UP
To which category does the disposition refer?
PROTOCOL MILESTONE
OTHER EVENT
DISPOSITION EVENT
What was the subject's status?
ADVERSE EVENT
COMPLETED
DEATH
FAILURE TO MEET
INCLUSION/EXCLUSION
CRITERIA
LOST TO FOLLOW-UP
NON-COMPLIANCE WITH
STUDY DRUG
INVESTIGATOR DECISION
PREGNANCY
STUDY TERMINATED BY
SPONSOR
WITHDRAWAL BY SUBJECT
PROTOCOL VIOLATION
OTHER
Other Specify Status
What was the date of study completion or discontinuation?
(dd-mon-yyyy)
If AE, specify Corresponding AE
120 of 120
Page 494


SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.3 
IRB (Plus the Name of the Committee Chair if Required by 
the Regulatory Authority) and Representative Written 
Information for Subject and Sample Consent Forms 
Information for the investigator who used a central IRB/IEC is provided below: 
Investigator 
IRB/IEC Name and Address 
Wood-Horrall, MD 
Advarra 
6940 Columbia Gateway Drive, Suite 110 
Columbia, MD 21046 
United States 
Chairperson name: Harnish, Sara, JD 
The sample informed consent form is provided on the following pages: 
Site Specific ICF Version 1.0 dated 13 June 2019 
Site Specific ICF Version 2.0 dated 23 July 2019 
Site Specific ICF Version 3.0 dated 23 September 2019 
Page 495


SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 1 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
AN AGREEMENT TO BE IN A RESEARCH STUDY 
INFORMED CONSENT DOCUMENT 
 
Sponsor / Study Title: 
  
SIGA Technologies, Inc. / “A Post Marketing Study of the Safety, 
Tolerability, and Pharmacokinetics of TPOXX® in Adult Subjects 
Weighing More Than 120 kg” 
 
Protocol Number: 
 
SIGA-246-022 
 
Principal Investigator: 
(Study Doctor) 
 
Additional Contact (Study Staff):  
Rebecca Wood-Horrall, M.D. 
 
 
Lucy Flores 
 
Telephone: 
 
512-447-2985 (24 Hours) 
 
Address: 
PPD Development, LP 
7551 Metro Center Drive 
Suite 200 
Austin, TX    78744 
 
INTRODUCTION 
 
You are being asked to volunteer and take part in a medical research study.  Before you decide to take part 
in this study, you must read, sign, and date this form.  This form, called an informed consent document, 
explains the study.  Please ask as many questions as you need to help you decide whether you want to be in 
the study. This consent document may contain words that you do not understand. Please ask the study 
doctor or the study staff to explain any words or anything else that you do not clearly understand before you 
sign and date this consent document. 
 
To be in this research study, you cannot already be in another medical research study anywhere or have been 
in any other research study within 30 days before taking the study drug in this study. 
 
You must be honest with the study doctor and study staff about your health history or you may harm 
yourself by being in this study.  It is very important that you give complete and truthful answers to all 
questions that you are asked during the study.  The answers will help the study staff to decide if you can 
be in the study or stay in the study.  If you do not wish to answer a question, tell the study doctor or study 
staff that you do not want to answer the question.  Not answering some questions may mean that you 
cannot be in the study. 
 
The study doctor is being paid by SIGA Technologies, Inc., the sponsor (the company paying for this 
study), to run this study.  Also, the Biomedical Advanced Research and Development Authority 
(BARDA), an organization with the United States Department of Health and Human Services, is 
contributing to the funding of the study.   
 
Please read this form carefully. Take your time to ask the study doctor or study staff as many questions 
about the study as you would like. The study doctor or study staff can explain words or information that 
you do not understand. Reading this form and talking to the study doctor or study staff may help you 
decide whether to take part or not. If you decide to take part in this study, you must sign your name at the 
end of this form and date it.  
 
Page 496


SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 2 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
PURPOSE OF THE STUDY 
 
In July 2018, TPOXX was approved by the United States Food and Drug Administration (FDA) for the 
treatment of smallpox (variola virus).  
 
The FDA has asked SIGA Technologies to also do a research study in people that weigh more than 120 
kilograms (264.5 pounds), which is this study.   
 
In this document, you may see the terms “study drug”, “study treatment”, and “study treatment period”; 
these are terms used in research studies as mentioned above, and this does not mean that you will be 
receiving medical treatment for any condition.  These terms apply to the study drug and parts of the study 
where you will be receiving this study drug. 
 
The purpose(s) of this study are: 
 
• 
To measure the amount of TPOXX in the blood  
• 
To see how safe TPOXX is, and how well you tolerate it 
 
The dose(s) you will receive are as follows: 
 
• 
An oral dose of 600 mg (3 x 200 mg capsules) of TPOXX twice a day for 7 days (Days 1 through 7) 
 
Meals of about 600 calories and 25 grams of fat will be given to you by the study staff 30 minutes before 
taking study drug.  You should eat this entire meal within 30 minutes before taking the study drug. Study 
drug will be given to you about 30 minutes after you start eating your meal and with about 240 mL (1 cup) 
of water.  You will be told not to eat anything after taking study drug for 2 hours after dosing. In addition, 
you will be asked not to drink anything (except water) 3 hours before and after taking the study drug. 
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to continue 
participation we will tell you. You can then decide if you still want to be in the study.   
 
If the FDA or the sponsor makes changes to the study before the study starts, the study staff will try to 
notify you before you check-in.  If changes are made after the study has started, the study staff will tell 
you about them as soon as they have been approved.  You can use this information to decide if you want 
to stay in the study. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
Before you are asked to do any study-related tests or procedures you will be asked to read, sign, and date 
this consent document. The following screening tests and procedures will then be performed to determine 
if you can take part in this study. 
 
You will have medical tests and procedures to help the study doctor decide if you can be in the study. 
This is called “screening” and will take place between 28 to 2 days before the day you start taking study 
drug. 
 
Screening does not mean that you will be in the study.  Whether you can be in the study will depend upon 
the results of your lab tests, study specific guidelines, and the decision of the study doctor.  Even if your 
screening tests are okay, there is a chance that you will not be able to participate.   
Page 497


SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 3 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
 
There may be other reasons why you cannot be in the study. The study doctor and/or the study staff will 
discuss this with you. You will not be paid for your screening visit(s). 
 
You will need to have at least two visits to the research facility for screening tests.  After your first 
screening results have been reviewed, at least one more screening visit will be scheduled by the study 
staff. 
 
Screening for this study includes:  
 
• 
A talk about your medical history (including recreational, prescription, and over-the-counter drug 
use; nicotine and alcohol use; and past hospitalizations) 
• 
Physical exam 
• 
Measurement of your weight 
• 
Your vital signs (temperature, breathing rate, blood pressure and heart rate) after at least 5 
minutes sitting 
• 
Your blood and urine will be collected for clinical lab testing (after not eating for at least 8 hours) 
• 
If you are a post-menopausal female, you will have a blood Follicle Stimulating Hormone (FSH) 
test done 
• 
If female, you will have a blood pregnancy test done 
• 
A urine sample to screen for drugs of abuse, including alcohol (must be negative to participate in 
the study) will be collected 
• 
You will have blood collected for HIV and hepatitis B and C (these tests must be negative in 
order for you to be in the study). The study doctor may be required by law to report the result of 
these tests to the local health authority 
• 
An Electrocardiogram (ECG - measures the electrical activity of the heart) after lying down for at 
least 10 minutes will be done 
• 
The study doctor will review your nicotine/tobacco and alcohol use 
 
One of the study staff will talk with you about your medical history, draw blood, and collect urine for lab 
tests.   
 
For screening, the amount of blood taken from you will be a little over 2 teaspoons (11 mL).  It may be 
necessary to try more than one time if the needed amount cannot be collected.  A new needle will be used 
for each blood draw. 
 
A urine test will be done to check for drugs of abuse such as: 
 
• 
Amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine) 
• 
Barbiturates 
• 
Benzodiazepines 
• 
Cannabinoids (including tetrahydrocannabinol) 
• 
Cocaine  
• 
Opiates (including heroin, codeine, and oxycodone) 
• 
Alcohol 
 
Day -1 (Check-in) 
 
If you are eligible to be in the study, you will be admitted to the research facility on Day -1 (check-in), the 
day before you start taking study drug.  You will remain in the research facility overnight for 9 nights. 
Page 498


SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 4 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
 
At check-in, a blood sample of a little less than 2 teaspoons (9 mL) and urine sample will be taken from 
you for lab testing and to test for drugs of abuse to see if you can still be in the study.   
 
If you have a positive urine drug test including alcohol, you will not be allowed to take part or to stay in 
the study. All results of drug tests will remain private.  
 
You will be asked questions regarding your general health and any medication you may have taken since 
your screening visit to see if you can still be in the study. Vital signs will be taken (temperature, blood 
pressure, heart rate and breathing rate) after sitting for at least 5 minutes, measurement of weight, 
physical exam, blood pregnancy test (if female), and ECG performed (after lying down for at least 10 
minutes).  
 
Day 1 will be the first day that you take study drug. The following will happen on study days 1 through 
Day 8. 
 
Days 1 - 8 
 
• 
Vital signs taken (temperature, breathing rate, blood pressure and heart rate) after sitting for at 
least 5 minutes (Days 1, 4, 7, and 8) 
• 
Measurement of your weight (Day 1) 
• 
Blood sample for clinical labs (Days 4 and 8) 
• 
Physical exam (Day 7) 
• 
ECG after lying down for at least 10 minutes (Days 1, 4, and 7) 
• 
Blood samples of about 1 teaspoon (5 ml) will be collected before the morning dose and 30 
minutes, 1, 2, 4, 6, 8, 12 (before the afternoon dose), 14, 16, 18, 20, and 24 hours after dosing on 
Days 1 and 7, to measure the amount of study drug in your blood 
• 
Blood samples of about 1 teaspoon (5 ml) will be collected before and 4 hours after the morning 
dose on Day 6, to measure the amount of study drug in your blood 
• 
Review of current medications and side effects 
 
Day 9 (Study Discharge) 
 
• 
Physical exam  
• 
Measurement of your weight 
• 
Vital signs (temperature, breathing rate, blood pressure and heart rate) after sitting for at least 5 
minutes 
• 
Blood and urine sample for clinical labs 
• 
ECG after lying down for at least 10 minutes  
• 
Blood samples of about 1 teaspoon (5 ml) will be collected 48 hours after the morning dose on 
Day 7, to measure the amount of study drug in your blood  
• 
Review of current medications and side effects 
 
Before exiting the study, a blood sample of a little less than 2 teaspoons (9 mL) and a urine sample will be 
collected for clinical lab tests.  For your safety, if lab test results are not normal, more blood and/or urine 
samples may be collected. 
 
You can leave the research facility after all study tests and procedures on Day 9 have been completed. If 
you have ongoing side effects or abnormal findings on your physical exam on Day 9, you will be asked to 
return to the research facility five days later, on Day 14.  
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Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
 
If you do not have any abnormal findings on your physical exam, the study staff will call you by phone on 
Day 14 to check on your wellbeing.  
 
You will be contacted by telephone about 30 days after the last dose of study drug (Day 37) to see how you 
are feeling. You should also contact PPD during this time if you are experiencing any side effects.  
 
A small needle with a thin plastic tube covering it (like a small straw) called a "cannula" may be inserted 
into a vein in your arm or hand to make blood draws easier. A study staff member puts the needle with the 
cannula over it into a vein in your arm or hand, and then slides the cannula over the needle into your arm 
or hand vein. The cannula stays in your arm or hand vein, and the needle is taken out. You will need to 
keep your arm very still for the period while the needle is in place. Use of a cannula is optional and the 
study doctor will decide if it is needed. Very small amounts of saline (salt water) will be injected into this 
cannula to prevent clogging. This procedure may cause pain, swelling and redness at the place where the 
cannula is put into your vein. When a cannula is used for blood collected, the study staff will take about 
an extra 1 mL of blood. The cannula will be left in for as long as it is needed to help with blood 
collections, but not for longer than about 72 hours. 
 
If you take part in this study, you will have your blood drawn about 32 times during this study.  About 
less than 1 cup (187 mL) of blood will be taken from you during this study. You may want to know that 
the standard blood donation is about 2 cups (480 mL) of blood.   
 
Signing and dating this consent form means that you agree to allow PPD, the sponsor, or other 
laboratories involved in this study to store and test any used or unused blood samples or plasma samples 
(taken from the blood samples, for study related testing) until all research on the study drug is stopped.  
When all research is stopped, all blood or plasma samples will be destroyed. If you do not agree to this, 
you will not be enrolled in the study. 
 
After Study Treatment: 
 
Because this is a research study, the study drug will be given to you only during this study and not after 
the study is over. 
 
HIV AND HEPATITIS TESTING 
 
As required by the study and if any person is exposed to your blood, you must be tested for the hepatitis 
viruses and for HIV (Human Immunodeficiency Virus).  HIV is the virus that causes AIDS (Acquired 
Immunodeficiency Syndrome).  If you have a positive HIV or hepatitis test, you cannot remain in the 
study. 
 
If the HIV test is positive, a follow-up test will be done.  If the follow-up test is also positive, you will be 
given the results in private and will also be given information about counseling. 
 
It may take weeks or months after being infected with HIV for the test to be positive.  The HIV test is not 
always right. 
 
Positive HIV and hepatitis test results must be reported to the Department of Health, and the law may 
require that your name be reported. Although this testing is supposed to be private, this cannot be 
guaranteed.  For example, it is possible for a court of law to get medical or study records without your 
permission. 
 
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Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
LENGTH OF THE STUDY AND NUMBER OF SUBJECTS EXPECTED TO PARTICIPATE 
 
About 36 male and female subjects, ages 18 to 50, will be in this study. You will be in this study up to 65 
days; this begins with your screening visit and continues until your last study visit.  You will be confined 
to the research facility continuously for 9 nights and 10 days, during this period. 
 
RESTRICTIONS 
 
• 
You must not have participated in another clinical research trial where you received any other 
study drug in a previous study within 30 days before the first dose of study drug. 
• 
You must not have been in any other clinical research study with the study drug TPOXX (also 
known as tecovirimat). 
• 
You should not have donated more than 450 mL of blood or blood components within 30 days 
before the first dose of study drug. You should not donate blood or blood components for 4 weeks 
after the completion of the study. 
• 
You may not consume any food or drink containing grapefruit or grapefruit juice, Seville orange 
or Seville orange-containing products (for example, marmalade) within 48 hours before the first 
dose of study drug or throughout the study. 
• 
You may not consume caffeine- or xanthine-containing beverages within 48 hours before the first 
dose of study drug or throughout the study. 
• 
You may not consume pomegranate or pomegranate juice, pomelo fruits or pomelo juice within 
72 hours before the first dose of study drug. 
• 
You may not consume alcohol-containing beverages within 72 hours before the first dose of study 
drug. 
• 
You must not have used nicotine or nicotine-containing products (for example, cigarettes, 
electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine gum) 
within 6 months before the first dose of study drug and throughout the duration of the study. 
• 
You must refrain from strenuous exercise or contact sports within 24 hours before first dose of 
study drug until study discharge. 
• 
You must not have used any herbal or nutritional supplements, prescription, or over-the-counter 
medications within 14 days before the first dose of study drug. 
• 
You must not intend to lose weight (diet or weight loss) from screening and throughout the study. 
• 
The following medications are not allowed to be taken within 7 days before receiving study drug 
on study Day 1 through check out (Day 9): 
o antidiabetic medications 
o anticoagulants 
o anticonvulsants 
o substrates of the breast cancer resistance protein transporter including 
▪ 
methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, 
sulfasalazine, and topotecan; 
o substrates of cytochrome P450 (CYP) 2C8 including 
▪ 
repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and  
o substrates of CYP2C19 including 
▪ 
S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole, 
and omeprazole   
 
If you are on any of these medications, do not stop taking them without first consulting your personal 
doctor. 
 
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Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
You must not use any drugs (over-the-counter, prescription, or illegal) without approval from the study 
doctor.  Oral birth control pills or other hormonal birth control methods are allowed. Taking other drugs 
or drinking alcohol could result in serious and even life-threatening reactions. If you decide to take any 
medication without approval from the study doctor, you may not be allowed to continue in the study. You 
must inform the study staff of any prescription birth control you are using including intrauterine devices 
(IUDs). 
 
Taking other drugs or alcohol could result in serious and even life-threatening reactions. If you decide to 
take any medication without approval from the study doctor you may not be allowed to continue in the 
study. 
 
RISKS, SIDE EFFECTS, AND/OR DISCOMFORTS 
 
It is very important that you tell the study staff right away about any side effects.  It is also very important 
that you do not talk to other people participating in this study about your side effects or theirs.   
 
If you do not tell the study staff about a side effect, or if you talk to other people in the study with you 
about your side effects, you may be removed from this study. In addition to being removed from the 
current study, your payment may be reduced, and you may not be allowed to take part in future studies for 
PPD. 
 
All side effects or changes in your normal health must be reported, even those changes you might not 
consider to be important.  Some examples may include:  
 
• 
Headache 
• 
Tooth pain 
• 
Bruising 
• 
Hiccups 
• 
Changes in your eating or sleeping patterns 
 
If you have any changes in your health/medical history after signing and dating this consent document, 
please tell your study doctor or study staff. 
 
One of the reasons for this study is to learn more about the possible side effects of the study drug. It is 
important that you tell the study staff about possible side effects. Contact PPD if you experience any side 
effects through the follow-up phone call on Day 37. 
 
Rare or unknown side effects could possibly occur, including allergic reactions, and life-threatening 
reactions. 
 
You may harm yourself by taking part in this study if you are not fully truthful about any side effect with the 
study doctor and study staff. 
 
The most common side effects of TPOXX include: 
 
• 
Headache (12%) 
• 
Nausea (5%) 
• 
Abdominal Pain (2%) 
• 
Vomiting (2%) 
• 
Diarrhea 
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Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
• 
Dizziness 
 
If you do not understand what any of these side effects mean, please ask the study doctor or study staff to 
explain these terms to you.  
 
In animal studies, seizures were seen in dogs, but not any other species.  The significance of this for 
humans is unknown.  You may not participate in the study if you have a history of seizures and you will 
be monitored for any signs of seizure. 
 
ADDITIONAL RISKS OR DISCOMFORTS 
 
Until you know how the study drug will affect you, you should use caution by avoiding stairs, not driving 
a car or working with machinery.  If you later feel that the study drug has affected your ability to perform 
these things, stop doing them. 
 
Blood Samples: 
 
There may be side effects of having blood taken such as: 
 
• 
Fainting 
• 
Redness 
• 
Swelling of the vein 
• 
Pain 
• 
Bruising 
• 
Bleeding 
 
There is also a slight possibility of infection or nerve damage.  
 
If you feel faint tell the study staff or study doctor right away. 
 
Scarring can occur at the sites of repetitive blood draws.  If you have a “cannula” or intravenous catheter, 
you could also have pain, swelling, and redness of the vein, which may not go away quickly. 
 
Electrocardiogram (ECG): 
 
The ECG test is a recording of the electrical activity of your heart.  The sticky pads used may be cold when 
applied and sometimes cause some discomfort such as redness or itching.  If the hair under the patches 
needs to be shaved, irritation from shaving also could occur. 
 
Other Risks 
 
PPD requires that you agree to have pictures taken of your skin if you develop a side effect such as a rash. 
The picture(s) are only for the use of the study doctor and study sponsor. 
 
Since as with any drug, there may be other risks that are unknown. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
The effects of the study drug on an unborn or breastfed baby are unknown, but could be a risk. If you are 
pregnant or breastfeeding, you cannot be in this study.  
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It is very important that you not become pregnant or breastfeed during this study or within 3 months after 
the last dose of study drug. Not having sex is the only certain way to prevent pregnancy. If you are a woman 
who is able to become pregnant, and choose to have sex, you must agree to use one of the methods of birth 
control listed below for at least 30 days before first dose through 30 days after last dose of study drug.  
 
The only birth control methods that can be used during this study include: 
 
• 
Condom, male or female, with spermicide (male and female condoms must NOT be used together) 
• 
Diaphragm or cervical cap with spermicide 
• 
Intrauterine device (IUD) with spermicide 
• 
Oral contraceptives or other hormonal methods with another nonhormonal method 
• 
Male sexual partner who had undergone a vasectomy at least 3 months before screening 
• 
Not having sex (abstinence)* 
 
*Abstinence 
You must understand that sexual abstinence means heterosexual sexual intercourse for medical, 
psychological, legal, social, financial, philosophical, moral or religious reasons. Heterosexual 
sexual activity refers to sexual activity between a male and a female.  Any types of heterosexual 
activity where any amount of male semen (or ejaculate) could be present are to be strictly avoided, 
without exception.  
 
This does not mean periodic abstinence (for example, calendar, ovulation, profession of abstinence 
for entry into a clinical trial). 
 
Abstinence must be your preferred and usual lifestyle. By agreeing to this you affirm (commit) that 
this has been your lifestyle for at least the past 6 months and this will be true until the specified 
amount of time required for the study has been met. 
 
If there is a possibility that you will engage in any heterosexual activity at any time during the study 
time requirement, you must not choose sexual abstinence as your method of birth control. 
 
If you choose abstinence as your method of contraception and become pregnant/father a child 
during participation in this study, you will be excluded from all future participation in PPD studies.  
 
If you cannot have children because of a surgery (for example if you have had a hysterectomy [removal of 
the uterus] or tubal ligation [tubes tied]), or if you are postmenopausal for at least 12 months, you can 
participate in this study without using additional forms of contraception. 
 
Even if you use a medically acceptable birth control method, you could still become pregnant. 
 
There is a chance that a pregnancy test could indicate that you are not pregnant, even though you are. If it is 
early enough in your pregnancy, a pregnancy test may not be able to detect that you are pregnant.  
 
If you are pregnant, become pregnant or breastfeed during the study, the study drug or procedures may 
involve risks to the unborn or breastfed baby, which are currently unforeseeable.  
 
If you are a man, there may be risks to an unborn baby if you father a child during the study.  Men must 
agree to use a condom throughout the study and for 90 days after you take the last dose of study drug.  
 
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Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
Men must agree not to donate sperm from the first dose of study drug through 90 days after the last dose 
of study drug. 
 
Even if you and your partner use birth control, you or your partner could become pregnant.  If you or your 
partner are pregnant, become pregnant, or breastfeed during the study, the study drug may involve risks to 
the unborn or breastfed baby, which we are not aware of at this time. 
 
In the event you (if you are female) or your partner (if you are male) become pregnant during the course 
of the study, you (or your partner) may be requested to sign and date a separate informed consent form to 
allow PPD study staff to contact you throughout the course of the pregnancy to get updates on how the 
pregnancy is progressing, and for 3 months after the birth.  PPD and the sponsor are required to attempt to 
collect and report information about any pregnancy that occurs in a subject who is participating in a study.  
They may also be required to attempt to collect and report this information if the female partner of a male 
subject who is participating in a study becomes pregnant and could have been exposed to study drug 
through the male subject’s semen.   
 
If you are female, and you have had sex without using a medically acceptable method of birth control during 
the three weeks before the start of the study, you must not be in this study. 
 
COSTS 
 
All study tests are being done for research only and are not replacements for medical care.  There will be 
no charge to you for your participation in this study.  The study drug, study-related procedures, and 
testing supplies, as well as study visits will be provided at no charge to you or your insurance company. 
While confined to the research facility all your meals, snacks and beverages will be provided. 
 
POSSIBLE BENEFITS OF THE STUDY 
 
This study is for research purposes only.  There is no direct benefit to you from your participation in the 
study.  Information learned from the study may help other people in the future. 
 
ALTERNATIVES TO PARTICIPATING  
 
This research study is for research purposes only. The only alternative is to not participate in this study. 
 
PAYMENT FOR PARTICIPATION 
 
For the current study, you will receive: 
 
• 
$225.00/night for each night that you spend at the research facility ($225.00/night x 9 nights) 
 
• 
$125.00/visit for each outpatient visit/phone call to the research facility ($125.00/visit x 2 outpatient 
visit/phone call) 
 
If you successfully complete the study, you will receive an additional $725.00 making your total payment 
$3,000.00.  You will receive payment within 3 weeks of your last study visit or your study completion.  
 
If you have a side effect linked to the study drug and the study doctor thinks that this may harm your 
safety, you will be taken out of the study. You may be paid in full, including the study completion bonus, 
at the discretion of the study doctor.  
 
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Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
However full payment is not guaranteed. If you have a side effect linked to the study drug and you leave 
the study when the study doctor does not think your safety is at risk, your pay will be lower. You will 
receive a pro-rated payment and pro-rated study completion bonus based on the days you were in the 
study. If the study doctor releases you from the study and it is non-drug related, you will receive a pro-
rated payment and pro-rated study completion bonus based on the number of days you were in the study. 
 
If you are a backup subject who is required to stay in the facility overnight you will be paid $75.00. If you 
are not required to stay overnight you will be paid $25.00. If you are required to stay for additional nights 
for safety procedures or observation, then you will be paid $200.00 for the additional night(s).  
 
You will be paid an amount based on the extent of your participation, if: 
 
• 
You are unable to complete the study 
• 
You miss multiple outpatient visits (your completion bonus will be reduced accordingly) 
• 
You voluntarily leave the study 
• 
The study doctor withdraws you early from the study 
• 
The study is stopped early 
• 
You are qualified but not chosen to participate 
 
You will be expected to read and follow the Phase 1 Clinic Subject Rules and Regulations, available at 
http://www.ppdi.com, while participating in the study. If you do not have access to the internet, let a PPD 
study staff member know and you will be provided with a printed version to review. The study staff will be 
available to answer any questions or clarify any information you do not understand. You will be asked to 
confirm whether you have fully read the Rules and Regulations document, acknowledge that you have been 
given the opportunity to ask questions and that you have received satisfactory answers. If you do not read 
and acknowledge the Rules and Regulations document, you will not be able to participate in the study.  If 
you do not follow the Rules and Regulations of the Phase I Clinic during your participation in the study, you 
may not be paid as stated above. 
 
If at any time you test positive for drugs or substances other than the study drug or if you engage in 
disruptive behavior, you may not be paid as stated above. Disruptive behavior includes, but is not limited to: 
 
• 
Destruction of property 
• 
Stealing 
• 
Verbal abuse or profanity 
• 
Bodily or verbal threats 
• 
Sexual harassment 
 
If you engage in disruptive behavior, or if you test positive for drugs or substances other than the study drug, 
you will be paid $2.00 per night and/or outpatient visit for the time you were in the study. You will 
immediately be dropped from the study. Also, you may not be allowed to take part in other studies for PPD. 
 
If you feel that the payment listed may interfere with your making a good decision about whether or not 
you should volunteer to be in this study, you should not agree to participate. 
 
You may be required to report the payment received for this study to the Internal Revenue Service as 
taxable income. 
 
You have to provide your social security number because the IRS may be told how much you were paid to 
take part in this study. 
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IN CASE OF AN INJURY RELATED TO THIS RESEARCH STUDY 
 
If you have any adverse reaction (side effect) to the study drug or changes in your physical or mental 
condition during the course of the study, you should tell the study doctor or study staff right away at the 
phone number listed on the first page of this document. 
 
The study doctor will treat you as needed, at no cost, for any physical injury caused directly by this study. 
The study doctor will not offer to cover the medical care costs for injuries or illnesses that are not caused 
directly by the study.   
 
If you become injured during this study and your injury is a direct result of the study drug or the 
administration of the study drug or properly performed study procedures according to the study 
directions, medical treatment will be available to you. The costs of treatment will be paid by SIGA 
Technologies, Inc. to the extent they are not covered by your health insurance. SIGA Technologies, Inc. 
does not plan to make further compensation for research-related injury available to you. 
 
Be aware that your health care payer/insurance provider might not cover the costs of study-related injuries 
or illnesses. 
 
You do not give up any of your legal rights by signing and dating this form. Further information 
regarding medical treatment for research-related injuries can be obtained from the study doctor or other 
authorized personnel. You must notify the study doctor immediately of any research related injury. 
 
When the sponsor is going to pay for treatment for your injury, the sponsor or its representatives may 
need to collect certain personal information about you, such as your name, date of birth, gender, social 
security number, and Medicare identification number (if you have one). The sponsor needs this 
information to comply with a Medicare reporting obligation.  This information may be collected directly 
from you, or from researchers, physicians or other healthcare providers who treated your problem or 
injury.  This information and also information about your injury or other health problems may be shared 
with others, including sponsor representatives, the sponsor’s insurance company, and the Centers for 
Medicare & Medicaid Services. 
 
Public Readiness and Emergency Preparedness Act (PREP Act) 
 
This clinical trial is covered by the PREP Act.  
If you are physically injured by taking part in this study, the study doctor will provide immediate medical 
treatment.  The study doctor will also refer you to the health care facilities that can best treat your injury. 
No financial compensation by the study doctors that gave you the study drug will be offered for any 
discomfort caused by your taking part in this study. 
 
This clinical trial involves the use of TPOXX, which is covered by the Public Readiness and Emergency 
Preparedness (PREP) Act.  The PREP Act limits your ability to sue under U.S. law from any harm that 
may result from your use of TPOXX unless the harm is caused by willful misconduct (certain types of 
intentional acts).  A federal program called the Countermeasures Injury Compensation Program (CICP) 
has been created to provide compensation for some types of serious injuries or death directly caused by 
medical products covered by the PREP Act.  If you are injured by TPOXX and meet all of the CICP’s 
eligibility requirements, you may be able to receive compensation under this program.  Information about 
the CICP, including how to file a claim follows.   
 
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Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 13 Jun 2019 
 
 
What is the PREP Act?  
The PREP Act was passed in December 2005.  With regard to clinical trials, it provides compensation to 
subjects in the event of serious physical injury or death directly caused by a drug, device, or biological 
product, including a vaccine, against certain pandemic, epidemic, biological, chemical, radiological, or 
nuclear threats, and liability protection for persons conducting the clinical trial and the manufacturer.  
This coverage becomes effective only when the Secretary of HHS issues a Declaration covering that 
category or health threat or condition.  
 
What does the PREP Act do?  
The PREP Act protects those who make, test, develop, distribute and/or use the product covered by the 
Declaration. Those protected may not be sued for an adverse event related to the covered product, except 
for willful misconduct. However, the PREP Act authorizes the Countermeasures Injury Compensation 
Program (CICP) to provide compensation to eligible individuals for serious physical injury or death 
determined to be directly caused by administration or use of the covered product. This compensation may 
include out‐of‐pocket medical expenses, lost employment income and/or survivor death benefits. Claims 
must be filed within one calendar year of receiving the covered vaccine or drug.  
 
What do I do if I am injured as a result of being in this clinical trial?  
If you believe that your injury may be covered by the PREP Act, or you are representing someone who 
has died, and wish to file a request for benefits with the CICP, your request form must be postmarked 
within one year of receipt of the covered vaccine or drug.  The request for benefits form and instructions 
on how to file a claim are available online at:  
http://www.hrsa.gov/gethealthcare/conditions/countermeasurescomp/howtofile.html.   
 
A paper copy of the request for benefits form may be obtained by calling 1 (855) 266-2427. 
 
Send the letter by mail or a commercial carrier or courier service to:  
 
Health Resources and Services Administration 
Countermeasures Injury Compensation Program 
5600 Fishers Lane, Room 11C-06 
Rockville, MD 20857 
 
For additional information, please refer to these websites:  
 
HRSA Countermeasures Injury Compensation Program https://www.hrsa.gov/cicp/ 
 
CICP Administrative Final Rule 
http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx 
 
While you should understand the impact of the PREP Act and how it may limit your rights if you are 
injured during the research, by signing and dating this form you are not giving up any legal rights that you 
may otherwise have. 
 
WHOM TO CONTACT ABOUT THIS STUDY 
 
During this study, if you experience any medical problems, suffer a research-related injury, or have 
questions, concerns or complaints about the study, please contact the Investigator at the telephone number 
listed on the first page of this consent document. If you seek emergency care, or hospitalization is required, 
alert the treating physician that you are participating in this research study. 
 
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Advarra IRB Approved Version 13 Jun 2019 
 
 
If you are unable to reach anyone at the facility and you need medical attention, please go to the 
nearest emergency room.  If you feel this emergency may be life-threatening, call 911 before 
contacting PPD. 
 
An institutional review board (IRB) is an independent committee established to help protect the rights of 
research subjects. If you have any questions about your rights as a research subject, and/or concerns or 
complaints regarding this research study, contact:  
 
• 
By mail:  
Study Subject Adviser  
Advarra IRB  
6940 Columbia Gateway Drive, Suite 110  
Columbia, MD 21046  
• 
or call toll free: 877-992-4724  
• 
or by email: adviser@advarra.com 
 
Please reference the following number when contacting the Study Subject Adviser: Pro00035974. 
 
Advarra has approved the information in this consent document and has given approval for the study 
doctor to do the study. This does not mean Advarra has approved you being in the study.  You must 
consider the information in this consent document for yourself and decide if you want to be in this study. 
 
YOUR PARTICIPATION IN THE STUDY 
 
Your decision to participate in this study is voluntary.  You may choose to not participate or you may 
withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise 
entitled and without any effect on your future medical care.  However, please note that the FDA requires 
that any information collected up to the point of your withdrawal cannot be removed from the study. 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You can leave 
the study at any time.  You will not be punished for leaving the study. 
 
If you believe it is in your best interest to leave the study, you must withdraw, even if that means you will be 
paid less. 
 
If you wish to leave this study, please call the study staff at the phone number listed on the first page of this 
document. 
 
Your part in this study may be stopped at any time without you being asked.  The following people can stop 
your participation: 
 
• 
The study doctor 
• 
Advarra IRB 
• 
The United States Food and Drug Administration (FDA) 
• 
The sponsor company 
 
You may be taken out of the study without your permission at any time for the following reasons: 
 
• 
If you do not follow the study requirements 
• 
If you do not follow the study doctor’s instructions 
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Rebecca Wood-Horrall, M.D. 
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• 
If it is discovered that you do not meet the study requirements (including any requirements in this 
consent document) 
• 
If the study is cancelled 
• 
If it becomes harmful to your health 
• 
If you are not truthful 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed. If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
Certain effects of the study may exist that while under a controlled environment normally do not pose a 
threat to a subject’s safety, but which without proper control such as is found in the PPD facility, may be 
hazardous to your health. 
 
If you decide to leave the PPD facility against the advice of the study doctor you will be asked to sign a 
release form acknowledging so. 
 
RELEASE OF MEDICAL RECORDS AND PRIVACY  
 
Your records of being in this study will be kept private except when ordered by law. The following 
people will have access to your study records: 
 
• 
Study doctor and study staff 
• 
Study Monitor 
• 
SIGA Technologies, Inc. [including monitor(s) and auditor(s)] 
• 
The United States Food and Drug Administration (FDA)  
• 
Other country, state or federal regulatory agencies including the Biomedical Advanced Research 
and Development Authority (BARDA) 
• 
Advarra IRB 
 
In the event you require emergency treatment at a medical facility other than PPD during the study, PPD 
may need to provide your study records, which may include demographic and/or personal information, to 
the healthcare provider involved in your care or treatment. The information disclosed may include 
records/reports including but not limited to clinical lab reports, ECGs, vital sign measurements and 
information related to ongoing side effects and/or concomitant medications. 
 
The Independent Review Board (IRB), Advarra, and accrediting agencies, may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed. If the 
study results are presented at meetings or printed in publications, your name will not be used. 
 
If you require medical care outside of the PPD Phase I Clinic, the study doctor may ask for your approval 
to obtain health records of any hospitalizations or medical visits.  The health records will become part of 
your research record. 
 
If PPD is notified that you have participated in a research study at another research facility while also 
participating in a research study at PPD, it may be necessary for PPD to share certain details about your 
study participation with the other research facility. 
 
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Identification Photo 
 
Prior to screening for the study, you may be required to have your photo taken by a study staff 
member.  Your photo will be used as a means of verifying your identification and will be saved in PPD’s 
internal database for future reference.  Only the study doctor and study staff who have access to the 
database will be able to view your photo. 
 
Electronic Surveillance 
 
The facility is equipped with electronic surveillance and your activities may be monitored. 
 
CONSENT 
 
I have read and understand the information in this informed consent document.  I have had an opportunity 
to ask questions and all of my questions have been answered to my satisfaction.  I voluntarily agree to 
participate in this study until I decide otherwise.  I do not give up any of my legal rights by signing and 
dating this consent document.  I will receive a copy of this signed and dated consent document. 
 
IF YOU DO NOT AGREE WITH THE STATEMENT ABOVE, YOU SHOULD NOT 
SIGN OR DATE THIS INFORMED CONSENT DOCUMENT. 
 
 
 
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AN AGREEMENT TO BE IN A RESEARCH STUDY 
INFORMED CONSENT DOCUMENT 
 
Sponsor / Study Title: 
  
SIGA Technologies, Inc. / “A Post Marketing Study of the Safety, 
Tolerability, and Pharmacokinetics of TPOXX® in Adult Subjects 
Weighing More Than 120 kg” 
 
Protocol Number: 
 
SIGA-246-022 
 
Principal Investigator: 
(Study Doctor) 
 
Additional Contact (Study Staff):  
Rebecca Wood-Horrall, M.D. 
 
 
Lucy Flores 
 
Telephone: 
 
512-447-2985 (24 Hours) 
 
Address: 
PPD Development, LP 
7551 Metro Center Drive 
Suite 200 
Austin, TX    78744 
 
INTRODUCTION 
 
You are being asked to volunteer and take part in a medical research study.  Before you decide to take part 
in this study, you must read, sign, and date this form.  This form, called an informed consent document, 
explains the study.  Please ask as many questions as you need to help you decide whether you want to be in 
the study. This consent document may contain words that you do not understand. Please ask the study 
doctor or the study staff to explain any words or anything else that you do not clearly understand before you 
sign and date this consent document. 
 
To be in this research study, you cannot already be in another medical research study anywhere or have been 
in any other research study within 30 days before taking the study drug in this study. 
 
You must be honest with the study doctor and study staff about your health history or you may harm 
yourself by being in this study.  It is very important that you give complete and truthful answers to all 
questions that you are asked during the study.  The answers will help the study staff to decide if you can 
be in the study or stay in the study.  If you do not wish to answer a question, tell the study doctor or study 
staff that you do not want to answer the question.  Not answering some questions may mean that you 
cannot be in the study. 
 
The study doctor is being paid by SIGA Technologies, Inc., the sponsor (the company paying for this 
study), to run this study.  Also, the Biomedical Advanced Research and Development Authority 
(BARDA), an organization with the United States Department of Health and Human Services, is 
contributing to the funding of the study.   
 
Please read this form carefully. Take your time to ask the study doctor or study staff as many questions 
about the study as you would like. The study doctor or study staff can explain words or information that 
you do not understand. Reading this form and talking to the study doctor or study staff may help you 
decide whether to take part or not. If you decide to take part in this study, you must sign your name at the 
end of this form and date it.  
 
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PURPOSE OF THE STUDY 
 
In July 2018, TPOXX was approved by the United States Food and Drug Administration (FDA) for the 
treatment of smallpox (variola virus).  
 
The FDA has asked SIGA Technologies to also do a research study in people that weigh more than 120 
kilograms (264.5 pounds), which is this study.   
 
In this document, you may see the terms “study drug”, “study treatment”, and “study treatment period”; 
these are terms used in research studies as mentioned above, and this does not mean that you will be 
receiving medical treatment for any condition.  These terms apply to the study drug and parts of the study 
where you will be receiving this study drug. 
 
The purpose(s) of this study are: 
 
• 
To measure the amount of TPOXX in the blood  
• 
To see how safe TPOXX is, and how well you tolerate it 
 
The dose(s) you will receive are as follows: 
 
• 
An oral dose of 600 mg (3 x 200 mg capsules) of TPOXX twice a day for 7 days (Days 1 through 7) 
 
Meals of about 600 calories and 25 grams of fat will be given to you by the study staff 30 minutes before 
taking study drug.  You should eat this entire meal within 30 minutes before taking the study drug. Study 
drug will be given to you about 30 minutes after you start eating your meal and with about 240 mL (1 cup) 
of water.  You will be told not to eat anything after taking study drug for 2 hours after dosing. In addition, 
you will be asked not to drink anything (except water) 3 hours before and after taking the study drug. 
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to continue 
participation we will tell you. You can then decide if you still want to be in the study.   
 
If the FDA or the sponsor makes changes to the study before the study starts, the study staff will try to 
notify you before you check-in.  If changes are made after the study has started, the study staff will tell 
you about them as soon as they have been approved.  You can use this information to decide if you want 
to stay in the study. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
Before you are asked to do any study-related tests or procedures you will be asked to read, sign, and date 
this consent document. The following screening tests and procedures will then be performed to determine 
if you can take part in this study. 
 
You will have medical tests and procedures to help the study doctor decide if you can be in the study. 
This is called “screening” and will take place between 28 to 2 days before the day you start taking study 
drug. 
 
Screening does not mean that you will be in the study.  Whether you can be in the study will depend upon 
the results of your lab tests, study specific guidelines, and the decision of the study doctor.  Even if your 
screening tests are okay, there is a chance that you will not be able to participate.   
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There may be other reasons why you cannot be in the study. The study doctor and/or the study staff will 
discuss this with you. You will not be paid for your screening visit(s). 
 
You will need to have at least two visits to the research facility for screening tests.  After your first 
screening results have been reviewed, at least one more screening visit will be scheduled by the study 
staff. 
 
Screening for this study includes:  
 
• 
A talk about your medical history (including recreational, prescription, and over-the-counter drug 
use; nicotine and alcohol use; and past hospitalizations) 
• 
Physical exam 
• 
Measurement of your weight 
• 
Your vital signs (temperature, breathing rate, blood pressure and heart rate) after at least 5 
minutes sitting 
• 
Your blood and urine will be collected for clinical lab testing (after not eating for at least 8 hours) 
• 
If you are a post-menopausal female, you will have a blood Follicle Stimulating Hormone (FSH) 
test done 
• 
If female, you will have a blood pregnancy test done 
• 
A urine sample to screen for drugs of abuse, including alcohol (must be negative to participate in 
the study) will be collected 
• 
You will have blood collected for HIV and hepatitis B and C (these tests must be negative in 
order for you to be in the study). The study doctor may be required by law to report the result of 
these tests to the local health authority 
• 
An Electrocardiogram (ECG - measures the electrical activity of the heart) after lying down for at 
least 10 minutes will be done 
• 
The study doctor will review your nicotine/tobacco and alcohol use 
 
One of the study staff will talk with you about your medical history, draw blood, and collect urine for lab 
tests.   
 
For screening, the amount of blood taken from you will be a little over 2 teaspoons (11 mL).  It may be 
necessary to try more than one time if the needed amount cannot be collected.  A new needle will be used 
for each blood draw. 
 
A urine test will be done to check for drugs of abuse such as: 
 
• 
Amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine) 
• 
Barbiturates 
• 
Benzodiazepines 
• 
Cannabinoids (including tetrahydrocannabinol) 
• 
Cocaine  
• 
Opiates (including heroin, codeine, and oxycodone) 
• 
Alcohol 
 
Day -1 (Check-in) 
 
If you are eligible to be in the study, you will be admitted to the research facility on Day -1 (check-in), the 
day before you start taking study drug.  You will remain in the research facility overnight for 9 nights. 
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Rebecca Wood-Horrall, M.D. 
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At check-in, a blood sample of a little less than 2 teaspoons (9 mL) and urine sample will be taken from 
you for lab testing and to test for drugs of abuse to see if you can still be in the study.   
 
If you have a positive urine drug test including alcohol, you will not be allowed to take part or to stay in 
the study. All results of drug tests will remain private.  
 
You will be asked questions regarding your general health and any medication you may have taken since 
your screening visit to see if you can still be in the study. Vital signs will be taken (temperature, blood 
pressure, heart rate and breathing rate) after sitting for at least 5 minutes, measurement of weight and 
height, physical exam, blood pregnancy test (if female), and ECG performed (after lying down for at least 
10 minutes).  
 
Day 1 will be the first day that you take study drug. The following will happen on study days 1 through 
Day 8. 
 
Days 1 - 8 
 
• 
Vital signs taken (temperature, breathing rate, blood pressure and heart rate) after sitting for at 
least 5 minutes (Days 1, 4, 7, and 8) 
• 
Measurement of your weight (Day 1) 
• 
Blood sample for clinical labs (Days 4 and 8) 
• 
Physical exam (Day 7) 
• 
ECG after lying down for at least 10 minutes (Days 1, 4, and 7) 
• 
Blood samples of about 1 teaspoon (5 ml) will be collected before the morning dose and 30 
minutes, 1, 2, 4, 6, 8, 12 (before the afternoon dose), 14, 16, 18, 20, and 24 hours after dosing on 
Days 1 and 7, to measure the amount of study drug in your blood 
• 
Blood samples of about 1 teaspoon (5 ml) will be collected before and 4 hours after the morning 
dose on Day 6, to measure the amount of study drug in your blood 
• 
Review of current medications and side effects 
 
Day 9 (Study Discharge) 
 
• 
Physical exam  
• 
Measurement of your weight 
• 
Vital signs (temperature, breathing rate, blood pressure and heart rate) after sitting for at least 5 
minutes 
• 
Blood and urine sample for clinical labs 
• 
ECG after lying down for at least 10 minutes  
• 
Blood samples of about 1 teaspoon (5 ml) will be collected 48 hours after the morning dose on 
Day 7, to measure the amount of study drug in your blood  
• 
Review of current medications and side effects 
 
Before exiting the study, a blood sample of a little less than 2 teaspoons (9 mL) and a urine sample will be 
collected for clinical lab tests.  For your safety, if lab test results are not normal, more blood and/or urine 
samples may be collected. 
 
You can leave the research facility after all study tests and procedures on Day 9 have been completed. If 
you have ongoing side effects or abnormal findings on your physical exam on Day 9, you will be asked to 
return to the research facility five days later, on Day 14.  
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Rebecca Wood-Horrall, M.D. 
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If you do not have any abnormal findings on your physical exam, the study staff will call you by phone on 
Day 14 to check on your wellbeing.  
 
You will be contacted by telephone about 30 days after the last dose of study drug (Day 37) to see how you 
are feeling. You should also contact PPD during this time if you are experiencing any side effects.  
 
A small needle with a thin plastic tube covering it (like a small straw) called a "cannula" may be inserted 
into a vein in your arm or hand to make blood draws easier. A study staff member puts the needle with the 
cannula over it into a vein in your arm or hand, and then slides the cannula over the needle into your arm 
or hand vein. The cannula stays in your arm or hand vein, and the needle is taken out. You will need to 
keep your arm very still for the period while the needle is in place. Use of a cannula is optional and the 
study doctor will decide if it is needed. Very small amounts of saline (salt water) will be injected into this 
cannula to prevent clogging. This procedure may cause pain, swelling and redness at the place where the 
cannula is put into your vein. When a cannula is used for blood collected, the study staff will take about 
an extra 1 mL of blood. The cannula will be left in for as long as it is needed to help with blood 
collections, but not for longer than about 72 hours. 
 
If you take part in this study, you will have your blood drawn about 32 times during this study.  About 
less than 1 cup (187 mL) of blood will be taken from you during this study. You may want to know that 
the standard blood donation is about 2 cups (480 mL) of blood.   
 
Signing and dating this consent form means that you agree to allow PPD, the sponsor, or other 
laboratories involved in this study to store and test any used or unused blood samples or plasma samples 
(taken from the blood samples, for study related testing) until all research on the study drug is stopped.  
When all research is stopped, all blood or plasma samples will be destroyed. If you do not agree to this, 
you will not be enrolled in the study. 
 
After Study Treatment: 
 
Because this is a research study, the study drug will be given to you only during this study and not after 
the study is over. 
 
HIV AND HEPATITIS TESTING 
 
As required by the study and if any person is exposed to your blood, you must be tested for the hepatitis 
viruses and for HIV (Human Immunodeficiency Virus).  HIV is the virus that causes AIDS (Acquired 
Immunodeficiency Syndrome).  If you have a positive HIV or hepatitis test, you cannot remain in the 
study. 
 
If the HIV test is positive, a follow-up test will be done.  If the follow-up test is also positive, you will be 
given the results in private and will also be given information about counseling. 
 
It may take weeks or months after being infected with HIV for the test to be positive.  The HIV test is not 
always right. 
 
Positive HIV and hepatitis test results must be reported to the Department of Health, and the law may 
require that your name be reported. Although this testing is supposed to be private, this cannot be 
guaranteed.  For example, it is possible for a court of law to get medical or study records without your 
permission. 
 
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Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Jul 2019 
 
 
LENGTH OF THE STUDY AND NUMBER OF SUBJECTS EXPECTED TO PARTICIPATE 
 
About 36 male and female subjects, ages 18 to 50, will be in this study. You will be in this study up to 65 
days; this begins with your screening visit and continues until your last study visit.  You will be confined 
to the research facility continuously for 9 nights and 10 days, during this period. 
 
RESTRICTIONS 
 
• 
You must not have participated in another clinical research trial where you received any other 
study drug in a previous study within 30 days before the first dose of study drug. 
• 
You must not have been in any other clinical research study with the study drug TPOXX (also 
known as tecovirimat). 
• 
You should not have donated more than 450 mL of blood or blood components within 30 days 
before the first dose of study drug. You should not donate blood or blood components for 4 weeks 
after the completion of the study. 
• 
You may not consume any food or drink containing grapefruit or grapefruit juice, Seville orange 
or Seville orange-containing products (for example, marmalade) within 48 hours before the first 
dose of study drug or throughout the study. 
• 
You may not consume caffeine- or xanthine-containing beverages within 48 hours before the first 
dose of study drug or throughout the study. 
• 
You may not consume pomegranate or pomegranate juice, pomelo fruits or pomelo juice within 
72 hours before the first dose of study drug. 
• 
You may not consume alcohol-containing beverages within 72 hours before the first dose of study 
drug. 
• 
You must not have used nicotine or nicotine-containing products (for example, cigarettes, 
electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine gum) 
within 6 months before the first dose of study drug and throughout the duration of the study. 
• 
You must refrain from strenuous exercise or contact sports within 24 hours before first dose of 
study drug until study discharge. 
• 
You must not have used any herbal or nutritional supplements, prescription, or over-the-counter 
medications within 14 days before the first dose of study drug. 
• 
You must not intend to lose weight (diet or weight loss) from screening and throughout the study. 
• 
The following medications are not allowed to be taken within 7 days before receiving study drug 
on study Day 1 through check out (Day 9): 
o antidiabetic medications 
o anticoagulants 
o anticonvulsants 
o substrates of the breast cancer resistance protein transporter including 
▪ 
methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, 
sulfasalazine, and topotecan; 
o substrates of cytochrome P450 (CYP) 2C8 including 
▪ 
repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and  
o substrates of CYP2C19 including 
▪ 
S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole, 
and omeprazole   
 
If you are on any of these medications, do not stop taking them without first consulting your personal 
doctor. 
 
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You must not use any drugs (over-the-counter, prescription, or illegal) without approval from the study 
doctor.  Oral birth control pills or other hormonal birth control methods are allowed. Taking other drugs 
or drinking alcohol could result in serious and even life-threatening reactions. If you decide to take any 
medication without approval from the study doctor, you may not be allowed to continue in the study. You 
must inform the study staff of any prescription birth control you are using including intrauterine devices 
(IUDs). 
 
Taking other drugs or alcohol could result in serious and even life-threatening reactions. If you decide to 
take any medication without approval from the study doctor you may not be allowed to continue in the 
study. 
 
RISKS, SIDE EFFECTS, AND/OR DISCOMFORTS 
 
It is very important that you tell the study staff right away about any side effects.  It is also very important 
that you do not talk to other people participating in this study about your side effects or theirs.   
 
If you do not tell the study staff about a side effect, or if you talk to other people in the study with you 
about your side effects, you may be removed from this study. In addition to being removed from the 
current study, your payment may be reduced, and you may not be allowed to take part in future studies for 
PPD. 
 
All side effects or changes in your normal health must be reported, even those changes you might not 
consider to be important.  Some examples may include:  
 
• 
Headache 
• 
Tooth pain 
• 
Bruising 
• 
Hiccups 
• 
Changes in your eating or sleeping patterns 
 
If you have any changes in your health/medical history after signing and dating this consent document, 
please tell your study doctor or study staff. 
 
One of the reasons for this study is to learn more about the possible side effects of the study drug. It is 
important that you tell the study staff about possible side effects. Contact PPD if you experience any side 
effects through the follow-up phone call on Day 37. 
 
Rare or unknown side effects could possibly occur, including allergic reactions, and life-threatening 
reactions. 
 
You may harm yourself by taking part in this study if you are not fully truthful about any side effect with the 
study doctor and study staff. 
 
The most common side effects of TPOXX include: 
 
• 
Headache (12%) 
• 
Nausea (5%) 
• 
Abdominal Pain (2%) 
• 
Vomiting (2%) 
• 
Diarrhea 
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Rebecca Wood-Horrall, M.D. 
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• 
Dizziness 
 
If you do not understand what any of these side effects mean, please ask the study doctor or study staff to 
explain these terms to you.  
 
In animal studies, seizures were seen in dogs, but not any other species.  The significance of this for 
humans is unknown.  You may not participate in the study if you have a history of seizures and you will 
be monitored for any signs of seizure. 
 
ADDITIONAL RISKS OR DISCOMFORTS 
 
Until you know how the study drug will affect you, you should use caution by avoiding stairs, not driving 
a car or working with machinery.  If you later feel that the study drug has affected your ability to perform 
these things, stop doing them. 
 
Blood Samples: 
 
There may be side effects of having blood taken such as: 
 
• 
Fainting 
• 
Redness 
• 
Swelling of the vein 
• 
Pain 
• 
Bruising 
• 
Bleeding 
 
There is also a slight possibility of infection or nerve damage.  
 
If you feel faint tell the study staff or study doctor right away. 
 
Scarring can occur at the sites of repetitive blood draws.  If you have a “cannula” or intravenous catheter, 
you could also have pain, swelling, and redness of the vein, which may not go away quickly. 
 
Electrocardiogram (ECG): 
 
The ECG test is a recording of the electrical activity of your heart.  The sticky pads used may be cold when 
applied and sometimes cause some discomfort such as redness or itching.  If the hair under the patches 
needs to be shaved, irritation from shaving also could occur. 
 
Other Risks 
 
PPD requires that you agree to have pictures taken of your skin if you develop a side effect such as a rash. 
The picture(s) are only for the use of the study doctor and study sponsor. 
 
Since as with any drug, there may be other risks that are unknown. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
The effects of the study drug on an unborn or breastfed baby are unknown, but could be a risk. If you are 
pregnant or breastfeeding, you cannot be in this study.  
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It is very important that you not become pregnant or breastfeed during this study or within 3 months after 
the last dose of study drug. Not having sex is the only certain way to prevent pregnancy. If you are a woman 
who is able to become pregnant, and choose to have sex, you must agree to use one of the methods of birth 
control listed below for at least 30 days before first dose through 30 days after last dose of study drug.  
 
The only birth control methods that can be used during this study include: 
 
• 
Condom, male or female, with spermicide (male and female condoms must NOT be used together) 
• 
Diaphragm or cervical cap with spermicide 
• 
Intrauterine device (IUD) with spermicide 
• 
Oral contraceptives or other hormonal methods with another nonhormonal method 
• 
Male sexual partner who had undergone a vasectomy at least 3 months before screening 
• 
Not having sex (abstinence)* 
 
*Abstinence 
You must understand that sexual abstinence means heterosexual sexual intercourse for medical, 
psychological, legal, social, financial, philosophical, moral or religious reasons. Heterosexual 
sexual activity refers to sexual activity between a male and a female.  Any types of heterosexual 
activity where any amount of male semen (or ejaculate) could be present are to be strictly avoided, 
without exception.  
 
This does not mean periodic abstinence (for example, calendar, ovulation, profession of abstinence 
for entry into a clinical trial). 
 
Abstinence must be your preferred and usual lifestyle. By agreeing to this you affirm (commit) that 
this has been your lifestyle for at least the past 6 months and this will be true until the specified 
amount of time required for the study has been met. 
 
If there is a possibility that you will engage in any heterosexual activity at any time during the study 
time requirement, you must not choose sexual abstinence as your method of birth control. 
 
If you choose abstinence as your method of contraception and become pregnant/father a child 
during participation in this study, you will be excluded from all future participation in PPD studies.  
 
If you cannot have children because of a surgery (for example if you have had a hysterectomy [removal of 
the uterus] or tubal ligation [tubes tied]), or if you are postmenopausal for at least 12 months, you can 
participate in this study without using additional forms of contraception. 
 
Even if you use a medically acceptable birth control method, you could still become pregnant. 
 
There is a chance that a pregnancy test could indicate that you are not pregnant, even though you are. If it is 
early enough in your pregnancy, a pregnancy test may not be able to detect that you are pregnant.  
 
If you are pregnant, become pregnant or breastfeed during the study, the study drug or procedures may 
involve risks to the unborn or breastfed baby, which are currently unforeseeable.  
 
If you are a man, there may be risks to an unborn baby if you father a child during the study.  Men must 
agree to use a condom throughout the study and for 90 days after you take the last dose of study drug.  
 
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Men must agree not to donate sperm from the first dose of study drug through 90 days after the last dose 
of study drug. 
 
Even if you and your partner use birth control, you or your partner could become pregnant.  If you or your 
partner are pregnant, become pregnant, or breastfeed during the study, the study drug may involve risks to 
the unborn or breastfed baby, which we are not aware of at this time. 
 
In the event you (if you are female) or your partner (if you are male) become pregnant during the course 
of the study, you (or your partner) may be requested to sign and date a separate informed consent form to 
allow PPD study staff to contact you throughout the course of the pregnancy to get updates on how the 
pregnancy is progressing, and for 3 months after the birth.  PPD and the sponsor are required to attempt to 
collect and report information about any pregnancy that occurs in a subject who is participating in a study.  
They may also be required to attempt to collect and report this information if the female partner of a male 
subject who is participating in a study becomes pregnant and could have been exposed to study drug 
through the male subject’s semen.   
 
If you are female, and you have had sex without using a medically acceptable method of birth control during 
the three weeks before the start of the study, you must not be in this study. 
 
COSTS 
 
All study tests are being done for research only and are not replacements for medical care.  There will be 
no charge to you for your participation in this study.  The study drug, study-related procedures, and 
testing supplies, as well as study visits will be provided at no charge to you or your insurance company. 
While confined to the research facility all your meals, snacks and beverages will be provided. 
 
POSSIBLE BENEFITS OF THE STUDY 
 
This study is for research purposes only.  There is no direct benefit to you from your participation in the 
study.  Information learned from the study may help other people in the future. 
 
ALTERNATIVES TO PARTICIPATING  
 
This research study is for research purposes only. The only alternative is to not participate in this study. 
 
PAYMENT FOR PARTICIPATION 
 
For the current study, you will receive: 
 
• 
$225.00/night for each night that you spend at the research facility ($225.00/night x 9 nights) 
 
• 
$125.00/visit for each outpatient visit/phone call to the research facility ($125.00/visit x 2 outpatient 
visit/phone call) 
 
If you successfully complete the study, you will receive an additional $725.00 making your total payment 
$3,000.00.  You will receive payment within 3 weeks of your last study visit or your study completion.  
 
If you have a side effect linked to the study drug and the study doctor thinks that this may harm your 
safety, you will be taken out of the study. You may be paid in full, including the study completion bonus, 
at the discretion of the study doctor.  
 
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However full payment is not guaranteed. If you have a side effect linked to the study drug and you leave 
the study when the study doctor does not think your safety is at risk, your pay will be lower. You will 
receive a pro-rated payment and pro-rated study completion bonus based on the days you were in the 
study. If the study doctor releases you from the study and it is non-drug related, you will receive a pro-
rated payment and pro-rated study completion bonus based on the number of days you were in the study. 
 
If you are a backup subject who is required to stay in the facility overnight you will be paid $75.00. If you 
are not required to stay overnight you will be paid $25.00. If you are required to stay for additional nights 
for safety procedures or observation, then you will be paid $200.00 for the additional night(s).  
 
You will be paid an amount based on the extent of your participation, if: 
 
• 
You are unable to complete the study 
• 
You miss multiple outpatient visits (your completion bonus will be reduced accordingly) 
• 
You voluntarily leave the study 
• 
The study doctor withdraws you early from the study 
• 
The study is stopped early 
• 
You are qualified but not chosen to participate 
 
You will be expected to read and follow the Phase 1 Clinic Subject Rules and Regulations, available at 
http://www.ppdi.com, while participating in the study. If you do not have access to the internet, let a PPD 
study staff member know and you will be provided with a printed version to review. The study staff will be 
available to answer any questions or clarify any information you do not understand. You will be asked to 
confirm whether you have fully read the Rules and Regulations document, acknowledge that you have been 
given the opportunity to ask questions and that you have received satisfactory answers. If you do not read 
and acknowledge the Rules and Regulations document, you will not be able to participate in the study.  If 
you do not follow the Rules and Regulations of the Phase I Clinic during your participation in the study, you 
may not be paid as stated above. 
 
If at any time you test positive for drugs or substances other than the study drug or if you engage in 
disruptive behavior, you may not be paid as stated above. Disruptive behavior includes, but is not limited to: 
 
• 
Destruction of property 
• 
Stealing 
• 
Verbal abuse or profanity 
• 
Bodily or verbal threats 
• 
Sexual harassment 
 
If you engage in disruptive behavior, or if you test positive for drugs or substances other than the study drug, 
you will be paid $2.00 per night and/or outpatient visit for the time you were in the study. You will 
immediately be dropped from the study. Also, you may not be allowed to take part in other studies for PPD. 
 
If you feel that the payment listed may interfere with your making a good decision about whether or not 
you should volunteer to be in this study, you should not agree to participate. 
 
You may be required to report the payment received for this study to the Internal Revenue Service as 
taxable income. 
 
You have to provide your social security number because the IRS may be told how much you were paid to 
take part in this study. 
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IN CASE OF AN INJURY RELATED TO THIS RESEARCH STUDY 
 
If you have any adverse reaction (side effect) to the study drug or changes in your physical or mental 
condition during the course of the study, you should tell the study doctor or study staff right away at the 
phone number listed on the first page of this document. 
 
The study doctor will treat you as needed, at no cost, for any physical injury caused directly by this study. 
The study doctor will not offer to cover the medical care costs for injuries or illnesses that are not caused 
directly by the study.   
 
If you become injured during this study and your injury is a direct result of the study drug or the 
administration of the study drug or properly performed study procedures according to the study 
directions, medical treatment will be available to you. The costs of treatment will be paid by SIGA 
Technologies, Inc. to the extent they are not covered by your health insurance. SIGA Technologies, Inc. 
does not plan to make further compensation for research-related injury available to you. 
 
Be aware that your health care payer/insurance provider might not cover the costs of study-related injuries 
or illnesses. 
 
You do not give up any of your legal rights by signing and dating this form. Further information 
regarding medical treatment for research-related injuries can be obtained from the study doctor or other 
authorized personnel. You must notify the study doctor immediately of any research related injury. 
 
When the sponsor is going to pay for treatment for your injury, the sponsor or its representatives may 
need to collect certain personal information about you, such as your name, date of birth, gender, social 
security number, and Medicare identification number (if you have one). The sponsor needs this 
information to comply with a Medicare reporting obligation.  This information may be collected directly 
from you, or from researchers, physicians or other healthcare providers who treated your problem or 
injury.  This information and also information about your injury or other health problems may be shared 
with others, including sponsor representatives, the sponsor’s insurance company, and the Centers for 
Medicare & Medicaid Services. 
 
Public Readiness and Emergency Preparedness Act (PREP Act) 
 
This clinical trial is covered by the PREP Act.  
If you are physically injured by taking part in this study, the study doctor will provide immediate medical 
treatment.  The study doctor will also refer you to the health care facilities that can best treat your injury. 
No financial compensation by the study doctors that gave you the study drug will be offered for any 
discomfort caused by your taking part in this study. 
 
This clinical trial involves the use of TPOXX, which is covered by the Public Readiness and Emergency 
Preparedness (PREP) Act.  The PREP Act limits your ability to sue under U.S. law from any harm that 
may result from your use of TPOXX unless the harm is caused by willful misconduct (certain types of 
intentional acts).  A federal program called the Countermeasures Injury Compensation Program (CICP) 
has been created to provide compensation for some types of serious injuries or death directly caused by 
medical products covered by the PREP Act.  If you are injured by TPOXX and meet all of the CICP’s 
eligibility requirements, you may be able to receive compensation under this program.  Information about 
the CICP, including how to file a claim follows.   
 
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What is the PREP Act?  
The PREP Act was passed in December 2005.  With regard to clinical trials, it provides compensation to 
subjects in the event of serious physical injury or death directly caused by a drug, device, or biological 
product, including a vaccine, against certain pandemic, epidemic, biological, chemical, radiological, or 
nuclear threats, and liability protection for persons conducting the clinical trial and the manufacturer.  
This coverage becomes effective only when the Secretary of HHS issues a Declaration covering that 
category or health threat or condition.  
 
What does the PREP Act do?  
The PREP Act protects those who make, test, develop, distribute and/or use the product covered by the 
Declaration. Those protected may not be sued for an adverse event related to the covered product, except 
for willful misconduct. However, the PREP Act authorizes the Countermeasures Injury Compensation 
Program (CICP) to provide compensation to eligible individuals for serious physical injury or death 
determined to be directly caused by administration or use of the covered product. This compensation may 
include out‐of‐pocket medical expenses, lost employment income and/or survivor death benefits. Claims 
must be filed within one calendar year of receiving the covered vaccine or drug.  
 
What do I do if I am injured as a result of being in this clinical trial?  
If you believe that your injury may be covered by the PREP Act, or you are representing someone who 
has died, and wish to file a request for benefits with the CICP, your request form must be postmarked 
within one year of receipt of the covered vaccine or drug.  The request for benefits form and instructions 
on how to file a claim are available online at:  
http://www.hrsa.gov/gethealthcare/conditions/countermeasurescomp/howtofile.html.   
 
A paper copy of the request for benefits form may be obtained by calling 1 (855) 266-2427. 
 
Send the letter by mail or a commercial carrier or courier service to:  
 
Health Resources and Services Administration 
Countermeasures Injury Compensation Program 
5600 Fishers Lane, Room 11C-06 
Rockville, MD 20857 
 
For additional information, please refer to these websites:  
 
HRSA Countermeasures Injury Compensation Program https://www.hrsa.gov/cicp/ 
 
CICP Administrative Final Rule 
http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx 
 
While you should understand the impact of the PREP Act and how it may limit your rights if you are 
injured during the research, by signing and dating this form you are not giving up any legal rights that you 
may otherwise have. 
 
WHOM TO CONTACT ABOUT THIS STUDY 
 
During this study, if you experience any medical problems, suffer a research-related injury, or have 
questions, concerns or complaints about the study, please contact the Investigator at the telephone number 
listed on the first page of this consent document. If you seek emergency care, or hospitalization is required, 
alert the treating physician that you are participating in this research study. 
 
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If you are unable to reach anyone at the facility and you need medical attention, please go to the 
nearest emergency room.  If you feel this emergency may be life-threatening, call 911 before 
contacting PPD. 
 
An institutional review board (IRB) is an independent committee established to help protect the rights of 
research subjects. If you have any questions about your rights as a research subject, and/or concerns or 
complaints regarding this research study, contact:  
 
• 
By mail:  
Study Subject Adviser  
Advarra IRB  
6940 Columbia Gateway Drive, Suite 110  
Columbia, MD 21046  
• 
or call toll free: 877-992-4724  
• 
or by email: adviser@advarra.com 
 
Please reference the following number when contacting the Study Subject Adviser: Pro00035974. 
 
Advarra has approved the information in this consent document and has given approval for the study 
doctor to do the study. This does not mean Advarra has approved you being in the study.  You must 
consider the information in this consent document for yourself and decide if you want to be in this study. 
 
YOUR PARTICIPATION IN THE STUDY 
 
Your decision to participate in this study is voluntary.  You may choose to not participate or you may 
withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise 
entitled and without any effect on your future medical care.  However, please note that the FDA requires 
that any information collected up to the point of your withdrawal cannot be removed from the study. 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You can leave 
the study at any time.  You will not be punished for leaving the study. 
 
If you believe it is in your best interest to leave the study, you must withdraw, even if that means you will be 
paid less. 
 
If you wish to leave this study, please call the study staff at the phone number listed on the first page of this 
document. 
 
Your part in this study may be stopped at any time without you being asked.  The following people can stop 
your participation: 
 
• 
The study doctor 
• 
Advarra IRB 
• 
The United States Food and Drug Administration (FDA) 
• 
The sponsor company 
 
You may be taken out of the study without your permission at any time for the following reasons: 
 
• 
If you do not follow the study requirements 
• 
If you do not follow the study doctor’s instructions 
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• 
If it is discovered that you do not meet the study requirements (including any requirements in this 
consent document) 
• 
If the study is cancelled 
• 
If it becomes harmful to your health 
• 
If you are not truthful 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed. If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
Certain effects of the study may exist that while under a controlled environment normally do not pose a 
threat to a subject’s safety, but which without proper control such as is found in the PPD facility, may be 
hazardous to your health. 
 
If you decide to leave the PPD facility against the advice of the study doctor you will be asked to sign a 
release form acknowledging so. 
 
RELEASE OF MEDICAL RECORDS AND PRIVACY  
 
Your records of being in this study will be kept private except when ordered by law. The following 
people will have access to your study records: 
 
• 
Study doctor and study staff 
• 
Study Monitor 
• 
SIGA Technologies, Inc. [including monitor(s) and auditor(s)] 
• 
The United States Food and Drug Administration (FDA)  
• 
Other country, state or federal regulatory agencies including the Biomedical Advanced Research 
and Development Authority (BARDA) 
• 
Advarra IRB 
 
In the event you require emergency treatment at a medical facility other than PPD during the study, PPD 
may need to provide your study records, which may include demographic and/or personal information, to 
the healthcare provider involved in your care or treatment. The information disclosed may include 
records/reports including but not limited to clinical lab reports, ECGs, vital sign measurements and 
information related to ongoing side effects and/or concomitant medications. 
 
The Independent Review Board (IRB), Advarra, and accrediting agencies, may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed. If the 
study results are presented at meetings or printed in publications, your name will not be used. 
 
If you require medical care outside of the PPD Phase I Clinic, the study doctor may ask for your approval 
to obtain health records of any hospitalizations or medical visits.  The health records will become part of 
your research record. 
 
If PPD is notified that you have participated in a research study at another research facility while also 
participating in a research study at PPD, it may be necessary for PPD to share certain details about your 
study participation with the other research facility. 
 
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Identification Photo 
 
Prior to screening for the study, you may be required to have your photo taken by a study staff 
member.  Your photo will be used as a means of verifying your identification and will be saved in PPD’s 
internal database for future reference.  Only the study doctor and study staff who have access to the 
database will be able to view your photo. 
 
Electronic Surveillance 
 
The facility is equipped with electronic surveillance and your activities may be monitored. 
 
CONSENT 
 
I have read and understand the information in this informed consent document.  I have had an opportunity 
to ask questions and all of my questions have been answered to my satisfaction.  I voluntarily agree to 
participate in this study until I decide otherwise.  I do not give up any of my legal rights by signing and 
dating this consent document.  I will receive a copy of this signed and dated consent document. 
 
IF YOU DO NOT AGREE WITH THE STATEMENT ABOVE, YOU SHOULD NOT 
SIGN OR DATE THIS INFORMED CONSENT DOCUMENT. 
 
 
 
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AN AGREEMENT TO BE IN A RESEARCH STUDY 
INFORMED CONSENT DOCUMENT 
 
Sponsor / Study Title: 
  
SIGA Technologies, Inc. / “A Post Marketing Study of the 
Safety, Tolerability, and Pharmacokinetics of TPOXX® in 
Adult Subjects Weighing More Than 120 kg” 
 
Protocol Number: 
 
SIGA-246-022 
 
Principal Investigator: 
(Study Doctor) 
 
Additional Contact (Study Staff):  
Rebecca Wood-Horrall, M.D. 
 
 
Lucy Flores 
 
Telephone: 
 
512-447-2985 (24 Hours) 
 
Address: 
PPD Development, LP 
7551 Metro Center Drive 
Suite 200 
Austin, TX 78744 
 
INTRODUCTION 
 
You are being asked to volunteer and take part in a medical research study.  Before you decide to take part 
in this study, you must read, sign, and date this form.  This form, called an informed consent document, 
explains the study.  Please ask as many questions as you need to help you decide whether you want to be in 
the study. This consent document may contain words that you do not understand. Please ask the study 
doctor or the study staff to explain any words or anything else that you do not clearly understand before you 
sign and date this consent document. 
 
To be in this research study, you cannot already be in another medical research study anywhere or have been 
in any other research study within 30 days before taking the study drug in this study. 
 
You must be honest with the study doctor and study staff about your health history or you may harm 
yourself by being in this study.  It is very important that you give complete and truthful answers to all 
questions that you are asked during the study.  The answers will help the study staff to decide if you can 
be in the study or stay in the study.  If you do not wish to answer a question, tell the study doctor or study 
staff that you do not want to answer the question.  Not answering some questions may mean that you 
cannot be in the study. 
 
The study doctor is being paid by SIGA Technologies, Inc., the sponsor (the company paying for this 
study), to run this study.  Also, the Biomedical Advanced Research and Development Authority 
(BARDA), an organization with the United States Department of Health and Human Services, is 
contributing to the funding of the study.   
 
Please read this form carefully. Take your time to ask the study doctor or study staff as many questions 
about the study as you would like. The study doctor or study staff can explain words or information that 
you do not understand. Reading this form and talking to the study doctor or study staff may help you 
decide whether to take part or not. If you decide to take part in this study, you must sign your name at the 
end of this form and date it.  
 
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PURPOSE OF THE STUDY 
 
In July 2018, TPOXX was approved by the United States Food and Drug Administration (FDA) for the 
treatment of smallpox (variola virus).  
 
The FDA has asked SIGA Technologies to also do a research study in people that weigh more than 120 
kilograms (264.5 pounds), which is this study.   
 
In this document, you may see the terms “study drug”, “study treatment”, and “study treatment period”; 
these are terms used in research studies as mentioned above, and this does not mean that you will be 
receiving medical treatment for any condition.  These terms apply to the study drug and parts of the study 
where you will be receiving this study drug. 
 
The purpose(s) of this study are: 
 
• 
To measure the amount of TPOXX in the blood  
• 
To see how safe TPOXX is, and how well you tolerate it 
 
The dose(s) you will receive are as follows: 
 
• 
An oral dose of 600 mg (3 x 200 mg capsules) of TPOXX twice a day for 7 days (Days 1 through 7) 
 
Meals of about 600 calories and 25 grams of fat will be given to you by the study staff 30 minutes before 
taking study drug.  You should eat this entire meal within 30 minutes before taking the study drug. Study 
drug will be given to you about 30 minutes after you start eating your meal and with about 240 mL (1 cup) 
of water.  You will be told not to eat anything after taking study drug for 2 hours after dosing. In addition, 
you will be asked not to drink anything (except water) 3 hours before and after taking the study drug. 
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to continue 
participation we will tell you. You can then decide if you still want to be in the study.   
 
If the FDA or the sponsor makes changes to the study before the study starts, the study staff will try to 
notify you before you check-in.  If changes are made after the study has started, the study staff will tell 
you about them as soon as they have been approved.  You can use this information to decide if you want 
to stay in the study. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
Before you are asked to do any study-related tests or procedures you will be asked to read, sign, and date 
this consent document. The following screening tests and procedures will then be performed to determine 
if you can take part in this study. 
 
You will have medical tests and procedures to help the study doctor decide if you can be in the study. 
This is called “screening” and will take place between 28 to 2 days before the day you start taking study 
drug. 
 
Screening does not mean that you will be in the study.  Whether you can be in the study will depend upon 
the results of your lab tests, study specific guidelines, and the decision of the study doctor.  Even if your 
screening tests are okay, there is a chance that you will not be able to participate.   
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There may be other reasons why you cannot be in the study. The study doctor and/or the study staff will 
discuss this with you. You will not be paid for your screening visit(s). 
 
You will need to have at least two visits to the research facility for screening tests.  After your first 
screening results have been reviewed, at least one more screening visit will be scheduled by the study 
staff. 
 
Screening for this study includes:  
 
• 
A talk about your medical history (including recreational, prescription, and over-the-counter drug 
use; nicotine and alcohol use; and past hospitalizations) 
• 
Physical exam 
• 
Measurement of your weight 
• 
Your vital signs (temperature, breathing rate, blood pressure and heart rate) after at least 5 
minutes sitting 
• 
Your blood and urine will be collected for clinical lab testing (after not eating for at least 8 hours) 
• 
If you are a post-menopausal female, you will have a blood Follicle Stimulating Hormone (FSH) 
test done 
• 
If female, you will have a blood pregnancy test done 
• 
A urine sample to screen for drugs of abuse, including alcohol (must be negative to participate in 
the study) will be collected 
• 
You will have blood collected for HIV and hepatitis B and C (these tests must be negative in 
order for you to be in the study). The study doctor may be required by law to report the result of 
these tests to the local health authority 
• 
An Electrocardiogram (ECG - measures the electrical activity of the heart) after lying down for at 
least 10 minutes will be done 
• 
The study doctor will review your nicotine/tobacco and alcohol use 
 
One of the study staff will talk with you about your medical history, draw blood, and collect urine for lab 
tests.   
 
For screening, the amount of blood taken from you will be a little over 2 teaspoons (11 mL).  It may be 
necessary to try more than one time if the needed amount cannot be collected.  A new needle will be used 
for each blood draw. 
 
A urine test will be done to check for drugs of abuse such as: 
 
• 
Amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine) 
• 
Barbiturates 
• 
Benzodiazepines 
• 
Cannabinoids (including tetrahydrocannabinol) 
• 
Cocaine  
• 
Opiates (including heroin, codeine, and oxycodone) 
• 
Alcohol 
 
Day -1 (Check-in) 
 
If you are eligible to be in the study, you will be admitted to the research facility on Day -1 (check-in), the 
day before you start taking study drug.  You will remain in the research facility overnight for 9 nights. 
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At check-in, a blood sample of a little less than 2 teaspoons (9 mL) and urine sample will be taken from 
you for lab testing and to test for drugs of abuse to see if you can still be in the study.   
 
If you have a positive urine drug test including alcohol, you will not be allowed to take part or to stay in 
the study. All results of drug tests will remain private.  
 
You will be asked questions regarding your general health and any medication you may have taken since 
your screening visit to see if you can still be in the study. Vital signs will be taken (temperature, blood 
pressure, heart rate and breathing rate) after sitting for at least 5 minutes, measurement of weight and 
height, physical exam, blood pregnancy test (if female), and ECG performed (after lying down for at least 
10 minutes).  
 
Day 1 will be the first day that you take study drug. The following will happen on study days 1 through 
Day 8. 
 
Days 1 - 8 
 
• 
Vital signs taken (temperature, breathing rate, blood pressure and heart rate) after sitting for at 
least 5 minutes (Days 1, 4, 7, and 8) 
• 
Measurement of your weight (Day 1) 
• 
Blood sample for clinical labs (Days 4 and 8) 
• 
Physical exam (Day 7) 
• 
ECG after lying down for at least 10 minutes (Days 1, 4, and 7) 
• 
Blood samples of about 1 teaspoon (5 ml) will be collected before the morning dose and 30 
minutes, 1, 2, 4, 6, 8, 12 (before the afternoon dose), 14, 16, 18, 20, and 24 hours after dosing on 
Days 1 and 7, to measure the amount of study drug in your blood 
• 
Blood samples of about 1 teaspoon (5 ml) will be collected before and 4 hours after the morning 
dose on Day 6, to measure the amount of study drug in your blood 
• 
Review of current medications and side effects 
 
Day 9 (Study Discharge) 
 
• 
Physical exam  
• 
Measurement of your weight 
• 
Vital signs (temperature, breathing rate, blood pressure and heart rate) after sitting for at least 5 
minutes 
• 
Blood and urine sample for clinical labs 
• 
ECG after lying down for at least 10 minutes  
• 
Blood samples of about 1 teaspoon (5 ml) will be collected 48 hours after the morning dose on 
Day 7, to measure the amount of study drug in your blood  
• 
Review of current medications and side effects 
 
Before exiting the study, a blood sample of a little less than 2 teaspoons (9 mL) and a urine sample will be 
collected for clinical lab tests.  For your safety, if lab test results are not normal, more blood and/or urine 
samples may be collected. 
 
You can leave the research facility after all study tests and procedures on Day 9 have been completed. If 
you have ongoing side effects or abnormal findings on your physical exam on Day 9, you will be asked to 
return to the research facility five days later, on Day 14.  
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If you do not have any abnormal findings on your physical exam, the study staff will call you by phone on 
Day 14 to check on your wellbeing.  
 
You will be contacted by telephone about 30 days after the last dose of study drug (Day 37) to see how you 
are feeling. You should also contact PPD during this time if you are experiencing any side effects.  
 
A small needle with a thin plastic tube covering it (like a small straw) called a "cannula" may be inserted 
into a vein in your arm or hand to make blood draws easier. A study staff member puts the needle with the 
cannula over it into a vein in your arm or hand, and then slides the cannula over the needle into your arm 
or hand vein. The cannula stays in your arm or hand vein, and the needle is taken out. You will need to 
keep your arm very still for the period while the needle is in place. Use of a cannula is optional and the 
study doctor will decide if it is needed. Very small amounts of saline (salt water) will be injected into this 
cannula to prevent clogging. This procedure may cause pain, swelling and redness at the place where the 
cannula is put into your vein. When a cannula is used for blood collected, the study staff will take about 
an extra 1 mL of blood. The cannula will be left in for as long as it is needed to help with blood 
collections, but not for longer than about 72 hours. 
 
If you take part in this study, you will have your blood drawn about 32 times during this study.  About 
less than 1 cup (187 mL) of blood will be taken from you during this study. You may want to know that 
the standard blood donation is about 2 cups (480 mL) of blood.   
 
Signing and dating this consent form means that you agree to allow PPD, the sponsor, or other 
laboratories involved in this study to store and test any used or unused blood samples or plasma samples 
(taken from the blood samples, for study related testing) until all research on the study drug is stopped.  
When all research is stopped, all blood or plasma samples will be destroyed. If you do not agree to this, 
you will not be enrolled in the study. 
 
After Study Treatment: 
 
Because this is a research study, the study drug will be given to you only during this study and not after 
the study is over. 
 
HIV AND HEPATITIS TESTING 
 
As required by the study and if any person is exposed to your blood, you must be tested for the hepatitis 
viruses and for HIV (Human Immunodeficiency Virus).  HIV is the virus that causes AIDS (Acquired 
Immunodeficiency Syndrome).  If you have a positive HIV or hepatitis test, you cannot remain in the 
study. 
 
If the HIV test is positive, a follow-up test will be done.  If the follow-up test is also positive, you will be 
given the results in private and will also be given information about counseling. 
 
It may take weeks or months after being infected with HIV for the test to be positive.  The HIV test is not 
always right. 
 
Positive HIV and hepatitis test results must be reported to the Department of Health, and the law may 
require that your name be reported. Although this testing is supposed to be private, this cannot be 
guaranteed.  For example, it is possible for a court of law to get medical or study records without your 
permission. 
 
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Page 6 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
LENGTH OF THE STUDY AND NUMBER OF SUBJECTS EXPECTED TO PARTICIPATE 
 
About 36 male and female subjects, ages 18 to 50, will be in this study. You will be in this study up to 65 
days; this begins with your screening visit and continues until your last study visit.  You will be confined 
to the research facility continuously for 9 nights and 10 days, during this period. 
 
RESTRICTIONS 
 
• 
You must not have participated in another clinical research trial where you received any other 
study drug in a previous study within 30 days before the first dose of study drug. 
• 
You must not have been in any other clinical research study with the study drug TPOXX (also 
known as tecovirimat). 
• 
You should not have donated more than 450 mL of blood or blood components within 30 days 
before the first dose of study drug. You should not donate blood or blood components for 4 weeks 
after the completion of the study. 
• 
You may not consume any food or drink containing grapefruit or grapefruit juice, Seville orange 
or Seville orange-containing products (for example, marmalade) within 48 hours before the first 
dose of study drug or throughout the study. 
• 
You may not consume caffeine- or xanthine-containing beverages within 48 hours before the first 
dose of study drug or throughout the study. 
• 
You may not consume pomegranate or pomegranate juice, pomelo fruits or pomelo juice within 
72 hours before the first dose of study drug. 
• 
You may not consume alcohol-containing beverages within 72 hours before the first dose of study 
drug. 
• 
You must not have used nicotine or nicotine-containing products (for example, cigarettes, 
electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine gum) 
within 6 months before the first dose of study drug and throughout the duration of the study. 
• 
You must refrain from strenuous exercise or contact sports within 24 hours before first dose of 
study drug until study discharge. 
• 
You must not have used any herbal or nutritional supplements, prescription, or over-the-counter 
medications within 14 days before the first dose of study drug. 
• 
You must not intend to lose weight (diet or weight loss) from screening and throughout the study. 
• 
The following medications are not allowed to be taken within 7 days before receiving study drug 
on study Day 1 through check out (Day 9): 
o antidiabetic medications 
o anticoagulants 
o anticonvulsants 
o substrates of the breast cancer resistance protein transporter including 
▪ 
methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, 
sulfasalazine, and topotecan; 
o substrates of cytochrome P450 (CYP) 2C8 including 
▪ 
repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and  
o substrates of CYP2C19 including 
▪ 
S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole, 
and omeprazole   
 
If you are on any of these medications, do not stop taking them without first consulting your personal 
doctor. 
 
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SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 7 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
You must not use any drugs (over-the-counter, prescription, or illegal) without approval from the study 
doctor.  Oral birth control pills or other hormonal birth control methods are allowed. Taking other drugs 
or drinking alcohol could result in serious and even life-threatening reactions. If you decide to take any 
medication without approval from the study doctor, you may not be allowed to continue in the study. You 
must inform the study staff of any prescription birth control you are using including intrauterine devices 
(IUDs). 
 
Taking other drugs or alcohol could result in serious and even life-threatening reactions. If you decide to 
take any medication without approval from the study doctor you may not be allowed to continue in the 
study. 
 
RISKS, SIDE EFFECTS, AND/OR DISCOMFORTS 
 
It is very important that you tell the study staff right away about any side effects.  It is also very important 
that you do not talk to other people participating in this study about your side effects or theirs.   
 
If you do not tell the study staff about a side effect, or if you talk to other people in the study with you 
about your side effects, you may be removed from this study. In addition to being removed from the 
current study, your payment may be reduced, and you may not be allowed to take part in future studies for 
PPD. 
 
All side effects or changes in your normal health must be reported, even those changes you might not 
consider to be important.  Some examples may include:  
 
• 
Headache 
• 
Tooth pain 
• 
Bruising 
• 
Hiccups 
• 
Changes in your eating or sleeping patterns 
 
If you have any changes in your health/medical history after signing and dating this consent document, 
please tell your study doctor or study staff. 
 
One of the reasons for this study is to learn more about the possible side effects of the study drug. It is 
important that you tell the study staff about possible side effects. Contact PPD if you experience any side 
effects through the follow-up phone call on Day 37. 
 
Rare or unknown side effects could possibly occur, including allergic reactions, and life-threatening 
reactions. 
 
You may harm yourself by taking part in this study if you are not fully truthful about any side effect with the 
study doctor and study staff. 
 
The most common side effects of TPOXX include: 
 
• 
Headache (12%) 
• 
Nausea (5%) 
• 
Abdominal Pain (2%) 
• 
Vomiting (2%) 
• 
Diarrhea 
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SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 8 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
• 
Dizziness 
 
If you do not understand what any of these side effects mean, please ask the study doctor or study staff to 
explain these terms to you.  
 
In animal studies, seizures were seen in dogs, but not any other species.  The significance of this for 
humans is unknown.  You may not participate in the study if you have a history of seizures and you will 
be monitored for any signs of seizure. 
 
ADDITIONAL RISKS OR DISCOMFORTS 
 
Until you know how the study drug will affect you, you should use caution by avoiding stairs, not driving 
a car or working with machinery.  If you later feel that the study drug has affected your ability to perform 
these things, stop doing them. 
 
Blood Samples: 
 
There may be side effects of having blood taken such as: 
 
• 
Fainting 
• 
Redness 
• 
Swelling of the vein 
• 
Pain 
• 
Bruising 
• 
Bleeding 
 
There is also a slight possibility of infection or nerve damage.  
 
If you feel faint tell the study staff or study doctor right away. 
 
Scarring can occur at the sites of repetitive blood draws.  If you have a “cannula” or intravenous catheter, 
you could also have pain, swelling, and redness of the vein, which may not go away quickly. 
 
Electrocardiogram (ECG): 
 
The ECG test is a recording of the electrical activity of your heart.  The sticky pads used may be cold when 
applied and sometimes cause some discomfort such as redness or itching.  If the hair under the patches 
needs to be shaved, irritation from shaving also could occur. 
 
Other Risks 
 
PPD requires that you agree to have pictures taken of your skin if you develop a side effect such as a rash. 
The picture(s) are only for the use of the study doctor and study sponsor. 
 
Since as with any drug, there may be other risks that are unknown. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
The effects of the study drug on an unborn or breastfed baby are unknown, but could be a risk. If you are 
pregnant or breastfeeding, you cannot be in this study.  
Page 535


SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 9 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
 
It is very important that you not become pregnant or breastfeed during this study or within 3 months after 
the last dose of study drug. Not having sex is the only certain way to prevent pregnancy. If you are a woman 
who is able to become pregnant, and choose to have sex, you must agree to use one of the methods of birth 
control listed below for at least 30 days before first dose through 30 days after last dose of study drug.  
 
The only birth control methods that can be used during this study include: 
 
• 
Condom, male or female, with spermicide (male and female condoms must NOT be used together) 
• 
Diaphragm or cervical cap with spermicide 
• 
Intrauterine device (IUD) with spermicide 
• 
Oral contraceptives or other hormonal methods with another nonhormonal method 
• 
Male sexual partner who had undergone a vasectomy at least 3 months before screening 
• 
Not having sex (abstinence)* 
 
*Abstinence 
You must understand that sexual abstinence means heterosexual sexual intercourse for medical, 
psychological, legal, social, financial, philosophical, moral or religious reasons. Heterosexual 
sexual activity refers to sexual activity between a male and a female.  Any types of heterosexual 
activity where any amount of male semen (or ejaculate) could be present are to be strictly avoided, 
without exception.  
 
This does not mean periodic abstinence (for example, calendar, ovulation, profession of abstinence 
for entry into a clinical trial). 
 
Abstinence must be your preferred and usual lifestyle. By agreeing to this you affirm (commit) that 
this has been your lifestyle for at least the past 6 months and this will be true until the specified 
amount of time required for the study has been met. 
 
If there is a possibility that you will engage in any heterosexual activity at any time during the study 
time requirement, you must not choose sexual abstinence as your method of birth control. 
 
If you choose abstinence as your method of contraception and become pregnant/father a child 
during participation in this study, you will be excluded from all future participation in PPD studies.  
 
If you cannot have children because of a surgery (for example if you have had a hysterectomy [removal of 
the uterus] or tubal ligation [tubes tied]), or if you are postmenopausal for at least 12 months, you can 
participate in this study without using additional forms of contraception. 
 
Even if you use a medically acceptable birth control method, you could still become pregnant. 
 
There is a chance that a pregnancy test could indicate that you are not pregnant, even though you are. If it is 
early enough in your pregnancy, a pregnancy test may not be able to detect that you are pregnant.  
 
If you are pregnant, become pregnant or breastfeed during the study, the study drug or procedures may 
involve risks to the unborn or breastfed baby, which are currently unforeseeable.  
 
If you are a man, there may be risks to an unborn baby if you father a child during the study.  Men must 
agree to use a condom throughout the study and for 90 days after you take the last dose of study drug.  
 
Page 536


SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 10 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
Men must agree not to donate sperm from the first dose of study drug through 90 days after the last dose 
of study drug. 
 
Even if you and your partner use birth control, you or your partner could become pregnant.  If you or your 
partner are pregnant, become pregnant, or breastfeed during the study, the study drug may involve risks to 
the unborn or breastfed baby, which we are not aware of at this time. 
 
In the event you (if you are female) or your partner (if you are male) become pregnant during the course 
of the study, you (or your partner) may be requested to sign and date a separate informed consent form to 
allow PPD study staff to contact you throughout the course of the pregnancy to get updates on how the 
pregnancy is progressing, and for 3 months after the birth.  PPD and the sponsor are required to attempt to 
collect and report information about any pregnancy that occurs in a subject who is participating in a study.  
They may also be required to attempt to collect and report this information if the female partner of a male 
subject who is participating in a study becomes pregnant and could have been exposed to study drug 
through the male subject’s semen.   
 
If you are female, and you have had sex without using a medically acceptable method of birth control during 
the three weeks before the start of the study, you must not be in this study. 
 
COSTS 
 
All study tests are being done for research only and are not replacements for medical care.  There will be 
no charge to you for your participation in this study.  The study drug, study-related procedures, and 
testing supplies, as well as study visits will be provided at no charge to you or your insurance company. 
While confined to the research facility all your meals, snacks and beverages will be provided. 
 
POSSIBLE BENEFITS OF THE STUDY 
 
This study is for research purposes only.  There is no direct benefit to you from your participation in the 
study.  Information learned from the study may help other people in the future. 
 
ALTERNATIVES TO PARTICIPATING  
 
This research study is for research purposes only. The only alternative is to not participate in this study. 
 
PAYMENT FOR PARTICIPATION 
 
For the current study, you will receive: 
 
• 
$75.00 for screening 
 
• 
$225.00/night for each night that you spend at the research facility ($225.00/night x 9 nights) 
 
• 
$125.00/visit for each outpatient visit/phone call to the research facility ($125.00/visit x 2 outpatient 
visit/phone call) 
 
If you successfully complete the study, you will receive an additional $650.00 making your total payment 
$3,000.00.  You will receive payment within 3 weeks of your last study visit or your study completion.  
 
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SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 11 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
If you have a side effect linked to the study drug and the study doctor thinks that this may harm your 
safety, you will be taken out of the study. You may be paid in full, including the study completion bonus, 
at the discretion of the study doctor.  
 
However full payment is not guaranteed. If you have a side effect linked to the study drug and you leave 
the study when the study doctor does not think your safety is at risk, your pay will be lower. You will 
receive a pro-rated payment and pro-rated study completion bonus based on the days you were in the 
study. If the study doctor releases you from the study and it is non-drug related, you will receive a pro-
rated payment and pro-rated study completion bonus based on the number of days you were in the study. 
 
If you are a backup subject who is required to stay in the facility overnight you will be paid $75.00. If you 
are not required to stay overnight you will be paid $25.00. If you are required to stay for additional nights 
for safety procedures or observation, then you will be paid $200.00 for the additional night(s).  
 
You will be paid an amount based on the extent of your participation, if: 
 
• 
You are unable to complete the study 
• 
You miss multiple outpatient visits (your completion bonus will be reduced accordingly) 
• 
You voluntarily leave the study 
• 
The study doctor withdraws you early from the study 
• 
The study is stopped early 
• 
You are qualified but not chosen to participate 
 
You will be expected to read and follow the Phase 1 Clinic Subject Rules and Regulations, available at 
http://www.ppdi.com, while participating in the study. If you do not have access to the internet, let a PPD 
study staff member know and you will be provided with a printed version to review. The study staff will be 
available to answer any questions or clarify any information you do not understand. You will be asked to 
confirm whether you have fully read the Rules and Regulations document, acknowledge that you have been 
given the opportunity to ask questions and that you have received satisfactory answers. If you do not read 
and acknowledge the Rules and Regulations document, you will not be able to participate in the study.  If 
you do not follow the Rules and Regulations of the Phase I Clinic during your participation in the study, you 
may not be paid as stated above. 
 
If at any time you test positive for drugs or substances other than the study drug or if you engage in 
disruptive behavior, you may not be paid as stated above. Disruptive behavior includes, but is not limited to: 
 
• 
Destruction of property 
• 
Stealing 
• 
Verbal abuse or profanity 
• 
Bodily or verbal threats 
• 
Sexual harassment 
 
If you engage in disruptive behavior, or if you test positive for drugs or substances other than the study drug, 
you will be paid $2.00 per night and/or outpatient visit for the time you were in the study. You will 
immediately be dropped from the study. Also, you may not be allowed to take part in other studies for PPD. 
 
If you feel that the payment listed may interfere with your making a good decision about whether or not 
you should volunteer to be in this study, you should not agree to participate. 
 
Page 538


SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 12 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
You may be required to report the payment received for this study to the Internal Revenue Service as 
taxable income. 
 
You have to provide your social security number because the IRS may be told how much you were paid to 
take part in this study. 
 
IN CASE OF AN INJURY RELATED TO THIS RESEARCH STUDY 
 
If you have any adverse reaction (side effect) to the study drug or changes in your physical or mental 
condition during the course of the study, you should tell the study doctor or study staff right away at the 
phone number listed on the first page of this document. 
 
The study doctor will treat you as needed, at no cost, for any physical injury caused directly by this study. 
The study doctor will not offer to cover the medical care costs for injuries or illnesses that are not caused 
directly by the study.   
 
If you become injured during this study and your injury is a direct result of the study drug or the 
administration of the study drug or properly performed study procedures according to the study 
directions, medical treatment will be available to you. The costs of treatment will be paid by SIGA 
Technologies, Inc. to the extent they are not covered by your health insurance. SIGA Technologies, Inc. 
does not plan to make further compensation for research-related injury available to you. 
 
Be aware that your health care payer/insurance provider might not cover the costs of study-related injuries 
or illnesses. 
 
You do not give up any of your legal rights by signing and dating this form. Further information 
regarding medical treatment for research-related injuries can be obtained from the study doctor or other 
authorized personnel. You must notify the study doctor immediately of any research related injury. 
 
When the sponsor is going to pay for treatment for your injury, the sponsor or its representatives may 
need to collect certain personal information about you, such as your name, date of birth, gender, social 
security number, and Medicare identification number (if you have one). The sponsor needs this 
information to comply with a Medicare reporting obligation.  This information may be collected directly 
from you, or from researchers, physicians or other healthcare providers who treated your problem or 
injury.  This information and also information about your injury or other health problems may be shared 
with others, including sponsor representatives, the sponsor’s insurance company, and the Centers for 
Medicare & Medicaid Services. 
 
Public Readiness and Emergency Preparedness Act (PREP Act) 
 
This clinical trial is covered by the PREP Act.  
If you are physically injured by taking part in this study, the study doctor will provide immediate medical 
treatment.  The study doctor will also refer you to the health care facilities that can best treat your injury. 
No financial compensation by the study doctors that gave you the study drug will be offered for any 
discomfort caused by your taking part in this study. 
 
This clinical trial involves the use of TPOXX, which is covered by the Public Readiness and Emergency 
Preparedness (PREP) Act.  The PREP Act limits your ability to sue under U.S. law from any harm that 
may result from your use of TPOXX unless the harm is caused by willful misconduct (certain types of 
intentional acts).   
 
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SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 13 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
A federal program called the Countermeasures Injury Compensation Program (CICP) has been created to 
provide compensation for some types of serious injuries or death directly caused by medical products 
covered by the PREP Act.  If you are injured by TPOXX and meet all of the CICP’s eligibility 
requirements, you may be able to receive compensation under this program.  Information about the CICP, 
including how to file a claim follows.   
 
What is the PREP Act?  
The PREP Act was passed in December 2005.  With regard to clinical trials, it provides compensation to 
subjects in the event of serious physical injury or death directly caused by a drug, device, or biological 
product, including a vaccine, against certain pandemic, epidemic, biological, chemical, radiological, or 
nuclear threats, and liability protection for persons conducting the clinical trial and the manufacturer.  
This coverage becomes effective only when the Secretary of HHS issues a Declaration covering that 
category or health threat or condition.  
 
What does the PREP Act do?  
The PREP Act protects those who make, test, develop, distribute and/or use the product covered by the 
Declaration. Those protected may not be sued for an adverse event related to the covered product, except 
for willful misconduct. However, the PREP Act authorizes the Countermeasures Injury Compensation 
Program (CICP) to provide compensation to eligible individuals for serious physical injury or death 
determined to be directly caused by administration or use of the covered product. This compensation may 
include out‐of‐pocket medical expenses, lost employment income and/or survivor death benefits. Claims 
must be filed within one calendar year of receiving the covered vaccine or drug.  
 
What do I do if I am injured as a result of being in this clinical trial?  
If you believe that your injury may be covered by the PREP Act, or you are representing someone who 
has died, and wish to file a request for benefits with the CICP, your request form must be postmarked 
within one year of receipt of the covered vaccine or drug.  The request for benefits form and instructions 
on how to file a claim are available online at:  
http://www.hrsa.gov/gethealthcare/conditions/countermeasurescomp/howtofile.html.   
 
A paper copy of the request for benefits form may be obtained by calling 1 (855) 266-2427. 
 
Send the letter by mail or a commercial carrier or courier service to:  
 
Health Resources and Services Administration 
Countermeasures Injury Compensation Program 
5600 Fishers Lane, Room 11C-06 
Rockville, MD 20857 
 
For additional information, please refer to these websites:  
 
HRSA Countermeasures Injury Compensation Program https://www.hrsa.gov/cicp/ 
 
CICP Administrative Final Rule 
http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx 
 
While you should understand the impact of the PREP Act and how it may limit your rights if you are 
injured during the research, by signing and dating this form you are not giving up any legal rights that you 
may otherwise have. 
 
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SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 14 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
WHOM TO CONTACT ABOUT THIS STUDY 
 
During this study, if you experience any medical problems, suffer a research-related injury, or have 
questions, concerns or complaints about the study, please contact the Investigator at the telephone number 
listed on the first page of this consent document. If you seek emergency care, or hospitalization is required, 
alert the treating physician that you are participating in this research study. 
 
If you are unable to reach anyone at the facility and you need medical attention, please go to the 
nearest emergency room.  If you feel this emergency may be life-threatening, call 911 before 
contacting PPD. 
 
An institutional review board (IRB) is an independent committee established to help protect the rights of 
research subjects. If you have any questions about your rights as a research subject, and/or concerns or 
complaints regarding this research study, contact:  
 
• 
By mail:  
Study Subject Adviser  
Advarra IRB  
6940 Columbia Gateway Drive, Suite 110  
Columbia, MD 21046  
• 
or call toll free: 877-992-4724  
• 
or by email: adviser@advarra.com 
 
Please reference the following number when contacting the Study Subject Adviser: Pro00035974. 
 
Advarra has approved the information in this consent document and has given approval for the study 
doctor to do the study. This does not mean Advarra has approved you being in the study.  You must 
consider the information in this consent document for yourself and decide if you want to be in this study. 
 
YOUR PARTICIPATION IN THE STUDY 
 
Your decision to participate in this study is voluntary.  You may choose to not participate or you may 
withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise 
entitled and without any effect on your future medical care.  However, please note that the FDA requires 
that any information collected up to the point of your withdrawal cannot be removed from the study. 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You can leave 
the study at any time.  You will not be punished for leaving the study. 
 
If you believe it is in your best interest to leave the study, you must withdraw, even if that means you will be 
paid less. 
 
If you wish to leave this study, please call the study staff at the phone number listed on the first page of this 
document. 
 
Your part in this study may be stopped at any time without you being asked.  The following people can stop 
your participation: 
 
• 
The study doctor 
• 
Advarra IRB 
Page 541


SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 15 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
• 
The United States Food and Drug Administration (FDA) 
• 
The sponsor company 
 
You may be taken out of the study without your permission at any time for the following reasons: 
 
• 
If you do not follow the study requirements 
• 
If you do not follow the study doctor’s instructions 
• 
If it is discovered that you do not meet the study requirements (including any requirements in this 
consent document) 
• 
If the study is cancelled 
• 
If it becomes harmful to your health 
• 
If you are not truthful 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed. If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
Certain effects of the study may exist that while under a controlled environment normally do not pose a 
threat to a subject’s safety, but which without proper control such as is found in the PPD facility, may be 
hazardous to your health. 
 
If you decide to leave the PPD facility against the advice of the study doctor you will be asked to sign a 
release form acknowledging so. 
 
RELEASE OF MEDICAL RECORDS AND PRIVACY  
 
Your records of being in this study will be kept private except when ordered by law. The following 
people will have access to your study records: 
 
• 
Study doctor and study staff 
• 
Study Monitor 
• 
SIGA Technologies, Inc. [including monitor(s) and auditor(s)] 
• 
The United States Food and Drug Administration (FDA)  
• 
Other country, state or federal regulatory agencies including the Biomedical Advanced Research 
and Development Authority (BARDA) 
• 
Advarra IRB 
 
In the event you require emergency treatment at a medical facility other than PPD during the study, PPD 
may need to provide your study records, which may include demographic and/or personal information, to 
the healthcare provider involved in your care or treatment. The information disclosed may include 
records/reports including but not limited to clinical lab reports, ECGs, vital sign measurements and 
information related to ongoing side effects and/or concomitant medications. 
 
The Independent Review Board (IRB), Advarra, and accrediting agencies, may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed. If the 
study results are presented at meetings or printed in publications, your name will not be used. 
 
 
Page 542


SIGA Technologies, Inc. / Protocol Number SIGA-246-022 
Page 16 of 16 
 
Rebecca Wood-Horrall, M.D. 
Advarra IRB Approved Version 23 Sep 2019 
 
 
If you require medical care outside of the PPD Phase I Clinic, the study doctor may ask for your approval 
to obtain health records of any hospitalizations or medical visits.  The health records will become part of 
your research record. 
 
If PPD is notified that you have participated in a research study at another research facility while also 
participating in a research study at PPD, it may be necessary for PPD to share certain details about your 
study participation with the other research facility. 
 
Identification Photo 
 
Prior to screening for the study, you may be required to have your photo taken by a study staff 
member.  Your photo will be used as a means of verifying your identification and will be saved in PPD’s 
internal database for future reference.  Only the study doctor and study staff who have access to the 
database will be able to view your photo. 
 
Electronic Surveillance 
 
The facility is equipped with electronic surveillance and your activities may be monitored. 
 
CONSENT 
 
I have read and understand the information in this informed consent document.  I have had an opportunity 
to ask questions and all of my questions have been answered to my satisfaction.  I voluntarily agree to 
participate in this study until I decide otherwise.  I do not give up any of my legal rights by signing and 
dating this consent document.  I will receive a copy of this signed and dated consent document. 
 
IF YOU DO NOT AGREE WITH THE STATEMENT ABOVE, YOU SHOULD NOT 
SIGN OR DATE THIS INFORMED CONSENT DOCUMENT. 
Page 543


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.4 
List and Description of Investigators and Other Important 
Participants in the Study, Including Brief Curriculum Vitae 
or Equivalent Summaries of Training and Experience 
Relevant to the Performance of the Study 
Investigator 
Site # 
Sub-investigator 
Address 
Rebecca N. 
Wood-Horrall, 
MD 
001 
Lu Ann Bundrant, MD  
Theresa T. Pham, MD 
Antonia M. Davidson, MD 
Gregg H. Lucksinger, MD  
PPD Development, LP 
7551 Metro Center Drive, 
Suite 200 
Austin, TX 78744  
United States 
A CV for the principal investigator is provided on the following pages. 
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Page 546


Page 547


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.5 
Signature of Principal Investigator 
Please refer to page 2 of the study report for the signature of the Principal Investigator. 
Page 548


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.6 
Listing of Subjects Receiving Test Drug/Investigational 
Product(s) From Specific Batches, Where More Than 1 Batch 
was Used 
Only one batch of study drug was used in this study. 
Name of Drug/Investigational Product 
Formulation 
Lot Number 
Tecovirimat (TPOXX®) 
200 mg capsule 
24601069BS 
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SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.7 
Randomization Scheme and Codes (Subject Identification 
and Treatment Assigned) 
This was an open-label study. 
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SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.8 
Audit Certificates 
No audits certificates are included for this study. 
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SIGA Technologies, Inc. 
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.9 
Documentation of Statistical Methods 
This section contains the following documents: 
Statistical analysis plan version 1.0 dated 11 October 2019 
Page 552


  
 
 
 
 
 
 
 
 
 
 
SIGA Technologies, Inc. 
 
SIGA-246-022 
 
A POST MARKETING STUDY OF THE SAFETY, TOLERABILITY, 
AND PHARMACOKINETICS OF TPOXX® IN ADULT SUBJECTS 
WEIGHING MORE THAN 120 KG 
Post Marketing Commitment: 3417-4 
 
 
11OCT2019 
 
Statistical Analysis Plan 
 
Version 1.0 
 
Prepared by: 
 
PPD 
3900 Paramount Parkway 
Morrisville, NC 27560 USA 
 
 
 
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SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
TABLE OF CONTENTS 
LIST OF ABBREVIATIONS ..............................................................................................4 
1. 
INTRODUCTION ....................................................................................................5 
2. 
OBJECTIVES ...........................................................................................................5 
2.1. PRIMARY OBJECTIVES ............................................................................................... 5 
2.2. SECONDARY OBJECTIVES .......................................................................................... 5 
3. 
INVESTIGATIONAL PLAN ..................................................................................5 
3.1. OVERALL STUDY DESIGN AND PLAN ........................................................................ 5 
3.2. STUDY ENDPOINTS .................................................................................................... 6 
3.2.1. 
Pharmacokinetic Endpoints .............................................................................. 6 
3.2.2. 
Safety Endpoints ................................................................................................ 7 
4. 
GENERAL STATISTICAL CONSIDERATIONS ...............................................7 
4.1. SAMPLE SIZE ............................................................................................................. 8 
4.2. ANALYSIS POPULATIONS .......................................................................................... 8 
5. 
SUBJECT DISPOSITION, PROTOCOL DEVIATIONS, AND FOLLOW-UP
 ....................................................................................................................................8 
5.1. DISPOSITION ............................................................................................................. 8 
5.2. PROTOCOL DEVIATIONS ............................................................................................ 8 
6. 
DEMOGRAPHICS AND BASELINE CHARACTERISTICS ............................9 
6.1. DEMOGRAPHICS ........................................................................................................ 9 
6.1.1. 
General Medical History ................................................................................... 9 
6.2. INCLUSION AND EXCLUSION CRITERIA ..................................................................... 9 
7. 
TREATMENTS, MEDICATIONS, AND MEALS ...............................................9 
7.1. PRIOR AND CONCOMITANT MEDICATIONS ................................................................ 9 
7.2. MEDICAL AND SURGICAL TREATMENT PROCEDURES ............................................. 10 
7.3. STUDY DRUG ADMINISTRATION ............................................................................. 10 
7.4. MEALS .................................................................................................................... 10 
8. 
PHARMACOKINETIC ANALYSIS ...................................................................10 
8.1. PHARMACOKINETIC SAMPLE CONCENTRATIONS ..................................................... 10 
8.2. PHARMACOKINETIC PARAMETERS .......................................................................... 11 
9. 
SAFETY ANALYSIS .............................................................................................12 
9.1. ADVERSE EVENTS ................................................................................................... 12 
9.1.1. 
Incidence of Adverse Events ............................................................................ 13 
9.1.2. 
Relationship of Adverse Events to Study Drug ................................................ 13 
9.1.3. 
Severity of Adverse Event ................................................................................ 13 
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SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
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Date Issued: 11OCT2019 
 
  
 
9.1.4. 
Serious Adverse Events ................................................................................... 14 
9.1.5. 
Adverse Events Leading to Study Drug Discontinuation ................................ 15 
9.2. CLINICAL LABORATORY EVALUATIONS .................................................................. 15 
9.2.1. 
Hematology ..................................................................................................... 15 
9.2.2. 
Serum Chemistry ............................................................................................. 16 
9.2.3. 
Urinalysis ........................................................................................................ 16 
9.2.4. 
Other Clinical Laboratory Assessments .......................................................... 17 
9.3. VITAL SIGN MEASUREMENTS ................................................................................. 17 
9.4. ELECTROCARDIOGRAMS ......................................................................................... 18 
9.5. PHYSICAL MEASUREMENTS .................................................................................... 19 
9.6. PHYSICAL EXAMINATION ........................................................................................ 19 
9.7. FOLLOW-UP VISIT/CALL ......................................................................................... 19 
10. 
INTERIM ANALYSIS ...........................................................................................19 
11. 
CHANGES TO THE PLANNED ANALYSIS ....................................................20 
12. 
APPENDICES ........................................................................................................21 
12.1. 
SCHEDULE OF EVENTS ......................................................................................... 21 
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SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
List of Abbreviations 
λz 
terminal elimination rate constant 
%AUCextrap 
percentage of AUC0-∞ extrapolated from the last quantifiable 
measurement to infinity 
AE 
adverse event 
AUC 
area under the plasma concentration-time curve 
AUC0-24 
area under the plasma concentration-time curve from time 0 to 
24 hours 
AUC0-∞ 
area under the plasma concentration-time curve from time 0 
extrapolated to infinity 
AUC0-t 
AUC from time 0 to the last measurable concentration in 
plasma 
AUC0-tau 
area under the plasma concentration-time curve during the 
first dosing interval 
BID 
twice daily 
BLQ 
below the limit of quantification 
Cavg 
average plasma concentration 
CL/F 
apparent total body clearance 
Cmax 
maximum drug concentration in plasma 
Ctrough 
concentration observed prior to the next dose administration 
CSR 
clinical study report 
CV 
coefficient of variation 
DAIDS 
Division of Acquired Immune Deficiency Syndrome 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
FDA 
Food and Drug Administration 
MedDRA 
Medical Dictionary for Regulatory Activities 
PK 
pharmacokinetic(s) 
PT 
preferred term 
SAE 
serious adverse event 
SD 
standard deviation 
SOC 
system organ class 
t1/2 
terminal elimination half-life 
TRAE 
treatment-related adverse event 
Tmax 
time to maximum drug concentration in plasma 
Vd/F 
apparent volume of distribution 
 
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SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
1. Introduction 
 
This document outlines the statistical methods to be implemented during the analysis of 
data collected within the scope of SIGA Technologies, Inc., protocol SIGA-246-022 (A 
Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of TPOXX® in 
Adult Subjects Weighing More Than 120 kg), Version 2.0, 27 Jun 2019. The 
SIGA-246-022 clinical study is being conducted as a Food and Drug Administration 
(FDA) post marketing commitment (3417-4) to the approved New Drug Application for 
TPOXX. SIGA is required to conduct a study to determine the pharmacokinetic (PK) 
profile of TPOXX in subjects with a body weight greater than 120 kilograms (>120 kg) to 
determine if a change in dosing regimen would be needed in these patients. 
 
The purpose of this statistical analysis plan is to define the planned statistical analysis of 
the study data consistent with the study objectives. 
2. Objectives 
2.1. Primary Objectives 
 
The primary objective of this study is to determine the PK profile of 600 mg oral TPOXX 
(3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects 
weighing more than 120 kg to determine if a change in dosing regimen would be needed in 
these patients. 
2.2. Secondary Objectives 
 
The secondary objective of this study is to evaluate the safety and tolerability of 600 mg 
oral TPOXX administered BID for 7 days in adult subjects weighing more than 120 kg. 
3. Investigational Plan 
3.1. Overall Study Design and Plan 
 
This is an open-label, multiple-dose study to assess the safety, tolerability, and PK of 
TPOXX 600 mg BID when administered orally for 7 days to adult subjects weighing more 
than 120 kg. A total of 36 subjects, ages 18 to 50, inclusive, will be enrolled. The study 
will consist of a screening period (Day –28 to Day –2), a treatment and confinement period 
(Days –1 to 9), a follow-up telephone call or visit (Day 14 [+2 days]), and a follow-up 
telephone call (Day 37 [+2 days]).  
 
Subjects will undergo screening evaluations to determine eligibility within 28 days before 
study drug administration. Subjects will be admitted to the study site on Day –1 to 
complete baseline assessments; results of these assessments must be reviewed by the 
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SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
investigator before dosing. Starting in the morning of Day 1, subjects will receive 600 mg 
oral TPOXX BID for 7 days (Days 1 through 7). 
 
All subjects will be provided meals (consisting of approximately 600 calories and 25 g fat) 
30 minutes prior to study drug administration and subjects must fast for 2 hours after 
taking study drug. Subjects should eat this meal within 30 minutes or less of taking study 
drug. Study drug and meals must be taken with water only, and no other beverage except 
water should be ingested within 3 hours before or 3 hours after study drug administration. 
 
Subjects will remain confined to the study site for collection of PK samples and will be 
carefully monitored for safety and tolerability until discharge on Day 9. Subjects who have 
abnormal physical examination findings or an ongoing adverse event (AE)/serious adverse 
event (SAE) on Day 9 that is deemed related to study drug or per investigator or SIGA 
discretion will return to the study site on Day 14 (+2 days) for a follow-up visit. All other 
subjects will have the Day 14 (+2 days) follow-up via telephone. All subjects will have a 
follow-up telephone call 30 days after administration of the last dose of study drug 
(Day 37 [+2 days]) to report any SAEs. At the time of discharge from the clinical research 
unit, subjects will be instructed to notify the investigator of any SAEs that occur within 
30 days after administration of the last dose of study drug. Serious AEs will be followed 
until the SAE is stable or until resolution as determined by the investigator and/or medical 
monitor. 
 
The total duration of the study for each subject, including the screening period, treatment 
period, and the Day 37 (+2 days) follow-up telephone call, will be approximately 65 days. 
The schedule of events is presented in Appendix 12.1. 
3.2. Study Endpoints 
3.2.1. Pharmacokinetic Endpoints 
 
Blood samples for PK analysis of TPOXX will be collected from all subjects Day 1 before 
study drug administration (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 
20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 
4 hours after the AM dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 
(before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on 
Day 7), and on Day 9 (48 hours after the AM dose on Day 7). 
 
For PK samples, the acceptable window for collection from the scheduled collection time 
point will be as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes 
for the 12- to 48-hour time points. 
 
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Pharmacokinetic endpoints include but are not limited to the following:  
 
• Area under the plasma concentration-time curve (AUC) from time 0 to the last 
quantifiable measurement (AUC0-t) 
• AUC from time 0 extrapolated to infinity (AUC0-∞) 
• AUC from time 0 to 24 hour (AUC0-24) 
• AUC during the first dosing interval (tau = 12 hours) (AUC0-tau) 
• Maximum drug concentration in plasma (Cmax) 
• Time to Cmax (Tmax) 
• Apparent volume of distribution (Vd/F) 
• 
Apparent total body clearance (CL/F) 
• Concentration observed prior to the next dose administration (Ctrough) 
• Terminal elimination half-life (t1/2) 
• Terminal elimination rate constant (λz) 
• Percentage of AUC0-∞ extrapolated from the last quantifiable measurement to 
infinity (%AUCextrap). 
3.2.2. Safety Endpoints 
 
Safety and tolerability will be assessed by monitoring and recording of AEs, clinical 
laboratory test results (hematology, serum chemistry, pregnancy, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body 
temperature), 12-lead electrocardiogram (ECG) results, and physical examination findings. 
Adverse events will be assessed from the time of the first dose of study drug until the 
follow-up telephone call on Day 37 (+2 days). 
4. General Statistical Considerations 
 
All data collected will be presented in data listings. Data from subjects excluded from an 
analysis population will be presented in the data listings but not included in the calculation 
of summary statistics. 
 
For categorical variables, frequencies and percentages will be presented. Continuous 
variables will be summarized using descriptive statistics (number of subjects, mean, 
median, standard deviation [SD], minimum, and maximum). 
 
During the analysis and reporting process, any deviations from the statistical plan designed 
for this protocol will be described and justified in the clinical study report. 
 
Unless specified otherwise, baseline will be defined as the last non-missing assessment 
prior to dosing for each study period. Unscheduled visits will be used in determining 
baseline. 
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SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
4.1. Sample Size 
 
The sample size (N = 36 [to allow at least 32 enrolled subjects to complete]) for this study 
is based on clinical and practical considerations and not on a formal statistical power 
calculation. The sample size is considered sufficient to effectively assess the PK and safety 
profiles of TPOXX. 
4.2. Analysis Populations 
 
The Safety Population will include all subjects who receive at least 1 dose of study drug. 
 
The PK Population will include subjects who receive study drug and have sufficient 
concentration data to facilitate the calculation of PK variables. 
5. Subject Disposition, Protocol Deviations, and Follow-up 
5.1. Disposition 
 
Subject disposition will be summarized overall for all subjects. 
 
The number of subjects who enroll in the study and the number and percentage of subjects 
who complete the study will be presented. Frequency and percentage of subjects who 
withdraw or discontinue from the study, and the reason for withdrawal or discontinuation, 
will also be summarized. 
 
Subject disposition data and analysis populations will be presented in data listings. 
5.2. Protocol Deviations 
 
A protocol deviation is any change, divergence, or departure from the study design or 
procedures defined in the protocol. An important protocol deviation (sometimes referred to 
as a protocol violation or a major protocol deviation) is a subset of protocol deviations that 
might significantly affect the reliability of the study data or that might significantly affect a 
subject's safety. An important deviation can include nonadherence to inclusion or 
exclusion criteria or nonadherence to FDA regulations or International Council for 
Harmonisation E6(R2) guidelines. 
 
Protocol deviations will be documented by the clinical monitor throughout the course of 
monitoring visits. The investigator will be notified in writing by the monitor of deviations. 
The institutional review board should be notified of all protocol deviations, if appropriate, 
in a timely manner. 
 
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SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
Major protocol deviations will be summarized overall. All protocol deviations will be 
presented in a data listing, including the categorization of the deviation as major or minor. 
6. Demographics and Baseline Characteristics 
6.1. Demographics 
 
Baseline demographic and background variables will be summarized overall for all 
subjects.  
 
The demographic characteristics consist of age (years), sex, race, and ethnicity. The 
baseline characteristics consist of baseline weight (kg) and height (cm). A subject’s age in 
years is calculated using the date of the informed consent and date of birth. Age (years) 
and baseline weight (kg) will be summarized using descriptive statistics. The number and 
percentage of subjects by race (American Indian or Alaska Native, Asian, Black or African 
American, Native Hawaiian or Other Pacific Islander, and White), ethnicity (Hispanic or 
Latino, Not Hispanic or Latino), and reproductive status (for females only; Sterile, 
Post-Menopausal, Potentially Able to Bear Children) will also be reported. Percentages 
will be based on the total number of subjects in the Safety population. 
 
Subject demographic and baseline characteristics will be presented in a data listing. 
6.1.1. General Medical History 
 
A complete medical history will be obtained, including recreational, prescription drug use, 
over-the-counter drug use, nicotine and alcohol use, and past hospitalizations.  
Medical history will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA, version to be delineated in the clinical study report [CSR]). 
 
Medical history will be presented in a data listing. 
6.2. Inclusion and Exclusion Criteria 
 
All inclusion/exclusion criteria deviations recorded in the electronic case report form 
(eCRF) will be presented in a data listing. 
7. Treatments, Medications, and Meals 
7.1. Prior and Concomitant Medications 
 
A prior medication is defined as any medication that is taken within 30 days before signing 
the informed consent form. A concomitant medication is defined as any medication that 
has a start date on or after date of first dose. 
 
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SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
Prior and concomitant medications and therapies will be coded using the latest version of 
the World Health Organization Drug Dictionary. 
 
All prior and concomitant medications will be presented in a data listing. 
7.2. Medical and Surgical Treatment Procedures 
 
All medical and surgical treatment procedures will be coded using the MedDRA (version 
to be delineated in the CSR). All medical and surgical treatment procedures will be 
presented in a data listing. 
7.3. Study Drug Administration 
 
All doses of study drug will be administered at the study site under direct observation of 
site personnel and recorded in the eCRF. Study site personnel will confirm that the subject 
has received the dose of study drug. The date, time, and amount of study drug dosing will 
be recorded on the appropriate page of the eCRF. If a subject does not receive study drug, 
the reason for the missed dose will be recorded. 
 
A summary of study drug administration data will be presented. The summary will include 
the number and percentage of subjects dosed, as well as summary statistics of the number 
of complete doses received and the number and percentage of subjects who receive all 
14 doses.  
 
All study drug administration data will be presented in a data listing. 
7.4. Meals 
 
Meal data will be presented in a data listing. 
8. Pharmacokinetic Analysis 
8.1. Pharmacokinetic Sample Concentrations 
 
Individual plasma concentrations, actual time, and deviation from the scheduled time will 
be presented in a data listing by subject, study day and nominal time point. Plasma 
concentration data will be summarized by day and time point using the following 
descriptive statistics: sample size (n), arithmetic mean, geometric mean, SD, geometric 
SD, coefficient of variation (CV), geometric CV (calculated as sqrt [exp [variance for log 
transformed data]-1]*100), median, minimum, and maximum.  
 
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SIGA Technologies, Inc. 
 
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Date Issued: 11OCT2019 
 
  
 
If the minimum value is zero, the geometric mean will not be calculated and displayed. If 
the mean concentration values are below the limit of quantification (BLQ), they will be 
displayed as BLQ; in this case the SD and CV will be reported as NA (not applicable). 
Plasma concentrations that are BLQ will be treated as zero for descriptive statistics.  
Missing concentrations will be excluded from the calculations. 
 
Individual and mean (±SD) and trough (±SD) plasma TPOXX concentration versus time 
profiles will be presented in figures on both linear and semi-logarithmic scales. Mean 
plasma concentration versus time profiles will be presented using nominal time and 
individual plasma concentration versus time profiles will be presented using actual time. 
8.2. Pharmacokinetic Parameters 
 
The individual plasma concentration versus actual time data for TPOXX will be used to 
derive the following PK parameters, by noncompartmental methods using Phoenix® 
WinNonlin® Version 8.0 or higher (Certara USA, Inc., Princeton, NJ). 
 
Parameter Day 
Definition  
AUC0-t 
1, 7 
AUC versus time curve from time 0 to the last 
quantifiable measurement, calculated using the linear 
trapezoidal rule. 
AUC0-t = 
, where Ci and Ci-1 is the 
plasma concentration at ti and ti-1, respectively, and ti-ti-1 is 
the time interval.
 
AUC0-24 
1, 7 
AUC versus time curve from time 0 to 24 hours postdose, 
calculated using the linear trapezoidal rule. 
AUC0-tau 
1, 7 
AUC during the first dosing interval (tau = 12 hours) 
AUC0-∞ 
7 
AUC versus time curve from time 0 extrapolated to 
infinity, calculated using the linear trapezoidal rule,  
AUC0-∞= AUC0-t + Clast/z, where Clast is the last 
quantifiable plasma drug concentration and z is the 
terminal elimination rate constant. 
%AUCextrap 7 
Percentage of AUC0-∞ extrapolated from the last 
quantifiable measurement to infinity 
Cmax 
1, 7 
Maximum observed plasma drug concentration 
Tmax 
1, 7 
Time to reach Cmax 
λz 
1, 7 
Terminal elimination rate constant 
t1/2 
1, 7 
Terminal elimination half-life, calculated as t1/2 = ln2/λz  
CL/F 
7 
Apparent total body clearance, calculated as: 
Dose/AUC0-∞ 

=
−
−
−
+
n
i
i
i
i
i
t
t
C
C
1
1
1
)
(
2
)
(
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SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
Vd/F 
7 
Apparent volume of distribution, calculated as: CL/F/λz  
Ctrough 
1, 2, 6, 7 
Concentration observed prior to the next dose 
administration 
 
No concentration estimates will be imputed for missing sample values. Any sample with a 
missing value will be treated as if the sample had not been scheduled for collection and 
will be ignored when calculating mean concentrations or PK parameters. For the purpose 
of calculating the PK parameters only, all plasma concentrations that are BLQ prior to the 
first measurable concentration will be set to zero and treated as missing thereafter. 
 
For the calculation of λz and all associated parameters, at least 3 time points (excluding 
Cmax) are required, and the correlation coefficient (r2) must be ≥0.80.  
 
Actual sampling times, rather than scheduled sampling times, will be used in the 
computation of PK parameters. However, for ease of presentation, scheduled sampling 
times will be used to present results in summary tables. The individual PK parameters of 
TPOXX will be presented in a data listing. The PK parameters will be summarized by day 
using the following descriptive statistics: n, arithmetic mean, geometric mean, SD, CV, 
geometric SD, geometric CV, median, minimum, and maximum. For Tmax, only n, median, 
minimum, and maximum will be included in descriptive statistics. Geometric mean, 
geometric SD, and geometric CV will be included for the AUCs and Cmax. 
9. Safety Analysis 
 
Safety and tolerability will be assessed by monitoring and recording of AEs, clinical 
laboratory test results (hematology, serum chemistry, and urinalysis), vital sign 
measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and 
temperature), 12-lead ECG results, and physical examination findings. 
 
All safety summaries and analyses will be conducted for the Safety population. Safety data 
will be presented in listings. 
9.1. Adverse Events 
 
An AE is any event or other untoward medical occurrence, including those AEs that result 
from dosing errors, which may present during administration of a study drug or during a 
reasonable follow-up period and which does not necessarily have a causal relationship with 
this treatment. An AE is any unfavorable and unintended sign (e.g., a clinically significant 
abnormal laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal product, whether or not considered to be related to the medicinal product. 
A treatment-emergent AE is defined as any event not present before exposure to study drug 
or any event already present that worsens in intensity or frequency after exposure to study 
drug. 
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Adverse events will be coded by preferred term (PT) and system organ class (SOC) using 
MedDRA (version to be delineated in the CSR). 
 
An overall summary of all AEs will be presented. The number and percentage of subjects, 
as well as the number of AEs will be presented for each of the following categories: any 
AE; any grade 2, grade 3, grade 4, and grade 5 AE; any treatment-related AE (TRAE); any 
grade 2, grade 3, grade 4, and grade 5 TRAE; any SAE; any serious TRAE, and any AE 
leading to discontinuation of study drug. In addition, the table will include a summary of 
the time to first AE and the time to first AE of grade 3 or higher. Time to first AE will be 
calculated for each period of the study in days as the date of the first AE in the period – the 
date of first dose of study drug in the period + 1. Time to first AE of grade 3 or higher will 
be computed similarly. These times will be summarized overall. 
 
All AEs will be presented in a data listing.  
9.1.1. Incidence of Adverse Events 
 
Adverse events will be summarized by SOC and PT and by PT alone, including the total 
number of AEs and the number and percentage of subjects with at least one AE. At each 
level of subject summarization, a subject is counted once if the subject reported one or 
more events. Percentages will be calculated out of the number of subjects in the Safety 
population.  
9.1.2. Relationship of Adverse Events to Study Drug 
 
A summary of AEs by relationship to study drug will be presented in a table by incidence 
of occurrence. The investigator will provide an assessment of the relationship of the event 
to the study drug. The possible relationships are “Not Related”, “Unlikely Related”, 
“Possibly Related”, “Probably Related”, and “Definitely Related”. In the summary of AEs 
by relationship, if a subject reports multiple occurrence of the same AE, only the most 
closely related occurrence will be presented. Adverse events that are missing a relationship 
will be presented in the summary table as “Definitely Related” but will be presented in the 
data listing with a missing relationship. Percentages will be calculated based on the 
number of subjects in the Safety Population. 
 
An AE is considered treatment-related if it is assessed as probably, possibly, or definitely 
related by the investigator. Treatment-related AEs will be presented in a data listing. 
9.1.3. Severity of Adverse Event 
 
All AEs will be graded for severity according to the current Division of Acquired 
Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and 
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Pediatric Adverse Events, version 2.1. Any laboratory or clinical AE that is not listed on 
the DAIDS table will be assessed for severity and classified into 1 of 5 clearly defined 
categories as follows: 
 
• Grade 1 (Mild): Events require minimal or no treatment and do not interfere with 
the subject’s daily activities 
• Grade 2 (Moderate): Events result in a low level of inconvenience or concern with 
the therapeutic measures and may cause some interference with normal functioning 
• Grade 3 (Severe): Events interrupt a subject’s usual daily activity, may require 
systemic drug therapy or other treatment, and are usually incapacitating 
• Grade 4 (Life-threatening): Event that, in the opinion of the investigator, places the 
subject at immediate risk of death from the reaction as it occurred (i.e., it does not 
include a reaction that, had it occurred in a more severe form, might have caused 
death) 
• Grade 5 (Death) 
 
A summary of AEs by severity will be presented in a table. The severity that will be 
presented represents the most extreme severity captured on the eCRF page. In this 
summary, if a subject reported multiple occurrences of the same AE, only the most severe 
will be presented. Adverse events that are missing severity will be presented in tables as 
Grade 3 but will be presented in the data listing with a missing severity. Percentages will 
be calculated out of the number of subjects in the Safety Population. 
9.1.4. Serious Adverse Events 
 
An AE is considered an SAE if, in the view of either the investigator or sponsor, it results 
in any of the following outcomes: 
 
• Results in death 
• Is life threatening (subject is at immediate risk of death at the time of the event) 
• Requires inpatient hospitalization or prolongation of existing hospitalization, other 
than elective hospitalization, during the period of protocol defined surveillance 
• Results in congenital anomaly or birth defect 
• Results in a persistent or significant disability/incapacity 
• Any other important medical event that may not result in death, be life threatening, 
or requires hospitalization may be considered an SAE when, based on appropriate 
medical judgment, the event may jeopardize the subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition or is 
otherwise considered to be medically significant. 
 
The seriousness of an AE should be assessed by the investigator independently from the 
severity of the AE.  
 
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All SAEs will be presented in a data listing. 
9.1.5. Adverse Events Leading to Study Drug Discontinuation 
 
An AE where the answer to “What action was taken with study treatment?” is “Drug 
Withdrawn” will be considered an AE leading to study drug discontinuation. 
 
All AEs leading to study drug discontinuation will be presented in a data listing. 
9.2. Clinical Laboratory Evaluations 
 
Abnormal clinical laboratory values will be flagged as either high or low (or normal or 
abnormal) based on the reference ranges for each laboratory parameter. The investigator 
will determine whether any of the abnormally high or low results are clinically significant 
or not clinically significant. Clinical significance is defined as any variation in results that 
has medical relevance and may result in an alteration in medical care (e.g., active 
observation, diagnostic measures, or therapeutic measures). If a clinically significant 
change from the screening value is noted, the clinically significant value and reason for 
clinical significance will be documented on the AE page in the eCRF. The investigator will 
continue to monitor the subject with additional assessments until the values have reached 
the reference range or the values at screening or until the investigator determines that 
follow-up is no longer medically necessary.  
 
Where possible, abnormal clinical laboratory values will be graded for severity according 
to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, 
version 2.1.  
 
9.2.1. Hematology 
 
The following clinical laboratory hematology assessments will be performed: hematocrit, 
hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, 
total and differential leukocyte count (basophils, eosinophils, lymphocytes, monocytes, 
neutrophils), mean corpuscular volume, platelet count, red blood cell count, and red cell 
distribution width. 
 
Summary tables presenting observed values and changes from baseline will be presented 
for hematology laboratory tests with numeric values for subjects in the Safety Population. 
Changes from baseline to each scheduled post-baseline visit will be presented. 
 
Changes in low, normal, high, and abnormal classifications will be summarized in shift 
tables comparing the results at each scheduled post-baseline visit with those at the baseline 
visit.  
 
Page 567


SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
The maximum increase in DAIDS grade post-baseline (including both scheduled and 
unscheduled visits) will be summarized. 
 
All hematology laboratory data will be presented in a data listing. 
9.2.2. Serum Chemistry 
 
The following clinical laboratory serum chemistry assessments will be performed: alanine 
aminotransferase, albumin, alkaline phosphatase, anion gap, aspartate aminotransferase, 
bilirubin (total), blood urea nitrogen, calcium, carbon dioxide, chloride, creatinine 
clearance (calculated), gamma-glutamyl transferase, globulin, glucose, lactate 
dehydrogenase, phosphorus, potassium, sodium, total protein, and uric acid. 
 
Creatinine clearance will be calculated using the Cockcroft-Gault formula: 
𝐶𝐿𝑐𝑟 (𝑚𝐿/𝑚𝑖𝑛) =
[140 −𝑎𝑔𝑒(𝑦𝑒𝑎𝑟𝑠)] × 𝑤𝑒𝑖𝑔ℎ𝑡(𝑘𝑔)
72 × 𝑠𝑒𝑟𝑢𝑚 𝑐𝑟𝑒𝑎𝑡𝑖𝑛𝑖𝑛𝑒(𝑚𝑔/𝑑𝐿) {× 0.85 𝑖𝑓 𝑓𝑒𝑚𝑎𝑙𝑒}  
 
Summary tables presenting observed values and changes from baseline will be presented 
for serum chemistry laboratory tests with numeric values for subjects in the Safety 
Population. Changes from baseline to each scheduled post-baseline visit will be presented. 
 
Changes in low, normal, high, and abnormal classifications will be summarized in shift 
tables comparing the results at each scheduled post-baseline visit with those at the baseline 
visit. Shift tables will be presented for subjects in the Safety Population. 
 
The maximum increase in DAIDS grade post-baseline (including both scheduled and 
unscheduled visits) will be summarized. 
 
All serum chemistry laboratory data will be presented in a data listing. 
9.2.3. Urinalysis 
 
The following clinical laboratory urinalysis assessments will be performed: appearance 
(scored using nephelometry as clear, slightly cloudy, cloudy, or turbid), bilirubin, blood, 
color, glucose, ketones, leukocytes, microscopy (performed if dipstick is ≥1+; includes 
bacteria, cast, crystals, epithelial cells, red blood cells, and white blood cells), nitrates, pH, 
protein, specific gravity, turbidity, and urobilinogen. 
 
Summary tables presenting observed values and changes from baseline will be presented 
for urinalysis laboratory tests with numeric values for subjects in the Safety Population. 
Changes from baseline to each scheduled post-baseline visit will be presented. 
 
Page 568


SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
Changes in low, normal, high, and abnormal classifications will be summarized in shift 
tables comparing the results at each scheduled post-baseline visit with those at the baseline 
visit. Shift tables will be presented for subjects in the Safety Population.  
 
The maximum increase in DAIDS grade post-baseline (including both scheduled and 
unscheduled visits) will be summarized. 
 
Microscopy data will not be included in the summaries. 
 
All urinalysis laboratory data will be presented in a data listing. 
9.2.4. Other Clinical Laboratory Assessments 
 
Glycosylated hemoglobin A1c and a fasting lipid panel including cholesterol (total, 
high-density lipoprotein, calculated low-density lipoprotein, and triglycerides) will be 
performed at screening. 
 
Serum pregnancy test ( human chorionic gonadotropin) for women of childbearing 
potential will be performed at screening and on Day –1. 
 
A serum follicle-stimulating hormone test for postmenopausal women will be performed at 
screening.  
 
Human immunodeficiency virus (type 1 and 2) antibodies, hepatitis B surface antigen, and 
hepatitis C virus antibody will be assessed at screening only. 
 
A urine drug screen for alcohol, amphetamines (including methamphetamines and 
ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids 
(including tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, 
codeine, and oxycodone) will be performed at screening and on Day –1. 
 
The results of these assessments will be presented in a data listing. 
9.3. Vital Sign Measurements 
 
Vital signs will be measured after the subject has been seated for at least 5 minutes at the 
time points indicated in the schedule of events (Appendix 12.1). 
 
Vital sign measurements will include systolic and diastolic blood pressures, heart rate, 
respiratory rate, and body temperature.   
 
The investigator will determine whether any of the vital sign measurements are clinically 
significant or not clinically significant. Clinical significance is defined as any variation in 
Page 569


SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
results that has medical relevance and may result in an alteration in medical care (e.g., 
active observation, diagnostic measures, or therapeutic measures). If a clinically significant 
change from the screening values is noted, the clinically significant value and reason for 
clinical significance will be documented on the AE page of the subject’s eCRF. The 
investigator will continue to monitor the subject with additional assessments until the value 
has reached the reference range or the value at screening or until the investigator 
determines that follow up is no longer medically necessary.  
 
Summary tables presenting observed values and changes from baseline will be presented 
for vital sign data for subjects in the Safety Population. Changes from baseline to each 
scheduled post-baseline visit will be presented. 
 
All vital sign data will be presented in a data listing. 
 
9.4. Electrocardiograms 
 
A 12-lead ECG will be obtained after the subject has been in the supine position for at least 
10 minutes at the time points indicated in the schedule of events (Appendix 12.1).  
 
Electrocardiogram assessments will include comments on whether the tracings are normal 
or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any 
evidence of myocardial infarction, or ST segment, T wave, and U wave abnormalities. In 
addition, the following parameters will be measured and reported: heart rate; PR, RR, and 
QT intervals; QT interval corrected using Fridericia’s formula (QTcF); QT interval 
corrected using Bazett’s formula (QTcB); and QRS duration. All ECGs must be performed 
by an experienced ECG technician. 
 
The investigator will determine whether any of the 12-lead ECG results are clinically 
significant or not clinically significant. Clinical significance is defined as any variation in 
results that has medical relevance and may result in an alteration in medical care (e.g., 
active observation, diagnostic measures, or therapeutic measures). If a clinically significant 
change from screening is noted, the clinically significant value and reason for clinical 
significance will be documented on the AE page of the subject’s eCRF. The investigator 
will continue to monitor the subject with additional assessments until either the values 
have reached reference range or the values at screening or until the investigator determines 
that follow-up is no longer medically necessary. 
 
Summary tables presenting observed values and changes from baseline will be presented 
for ECG numeric results for subjects in the Safety population. Changes from baseline to 
each scheduled post baseline visit will be presented. 
 
All ECG data will be presented in a data listing. 
Page 570


SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
9.5. Physical Measurements 
 
Physical measurements (height and weight) will be performed at the time points indicated 
in the schedule of events (Appendix 12.1). 
 
Height and weight data will be presented in a data listing. 
9.6. Physical Examination 
 
A full physical examination will be performed at the time points indicated in the schedule 
of events (Appendix 12.1) and will include assessment of the following body systems: 
 
• Head, ears, eyes, nose and throat 
• Cardiac (including auscultation of heart) 
• Pulmonary (chest) auscultation of lungs 
• Abdomen 
• Skin 
• Musculoskeletal system 
• Lymphatic system 
• Neurologic system (cranial nerves, sensation, motor function, coordination, 
reflexes, and mental status). 
 
A symptom-directed physical examination will be performed at the time points indicated in 
the schedule of events (Appendix 12.1) (for those subjects who require it), and at 
unscheduled visits as necessary. This examination will include an assessment of the heart, 
lungs, abdomen, a neurologic review, and a review of symptoms for assessments and/or 
follow-up of reported or potential AEs. 
 
Physical examination results will be presented in a data listing. 
 
9.7. Follow-up Visit/Call 
 
Follow-up visit and follow-up call data will be presented in a data listing. 
10. Interim Analysis 
 
No formal interim safety analyses will be performed in this study. 
Page 571


SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
11. Changes to the Planned Analysis 
 
Per FDA request, clinical laboratory values will be graded for severity according to the 
DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1. 
Summary tables for the maximum increase in DAIDS grade post-baseline (including both 
scheduled and unscheduled visits) have been added. 
 
No other changes were made from the planned analysis in the protocol. 
 
Page 572


SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
12. Appendices 
12.1. 
Schedule of Events  
 Screening Check-in 
Treatment Period 
Telephone 
Call or 
Follow-up 
Visit(a) 
Follow-up 
Telephone 
Call(b) 
Procedure(c) 
Day –28 to –2 
–1 
1 
2 
3 
4 
5 
6 
7 
8 
9 or Early 
Discontinuation 
(±2) 
14 (+2) 
  
37 (+2) 
Admission to clinic 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Discharge from clinic(d) 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical history(e) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Complete physical examination(f) 
X 
X 
 
 
 
 
 
 
X 
 
X 
 
 
Weight(g) 
X 
X 
X(h) 
 
 
 
 
 
 
 
X 
 
 
Height 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Vital sign measurements(i) 
X 
X 
X(j) 
 
 
X(j) 
 
 
X(j) 
X 
X 
X(k) 
 
Glycosylated hemoglobin 
(HbA1c) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Fasting lipid panel(l) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical laboratory testing(m) 
X(n) 
X 
 
 
 
X 
 
 
 
X(o) 
X(n) 
 
 
Serum follicle-stimulating 
hormone(p) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Serum pregnancy test(q) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Urine drug/alcohol screen(r) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Serology (HBsAg, HCV, and 
HIV) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Page 573


SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
Abbreviations: AE, adverse event; ECG, electrocardiogram; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; PK, 
pharmacokinetic; SAE, serious adverse event. 
Notes: 
(a) The follow-up visit, or telephone call will occur on Day 14 (+2 days), 7 days after the last dose of study drug. Subjects who have abnormal physical examination 
findings or an ongoing AE/SAE on Day 9 that is deemed related to study drug or per investigator or SIGA discretion will return to the study site on Day 14 (+2 
days) for a follow-up visit. All other subjects will have the Day 14 (+2 days) follow-up via telephone.  
(b) The follow-up telephone call will be made 30 days after the last dose of study drug (Day 37 [+2 days]). 
(c) When procedures are overlapping and occurring at the same time point, the order of procedures should be ECG, vital sign measurements, and then blood collection, 
with the blood collection scheduled to occur at the nominal time point, unless dictated by other study events happening at that time, such as dosing requirements. 
(d) Discharge following collection of all safety assessments. 
(e) Including a review of systems; recreational, prescription, and over-the-counter drug use; nicotine and alcohol use; and past hospitalizations. 
(f) Including assessment of the following body systems: head, ears, eyes, nose, and throat; cardiac (including auscultation of heart); pulmonary (chest) auscultation of 
lungs; abdomen; skin; musculoskeletal system; lymphatic system; and neurologic system (cranial nerves, sensation, motor function, coordination, reflexes, and 
mental status). 
(g) Weight will be measured without shoes and in light clothing at screening and without shoes and in hospital gowns at all other time points. The scales should be 
calibrated, and the same weight scale should be used throughout the study starting on Day –1. 
(h) Weight will be collected prior to dosing. 
(i) Vital sign measurements will include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Vital signs will be measured after the 
subject has been seated for at least 5 minutes.  
(j) Vital sign measurements will be performed before dosing and 4 hours after the AM study drug administration on Days 1 and 7 and 4 hours after the AM study drug 
administration on Day 4. The acceptable window for collection from the scheduled collection time point is ±15 minutes. 
(k) Collected only if subjects are required to return to the study site on Day 14 (+2 days) for a follow-up visit. 
(l) Including cholesterol (total, high-density lipoprotein, calculated low-density lipoprotein, and triglycerides). 
(m) Clinical laboratory testing will include hematology and serum chemistry.  
(n) Clinical laboratory testing at screening and at Day 9 or early discontinuation will include hematology, serum chemistry, and urinalysis. 
(o) Collect 12 hours after the PM study drug administration on Day 7.  
(p) For postmenopausal women, a serum follicle-stimulating hormone test will be performed at screening. 
(q) Women of childbearing potential only. 
(r) Includes alcohol, amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids 
(including tetrahydrocannabinol), cocaine metabolites, and opiates (including heroin, codeine, and oxycodone). 
(s) A 12-lead ECG will be collected after the subject has been in the supine position for at least 10 minutes. On Days 1, 4, and 7, an ECG will be recorded 4 hours after 
the AM study drug administration. The acceptable window for collection from the scheduled collection time point is ±15 minutes. 
12-Lead ECG(s) 
X 
X 
X 
 
 
X 
 
 
X 
 
X 
 
 
TPOXX administration(t) 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Pharmacokinetic sampling(u) 
 
 
X 
X 
 
 
 
X 
X 
X 
X 
 
 
Symptom-directed physical 
examination(v) 
 
 
 
X 
X 
X 
X 
X 
X 
 
 
X(k) 
 
Adverse events 
 
 
X 
Prior/concomitant medications 
X 
Page 574


SIGA Technologies, Inc. 
 
Statistical Analysis Plan, Version 1.0 
SIGA-246-022 
 
Date Issued: 11OCT2019 
 
  
 
(t) TPOXX, 600 mg (3 × 200-mg capsules) will be administered orally twice daily, approximately 12 hours (± 30 minutes) apart on Days 1 through 7. All subjects will 
be provided meals consisting of approximately 600 calories and 25 g fat, which will start 30 minutes before study drug administration. Subjects should eat this meal 
within 30 minutes or less of taking study drug. Study drug will be administered approximately 30 minutes after the start of the meal. All doses of study drug will be 
administered to subjects by study site personnel with approximately 240 mL of water. Subjects must fast 2 hours after taking study drug. Study drug and meals 
must be taken with water only, and no other beverage except water should be ingested within 3 hours before or 3 hours after study drug administration. 
(u) Blood samples for PK analysis of TPOXX will be collected from all subjects at the following tome points: on Day 1 before study drug administration (0 hour), at 
0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (before the AM dose on Day 2), on Day 6 (before the AM dose and 4 hours after the AM 
dose), on Day 7 before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 
7), and on Day 9 (48 hours after the AM dose on Day 7). For PK blood samples, the acceptable window for collection from the scheduled collection time point will 
be as follows: ±5 minutes for the time points from 1 to 8 hours and ±15 minutes for the 12- to 48-hour time points. 
(v) Including assessment of heart, lungs, abdomen, a neurologic review, and a review of symptoms for assessment and/or follow-up of reported or potential adverse 
events. 
 
 
Page 575


PPD Biostatistics and Programming 
Statrstrcal Analysis Plan (SAP) Client Approval Form 
SIGA Technologies, Inc. 
SIGA-246-022 
Final Statistical Analysis Plan 
A Post Marketing Study of the Safety, Tolerability, and 
Pharmacokinetics of TPOXX® in Adult Subjects Weighing 
More Than 120 k 
11OCT2019 
For PPD: Rebekah Hahn, Sr. Biostatistician; Nancy Zheng, Pharrnacokineticist 
Rebekah Hahn, Senior Biostatistician 
Early Development Services, PPD 
NancyK. Zheng 
Pharmacokineticist 
T approve this document 
Oct 11 201\14:18 PM 
Nancy Zheng, Pharmacokineticist 
Clinical Pharmacology, PPD 
Date (DD-MMM-YYYY) 
Rcbckah.Jiabn 
Senior Biostatistician 
I approve lhis document 
11 Oct 20] ') 17:38:05 -0.5:00 
Date (DD-MMM-YYYY) 
Date (DD-MMM-YYYY) 
PPD CONFIDENTIAL AND PROPRIETARY 
SOP-BST-05ar05 
Effective Date: 20 September 2017 
Page 1 of 1 
Page 576


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.10 
Documentation of Interlaboratory Standardization Methods 
and Quality Assurance Procedures if Used 
The following laboratories were used in the study: 
Clinical Laboratory: 
PPD Austin Central Laboratory 
7551 Metro Center Drive, Suite 200 
Austin, TX 78744 
USA 
Bioanalytical Laboratory: 
Alturas Analytics, Inc. 
1324 Alturas Drive 
Moscow, ID 83843 
USA 
Laboratory ranges can be found in Listings 16.2.8.1, 16.2.8.2, 16.2.8.3, 16.2.8.4 and 16.2.8.5. 
Page 577


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.11 
Publications Based on the Study 
There were no publications based on the study. 
Page 578


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.1.12 
Important Publications Referenced in the Report 
Please refer to Section 15 of the study report for the complete reference list. 
Page 579


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.2 
DATA LISTINGS 
Page 580


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.2.1 
Discontinued Subjects 
Listing 16.2.1.1 
Disposition Enrolled Population 
Listing 16.2.1.2 
Analysis Sets Enrolled Population 
Page 581


SIGA TECHNOLOGIES, INC.  
Page 1 of 5 
SIGA-246-022  
Listing 16.2.1.1  
Disposition  
Enrolled Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020101.SAS  Executed: 21JAN2020 22:49  
 
Discontinuation 
Subject ID 
Age(yrs)/ 
Sex/Race 
Informed Consent 
Date 
First Dose Date/ 
Last Dose Date (Day) 
Completed 
Study? 
Date (Day) 
Reason 
9001 
41/M/BL 
19JUL2019 
14AUG2019/ 
20AUG2019 (7) 
Yes 
9002 
48/M/W 
19JUL2019 
14AUG2019/ 
20AUG2019 (7) 
Yes 
9005 
40/M/W 
23JUL2019 
14AUG2019/ 
20AUG2019 (7) 
Yes 
9009 
21/F/BL 
31JUL2019 
14AUG2019/ 
20AUG2019 (7) 
Yes 
9012 
34/M/BL 
06AUG2019 
14AUG2019/ 
20AUG2019 (7) 
Yes 
9015 
29/M/BL 
12AUG2019 
14AUG2019/ 
20AUG2019 (7) 
Yes 
9016 
48/F/W 
12AUG2019 
04SEP2019/ 
10SEP2019 (7) 
Yes 
9019 
41/M/BL 
15AUG2019 
04SEP2019/ 
10SEP2019 (7) 
Yes 
Page 582


SIGA TECHNOLOGIES, INC.  
Page 2 of 5 
SIGA-246-022  
Listing 16.2.1.1  
Disposition  
Enrolled Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020101.SAS  Executed: 21JAN2020 22:49  
 
Discontinuation 
Subject ID 
Age(yrs)/ 
Sex/Race 
Informed Consent 
Date 
First Dose Date/ 
Last Dose Date (Day) 
Completed 
Study? 
Date (Day) 
Reason 
9020 
47/F/BL 
21AUG2019 
04SEP2019/ 
10SEP2019 (7) 
Yes 
9021 
39/F/BL 
21AUG2019 
04SEP2019/ 
10SEP2019 (7) 
Yes 
9022 
31/M/W 
21AUG2019 
04SEP2019/ 
10SEP2019 (7) 
Yes 
9024 
20/M/BL 
23AUG2019 
04SEP2019/ 
10SEP2019 (7) 
Yes 
9025 
50/M/W 
23AUG2019 
18SEP2019/ 
24SEP2019 (7) 
Yes 
9033 
32/M/W 
29AUG2019 
04SEP2019/ 
10SEP2019 (7) 
Yes 
9043 
22/M/BL 
11SEP2019 
18SEP2019/ 
24SEP2019 (7) 
Yes 
9046 
34/M/BL 
13SEP2019 
18SEP2019/ 
24SEP2019 (7) 
Yes 
Page 583


SIGA TECHNOLOGIES, INC.  
Page 3 of 5 
SIGA-246-022  
Listing 16.2.1.1  
Disposition  
Enrolled Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020101.SAS  Executed: 21JAN2020 22:49  
 
Discontinuation 
Subject ID 
Age(yrs)/ 
Sex/Race 
Informed Consent 
Date 
First Dose Date/ 
Last Dose Date (Day) 
Completed 
Study? 
Date (Day) 
Reason 
9051 
34/M/BL 
19SEP2019 
02OCT2019/ 
08OCT2019 (7) 
Yes 
9052 
42/M/BL 
21SEP2019 
02OCT2019/ 
08OCT2019 (7) 
Yes 
9056 
31/F/BL 
24SEP2019 
02OCT2019/ 
08OCT2019 (7) 
Yes 
9057 
29/F/W 
25SEP2019 
02OCT2019/ 
08OCT2019 (7) 
Yes 
9058 
32/M/W 
26SEP2019 
16OCT2019/ 
22OCT2019 (7) 
Yes 
9061 
21/F/BL 
26SEP2019 
16OCT2019/ 
22OCT2019 (7) 
Yes 
9062 
33/M/BL 
30SEP2019 
02OCT2019/ 
08OCT2019 (7) 
Yes 
9063 
35/M/W 
30SEP2019 
02OCT2019/ 
08OCT2019 (7) 
Yes 
Page 584


SIGA TECHNOLOGIES, INC.  
Page 4 of 5 
SIGA-246-022  
Listing 16.2.1.1  
Disposition  
Enrolled Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020101.SAS  Executed: 21JAN2020 22:49  
 
Discontinuation 
Subject ID 
Age(yrs)/ 
Sex/Race 
Informed Consent 
Date 
First Dose Date/ 
Last Dose Date (Day) 
Completed 
Study? 
Date (Day) 
Reason 
9069 
41/F/BL 
30SEP2019 
16OCT2019/ 
22OCT2019 (7) 
Yes 
9073 
40/M/BL 
04OCT2019 
16OCT2019/ 
22OCT2019 (7) 
Yes 
9077 
37/F/W 
05OCT2019 
16OCT2019/ 
22OCT2019 (7) 
Yes 
9080 
41/F/BL 
08OCT2019 
16OCT2019/ 
22OCT2019 (7) 
Yes 
9081 
49/M/BL 
10OCT2019 
30OCT2019/ 
05NOV2019 (7) 
Yes 
9086 
36/M/BL 
11OCT2019 
16OCT2019/ 
22OCT2019 (7) 
Yes 
9087 
34/F/BL 
11OCT2019 
16OCT2019/ 
22OCT2019 (7) 
Yes 
9089 
29/M/BL 
14OCT2019 
16OCT2019/ 
22OCT2019 (7) 
Yes 
Page 585


SIGA TECHNOLOGIES, INC.  
Page 5 of 5 
SIGA-246-022  
Listing 16.2.1.1  
Disposition  
Enrolled Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020101.SAS  Executed: 21JAN2020 22:49  
 
Discontinuation 
Subject ID 
Age(yrs)/ 
Sex/Race 
Informed Consent 
Date 
First Dose Date/ 
Last Dose Date (Day) 
Completed 
Study? 
Date (Day) 
Reason 
9092 
24/M/W 
14OCT2019 
16OCT2019/ 
22OCT2019 (7) 
Yes 
9095 
42/M/W 
17OCT2019 
30OCT2019/ 
05NOV2019 (7) 
Yes 
 
Page 586


SIGA TECHNOLOGIES, INC.  
Page 1 of 3 
SIGA-246-022  
Listing 16.2.1.2  
Analysis Sets  
Enrolled Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: The Safety population includes all subjects who receive at least 1 dose of study drug.  
The PK population includes all subjects who receive study drug and have sufficient concentration data to facilitate the calculation 
of PK variables.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020102.SAS  Executed: 21JAN2020 22:50  
Subject ID 
Age(yrs)/Sex/Race 
Safety Population/Reason Excluded 
PK Population/Reason Excluded 
9001 
41/M/BL 
Yes 
Yes 
9002 
48/M/W 
Yes 
Yes 
9005 
40/M/W 
Yes 
Yes 
9009 
21/F/BL 
Yes 
Yes 
9012 
34/M/BL 
Yes 
Yes 
9015 
29/M/BL 
Yes 
Yes 
9016 
48/F/W 
Yes 
Yes 
9019 
41/M/BL 
Yes 
Yes 
9020 
47/F/BL 
Yes 
Yes 
9021 
39/F/BL 
Yes 
Yes 
9022 
31/M/W 
Yes 
Yes 
9024 
20/M/BL 
Yes 
Yes 
9025 
50/M/W 
Yes 
Yes 
Page 587


SIGA TECHNOLOGIES, INC.  
Page 2 of 3 
SIGA-246-022  
Listing 16.2.1.2  
Analysis Sets  
Enrolled Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: The Safety population includes all subjects who receive at least 1 dose of study drug.  
The PK population includes all subjects who receive study drug and have sufficient concentration data to facilitate the calculation 
of PK variables.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020102.SAS  Executed: 21JAN2020 22:50  
Subject ID 
Age(yrs)/Sex/Race 
Safety Population/Reason Excluded 
PK Population/Reason Excluded 
9033 
32/M/W 
Yes 
Yes 
9043 
22/M/BL 
Yes 
Yes 
9046 
34/M/BL 
Yes 
Yes 
9051 
34/M/BL 
Yes 
Yes 
9052 
42/M/BL 
Yes 
Yes 
9056 
31/F/BL 
Yes 
Yes 
9057 
29/F/W 
Yes 
Yes 
9058 
32/M/W 
Yes 
Yes 
9061 
21/F/BL 
Yes 
Yes 
9062 
33/M/BL 
Yes 
Yes 
9063 
35/M/W 
Yes 
Yes 
9069 
41/F/BL 
Yes 
Yes 
9073 
40/M/BL 
Yes 
Yes 
Page 588


SIGA TECHNOLOGIES, INC.  
Page 3 of 3 
SIGA-246-022  
Listing 16.2.1.2  
Analysis Sets  
Enrolled Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: The Safety population includes all subjects who receive at least 1 dose of study drug.  
The PK population includes all subjects who receive study drug and have sufficient concentration data to facilitate the calculation 
of PK variables.  
TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020102.SAS  Executed: 21JAN2020 22:50  
Subject ID 
Age(yrs)/Sex/Race 
Safety Population/Reason Excluded 
PK Population/Reason Excluded 
9077 
37/F/W 
Yes 
Yes 
9080 
41/F/BL 
Yes 
Yes 
9081 
49/M/BL 
Yes 
Yes 
9086 
36/M/BL 
Yes 
Yes 
9087 
34/F/BL 
Yes 
Yes 
9089 
29/M/BL 
Yes 
Yes 
9092 
24/M/W 
Yes 
Yes 
9095 
42/M/W 
Yes 
Yes 
 
Page 589


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.2.2 
Protocol Deviations 
Protocol Deviations Safety Population 
Inclusion/Exclusion Criteria Deviations Safety Population 
Listing 16.2.2.1 
Listing 16.2.2.2  
Page 590


SIGA TECHNOLOGIES, INC.  
Page 1 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9001 
41/M/BL 
15AUG2019/ 
 Day 2 
MINOR 
Study Procedures/Assessments 
Subject 9001/105 - Period 1 Day 2 AM dose was
administered 34 minutes after start of meal.
MINOR 
Study Procedures/Assessments 
Subject R105/S9001 Day 2 Breakfast did not 
begin within 30 mins of dose due to late 
dose; Subject began meal 34 mins prior to 
dose; 4 mins outside of protocol window 
17AUG2019/ 
 Day 4 
MINOR 
Study Treatment Admin/Dispense Subject R105/S9001 - Day 4 AM dose 1 min late
due to late breakfast; adjusted in error 
MINOR 
Study Treatment Admin/Dispense Subject R105/S9001 Day 4 AM dose 1 min late 
due to late breakfast; adjusted in error 
9002 
48/M/W 
14AUG2019/ 
 Day 1 
MINOR 
Study Procedures/Assessments 
Subject 9002/101 - Period 1 Day 1 4HR PK was
collected 18 minutes late; 13 mins outside 
of protocol window 
15AUG2019/ 
 Day 2 
MINOR 
Study Procedures/Assessments 
Subject 9002/101 - Period 1 Day 2 AM dose was
administered 32 minutes after the start of 
the AM meal "breakfast". 
MINOR 
Study Treatment Admin/Dispense Subject R101/S9002 - Day 2 AM dose 2 mins 
late due to AE confirmation 
Page 591


SIGA TECHNOLOGIES, INC.  
Page 2 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9002 
48/M/W 
17AUG2019/ 
 Day 4 
MINOR 
Other GCP Deviation 
Subject R101/S9002 - Day 4 4Hr Vital signs 
Subject had three total out of range vital 
signs, including original timepoint and two
repeats; 3rd repeat performed by paramedic 
with result of 162/100 outs ide of systolic
range 90-160 and diastolic range 40-96. No 
PI assessment documented. 
MINOR 
Study Treatment Admin/Dispense Subject R101/S9002 - Day 4 AM dose 1 min late
due to late breakfast; adjusted in error 
19AUG2019/ 
 Day 6 
MAJOR 
Missing Endpoint Assessments 
(P17:01: Missing endpoint assessments) - 
R101/S9002 Day 6 4Hr Pk sample hemolyzed 
MINOR 
Study Procedures/Assessments 
Subject R101/S9002 Day 6 Breakfast did not 
begin within 30 mins of dose due to late 
dose; Subject began meal 37 mins prior to 
dose; 7 mins outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R101/S9002 Day 6 AM dose 6 mins late
late to difficulty collecting blood at 
previous procedure 
Page 592


SIGA TECHNOLOGIES, INC.  
Page 3 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9002 
48/M/W 
20AUG2019/ 
 Day 7 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R101/S9002 Day 7 2Hr PK 
sample drawn 9 mins late due to restick; 4 
mins outside of protocol window 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R101/S9002 Day 7 6Hr PK 
sample drawn 8 mins late due to restick; 3 
mins outside of protocol window 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R101/S9002 Day 7 8Hr PK 
sample drawn 30 mins late due to restick; 25
mins outside of protocol window 
MINOR 
Study Procedures/Assessments 
Subject R101/S9002 Day 7 Breakfast did not 
begin within 30 mins of dose due to late 
dose; Subject began meal 33 mins prior to 
dose; 3 mins outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R101/S9002 Day 7 AM dose 3 mins late
late to difficulty collecting blood at 
previous procedure 
9009 
21/F/BL 
14AUG2019/ 
 Day 1 
MAJOR 
Study Procedures/Assessments 
P07:01 - Subject 9009/104 - Period 1 Day 1 
8HR PK sample was not able to be obtained. 
Page 593


SIGA TECHNOLOGIES, INC.  
Page 4 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9009 
21/F/BL 
14AUG2019/ 
 Day 1 
MINOR 
Study Procedures/Assessments 
Subject 9009/104 - Period 1 Day 1 4HR PK was
collected 8 minutes late; 3 mins outside of
protocol window 
9012 
34/M/BL 
15AUG2019/ 
 Day 2 
MINOR 
Study Treatment Admin/Dispense Subject R106/S9012 - Day 2 AM dose 4 mins 
late due to late breakfast; adjusted in 
error 
9015 
29/M/BL 
14AUG2019/ 
 Day 1 
MINOR 
Study Procedures/Assessments 
Subject R103/S9015 Day 1 Breakfast did not 
begin within 30 mins of dose due to late 
dose; Subject began meal 34 mins prior to 
dose; 4 mins outside of protocol window 
9019 
41/M/BL 
04SEP2019/ 
 Day 1 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R108/S9019 Day 1 .5Hr PK 
sample drawn 1 min late; no window given per
protocol; 1 min outside of planned protocol
time 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R108/S9019 Day 1 8Hr PK 
sample respun for 3 mins 
Page 594


SIGA TECHNOLOGIES, INC.  
Page 5 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9019 
41/M/BL 
05SEP2019/ 
 Day 2 
MINOR 
Study Procedures/Assessments 
Subject R108/S9019 Day 2 Breakfast did not 
begin within 30 mins of dose due to late 
dose; Subject began meal 36 mins prior to 
dose; 6 mins outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R108/S9019 - Day 1 PM dose 3 mins 
late due to late dinner; adjusted in error 
MINOR 
Study Treatment Admin/Dispense Subject R108/S9019 Day 2 AM dose 6 mins late
late to difficulty collecting blood at 
previous procedure 
07SEP2019/ 
 Day 4 
MINOR 
Study Treatment Admin/Dispense Subject R108/S9019 - Day 4 AM dose 6 mins 
late due to late breakfast; adjusted in 
error 
9021 
39/F/BL 
05SEP2019/ 
 Day 2 
MINOR 
Study Treatment Admin/Dispense Subject R110/S9021 - Day 2 AM dose 3 mins 
late due to late breakfast; adjusted in 
error 
9022 
31/M/W 
07SEP2019/ 
 Day 4 
MINOR 
Study Treatment Admin/Dispense Subject R111/S9022 - Day 4 AM dose 6 mins 
late due to late breakfast; adjusted in 
error 
Page 595


SIGA TECHNOLOGIES, INC.  
Page 6 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9024 
20/M/BL 
04SEP2019/ 
 Day 1 
MAJOR 
Missing Endpoint Assessments 
(P17:01: Missing endpoint assessments) - 
R112/S9024 Day 1 1Hr Pk sample hemolyzed 
MAJOR 
Missing Endpoint Assessments 
(P17:01: Missing endpoint assessments) - 
R112/S9024 Day 1 4Hr Pk sample hemolyzed 
9025 
50/M/W 
22SEP2019/ 
 Day 5 
MINOR 
Study Procedures/Assessments 
Subject R114/S9025 Day 5 Dinner did not begin
within 30 mins of dose due to late dose; 
Subject began meal 35 mins prior to dose; 5
mins outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R114/S9025 - Day 5 PM dose 5 mins 
late 
9033 
32/M/W 
05SEP2019/ 
 Day 2 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R113/S9033 Day 2 18Hr PK 
sample drawn 34 mins late due to restick; 19
mins outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R113/S9033 - Day 2 AM dose 1 min late
due to late breakfast; adjusted in error 
07SEP2019/ 
 Day 4 
MINOR 
Study Treatment Admin/Dispense Subject R113/S9033 - Day 4 AM dose 3 mins 
late due to late breakfast; adjusted in 
error 
Page 596


SIGA TECHNOLOGIES, INC.  
Page 7 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9033 
32/M/W 
10SEP2019/ 
 Day 7 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R113/S9033 Day 7 .5Hr PK 
sample drawn 1 min late; no window given per
protocol; 1 min outside of planned protocol
time 
9043 
22/M/BL 
18SEP2019/ 
 Day 1 
MAJOR 
Missing Endpoint Assessments 
(P17:01: Missing endpoint assessments) - 
R115/S9043 Day 1 12Hr PK sample not 
collected due to unable to obtain 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R115/S9043 Day 1 14Hr PK 
sample drawn 33 mins late due to adjusted 
for late PM dose; 18 mins outside of 
protocol window 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R115/S9043 Day 1 2Hr PK 
sample drawn 6 mins late due to restick; 1 
min outside of protocol window 
MINOR 
Study Procedures/Assessments 
Subject R115/S9043 Day 1 Dinner did not begin
within 30 mins of dose due to late dose; 
Subject began meal 1 Hr 3 mins prior to 
dose; 33 mins outside of protocol window 
Page 597


SIGA TECHNOLOGIES, INC.  
Page 8 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9043 
22/M/BL 
18SEP2019/ 
 Day 1 
MINOR 
Study Treatment Admin/Dispense Subject R115/S9043 - Day 1 PM dose 33 min 
late due to previous procedure 
19SEP2019/ 
 Day 2 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R115/S9043 Day 2 16Hr PK 
sample drawn 33 mins late due to adjusted 
for late PM dose; 18 mins outside of 
protocol window 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R115/S9043 Day 2 18Hr PK 
sample drawn 49 mins late due to adjusted 
for late PM dose and restick; 34 mins 
outside of protocol window 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R115/S9043 Day 2 20Hr PK 
sample drawn 33 mins late due to adjusted 
for late PM dose; 18 mins outside of 
protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R115/S9043 - Day 2 PM dose 5 mins 
late due to previous procedure 
Page 598


SIGA TECHNOLOGIES, INC.  
Page 9 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9043 
22/M/BL 
22SEP2019/ 
 Day 5 
MINOR 
Study Procedures/Assessments 
Subject R115/S9043 Day 5 Dinner did not begin
within 30 mins of dose due to late dose; 
Subject began meal 33 mins prior to dose; 3
mins outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R115/S9043 - Day 5 PM dose 3 mins 
late due to previous subject 
24SEP2019/ 
 Day 7 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R115/S9043 Day 7 .5Hr PK 
sample drawn 1 min late; no window given per
protocol; 1 min outside of planned protocol
time 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R115/S9043 Day 7 8Hr PK 
sample drawn 15 mins late due to restick; 10
mins outside of protocol window 
25SEP2019/ 
 Day 8 
MINOR 
Study Procedures/Assessments 
Subject R115/S9043 Day 8 24Hr clinical labs 
drawn 29 mins late due to additional time 
needed 
Page 599


SIGA TECHNOLOGIES, INC.  
Page 10 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9046 
34/M/BL 
22SEP2019/ 
 Day 5 
MINOR 
Study Procedures/Assessments 
Subject R116/S9046 Day 2 dinner did not begin
within 30 mins of dose due to late dose; 
Subject began meal 31 mins prior to dose; 1
min outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R116/S9046 - Day 5 PM dose 1 min late
24SEP2019/ 
 Day 7 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R116/S9046 Day 7 .5Hr PK 
sample drawn 1 min late; no window given per
protocol; 1 min outside of planned protocol
time 
9052 
42/M/BL 
02OCT2019/ 
 Day 1 
MINOR 
Study Treatment Admin/Dispense Subject R121/S9052 - Day 1 AM dose 7 min late
due to late breakfast; adjusted in error 
9056 
31/F/BL 
08OCT2019/ 
 Day 7 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R117/S9056 Day 7 .5Hr PK 
sample drawn 5 mins late; no window given 
per protocol; 5 mins outside of planned 
protocol time 
Page 600


SIGA TECHNOLOGIES, INC.  
Page 11 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9056 
31/F/BL 
08OCT2019/ 
 Day 7 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R117/S9056 Day 7 6Hr PK 
sample drawn 6 mins late; 1 min outside of 
protocol window 
09OCT2019/ 
 Day 8 
MINOR 
Study Procedures/Assessments 
Subject R117/S9056 Day 8 24Hr clinical labs 
drawn 3 mins late 
9058 
32/M/W 
16OCT2019/ 
 Day 1 
MAJOR 
Missing Endpoint Assessments 
(P17:01: Missing endpoint assessments) - 
R123/S9058 Day 1 .5Hr Pk sample hemolyzed 
MAJOR 
Missing Endpoint Assessments 
(P17:01: Missing endpoint assessments) - 
R123/S9058 Day 1 1Hr Pk sample hemolyzed 
MINOR 
Study Procedures/Assessments 
Subject R123/S9058 Day 1 Breakfast did not 
begin within 30 mins of dose due to late 
dose; Subject began meal 37 mins prior to 
dose; 7 mins outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R123/S9058 - Day 1 AM dose 7 min late
due to restick 
Page 601


SIGA TECHNOLOGIES, INC.  
Page 12 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9058 
32/M/W 
22OCT2019/ 
 Day 7 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R123/S9058 Day 7 8Hr PK 
sample drawn 13 mins late due to restick; 8
mins outside of protocol window 
MINOR 
Study Procedures/Assessments 
Subject R123/S9058 Day 7 Dinner did not begin
within 30 mins of dose due to late dose; 
Subject began meal 40 mins prior to dose; 10
mins outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R123/S9058 - Day 7 PM dose 10 mins 
late due to previous procedure difficulty 
obtaining blood 
23OCT2019/ 
 Day 8 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R123/S9058 Day 8 24Hr PK 
sample drawn 22 mins late due to restick; 7
mins outside of protocol window 
24OCT2019/ 
 Day 9 
MINOR 
Study Procedures/Assessments 
(P13: Other deviations) - R123/S9058 Day 9 
48Hr clinical BC drawn 1 min late due to 
additional time needed 
Page 602


SIGA TECHNOLOGIES, INC.  
Page 13 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9061 
21/F/BL 
16OCT2019/ 
 Day 1 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R124/S9061 Day 1 .5Hr PK 
sample drawn 1 min late; no window given per
protocol; 1 min outside of planned protocol
time 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R124/S9061 Day 1 .5Hr PK 
sample drawn 2 mins late; no window given 
per protocol; 2 mins outside of planned 
protocol time 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R124/S9061 Day 1 1Hr PK 
sample drawn 7 mins late due to restick; 2 
mins outside of protocol window 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R124/S9061 Day 1 8Hr PK 
sample drawn 32 mins late due to restick; 27
mins outside of protocol window 
17OCT2019/ 
 Day 2 
MAJOR 
Missing Endpoint Assessments 
(P17:01: Missing endpoint assessments) - 
R124/S9061 Day 2 18Hr PK sample not 
collected due to unable to obtain 
Page 603


SIGA TECHNOLOGIES, INC.  
Page 14 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9061 
21/F/BL 
17OCT2019/ 
 Day 2 
MAJOR 
Missing Endpoint Assessments 
(P17:01: Missing endpoint assessments) - 
R124/S9061 Day 2 20Hr PK sample not 
collected due to unable to obtain 
22OCT2019/ 
 Day 7 
MINOR 
Study Procedures/Assessments 
Subject R124/S9061 Day 7 Dinner did not begin
within 30 mins of dose; Subject began meal 
31 mins prior to dose; 1 min outside of 
protocol window 
23OCT2019/ 
 Day 8 
MINOR 
Study Procedures/Assessments 
Subject R124/S9061 Day 8 24Hr clinical labs 
drawn 3 mins late due to restick 
9069 
41/F/BL 
16OCT2019/ 
 Day 1 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R125/S9069 Day 1 .5Hr PK 
sample drawn 18 mins late; no window given 
per protocol; 18 mins outside of planned 
protocol time 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R125/S9069 Day 1 14Hr PK 
sample drawn 16 mins late due to late dose 
adjusted; 1 min outside of protocol window 
Page 604


SIGA TECHNOLOGIES, INC.  
Page 15 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9069 
41/F/BL 
16OCT2019/ 
 Day 1 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R125/S9069 Day 1 4Hr PK 
sample drawn 6 mins late due to previous VS
procedure; 1 min outside of protocol window
MINOR 
Study Procedures/Assessments 
Subject R125/S9069 Day 1 Dinner did not begin
within 30 mins of dose due to late dose; 
Subject began meal 46 mins prior to dose; 16
mins outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R125/S9069 Day 1 PM dose 16 mins late
due to subject late 
17OCT2019/ 
 Day 2 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R125/S9069 Day 2 16Hr PK 
sample drawn 17 mins late due to late dose 
adjusted; 2 mins outside of protocol window
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R125/S9069 Day 2 18Hr PK 
sample drawn 16 mins late due to late dose 
adjusted; 1 min outside of protocol window 
Page 605


SIGA TECHNOLOGIES, INC.  
Page 16 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9069 
41/F/BL 
17OCT2019/ 
 Day 2 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R125/S9069 Day 2 20Hr PK 
sample drawn 16 mins late due to late dose 
adjusted; 1 min outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R125/S9069 - Day 2 AM dose 4 min late
due to late breakfast; adjusted in error 
MINOR 
Study Treatment Admin/Dispense Subject R125/S9069 - Day 2 AM dose 4 mins 
late due to late breakfast; adjusted in 
error 
23OCT2019/ 
 Day 8 
MINOR 
Study Procedures/Assessments 
(P13: Other deviations) - R125/S9069 Day 8 
24Hr clinical BC drawn 9 mins late due to 
restick 
9073 
40/M/BL 
16OCT2019/ 
 Day 1 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R126/S9073 Day 1 .5Hr PK 
sample drawn 5 mins late; no window given 
per protocol; 5 mins outside of planned 
protocol time 
Page 606


SIGA TECHNOLOGIES, INC.  
Page 17 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9073 
40/M/BL 
16OCT2019/ 
 Day 1 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R126/S9073 Day 1 6Hr PK 
sample drawn 6 mins late due to restick; 1 
mins outside of protocol window 
MINOR 
Study Procedures/Assessments 
Subject R126/S9073 - Day 1 breakfast not 
started within 30 mins of dose due to late 
dose; breakfast started 37 mins mins prior 
to dose; 7 mins outsode of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R126/S9073 - Day 1 AM dose 7 min late
due to restick 
9077 
37/F/W 
22OCT2019/ 
 Day 7 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R127/S9077 Day 7 4Hr PK 
sample drawn 19 mins late due to restick; 14
mins outside of protocol window 
MINOR 
Study Procedures/Assessments 
R127/S9077 Day 7 4Hr VS collected 16 mins 
late; 1 min ouside of protocol window 
9080 
41/F/BL 
23OCT2019/ 
 Day 8 
MAJOR 
Missing Endpoint Assessments 
(P17:01: Missing endpoint assessments) - 
R130/S9080 Day 8 18Hr PK sample not 
collected due to unable to obtain 
Page 607


SIGA TECHNOLOGIES, INC.  
Page 18 of 18 
SIGA-246-022  
Listing 16.2.2.1  
Protocol Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020201.SAS  Executed: 22JAN2020 02:39  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Deviation Date/ 
 Visit 
Type 
Category 
Protocol Deviation 
9081 
49/M/BL 
06NOV2019/ 
 Day 7 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R133/S9081 Day 7 .5Hr PK 
sample drawn 1 mins late; 1 min outside of 
planned protocol time; no allowable window 
given 
07NOV2019/ 
 Day 9 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R133/S9081 Day 9 48Hr PK 
sample re-spun for 3 mins 
9086 
36/M/BL 
21OCT2019/ 
 Day 6 
MINOR 
Study Procedures/Assessments 
Subject R128/S9086 - Day 6 breakfast not 
started within 30 mins prior to dose due to
late dose; breakfast started 33 mins prior 
to dose; 3 mins outside of protocol window 
MINOR 
Study Treatment Admin/Dispense Subject R128/S9086 - Day 6 AM dose 3 mins 
late due to additional time needed 
9089 
29/M/BL 
24OCT2019/ 
 Day 9 
MINOR 
Study Procedures/Assessments 
(P13:01: PK sample not per protocol 
requirements) - R131/S9089 Day 9 48Hr PK 
sample re-spun for 3 mins 
 
Page 608


SIGA TECHNOLOGIES, INC.  
Page 1 of 1 
SIGA-246-022  
Listing 16.2.2.2  
Inclusion/Exclusion Criteria Deviations  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020202.SAS  Executed: 21JAN2020 22:51  
Subject ID Age(yrs)/Sex/Race 
Protocol Version 
Inclusion Criteria Not Met 
Exclusion Criteria Met 
No data to display 
 
 
 
 
Page 609


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.2.3 
Subjects Excluded From the Analyses 
Not Applicable 
 
Page 610


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.2.4 
Demographic Data 
Listing 16.2.4.1 
Demographics Safety Population 
Listing 16.2.4.2 
Medical History Safety Population 
Listing 16.2.4.3 
Prior and Concomitant Medications Safety Population 
Listing 16.2.4.4 
Medical and Surgical Treatment Procedures Safety Population 
Page 611


SIGA TECHNOLOGIES, INC.  
Page 1 of 4 
SIGA-246-022  
Listing 16.2.4.1  
Demographics  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] Reproductive status and methods of birth control are presented for female subjects only.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020401.SAS  Executed: 21JAN2020 22:52  
Subject 
ID 
Age(yrs)/ 
Sex/Race 
Birth Date 
Ethnicity 
Weight 
(kg) 
Height 
(cm) 
Reproductive Status/ 
Methods of Birth Control [1] 
9001 
41/M/BL 
21MAR1978 
NOT HISPANIC OR LATINO 
129.9 
174.3 
9002 
48/M/W 
07MAR1971 
NOT HISPANIC OR LATINO 
159.7 
178.5 
9005 
40/M/W 
21JAN1979 
NOT HISPANIC OR LATINO 
141.9 
176.8 
9009 
21/F/BL 
03JAN1998 
NOT HISPANIC OR LATINO 
137.2 
174.0 
POTENTIALLY ABLE TO BEAR CHILDREN/
ABSTINENCE 
9012 
34/M/BL 
02JUN1985 
NOT HISPANIC OR LATINO 
130.4 
177.0 
9015 
29/M/BL 
01NOV1989 
NOT HISPANIC OR LATINO 
120.4 
195.3 
9016 
48/F/W 
15DEC1970 
HISPANIC OR LATINO 
144.9 
173.6 
POTENTIALLY ABLE TO BEAR CHILDREN/
ABSTINENCE 
9019 
41/M/BL 
07OCT1977 
NOT HISPANIC OR LATINO 
133.5 
181.6 
9020 
47/F/BL 
25JUL1972 
NOT HISPANIC OR LATINO 
135.0 
164.8 
STERILE/ 
BARRIER WITH SPERMICIDE 
Page 612


SIGA TECHNOLOGIES, INC.  
Page 2 of 4 
SIGA-246-022  
Listing 16.2.4.1  
Demographics  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] Reproductive status and methods of birth control are presented for female subjects only.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020401.SAS  Executed: 21JAN2020 22:52  
Subject 
ID 
Age(yrs)/ 
Sex/Race 
Birth Date 
Ethnicity 
Weight 
(kg) 
Height 
(cm) 
Reproductive Status/ 
Methods of Birth Control [1] 
9021 
39/F/BL 
09JUL1980 
NOT HISPANIC OR LATINO 
123.4 
172.8 
POTENTIALLY ABLE TO BEAR CHILDREN/
BARRIER WITH SPERMICIDE 
9022 
31/M/W 
24JUL1988 
HISPANIC OR LATINO 
172.1 
177.3 
9024 
20/M/BL 
08MAR1999 
NOT HISPANIC OR LATINO 
133.3 
186.4 
9025 
50/M/W 
28APR1969 
NOT HISPANIC OR LATINO 
123.5 
175.5 
9033 
32/M/W 
10DEC1986 
HISPANIC OR LATINO 
148.0 
172.7 
9043 
22/M/BL 
19MAR1997 
NOT HISPANIC OR LATINO 
158.9 
186.4 
9046 
34/M/BL 
19FEB1985 
NOT HISPANIC OR LATINO 
121.3 
190.4 
9051 
34/M/BL 
23JUN1985 
NOT HISPANIC OR LATINO 
130.0 
182.0 
9052 
42/M/BL 
31JUL1977 
NOT HISPANIC OR LATINO 
121.6 
179.4 
9056 
31/F/BL 
23OCT1987 
NOT HISPANIC OR LATINO 
120.9 
171.0 
POTENTIALLY ABLE TO BEAR CHILDREN/
BARRIER WITH SPERMICIDE 
Page 613


SIGA TECHNOLOGIES, INC.  
Page 3 of 4 
SIGA-246-022  
Listing 16.2.4.1  
Demographics  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] Reproductive status and methods of birth control are presented for female subjects only.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020401.SAS  Executed: 21JAN2020 22:52  
Subject 
ID 
Age(yrs)/ 
Sex/Race 
Birth Date 
Ethnicity 
Weight 
(kg) 
Height 
(cm) 
Reproductive Status/ 
Methods of Birth Control [1] 
9057 
29/F/W 
30MAY1990 
HISPANIC OR LATINO 
127.6 
151.2 
POTENTIALLY ABLE TO BEAR CHILDREN/
BARRIER WITH SPERMICIDE 
9058 
32/M/W 
31MAY1987 
NOT HISPANIC OR LATINO 
121.3 
185.9 
9061 
21/F/BL 
11APR1998 
NOT HISPANIC OR LATINO 
127.2 
169.8 
POTENTIALLY ABLE TO BEAR CHILDREN/
ABSTINENCE 
9062 
33/M/BL 
09MAY1986 
NOT HISPANIC OR LATINO 
131.9 
173.5 
9063 
35/M/W 
22APR1984 
NOT HISPANIC OR LATINO 
120.3 
189.0 
9069 
41/F/BL 
14JAN1978 
NOT HISPANIC OR LATINO 
151.4 
160.0 
STERILE 
9073 
40/M/BL 
11SEP1979 
NOT HISPANIC OR LATINO 
161.5 
182.5 
9077 
37/F/W 
31DEC1981 
NOT HISPANIC OR LATINO 
125.7 
167.4 
POTENTIALLY ABLE TO BEAR CHILDREN/
BARRIER WITH SPERMICIDE 
9080 
41/F/BL 
19MAR1978 
NOT HISPANIC OR LATINO 
121.2 
161.8 
STERILE 
9081 
49/M/BL 
19FEB1970 
NOT HISPANIC OR LATINO 
220.4 
192.0 
Page 614


SIGA TECHNOLOGIES, INC.  
Page 4 of 4 
SIGA-246-022  
Listing 16.2.4.1  
Demographics  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] Reproductive status and methods of birth control are presented for female subjects only.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020401.SAS  Executed: 21JAN2020 22:52  
Subject 
ID 
Age(yrs)/ 
Sex/Race 
Birth Date 
Ethnicity 
Weight 
(kg) 
Height 
(cm) 
Reproductive Status/ 
Methods of Birth Control [1] 
9086 
36/M/BL 
26SEP1983 
NOT HISPANIC OR LATINO 
139.9 
186.4 
9087 
34/F/BL 
14AUG1985 
NOT HISPANIC OR LATINO 
123.0 
167.2 
POTENTIALLY ABLE TO BEAR CHILDREN/
ABSTINENCE 
9089 
29/M/BL 
30SEP1990 
NOT HISPANIC OR LATINO 
122.0 
167.9 
9092 
24/M/W 
29JAN1995 
HISPANIC OR LATINO 
168.6 
176.5 
9095 
42/M/W 
18AUG1977 
NOT HISPANIC OR LATINO 
148.6 
176.6 
 
Page 615


SIGA TECHNOLOGIES, INC.  
Page 1 of 8 
SIGA-246-022  
Listing 16.2.4.2  
Medical History  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other. Medical History was coded using MedDRA version 22.0.  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020402.SAS  Executed: 21JAN2020 22:52  
Subject ID 
Age(yrs)/ 
Sex/Race 
MH ID 
System Organ Class/ 
Preferred Term / 
 Verbatim term of Medical Condition(s) 
Start Date 
End date 
Ongoing 
9002 
48/M/W 
1 
Infections and infestations/ 
Tinea versicolour/ 
 TINEA VERSICOLOR 
2017 
 
Yes 
9012 
34/M/BL 
1 
Surgical and medical procedures/ 
Open reduction of fracture/ 
 LEFT FEMUR FRACTURE OPEN REDUCTION 
 AND INTERNAL FIXATION 
MAY1998 
MAY1998 
No 
 
2 
Injury, poisoning and procedural 
complications/ 
Femur fracture/ 
 LEFT FEMUR FRACTURE 
MAY1998 
MAY1998 
No 
 
3 
Surgical and medical procedures/ 
Vasectomy/ 
 VASECTOMY 
07FEB2019 
07FEB2019 
No 
9016 
48/F/W 
1 
Injury, poisoning and procedural 
complications/ 
Ankle fracture/ 
 LEFT BROKEN ANKLE 
OCT2011 
OCT2011 
No 
Page 616


SIGA TECHNOLOGIES, INC.  
Page 2 of 8 
SIGA-246-022  
Listing 16.2.4.2  
Medical History  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other. Medical History was coded using MedDRA version 22.0.  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020402.SAS  Executed: 21JAN2020 22:52  
Subject ID 
Age(yrs)/ 
Sex/Race 
MH ID 
System Organ Class/ 
Preferred Term / 
 Verbatim term of Medical Condition(s) 
Start Date 
End date 
Ongoing 
9016 
48/F/W 
2 
Surgical and medical procedures/ 
Open reduction of fracture/ 
 LEFT ANKLE OPEN REDUCTION AND 
 INTERNAL FIXATION 
OCT2011 
OCT2011 
No 
9019 
41/M/BL 
1 
Musculoskeletal and connective tissue 
disorders/ 
Osteoarthritis/ 
 MILD RIGHT KNEE OSTEOARTHRITIS 
03SEP2019 
11SEP2019 
No 
9020 
47/F/BL 
1 
Surgical and medical procedures/ 
Hysterectomy/ 
 HYSTERECTOMY 
2017 
2017 
No 
9022 
31/M/W 
1 
Surgical and medical procedures/ 
Ligament operation/ 
 RIGHT ANTERIOR CRUCIATE LIGAMENT 
 REPAIR 
MAY2010 
MAY2010 
No 
 
2 
Injury, poisoning and procedural 
complications/ 
Ligament rupture/ 
 RIGHT ANTERIOR CRUCIATE LIGAMENT TEAR 
MAY2010 
MAY2010 
No 
Page 617


SIGA TECHNOLOGIES, INC.  
Page 3 of 8 
SIGA-246-022  
Listing 16.2.4.2  
Medical History  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other. Medical History was coded using MedDRA version 22.0.  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020402.SAS  Executed: 21JAN2020 22:52  
Subject ID 
Age(yrs)/ 
Sex/Race 
MH ID 
System Organ Class/ 
Preferred Term / 
 Verbatim term of Medical Condition(s) 
Start Date 
End date 
Ongoing 
9025 
50/M/W 
1 
Skin and subcutaneous tissue disorders/ 
Eczema/ 
 REMOTE ECZEMA 
2004 
2004 
No 
 
2 
Investigations/ 
Medical observation/ 
 OVERNIGHT OBSERVATION-NEGATIVE WORKUP 
 FOR MENINGITIS 
1993 
1993 
No 
 
3 
Immune system disorders/ 
Seasonal allergy/ 
 SEASONAL ALLERGIES 
1994 
 
Yes 
9043 
22/M/BL 
1 
Infections and infestations/ 
Meningitis/ 
 IMMEDIATE POSTNATAL PERIOD 
 HOSPITALIZATION FOR MENINGITIS 
19MAR1997 
19MAR1997 
No 
9046 
34/M/BL 
1 
Investigations/ 
Arthroscopy/ 
 LEFT KNEE ARTHROSCOPY 
APR2005 
APR2005 
No 
 
2 
Surgical and medical procedures/ 
Tenoplasty/ 
 RIGHT INDEX FINGER TENDON REPAIR 
JAN2011 
JAN2011 
No 
Page 618


SIGA TECHNOLOGIES, INC.  
Page 4 of 8 
SIGA-246-022  
Listing 16.2.4.2  
Medical History  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other. Medical History was coded using MedDRA version 22.0.  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020402.SAS  Executed: 21JAN2020 22:52  
Subject ID 
Age(yrs)/ 
Sex/Race 
MH ID 
System Organ Class/ 
Preferred Term / 
 Verbatim term of Medical Condition(s) 
Start Date 
End date 
Ongoing 
9046 
34/M/BL 
3 
Investigations/ 
Arthroscopy/ 
 LEFT KNEE ARTHROSCOPY 
OCT2005 
OCT2005 
No 
9056 
31/F/BL 
1 
Surgical and medical procedures/ 
Caesarean section/ 
 CESAREAN SECTION 
11DEC2008 
11DEC2008 
No 
9057 
29/F/W 
1 
Surgical and medical procedures/ 
Appendicectomy/ 
 APPENDECTOMY 
SEP2001 
SEP2001 
No 
 
2 
Infections and infestations/ 
Appendicitis/ 
 APPENDICITIS 
SEP2001 
SEP2001 
No 
 
3 
Reproductive system and breast 
disorders/ 
Menstruation irregular/ 
 IRREGULAR MENSTRUAL CYCLES 
OCT2013 
 
Yes 
9069 
41/F/BL 
1 
Surgical and medical procedures/ 
Caesarean section/ 
 CESAREAN SECTION 
31MAR2008 
31MAR2008 
No 
Page 619


SIGA TECHNOLOGIES, INC.  
Page 5 of 8 
SIGA-246-022  
Listing 16.2.4.2  
Medical History  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other. Medical History was coded using MedDRA version 22.0.  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020402.SAS  Executed: 21JAN2020 22:52  
Subject ID 
Age(yrs)/ 
Sex/Race 
MH ID 
System Organ Class/ 
Preferred Term / 
 Verbatim term of Medical Condition(s) 
Start Date 
End date 
Ongoing 
9069 
41/F/BL 
2 
Surgical and medical procedures/ 
Female sterilisation/ 
 BILATERAL TUBAL LIGATION 
31MAR2008 
31MAR2008 
No 
 
3 
Skin and subcutaneous tissue disorders/ 
Drug eruption/ 
 RASH WITH ORAL FLAGYL 
MAY2001 
 
Yes 
 
4 
Musculoskeletal and connective tissue 
disorders/ 
Back pain/ 
 BACK PAIN 
MAY2018 
FEB2019 
No 
9077 
37/F/W 
1 
Surgical and medical procedures/ 
Caesarean section/ 
 CESAREAN SECTION 
19JAN2010 
19JAN2010 
No 
 
2 
Surgical and medical procedures/ 
Caesarean section/ 
 CESAREAN SECTION 
27DEC2010 
27DEC2010 
No 
9080 
41/F/BL 
1 
Surgical and medical procedures/ 
Female sterilisation/ 
 BILATERAL TUBAL LIGATION 
AUG2001 
AUG2001 
No 
Page 620


SIGA TECHNOLOGIES, INC.  
Page 6 of 8 
SIGA-246-022  
Listing 16.2.4.2  
Medical History  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other. Medical History was coded using MedDRA version 22.0.  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020402.SAS  Executed: 21JAN2020 22:52  
Subject ID 
Age(yrs)/ 
Sex/Race 
MH ID 
System Organ Class/ 
Preferred Term / 
 Verbatim term of Medical Condition(s) 
Start Date 
End date 
Ongoing 
9080 
41/F/BL 
2 
Surgical and medical procedures/ 
Endometrial ablation/ 
 UTERINE ABLATION 
MAY2005 
MAY2005 
No 
 
3 
Reproductive system and breast 
disorders/ 
Menorrhagia/ 
 MENORRHAGIA 
AUG2001 
MAY2005 
No 
9081 
49/M/BL 
1 
Surgical and medical procedures/ 
Knee arthroplasty/ 
 LEFT KNEE RECONSTRUCTION 
FEB2014 
FEB2014 
No 
 
2 
Surgical and medical procedures/ 
Appendicectomy/ 
 APPENDECTOMY 
1982 
1982 
No 
 
3 
Infections and infestations/ 
Appendicitis/ 
 APPENDICITIS 
1982 
1982 
No 
 
4 
Surgical and medical procedures/ 
Knee operation/ 
 REPAIR OF PATELLA 
FEB2014 
FEB2014 
No 
Page 621


SIGA TECHNOLOGIES, INC.  
Page 7 of 8 
SIGA-246-022  
Listing 16.2.4.2  
Medical History  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other. Medical History was coded using MedDRA version 22.0.  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020402.SAS  Executed: 21JAN2020 22:52  
Subject ID 
Age(yrs)/ 
Sex/Race 
MH ID 
System Organ Class/ 
Preferred Term / 
 Verbatim term of Medical Condition(s) 
Start Date 
End date 
Ongoing 
9081 
49/M/BL 
5 
Surgical and medical procedures/ 
Peripheral nerve operation/ 
 REPAIR OF FOOT DROP 
FEB2014 
FEB2014 
No 
 
6 
Musculoskeletal and connective tissue 
disorders/ 
Arthralgia/ 
 LEFT KNEE PAIN 
11OCT2019 
11OCT2019 
No 
 
7 
Vascular disorders/ 
Lymphoedema/ 
 LEFT LEG LYMPHEDEMA 2/2  ORTHOPEDIC 
 SURGERY TO THAT LIMB 
FEB2014 
 
Yes 
9086 
36/M/BL 
1 
Surgical and medical procedures/ 
Cyst removal/ 
 REMOVAL OF BENIGN CYST FROM RIGHT 
 CHEST WALL FOR COSMETIC REASONS 
1991 
1991 
No 
 
2 
Musculoskeletal and connective tissue 
disorders/ 
Chest wall cyst/ 
 BENIGN CYST ON RIGHT CHEST WALL 
1991 
1991 
No 
Page 622


SIGA TECHNOLOGIES, INC.  
Page 8 of 8 
SIGA-246-022  
Listing 16.2.4.2  
Medical History  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other. Medical History was coded using MedDRA version 22.0.  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\L16020402.SAS  Executed: 21JAN2020 22:52  
Subject ID 
Age(yrs)/ 
Sex/Race 
MH ID 
System Organ Class/ 
Preferred Term / 
 Verbatim term of Medical Condition(s) 
Start Date 
End date 
Ongoing 
9095 
42/M/W 
1 
Immune system disorders/ 
Seasonal allergy/ 
 SEASONAL ALLERGIES 
SEP2012 
 
Yes 
 
Page 623


SIGA TECHNOLOGIES, INC.  
Page 1 of 6 
SIGA-246-022  
Listing 16.2.4.3  
Prior and Concomitant Medications  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Prior and concomitant medications were coded with the WHODD version March 2019 Global B3.  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] If ATC Level 4 description is not available, ATC Level 3 will be used. If ATC Level 3 is also not available, ATC Level 2 will 
be used.  
[2] Associated adverse events or medical history conditions for which the medication was taken. Assoc.=Associated, AE=Adverse event, 
MH=Medical history, ID=Identification.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020403.SAS  Executed: 21JAN2020 22:53  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
CM ID 
ATC Level 4 [1]/ 
Preferred Term/ 
 Medication Reported/ 
  Indication 
Prior 
to 
Study 
Start 
Date Time (Day)/ 
Stop 
Date Time (Day) 
Ongoing/ 
Dose 
Route/ 
Freq 
Assoc. AE/ 
MH IDs [2] 
9005 
40/M/W 
1 VITAMIN D AND ANALOGUES/ 
COLECALCIFEROL/ 
 VITAMIN D3/ 
  IMPROVE BODY 
YES 
04JUN2019 (-71)/ 
30JUL2019 (-15) 
NO/ 
2 UNKNOWN 
ORAL/ 
QD 
2 OTHER PLAIN VITAMIN PREPARATIONS/ 
BIOTIN/ 
 BIOTIN/ 
  IMPROVE HAIR, SKIN 
YES 
04JUN2019 (-71)/ 
30JUL2019 (-15) 
NO/ 
3000 ug 
ORAL/ 
QD 
9016 
48/F/W 
1 PROPIONIC ACID DERIVATIVES/ 
IBUPROFEN/ 
 IBUPROFEN/ 
  MENSTRUAL SYMPTOMS 
YES 
05AUG2019 (-30)/ 
09AUG2019 (-26) 
NO/ 
800 mg 
ORAL/ 
QD 
Page 624


SIGA TECHNOLOGIES, INC.  
Page 2 of 6 
SIGA-246-022  
Listing 16.2.4.3  
Prior and Concomitant Medications  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Prior and concomitant medications were coded with the WHODD version March 2019 Global B3.  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] If ATC Level 4 description is not available, ATC Level 3 will be used. If ATC Level 3 is also not available, ATC Level 2 will 
be used.  
[2] Associated adverse events or medical history conditions for which the medication was taken. Assoc.=Associated, AE=Adverse event, 
MH=Medical history, ID=Identification.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020403.SAS  Executed: 21JAN2020 22:53  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
CM ID 
ATC Level 4 [1]/ 
Preferred Term/ 
 Medication Reported/ 
  Indication 
Prior 
to 
Study 
Start 
Date Time (Day)/ 
Stop 
Date Time (Day) 
Ongoing/ 
Dose 
Route/ 
Freq 
Assoc. AE/ 
MH IDs [2] 
9021 
39/F/BL 
1 UNSPECIFIED HERBAL AND TRADITIONAL 
MEDICINE/ 
PRUNUS SPP./ 
 PRUNE JUICE/ 
  DECREASED FREQUENCY OF BOWEL 
  MOVEMENT 
NO 
10SEP2019 
15:06 (7)/ 
10SEP2019 
15:06 (7) 
NO/ 
1 oz 
ORAL/ 
ONCE 
AE ID:3 
2 UNSPECIFIED HERBAL AND TRADITIONAL 
MEDICINE/ 
PRUNUS SPP./ 
 PRUNE JUICE/ 
  DECREASED FREQUENCY OF BOWEL 
  MOVEMENT 
NO 
10SEP2019 
15:50 (7)/ 
11SEP2019 
17:41 (8) 
NO/ 
1 oz 
ORAL/ 
PRN 
AE ID:3 
9025 
50/M/W 
1 SUBSTITUTED ALKYLAMINES/ 
CHLORPHENAMINE MALEATE/ 
 CHLORTRIMETON/ 
  ALLERGIES 
YES 
FEB2019/ 
21AUG2019 (-28) 
NO/ 
4 mg 
ORAL/ 
BID 
MH ID:3 
Page 625


SIGA TECHNOLOGIES, INC.  
Page 3 of 6 
SIGA-246-022  
Listing 16.2.4.3  
Prior and Concomitant Medications  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Prior and concomitant medications were coded with the WHODD version March 2019 Global B3.  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] If ATC Level 4 description is not available, ATC Level 3 will be used. If ATC Level 3 is also not available, ATC Level 2 will 
be used.  
[2] Associated adverse events or medical history conditions for which the medication was taken. Assoc.=Associated, AE=Adverse event, 
MH=Medical history, ID=Identification.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020403.SAS  Executed: 21JAN2020 22:53  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
CM ID 
ATC Level 4 [1]/ 
Preferred Term/ 
 Medication Reported/ 
  Indication 
Prior 
to 
Study 
Start 
Date Time (Day)/ 
Stop 
Date Time (Day) 
Ongoing/ 
Dose 
Route/ 
Freq 
Assoc. AE/ 
MH IDs [2] 
9025 
50/M/W 
2 AMINO ACIDS, INCL. COMBINATIONS WITH 
POLYPEPTIDES/ 
LYSINE/ 
 LYSINE/ 
  SUPPLEMENT 
YES 
FEB2019/ 
21AUG2019 (-28) 
NO/ 
500 mg 
ORAL/ 
QD 
3 PROPIONIC ACID DERIVATIVES/ 
IBUPROFEN/ 
 IBUPROFEN/ 
  HEADACHE 
YES 
FEB2019/ 
21APR2019 (-150) 
NO/ 
400 mg 
ORAL/ 
PRN 
4 SUBSTITUTED ALKYLAMINES/ 
CHLORPHENAMINE MALEATE/ 
 CHLORTRIMETON/ 
  SEASONAL ALLERGIES 
NO 
28SEP2019 
07:00 (11)/ 
YES/ 
4 mg 
ORAL/ 
BID 
MH ID:3 
Page 626


SIGA TECHNOLOGIES, INC.  
Page 4 of 6 
SIGA-246-022  
Listing 16.2.4.3  
Prior and Concomitant Medications  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Prior and concomitant medications were coded with the WHODD version March 2019 Global B3.  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] If ATC Level 4 description is not available, ATC Level 3 will be used. If ATC Level 3 is also not available, ATC Level 2 will 
be used.  
[2] Associated adverse events or medical history conditions for which the medication was taken. Assoc.=Associated, AE=Adverse event, 
MH=Medical history, ID=Identification.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020403.SAS  Executed: 21JAN2020 22:53  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
CM ID 
ATC Level 4 [1]/ 
Preferred Term/ 
 Medication Reported/ 
  Indication 
Prior 
to 
Study 
Start 
Date Time (Day)/ 
Stop 
Date Time (Day) 
Ongoing/ 
Dose 
Route/ 
Freq 
Assoc. AE/ 
MH IDs [2] 
9058 
32/M/W 
1 OTHER DERMATOLOGICALS/ 
FINASTERIDE/ 
 FINASTERIDE/ 
  PROPHLAXIS HAIR GROWTH 
YES 
01DEC2017 (-684)/ 
22SEP2019 (-24) 
NO/ 
1 mg 
ORAL/ 
QD 
9061 
21/F/BL 
1 ANILIDES/ 
PARACETAMOL/ 
 TYLENOL/ 
  MENSTRUAL CRAMPS 
YES 
21SEP2019 (-25)/ 
21SEP2019 (-25) 
NO/ 
200 mg 
ORAL/ 
ONCE 
2 NITROFURAN DERIVATIVES/ 
NITROFURANTOIN/ 
 NITROFURANTOIN-MON  O/ 
  URINARY TRACT INFECTION 
NO 
04NOV2019 
00:00 (20)/ 
11NOV2019 
12:00 (27) 
NO/ 
1 CAPSULE 
ORAL/ 
Q12H 
AE ID:1 
Page 627


SIGA TECHNOLOGIES, INC.  
Page 5 of 6 
SIGA-246-022  
Listing 16.2.4.3  
Prior and Concomitant Medications  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Prior and concomitant medications were coded with the WHODD version March 2019 Global B3.  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] If ATC Level 4 description is not available, ATC Level 3 will be used. If ATC Level 3 is also not available, ATC Level 2 will 
be used.  
[2] Associated adverse events or medical history conditions for which the medication was taken. Assoc.=Associated, AE=Adverse event, 
MH=Medical history, ID=Identification.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020403.SAS  Executed: 21JAN2020 22:53  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
CM ID 
ATC Level 4 [1]/ 
Preferred Term/ 
 Medication Reported/ 
  Indication 
Prior 
to 
Study 
Start 
Date Time (Day)/ 
Stop 
Date Time (Day) 
Ongoing/ 
Dose 
Route/ 
Freq 
Assoc. AE/ 
MH IDs [2] 
9069 
41/F/BL 
1 OTHER OPIOIDS/ 
TRAMADOL/ 
 TRAMADOL/ 
  BACK PAIN 
YES 
29SEP2019 (-17)/ 
29SEP2019 (-17) 
NO/ 
35 mg 
ORAL/ 
ONCE 
MH ID:4 
9081 
49/M/BL 
1 MULTIVITAMINS WITH MINERALS/ 
MINERALS NOS;VITAMINS NOS/ 
 CENTRUM 1 A DAY/ 
  HEALTH 
YES 
26SEP2019 (-34)/ 
06OCT2019 (-24) 
NO/ 
220 mg 
ORAL/ 
QD 
2 PROPIONIC ACID DERIVATIVES/ 
NAPROXEN SODIUM/ 
 ALEVE/ 
  LEFT KNEE PAIN 
NO 
11OCT2019 (-19)/ 
11OCT2019 (-19) 
NO/ 
200 mg 
ORAL/ 
ONCE 
MH ID:6 
Page 628


SIGA TECHNOLOGIES, INC.  
Page 6 of 6 
SIGA-246-022  
Listing 16.2.4.3  
Prior and Concomitant Medications  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Prior and concomitant medications were coded with the WHODD version March 2019 Global B3.  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] If ATC Level 4 description is not available, ATC Level 3 will be used. If ATC Level 3 is also not available, ATC Level 2 will 
be used.  
[2] Associated adverse events or medical history conditions for which the medication was taken. Assoc.=Associated, AE=Adverse event, 
MH=Medical history, ID=Identification.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020403.SAS  Executed: 21JAN2020 22:53  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
CM ID 
ATC Level 4 [1]/ 
Preferred Term/ 
 Medication Reported/ 
  Indication 
Prior 
to 
Study 
Start 
Date Time (Day)/ 
Stop 
Date Time (Day) 
Ongoing/ 
Dose 
Route/ 
Freq 
Assoc. AE/ 
MH IDs [2] 
9095 
42/M/W 
1 OTHER ANTIHISTAMINES FOR SYSTEMIC USE/
LORATADINE/ 
 LORATADINE/ 
  SEASONAL ALLERGIES 
NO 
10NOV2019 
22:00 (12)/ 
04DEC2019 
22:00 (36) 
NO/ 
5 mg 
ORAL/ 
QD 
MH ID:1 
 
Page 629


SIGA TECHNOLOGIES, INC.  
Page 1 of 1 
SIGA-246-022  
Listing 16.2.4.4  
Medical and Surgical Treatment Procedures  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Medical and Surgical Treatment Procedures were coded using MedDRA version 22.0.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020404.SAS  Executed: 21JAN2020 23:04  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treatment Procedure 
Indication 
AE ID 
Start Date 
End Date 
Ongoing 
9025 
50/M/W 
AD HOC SAFETY - OBSERVATION Other: FREQUENT PVCS 
18SEP2019 
19SEP2019 
NO 
RHYTHM STRIPS 
Other: ASSESS 
FREQUENCY OF PVC'S 
18SEP2019 
18SEP2019 
NO 
 
Page 630


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.2.5 
Compliance and/or Drug Concentration Data 
Listing 16.2.5.1 
Study Drug Administration Safety Population 
Listing 16.2.5.2 
Meals Safety Population 
Page 631


SIGA TECHNOLOGIES, INC.  
Page 1 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9001/ 
41/M/BL 
Day 1-AM 
14AUG2019 09:25 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
14AUG2019 21:25 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
15AUG2019 09:29 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
15AUG2019 21:25 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
16AUG2019 09:25 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
16AUG2019 21:25 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
17AUG2019 09:26 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
17AUG2019 21:25 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
18AUG2019 09:25 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
18AUG2019 21:25 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
19AUG2019 09:25 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
19AUG2019 21:25 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
20AUG2019 09:25 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
20AUG2019 21:25 (7) 
600 (mg) 
ORAL/BID 
NO 
9002/ 
48/M/W 
Day 1-AM 
14AUG2019 09:24 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
14AUG2019 21:24 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
15AUG2019 09:26 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
15AUG2019 21:24 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
16AUG2019 09:24 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
16AUG2019 21:24 (3) 
600 (mg) 
ORAL/BID 
NO 
Page 632


SIGA TECHNOLOGIES, INC.  
Page 2 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9002/ 
48/M/W 
Day 4-AM 
17AUG2019 09:25 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
17AUG2019 21:24 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
18AUG2019 09:24 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
18AUG2019 21:24 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
19AUG2019 09:31 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
19AUG2019 21:24 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
20AUG2019 09:27 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
20AUG2019 21:24 (7) 
600 (mg) 
ORAL/BID 
NO 
9005/ 
40/M/W 
Day 1-AM 
14AUG2019 09:02 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
14AUG2019 21:02 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
15AUG2019 09:02 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
15AUG2019 21:02 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
16AUG2019 09:02 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
16AUG2019 21:02 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
17AUG2019 09:02 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
17AUG2019 21:02 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
18AUG2019 09:02 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
18AUG2019 21:02 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
19AUG2019 09:02 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
19AUG2019 21:02 (6) 
600 (mg) 
ORAL/BID 
NO 
Page 633


SIGA TECHNOLOGIES, INC.  
Page 3 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9005/ 
40/M/W 
Day 7-AM 
20AUG2019 09:02 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
20AUG2019 21:02 (7) 
600 (mg) 
ORAL/BID 
NO 
9009/ 
21/F/BL 
Day 1-AM 
14AUG2019 09:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
14AUG2019 21:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
15AUG2019 09:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
15AUG2019 21:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
16AUG2019 09:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
16AUG2019 21:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
17AUG2019 09:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
17AUG2019 21:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
18AUG2019 09:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
18AUG2019 21:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
19AUG2019 09:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
19AUG2019 21:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
20AUG2019 09:06 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
20AUG2019 21:06 (7) 
600 (mg) 
ORAL/BID 
NO 
9012/ 
34/M/BL 
Day 1-AM 
14AUG2019 09:10 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
14AUG2019 21:10 (1) 
600 (mg) 
ORAL/BID 
NO 
Page 634


SIGA TECHNOLOGIES, INC.  
Page 4 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9012/ 
34/M/BL 
Day 2-AM 
15AUG2019 09:14 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
15AUG2019 21:10 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
16AUG2019 09:10 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
16AUG2019 21:10 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
17AUG2019 09:10 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
17AUG2019 21:10 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
18AUG2019 09:10 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
18AUG2019 21:10 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
19AUG2019 09:10 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
19AUG2019 21:10 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
20AUG2019 09:10 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
20AUG2019 21:10 (7) 
600 (mg) 
ORAL/BID 
NO 
9015/ 
29/M/BL 
Day 1-AM 
14AUG2019 09:08 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
14AUG2019 21:08 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
15AUG2019 09:08 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
15AUG2019 21:08 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
16AUG2019 09:08 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
16AUG2019 21:08 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
17AUG2019 09:08 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
17AUG2019 21:08 (4) 
600 (mg) 
ORAL/BID 
NO 
Page 635


SIGA TECHNOLOGIES, INC.  
Page 5 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9015/ 
29/M/BL 
Day 5-AM 
18AUG2019 09:08 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
18AUG2019 21:08 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
19AUG2019 09:08 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
19AUG2019 21:08 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
20AUG2019 09:08 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
20AUG2019 21:08 (7) 
600 (mg) 
ORAL/BID 
NO 
9016/ 
48/F/W 
Day 1-AM 
04SEP2019 08:00 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
04SEP2019 20:00 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
05SEP2019 08:00 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
05SEP2019 20:00 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
06SEP2019 08:00 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
06SEP2019 20:00 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
07SEP2019 08:00 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
07SEP2019 20:00 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
08SEP2019 08:00 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
08SEP2019 20:00 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
09SEP2019 08:00 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
09SEP2019 20:00 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
10SEP2019 08:00 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
10SEP2019 20:00 (7) 
600 (mg) 
ORAL/BID 
NO 
Page 636


SIGA TECHNOLOGIES, INC.  
Page 6 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9019/ 
41/M/BL 
Day 1-AM 
04SEP2019 08:03 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
04SEP2019 20:03 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
05SEP2019 08:09 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
05SEP2019 20:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
06SEP2019 08:03 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
06SEP2019 20:03 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
07SEP2019 08:09 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
07SEP2019 20:03 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
08SEP2019 08:03 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
08SEP2019 20:03 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
09SEP2019 08:03 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
09SEP2019 20:03 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
10SEP2019 08:03 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
10SEP2019 20:03 (7) 
600 (mg) 
ORAL/BID 
NO 
9020/ 
47/F/BL 
Day 1-AM 
04SEP2019 08:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
04SEP2019 20:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
05SEP2019 08:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
05SEP2019 20:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
06SEP2019 08:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
06SEP2019 20:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Page 637


SIGA TECHNOLOGIES, INC.  
Page 7 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9020/ 
47/F/BL 
Day 4-AM 
07SEP2019 08:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
07SEP2019 20:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
08SEP2019 08:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
08SEP2019 20:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
09SEP2019 08:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
09SEP2019 20:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
10SEP2019 08:06 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
10SEP2019 20:06 (7) 
600 (mg) 
ORAL/BID 
NO 
9021/ 
39/F/BL 
Day 1-AM 
04SEP2019 08:09 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
04SEP2019 20:09 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
05SEP2019 08:12 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
05SEP2019 20:09 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
06SEP2019 08:09 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
06SEP2019 20:09 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
07SEP2019 08:09 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
07SEP2019 20:09 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
08SEP2019 08:09 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
08SEP2019 20:09 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
09SEP2019 08:09 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
09SEP2019 20:09 (6) 
600 (mg) 
ORAL/BID 
NO 
Page 638


SIGA TECHNOLOGIES, INC.  
Page 8 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9021/ 
39/F/BL 
Day 7-AM 
10SEP2019 08:09 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
10SEP2019 20:09 (7) 
600 (mg) 
ORAL/BID 
NO 
9022/ 
31/M/W 
Day 1-AM 
04SEP2019 08:12 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
04SEP2019 20:12 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
05SEP2019 08:12 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
05SEP2019 20:12 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
06SEP2019 08:12 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
06SEP2019 20:12 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
07SEP2019 08:18 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
07SEP2019 20:12 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
08SEP2019 08:12 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
08SEP2019 20:12 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
09SEP2019 08:12 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
09SEP2019 20:12 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
10SEP2019 08:12 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
10SEP2019 20:12 (7) 
600 (mg) 
ORAL/BID 
NO 
9024/ 
20/M/BL 
Day 1-AM 
04SEP2019 08:15 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
04SEP2019 20:15 (1) 
600 (mg) 
ORAL/BID 
NO 
Page 639


SIGA TECHNOLOGIES, INC.  
Page 9 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9024/ 
20/M/BL 
Day 2-AM 
05SEP2019 08:15 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
05SEP2019 20:15 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
06SEP2019 08:15 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
06SEP2019 20:15 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
07SEP2019 08:15 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
07SEP2019 20:15 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
08SEP2019 08:15 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
08SEP2019 20:15 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
09SEP2019 08:15 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
09SEP2019 20:15 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
10SEP2019 08:15 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
10SEP2019 20:15 (7) 
600 (mg) 
ORAL/BID 
NO 
9025/ 
50/M/W 
Day 1-AM 
18SEP2019 08:00 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
18SEP2019 20:00 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
19SEP2019 08:00 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
19SEP2019 20:00 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
20SEP2019 08:00 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
20SEP2019 20:00 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
21SEP2019 08:00 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
21SEP2019 20:00 (4) 
600 (mg) 
ORAL/BID 
NO 
Page 640


SIGA TECHNOLOGIES, INC.  
Page 10 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9025/ 
50/M/W 
Day 5-AM 
22SEP2019 08:00 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
22SEP2019 20:05 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
23SEP2019 08:00 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
23SEP2019 20:00 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
24SEP2019 08:00 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
24SEP2019 20:00 (7) 
600 (mg) 
ORAL/BID 
NO 
9033/ 
32/M/W 
Day 1-AM 
04SEP2019 08:18 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
04SEP2019 20:18 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
05SEP2019 08:19 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
05SEP2019 20:18 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
06SEP2019 08:18 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
06SEP2019 20:18 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
07SEP2019 08:21 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
07SEP2019 20:18 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
08SEP2019 08:18 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
08SEP2019 20:18 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
09SEP2019 08:18 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
09SEP2019 20:18 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
10SEP2019 08:18 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
10SEP2019 20:18 (7) 
600 (mg) 
ORAL/BID 
NO 
Page 641


SIGA TECHNOLOGIES, INC.  
Page 11 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9043/ 
22/M/BL 
Day 1-AM 
18SEP2019 08:03 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
18SEP2019 20:36 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
19SEP2019 08:03 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
19SEP2019 20:08 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
20SEP2019 08:03 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
20SEP2019 20:03 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
21SEP2019 08:03 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
21SEP2019 20:03 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
22SEP2019 08:03 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
22SEP2019 20:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
23SEP2019 08:03 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
23SEP2019 20:03 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
24SEP2019 08:03 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
24SEP2019 20:03 (7) 
600 (mg) 
ORAL/BID 
NO 
9046/ 
34/M/BL 
Day 1-AM 
18SEP2019 08:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
18SEP2019 20:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
19SEP2019 08:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
19SEP2019 20:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
20SEP2019 08:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
20SEP2019 20:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Page 642


SIGA TECHNOLOGIES, INC.  
Page 12 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9046/ 
34/M/BL 
Day 4-AM 
21SEP2019 08:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
21SEP2019 20:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
22SEP2019 08:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
22SEP2019 20:07 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
23SEP2019 08:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
23SEP2019 20:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
24SEP2019 08:06 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
24SEP2019 20:06 (7) 
600 (mg) 
ORAL/BID 
NO 
9051/ 
34/M/BL 
Day 1-AM 
02OCT2019 08:15 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
02OCT2019 20:15 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
03OCT2019 08:15 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
03OCT2019 20:15 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
04OCT2019 08:15 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
04OCT2019 20:15 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
05OCT2019 08:15 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
05OCT2019 20:15 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
06OCT2019 08:15 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
06OCT2019 20:15 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
07OCT2019 08:15 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
07OCT2019 20:15 (6) 
600 (mg) 
ORAL/BID 
NO 
Page 643


SIGA TECHNOLOGIES, INC.  
Page 13 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9051/ 
34/M/BL 
Day 7-AM 
08OCT2019 08:15 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
08OCT2019 20:15 (7) 
600 (mg) 
ORAL/BID 
NO 
9052/ 
42/M/BL 
Day 1-AM 
02OCT2019 08:19 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
02OCT2019 20:19 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
03OCT2019 08:19 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
03OCT2019 20:19 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
04OCT2019 08:19 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
04OCT2019 20:19 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
05OCT2019 08:19 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
05OCT2019 20:19 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
06OCT2019 08:19 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
06OCT2019 20:19 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
07OCT2019 08:19 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
07OCT2019 20:19 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
08OCT2019 08:19 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
08OCT2019 20:19 (7) 
600 (mg) 
ORAL/BID 
NO 
9056/ 
31/F/BL 
Day 1-AM 
02OCT2019 08:00 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
02OCT2019 20:00 (1) 
600 (mg) 
ORAL/BID 
NO 
Page 644


SIGA TECHNOLOGIES, INC.  
Page 14 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9056/ 
31/F/BL 
Day 2-AM 
03OCT2019 08:00 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
03OCT2019 20:00 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
04OCT2019 08:00 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
04OCT2019 20:00 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
05OCT2019 08:00 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
05OCT2019 20:00 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
06OCT2019 08:00 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
06OCT2019 20:00 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
07OCT2019 08:00 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
07OCT2019 20:00 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
08OCT2019 08:00 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
08OCT2019 20:00 (7) 
600 (mg) 
ORAL/BID 
NO 
9057/ 
29/F/W 
Day 1-AM 
02OCT2019 08:03 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
02OCT2019 20:03 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
03OCT2019 08:03 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
03OCT2019 20:03 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
04OCT2019 08:03 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
04OCT2019 20:03 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
05OCT2019 08:03 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
05OCT2019 20:03 (4) 
600 (mg) 
ORAL/BID 
NO 
Page 645


SIGA TECHNOLOGIES, INC.  
Page 15 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9057/ 
29/F/W 
Day 5-AM 
06OCT2019 08:03 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
06OCT2019 20:03 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
07OCT2019 08:03 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
07OCT2019 20:03 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
08OCT2019 08:03 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
08OCT2019 20:03 (7) 
600 (mg) 
ORAL/BID 
NO 
9058/ 
32/M/W 
Day 1-AM 
16OCT2019 08:07 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
16OCT2019 20:07 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
17OCT2019 08:07 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
17OCT2019 20:07 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
18OCT2019 08:07 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
18OCT2019 20:07 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
19OCT2019 08:07 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
19OCT2019 20:07 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
20OCT2019 08:07 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
20OCT2019 20:07 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
21OCT2019 08:07 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
21OCT2019 20:07 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
22OCT2019 08:07 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
22OCT2019 20:17 (7) 
600 (mg) 
ORAL/BID 
NO 
Page 646


SIGA TECHNOLOGIES, INC.  
Page 16 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9061/ 
21/F/BL 
Day 1-AM 
16OCT2019 08:03 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
16OCT2019 20:03 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
17OCT2019 08:03 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
17OCT2019 20:03 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
18OCT2019 08:03 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
18OCT2019 20:03 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
19OCT2019 08:03 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
19OCT2019 20:03 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
20OCT2019 08:03 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
20OCT2019 20:03 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
21OCT2019 08:03 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
21OCT2019 20:03 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
22OCT2019 08:03 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
22OCT2019 20:03 (7) 
600 (mg) 
ORAL/BID 
NO 
9062/ 
33/M/BL 
Day 1-AM 
02OCT2019 08:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
02OCT2019 20:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
03OCT2019 08:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
03OCT2019 20:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
04OCT2019 08:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
04OCT2019 20:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Page 647


SIGA TECHNOLOGIES, INC.  
Page 17 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9062/ 
33/M/BL 
Day 4-AM 
05OCT2019 08:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
05OCT2019 20:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
06OCT2019 08:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
06OCT2019 20:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
07OCT2019 08:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
07OCT2019 20:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
08OCT2019 08:06 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
08OCT2019 20:06 (7) 
600 (mg) 
ORAL/BID 
NO 
9063/ 
35/M/W 
Day 1-AM 
02OCT2019 08:09 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
02OCT2019 20:09 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
03OCT2019 08:09 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
03OCT2019 20:09 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
04OCT2019 08:09 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
04OCT2019 20:09 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
05OCT2019 08:09 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
05OCT2019 20:09 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
06OCT2019 08:09 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
06OCT2019 20:09 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
07OCT2019 08:09 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
07OCT2019 20:09 (6) 
600 (mg) 
ORAL/BID 
NO 
Page 648


SIGA TECHNOLOGIES, INC.  
Page 18 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9063/ 
35/M/W 
Day 7-AM 
08OCT2019 08:09 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
08OCT2019 20:09 (7) 
600 (mg) 
ORAL/BID 
NO 
9069/ 
41/F/BL 
Day 1-AM 
16OCT2019 08:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
16OCT2019 20:22 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
17OCT2019 08:10 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
17OCT2019 20:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
18OCT2019 08:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
18OCT2019 20:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
19OCT2019 08:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
19OCT2019 20:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
20OCT2019 08:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
20OCT2019 20:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
21OCT2019 08:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
21OCT2019 20:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
22OCT2019 08:06 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
22OCT2019 20:06 (7) 
600 (mg) 
ORAL/BID 
NO 
9073/ 
40/M/BL 
Day 1-AM 
16OCT2019 08:16 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
16OCT2019 20:16 (1) 
600 (mg) 
ORAL/BID 
NO 
Page 649


SIGA TECHNOLOGIES, INC.  
Page 19 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9073/ 
40/M/BL 
Day 2-AM 
17OCT2019 08:16 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
17OCT2019 20:16 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
18OCT2019 08:16 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
18OCT2019 20:16 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
19OCT2019 08:16 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
19OCT2019 20:16 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
20OCT2019 08:16 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
20OCT2019 20:16 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
21OCT2019 08:16 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
21OCT2019 20:16 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
22OCT2019 08:16 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
22OCT2019 20:16 (7) 
600 (mg) 
ORAL/BID 
NO 
9077/ 
37/F/W 
Day 1-AM 
16OCT2019 08:12 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
16OCT2019 20:12 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
17OCT2019 08:12 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
17OCT2019 20:12 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
18OCT2019 08:12 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
18OCT2019 20:12 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
19OCT2019 08:12 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
19OCT2019 20:12 (4) 
600 (mg) 
ORAL/BID 
NO 
Page 650


SIGA TECHNOLOGIES, INC.  
Page 20 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9077/ 
37/F/W 
Day 5-AM 
20OCT2019 08:12 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
20OCT2019 20:12 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
21OCT2019 08:12 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
21OCT2019 20:12 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
22OCT2019 08:12 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
22OCT2019 20:12 (7) 
600 (mg) 
ORAL/BID 
NO 
9080/ 
41/F/BL 
Day 1-AM 
16OCT2019 08:21 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
16OCT2019 20:21 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
17OCT2019 08:21 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
17OCT2019 20:21 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
18OCT2019 08:21 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
18OCT2019 20:21 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
19OCT2019 08:21 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
19OCT2019 20:21 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
20OCT2019 08:21 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
20OCT2019 20:21 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
21OCT2019 08:21 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
21OCT2019 20:21 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
22OCT2019 08:21 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
22OCT2019 20:21 (7) 
600 (mg) 
ORAL/BID 
NO 
Page 651


SIGA TECHNOLOGIES, INC.  
Page 21 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9081/ 
49/M/BL 
Day 1-AM 
30OCT2019 08:00 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
30OCT2019 20:00 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
31OCT2019 08:00 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
31OCT2019 20:00 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
01NOV2019 08:00 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
01NOV2019 20:00 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
02NOV2019 08:00 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
02NOV2019 20:00 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
03NOV2019 07:00 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
03NOV2019 19:00 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
04NOV2019 07:00 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
04NOV2019 19:00 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
05NOV2019 07:00 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
05NOV2019 19:00 (7) 
600 (mg) 
ORAL/BID 
NO 
9086/ 
36/M/BL 
Day 1-AM 
16OCT2019 08:15 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
16OCT2019 20:15 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
17OCT2019 08:15 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
17OCT2019 20:15 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
18OCT2019 08:15 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
18OCT2019 20:15 (3) 
600 (mg) 
ORAL/BID 
NO 
Page 652


SIGA TECHNOLOGIES, INC.  
Page 22 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9086/ 
36/M/BL 
Day 4-AM 
19OCT2019 08:15 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
19OCT2019 20:15 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
20OCT2019 08:15 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
20OCT2019 20:15 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
21OCT2019 08:18 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
21OCT2019 20:15 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
22OCT2019 08:15 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
22OCT2019 20:15 (7) 
600 (mg) 
ORAL/BID 
NO 
9087/ 
34/F/BL 
Day 1-AM 
16OCT2019 08:18 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
16OCT2019 20:18 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
17OCT2019 08:18 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
17OCT2019 20:18 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
18OCT2019 08:18 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
18OCT2019 20:18 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
19OCT2019 08:18 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
19OCT2019 20:18 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
20OCT2019 08:18 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
20OCT2019 20:18 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
21OCT2019 08:18 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
21OCT2019 20:18 (6) 
600 (mg) 
ORAL/BID 
NO 
Page 653


SIGA TECHNOLOGIES, INC.  
Page 23 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9087/ 
34/F/BL 
Day 7-AM 
22OCT2019 08:18 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
22OCT2019 20:18 (7) 
600 (mg) 
ORAL/BID 
NO 
9089/ 
29/M/BL 
Day 1-AM 
16OCT2019 08:24 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
16OCT2019 20:24 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
17OCT2019 08:24 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
17OCT2019 20:24 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
18OCT2019 08:24 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
18OCT2019 20:24 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
19OCT2019 08:24 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
19OCT2019 20:24 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
20OCT2019 08:24 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
20OCT2019 20:24 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
21OCT2019 08:24 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
21OCT2019 20:24 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
22OCT2019 08:24 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
22OCT2019 20:24 (7) 
600 (mg) 
ORAL/BID 
NO 
9092/ 
24/M/W 
Day 1-AM 
16OCT2019 08:27 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
16OCT2019 20:27 (1) 
600 (mg) 
ORAL/BID 
NO 
Page 654


SIGA TECHNOLOGIES, INC.  
Page 24 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9092/ 
24/M/W 
Day 2-AM 
17OCT2019 08:27 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
17OCT2019 20:27 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
18OCT2019 08:27 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
18OCT2019 20:27 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
19OCT2019 08:27 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
19OCT2019 20:27 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 5-AM 
20OCT2019 08:27 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
20OCT2019 20:27 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
21OCT2019 08:27 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
21OCT2019 20:27 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
22OCT2019 08:27 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
22OCT2019 20:27 (7) 
600 (mg) 
ORAL/BID 
NO 
9095/ 
42/M/W 
Day 1-AM 
30OCT2019 08:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 1-PM 
30OCT2019 20:06 (1) 
600 (mg) 
ORAL/BID 
NO 
Day 2-AM 
31OCT2019 08:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 2-PM 
31OCT2019 20:06 (2) 
600 (mg) 
ORAL/BID 
NO 
Day 3-AM 
01NOV2019 08:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 3-PM 
01NOV2019 20:06 (3) 
600 (mg) 
ORAL/BID 
NO 
Day 4-AM 
02NOV2019 08:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Day 4-PM 
02NOV2019 20:06 (4) 
600 (mg) 
ORAL/BID 
NO 
Page 655


SIGA TECHNOLOGIES, INC.  
Page 25 of 25 
SIGA-246-022  
Listing 16.2.5.1  
Study Drug Administration  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Freq=Frequency;  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020501.SAS  Executed: 21JAN2020 23:05  
Subject ID/ 
Age(yrs)/ 
Sex/Race 
Visit - 
Timepoint 
Treatment 
Date/Time (Day) 
Dose (Units) 
Route/Freq 
Dose Adjusted/ 
Reason 
9095/ 
42/M/W 
Day 5-AM 
03NOV2019 07:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 5-PM 
03NOV2019 19:06 (5) 
600 (mg) 
ORAL/BID 
NO 
Day 6-AM 
04NOV2019 07:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 6-PM 
04NOV2019 19:06 (6) 
600 (mg) 
ORAL/BID 
NO 
Day 7-AM 
05NOV2019 07:06 (7) 
600 (mg) 
ORAL/BID 
NO 
Day 7-PM 
05NOV2019 19:06 (7) 
600 (mg) 
ORAL/BID 
NO 
 
Page 656


SIGA TECHNOLOGIES, INC.  
Page 1 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9001 
41/M/BL 
Day 1 
BREAKFAST 
14AUG2019 (1) 
08:55/09:00 
100 
Day 1 
DINNER 
14AUG2019 (1) 
20:55/21:00 
100 
Day 2 
BREAKFAST 
15AUG2019 (2) 
08:55/08:58 
100 
Day 2 
DINNER 
15AUG2019 (2) 
20:55/21:00 
100 
Day 3 
BREAKFAST 
16AUG2019 (3) 
08:55/09:02 
100 
Day 3 
DINNER 
16AUG2019 (3) 
20:55/21:02 
100 
Day 4 
BREAKFAST 
17AUG2019 (4) 
08:56/09:01 
100 
Day 4 
DINNER 
17AUG2019 (4) 
20:55/21:01 
100 
Day 5 
BREAKFAST 
18AUG2019 (5) 
08:55/08:58 
100 
Day 5 
DINNER 
18AUG2019 (5) 
20:55/21:00 
100 
Day 6 
BREAKFAST 
19AUG2019 (6) 
08:55/09:00 
100 
Day 6 
DINNER 
19AUG2019 (6) 
20:55/21:01 
25 
Day 7 
BREAKFAST 
20AUG2019 (7) 
08:55/09:01 
100 
Day 7 
DINNER 
20AUG2019 (7) 
20:55/20:59 
100 
9002 
48/M/W 
Day 1 
BREAKFAST 
14AUG2019 (1) 
08:54/09:03 
100 
Day 1 
DINNER 
14AUG2019 (1) 
20:54/21:04 
100 
Day 2 
BREAKFAST 
15AUG2019 (2) 
08:54/09:02 
100 
Day 2 
DINNER 
15AUG2019 (2) 
20:54/21:03 
100 
Day 3 
BREAKFAST 
16AUG2019 (3) 
08:54/09:04 
100 
Day 3 
DINNER 
16AUG2019 (3) 
20:54/21:00 
75 
Day 4 
BREAKFAST 
17AUG2019 (4) 
08:55/09:03 
100 
Day 4 
DINNER 
17AUG2019 (4) 
20:54/21:03 
100 
Day 5 
BREAKFAST 
18AUG2019 (5) 
08:54/08:59 
100 
Page 657


SIGA TECHNOLOGIES, INC.  
Page 2 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9002 
48/M/W 
Day 5 
DINNER 
18AUG2019 (5) 
20:54/21:02 
100 
Day 6 
BREAKFAST 
19AUG2019 (6) 
08:54/09:05 
100 
Day 6 
DINNER 
19AUG2019 (6) 
20:54/21:04 
75 
Day 7 
BREAKFAST 
20AUG2019 (7) 
08:54/09:05 
100 
Day 7 
DINNER 
20AUG2019 (7) 
20:54/21:00 
100 
9005 
40/M/W 
Day 1 
BREAKFAST 
14AUG2019 (1) 
08:32/08:41 
100 
Day 1 
DINNER 
14AUG2019 (1) 
20:33/20:46 
100 
Day 2 
BREAKFAST 
15AUG2019 (2) 
08:32/08:48 
75 
Day 2 
DINNER 
15AUG2019 (2) 
20:32/20:44 
100 
Day 3 
BREAKFAST 
16AUG2019 (3) 
08:32/08:47 
100 
Day 3 
DINNER 
16AUG2019 (3) 
20:32/20:44 
100 
Day 4 
BREAKFAST 
17AUG2019 (4) 
08:32/08:44 
100 
Day 4 
DINNER 
17AUG2019 (4) 
20:32/20:48 
100 
Day 5 
BREAKFAST 
18AUG2019 (5) 
08:32/08:38 
100 
Day 5 
DINNER 
18AUG2019 (5) 
20:32/20:48 
100 
Day 6 
BREAKFAST 
19AUG2019 (6) 
08:32/08:46 
100 
Day 6 
DINNER 
19AUG2019 (6) 
20:32/20:45 
100 
Day 7 
BREAKFAST 
20AUG2019 (7) 
08:32/08:45 
100 
Day 7 
DINNER 
20AUG2019 (7) 
20:32/20:40 
100 
9009 
21/F/BL 
Day 1 
BREAKFAST 
14AUG2019 (1) 
08:36/08:42 
100 
Day 1 
DINNER 
14AUG2019 (1) 
20:36/20:46 
100 
Day 2 
BREAKFAST 
15AUG2019 (2) 
08:36/08:46 
100 
Page 658


SIGA TECHNOLOGIES, INC.  
Page 3 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9009 
21/F/BL 
Day 2 
DINNER 
15AUG2019 (2) 
20:36/20:47 
100 
Day 3 
BREAKFAST 
16AUG2019 (3) 
08:36/08:48 
100 
Day 3 
DINNER 
16AUG2019 (3) 
20:36/20:56 
100 
Day 4 
BREAKFAST 
17AUG2019 (4) 
08:36/08:49 
100 
Day 4 
DINNER 
17AUG2019 (4) 
20:36/20:49 
100 
Day 5 
BREAKFAST 
18AUG2019 (5) 
08:36/08:42 
100 
Day 5 
DINNER 
18AUG2019 (5) 
20:36/20:49 
100 
Day 6 
BREAKFAST 
19AUG2019 (6) 
08:36/08:48 
100 
Day 6 
DINNER 
19AUG2019 (6) 
20:36/20:48 
100 
Day 7 
BREAKFAST 
20AUG2019 (7) 
08:36/08:47 
100 
Day 7 
DINNER 
20AUG2019 (7) 
20:36/20:45 
100 
9012 
34/M/BL 
Day 1 
BREAKFAST 
14AUG2019 (1) 
08:40/08:45 
100 
Day 1 
DINNER 
14AUG2019 (1) 
20:40/20:48 
100 
Day 2 
BREAKFAST 
15AUG2019 (2) 
08:48/08:55 
100 
Day 2 
DINNER 
15AUG2019 (2) 
20:40/20:49 
100 
Day 3 
BREAKFAST 
16AUG2019 (3) 
08:40/08:49 
100 
Day 3 
DINNER 
16AUG2019 (3) 
20:40/20:49 
100 
Day 4 
BREAKFAST 
17AUG2019 (4) 
08:40/08:47 
100 
Day 4 
DINNER 
17AUG2019 (4) 
20:40/20:50 
100 
Day 5 
BREAKFAST 
18AUG2019 (5) 
08:40/08:45 
100 
Day 5 
DINNER 
18AUG2019 (5) 
20:40/20:51 
100 
Day 6 
BREAKFAST 
19AUG2019 (6) 
08:40/08:50 
100 
Day 6 
DINNER 
19AUG2019 (6) 
20:40/20:50 
100 
Page 659


SIGA TECHNOLOGIES, INC.  
Page 4 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9012 
34/M/BL 
Day 7 
BREAKFAST 
20AUG2019 (7) 
08:40/08:50 
100 
Day 7 
DINNER 
20AUG2019 (7) 
20:40/20:46 
100 
9015 
29/M/BL 
Day 1 
BREAKFAST 
14AUG2019 (1) 
08:34/08:42 
100 
Day 1 
DINNER 
14AUG2019 (1) 
20:38/20:48 
100 
Day 2 
BREAKFAST 
15AUG2019 (2) 
08:38/08:47 
100 
Day 2 
DINNER 
15AUG2019 (2) 
20:38/20:48 
100 
Day 3 
BREAKFAST 
16AUG2019 (3) 
08:38/08:49 
100 
Day 3 
DINNER 
16AUG2019 (3) 
20:38/20:49 
100 
Day 4 
BREAKFAST 
17AUG2019 (4) 
08:38/08:46 
100 
Day 4 
DINNER 
17AUG2019 (4) 
20:38/20:47 
100 
Day 5 
BREAKFAST 
18AUG2019 (5) 
08:38/08:47 
100 
Day 5 
DINNER 
18AUG2019 (5) 
20:38/20:48 
100 
Day 6 
BREAKFAST 
19AUG2019 (6) 
08:38/08:48 
100 
Day 6 
DINNER 
19AUG2019 (6) 
20:38/20:47 
100 
Day 7 
BREAKFAST 
20AUG2019 (7) 
08:38/08:48 
100 
Day 7 
DINNER 
20AUG2019 (7) 
20:38/20:44 
100 
9016 
48/F/W 
Day 1 
BREAKFAST 
04SEP2019 (1) 
07:30/07:40 
100 
Day 1 
DINNER 
04SEP2019 (1) 
19:30/19:44 
100 
Day 2 
BREAKFAST 
05SEP2019 (2) 
07:30/07:38 
100 
Day 2 
DINNER 
05SEP2019 (2) 
19:30/19:41 
100 
Day 3 
BREAKFAST 
06SEP2019 (3) 
07:30/07:46 
100 
Day 3 
DINNER 
06SEP2019 (3) 
19:30/19:41 
100 
Page 660


SIGA TECHNOLOGIES, INC.  
Page 5 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9016 
48/F/W 
Day 4 
BREAKFAST 
07SEP2019 (4) 
07:30/07:38 
100 
Day 4 
DINNER 
07SEP2019 (4) 
19:30/19:42 
100 
Day 5 
BREAKFAST 
08SEP2019 (5) 
07:30/07:39 
100 
Day 5 
DINNER 
08SEP2019 (5) 
19:30/19:40 
100 
Day 6 
BREAKFAST 
09SEP2019 (6) 
07:30/07:39 
100 
Day 6 
DINNER 
09SEP2019 (6) 
19:30/19:44 
100 
Day 7 
BREAKFAST 
10SEP2019 (7) 
07:30/07:39 
100 
Day 7 
DINNER 
10SEP2019 (7) 
19:30/19:38 
100 
9019 
41/M/BL 
Day 1 
BREAKFAST 
04SEP2019 (1) 
07:33/07:48 
100 
Day 1 
DINNER 
04SEP2019 (1) 
19:33/19:45 
100 
Day 2 
BREAKFAST 
05SEP2019 (2) 
07:33/07:43 
100 
Day 2 
DINNER 
05SEP2019 (2) 
19:36/19:47 
100 
Day 3 
BREAKFAST 
06SEP2019 (3) 
07:33/07:46 
100 
Day 3 
DINNER 
06SEP2019 (3) 
19:33/19:44 
100 
Day 4 
BREAKFAST 
07SEP2019 (4) 
07:39/07:47 
100 
Day 4 
DINNER 
07SEP2019 (4) 
19:33/19:44 
100 
Day 5 
BREAKFAST 
08SEP2019 (5) 
07:33/07:40 
100 
Day 5 
DINNER 
08SEP2019 (5) 
19:33/19:42 
100 
Day 6 
BREAKFAST 
09SEP2019 (6) 
07:33/07:41 
100 
Day 6 
DINNER 
09SEP2019 (6) 
19:33/19:46 
100 
Day 7 
BREAKFAST 
10SEP2019 (7) 
07:33/07:43 
100 
Day 7 
DINNER 
10SEP2019 (7) 
19:33/19:43 
100 
Page 661


SIGA TECHNOLOGIES, INC.  
Page 6 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9020 
47/F/BL 
Day 1 
BREAKFAST 
04SEP2019 (1) 
07:36/07:52 
100 
Day 1 
DINNER 
04SEP2019 (1) 
19:36/19:53 
100 
Day 2 
BREAKFAST 
05SEP2019 (2) 
07:36/07:53 
100 
Day 2 
DINNER 
05SEP2019 (2) 
19:36/19:53 
100 
Day 3 
BREAKFAST 
06SEP2019 (3) 
07:36/07:51 
50 
Day 3 
DINNER 
06SEP2019 (3) 
19:36/19:52 
Day 4 
BREAKFAST 
07SEP2019 (4) 
07:36/07:49 
100 
Day 4 
DINNER 
07SEP2019 (4) 
19:36/19:52 
100 
Day 5 
BREAKFAST 
08SEP2019 (5) 
07:36/07:46 
100 
Day 5 
DINNER 
08SEP2019 (5) 
19:36/19:52 
100 
Day 6 
BREAKFAST 
09SEP2019 (6) 
07:36/07:50 
100 
Day 6 
DINNER 
09SEP2019 (6) 
19:36/19:51 
25 
Day 7 
BREAKFAST 
10SEP2019 (7) 
07:36/07:49 
100 
Day 7 
DINNER 
10SEP2019 (7) 
19:36/19:48 
100 
9021 
39/F/BL 
Day 1 
BREAKFAST 
04SEP2019 (1) 
07:39/07:52 
100 
Day 1 
DINNER 
04SEP2019 (1) 
19:39/19:54 
100 
Day 2 
BREAKFAST 
05SEP2019 (2) 
07:42/07:54 
100 
Day 2 
DINNER 
05SEP2019 (2) 
19:39/19:57 
100 
Day 3 
BREAKFAST 
06SEP2019 (3) 
07:39/07:58 
100 
Day 3 
DINNER 
06SEP2019 (3) 
19:39/19:55 
100 
Day 4 
BREAKFAST 
07SEP2019 (4) 
07:39/07:53 
100 
Day 4 
DINNER 
07SEP2019 (4) 
19:39/19:54 
100 
Day 5 
BREAKFAST 
08SEP2019 (5) 
07:39/07:52 
100 
Page 662


SIGA TECHNOLOGIES, INC.  
Page 7 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9021 
39/F/BL 
Day 5 
DINNER 
08SEP2019 (5) 
19:39/19:54 
100 
Day 6 
BREAKFAST 
09SEP2019 (6) 
07:39/07:55 
100 
Day 6 
DINNER 
09SEP2019 (6) 
19:39/19:57 
100 
Day 7 
BREAKFAST 
10SEP2019 (7) 
07:39/07:55 
100 
Day 7 
DINNER 
10SEP2019 (7) 
19:39/19:51 
100 
9022 
31/M/W 
Day 1 
BREAKFAST 
04SEP2019 (1) 
07:42/07:48 
100 
Day 1 
DINNER 
04SEP2019 (1) 
19:42/19:50 
100 
Day 2 
BREAKFAST 
05SEP2019 (2) 
07:42/07:47 
100 
Day 2 
DINNER 
05SEP2019 (2) 
19:42/19:52 
100 
Day 3 
BREAKFAST 
06SEP2019 (3) 
07:42/07:53 
100 
Day 3 
DINNER 
06SEP2019 (3) 
19:42/19:54 
100 
Day 4 
BREAKFAST 
07SEP2019 (4) 
07:48/07:56 
100 
Day 4 
DINNER 
07SEP2019 (4) 
19:42/19:50 
100 
Day 5 
BREAKFAST 
08SEP2019 (5) 
07:42/07:44 
100 
Day 5 
DINNER 
08SEP2019 (5) 
19:42/19:48 
100 
Day 6 
BREAKFAST 
09SEP2019 (6) 
07:42/07:53 
100 
Day 6 
DINNER 
09SEP2019 (6) 
19:42/19:53 
100 
Day 7 
BREAKFAST 
10SEP2019 (7) 
07:42/07:52 
100 
Day 7 
DINNER 
10SEP2019 (7) 
19:42/19:49 
100 
9024 
20/M/BL 
Day 1 
BREAKFAST 
04SEP2019 (1) 
07:45/07:55 
100 
Day 1 
DINNER 
04SEP2019 (1) 
19:45/19:54 
100 
Day 2 
BREAKFAST 
05SEP2019 (2) 
07:45/07:55 
100 
Page 663


SIGA TECHNOLOGIES, INC.  
Page 8 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9024 
20/M/BL 
Day 2 
DINNER 
05SEP2019 (2) 
19:45/19:55 
100 
Day 3 
BREAKFAST 
06SEP2019 (3) 
07:45/07:56 
100 
Day 3 
DINNER 
06SEP2019 (3) 
19:45/19:53 
100 
Day 4 
BREAKFAST 
07SEP2019 (4) 
07:45/07:52 
75 
Day 4 
DINNER 
07SEP2019 (4) 
19:45/19:53 
100 
Day 5 
BREAKFAST 
08SEP2019 (5) 
07:45/07:50 
100 
Day 5 
DINNER 
08SEP2019 (5) 
19:45/19:55 
100 
Day 6 
BREAKFAST 
09SEP2019 (6) 
07:45/07:54 
100 
Day 6 
DINNER 
09SEP2019 (6) 
19:45/19:54 
100 
Day 7 
BREAKFAST 
10SEP2019 (7) 
07:45/07:59 
100 
Day 7 
DINNER 
10SEP2019 (7) 
19:45/19:52 
100 
9025 
50/M/W 
Day 1 
BREAKFAST 
18SEP2019 (1) 
07:30/07:38 
100 
Day 1 
DINNER 
18SEP2019 (1) 
19:30/19:41 
100 
Day 2 
BREAKFAST 
19SEP2019 (2) 
07:30/07:39 
100 
Day 2 
DINNER 
19SEP2019 (2) 
19:30/19:40 
100 
Day 3 
BREAKFAST 
20SEP2019 (3) 
07:30/07:39 
100 
Day 3 
DINNER 
20SEP2019 (3) 
19:30/19:39 
75 
Day 4 
BREAKFAST 
21SEP2019 (4) 
07:30/07:37 
100 
Day 4 
DINNER 
21SEP2019 (4) 
19:30/19:39 
100 
Day 5 
BREAKFAST 
22SEP2019 (5) 
07:30/07:34 
100 
Day 5 
DINNER 
22SEP2019 (5) 
19:30/19:41 
100 
Day 6 
BREAKFAST 
23SEP2019 (6) 
07:30/07:42 
100 
Day 6 
DINNER 
23SEP2019 (6) 
19:30/19:41 
100 
Page 664


SIGA TECHNOLOGIES, INC.  
Page 9 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9025 
50/M/W 
Day 7 
BREAKFAST 
24SEP2019 (7) 
07:30/07:37 
100 
Day 7 
DINNER 
24SEP2019 (7) 
19:30/19:35 
100 
9033 
32/M/W 
Day 1 
BREAKFAST 
04SEP2019 (1) 
07:48/07:54 
100 
Day 1 
DINNER 
04SEP2019 (1) 
19:48/19:53 
100 
Day 2 
BREAKFAST 
05SEP2019 (2) 
07:49/07:54 
100 
Day 2 
DINNER 
05SEP2019 (2) 
19:48/19:55 
100 
Day 3 
BREAKFAST 
06SEP2019 (3) 
07:48/07:54 
100 
Day 3 
DINNER 
06SEP2019 (3) 
19:48/19:54 
100 
Day 4 
BREAKFAST 
07SEP2019 (4) 
07:51/07:55 
100 
Day 4 
DINNER 
07SEP2019 (4) 
19:48/19:54 
100 
Day 5 
BREAKFAST 
08SEP2019 (5) 
07:48/07:52 
100 
Day 5 
DINNER 
08SEP2019 (5) 
19:48/19:54 
100 
Day 6 
BREAKFAST 
09SEP2019 (6) 
07:48/07:53 
100 
Day 6 
DINNER 
09SEP2019 (6) 
19:48/19:55 
100 
Day 7 
BREAKFAST 
10SEP2019 (7) 
07:48/07:57 
100 
Day 7 
DINNER 
10SEP2019 (7) 
19:48/19:54 
100 
9043 
22/M/BL 
Day 1 
BREAKFAST 
18SEP2019 (1) 
07:33/07:39 
100 
Day 1 
DINNER 
18SEP2019 (1) 
19:33/19:42 
100 
Day 2 
BREAKFAST 
19SEP2019 (2) 
07:33/07:40 
100 
Day 2 
DINNER 
19SEP2019 (2) 
19:38/19:44 
100 
Day 3 
BREAKFAST 
20SEP2019 (3) 
07:33/07:40 
100 
Day 3 
DINNER 
20SEP2019 (3) 
19:33/19:38 
100 
Page 665


SIGA TECHNOLOGIES, INC.  
Page 10 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9043 
22/M/BL 
Day 4 
BREAKFAST 
21SEP2019 (4) 
07:33/07:38 
100 
Day 4 
DINNER 
21SEP2019 (4) 
19:33/19:38 
100 
Day 5 
BREAKFAST 
22SEP2019 (5) 
07:33/07:36 
100 
Day 5 
DINNER 
22SEP2019 (5) 
19:33/19:38 
100 
Day 6 
BREAKFAST 
23SEP2019 (6) 
07:33/07:41 
100 
Day 6 
DINNER 
23SEP2019 (6) 
19:33/19:40 
100 
Day 7 
BREAKFAST 
24SEP2019 (7) 
07:33/07:39 
100 
Day 7 
DINNER 
24SEP2019 (7) 
19:33/19:37 
100 
9046 
34/M/BL 
Day 1 
BREAKFAST 
18SEP2019 (1) 
07:36/07:42 
100 
Day 1 
DINNER 
18SEP2019 (1) 
19:36/19:49 
100 
Day 2 
BREAKFAST 
19SEP2019 (2) 
07:36/07:46 
100 
Day 2 
DINNER 
19SEP2019 (2) 
19:36/19:44 
100 
Day 3 
BREAKFAST 
20SEP2019 (3) 
07:36/07:45 
100 
Day 3 
DINNER 
20SEP2019 (3) 
19:36/19:43 
100 
Day 4 
BREAKFAST 
21SEP2019 (4) 
07:36/07:45 
100 
Day 4 
DINNER 
21SEP2019 (4) 
19:36/19:46 
100 
Day 5 
BREAKFAST 
22SEP2019 (5) 
07:36/07:42 
100 
Day 5 
DINNER 
22SEP2019 (5) 
19:36/19:44 
100 
Day 6 
BREAKFAST 
23SEP2019 (6) 
07:36/07:49 
100 
Day 6 
DINNER 
23SEP2019 (6) 
19:36/19:44 
100 
Day 7 
BREAKFAST 
24SEP2019 (7) 
07:36/07:45 
100 
Day 7 
DINNER 
24SEP2019 (7) 
19:36/19:43 
100 
Page 666


SIGA TECHNOLOGIES, INC.  
Page 11 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9051 
34/M/BL 
Day 1 
BREAKFAST 
02OCT2019 (1) 
07:45/07:51 
100 
Day 1 
DINNER 
02OCT2019 (1) 
19:45/19:54 
100 
Day 2 
BREAKFAST 
03OCT2019 (2) 
07:45/07:52 
100 
Day 2 
DINNER 
03OCT2019 (2) 
19:45/19:53 
100 
Day 3 
BREAKFAST 
04OCT2019 (3) 
07:45/07:53 
100 
Day 3 
DINNER 
04OCT2019 (3) 
19:45/19:54 
100 
Day 4 
BREAKFAST 
05OCT2019 (4) 
07:45/07:51 
100 
Day 4 
DINNER 
05OCT2019 (4) 
19:45/19:53 
100 
Day 5 
BREAKFAST 
06OCT2019 (5) 
07:45/07:48 
100 
Day 5 
DINNER 
06OCT2019 (5) 
19:45/19:52 
100 
Day 6 
BREAKFAST 
07OCT2019 (6) 
07:45/07:53 
100 
Day 6 
DINNER 
07OCT2019 (6) 
19:45/19:55 
100 
Day 7 
BREAKFAST 
08OCT2019 (7) 
07:45/07:51 
100 
Day 7 
DINNER 
08OCT2019 (7) 
19:45/19:52 
100 
9052 
42/M/BL 
Day 1 
BREAKFAST 
02OCT2019 (1) 
07:49/07:54 
100 
Day 1 
DINNER 
02OCT2019 (1) 
19:49/19:57 
100 
Day 2 
BREAKFAST 
03OCT2019 (2) 
07:49/07:55 
100 
Day 2 
DINNER 
03OCT2019 (2) 
19:49/19:58 
100 
Day 3 
BREAKFAST 
04OCT2019 (3) 
07:49/08:00 
100 
Day 3 
DINNER 
04OCT2019 (3) 
19:49/19:57 
100 
Day 4 
BREAKFAST 
05OCT2019 (4) 
07:49/07:56 
100 
Day 4 
DINNER 
05OCT2019 (4) 
19:49/19:58 
100 
Day 5 
BREAKFAST 
06OCT2019 (5) 
07:49/07:55 
100 
Page 667


SIGA TECHNOLOGIES, INC.  
Page 12 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9052 
42/M/BL 
Day 5 
DINNER 
06OCT2019 (5) 
19:49/19:56 
100 
Day 6 
BREAKFAST 
07OCT2019 (6) 
07:49/07:58 
100 
Day 6 
DINNER 
07OCT2019 (6) 
19:49/20:00 
100 
Day 7 
BREAKFAST 
08OCT2019 (7) 
07:49/07:57 
100 
Day 7 
DINNER 
08OCT2019 (7) 
19:49/19:56 
100 
9056 
31/F/BL 
Day 1 
BREAKFAST 
02OCT2019 (1) 
07:30/07:38 
100 
Day 1 
DINNER 
02OCT2019 (1) 
19:30/19:45 
100 
Day 2 
BREAKFAST 
03OCT2019 (2) 
07:30/07:45 
100 
Day 2 
DINNER 
03OCT2019 (2) 
19:30/19:45 
100 
Day 3 
BREAKFAST 
04OCT2019 (3) 
07:30/07:47 
100 
Day 3 
DINNER 
04OCT2019 (3) 
19:30/19:43 
100 
Day 4 
BREAKFAST 
05OCT2019 (4) 
07:30/07:44 
100 
Day 4 
DINNER 
05OCT2019 (4) 
19:30/19:43 
100 
Day 5 
BREAKFAST 
06OCT2019 (5) 
07:30/07:44 
100 
Day 5 
DINNER 
06OCT2019 (5) 
19:30/19:46 
100 
Day 6 
BREAKFAST 
07OCT2019 (6) 
07:30/07:44 
100 
Day 6 
DINNER 
07OCT2019 (6) 
19:30/19:47 
100 
Day 7 
BREAKFAST 
08OCT2019 (7) 
07:30/07:44 
100 
Day 7 
DINNER 
08OCT2019 (7) 
19:30/19:40 
100 
9057 
29/F/W 
Day 1 
BREAKFAST 
02OCT2019 (1) 
07:33/07:47 
100 
Day 1 
DINNER 
02OCT2019 (1) 
19:33/19:51 
100 
Day 2 
BREAKFAST 
03OCT2019 (2) 
07:33/07:52 
100 
Page 668


SIGA TECHNOLOGIES, INC.  
Page 13 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9057 
29/F/W 
Day 2 
DINNER 
03OCT2019 (2) 
19:33/19:46 
100 
Day 3 
BREAKFAST 
04OCT2019 (3) 
07:33/07:52 
100 
Day 3 
DINNER 
04OCT2019 (3) 
19:33/19:44 
100 
Day 4 
BREAKFAST 
05OCT2019 (4) 
07:33/07:45 
100 
Day 4 
DINNER 
05OCT2019 (4) 
19:33/19:45 
100 
Day 5 
BREAKFAST 
06OCT2019 (5) 
07:33/07:46 
100 
Day 5 
DINNER 
06OCT2019 (5) 
19:33/19:50 
100 
Day 6 
BREAKFAST 
07OCT2019 (6) 
07:33/07:49 
100 
Day 6 
DINNER 
07OCT2019 (6) 
19:33/19:46 
100 
Day 7 
BREAKFAST 
08OCT2019 (7) 
07:33/07:48 
100 
Day 7 
DINNER 
08OCT2019 (7) 
19:33/19:43 
100 
9058 
32/M/W 
Day 1 
BREAKFAST 
16OCT2019 (1) 
07:30/07:36 
100 
Day 1 
DINNER 
16OCT2019 (1) 
19:37/19:44 
100 
Day 2 
BREAKFAST 
17OCT2019 (2) 
07:37/07:43 
100 
Day 2 
DINNER 
17OCT2019 (2) 
19:37/19:44 
100 
Day 3 
BREAKFAST 
18OCT2019 (3) 
07:37/07:44 
100 
Day 3 
DINNER 
18OCT2019 (3) 
19:37/19:44 
100 
Day 4 
BREAKFAST 
19OCT2019 (4) 
07:40/07:46 
100 
Day 4 
DINNER 
19OCT2019 (4) 
19:37/19:42 
100 
Day 5 
BREAKFAST 
20OCT2019 (5) 
07:37/07:40 
100 
Day 5 
DINNER 
20OCT2019 (5) 
19:37/19:47 
100 
Day 6 
BREAKFAST 
21OCT2019 (6) 
07:37/07:43 
100 
Day 6 
DINNER 
21OCT2019 (6) 
19:37/19:48 
100 
Page 669


SIGA TECHNOLOGIES, INC.  
Page 14 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9058 
32/M/W 
Day 7 
BREAKFAST 
22OCT2019 (7) 
07:37/07:45 
100 
Day 7 
DINNER 
22OCT2019 (7) 
19:37/19:41 
100 
9061 
21/F/BL 
Day 1 
BREAKFAST 
16OCT2019 (1) 
07:33/07:40 
100 
Day 1 
DINNER 
16OCT2019 (1) 
19:33/19:46 
100 
Day 2 
BREAKFAST 
17OCT2019 (2) 
07:38/07:52 
100 
Day 2 
DINNER 
17OCT2019 (2) 
19:33/19:43 
100 
Day 3 
BREAKFAST 
18OCT2019 (3) 
07:33/07:45 
100 
Day 3 
DINNER 
18OCT2019 (3) 
19:33/19:45 
100 
Day 4 
BREAKFAST 
19OCT2019 (4) 
07:40/07:46 
100 
Day 4 
DINNER 
19OCT2019 (4) 
19:33/19:44 
100 
Day 5 
BREAKFAST 
20OCT2019 (5) 
07:33/07:38 
75 
Day 5 
DINNER 
20OCT2019 (5) 
19:33/19:44 
100 
Day 6 
BREAKFAST 
21OCT2019 (6) 
07:33/07:44 
100 
Day 6 
DINNER 
21OCT2019 (6) 
19:33/19:53 
100 
Day 7 
BREAKFAST 
22OCT2019 (7) 
07:33/07:44 
100 
Day 7 
DINNER 
22OCT2019 (7) 
19:32/19:41 
100 
9062 
33/M/BL 
Day 1 
BREAKFAST 
02OCT2019 (1) 
07:36/07:42 
100 
Day 1 
DINNER 
02OCT2019 (1) 
19:36/19:42 
100 
Day 2 
BREAKFAST 
03OCT2019 (2) 
07:36/07:43 
100 
Day 2 
DINNER 
03OCT2019 (2) 
19:36/19:43 
100 
Day 3 
BREAKFAST 
04OCT2019 (3) 
07:36/07:45 
100 
Day 3 
DINNER 
04OCT2019 (3) 
19:36/19:42 
100 
Page 670


SIGA TECHNOLOGIES, INC.  
Page 15 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9062 
33/M/BL 
Day 4 
BREAKFAST 
05OCT2019 (4) 
07:36/07:43 
100 
Day 4 
DINNER 
05OCT2019 (4) 
19:36/19:42 
100 
Day 5 
BREAKFAST 
06OCT2019 (5) 
07:36/07:42 
100 
Day 5 
DINNER 
06OCT2019 (5) 
19:36/19:44 
100 
Day 6 
BREAKFAST 
07OCT2019 (6) 
07:36/07:43 
100 
Day 6 
DINNER 
07OCT2019 (6) 
19:36/19:45 
100 
Day 7 
BREAKFAST 
08OCT2019 (7) 
07:36/07:43 
100 
Day 7 
DINNER 
08OCT2019 (7) 
19:36/19:40 
100 
9063 
35/M/W 
Day 1 
BREAKFAST 
02OCT2019 (1) 
07:39/07:45 
100 
Day 1 
DINNER 
02OCT2019 (1) 
19:39/19:46 
100 
Day 2 
BREAKFAST 
03OCT2019 (2) 
07:39/07:44 
100 
Day 2 
DINNER 
03OCT2019 (2) 
19:39/19:44 
100 
Day 3 
BREAKFAST 
04OCT2019 (3) 
07:39/07:46 
100 
Day 3 
DINNER 
04OCT2019 (3) 
19:39/19:43 
100 
Day 4 
BREAKFAST 
05OCT2019 (4) 
07:39/07:44 
100 
Day 4 
DINNER 
05OCT2019 (4) 
19:39/19:43 
100 
Day 5 
BREAKFAST 
06OCT2019 (5) 
07:39/07:44 
100 
Day 5 
DINNER 
06OCT2019 (5) 
19:39/19:44 
100 
Day 6 
BREAKFAST 
07OCT2019 (6) 
07:39/07:44 
100 
Day 6 
DINNER 
07OCT2019 (6) 
19:39/19:45 
100 
Day 7 
BREAKFAST 
08OCT2019 (7) 
07:39/07:44 
100 
Day 7 
DINNER 
08OCT2019 (7) 
19:39/19:42 
100 
Page 671


SIGA TECHNOLOGIES, INC.  
Page 16 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9069 
41/F/BL 
Day 1 
BREAKFAST 
16OCT2019 (1) 
07:36/07:42 
100 
Day 1 
DINNER 
16OCT2019 (1) 
19:36/19:45 
100 
Day 2 
BREAKFAST 
17OCT2019 (2) 
07:40/07:51 
100 
Day 2 
DINNER 
17OCT2019 (2) 
19:36/19:47 
100 
Day 3 
BREAKFAST 
18OCT2019 (3) 
07:36/07:47 
100 
Day 3 
DINNER 
18OCT2019 (3) 
19:36/19:45 
100 
Day 4 
BREAKFAST 
19OCT2019 (4) 
07:38/07:46 
100 
Day 4 
DINNER 
19OCT2019 (4) 
19:36/19:44 
100 
Day 5 
BREAKFAST 
20OCT2019 (5) 
07:36/07:40 
100 
Day 5 
DINNER 
20OCT2019 (5) 
19:36/19:44 
100 
Day 6 
BREAKFAST 
21OCT2019 (6) 
07:36/07:46 
100 
Day 6 
DINNER 
21OCT2019 (6) 
19:36/19:50 
100 
Day 7 
BREAKFAST 
22OCT2019 (7) 
07:36/07:47 
100 
Day 7 
DINNER 
22OCT2019 (7) 
19:36/19:42 
100 
9073 
40/M/BL 
Day 1 
BREAKFAST 
16OCT2019 (1) 
07:39/07:46 
100 
Day 1 
DINNER 
16OCT2019 (1) 
19:46/19:56 
100 
Day 2 
BREAKFAST 
17OCT2019 (2) 
07:46/07:54 
100 
Day 2 
DINNER 
17OCT2019 (2) 
19:46/19:55 
100 
Day 3 
BREAKFAST 
18OCT2019 (3) 
07:46/07:56 
100 
Day 3 
DINNER 
18OCT2019 (3) 
19:46/19:55 
100 
Day 4 
BREAKFAST 
19OCT2019 (4) 
07:46/07:52 
100 
Day 4 
DINNER 
19OCT2019 (4) 
19:46/19:54 
100 
Day 5 
BREAKFAST 
20OCT2019 (5) 
07:46/07:50 
100 
Page 672


SIGA TECHNOLOGIES, INC.  
Page 17 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9073 
40/M/BL 
Day 5 
DINNER 
20OCT2019 (5) 
19:46/19:54 
100 
Day 6 
BREAKFAST 
21OCT2019 (6) 
07:46/07:54 
100 
Day 6 
DINNER 
21OCT2019 (6) 
19:46/19:58 
100 
Day 7 
BREAKFAST 
22OCT2019 (7) 
07:46/07:55 
100 
Day 7 
DINNER 
22OCT2019 (7) 
19:46/19:53 
100 
9077 
37/F/W 
Day 1 
BREAKFAST 
16OCT2019 (1) 
07:42/07:49 
75 
Day 1 
DINNER 
16OCT2019 (1) 
19:42/19:51 
100 
Day 2 
BREAKFAST 
17OCT2019 (2) 
07:42/07:52 
100 
Day 2 
DINNER 
17OCT2019 (2) 
19:42/19:51 
100 
Day 3 
BREAKFAST 
18OCT2019 (3) 
07:42/07:56 
100 
Day 3 
DINNER 
18OCT2019 (3) 
19:42/19:54 
100 
Day 4 
BREAKFAST 
19OCT2019 (4) 
07:42/07:52 
100 
Day 4 
DINNER 
19OCT2019 (4) 
19:42/19:55 
100 
Day 5 
BREAKFAST 
20OCT2019 (5) 
07:42/07:47 
100 
Day 5 
DINNER 
20OCT2019 (5) 
19:42/19:53 
100 
Day 6 
BREAKFAST 
21OCT2019 (6) 
07:42/07:52 
100 
Day 6 
DINNER 
21OCT2019 (6) 
19:42/20:01 
100 
Day 7 
BREAKFAST 
22OCT2019 (7) 
07:42/07:54 
100 
Day 7 
DINNER 
22OCT2019 (7) 
19:42/19:50 
100 
9080 
41/F/BL 
Day 1 
BREAKFAST 
16OCT2019 (1) 
07:51/08:04 
100 
Day 1 
DINNER 
16OCT2019 (1) 
19:51/20:08 
100 
Day 2 
BREAKFAST 
17OCT2019 (2) 
07:51/08:09 
100 
Page 673


SIGA TECHNOLOGIES, INC.  
Page 18 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9080 
41/F/BL 
Day 2 
DINNER 
17OCT2019 (2) 
19:51/20:07 
75 
Day 3 
BREAKFAST 
18OCT2019 (3) 
07:51/08:07 
75 
Day 3 
DINNER 
18OCT2019 (3) 
19:51/20:05 
100 
Day 4 
BREAKFAST 
19OCT2019 (4) 
07:51/08:07 
100 
Day 4 
DINNER 
19OCT2019 (4) 
19:51/20:10 
75 
Day 5 
BREAKFAST 
20OCT2019 (5) 
07:51/08:02 
100 
Day 5 
DINNER 
20OCT2019 (5) 
19:51/20:09 
100 
Day 6 
BREAKFAST 
21OCT2019 (6) 
07:51/08:11 
100 
Day 6 
DINNER 
21OCT2019 (6) 
19:51/20:13 
100 
Day 7 
BREAKFAST 
22OCT2019 (7) 
07:51/08:07 
100 
Day 7 
DINNER 
22OCT2019 (7) 
19:51/20:05 
100 
9081 
49/M/BL 
Day 1 
BREAKFAST 
30OCT2019 (1) 
07:30/07:35 
100 
Day 1 
DINNER 
30OCT2019 (1) 
19:47/19:53 
100 
Day 2 
BREAKFAST 
31OCT2019 (2) 
07:30/07:38 
100 
Day 2 
DINNER 
31OCT2019 (2) 
19:30/19:40 
100 
Day 3 
BREAKFAST 
01NOV2019 (3) 
07:30/07:41 
100 
Day 3 
DINNER 
01NOV2019 (3) 
19:30/19:44 
100 
Day 4 
BREAKFAST 
02NOV2019 (4) 
07:30/07:38 
100 
Day 4 
DINNER 
02NOV2019 (4) 
19:30/19:39 
100 
Day 5 
BREAKFAST 
03NOV2019 (5) 
06:30/06:39 
100 
Day 5 
DINNER 
03NOV2019 (5) 
18:30/18:38 
100 
Day 6 
BREAKFAST 
04NOV2019 (6) 
06:30/06:45 
100 
Day 6 
DINNER 
04NOV2019 (6) 
18:30/18:40 
100 
Page 674


SIGA TECHNOLOGIES, INC.  
Page 19 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9081 
49/M/BL 
Day 7 
BREAKFAST 
05NOV2019 (7) 
06:30/06:40 
100 
Day 7 
DINNER 
05NOV2019 (7) 
18:30/18:34 
100 
9086 
36/M/BL 
Day 1 
BREAKFAST 
16OCT2019 (1) 
07:45/07:53 
100 
Day 1 
DINNER 
16OCT2019 (1) 
19:45/19:55 
100 
Day 2 
BREAKFAST 
17OCT2019 (2) 
07:45/08:15 
100 
Day 2 
DINNER 
17OCT2019 (2) 
19:45/19:55 
100 
Day 3 
BREAKFAST 
18OCT2019 (3) 
07:45/07:57 
100 
Day 3 
DINNER 
18OCT2019 (3) 
19:45/19:59 
100 
Day 4 
BREAKFAST 
19OCT2019 (4) 
07:45/07:56 
100 
Day 4 
DINNER 
19OCT2019 (4) 
19:45/19:57 
100 
Day 5 
BREAKFAST 
20OCT2019 (5) 
07:45/07:50 
100 
Day 5 
DINNER 
20OCT2019 (5) 
19:45/19:58 
100 
Day 6 
BREAKFAST 
21OCT2019 (6) 
07:45/07:56 
100 
Day 6 
DINNER 
21OCT2019 (6) 
19:45/20:04 
100 
Day 7 
BREAKFAST 
22OCT2019 (7) 
07:45/07:58 
100 
Day 7 
DINNER 
22OCT2019 (7) 
19:45/19:54 
100 
9087 
34/F/BL 
Day 1 
BREAKFAST 
16OCT2019 (1) 
07:48/07:54 
100 
Day 1 
DINNER 
16OCT2019 (1) 
19:48/20:00 
100 
Day 2 
BREAKFAST 
17OCT2019 (2) 
07:48/08:00 
100 
Day 2 
DINNER 
17OCT2019 (2) 
19:48/19:58 
100 
Day 3 
BREAKFAST 
18OCT2019 (3) 
07:48/08:05 
100 
Day 3 
DINNER 
18OCT2019 (3) 
19:18/20:01 
100 
Page 675


SIGA TECHNOLOGIES, INC.  
Page 20 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9087 
34/F/BL 
Day 4 
BREAKFAST 
19OCT2019 (4) 
07:48/07:58 
100 
Day 4 
DINNER 
19OCT2019 (4) 
19:48/20:01 
100 
Day 5 
BREAKFAST 
20OCT2019 (5) 
07:48/07:54 
100 
Day 5 
DINNER 
20OCT2019 (5) 
19:48/20:00 
100 
Day 6 
BREAKFAST 
21OCT2019 (6) 
07:48/08:06 
100 
Day 6 
DINNER 
21OCT2019 (6) 
19:48/20:06 
100 
Day 7 
BREAKFAST 
22OCT2019 (7) 
07:48/07:59 
100 
Day 7 
DINNER 
22OCT2019 (7) 
19:48/19:59 
100 
9089 
29/M/BL 
Day 1 
BREAKFAST 
16OCT2019 (1) 
07:54/08:02 
100 
Day 1 
DINNER 
16OCT2019 (1) 
19:54/20:03 
100 
Day 2 
BREAKFAST 
17OCT2019 (2) 
07:54/08:07 
100 
Day 2 
DINNER 
17OCT2019 (2) 
19:54/20:08 
75 
Day 3 
BREAKFAST 
18OCT2019 (3) 
07:54/08:08 
75 
Day 3 
DINNER 
18OCT2019 (3) 
19:54/20:03 
100 
Day 4 
BREAKFAST 
19OCT2019 (4) 
07:54/08:08 
100 
Day 4 
DINNER 
19OCT2019 (4) 
19:54/20:07 
100 
Day 5 
BREAKFAST 
20OCT2019 (5) 
07:54/08:02 
100 
Day 5 
DINNER 
20OCT2019 (5) 
19:54/20:08 
100 
Day 6 
BREAKFAST 
21OCT2019 (6) 
07:54/08:09 
100 
Day 6 
DINNER 
21OCT2019 (6) 
19:54/20:13 
100 
Day 7 
BREAKFAST 
22OCT2019 (7) 
07:54/08:08 
100 
Day 7 
DINNER 
22OCT2019 (7) 
19:54/20:05 
100 
Page 676


SIGA TECHNOLOGIES, INC.  
Page 21 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9092 
24/M/W 
Day 1 
BREAKFAST 
16OCT2019 (1) 
07:57/08:05 
100 
Day 1 
DINNER 
16OCT2019 (1) 
19:57/20:08 
100 
Day 2 
BREAKFAST 
17OCT2019 (2) 
07:57/08:08 
100 
Day 2 
DINNER 
17OCT2019 (2) 
19:57/20:09 
100 
Day 3 
BREAKFAST 
18OCT2019 (3) 
07:57/08:08 
100 
Day 3 
DINNER 
18OCT2019 (3) 
19:57/20:06 
100 
Day 4 
BREAKFAST 
19OCT2019 (4) 
07:57/08:04 
100 
Day 4 
DINNER 
19OCT2019 (4) 
19:57/20:05 
100 
Day 5 
BREAKFAST 
20OCT2019 (5) 
07:57/08:03 
100 
Day 5 
DINNER 
20OCT2019 (5) 
19:57/20:08 
100 
Day 6 
BREAKFAST 
21OCT2019 (6) 
07:57/08:06 
100 
Day 6 
DINNER 
21OCT2019 (6) 
19:57/20:11 
100 
Day 7 
BREAKFAST 
22OCT2019 (7) 
07:57/08:07 
100 
Day 7 
DINNER 
22OCT2019 (7) 
19:57/20:06 
100 
9095 
42/M/W 
Day 1 
BREAKFAST 
30OCT2019 (1) 
07:36/07:41 
100 
Day 1 
DINNER 
30OCT2019 (1) 
19:47/19:56 
100 
Day 2 
BREAKFAST 
31OCT2019 (2) 
07:36/07:46 
100 
Day 2 
DINNER 
31OCT2019 (2) 
19:36/19:46 
100 
Day 3 
BREAKFAST 
01NOV2019 (3) 
07:36/07:45 
100 
Day 3 
DINNER 
01NOV2019 (3) 
19:36/19:45 
100 
Day 4 
BREAKFAST 
02NOV2019 (4) 
07:36/07:43 
100 
Day 4 
DINNER 
02NOV2019 (4) 
19:36/19:45 
100 
Day 5 
BREAKFAST 
03NOV2019 (5) 
06:36/06:41 
100 
Page 677


SIGA TECHNOLOGIES, INC.  
Page 22 of 22 
SIGA-246-022  
Listing 16.2.5.2  
Meals  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart. Subject 9020 did not eat onions in the dinner on Day 3.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020502.SAS  Executed: 21JAN2020 23:05  
Subject ID 
Age(yrs)/ 
Sex/Race 
Visit 
Meal Type 
Meal Date (Day) 
Start/Stop Time 
Percent 
Consumed 
9095 
42/M/W 
Day 5 
DINNER 
03NOV2019 (5) 
18:36/18:44 
100 
Day 6 
BREAKFAST 
04NOV2019 (6) 
06:36/06:45 
100 
Day 6 
DINNER 
04NOV2019 (6) 
18:36/18:46 
100 
Day 7 
BREAKFAST 
05NOV2019 (7) 
06:36/06:44 
100 
Day 7 
DINNER 
05NOV2019 (7) 
18:36/18:41 
100 
 
Page 678


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.2.6 
Individual Pharmacokinetic Response Data 
Listing 16.2.6.1 
Individual Plasma Collection Times and Concentrations of TPOXX 
Safety Population  
Listing 16.2.6.2 
Individual Plasma Pharmacokinetic Parameters of TPOXX — Day 
1 Pharmacokinetic Population  
Listing 16.2.6.3 
Individual Plasma Pharmacokinetic Parameters of TPOXX — Day 
7 Pharmacokinetic Population  
Page 679


SIGA TECHNOLOGIES, INC.  
Page 1 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9001 
PREDOSE 
14AUG2019/09:20 
. 
BLQ 
 
 
 
0.5 
14AUG2019/09:55 
0.00 
10.8 
 
 
 
1 
14AUG2019/10:25 
0.00 
104 
 
 
 
2 
14AUG2019/11:25 
0.00 
469 
 
 
 
4 
14AUG2019/13:25 
0.00 
1100 
 
 
 
6 
14AUG2019/15:25 
0.00 
759 
 
 
 
8 
14AUG2019/17:27 
2.00 
397 
 
 
 
12 
14AUG2019/21:22 
-3.00 
240 
 
 
 
14 
14AUG2019/23:28 
3.00 
173 
 
 
 
16 
15AUG2019/01:25 
0.00 
485 
 
 
 
18 
15AUG2019/03:25 
0.00 
688 
 
 
 
20 
15AUG2019/05:26 
1.00 
695 
 
 
 
24 
15AUG2019/09:25 
0.00 
455 
 
Page 680


SIGA TECHNOLOGIES, INC.  
Page 2 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9002 
PREDOSE 
14AUG2019/09:22 
. 
BLQ 
 
 
 
0.5 
14AUG2019/09:54 
0.00 
BLQ 
 
 
 
1 
14AUG2019/10:24 
0.00 
33.4 
 
 
 
2 
14AUG2019/11:24 
0.00 
323 
 
 
 
4 
14AUG2019/13:42 
18.00 
717 
 
 
 
6 
14AUG2019/15:28 
4.00 
548 
 
 
 
8 
14AUG2019/17:25 
1.00 
355 
 
 
 
12 
14AUG2019/21:23 
-1.00 
216 
 
 
 
14 
14AUG2019/23:24 
0.00 
273 
 
 
 
16 
15AUG2019/01:28 
4.00 
471 
 
 
 
18 
15AUG2019/03:28 
4.00 
674 
 
 
 
20 
15AUG2019/05:24 
0.00 
865 
 
 
 
24 
15AUG2019/09:19 
-5.00 
637 
 
Page 681


SIGA TECHNOLOGIES, INC.  
Page 3 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9005 
PREDOSE 
14AUG2019/08:57 
. 
BLQ 
 
 
 
0.5 
14AUG2019/09:32 
0.00 
22.2 
 
 
 
1 
14AUG2019/10:02 
0.00 
164 
 
 
 
2 
14AUG2019/11:02 
0.00 
840 
 
 
 
4 
14AUG2019/13:02 
0.00 
1080 
 
 
 
6 
14AUG2019/15:02 
0.00 
578 
 
 
 
8 
14AUG2019/17:02 
0.00 
360 
 
 
 
12 
14AUG2019/20:57 
-5.00 
233 
 
 
 
14 
14AUG2019/23:02 
0.00 
579 
 
 
 
16 
15AUG2019/01:02 
0.00 
1110 
 
 
 
18 
15AUG2019/03:02 
0.00 
1190 
 
 
 
20 
15AUG2019/05:02 
0.00 
811 
 
 
 
24 
15AUG2019/08:57 
-5.00 
555 
 
Page 682


SIGA TECHNOLOGIES, INC.  
Page 4 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9009 
PREDOSE 
14AUG2019/09:01 
. 
BLQ 
 
 
 
0.5 
14AUG2019/09:36 
0.00 
BLQ 
 
 
 
1 
14AUG2019/10:06 
0.00 
BLQ 
 
 
 
2 
14AUG2019/11:06 
0.00 
72.3 
 
 
 
4 
14AUG2019/13:14 
8.00 
523 
 
 
 
6 
14AUG2019/15:06 
0.00 
378 
 
 
 
12 
14AUG2019/21:01 
-5.00 
274 
 
 
 
14 
14AUG2019/23:06 
0.00 
346 
 
 
 
16 
15AUG2019/01:06 
0.00 
899 
 
 
 
18 
15AUG2019/03:06 
0.00 
1520 
 
 
 
20 
15AUG2019/05:10 
4.00 
935 
 
 
 
24 
15AUG2019/09:01 
-5.00 
550 
 
Page 683


SIGA TECHNOLOGIES, INC.  
Page 5 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9012 
PREDOSE 
14AUG2019/09:05 
. 
BLQ 
 
 
 
0.5 
14AUG2019/09:40 
0.00 
10.7 
 
 
 
1 
14AUG2019/10:10 
0.00 
78.9 
 
 
 
2 
14AUG2019/11:10 
0.00 
683 
 
 
 
4 
14AUG2019/13:10 
0.00 
757 
 
 
 
6 
14AUG2019/15:10 
0.00 
657 
 
 
 
8 
14AUG2019/17:10 
0.00 
367 
 
 
 
12 
14AUG2019/21:05 
-5.00 
193 
 
 
 
14 
14AUG2019/23:10 
0.00 
265 
 
 
 
16 
15AUG2019/01:10 
0.00 
667 
 
 
 
18 
15AUG2019/03:10 
0.00 
648 
 
 
 
20 
15AUG2019/05:10 
0.00 
685 
 
 
 
24 
15AUG2019/09:05 
-5.00 
451 
 
Page 684


SIGA TECHNOLOGIES, INC.  
Page 6 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9015 
PREDOSE 
14AUG2019/08:59 
. 
BLQ 
 
 
 
0.5 
14AUG2019/09:38 
0.00 
5.35 
 
 
 
1 
14AUG2019/10:08 
0.00 
69.1 
 
 
 
2 
14AUG2019/11:08 
0.00 
212 
 
 
 
4 
14AUG2019/13:08 
0.00 
331 
 
 
 
6 
14AUG2019/15:08 
0.00 
900 
 
 
 
8 
14AUG2019/17:08 
0.00 
544 
 
 
 
12 
14AUG2019/21:03 
-5.00 
256 
 
 
 
14 
14AUG2019/23:08 
0.00 
246 
 
 
 
16 
15AUG2019/01:08 
0.00 
393 
 
 
 
18 
15AUG2019/03:08 
0.00 
642 
 
 
 
20 
15AUG2019/05:08 
0.00 
741 
 
 
 
24 
15AUG2019/09:03 
-5.00 
507 
 
Page 685


SIGA TECHNOLOGIES, INC.  
Page 7 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9016 
PREDOSE 
04SEP2019/07:55 
. 
BLQ 
 
 
 
0.5 
04SEP2019/08:30 
0.00 
BLQ 
 
 
 
1 
04SEP2019/09:00 
0.00 
91.5 
 
 
 
2 
04SEP2019/10:00 
0.00 
205 
 
 
 
4 
04SEP2019/12:00 
0.00 
711 
 
 
 
6 
04SEP2019/14:00 
0.00 
547 
 
 
 
8 
04SEP2019/16:00 
0.00 
408 
 
 
 
12 
04SEP2019/19:55 
-5.00 
327 
 
 
 
14 
04SEP2019/22:00 
0.00 
321 
 
 
 
16 
05SEP2019/00:00 
0.00 
528 
 
 
 
18 
05SEP2019/02:00 
0.00 
624 
 
 
 
20 
05SEP2019/04:00 
0.00 
613 
 
 
 
24 
05SEP2019/07:55 
-5.00 
534 
 
Page 686


SIGA TECHNOLOGIES, INC.  
Page 8 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9019 
PREDOSE 
04SEP2019/07:59 
. 
BLQ 
 
 
 
0.5 
04SEP2019/08:34 
1.00 
BLQ 
 
 
 
1 
04SEP2019/09:03 
0.00 
16.6 
 
 
 
2 
04SEP2019/10:03 
0.00 
641 
 
 
 
4 
04SEP2019/12:03 
0.00 
922 
 
 
 
6 
04SEP2019/14:07 
4.00 
771 
 
 
 
8 
04SEP2019/16:07 
4.00 
511 
 
 
 
12 
04SEP2019/19:58 
-5.00 
271 
 
 
 
14 
04SEP2019/22:03 
0.00 
225 
 
 
 
16 
05SEP2019/00:03 
0.00 
493 
 
 
 
18 
05SEP2019/02:03 
0.00 
568 
 
 
 
20 
05SEP2019/04:03 
0.00 
761 
 
 
 
24 
05SEP2019/08:06 
3.00 
417 
 
Page 687


SIGA TECHNOLOGIES, INC.  
Page 9 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9020 
PREDOSE 
04SEP2019/08:01 
. 
BLQ 
 
 
 
0.5 
04SEP2019/08:36 
0.00 
BLQ 
 
 
 
1 
04SEP2019/09:06 
0.00 
BLQ 
 
 
 
2 
04SEP2019/10:06 
0.00 
25.6 
 
 
 
4 
04SEP2019/12:06 
0.00 
740 
 
 
 
6 
04SEP2019/14:06 
0.00 
684 
 
 
 
8 
04SEP2019/16:06 
0.00 
740 
 
 
 
12 
04SEP2019/20:01 
-5.00 
444 
 
 
 
14 
04SEP2019/22:15 
9.00 
334 
 
 
 
16 
05SEP2019/00:06 
0.00 
603 
 
 
 
18 
05SEP2019/02:06 
0.00 
801 
 
 
 
20 
05SEP2019/04:06 
0.00 
721 
 
 
 
24 
05SEP2019/08:02 
-4.00 
429 
 
Page 688


SIGA TECHNOLOGIES, INC.  
Page 10 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9021 
PREDOSE 
04SEP2019/08:04 
. 
BLQ 
 
 
 
0.5 
04SEP2019/08:39 
0.00 
BLQ 
 
 
 
1 
04SEP2019/09:09 
0.00 
21.9 
 
 
 
2 
04SEP2019/10:09 
0.00 
774 
 
 
 
4 
04SEP2019/12:11 
2.00 
890 
 
 
 
6 
04SEP2019/14:09 
0.00 
511 
 
 
 
8 
04SEP2019/16:10 
1.00 
292 
 
 
 
12 
04SEP2019/20:04 
-5.00 
272 
 
 
 
14 
04SEP2019/22:09 
0.00 
722 
 
 
 
16 
05SEP2019/00:09 
0.00 
748 
 
 
 
18 
05SEP2019/02:09 
0.00 
713 
 
 
 
20 
05SEP2019/04:09 
0.00 
714 
 
 
 
24 
05SEP2019/08:04 
-5.00 
336 
 
Page 689


SIGA TECHNOLOGIES, INC.  
Page 11 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9022 
PREDOSE 
04SEP2019/08:07 
. 
BLQ 
 
 
 
0.5 
04SEP2019/08:42 
0.00 
BLQ 
 
 
 
1 
04SEP2019/09:12 
0.00 
40.6 
 
 
 
2 
04SEP2019/10:12 
0.00 
309 
 
 
 
4 
04SEP2019/12:12 
0.00 
624 
 
 
 
6 
04SEP2019/14:12 
0.00 
648 
 
 
 
8 
04SEP2019/16:12 
0.00 
396 
 
 
 
12 
04SEP2019/20:07 
-5.00 
304 
 
 
 
14 
04SEP2019/22:12 
0.00 
402 
 
 
 
16 
05SEP2019/00:12 
0.00 
668 
 
 
 
18 
05SEP2019/02:12 
0.00 
632 
 
 
 
20 
05SEP2019/04:12 
0.00 
637 
 
 
 
24 
05SEP2019/08:07 
-5.00 
513 
 
Page 690


SIGA TECHNOLOGIES, INC.  
Page 12 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9024 
PREDOSE 
04SEP2019/08:13 
. 
BLQ 
 
 
 
0.5 
04SEP2019/08:45 
0.00 
BLQ 
 
 
 
1 
04SEP2019/09:17 
2.00 
23.5 
 
 
 
2 
04SEP2019/10:15 
0.00 
251 
 
 
 
4 
04SEP2019/12:15 
0.00 
840 
 
 
 
6 
04SEP2019/14:15 
0.00 
885 
 
 
 
8 
04SEP2019/16:15 
0.00 
845 
 
 
 
12 
04SEP2019/20:10 
-5.00 
456 
 
 
 
14 
04SEP2019/22:15 
0.00 
328 
 
 
 
16 
05SEP2019/00:15 
0.00 
835 
 
 
 
18 
05SEP2019/02:15 
0.00 
647 
 
 
 
20 
05SEP2019/04:15 
0.00 
1070 
 
 
 
24 
05SEP2019/08:10 
-5.00 
630 
 
Page 691


SIGA TECHNOLOGIES, INC.  
Page 13 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9025 
PREDOSE 
18SEP2019/07:55 
. 
BLQ 
 
 
 
0.5 
18SEP2019/08:30 
0.00 
BLQ 
 
 
 
1 
18SEP2019/09:00 
0.00 
BLQ 
 
 
 
2 
18SEP2019/10:00 
0.00 
50.1 
 
 
 
4 
18SEP2019/12:00 
0.00 
192 
 
 
 
6 
18SEP2019/14:00 
0.00 
628 
 
 
 
8 
18SEP2019/16:01 
1.00 
1330 
 
 
 
12 
18SEP2019/19:55 
-5.00 
758 
 
 
 
14 
18SEP2019/22:00 
0.00 
554 
 
 
 
16 
19SEP2019/00:00 
0.00 
1050 
 
 
 
18 
19SEP2019/02:00 
0.00 
936 
 
 
 
20 
19SEP2019/04:00 
0.00 
958 
 
 
 
24 
19SEP2019/07:55 
-5.00 
1110 
 
Page 692


SIGA TECHNOLOGIES, INC.  
Page 14 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9033 
PREDOSE 
04SEP2019/08:16 
. 
BLQ 
 
 
 
0.5 
04SEP2019/08:48 
0.00 
15.5 
 
 
 
1 
04SEP2019/09:18 
0.00 
129 
 
 
 
2 
04SEP2019/10:18 
0.00 
497 
 
 
 
4 
04SEP2019/12:18 
0.00 
574 
 
 
 
6 
04SEP2019/14:22 
4.00 
347 
 
 
 
8 
04SEP2019/16:18 
0.00 
191 
 
 
 
12 
04SEP2019/20:13 
-5.00 
160 
 
 
 
14 
04SEP2019/22:18 
0.00 
339 
 
 
 
16 
05SEP2019/00:18 
0.00 
631 
 
 
 
18 
05SEP2019/02:52 
34.00 
528 
 
 
 
20 
05SEP2019/04:18 
0.00 
467 
 
 
 
24 
05SEP2019/08:13 
-5.00 
292 
 
Page 693


SIGA TECHNOLOGIES, INC.  
Page 15 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9043 
PREDOSE 
18SEP2019/07:58 
. 
BLQ 
 
 
 
0.5 
18SEP2019/08:33 
0.00 
BLQ 
 
 
 
1 
18SEP2019/09:03 
0.00 
14.9 
 
 
 
2 
18SEP2019/10:09 
6.00 
711 
 
 
 
4 
18SEP2019/12:04 
1.00 
909 
 
 
 
6 
18SEP2019/14:03 
0.00 
571 
 
 
 
8 
18SEP2019/16:05 
2.00 
361 
 
 
 
14 
18SEP2019/22:36 
33.00 
269 
 
 
 
16 
19SEP2019/00:36 
33.00 
421 
 
 
 
18 
19SEP2019/02:52 
49.00 
635 
 
 
 
20 
19SEP2019/04:36 
33.00 
1100 
 
 
 
24 
19SEP2019/07:58 
-5.00 
504 
 
Page 694


SIGA TECHNOLOGIES, INC.  
Page 16 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9046 
PREDOSE 
18SEP2019/08:01 
. 
BLQ 
 
 
 
0.5 
18SEP2019/08:36 
0.00 
BLQ 
 
 
 
1 
18SEP2019/09:06 
0.00 
11.8 
 
 
 
2 
18SEP2019/10:06 
0.00 
370 
 
 
 
4 
18SEP2019/12:06 
0.00 
1030 
 
 
 
6 
18SEP2019/14:06 
0.00 
498 
 
 
 
8 
18SEP2019/16:06 
0.00 
331 
 
 
 
12 
18SEP2019/20:02 
-4.00 
265 
 
 
 
14 
18SEP2019/22:06 
0.00 
535 
 
 
 
16 
19SEP2019/00:06 
0.00 
1090 
 
 
 
18 
19SEP2019/02:06 
0.00 
951 
 
 
 
20 
19SEP2019/04:06 
0.00 
832 
 
 
 
24 
19SEP2019/08:01 
-5.00 
506 
 
Page 695


SIGA TECHNOLOGIES, INC.  
Page 17 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9051 
PREDOSE 
02OCT2019/08:10 
. 
BLQ 
 
 
 
0.5 
02OCT2019/08:45 
0.00 
BLQ 
 
 
 
1 
02OCT2019/09:15 
0.00 
26.7 
 
 
 
2 
02OCT2019/10:15 
0.00 
453 
 
 
 
4 
02OCT2019/12:15 
0.00 
811 
 
 
 
6 
02OCT2019/14:15 
0.00 
232 
 
 
 
8 
02OCT2019/16:15 
0.00 
136 
 
 
 
12 
02OCT2019/20:10 
-5.00 
149 
 
 
 
14 
02OCT2019/22:15 
0.00 
171 
 
 
 
16 
03OCT2019/00:15 
0.00 
553 
 
 
 
18 
03OCT2019/02:15 
0.00 
475 
 
 
 
20 
03OCT2019/04:15 
0.00 
409 
 
 
 
24 
03OCT2019/08:10 
-5.00 
294 
 
Page 696


SIGA TECHNOLOGIES, INC.  
Page 18 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9052 
PREDOSE 
02OCT2019/08:14 
. 
BLQ 
 
 
 
0.5 
02OCT2019/08:49 
0.00 
15.0 
 
 
 
1 
02OCT2019/09:19 
0.00 
54.2 
 
 
 
2 
02OCT2019/10:19 
0.00 
256 
 
 
 
4 
02OCT2019/12:19 
0.00 
556 
 
 
 
6 
02OCT2019/14:19 
0.00 
941 
 
 
 
8 
02OCT2019/16:19 
0.00 
522 
 
 
 
12 
02OCT2019/20:14 
-5.00 
346 
 
 
 
14 
02OCT2019/22:19 
0.00 
458 
 
 
 
16 
03OCT2019/00:19 
0.00 
1040 
 
 
 
18 
03OCT2019/02:19 
0.00 
1040 
 
 
 
20 
03OCT2019/04:19 
0.00 
958 
 
 
 
24 
03OCT2019/08:14 
-5.00 
705 
 
Page 697


SIGA TECHNOLOGIES, INC.  
Page 19 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9056 
PREDOSE 
02OCT2019/07:55 
. 
BLQ 
 
 
 
0.5 
02OCT2019/08:30 
0.00 
9.22 
 
 
 
1 
02OCT2019/09:00 
0.00 
33.0 
 
 
 
2 
02OCT2019/10:02 
2.00 
123 
 
 
 
4 
02OCT2019/12:00 
0.00 
938 
 
 
 
6 
02OCT2019/14:00 
0.00 
519 
 
 
 
8 
02OCT2019/16:00 
0.00 
327 
 
 
 
12 
02OCT2019/19:59 
-1.00 
213 
 
 
 
14 
02OCT2019/22:00 
0.00 
158 
 
 
 
16 
03OCT2019/00:00 
0.00 
398 
 
 
 
18 
03OCT2019/02:03 
3.00 
1140 
 
 
 
20 
03OCT2019/04:00 
0.00 
916 
 
 
 
24 
03OCT2019/07:55 
-5.00 
555 
 
Page 698


SIGA TECHNOLOGIES, INC.  
Page 20 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9057 
PREDOSE 
02OCT2019/07:58 
. 
BLQ 
 
 
 
0.5 
02OCT2019/08:33 
0.00 
BLQ 
 
 
 
1 
02OCT2019/09:03 
0.00 
45.8 
 
 
 
2 
02OCT2019/10:03 
0.00 
239 
 
 
 
4 
02OCT2019/12:03 
0.00 
489 
 
 
 
6 
02OCT2019/14:03 
0.00 
557 
 
 
 
8 
02OCT2019/16:03 
0.00 
362 
 
 
 
12 
02OCT2019/19:58 
-5.00 
210 
 
 
 
14 
02OCT2019/22:03 
0.00 
178 
 
 
 
16 
03OCT2019/00:03 
0.00 
457 
 
 
 
18 
03OCT2019/02:03 
0.00 
451 
 
 
 
20 
03OCT2019/04:03 
0.00 
504 
 
 
 
24 
03OCT2019/07:58 
-5.00 
472 
 
Page 699


SIGA TECHNOLOGIES, INC.  
Page 21 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9058 
PREDOSE 
16OCT2019/08:03 
. 
BLQ 
 
 
 
0.5 
16OCT2019/08:37 
0.00 
14.0 
 
 
 
1 
16OCT2019/09:12 
5.00 
355 
 
 
 
2 
16OCT2019/10:07 
0.00 
894 
 
 
 
4 
16OCT2019/12:07 
0.00 
881 
 
 
 
6 
16OCT2019/14:09 
2.00 
623 
 
 
 
8 
16OCT2019/16:08 
1.00 
359 
 
 
 
12 
16OCT2019/20:02 
-5.00 
192 
 
 
 
14 
16OCT2019/22:07 
0.00 
248 
 
 
 
16 
17OCT2019/00:07 
0.00 
513 
 
 
 
18 
17OCT2019/02:07 
0.00 
588 
 
 
 
20 
17OCT2019/04:07 
0.00 
702 
 
 
 
24 
17OCT2019/08:02 
-5.00 
746 
 
Page 700


SIGA TECHNOLOGIES, INC.  
Page 22 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9061 
PREDOSE 
16OCT2019/07:58 
. 
BLQ 
 
 
 
0.5 
16OCT2019/08:35 
2.00 
5.77 
 
 
 
1 
16OCT2019/09:10 
7.00 
288 
 
 
 
2 
16OCT2019/10:06 
3.00 
940 
 
 
 
4 
16OCT2019/12:03 
0.00 
965 
 
 
 
6 
16OCT2019/14:08 
5.00 
440 
 
 
 
8 
16OCT2019/16:35 
32.00 
311 
 
 
 
12 
16OCT2019/19:58 
-5.00 
325 
 
 
 
14 
16OCT2019/22:03 
0.00 
745 
 
 
 
16 
17OCT2019/00:04 
1.00 
833 
 
 
 
24 
17OCT2019/07:59 
-4.00 
448 
 
Page 701


SIGA TECHNOLOGIES, INC.  
Page 23 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9062 
PREDOSE 
02OCT2019/08:01 
. 
BLQ 
 
 
 
0.5 
02OCT2019/08:36 
0.00 
14.3 
 
 
 
1 
02OCT2019/09:06 
0.00 
127 
 
 
 
2 
02OCT2019/10:06 
0.00 
609 
 
 
 
4 
02OCT2019/12:06 
0.00 
583 
 
 
 
6 
02OCT2019/14:06 
0.00 
368 
 
 
 
8 
02OCT2019/16:06 
0.00 
232 
 
 
 
12 
02OCT2019/20:01 
-5.00 
157 
 
 
 
14 
02OCT2019/22:06 
0.00 
245 
 
 
 
16 
03OCT2019/00:06 
0.00 
467 
 
 
 
18 
03OCT2019/02:06 
0.00 
407 
 
 
 
20 
03OCT2019/04:06 
0.00 
441 
 
 
 
24 
03OCT2019/08:01 
-5.00 
370 
 
Page 702


SIGA TECHNOLOGIES, INC.  
Page 24 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9063 
PREDOSE 
02OCT2019/08:04 
. 
BLQ 
 
 
 
0.5 
02OCT2019/08:39 
0.00 
10.2 
 
 
 
1 
02OCT2019/09:09 
0.00 
41.2 
 
 
 
2 
02OCT2019/10:10 
1.00 
455 
 
 
 
4 
02OCT2019/12:09 
0.00 
762 
 
 
 
6 
02OCT2019/14:09 
0.00 
571 
 
 
 
8 
02OCT2019/16:09 
0.00 
382 
 
 
 
12 
02OCT2019/20:04 
-5.00 
170 
 
 
 
14 
02OCT2019/22:09 
0.00 
200 
 
 
 
16 
03OCT2019/00:09 
0.00 
653 
 
 
 
18 
03OCT2019/02:09 
0.00 
674 
 
 
 
20 
03OCT2019/04:09 
0.00 
761 
 
 
 
24 
03OCT2019/08:04 
-5.00 
469 
 
Page 703


SIGA TECHNOLOGIES, INC.  
Page 25 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9069 
PREDOSE 
16OCT2019/08:01 
. 
BLQ 
 
 
 
0.5 
16OCT2019/08:54 
18.00 
73.2 
 
 
 
1 
16OCT2019/09:06 
0.00 
102 
 
 
 
2 
16OCT2019/10:06 
0.00 
537 
 
 
 
4 
16OCT2019/12:12 
6.00 
957 
 
 
 
6 
16OCT2019/14:06 
0.00 
402 
 
 
 
8 
16OCT2019/16:06 
0.00 
331 
 
 
 
12 
16OCT2019/20:17 
11.00 
283 
 
 
 
14 
16OCT2019/22:22 
16.00 
629 
 
 
 
16 
17OCT2019/00:23 
17.00 
933 
 
 
 
18 
17OCT2019/02:22 
16.00 
831 
 
 
 
20 
17OCT2019/04:22 
16.00 
592 
 
 
 
24 
17OCT2019/08:01 
-5.00 
407 
 
Page 704


SIGA TECHNOLOGIES, INC.  
Page 26 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9073 
PREDOSE 
16OCT2019/08:13 
. 
BLQ 
 
 
 
0.5 
16OCT2019/08:51 
5.00 
11.1 
 
 
 
1 
16OCT2019/09:16 
0.00 
127 
 
 
 
2 
16OCT2019/10:19 
3.00 
702 
 
 
 
4 
16OCT2019/12:16 
0.00 
630 
 
 
 
6 
16OCT2019/14:22 
6.00 
237 
 
 
 
8 
16OCT2019/16:18 
2.00 
225 
 
 
 
12 
16OCT2019/20:14 
-2.00 
164 
 
 
 
14 
16OCT2019/22:16 
0.00 
208 
 
 
 
16 
17OCT2019/00:21 
5.00 
504 
 
 
 
18 
17OCT2019/02:27 
11.00 
540 
 
 
 
20 
17OCT2019/04:20 
4.00 
452 
 
 
 
24 
17OCT2019/08:11 
-5.00 
294 
 
Page 705


SIGA TECHNOLOGIES, INC.  
Page 27 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9077 
PREDOSE 
16OCT2019/08:07 
. 
BLQ 
 
 
 
0.5 
16OCT2019/08:42 
0.00 
BLQ 
 
 
 
1 
16OCT2019/09:12 
0.00 
15.2 
 
 
 
2 
16OCT2019/10:12 
0.00 
586 
 
 
 
4 
16OCT2019/12:12 
0.00 
1310 
 
 
 
6 
16OCT2019/14:12 
0.00 
810 
 
 
 
8 
16OCT2019/16:12 
0.00 
436 
 
 
 
12 
16OCT2019/20:07 
-5.00 
343 
 
 
 
14 
16OCT2019/22:12 
0.00 
694 
 
 
 
16 
17OCT2019/00:12 
0.00 
1220 
 
 
 
18 
17OCT2019/02:12 
0.00 
1060 
 
 
 
20 
17OCT2019/04:12 
0.00 
1100 
 
 
 
24 
17OCT2019/08:07 
-5.00 
1170 
 
Page 706


SIGA TECHNOLOGIES, INC.  
Page 28 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9080 
PREDOSE 
16OCT2019/08:19 
. 
BLQ 
 
 
 
0.5 
16OCT2019/08:51 
0.00 
5.31 
 
 
 
1 
16OCT2019/09:21 
0.00 
75.1 
 
 
 
2 
16OCT2019/10:21 
0.00 
454 
 
 
 
4 
16OCT2019/12:21 
0.00 
1130 
 
 
 
6 
16OCT2019/14:21 
0.00 
771 
 
 
 
8 
16OCT2019/16:21 
0.00 
494 
 
 
 
12 
16OCT2019/20:20 
-1.00 
407 
 
 
 
14 
16OCT2019/22:21 
0.00 
269 
 
 
 
16 
17OCT2019/00:22 
1.00 
382 
 
 
 
18 
17OCT2019/02:23 
2.00 
538 
 
 
 
20 
17OCT2019/04:21 
0.00 
771 
 
 
 
24 
17OCT2019/08:17 
-4.00 
584 
 
Page 707


SIGA TECHNOLOGIES, INC.  
Page 29 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9081 
PREDOSE 
30OCT2019/07:57 
. 
BLQ 
 
 
 
0.5 
30OCT2019/08:30 
0.00 
31.4 
 
 
 
1 
30OCT2019/09:00 
0.00 
105 
 
 
 
2 
30OCT2019/10:00 
0.00 
628 
 
 
 
4 
30OCT2019/12:05 
5.00 
527 
 
 
 
6 
30OCT2019/14:00 
0.00 
361 
 
 
 
8 
30OCT2019/16:00 
0.00 
223 
 
 
 
12 
30OCT2019/19:55 
-5.00 
152 
 
 
 
14 
30OCT2019/22:00 
0.00 
258 
 
 
 
16 
31OCT2019/00:00 
0.00 
471 
 
 
 
18 
31OCT2019/02:00 
0.00 
473 
 
 
 
20 
31OCT2019/04:00 
0.00 
496 
 
 
 
24 
31OCT2019/07:55 
-5.00 
340 
 
Page 708


SIGA TECHNOLOGIES, INC.  
Page 30 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9086 
PREDOSE 
16OCT2019/08:10 
. 
BLQ 
 
 
 
0.5 
16OCT2019/08:45 
0.00 
BLQ 
 
 
 
1 
16OCT2019/09:15 
0.00 
21.9 
 
 
 
2 
16OCT2019/10:15 
0.00 
215 
 
 
 
4 
16OCT2019/12:15 
0.00 
634 
 
 
 
6 
16OCT2019/14:15 
0.00 
324 
 
 
 
8 
16OCT2019/16:15 
0.00 
154 
 
 
 
12 
16OCT2019/20:12 
-3.00 
121 
 
 
 
14 
16OCT2019/22:15 
0.00 
148 
 
 
 
16 
17OCT2019/00:15 
0.00 
240 
 
 
 
18 
17OCT2019/02:12 
-3.00 
382 
 
 
 
20 
17OCT2019/04:15 
0.00 
395 
 
 
 
24 
17OCT2019/08:10 
-5.00 
215 
 
Page 709


SIGA TECHNOLOGIES, INC.  
Page 31 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9087 
PREDOSE 
16OCT2019/08:15 
. 
BLQ 
 
 
 
0.5 
16OCT2019/08:48 
0.00 
BLQ 
 
 
 
1 
16OCT2019/09:18 
0.00 
23.4 
 
 
 
2 
16OCT2019/10:18 
0.00 
304 
 
 
 
4 
16OCT2019/12:18 
0.00 
1160 
 
 
 
6 
16OCT2019/14:18 
0.00 
557 
 
 
 
8 
16OCT2019/16:18 
0.00 
296 
 
 
 
12 
16OCT2019/20:13 
-5.00 
177 
 
 
 
14 
16OCT2019/22:18 
0.00 
173 
 
 
 
16 
17OCT2019/00:21 
3.00 
478 
 
 
 
18 
17OCT2019/02:29 
11.00 
867 
 
 
 
20 
17OCT2019/04:19 
1.00 
704 
 
 
 
24 
17OCT2019/08:13 
-5.00 
436 
 
Page 710


SIGA TECHNOLOGIES, INC.  
Page 32 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9089 
PREDOSE 
16OCT2019/08:19 
. 
BLQ 
 
 
 
0.5 
16OCT2019/08:54 
0.00 
BLQ 
 
 
 
1 
16OCT2019/09:24 
0.00 
65.9 
 
 
 
2 
16OCT2019/10:24 
0.00 
237 
 
 
 
4 
16OCT2019/12:24 
0.00 
802 
 
 
 
6 
16OCT2019/14:24 
0.00 
649 
 
 
 
8 
16OCT2019/16:24 
0.00 
407 
 
 
 
12 
16OCT2019/20:19 
-5.00 
241 
 
 
 
14 
16OCT2019/22:24 
0.00 
252 
 
 
 
16 
17OCT2019/00:24 
0.00 
513 
 
 
 
18 
17OCT2019/02:24 
0.00 
638 
 
 
 
20 
17OCT2019/04:24 
0.00 
698 
 
 
 
24 
17OCT2019/08:19 
-5.00 
457 
 
Page 711


SIGA TECHNOLOGIES, INC.  
Page 33 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9092 
PREDOSE 
16OCT2019/08:22 
. 
BLQ 
 
 
 
0.5 
16OCT2019/08:57 
0.00 
26.8 
 
 
 
1 
16OCT2019/09:27 
0.00 
196 
 
 
 
2 
16OCT2019/10:27 
0.00 
596 
 
 
 
4 
16OCT2019/12:27 
0.00 
521 
 
 
 
6 
16OCT2019/14:27 
0.00 
439 
 
 
 
8 
16OCT2019/16:28 
1.00 
217 
 
 
 
12 
16OCT2019/20:22 
-5.00 
160 
 
 
 
14 
16OCT2019/22:27 
0.00 
300 
 
 
 
16 
17OCT2019/00:27 
0.00 
442 
 
 
 
18 
17OCT2019/02:27 
0.00 
427 
 
 
 
20 
17OCT2019/04:27 
0.00 
484 
 
 
 
24 
17OCT2019/08:22 
-5.00 
370 
 
Page 712


SIGA TECHNOLOGIES, INC.  
Page 34 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
1 
9095 
PREDOSE 
30OCT2019/08:01 
. 
BLQ 
 
 
 
0.5 
30OCT2019/08:36 
0.00 
BLQ 
 
 
 
1 
30OCT2019/09:06 
0.00 
13.3 
 
 
 
2 
30OCT2019/10:06 
0.00 
178 
 
 
 
4 
30OCT2019/12:06 
0.00 
697 
 
 
 
6 
30OCT2019/14:06 
0.00 
612 
 
 
 
8 
30OCT2019/16:06 
0.00 
396 
 
 
 
12 
30OCT2019/20:01 
-5.00 
331 
 
 
 
14 
30OCT2019/22:06 
0.00 
266 
 
 
 
16 
31OCT2019/00:06 
0.00 
554 
 
 
 
18 
31OCT2019/02:06 
0.00 
549 
 
 
 
20 
31OCT2019/04:06 
0.00 
582 
 
 
 
24 
31OCT2019/08:01 
-5.00 
810 
 
Page 713


SIGA TECHNOLOGIES, INC.  
Page 35 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9001 
PREDOSE 
19AUG2019/09:20 
. 
630 
 
 
 
4 
19AUG2019/13:25 
0.00 
1580 
 
Page 714


SIGA TECHNOLOGIES, INC.  
Page 36 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9002 
PREDOSE 
19AUG2019/09:30 
. 
537 
 
 
 
4 
19AUG2019/13:31 
0.00 
1180 
 
Page 715


SIGA TECHNOLOGIES, INC.  
Page 37 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9005 
PREDOSE 
19AUG2019/08:57 
. 
827 
 
 
 
4 
19AUG2019/13:03 
1.00 
1800 
 
Page 716


SIGA TECHNOLOGIES, INC.  
Page 38 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9009 
PREDOSE 
19AUG2019/09:01 
. 
750 
 
 
 
4 
19AUG2019/13:06 
0.00 
1620 
 
Page 717


SIGA TECHNOLOGIES, INC.  
Page 39 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9012 
PREDOSE 
19AUG2019/09:05 
. 
815 
 
 
 
4 
19AUG2019/13:10 
0.00 
982 
 
Page 718


SIGA TECHNOLOGIES, INC.  
Page 40 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9015 
PREDOSE 
19AUG2019/09:03 
. 
563 
 
 
 
4 
19AUG2019/13:08 
0.00 
1320 
 
Page 719


SIGA TECHNOLOGIES, INC.  
Page 41 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9016 
PREDOSE 
09SEP2019/07:55 
. 
831 
 
 
 
4 
09SEP2019/12:00 
0.00 
1700 
 
Page 720


SIGA TECHNOLOGIES, INC.  
Page 42 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9019 
PREDOSE 
09SEP2019/08:01 
. 
555 
 
 
 
4 
09SEP2019/12:03 
0.00 
1210 
 
Page 721


SIGA TECHNOLOGIES, INC.  
Page 43 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9020 
PREDOSE 
09SEP2019/08:01 
. 
550 
 
 
 
4 
09SEP2019/12:06 
0.00 
1090 
 
Page 722


SIGA TECHNOLOGIES, INC.  
Page 44 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9021 
PREDOSE 
09SEP2019/08:04 
. 
434 
 
 
 
4 
09SEP2019/12:09 
0.00 
1330 
 
Page 723


SIGA TECHNOLOGIES, INC.  
Page 45 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9022 
PREDOSE 
09SEP2019/08:07 
. 
511 
 
 
 
4 
09SEP2019/12:12 
0.00 
1150 
 
Page 724


SIGA TECHNOLOGIES, INC.  
Page 46 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9024 
PREDOSE 
09SEP2019/08:10 
. 
921 
 
 
 
4 
09SEP2019/12:15 
0.00 
1940 
 
Page 725


SIGA TECHNOLOGIES, INC.  
Page 47 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9025 
PREDOSE 
23SEP2019/07:55 
. 
1200 
 
 
 
4 
23SEP2019/12:00 
0.00 
1440 
 
Page 726


SIGA TECHNOLOGIES, INC.  
Page 48 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9033 
PREDOSE 
09SEP2019/08:13 
. 
356 
 
 
 
4 
09SEP2019/12:18 
0.00 
1590 
 
Page 727


SIGA TECHNOLOGIES, INC.  
Page 49 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9043 
PREDOSE 
23SEP2019/07:58 
. 
958 
 
 
 
4 
23SEP2019/12:03 
0.00 
1100 
 
Page 728


SIGA TECHNOLOGIES, INC.  
Page 50 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9046 
PREDOSE 
23SEP2019/08:01 
. 
702 
 
 
 
4 
23SEP2019/12:06 
0.00 
1440 
 
Page 729


SIGA TECHNOLOGIES, INC.  
Page 51 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9051 
PREDOSE 
07OCT2019/08:10 
. 
241 
 
 
 
4 
07OCT2019/12:15 
0.00 
816 
 
Page 730


SIGA TECHNOLOGIES, INC.  
Page 52 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9052 
PREDOSE 
07OCT2019/08:14 
. 
632 
 
 
 
4 
07OCT2019/12:19 
0.00 
1470 
 
Page 731


SIGA TECHNOLOGIES, INC.  
Page 53 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9056 
PREDOSE 
07OCT2019/07:55 
. 
738 
 
 
 
4 
07OCT2019/12:00 
0.00 
1140 
 
Page 732


SIGA TECHNOLOGIES, INC.  
Page 54 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9057 
PREDOSE 
07OCT2019/07:58 
. 
618 
 
 
 
4 
07OCT2019/12:03 
0.00 
940 
 
Page 733


SIGA TECHNOLOGIES, INC.  
Page 55 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9058 
PREDOSE 
21OCT2019/08:02 
. 
573 
 
 
 
4 
21OCT2019/12:07 
0.00 
1400 
 
Page 734


SIGA TECHNOLOGIES, INC.  
Page 56 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9061 
PREDOSE 
21OCT2019/07:59 
. 
415 
 
 
 
4 
21OCT2019/12:03 
0.00 
1020 
 
Page 735


SIGA TECHNOLOGIES, INC.  
Page 57 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9062 
PREDOSE 
07OCT2019/08:01 
. 
438 
 
 
 
4 
07OCT2019/12:06 
0.00 
997 
 
Page 736


SIGA TECHNOLOGIES, INC.  
Page 58 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9063 
PREDOSE 
07OCT2019/08:04 
. 
532 
 
 
 
4 
07OCT2019/12:09 
0.00 
1800 
 
Page 737


SIGA TECHNOLOGIES, INC.  
Page 59 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9069 
PREDOSE 
21OCT2019/08:01 
. 
634 
 
 
 
4 
21OCT2019/12:06 
0.00 
1220 
 
Page 738


SIGA TECHNOLOGIES, INC.  
Page 60 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9073 
PREDOSE 
21OCT2019/08:11 
. 
599 
 
 
 
4 
21OCT2019/12:20 
4.00 
1290 
 
Page 739


SIGA TECHNOLOGIES, INC.  
Page 61 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9077 
PREDOSE 
21OCT2019/08:07 
. 
1010 
 
 
 
4 
21OCT2019/12:12 
0.00 
2000 
 
Page 740


SIGA TECHNOLOGIES, INC.  
Page 62 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9080 
PREDOSE 
21OCT2019/08:16 
. 
724 
 
 
 
4 
21OCT2019/12:23 
2.00 
1360 
 
Page 741


SIGA TECHNOLOGIES, INC.  
Page 63 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9081 
PREDOSE 
04NOV2019/06:55 
. 
471 
 
 
 
4 
04NOV2019/11:00 
0.00 
982 
 
Page 742


SIGA TECHNOLOGIES, INC.  
Page 64 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9086 
PREDOSE 
21OCT2019/08:15 
. 
227 
 
 
 
4 
21OCT2019/12:18 
0.00 
633 
 
Page 743


SIGA TECHNOLOGIES, INC.  
Page 65 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9087 
PREDOSE 
21OCT2019/08:13 
. 
474 
 
 
 
4 
21OCT2019/12:18 
0.00 
744 
 
Page 744


SIGA TECHNOLOGIES, INC.  
Page 66 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9089 
PREDOSE 
21OCT2019/08:19 
. 
468 
 
 
 
4 
21OCT2019/12:24 
0.00 
941 
 
Page 745


SIGA TECHNOLOGIES, INC.  
Page 67 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9092 
PREDOSE 
21OCT2019/08:22 
. 
442 
 
 
 
4 
21OCT2019/12:27 
0.00 
1200 
 
Page 746


SIGA TECHNOLOGIES, INC.  
Page 68 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
6 
9095 
PREDOSE 
04NOV2019/07:01 
. 
717 
 
 
 
4 
04NOV2019/11:06 
0.00 
1040 
 
Page 747


SIGA TECHNOLOGIES, INC.  
Page 69 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9001 
PREDOSE 
20AUG2019/09:20 
. 
555 
 
 
 
0.5 
20AUG2019/09:55 
0.00 
387 
 
 
 
1 
20AUG2019/10:25 
0.00 
345 
 
 
 
2 
20AUG2019/11:25 
0.00 
603 
 
 
 
4 
20AUG2019/13:25 
0.00 
1600 
 
 
 
6 
20AUG2019/15:25 
0.00 
1270 
 
 
 
8 
20AUG2019/17:25 
0.00 
691 
 
 
 
12 
20AUG2019/21:20 
-5.00 
481 
 
 
 
14 
20AUG2019/23:25 
0.00 
568 
 
 
 
16 
21AUG2019/01:25 
0.00 
1020 
 
 
 
18 
21AUG2019/03:29 
4.00 
1070 
 
 
 
20 
21AUG2019/05:25 
0.00 
717 
 
 
 
24 
21AUG2019/09:25 
0.00 
488 
 
 
 
48 
22AUG2019/09:25 
0.00 
121 
 
Page 748


SIGA TECHNOLOGIES, INC.  
Page 70 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9002 
PREDOSE 
20AUG2019/09:25 
. 
533 
 
 
 
0.5 
20AUG2019/09:57 
0.00 
429 
 
 
 
1 
20AUG2019/10:27 
0.00 
410 
 
 
 
2 
20AUG2019/11:36 
9.00 
907 
 
 
 
4 
20AUG2019/13:27 
0.00 
1290 
 
 
 
6 
20AUG2019/15:35 
8.00 
839 
 
 
 
8 
20AUG2019/17:57 
30.00 
509 
 
 
 
12 
20AUG2019/21:19 
-8.00 
567 
 
 
 
14 
20AUG2019/23:24 
-3.00 
854 
 
 
 
16 
21AUG2019/01:24 
-3.00 
1140 
 
 
 
18 
21AUG2019/03:24 
-3.00 
934 
 
 
 
20 
21AUG2019/05:24 
-3.00 
862 
 
 
 
24 
21AUG2019/09:24 
-3.00 
624 
 
 
 
48 
22AUG2019/09:27 
0.00 
203 
 
Page 749


SIGA TECHNOLOGIES, INC.  
Page 71 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9005 
PREDOSE 
20AUG2019/08:57 
. 
719 
 
 
 
0.5 
20AUG2019/09:32 
0.00 
655 
 
 
 
1 
20AUG2019/10:02 
0.00 
572 
 
 
 
2 
20AUG2019/11:02 
0.00 
1410 
 
 
 
4 
20AUG2019/13:02 
0.00 
2270 
 
 
 
6 
20AUG2019/15:02 
0.00 
1170 
 
 
 
8 
20AUG2019/17:02 
0.00 
748 
 
 
 
12 
20AUG2019/21:01 
-1.00 
607 
 
 
 
14 
20AUG2019/23:02 
0.00 
1270 
 
 
 
16 
21AUG2019/01:02 
0.00 
1660 
 
 
 
18 
21AUG2019/03:02 
0.00 
1490 
 
 
 
20 
21AUG2019/05:02 
0.00 
997 
 
 
 
24 
21AUG2019/09:02 
0.00 
810 
 
 
 
48 
22AUG2019/09:02 
0.00 
314 
 
Page 750


SIGA TECHNOLOGIES, INC.  
Page 72 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9009 
PREDOSE 
20AUG2019/09:04 
. 
650 
 
 
 
0.5 
20AUG2019/09:36 
0.00 
516 
 
 
 
1 
20AUG2019/10:06 
0.00 
471 
 
 
 
2 
20AUG2019/11:06 
0.00 
630 
 
 
 
4 
20AUG2019/13:06 
0.00 
1190 
 
 
 
6 
20AUG2019/15:06 
0.00 
1030 
 
 
 
8 
20AUG2019/17:06 
0.00 
860 
 
 
 
12 
20AUG2019/21:01 
-5.00 
922 
 
 
 
14 
20AUG2019/23:07 
1.00 
962 
 
 
 
16 
21AUG2019/01:06 
0.00 
1260 
 
 
 
18 
21AUG2019/03:06 
0.00 
1350 
 
 
 
20 
21AUG2019/05:06 
0.00 
1070 
 
 
 
24 
21AUG2019/09:06 
0.00 
849 
 
 
 
48 
22AUG2019/09:07 
1.00 
273 
 
Page 751


SIGA TECHNOLOGIES, INC.  
Page 73 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9012 
PREDOSE 
20AUG2019/09:05 
. 
490 
 
 
 
0.5 
20AUG2019/09:40 
0.00 
435 
 
 
 
1 
20AUG2019/10:10 
0.00 
354 
 
 
 
2 
20AUG2019/11:10 
0.00 
334 
 
 
 
4 
20AUG2019/13:10 
0.00 
810 
 
 
 
6 
20AUG2019/15:10 
0.00 
1060 
 
 
 
8 
20AUG2019/17:10 
0.00 
662 
 
 
 
12 
20AUG2019/21:05 
-5.00 
424 
 
 
 
14 
20AUG2019/23:10 
0.00 
481 
 
 
 
16 
21AUG2019/01:10 
0.00 
675 
 
 
 
18 
21AUG2019/03:10 
0.00 
979 
 
 
 
20 
21AUG2019/05:10 
0.00 
1180 
 
 
 
24 
21AUG2019/09:10 
0.00 
603 
 
 
 
48 
22AUG2019/09:13 
3.00 
131 
 
Page 752


SIGA TECHNOLOGIES, INC.  
Page 74 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9015 
PREDOSE 
20AUG2019/09:03 
. 
727 
 
 
 
0.5 
20AUG2019/09:38 
0.00 
612 
 
 
 
1 
20AUG2019/10:08 
0.00 
524 
 
 
 
2 
20AUG2019/11:08 
0.00 
618 
 
 
 
4 
20AUG2019/13:08 
0.00 
878 
 
 
 
6 
20AUG2019/15:10 
2.00 
858 
 
 
 
8 
20AUG2019/17:08 
0.00 
612 
 
 
 
12 
20AUG2019/21:03 
-5.00 
305 
 
 
 
14 
20AUG2019/23:08 
0.00 
632 
 
 
 
16 
21AUG2019/01:08 
0.00 
746 
 
 
 
18 
21AUG2019/03:08 
0.00 
865 
 
 
 
20 
21AUG2019/05:08 
0.00 
742 
 
 
 
24 
21AUG2019/09:08 
0.00 
471 
 
 
 
48 
22AUG2019/09:10 
2.00 
107 
 
Page 753


SIGA TECHNOLOGIES, INC.  
Page 75 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9016 
PREDOSE 
10SEP2019/07:55 
. 
773 
 
 
 
0.5 
10SEP2019/08:30 
0.00 
569 
 
 
 
1 
10SEP2019/09:00 
0.00 
621 
 
 
 
2 
10SEP2019/10:00 
0.00 
870 
 
 
 
4 
10SEP2019/12:00 
0.00 
1750 
 
 
 
6 
10SEP2019/14:00 
0.00 
1430 
 
 
 
8 
10SEP2019/16:00 
0.00 
913 
 
 
 
12 
10SEP2019/19:55 
-5.00 
811 
 
 
 
14 
10SEP2019/22:00 
0.00 
739 
 
 
 
16 
11SEP2019/00:00 
0.00 
1090 
 
 
 
18 
11SEP2019/02:00 
0.00 
992 
 
 
 
20 
11SEP2019/04:00 
0.00 
1180 
 
 
 
24 
11SEP2019/08:00 
0.00 
1020 
 
 
 
48 
12SEP2019/08:05 
5.00 
205 
 
Page 754


SIGA TECHNOLOGIES, INC.  
Page 76 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9019 
PREDOSE 
10SEP2019/08:00 
. 
526 
 
 
 
0.5 
10SEP2019/08:33 
0.00 
465 
 
 
 
1 
10SEP2019/09:03 
0.00 
406 
 
 
 
2 
10SEP2019/10:03 
0.00 
617 
 
 
 
4 
10SEP2019/12:03 
0.00 
950 
 
 
 
6 
10SEP2019/14:03 
0.00 
1130 
 
 
 
8 
10SEP2019/16:03 
0.00 
846 
 
 
 
12 
10SEP2019/19:58 
-5.00 
557 
 
 
 
14 
10SEP2019/22:03 
0.00 
650 
 
 
 
16 
11SEP2019/00:03 
0.00 
992 
 
 
 
18 
11SEP2019/02:03 
0.00 
1020 
 
 
 
20 
11SEP2019/04:04 
1.00 
920 
 
 
 
24 
11SEP2019/08:03 
0.00 
574 
 
 
 
48 
12SEP2019/08:08 
5.00 
130 
 
Page 755


SIGA TECHNOLOGIES, INC.  
Page 77 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9020 
PREDOSE 
10SEP2019/08:01 
. 
506 
 
 
 
0.5 
10SEP2019/08:36 
0.00 
506 
 
 
 
1 
10SEP2019/09:06 
0.00 
450 
 
 
 
2 
10SEP2019/10:06 
0.00 
498 
 
 
 
4 
10SEP2019/12:06 
0.00 
1060 
 
 
 
6 
10SEP2019/14:08 
2.00 
1110 
 
 
 
8 
10SEP2019/16:06 
0.00 
678 
 
 
 
12 
10SEP2019/20:01 
-5.00 
627 
 
 
 
14 
10SEP2019/22:06 
0.00 
610 
 
 
 
16 
11SEP2019/00:12 
6.00 
920 
 
 
 
18 
11SEP2019/02:06 
0.00 
1010 
 
 
 
20 
11SEP2019/04:06 
0.00 
886 
 
 
 
24 
11SEP2019/08:06 
0.00 
601 
 
 
 
48 
12SEP2019/08:13 
7.00 
245 
 
Page 756


SIGA TECHNOLOGIES, INC.  
Page 78 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9021 
PREDOSE 
10SEP2019/08:04 
. 
247 
 
 
 
0.5 
10SEP2019/08:39 
0.00 
192 
 
 
 
1 
10SEP2019/09:09 
0.00 
157 
 
 
 
2 
10SEP2019/10:09 
0.00 
451 
 
 
 
4 
10SEP2019/12:09 
0.00 
1050 
 
 
 
6 
10SEP2019/14:09 
0.00 
459 
 
 
 
8 
10SEP2019/16:09 
0.00 
288 
 
 
 
12 
10SEP2019/20:04 
-5.00 
527 
 
 
 
14 
10SEP2019/22:09 
0.00 
638 
 
 
 
16 
11SEP2019/00:16 
7.00 
663 
 
 
 
18 
11SEP2019/02:09 
0.00 
670 
 
 
 
20 
11SEP2019/04:09 
0.00 
532 
 
 
 
24 
11SEP2019/08:09 
0.00 
307 
 
 
 
48 
12SEP2019/08:09 
0.00 
58.0 
 
Page 757


SIGA TECHNOLOGIES, INC.  
Page 79 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9022 
PREDOSE 
10SEP2019/08:07 
. 
669 
 
 
 
0.5 
10SEP2019/08:42 
0.00 
582 
 
 
 
1 
10SEP2019/09:12 
0.00 
581 
 
 
 
2 
10SEP2019/10:12 
0.00 
920 
 
 
 
4 
10SEP2019/12:12 
0.00 
1170 
 
 
 
6 
10SEP2019/14:12 
0.00 
1200 
 
 
 
8 
10SEP2019/16:12 
0.00 
727 
 
 
 
12 
10SEP2019/20:07 
-5.00 
577 
 
 
 
14 
10SEP2019/22:12 
0.00 
839 
 
 
 
16 
11SEP2019/00:12 
0.00 
1350 
 
 
 
18 
11SEP2019/02:12 
0.00 
1300 
 
 
 
20 
11SEP2019/04:12 
0.00 
931 
 
 
 
24 
11SEP2019/08:12 
0.00 
582 
 
 
 
48 
12SEP2019/08:12 
0.00 
148 
 
Page 758


SIGA TECHNOLOGIES, INC.  
Page 80 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9024 
PREDOSE 
10SEP2019/08:10 
. 
862 
 
 
 
0.5 
10SEP2019/08:45 
0.00 
711 
 
 
 
1 
10SEP2019/09:15 
0.00 
621 
 
 
 
2 
10SEP2019/10:15 
0.00 
774 
 
 
 
4 
10SEP2019/12:15 
0.00 
1860 
 
 
 
6 
10SEP2019/14:15 
0.00 
1440 
 
 
 
8 
10SEP2019/16:15 
0.00 
902 
 
 
 
12 
10SEP2019/20:10 
-5.00 
733 
 
 
 
14 
10SEP2019/22:15 
0.00 
1090 
 
 
 
16 
11SEP2019/00:15 
0.00 
1300 
 
 
 
18 
11SEP2019/02:15 
0.00 
1430 
 
 
 
20 
11SEP2019/04:15 
0.00 
1300 
 
 
 
24 
11SEP2019/08:15 
0.00 
804 
 
 
 
48 
12SEP2019/08:15 
0.00 
271 
 
Page 759


SIGA TECHNOLOGIES, INC.  
Page 81 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9025 
PREDOSE 
24SEP2019/07:55 
. 
1090 
 
 
 
0.5 
24SEP2019/08:30 
0.00 
978 
 
 
 
1 
24SEP2019/09:02 
2.00 
728 
 
 
 
2 
24SEP2019/10:01 
1.00 
884 
 
 
 
4 
24SEP2019/12:00 
0.00 
1200 
 
 
 
6 
24SEP2019/14:00 
0.00 
1480 
 
 
 
8 
24SEP2019/16:00 
0.00 
1210 
 
 
 
12 
24SEP2019/19:57 
-3.00 
760 
 
 
 
14 
24SEP2019/22:00 
0.00 
1060 
 
 
 
16 
25SEP2019/00:00 
0.00 
1510 
 
 
 
18 
25SEP2019/02:01 
1.00 
1300 
 
 
 
20 
25SEP2019/04:00 
0.00 
1170 
 
 
 
24 
25SEP2019/08:00 
0.00 
815 
 
 
 
48 
26SEP2019/08:00 
0.00 
236 
 
Page 760


SIGA TECHNOLOGIES, INC.  
Page 82 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9033 
PREDOSE 
10SEP2019/08:13 
. 
365 
 
 
 
0.5 
10SEP2019/08:50 
2.00 
283 
 
 
 
1 
10SEP2019/09:18 
0.00 
402 
 
 
 
2 
10SEP2019/10:18 
0.00 
701 
 
 
 
4 
10SEP2019/12:19 
1.00 
1160 
 
 
 
6 
10SEP2019/14:18 
0.00 
845 
 
 
 
8 
10SEP2019/16:18 
0.00 
535 
 
 
 
12 
10SEP2019/20:13 
-5.00 
463 
 
 
 
14 
10SEP2019/22:18 
0.00 
1020 
 
 
 
16 
11SEP2019/00:19 
1.00 
916 
 
 
 
18 
11SEP2019/02:18 
0.00 
844 
 
 
 
20 
11SEP2019/04:18 
0.00 
612 
 
 
 
24 
11SEP2019/08:18 
0.00 
411 
 
 
 
48 
12SEP2019/08:18 
0.00 
117 
 
Page 761


SIGA TECHNOLOGIES, INC.  
Page 83 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9043 
PREDOSE 
24SEP2019/07:59 
. 
840 
 
 
 
0.5 
24SEP2019/08:34 
1.00 
451 
 
 
 
1 
24SEP2019/09:03 
0.00 
442 
 
 
 
2 
24SEP2019/10:03 
0.00 
1050 
 
 
 
4 
24SEP2019/12:03 
0.00 
1640 
 
 
 
6 
24SEP2019/14:03 
0.00 
1020 
 
 
 
8 
24SEP2019/16:18 
15.00 
543 
 
 
 
12 
24SEP2019/19:58 
-5.00 
501 
 
 
 
14 
24SEP2019/22:03 
0.00 
468 
 
 
 
16 
25SEP2019/00:06 
3.00 
1120 
 
 
 
18 
25SEP2019/02:08 
5.00 
960 
 
 
 
20 
25SEP2019/04:05 
2.00 
859 
 
 
 
24 
25SEP2019/08:05 
2.00 
570 
 
 
 
48 
26SEP2019/08:11 
8.00 
237 
 
Page 762


SIGA TECHNOLOGIES, INC.  
Page 84 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9046 
PREDOSE 
24SEP2019/08:01 
. 
909 
 
 
 
0.5 
24SEP2019/08:37 
1.00 
694 
 
 
 
1 
24SEP2019/09:08 
2.00 
629 
 
 
 
2 
24SEP2019/10:06 
0.00 
721 
 
 
 
4 
24SEP2019/12:09 
3.00 
1350 
 
 
 
6 
24SEP2019/14:07 
1.00 
833 
 
 
 
8 
24SEP2019/16:06 
0.00 
567 
 
 
 
12 
24SEP2019/20:01 
-5.00 
523 
 
 
 
14 
24SEP2019/22:06 
0.00 
1330 
 
 
 
16 
25SEP2019/00:09 
3.00 
1470 
 
 
 
18 
25SEP2019/02:06 
0.00 
1170 
 
 
 
20 
25SEP2019/04:07 
1.00 
1070 
 
 
 
24 
25SEP2019/08:06 
0.00 
802 
 
 
 
48 
26SEP2019/08:06 
0.00 
264 
 
Page 763


SIGA TECHNOLOGIES, INC.  
Page 85 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9051 
PREDOSE 
08OCT2019/08:10 
. 
282 
 
 
 
0.5 
08OCT2019/08:45 
0.00 
239 
 
 
 
1 
08OCT2019/09:15 
0.00 
449 
 
 
 
2 
08OCT2019/10:15 
0.00 
937 
 
 
 
4 
08OCT2019/12:15 
0.00 
1020 
 
 
 
6 
08OCT2019/14:15 
0.00 
513 
 
 
 
8 
08OCT2019/16:15 
0.00 
285 
 
 
 
12 
08OCT2019/20:10 
-5.00 
352 
 
 
 
14 
08OCT2019/22:15 
0.00 
512 
 
 
 
16 
09OCT2019/00:15 
0.00 
641 
 
 
 
18 
09OCT2019/02:15 
0.00 
539 
 
 
 
20 
09OCT2019/04:15 
0.00 
322 
 
 
 
24 
09OCT2019/08:15 
0.00 
284 
 
 
 
48 
10OCT2019/08:15 
0.00 
27.9 
 
Page 764


SIGA TECHNOLOGIES, INC.  
Page 86 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9052 
PREDOSE 
08OCT2019/08:14 
. 
575 
 
 
 
0.5 
08OCT2019/08:49 
0.00 
440 
 
 
 
1 
08OCT2019/09:19 
0.00 
450 
 
 
 
2 
08OCT2019/10:19 
0.00 
745 
 
 
 
4 
08OCT2019/12:19 
0.00 
1930 
 
 
 
6 
08OCT2019/14:19 
0.00 
1160 
 
 
 
8 
08OCT2019/16:19 
0.00 
750 
 
 
 
12 
08OCT2019/20:14 
-5.00 
494 
 
 
 
14 
08OCT2019/22:19 
0.00 
890 
 
 
 
16 
09OCT2019/00:19 
0.00 
1850 
 
 
 
18 
09OCT2019/02:19 
0.00 
1310 
 
 
 
20 
09OCT2019/04:19 
0.00 
909 
 
 
 
24 
09OCT2019/08:19 
0.00 
622 
 
 
 
48 
10OCT2019/08:19 
0.00 
146 
 
Page 765


SIGA TECHNOLOGIES, INC.  
Page 87 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9056 
PREDOSE 
08OCT2019/07:55 
. 
653 
 
 
 
0.5 
08OCT2019/08:35 
5.00 
458 
 
 
 
1 
08OCT2019/09:00 
0.00 
384 
 
 
 
2 
08OCT2019/10:03 
3.00 
323 
 
 
 
4 
08OCT2019/12:03 
3.00 
901 
 
 
 
6 
08OCT2019/14:06 
6.00 
1130 
 
 
 
8 
08OCT2019/16:04 
4.00 
794 
 
 
 
12 
08OCT2019/19:57 
-3.00 
1220 
 
 
 
14 
08OCT2019/22:00 
0.00 
853 
 
 
 
16 
09OCT2019/00:05 
5.00 
1210 
 
 
 
18 
09OCT2019/02:00 
0.00 
1020 
 
 
 
20 
09OCT2019/04:00 
0.00 
894 
 
 
 
24 
09OCT2019/08:03 
3.00 
707 
 
 
 
48 
10OCT2019/08:00 
0.00 
257 
 
Page 766


SIGA TECHNOLOGIES, INC.  
Page 88 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9057 
PREDOSE 
08OCT2019/07:58 
. 
635 
 
 
 
0.5 
08OCT2019/08:33 
0.00 
421 
 
 
 
1 
08OCT2019/09:03 
0.00 
368 
 
 
 
2 
08OCT2019/10:03 
0.00 
512 
 
 
 
4 
08OCT2019/12:03 
0.00 
1270 
 
 
 
6 
08OCT2019/14:03 
0.00 
931 
 
 
 
8 
08OCT2019/16:03 
0.00 
760 
 
 
 
12 
08OCT2019/19:58 
-5.00 
761 
 
 
 
14 
08OCT2019/22:03 
0.00 
797 
 
 
 
16 
09OCT2019/00:03 
0.00 
977 
 
 
 
18 
09OCT2019/02:03 
0.00 
853 
 
 
 
20 
09OCT2019/04:03 
0.00 
913 
 
 
 
24 
09OCT2019/08:03 
0.00 
648 
 
 
 
48 
10OCT2019/08:03 
0.00 
182 
 
Page 767


SIGA TECHNOLOGIES, INC.  
Page 89 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9058 
PREDOSE 
22OCT2019/08:02 
. 
645 
 
 
 
0.5 
22OCT2019/08:37 
0.00 
488 
 
 
 
1 
22OCT2019/09:07 
0.00 
897 
 
 
 
2 
22OCT2019/10:07 
0.00 
1710 
 
 
 
4 
22OCT2019/12:12 
5.00 
1470 
 
 
 
6 
22OCT2019/14:07 
0.00 
1270 
 
 
 
8 
22OCT2019/16:20 
13.00 
837 
 
 
 
12 
22OCT2019/20:14 
7.00 
621 
 
 
 
14 
22OCT2019/22:17 
10.00 
481 
 
 
 
16 
23OCT2019/00:17 
10.00 
704 
 
 
 
18 
23OCT2019/02:17 
10.00 
854 
 
 
 
20 
23OCT2019/04:18 
11.00 
743 
 
 
 
24 
23OCT2019/08:29 
22.00 
742 
 
 
 
48 
24OCT2019/08:08 
1.00 
141 
 
Page 768


SIGA TECHNOLOGIES, INC.  
Page 90 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9061 
PREDOSE 
22OCT2019/07:58 
. 
572 
 
 
 
0.5 
22OCT2019/08:33 
0.00 
439 
 
 
 
1 
22OCT2019/09:05 
2.00 
413 
 
 
 
2 
22OCT2019/10:03 
0.00 
606 
 
 
 
4 
22OCT2019/12:07 
4.00 
1290 
 
 
 
6 
22OCT2019/14:03 
0.00 
1000 
 
 
 
8 
22OCT2019/16:03 
0.00 
603 
 
 
 
12 
22OCT2019/19:58 
-5.00 
554 
 
 
 
14 
22OCT2019/22:10 
7.00 
614 
 
 
 
16 
23OCT2019/00:03 
0.00 
888 
 
 
 
18 
23OCT2019/02:05 
2.00 
936 
 
 
 
20 
23OCT2019/04:05 
2.00 
734 
 
 
 
24 
23OCT2019/08:06 
3.00 
460 
 
 
 
48 
24OCT2019/08:03 
0.00 
129 
 
Page 769


SIGA TECHNOLOGIES, INC.  
Page 91 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9062 
PREDOSE 
08OCT2019/08:01 
. 
462 
 
 
 
0.5 
08OCT2019/08:36 
0.00 
386 
 
 
 
1 
08OCT2019/09:06 
0.00 
359 
 
 
 
2 
08OCT2019/10:06 
0.00 
692 
 
 
 
4 
08OCT2019/12:07 
1.00 
941 
 
 
 
6 
08OCT2019/14:06 
0.00 
1020 
 
 
 
8 
08OCT2019/16:06 
0.00 
736 
 
 
 
12 
08OCT2019/20:06 
0.00 
647 
 
 
 
14 
08OCT2019/22:06 
0.00 
561 
 
 
 
16 
09OCT2019/00:06 
0.00 
849 
 
 
 
18 
09OCT2019/02:06 
0.00 
901 
 
 
 
20 
09OCT2019/04:06 
0.00 
598 
 
 
 
24 
09OCT2019/08:06 
0.00 
381 
 
 
 
48 
10OCT2019/08:06 
0.00 
128 
 
Page 770


SIGA TECHNOLOGIES, INC.  
Page 92 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9063 
PREDOSE 
08OCT2019/08:04 
. 
687 
 
 
 
0.5 
08OCT2019/08:39 
0.00 
539 
 
 
 
1 
08OCT2019/09:09 
0.00 
721 
 
 
 
2 
08OCT2019/10:09 
0.00 
1860 
 
 
 
4 
08OCT2019/12:09 
0.00 
2180 
 
 
 
6 
08OCT2019/14:09 
0.00 
1450 
 
 
 
8 
08OCT2019/16:09 
0.00 
823 
 
 
 
12 
08OCT2019/20:04 
-5.00 
635 
 
 
 
14 
08OCT2019/22:09 
0.00 
962 
 
 
 
16 
09OCT2019/00:09 
0.00 
1440 
 
 
 
18 
09OCT2019/02:09 
0.00 
1150 
 
 
 
20 
09OCT2019/04:09 
0.00 
955 
 
 
 
24 
09OCT2019/08:09 
0.00 
690 
 
 
 
48 
10OCT2019/08:09 
0.00 
190 
 
Page 771


SIGA TECHNOLOGIES, INC.  
Page 93 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9069 
PREDOSE 
22OCT2019/08:01 
. 
689 
 
 
 
0.5 
22OCT2019/08:36 
0.00 
511 
 
 
 
1 
22OCT2019/09:06 
0.00 
472 
 
 
 
2 
22OCT2019/10:06 
0.00 
560 
 
 
 
4 
22OCT2019/12:06 
0.00 
1270 
 
 
 
6 
22OCT2019/14:06 
0.00 
709 
 
 
 
8 
22OCT2019/16:06 
0.00 
501 
 
 
 
12 
22OCT2019/20:01 
-5.00 
543 
 
 
 
14 
22OCT2019/22:06 
0.00 
987 
 
 
 
16 
23OCT2019/00:06 
0.00 
861 
 
 
 
18 
23OCT2019/02:06 
0.00 
772 
 
 
 
20 
23OCT2019/04:06 
0.00 
647 
 
 
 
24 
23OCT2019/08:17 
11.00 
517 
 
 
 
48 
24OCT2019/08:06 
0.00 
232 
 
Page 772


SIGA TECHNOLOGIES, INC.  
Page 94 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9073 
PREDOSE 
22OCT2019/08:11 
. 
502 
 
 
 
0.5 
22OCT2019/08:46 
0.00 
397 
 
 
 
1 
22OCT2019/09:16 
0.00 
350 
 
 
 
2 
22OCT2019/10:16 
0.00 
847 
 
 
 
4 
22OCT2019/12:16 
0.00 
1300 
 
 
 
6 
22OCT2019/14:16 
0.00 
931 
 
 
 
8 
22OCT2019/16:16 
0.00 
637 
 
 
 
12 
22OCT2019/20:11 
-5.00 
505 
 
 
 
14 
22OCT2019/22:16 
0.00 
1030 
 
 
 
16 
23OCT2019/00:16 
0.00 
959 
 
 
 
18 
23OCT2019/02:16 
0.00 
811 
 
 
 
20 
23OCT2019/04:18 
2.00 
696 
 
 
 
24 
23OCT2019/08:16 
0.00 
522 
 
 
 
48 
24OCT2019/08:16 
0.00 
195 
 
Page 773


SIGA TECHNOLOGIES, INC.  
Page 95 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9077 
PREDOSE 
22OCT2019/08:07 
. 
969 
 
 
 
0.5 
22OCT2019/08:42 
0.00 
739 
 
 
 
1 
22OCT2019/09:12 
0.00 
750 
 
 
 
2 
22OCT2019/10:12 
0.00 
847 
 
 
 
4 
22OCT2019/12:31 
19.00 
2120 
 
 
 
6 
22OCT2019/14:12 
0.00 
1230 
 
 
 
8 
22OCT2019/16:12 
0.00 
875 
 
 
 
12 
22OCT2019/20:07 
-5.00 
925 
 
 
 
14 
22OCT2019/22:12 
0.00 
1000 
 
 
 
16 
23OCT2019/00:12 
0.00 
1360 
 
 
 
18 
23OCT2019/02:12 
0.00 
1290 
 
 
 
20 
23OCT2019/04:12 
0.00 
1210 
 
 
 
24 
23OCT2019/08:12 
0.00 
1090 
 
 
 
48 
24OCT2019/08:12 
0.00 
381 
 
Page 774


SIGA TECHNOLOGIES, INC.  
Page 96 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9080 
PREDOSE 
22OCT2019/08:16 
. 
797 
 
 
 
0.5 
22OCT2019/08:51 
0.00 
613 
 
 
 
1 
22OCT2019/09:21 
0.00 
481 
 
 
 
2 
22OCT2019/10:21 
0.00 
474 
 
 
 
4 
22OCT2019/12:21 
0.00 
1120 
 
 
 
6 
22OCT2019/14:21 
0.00 
1370 
 
 
 
8 
22OCT2019/16:21 
0.00 
886 
 
 
 
12 
22OCT2019/20:16 
-5.00 
1280 
 
 
 
14 
22OCT2019/22:27 
6.00 
1110 
 
 
 
16 
23OCT2019/00:34 
13.00 
1500 
 
 
 
20 
23OCT2019/04:21 
0.00 
1290 
 
 
 
24 
23OCT2019/08:21 
0.00 
1030 
 
 
 
48 
24OCT2019/08:21 
0.00 
206 
 
Page 775


SIGA TECHNOLOGIES, INC.  
Page 97 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9081 
PREDOSE 
05NOV2019/06:55 
. 
491 
 
 
 
0.5 
05NOV2019/07:31 
1.00 
420 
 
 
 
1 
05NOV2019/08:00 
0.00 
409 
 
 
 
2 
05NOV2019/09:00 
0.00 
769 
 
 
 
4 
05NOV2019/11:00 
0.00 
1030 
 
 
 
6 
05NOV2019/13:00 
0.00 
906 
 
 
 
8 
05NOV2019/15:00 
0.00 
579 
 
 
 
12 
05NOV2019/18:55 
-5.00 
491 
 
 
 
14 
05NOV2019/21:00 
0.00 
851 
 
 
 
16 
05NOV2019/23:00 
0.00 
808 
 
 
 
18 
06NOV2019/01:00 
0.00 
708 
 
 
 
20 
06NOV2019/03:02 
2.00 
638 
 
 
 
24 
06NOV2019/07:00 
0.00 
461 
 
 
 
48 
07NOV2019/07:00 
0.00 
160 
 
Page 776


SIGA TECHNOLOGIES, INC.  
Page 98 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9086 
PREDOSE 
22OCT2019/08:10 
. 
339 
 
 
 
0.5 
22OCT2019/08:45 
0.00 
230 
 
 
 
1 
22OCT2019/09:15 
0.00 
357 
 
 
 
2 
22OCT2019/10:15 
0.00 
531 
 
 
 
4 
22OCT2019/12:15 
0.00 
690 
 
 
 
6 
22OCT2019/14:15 
0.00 
626 
 
 
 
8 
22OCT2019/16:15 
0.00 
286 
 
 
 
12 
22OCT2019/20:10 
-5.00 
265 
 
 
 
14 
22OCT2019/22:15 
0.00 
632 
 
 
 
16 
23OCT2019/00:15 
0.00 
654 
 
 
 
18 
23OCT2019/02:15 
0.00 
548 
 
 
 
20 
23OCT2019/04:15 
0.00 
391 
 
 
 
24 
23OCT2019/08:15 
0.00 
263 
 
 
 
48 
24OCT2019/08:15 
0.00 
114 
 
Page 777


SIGA TECHNOLOGIES, INC.  
Page 99 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9087 
PREDOSE 
22OCT2019/08:13 
. 
449 
 
 
 
0.5 
22OCT2019/08:48 
0.00 
364 
 
 
 
1 
22OCT2019/09:18 
0.00 
329 
 
 
 
2 
22OCT2019/10:18 
0.00 
291 
 
 
 
4 
22OCT2019/12:18 
0.00 
516 
 
 
 
6 
22OCT2019/14:18 
0.00 
751 
 
 
 
8 
22OCT2019/16:18 
0.00 
638 
 
 
 
12 
22OCT2019/20:17 
-1.00 
549 
 
 
 
14 
22OCT2019/22:18 
0.00 
712 
 
 
 
16 
23OCT2019/00:18 
0.00 
1010 
 
 
 
18 
23OCT2019/02:18 
0.00 
868 
 
 
 
20 
23OCT2019/04:18 
0.00 
782 
 
 
 
24 
23OCT2019/08:18 
0.00 
514 
 
 
 
48 
24OCT2019/08:18 
0.00 
121 
 
Page 778


SIGA TECHNOLOGIES, INC.  
Page 100 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9089 
PREDOSE 
22OCT2019/08:19 
. 
563 
 
 
 
0.5 
22OCT2019/08:54 
0.00 
450 
 
 
 
1 
22OCT2019/09:24 
0.00 
387 
 
 
 
2 
22OCT2019/10:24 
0.00 
355 
 
 
 
4 
22OCT2019/12:24 
0.00 
950 
 
 
 
6 
22OCT2019/14:24 
0.00 
972 
 
 
 
8 
22OCT2019/16:24 
0.00 
566 
 
 
 
12 
22OCT2019/20:19 
-5.00 
444 
 
 
 
14 
22OCT2019/22:24 
0.00 
439 
 
 
 
16 
23OCT2019/00:24 
0.00 
786 
 
 
 
18 
23OCT2019/02:24 
0.00 
998 
 
 
 
20 
23OCT2019/04:24 
0.00 
752 
 
 
 
24 
23OCT2019/08:24 
0.00 
480 
 
 
 
48 
24OCT2019/08:24 
0.00 
142 
 
Page 779


SIGA TECHNOLOGIES, INC.  
Page 101 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9092 
PREDOSE 
22OCT2019/08:22 
. 
460 
 
 
 
0.5 
22OCT2019/08:57 
0.00 
376 
 
 
 
1 
22OCT2019/09:27 
0.00 
590 
 
 
 
2 
22OCT2019/10:27 
0.00 
1530 
 
 
 
4 
22OCT2019/12:27 
0.00 
1390 
 
 
 
6 
22OCT2019/14:27 
0.00 
688 
 
 
 
8 
22OCT2019/16:27 
0.00 
444 
 
 
 
12 
22OCT2019/20:22 
-5.00 
598 
 
 
 
14 
22OCT2019/22:27 
0.00 
842 
 
 
 
16 
23OCT2019/00:27 
0.00 
960 
 
 
 
18 
23OCT2019/02:27 
0.00 
774 
 
 
 
20 
23OCT2019/04:27 
0.00 
638 
 
 
 
24 
23OCT2019/08:27 
0.00 
270 
 
 
 
48 
24OCT2019/08:27 
0.00 
129 
 
Page 780


SIGA TECHNOLOGIES, INC.  
Page 102 of 102 
SIGA-246-022  
Listing 16.2.6.1  
Individual Plasma Collection Times and Concentrations of TPOXX  
Safety Population  
 
 
BLQ = Below the Limit of Quantification.  
Note: The lower limit of quantification is 5.00 ng/mL.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Plasma concentration data and CRF data  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020601.SAS  Executed: 24JAN2020 08:05  
Day 
Subject 
Scheduled 
Time 
(hours) 
Blood Collection 
Date/Time 
Deviation From 
Scheduled Time 
(minutes) 
Concentration 
(ng/mL) 
Comment 
 
7 
9095 
PREDOSE 
05NOV2019/07:01 
. 
662 
 
 
 
0.5 
05NOV2019/07:36 
0.00 
579 
 
 
 
1 
05NOV2019/08:06 
0.00 
318 
 
 
 
2 
05NOV2019/09:06 
0.00 
527 
 
 
 
4 
05NOV2019/11:06 
0.00 
863 
 
 
 
6 
05NOV2019/13:06 
0.00 
1340 
 
 
 
8 
05NOV2019/15:06 
0.00 
1030 
 
 
 
12 
05NOV2019/19:01 
-5.00 
706 
 
 
 
14 
05NOV2019/21:06 
0.00 
905 
 
 
 
16 
05NOV2019/23:06 
0.00 
1300 
 
 
 
18 
06NOV2019/01:06 
0.00 
996 
 
 
 
20 
06NOV2019/03:06 
0.00 
976 
 
 
 
24 
06NOV2019/07:06 
0.00 
719 
 
 
 
48 
07NOV2019/07:06 
0.00 
252 
 
 
Page 781


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Listing 16.2.6.2  
Individual Plasma Pharmacokinetic Parameters of TPOXX — Day 1  
Pharmacokinetic Population  
 
 
NC = Not Calculated.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Listing 16.2.6.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020602.SAS  Executed: 24JAN2020 08:05  
Subject 
Cmax 
(ng/mL) 
AUC0-24 
(h*ng/mL) 
AUC0-t 
(h*ng/mL) 
AUC0-tau 
(h*ng/mL) 
Tmax 
(h) 
t1/2 
(h) 
Lambda_z 
(1/h) 
 
9001 
1100 
12100 
12100 
6180 
4.00 
9.35 
0.0742 
9002 
717 
11300 
11300 
4520 
4.30 
NC 
NC 
9005 
1080 
15700 
15700 
6250 
4.00 
NC 
NC 
9009 
523 
13100 
13100 
3460 
4.13 
NC 
NC 
9012 
757 
11700 
11700 
5400 
4.00 
NC 
NC 
9015 
900 
11000 
11000 
4970 
6.00 
NC 
NC 
9016 
711 
10900 
10900 
4770 
4.00 
NC 
NC 
9019 
922 
12400 
12400 
6460 
4.00 
NC 
NC 
9020 
740 
12900 
12900 
5980 
4.00 
NC 
NC 
9021 
890 
12800 
12800 
5410 
4.03 
5.09 
0.1362 
9022 
648 
11400 
11400 
4830 
6.00 
18.2 
0.0380 
9024 
885 
15700 
15700 
7270 
6.00 
NC 
NC 
9025 
1330 
18000 
18000 
7200 
8.02 
NC 
NC 
9033 
574 
8760 
8760 
3600 
4.00 
6.15 
0.1127 
9043 
909 
12500 
12500 
5690 
4.02 
NC 
NC 
9046 
1030 
14000 
14000 
5140 
4.00 
6.33 
0.1095 
9051 
811 
7830 
7830 
3490 
4.00 
8.50 
0.0815 
9052 
941 
15300 
15300 
5680 
6.00 
10.3 
0.0674 
9056 
938 
11900 
11900 
4520 
4.00 
NC 
NC 
9057 
557 
8780 
8780 
3980 
6.00 
NC 
NC 
9058 
894 
12500 
12500 
6050 
2.00 
NC 
NC 
9061 
965 
13800 
13800 
6000 
4.00 
NC 
NC 
9062 
609 
8350 
8350 
3920 
2.00 
NC 
NC 
9063 
762 
11300 
11300 
4860 
4.00 
NC 
NC 
Page 782


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Listing 16.2.6.2  
Individual Plasma Pharmacokinetic Parameters of TPOXX — Day 1  
Pharmacokinetic Population  
 
 
NC = Not Calculated.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Source Data: Listing 16.2.6.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020602.SAS  Executed: 24JAN2020 08:05  
Subject 
Cmax 
(ng/mL) 
AUC0-24 
(h*ng/mL) 
AUC0-t 
(h*ng/mL) 
AUC0-tau 
(h*ng/mL) 
Tmax 
(h) 
t1/2 
(h) 
Lambda_z 
(1/h) 
 
9069 
957 
12800 
12800 
5190 
4.10 
5.62 
0.1234 
9073 
702 
8470 
8470 
3890 
2.05 
6.49 
0.1069 
9077 
1310 
19000 
19000 
7120 
4.00 
NC 
NC 
9080 
1130 
13000 
13000 
6840 
4.00 
NC 
NC 
9081 
628 
8490 
8490 
3790 
2.00 
11.3 
0.0614 
9086 
634 
6210 
6210 
2960 
4.00 
NC 
NC 
9087 
1160 
11300 
11300 
5140 
4.00 
5.76 
0.1204 
9089 
802 
11000 
11000 
5000 
4.00 
NC 
NC 
9092 
596 
8610 
8610 
3950 
2.00 
NC 
NC 
9095 
697 
11100 
11100 
4740 
4.00 
NC 
NC 
 
Page 783


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Listing 16.2.6.3  
Individual Plasma Pharmacokinetic Parameters of TPOXX — Day 7  
Pharmacokinetic Population  
 
 
NC = Not Calculated.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Note: AUC0-inf estimate is unreliable when %AUCextrap is greater than 20%. CL/F is calculated as Dose/AUC0-12. Vz/F is calculated 
as Dose/(AUC0-12*Lambda_z).   
Source Data: Listing 16.2.6.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020603.SAS  Executed: 24JAN2020 08:06  
Subject 
Cmax 
(ng/mL) 
AUC0-24 
(h*ng/mL) 
AUC0-t 
(h*ng/mL) 
AUC0-tau 
(h*ng/mL) 
AUC0-inf 
(h*ng/mL) 
Tmax 
(h) 
t1/2 
(h) 
Lambda_z 
(1/h) 
CL/F 
(L/h) 
Vz/F 
(L) 
%AUCextrap 
(%) 
 
9001 
1600 
19200 
26500 
10300 
28500 
4.00 
11.2 
0.0616 
58.5 
948 
6.89 
9002 
1290 
19200 
29200 
8990 
33200 
4.00 
13.9 
0.0499 
66.7 
1340 
12.2 
9005 
2270 
27500 
40900 
13400 
48700 
4.00 
17.1 
0.0406 
44.8 
1100 
15.9 
9009 
1190 
23600 
37000 
10600 
42700 
4.00 
14.4 
0.0482 
56.7 
1180 
13.3 
9012 
1060 
17100 
25900 
7670 
NC 
6.00 
NC 
NC 
78.2 
NC 
NC 
9015 
878 
15700 
22600 
7720 
24200 
4.00 
10.4 
0.0665 
77.7 
1170 
6.64 
9016 
1750 
25000 
39700 
13000 
43000 
4.00 
10.9 
0.0638 
46.3 
725 
7.48 
9019 
1130 
19200 
27700 
9390 
29600 
6.00 
10.4 
0.0669 
63.9 
955 
6.56 
9020 
1110 
18600 
28800 
9100 
34600 
6.03 
16.2 
0.0427 
66.0 
1540 
16.6 
9021 
1050 
12600 
17000 
5900 
17700 
4.00 
9.15 
0.0758 
102 
1340 
4.32 
9022 
1200 
21900 
30600 
10300 
33000 
6.00 
11.1 
0.0627 
58.0 
926 
7.16 
9024 
1860 
26900 
39800 
13000 
44900 
4.00 
13.3 
0.0523 
46.3 
885 
11.5 
9025 
1480 
26800 
39400 
13100 
43700 
6.00 
12.5 
0.0552 
45.7 
827 
9.78 
9033 
1160 
16800 
23200 
8120 
25100 
4.02 
11.3 
0.0614 
73.9 
1200 
7.60 
9043 
1640 
19700 
29400 
10400 
34700 
4.00 
15.5 
0.0448 
57.9 
1290 
15.2 
9046 
1350 
22600 
35400 
9250 
40700 
4.05 
14.1 
0.0493 
64.9 
1320 
13.2 
9051 
1020 
11800 
15600 
6560 
15900 
4.00 
7.65 
0.0906 
91.5 
1010 
1.94 
9052 
1930 
23800 
33000 
11200 
35200 
4.00 
10.1 
0.0685 
53.4 
781 
6.07 
9056 
1220 
21500 
33100 
10000 
38800 
11.95 
15.4 
0.0449 
59.8 
1330 
14.7 
9057 
1270 
19700 
29600 
9620 
32900 
4.00 
12.4 
0.0560 
62.4 
1110 
9.89 
9058 
1710 
21600 
32100 
13000 
34300 
2.00 
11.0 
0.0633 
46.2 
731 
6.49 
9061 
1290 
17600 
24700 
9060 
26900 
4.07 
11.7 
0.0590 
66.2 
1120 
8.13 
9062 
1020 
16900 
23000 
9040 
25400 
6.00 
13.4 
0.0517 
66.4 
1280 
9.73 
9063 
2180 
26800 
37300 
14800 
40600 
4.00 
11.9 
0.0583 
40.6 
698 
8.04 
Page 784


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Listing 16.2.6.3  
Individual Plasma Pharmacokinetic Parameters of TPOXX — Day 7  
Pharmacokinetic Population  
 
 
NC = Not Calculated.  
Treatment: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
Note: AUC0-inf estimate is unreliable when %AUCextrap is greater than 20%. CL/F is calculated as Dose/AUC0-12. Vz/F is calculated 
as Dose/(AUC0-12*Lambda_z).   
Source Data: Listing 16.2.6.1  
Program path: \\\\wilbtib\wilbtib08\SIGA SGSIGA246022_PK\Trunk\TLF\l16020603.SAS  Executed: 24JAN2020 08:06  
Subject 
Cmax 
(ng/mL) 
AUC0-24 
(h*ng/mL) 
AUC0-t 
(h*ng/mL) 
AUC0-tau 
(h*ng/mL) 
AUC0-inf 
(h*ng/mL) 
Tmax 
(h) 
t1/2 
(h) 
Lambda_z 
(1/h) 
CL/F 
(L/h) 
Vz/F 
(L) 
%AUCextrap 
(%) 
 
9069 
1270 
17100 
26000 
8170 
32100 
4.00 
18.3 
0.0379 
73.4 
1940 
19.1 
9073 
1300 
18500 
27100 
9240 
31400 
4.00 
15.1 
0.0458 
65.0 
1420 
13.6 
9077 
2120 
27600 
45300 
13600 
54500 
4.32 
16.8 
0.0413 
44.2 
1070 
16.9 
9080 
1370 
27000 
41800 
11800 
44900 
6.00 
10.5 
0.0661 
50.9 
770 
6.94 
9081 
1030 
16500 
23900 
8380 
27200 
4.00 
14.2 
0.0487 
71.6 
1470 
12.1 
9086 
690 
10900 
15500 
5280 
17900 
4.00 
14.8 
0.0468 
114 
2430 
13.6 
9087 
751 
15600 
23200 
6520 
25100 
6.00 
10.6 
0.0652 
92.0 
1410 
7.39 
9089 
972 
15700 
23200 
7610 
25700 
6.00 
12.3 
0.0565 
78.8 
1400 
9.79 
9092 
1530 
17900 
22700 
9730 
25100 
2.00 
12.7 
0.0546 
61.7 
1130 
9.42 
9095 
1340 
21900 
33500 
10400 
38900 
6.00 
14.8 
0.0467 
57.8 
1240 
13.9 
 
Page 785


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.2.7 
Adverse Event Listings (Each Subject) 
Listing 16.2.7.1 
Adverse Events Safety Population 
Listing 16.2.7.2 
Treatment-Related Adverse Events Safety Population 
Listing 16.2.7.3 
Serious Adverse Events Safety Population 
Listing 16.2.7.4 
Adverse Events Leading to Study Drug Discontinuation Safety 
Population 
Page 786


SIGA TECHNOLOGIES, INC.  
Page 1 of 4 
SIGA-246-022  
Listing 16.2.7.1  
Adverse Events  
Safety Population  
 
 
   
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other   
Day=The presented date — First dose date + 1   
TEAE=Treatment-emergent Adverse Event   
Duration (Days)=Stop date — Start date + 1   
Time to AE (Days)=Start date — First dose date + 1   
CM=Concomitant or Additional Treatment Given? ; CM ID=ID of medication/therapy taken for AE   
Action=Action taken with study treatment   
Relationship=Relationship to study treatment   
Study Disc=Caused study discontinuation?   
Adverse Events were coded using MedDRA, Version 22.0.   
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.   
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020701.SAS  Executed: 21JAN2020 23:06   
Page 787


SIGA TECHNOLOGIES, INC.  
Page 2 of 4 
SIGA-246-022  
Listing 16.2.7.1  
Adverse Events  
Safety Population  
 
 
Note: Footnotes are listed on page 1.   
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
AE 
ID 
System Organ Class/ 
Preferred Term/ 
 Adverse Event Term 
Start Date/ 
Time (Day)/ 
Stop Date/ 
Time (Day) 
TEAE/ 
Time to AE 
(Days)/ 
 Duration 
 (Days) 
Frequency/ 
Outcome/ 
 Serious 
Severity/ 
Action/ 
 Other Action 
 Taken 
Relationship/ 
Study Disc/ 
 CM/CM ID 
9002 
48/M/W 
1 Gastrointestinal disorders/ 
Nausea/ 
 NAUSEA 
15AUG2019 
06:43 (2)/ 
15AUG2019 
23:00 (2) 
Yes/ 
2/ 
 1 
CONTINUOUS/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
UNLIKELY 
RELATED/ 
No/ 
 No 
2 Nervous system disorders/ 
Headache/ 
 HEADACHE 
15AUG2019 
06:43 (2)/ 
15AUG2019 
23:00 (2) 
Yes/ 
2/ 
 1 
CONTINUOUS/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
UNLIKELY 
RELATED/ 
No/ 
 No 
9005 
40/M/W 
1 Eye disorders/ 
Scleral hyperaemia/ 
 INJECTED SCLERAE 
16AUG2019 
19:25 (3)/ 
19AUG2019 
08:30 (6) 
Yes/ 
3/ 
 4 
CONTINUOUS/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
UNLIKELY 
RELATED/ 
No/ 
 No 
9009 
21/F/BL 
1 Gastrointestinal disorders/ 
Lip dry/ 
 DRY LIPS 
15AUG2019 
09:00 (2)/ 
16AUG2019 
17:00 (3) 
Yes/ 
2/ 
 2 
CONTINUOUS/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
NOT RELATED/ 
No/ 
 No 
9016 
48/F/W 
1 Skin and subcutaneous tissue 
disorders/ 
Dermatitis contact/ 
 CONTACT DERMATITIS (R SHOULDER) 
08SEP2019 
20:00 (5)/ 
11SEP2019 
00:00 (8) 
Yes/ 
5/ 
 4 
CONTINUOUS/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
UNLIKELY 
RELATED/ 
No/ 
 No 
Page 788


SIGA TECHNOLOGIES, INC.  
Page 3 of 4 
SIGA-246-022  
Listing 16.2.7.1  
Adverse Events  
Safety Population  
 
 
Note: Footnotes are listed on page 1.   
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
AE 
ID 
System Organ Class/ 
Preferred Term/ 
 Adverse Event Term 
Start Date/ 
Time (Day)/ 
Stop Date/ 
Time (Day) 
TEAE/ 
Time to AE 
(Days)/ 
 Duration 
 (Days) 
Frequency/ 
Outcome/ 
 Serious 
Severity/ 
Action/ 
 Other Action 
 Taken 
Relationship/ 
Study Disc/ 
 CM/CM ID 
9021 
39/F/BL 
1 Gastrointestinal disorders/ 
Nausea/ 
 NAUSEA 
05SEP2019 
12:30 (2)/ 
08SEP2019 
12:00 (5) 
Yes/ 
2/ 
 4 
INTERMITTENT/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
POSSIBLY 
RELATED/ 
No/ 
 No 
2 Musculoskeletal and connective 
tissue disorders/ 
Back pain/ 
 BACK PAIN (MUSCULOSKELETAL) 
06SEP2019 
07:22 (3)/ 
13SEP2019 
08:00 (10) 
Yes/ 
3/ 
 8 
INTERMITTENT/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
NOT RELATED/ 
No/ 
 No 
3 Gastrointestinal disorders/ 
Infrequent bowel movements/ 
 DECREASED FREQUENCY OF BOWEL 
 MOVEMENTS 
06SEP2019 
17:00 (3)/ 
11SEP2019 
20:30 (8) 
Yes/ 
3/ 
 6 
CONTINUOUS/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED; NON 
DRUG THERAPY 
GIVEN 
UNLIKELY 
RELATED/ 
No/ 
Yes/1,2 
9033 
32/M/W 
1 Injury, poisoning and procedural 
complications/ 
Palate injury/ 
 HARD PALATE TRAUMA 
07SEP2019 
07:00 (4)/ 
09SEP2019 
19:55 (6) 
Yes/ 
4/ 
 3 
CONTINUOUS/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
NOT RELATED/ 
No/ 
 No 
9043 
22/M/BL 
1 Renal and urinary disorders/ 
Dysuria/ 
 DYSURIA 
23SEP2019 
08:30 (6)/ 
23SEP2019 
11:00 (6) 
Yes/ 
6/ 
 1 
CONTINUOUS/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
UNLIKELY 
RELATED/ 
No/ 
 No 
Page 789


SIGA TECHNOLOGIES, INC.  
Page 4 of 4 
SIGA-246-022  
Listing 16.2.7.1  
Adverse Events  
Safety Population  
 
 
Note: Footnotes are listed on page 1.   
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
AE 
ID 
System Organ Class/ 
Preferred Term/ 
 Adverse Event Term 
Start Date/ 
Time (Day)/ 
Stop Date/ 
Time (Day) 
TEAE/ 
Time to AE 
(Days)/ 
 Duration 
 (Days) 
Frequency/ 
Outcome/ 
 Serious 
Severity/ 
Action/ 
 Other Action 
 Taken 
Relationship/ 
Study Disc/ 
 CM/CM ID 
9061 
21/F/BL 
1 Infections and infestations/ 
Urinary tract infection/ 
 URINARY TRACT INFECTION 
03NOV2019 
22:00 (19)/ 
11NOV2019 
12:00 (27) 
Yes/ 
19/ 
 9 
CONTINUOUS/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
NOT APPLICABLE; 
CON MED GIVEN 
NOT RELATED/ 
No/ 
 Yes/2 
9089 
29/M/BL 
1 Nervous system disorders/ 
Headache/ 
 HEADACHE 
17OCT2019 
15:03 (2)/ 
17OCT2019 
20:00 (2) 
Yes/ 
2/ 
 1 
INTERMITTENT/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
POSSIBLY 
RELATED/ 
No/ 
 No 
 
Page 790


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Listing 16.2.7.2  
Treatment-Related Adverse Events  
Safety Population  
 
 
   
Sex: M=Male, F=Female   
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other   
Day=The presented date — First dose date + 1   
TEAE=Treatment-emergent Adverse Event   
Duration (Days)=Stop date — Start date + 1   
Time to AE (Days)=Start date — First dose date + 1   
CM=Concomitant or Additional Treatment Given?; CM ID=ID of medication/therapy taken for AE   
Action=Action taken with study treatment   
Relationship=Relationship to study treatment   
Study Disc=Caused study discontinuation?   
Adverse Events were coded using MedDRA, Version 22.0.   
An adverse event is considered Treamtment-related if it is assessed as possibly, probably, or definitely related by the 
investigator.   
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.   
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020702.SAS  Executed: 21JAN2020 23:06   
Page 791


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Listing 16.2.7.2  
Treatment-Related Adverse Events  
Safety Population  
 
 
Note: Footnotes are listed on page 1.   
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
AE 
ID 
System Organ Class/ 
Preferred Term/ 
 Adverse Event Term 
Start Date/ 
Time (Day)/ 
Stop Date/ 
Time (Day) 
TEAE/ 
Time to AE 
(Days)/ 
 Duration 
 (Days) 
Frequency/ 
Outcome/ 
 Serious 
Severity/ 
Action/ 
 Other Action 
 Taken 
Relationship/ 
Study Disc/ 
 CM/CM ID 
9021 
39/F/BL 
1 Gastrointestinal disorders/ 
Nausea/ 
 NAUSEA 
05SEP2019 
12:30 (2)/ 
08SEP2019 
12:00 (5) 
Yes/ 
2/ 
 4 
INTERMITTENT/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
POSSIBLY 
RELATED/ 
No/ 
 No 
9089 
29/M/BL 
1 Nervous system disorders/ 
Headache/ 
 HEADACHE 
17OCT2019 
15:03 (2)/ 
17OCT2019 
20:00 (2) 
Yes/ 
2/ 
 1 
INTERMITTENT/ 
RECOVERED/ 
RESOLVED/ 
 No 
Grade 1/ 
DOSE NOT 
CHANGED 
POSSIBLY 
RELATED/ 
No/ 
 No 
 
Page 792


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Listing 16.2.7.3  
Serious Adverse Events  
Safety Population  
 
 
   
Sex: M=Male, F=Female   
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other   
Day=The presented date — First dose date + 1   
TEAE=Treatment-emergent Adverse Event   
Duration (Days)=Stop date — Start date + 1   
Time to AE (Days)=Start date — First dose date + 1   
CM=Concomitant or Additional Treatment Given?; CM ID=ID of medication/therapy taken for AE   
Action=Action taken with study treatment   
Relationship=Relationship to study treatment   
Study Disc=Caused study discontinuation?   
Adverse Events were coded using MedDRA, Version 22.0.   
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.   
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020703.SAS  Executed: 21JAN2020 23:07   
Page 793


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Listing 16.2.7.3  
Serious Adverse Events  
Safety Population  
 
 
Note: Footnotes are listed on page 1.   
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
AE 
ID 
System Organ Class/ 
Preferred Term/ 
 Adverse Event Term 
Start Date/ 
Time (Day)/ 
Stop Date/ 
Time (Day) 
TEAE/ 
Time to AE 
(Days)/ 
 Duration 
 (Days) 
Frequency/ 
Outcome/ 
 Serious 
Severity/ 
Action/ 
 Other Action 
 Taken 
Relationship/ 
Study Disc/ 
 CM/CM ID 
No data to display 
 
 
Page 794


SIGA TECHNOLOGIES, INC.  
Page 1 of 2 
SIGA-246-022  
Listing 16.2.7.4  
Adverse Events Leading to Study Drug Discontinuation  
Safety Population  
 
 
   
Sex: M=Male, F=Female   
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other   
Day=The presented date — First dose date + 1   
TEAE=Treatment-emergent Adverse Event   
Duration (Days)=Stop date — Start date + 1   
Time to AE (Days)=Start date — First dose date + 1   
CM=Concomitant or Additional Treatment Given?; CM ID=ID of medication/therapy taken for AE   
Action=Action taken with study treatment   
Relationship=Relationship to study treatment   
Adverse Events were coded using MedDRA, Version 22.0.   
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.   
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020704.SAS  Executed: 21JAN2020 23:07   
Page 795


SIGA TECHNOLOGIES, INC.  
Page 2 of 2 
SIGA-246-022  
Listing 16.2.7.4  
Adverse Events Leading to Study Drug Discontinuation  
Safety Population  
 
 
Note: Footnotes are listed on page 1.   
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
AE 
ID 
System Organ Class/ 
Preferred Term/ 
 Adverse Event Term 
Start Date/ 
Time (Day)/ 
Stop Date/ 
Time (Day) 
TEAE/ 
Time to AE 
(Days)/ 
 Duration 
 (Days) 
Frequency/ 
Outcome/ 
 Serious 
Severity/ 
Action/ 
 Other Action 
 Taken 
Relationship/ 
 CM/CM ID 
No data to display 
 
 
Page 796


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.2.8 
Listing of Individual Laboratory Measurements by Subject 
Listing 16.2.8.1 
Laboratory Results - Hematology Safety Population 
Listing 16.2.8.2 
Laboratory Results - Serum Chemistry Safety Population 
Listing 16.2.8.3 
Laboratory Results - Urinalysis Safety Population 
Listing 16.2.8.4 
Laboratory Results - Other Safety Population 
Listing 16.2.8.5 
Laboratory Results Meeting Toxicity Grade of 1 or Higher Safety 
Population 
Listing 16.2.8.6 
Vital Sign Results Safety Population 
Listing 16.2.8.7 
Electrocardiogram Results Safety Population 
Listing 16.2.8.8 
Physical Exam Safety Population 
Listing 16.2.8.9 
Physical Measurements Safety Population 
Listing 16.2.8.10 
Follow-Up Visit/Call Safety Population 
Page 797


SIGA TECHNOLOGIES, INC.  
Page 1 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
Screening 19JUL2019 
12:06 (-26) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.14 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
330 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
88.1 
fL 
76.5-97.5 
Erythrocytes 
5.18 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.3 
% 
11.8-15.5 
Page 798


SIGA TECHNOLOGIES, INC.  
Page 2 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
Screening 19JUL2019 
12:06 (-26) 
Hematocrit 
0.457 fraction 
of 1 
0.387-0.507 
Hemoglobin 
150 
g/L 
128-174 
Leukocytes 
5.0 
10^9/L 
3.1-9.7 
Lymphocytes 
1.59 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
31.5 
% 
13.9-48.3 
Monocytes 
0.37 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.4 
% 
3.3-12.1 
Neutrophils 
2.90 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
57.6 
% 
39.1-77.2 
Platelets 
227 
10^9/L 
140-400 
Check-in 13AUG2019 
09:44 (-1) 
Basophils 
0.04 
10^9/L 
0-0.08 
Page 799


SIGA TECHNOLOGIES, INC.  
Page 3 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
Check-in 13AUG2019 
09:44 (-1) 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.14 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
340 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
88.3 
fL 
76.5-97.5 
Erythrocytes 
4.99 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.9 
% 
11.8-15.5 
Hematocrit 
0.441 fraction 
of 1 
0.387-0.507 
Hemoglobin 
150 
g/L 
128-174 
Page 800


SIGA TECHNOLOGIES, INC.  
Page 4 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
Check-in 13AUG2019 
09:44 (-1) 
Leukocytes 
6.4 
10^9/L 
3.1-9.7 
Lymphocytes 
1.50 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
23.4 
% 
13.9-48.3 
Monocytes 
0.39 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.0 
% 
3.3-12.1 
Neutrophils 
4.36 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
67.8 
% 
39.1-77.2 
Platelets 
261 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:54 (4) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Page 801


SIGA TECHNOLOGIES, INC.  
Page 5 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:54 (4) 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
341 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.4 
fL 
76.5-97.5 
Erythrocytes 
5.03 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.6 
% 
11.8-15.5 
Hematocrit 
0.439 fraction 
of 1 
0.387-0.507 
Hemoglobin 
150 
g/L 
128-174 
Leukocytes 
7.6 
10^9/L 
3.1-9.7 
Page 802


SIGA TECHNOLOGIES, INC.  
Page 6 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:54 (4) 
Lymphocytes 
1.95 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
25.8 
% 
13.9-48.3 
Monocytes 
0.56 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.4 
% 
3.3-12.1 
Neutrophils 
4.85 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.2 
% 
39.1-77.2 
Platelets 
281 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:25 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Page 803


SIGA TECHNOLOGIES, INC.  
Page 7 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:25 (8) 
Eosinophils 
0.12 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
338 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.5 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.2 
fL 
76.5-97.5 
Erythrocytes 
5.03 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.2 
% 
11.8-15.5 
Hematocrit 
0.439 fraction 
of 1 
0.387-0.507 
Hemoglobin 
148 
g/L 
128-174 
Page 804


SIGA TECHNOLOGIES, INC.  
Page 8 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:25 (8) 
Leukocytes 
7.9 
10^9/L 
3.1-9.7 
Lymphocytes 
2.10 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
26.6 
% 
13.9-48.3 
Monocytes 
0.59 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.5 
% 
3.3-12.1 
Neutrophils 
5.05 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.0 
% 
39.1-77.2 
Platelets 
274 
10^9/L 
140-400 
Day 9 
22AUG2019 
09:25 (9) 
Basophils 
0.04 
10^9/L 
0-0.08 
Page 805


SIGA TECHNOLOGIES, INC.  
Page 9 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:25 (9) 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.09 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
340 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.4 
fL 
76.5-97.5 
Erythrocytes 
4.93 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.5 
% 
11.8-15.5 
Hematocrit 
0.431 fraction 
of 1 
0.387-0.507 
Hemoglobin 
146 
g/L 
128-174 
Page 806


SIGA TECHNOLOGIES, INC.  
Page 10 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:25 (9) 
Leukocytes 
6.9 
10^9/L 
3.1-9.7 
Lymphocytes 
1.68 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
24.5 
% 
13.9-48.3 
Monocytes 
0.44 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.4 
% 
3.3-12.1 
Neutrophils 
4.61 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
67.2 
% 
39.1-77.2 
Platelets 
275 
10^9/L 
140-400 
9002 
48/M/W 
Screening 19JUL2019 
12:02 (-26) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.1 
% 
0-1.4 
Page 807


SIGA TECHNOLOGIES, INC.  
Page 11 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
Screening 19JUL2019 
12:02 (-26) 
Eosinophils 
0.09 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.9 
fL 
76.5-97.5 
Erythrocytes 
4.48 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.7 
% 
11.8-15.5 
Hematocrit 
0.394 fraction 
of 1 
0.387-0.507 
Hemoglobin 
133 
g/L 
128-174 
Leukocytes 
6.2 
10^9/L 
3.1-9.7 
Page 808


SIGA TECHNOLOGIES, INC.  
Page 12 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
Screening 19JUL2019 
12:02 (-26) 
Lymphocytes 
1.94 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
31.4 
% 
13.9-48.3 
Monocytes 
0.67 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.8 
% 
3.3-12.1 
Neutrophils 
3.41 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
55.3 
% 
39.1-77.2 
Platelets 
336 
10^9/L 
140-400 
Check-in 13AUG2019 
10:01 (-1) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.9 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Page 809


SIGA TECHNOLOGIES, INC.  
Page 13 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
Check-in 13AUG2019 
10:01 (-1) 
Eosinophils/ 
Leukocytes 
1.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
344 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.9 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.0 
fL 
76.5-97.5 
Erythrocytes 
4.31 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.3 
% 
11.8-15.5 
Hematocrit 
0.375 fraction 
of 1 
L NCS 
0.387-0.507 
Hemoglobin 
129 
g/L 
128-174 
Leukocytes 
7.4 
10^9/L 
3.1-9.7 
Lymphocytes 
1.67 
10^9/L 
0.8-2.91 
Page 810


SIGA TECHNOLOGIES, INC.  
Page 14 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
Check-in 13AUG2019 
10:01 (-1) 
Lymphocytes/ 
Leukocytes 
22.4 
% 
13.9-48.3 
Monocytes 
0.61 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.3 
% 
3.3-12.1 
Neutrophils 
4.99 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
67.0 
% 
39.1-77.2 
Platelets 
320 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:49 (4) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.13 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.8 
% 
0-6.1 
Page 811


SIGA TECHNOLOGIES, INC.  
Page 15 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:49 (4) 
Ery. Mean Corpuscular 
HGB Concentration 
341 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.8 
fL 
76.5-97.5 
Erythrocytes 
4.81 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.3 
% 
11.8-15.5 
Hematocrit 
0.418 fraction 
of 1 
0.387-0.507 
Hemoglobin 
143 
g/L 
128-174 
Leukocytes 
7.5 
10^9/L 
3.1-9.7 
Lymphocytes 
2.46 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
33.0 
% 
13.9-48.3 
Monocytes 
0.64 
10^9/L 
0.15-0.75 
Page 812


SIGA TECHNOLOGIES, INC.  
Page 16 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:49 (4) 
Monocytes/ 
Leukocytes 
8.6 
% 
3.3-12.1 
Neutrophils 
4.15 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
55.7 
% 
39.1-77.2 
Platelets 
349 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:24 (8) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.12 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
352 
g/L 
320-354 
Page 813


SIGA TECHNOLOGIES, INC.  
Page 17 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:24 (8) 
Ery. Mean Corpuscular 
Hemoglobin 
30.3 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.1 
fL 
76.5-97.5 
Erythrocytes 
4.74 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.4 
% 
11.8-15.5 
Hematocrit 
0.408 fraction 
of 1 
0.387-0.507 
Hemoglobin 
144 
g/L 
128-174 
Leukocytes 
6.8 
10^9/L 
3.1-9.7 
Lymphocytes 
1.68 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
24.6 
% 
13.9-48.3 
Monocytes 
0.60 
10^9/L 
0.15-0.75 
Page 814


SIGA TECHNOLOGIES, INC.  
Page 18 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:24 (8) 
Monocytes/ 
Leukocytes 
8.8 
% 
3.3-12.1 
Neutrophils 
4.38 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.1 
% 
39.1-77.2 
Platelets 
349 
10^9/L 
140-400 
Day 9 
22AUG2019 
09:27 (9) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.15 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
339 
g/L 
320-354 
Page 815


SIGA TECHNOLOGIES, INC.  
Page 19 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:27 (9) 
Ery. Mean Corpuscular 
Hemoglobin 
29.5 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.9 
fL 
76.5-97.5 
Erythrocytes 
4.62 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.0 
% 
11.8-15.5 
Hematocrit 
0.402 fraction 
of 1 
0.387-0.507 
Hemoglobin 
136 
g/L 
128-174 
Leukocytes 
5.6 
10^9/L 
3.1-9.7 
Lymphocytes 
1.74 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
31.3 
% 
13.9-48.3 
Monocytes 
0.50 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.9 
% 
3.3-12.1 
Page 816


SIGA TECHNOLOGIES, INC.  
Page 20 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:27 (9) 
Neutrophils 
3.12 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
56.1 
% 
39.1-77.2 
Platelets 
337 
10^9/L 
140-400 
9005 
40/M/W 
Screening 23JUL2019 
10:05 (-22) 
Basophils 
0.08 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.15 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
347 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
31.5 
pg 
25-33.6 
Page 817


SIGA TECHNOLOGIES, INC.  
Page 21 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
Screening 23JUL2019 
10:05 (-22) 
Ery. Mean Corpuscular 
Volume 
90.9 
fL 
76.5-97.5 
Erythrocytes 
4.99 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.5 
% 
11.8-15.5 
Hematocrit 
0.454 fraction 
of 1 
0.387-0.507 
Hemoglobin 
157 
g/L 
128-174 
Leukocytes 
8.1 
10^9/L 
3.1-9.7 
Lymphocytes 
2.41 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
29.6 
% 
13.9-48.3 
Monocytes 
0.66 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.2 
% 
3.3-12.1 
Neutrophils 
4.84 
10^9/L 
1.5-6.75 
Page 818


SIGA TECHNOLOGIES, INC.  
Page 22 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
Screening 23JUL2019 
10:05 (-22) 
Neutrophils/ 
Leukocytes 
59.5 
% 
39.1-77.2 
Platelets 
188 
10^9/L 
140-400 
Check-in 13AUG2019 
09:35 (-1) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.21 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
350 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
31.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
90.7 
fL 
76.5-97.5 
Page 819


SIGA TECHNOLOGIES, INC.  
Page 23 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
Check-in 13AUG2019 
09:35 (-1) 
Erythrocytes 
5.04 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.4 
% 
11.8-15.5 
Hematocrit 
0.457 fraction 
of 1 
0.387-0.507 
Hemoglobin 
160 
g/L 
128-174 
Leukocytes 
9.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.19 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
23.8 
% 
13.9-48.3 
Monocytes 
0.79 
10^9/L 
H NCS 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.5 
% 
3.3-12.1 
Neutrophils 
5.97 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.8 
% 
39.1-77.2 
Page 820


SIGA TECHNOLOGIES, INC.  
Page 24 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
Check-in 13AUG2019 
09:35 (-1) 
Platelets 
192 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:27 (4) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.17 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
351 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
31.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
90.3 
fL 
76.5-97.5 
Erythrocytes 
5.18 
10^12/L 
4.28-6.03 
Page 821


SIGA TECHNOLOGIES, INC.  
Page 25 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:27 (4) 
Erythrocytes 
Distribution Width 
13.0 
% 
11.8-15.5 
Hematocrit 
0.468 fraction 
of 1 
0.387-0.507 
Hemoglobin 
164 
g/L 
128-174 
Leukocytes 
10.2 
10^9/L 
H NCS 
3.1-9.7 
Lymphocytes 
2.61 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
25.5 
% 
13.9-48.3 
Monocytes 
0.91 
10^9/L 
H NCS 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.9 
% 
3.3-12.1 
Neutrophils 
6.49 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
63.5 
% 
39.1-77.2 
Platelets 
213 
10^9/L 
140-400 
Page 822


SIGA TECHNOLOGIES, INC.  
Page 26 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 4 
18AUG2019 
05:21 (5), R 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.20 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.0 
% 
0-6.1 
Leukocytes 
10.1 
10^9/L 
H NCS 
3.1-9.7 
Lymphocytes 
2.62 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
25.9 
% 
13.9-48.3 
Monocytes 
0.80 
10^9/L 
H NCS 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.9 
% 
3.3-12.1 
Neutrophils 
6.43 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
63.5 
% 
39.1-77.2 
Page 823


SIGA TECHNOLOGIES, INC.  
Page 27 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 4 
19AUG2019 
07:06 (6), R 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.19 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Leukocytes 
9.9 
10^9/L 
H NCS 
3.1-9.7 
Lymphocytes 
2.64 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
26.7 
% 
13.9-48.3 
Monocytes 
0.79 
10^9/L 
H NCS 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.0 
% 
3.3-12.1 
Neutrophils 
6.20 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
62.8 
% 
39.1-77.2 
Page 824


SIGA TECHNOLOGIES, INC.  
Page 28 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:02 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.14 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
351 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
31.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
90.6 
fL 
76.5-97.5 
Erythrocytes 
4.98 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.2 
% 
11.8-15.5 
Page 825


SIGA TECHNOLOGIES, INC.  
Page 29 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:02 (8) 
Hematocrit 
0.452 fraction 
of 1 
0.387-0.507 
Hemoglobin 
158 
g/L 
128-174 
Leukocytes 
9.3 
10^9/L 
3.1-9.7 
Lymphocytes 
1.99 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
21.5 
% 
13.9-48.3 
Monocytes 
0.81 
10^9/L 
H NCS 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.7 
% 
3.3-12.1 
Neutrophils 
6.30 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
67.9 
% 
39.1-77.2 
Platelets 
210 
10^9/L 
140-400 
Page 826


SIGA TECHNOLOGIES, INC.  
Page 30 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:02 (9) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
346 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
31.2 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
90.1 
fL 
76.5-97.5 
Erythrocytes 
4.83 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.0 
% 
11.8-15.5 
Page 827


SIGA TECHNOLOGIES, INC.  
Page 31 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:02 (9) 
Hematocrit 
0.435 fraction 
of 1 
0.387-0.507 
Hemoglobin 
151 
g/L 
128-174 
Leukocytes 
9.0 
10^9/L 
3.1-9.7 
Lymphocytes 
2.33 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
26.0 
% 
13.9-48.3 
Monocytes 
0.75 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.4 
% 
3.3-12.1 
Neutrophils 
5.70 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
63.7 
% 
39.1-77.2 
Platelets 
199 
10^9/L 
140-400 
9009 
21/F/BL 
Screening 31JUL2019 
10:20 (-14) 
Basophils 
0.04 
10^9/L 
0-0.08 
Page 828


SIGA TECHNOLOGIES, INC.  
Page 32 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
Screening 31JUL2019 
10:20 (-14) 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.19 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
345 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
28.9 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
84.0 
fL 
72.2-99.1 
Erythrocytes 
4.67 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
14.2 
% 
11.1-17.3 
Hematocrit 
0.392 fraction 
of 1 
0.335-0.444 
Hemoglobin 
135 
g/L 
108-150 
Page 829


SIGA TECHNOLOGIES, INC.  
Page 33 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
Screening 31JUL2019 
10:20 (-14) 
Leukocytes 
6.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.16 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
35.1 
% 
13.9-48.3 
Monocytes 
0.44 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.1 
% 
3.3-12.1 
Neutrophils 
3.34 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.1 
% 
39.1-77.2 
Platelets 
365 
10^9/L 
140-400 
Check-in 13AUG2019 
09:32 (-1) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Page 830


SIGA TECHNOLOGIES, INC.  
Page 34 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
Check-in 13AUG2019 
09:32 (-1) 
Eosinophils 
0.13 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
351 
g/L 
H NCS 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
29.3 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
83.5 
fL 
72.2-99.1 
Erythrocytes 
4.70 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
14.1 
% 
11.1-17.3 
Hematocrit 
0.392 fraction 
of 1 
0.335-0.444 
Hemoglobin 
138 
g/L 
108-150 
Leukocytes 
5.9 
10^9/L 
3.1-9.7 
Page 831


SIGA TECHNOLOGIES, INC.  
Page 35 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
Check-in 13AUG2019 
09:32 (-1) 
Lymphocytes 
1.94 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
32.7 
% 
13.9-48.3 
Monocytes 
0.33 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.5 
% 
3.3-12.1 
Neutrophils 
3.50 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
59.0 
% 
39.1-77.2 
Platelets 
344 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:31 (4) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.22 
10^9/L 
0-0.35 
Page 832


SIGA TECHNOLOGIES, INC.  
Page 36 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:31 (4) 
Eosinophils/ 
Leukocytes 
3.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
348 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
28.9 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
83.2 
fL 
72.2-99.1 
Erythrocytes 
4.75 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.8 
% 
11.1-17.3 
Hematocrit 
0.395 fraction 
of 1 
0.335-0.444 
Hemoglobin 
137 
g/L 
108-150 
Leukocytes 
6.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.53 
10^9/L 
0.8-2.91 
Page 833


SIGA TECHNOLOGIES, INC.  
Page 37 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:31 (4) 
Lymphocytes/ 
Leukocytes 
40.6 
% 
13.9-48.3 
Monocytes 
0.53 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.6 
% 
3.3-12.1 
Neutrophils 
2.92 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
46.8 
% 
39.1-77.2 
Platelets 
359 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:06 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.21 
10^9/L 
0-0.35 
Page 834


SIGA TECHNOLOGIES, INC.  
Page 38 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:06 (8) 
Eosinophils/ 
Leukocytes 
3.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
349 
g/L 
H NCS 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
28.9 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
82.9 
fL 
72.2-99.1 
Erythrocytes 
4.52 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
14.0 
% 
11.1-17.3 
Hematocrit 
0.375 fraction 
of 1 
0.335-0.444 
Hemoglobin 
131 
g/L 
108-150 
Leukocytes 
6.6 
10^9/L 
3.1-9.7 
Lymphocytes 
2.79 
10^9/L 
0.8-2.91 
Page 835


SIGA TECHNOLOGIES, INC.  
Page 39 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:06 (8) 
Lymphocytes/ 
Leukocytes 
42.4 
% 
13.9-48.3 
Monocytes 
0.52 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.8 
% 
3.3-12.1 
Neutrophils 
3.03 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
46.1 
% 
39.1-77.2 
Platelets 
362 
10^9/L 
140-400 
Day 9 
22AUG2019 
09:07 (9) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.19 
10^9/L 
0-0.35 
Page 836


SIGA TECHNOLOGIES, INC.  
Page 40 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:07 (9) 
Eosinophils/ 
Leukocytes 
3.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
346 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
28.9 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
83.6 
fL 
72.2-99.1 
Erythrocytes 
4.52 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
14.1 
% 
11.1-17.3 
Hematocrit 
0.378 fraction 
of 1 
0.335-0.444 
Hemoglobin 
131 
g/L 
108-150 
Leukocytes 
6.0 
10^9/L 
3.1-9.7 
Lymphocytes 
2.29 
10^9/L 
0.8-2.91 
Page 837


SIGA TECHNOLOGIES, INC.  
Page 41 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:07 (9) 
Lymphocytes/ 
Leukocytes 
38.3 
% 
13.9-48.3 
Monocytes 
0.47 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.8 
% 
3.3-12.1 
Neutrophils 
2.99 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
50.1 
% 
39.1-77.2 
Platelets 
373 
10^9/L 
140-400 
9012 
34/M/BL 
Screening 06AUG2019 
10:31 (-8) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.3 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Page 838


SIGA TECHNOLOGIES, INC.  
Page 42 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
Screening 06AUG2019 
10:31 (-8) 
Ery. Mean Corpuscular 
HGB Concentration 
342 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.5 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.3 
fL 
76.5-97.5 
Erythrocytes 
4.66 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.5 
% 
11.8-15.5 
Hematocrit 
0.416 fraction 
of 1 
0.387-0.507 
Hemoglobin 
142 
g/L 
128-174 
Leukocytes 
5.5 
10^9/L 
3.1-9.7 
Lymphocytes 
2.71 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
49.3 
% 
H NCS 
13.9-48.3 
Monocytes 
0.57 
10^9/L 
0.15-0.75 
Page 839


SIGA TECHNOLOGIES, INC.  
Page 43 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
Screening 06AUG2019 
10:31 (-8) 
Monocytes/ 
Leukocytes 
10.3 
% 
3.3-12.1 
Neutrophils 
2.10 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
38.2 
% 
L NCS 
39.1-77.2 
Platelets 
226 
10^9/L 
140-400 
Check-in 13AUG2019 
09:53 (-1) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.3 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
346 
g/L 
320-354 
Page 840


SIGA TECHNOLOGIES, INC.  
Page 44 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
Check-in 13AUG2019 
09:53 (-1) 
Ery. Mean Corpuscular 
Hemoglobin 
31.2 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
90.4 
fL 
76.5-97.5 
Erythrocytes 
4.61 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.1 
% 
11.8-15.5 
Hematocrit 
0.416 fraction 
of 1 
0.387-0.507 
Hemoglobin 
144 
g/L 
128-174 
Leukocytes 
5.0 
10^9/L 
3.1-9.7 
Lymphocytes 
2.00 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
40.0 
% 
13.9-48.3 
Monocytes 
0.47 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.4 
% 
3.3-12.1 
Page 841


SIGA TECHNOLOGIES, INC.  
Page 45 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
Check-in 13AUG2019 
09:53 (-1) 
Neutrophils 
2.40 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
48.0 
% 
39.1-77.2 
Platelets 
202 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:35 (4) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.3 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
346 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
31.2 
pg 
25-33.6 
Page 842


SIGA TECHNOLOGIES, INC.  
Page 46 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:35 (4) 
Ery. Mean Corpuscular 
Volume 
89.9 
fL 
76.5-97.5 
Erythrocytes 
5.14 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.0 
% 
11.8-15.5 
Hematocrit 
0.462 fraction 
of 1 
0.387-0.507 
Hemoglobin 
160 
g/L 
128-174 
Leukocytes 
5.7 
10^9/L 
3.1-9.7 
Lymphocytes 
2.48 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
43.8 
% 
13.9-48.3 
Monocytes 
0.50 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.8 
% 
3.3-12.1 
Neutrophils 
2.55 
10^9/L 
1.5-6.75 
Page 843


SIGA TECHNOLOGIES, INC.  
Page 47 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:35 (4) 
Neutrophils/ 
Leukocytes 
45.1 
% 
39.1-77.2 
Platelets 
223 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:10 (8) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
345 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.9 
pg 
25-33.6 
Page 844


SIGA TECHNOLOGIES, INC.  
Page 48 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:10 (8) 
Ery. Mean Corpuscular 
Volume 
89.4 
fL 
76.5-97.5 
Erythrocytes 
4.90 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.9 
% 
11.8-15.5 
Hematocrit 
0.438 fraction 
of 1 
0.387-0.507 
Hemoglobin 
151 
g/L 
128-174 
Leukocytes 
4.7 
10^9/L 
3.1-9.7 
Lymphocytes 
2.23 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
47.4 
% 
13.9-48.3 
Monocytes 
0.47 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.9 
% 
3.3-12.1 
Neutrophils 
1.89 
10^9/L 
1.5-6.75 
Page 845


SIGA TECHNOLOGIES, INC.  
Page 49 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:10 (8) 
Neutrophils/ 
Leukocytes 
40.3 
% 
39.1-77.2 
Platelets 
229 
10^9/L 
140-400 
Day 9 
22AUG2019 
09:13 (9) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.3 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
349 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
31.5 
pg 
25-33.6 
Page 846


SIGA TECHNOLOGIES, INC.  
Page 50 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:13 (9) 
Ery. Mean Corpuscular 
Volume 
90.4 
fL 
76.5-97.5 
Erythrocytes 
4.75 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.7 
% 
11.8-15.5 
Hematocrit 
0.429 fraction 
of 1 
0.387-0.507 
Hemoglobin 
150 
g/L 
128-174 
Leukocytes 
5.1 
10^9/L 
3.1-9.7 
Lymphocytes 
2.44 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
47.4 
% 
13.9-48.3 
Monocytes 
0.45 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.7 
% 
3.3-12.1 
Neutrophils 
2.14 
10^9/L 
1.5-6.75 
Page 847


SIGA TECHNOLOGIES, INC.  
Page 51 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:13 (9) 
Neutrophils/ 
Leukocytes 
41.6 
% 
39.1-77.2 
Platelets 
225 
10^9/L 
140-400 
9015 
29/M/BL 
Screening 12AUG2019 
11:07 (-2) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.15 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
334 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.5 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
82.3 
fL 
76.5-97.5 
Page 848


SIGA TECHNOLOGIES, INC.  
Page 52 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
Screening 12AUG2019 
11:07 (-2) 
Erythrocytes 
5.09 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
17.3 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.419 fraction 
of 1 
0.387-0.507 
Hemoglobin 
140 
g/L 
128-174 
Leukocytes 
7.4 
10^9/L 
3.1-9.7 
Lymphocytes 
3.19 
10^9/L 
H NCS 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
43.2 
% 
13.9-48.3 
Monocytes 
0.42 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.6 
% 
3.3-12.1 
Neutrophils 
3.57 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
48.4 
% 
39.1-77.2 
Page 849


SIGA TECHNOLOGIES, INC.  
Page 53 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
Screening 12AUG2019 
11:07 (-2) 
Platelets 
315 
10^9/L 
140-400 
Check-in 13AUG2019 
09:39 (-1) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.23 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
337 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.9 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
82.9 
fL 
76.5-97.5 
Erythrocytes 
5.25 
10^12/L 
4.28-6.03 
Page 850


SIGA TECHNOLOGIES, INC.  
Page 54 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
Check-in 13AUG2019 
09:39 (-1) 
Erythrocytes 
Distribution Width 
17.1 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.435 fraction 
of 1 
0.387-0.507 
Hemoglobin 
147 
g/L 
128-174 
Leukocytes 
8.6 
10^9/L 
3.1-9.7 
Lymphocytes 
3.83 
10^9/L 
H NCS 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
44.7 
% 
13.9-48.3 
Monocytes 
0.44 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.1 
% 
3.3-12.1 
Neutrophils 
4.03 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
47.0 
% 
39.1-77.2 
Platelets 
326 
10^9/L 
140-400 
Page 851


SIGA TECHNOLOGIES, INC.  
Page 55 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:33 (4) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
333 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.5 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
82.6 
fL 
76.5-97.5 
Erythrocytes 
5.29 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
17.4 
% 
H NCS 
11.8-15.5 
Page 852


SIGA TECHNOLOGIES, INC.  
Page 56 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:33 (4) 
Hematocrit 
0.437 fraction 
of 1 
0.387-0.507 
Hemoglobin 
145 
g/L 
128-174 
Leukocytes 
8.0 
10^9/L 
3.1-9.7 
Lymphocytes 
3.68 
10^9/L 
H NCS 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
45.9 
% 
13.9-48.3 
Monocytes 
0.42 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.2 
% 
3.3-12.1 
Neutrophils 
3.72 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
46.4 
% 
39.1-77.2 
Platelets 
356 
10^9/L 
140-400 
Page 853


SIGA TECHNOLOGIES, INC.  
Page 57 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:08 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
334 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
82.5 
fL 
76.5-97.5 
Erythrocytes 
5.29 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
16.9 
% 
H NCS 
11.8-15.5 
Page 854


SIGA TECHNOLOGIES, INC.  
Page 58 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:08 (8) 
Hematocrit 
0.437 fraction 
of 1 
0.387-0.507 
Hemoglobin 
146 
g/L 
128-174 
Leukocytes 
8.4 
10^9/L 
3.1-9.7 
Lymphocytes 
4.05 
10^9/L 
H NCS 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
48.2 
% 
13.9-48.3 
Monocytes 
0.50 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.0 
% 
3.3-12.1 
Neutrophils 
3.64 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
43.4 
% 
39.1-77.2 
Platelets 
364 
10^9/L 
140-400 
Page 855


SIGA TECHNOLOGIES, INC.  
Page 59 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:10 (9) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.14 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
338 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
82.4 
fL 
76.5-97.5 
Erythrocytes 
5.24 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
16.3 
% 
H NCS 
11.8-15.5 
Page 856


SIGA TECHNOLOGIES, INC.  
Page 60 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:10 (9) 
Hematocrit 
0.431 fraction 
of 1 
0.387-0.507 
Hemoglobin 
146 
g/L 
128-174 
Leukocytes 
7.3 
10^9/L 
3.1-9.7 
Lymphocytes 
3.01 
10^9/L 
H NCS 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
41.4 
% 
13.9-48.3 
Monocytes 
0.42 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.8 
% 
3.3-12.1 
Neutrophils 
3.64 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
50.2 
% 
39.1-77.2 
Platelets 
350 
10^9/L 
140-400 
9016 
48/F/W 
Screening 12AUG2019 
11:08 (-23) 
Basophils 
0.09 
10^9/L 
H NCS 
0-0.08 
Page 857


SIGA TECHNOLOGIES, INC.  
Page 61 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
Screening 12AUG2019 
11:08 (-23) 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
325 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
26.7 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
82.0 
fL 
72.2-99.1 
Erythrocytes 
5.09 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.2 
% 
11.1-17.3 
Hematocrit 
0.418 fraction 
of 1 
0.335-0.444 
Hemoglobin 
136 
g/L 
108-150 
Page 858


SIGA TECHNOLOGIES, INC.  
Page 62 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
Screening 12AUG2019 
11:08 (-23) 
Leukocytes 
8.6 
10^9/L 
3.1-9.7 
Lymphocytes 
1.59 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
18.5 
% 
13.9-48.3 
Monocytes 
0.38 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
4.4 
% 
3.3-12.1 
Neutrophils 
6.44 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
74.9 
% 
39.1-77.2 
Platelets 
312 
10^9/L 
140-400 
Check-in 03SEP2019 
09:04 (-1) 
Basophils 
0.08 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Page 859


SIGA TECHNOLOGIES, INC.  
Page 63 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
Check-in 03SEP2019 
09:04 (-1) 
Eosinophils 
0.15 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
331 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
26.9 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
81.5 
fL 
72.2-99.1 
Erythrocytes 
4.96 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.2 
% 
11.1-17.3 
Hematocrit 
0.404 fraction 
of 1 
0.335-0.444 
Hemoglobin 
134 
g/L 
108-150 
Leukocytes 
7.9 
10^9/L 
3.1-9.7 
Page 860


SIGA TECHNOLOGIES, INC.  
Page 64 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
Check-in 03SEP2019 
09:04 (-1) 
Lymphocytes 
1.49 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
18.8 
% 
13.9-48.3 
Monocytes 
0.40 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.0 
% 
3.3-12.1 
Neutrophils 
5.81 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
73.4 
% 
39.1-77.2 
Platelets 
290 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:25 (4) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Page 861


SIGA TECHNOLOGIES, INC.  
Page 65 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:25 (4) 
Eosinophils/ 
Leukocytes 
2.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
329 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
27.0 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
82.2 
fL 
72.2-99.1 
Erythrocytes 
4.83 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.5 
% 
11.1-17.3 
Hematocrit 
0.397 fraction 
of 1 
0.335-0.444 
Hemoglobin 
130 
g/L 
108-150 
Leukocytes 
6.8 
10^9/L 
3.1-9.7 
Lymphocytes 
1.74 
10^9/L 
0.8-2.91 
Page 862


SIGA TECHNOLOGIES, INC.  
Page 66 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:25 (4) 
Lymphocytes/ 
Leukocytes 
25.7 
% 
13.9-48.3 
Monocytes 
0.41 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.1 
% 
3.3-12.1 
Neutrophils 
4.38 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.9 
% 
39.1-77.2 
Platelets 
296 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:00 (8) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.15 
10^9/L 
0-0.35 
Page 863


SIGA TECHNOLOGIES, INC.  
Page 67 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:00 (8) 
Eosinophils/ 
Leukocytes 
2.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
325 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
26.9 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
82.7 
fL 
72.2-99.1 
Erythrocytes 
4.99 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.6 
% 
11.1-17.3 
Hematocrit 
0.412 fraction 
of 1 
0.335-0.444 
Hemoglobin 
134 
g/L 
108-150 
Leukocytes 
5.9 
10^9/L 
3.1-9.7 
Lymphocytes 
1.54 
10^9/L 
0.8-2.91 
Page 864


SIGA TECHNOLOGIES, INC.  
Page 68 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:00 (8) 
Lymphocytes/ 
Leukocytes 
26.1 
% 
13.9-48.3 
Monocytes 
0.37 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.3 
% 
3.3-12.1 
Neutrophils 
3.78 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.2 
% 
39.1-77.2 
Platelets 
294 
10^9/L 
140-400 
Day 9 
12SEP2019 
08:05 (9) 
Basophils 
0.08 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.3 
% 
0-1.4 
Eosinophils 
0.14 
10^9/L 
0-0.35 
Page 865


SIGA TECHNOLOGIES, INC.  
Page 69 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:05 (9) 
Eosinophils/ 
Leukocytes 
2.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
329 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
27.2 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
82.8 
fL 
72.2-99.1 
Erythrocytes 
4.88 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.6 
% 
11.1-17.3 
Hematocrit 
0.404 fraction 
of 1 
0.335-0.444 
Hemoglobin 
133 
g/L 
108-150 
Leukocytes 
6.0 
10^9/L 
3.1-9.7 
Lymphocytes 
1.53 
10^9/L 
0.8-2.91 
Page 866


SIGA TECHNOLOGIES, INC.  
Page 70 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:05 (9) 
Lymphocytes/ 
Leukocytes 
25.7 
% 
13.9-48.3 
Monocytes 
0.37 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.2 
% 
3.3-12.1 
Neutrophils 
3.84 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.5 
% 
39.1-77.2 
Platelets 
304 
10^9/L 
140-400 
9019 
41/M/BL 
Screening 15AUG2019 
17:21 (-20) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.2 
% 
0-6.1 
Page 867


SIGA TECHNOLOGIES, INC.  
Page 71 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
Screening 15AUG2019 
17:21 (-20) 
Ery. Mean Corpuscular 
HGB Concentration 
328 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
90.9 
fL 
76.5-97.5 
Erythrocytes 
5.30 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.7 
% 
11.8-15.5 
Hematocrit 
0.481 fraction 
of 1 
0.387-0.507 
Hemoglobin 
158 
g/L 
128-174 
Leukocytes 
8.8 
10^9/L 
3.1-9.7 
Lymphocytes 
2.82 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
32.2 
% 
13.9-48.3 
Monocytes 
0.66 
10^9/L 
0.15-0.75 
Page 868


SIGA TECHNOLOGIES, INC.  
Page 72 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
Screening 15AUG2019 
17:21 (-20) 
Monocytes/ 
Leukocytes 
7.5 
% 
3.3-12.1 
Neutrophils 
5.13 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
58.5 
% 
39.1-77.2 
Platelets 
270 
10^9/L 
140-400 
Check-in 03SEP2019 
11:40 (-1) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.08 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
333 
g/L 
320-354 
Page 869


SIGA TECHNOLOGIES, INC.  
Page 73 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
Check-in 03SEP2019 
11:40 (-1) 
Ery. Mean Corpuscular 
Hemoglobin 
30.3 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
91.1 
fL 
76.5-97.5 
Erythrocytes 
5.05 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.8 
% 
11.8-15.5 
Hematocrit 
0.460 fraction 
of 1 
0.387-0.507 
Hemoglobin 
153 
g/L 
128-174 
Leukocytes 
6.8 
10^9/L 
3.1-9.7 
Lymphocytes 
2.05 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
30.0 
% 
13.9-48.3 
Monocytes 
0.60 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.8 
% 
3.3-12.1 
Page 870


SIGA TECHNOLOGIES, INC.  
Page 74 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
Check-in 03SEP2019 
11:40 (-1) 
Neutrophils 
4.06 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
59.3 
% 
39.1-77.2 
Platelets 
264 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:32 (4) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.5 
pg 
25-33.6 
Page 871


SIGA TECHNOLOGIES, INC.  
Page 75 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:32 (4) 
Ery. Mean Corpuscular 
Volume 
91.1 
fL 
76.5-97.5 
Erythrocytes 
4.97 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.2 
% 
11.8-15.5 
Hematocrit 
0.452 fraction 
of 1 
0.387-0.507 
Hemoglobin 
151 
g/L 
128-174 
Leukocytes 
5.8 
10^9/L 
3.1-9.7 
Lymphocytes 
2.03 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
34.9 
% 
13.9-48.3 
Monocytes 
0.48 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.2 
% 
3.3-12.1 
Neutrophils 
3.15 
10^9/L 
1.5-6.75 
Page 872


SIGA TECHNOLOGIES, INC.  
Page 76 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:32 (4) 
Neutrophils/ 
Leukocytes 
54.3 
% 
39.1-77.2 
Platelets 
261 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:03 (8) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.12 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
331 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.0 
pg 
25-33.6 
Page 873


SIGA TECHNOLOGIES, INC.  
Page 77 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:03 (8) 
Ery. Mean Corpuscular 
Volume 
90.7 
fL 
76.5-97.5 
Erythrocytes 
5.15 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.4 
% 
11.8-15.5 
Hematocrit 
0.467 fraction 
of 1 
0.387-0.507 
Hemoglobin 
155 
g/L 
128-174 
Leukocytes 
6.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.08 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
33.3 
% 
13.9-48.3 
Monocytes 
0.50 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.1 
% 
3.3-12.1 
Neutrophils 
3.50 
10^9/L 
1.5-6.75 
Page 874


SIGA TECHNOLOGIES, INC.  
Page 78 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:03 (8) 
Neutrophils/ 
Leukocytes 
56.0 
% 
39.1-77.2 
Platelets 
264 
10^9/L 
140-400 
Day 9 
12SEP2019 
08:08 (9) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.2 
pg 
25-33.6 
Page 875


SIGA TECHNOLOGIES, INC.  
Page 79 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:08 (9) 
Ery. Mean Corpuscular 
Volume 
90.2 
fL 
76.5-97.5 
Erythrocytes 
5.11 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.3 
% 
11.8-15.5 
Hematocrit 
0.461 fraction 
of 1 
0.387-0.507 
Hemoglobin 
155 
g/L 
128-174 
Leukocytes 
6.6 
10^9/L 
3.1-9.7 
Lymphocytes 
2.09 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
31.9 
% 
13.9-48.3 
Monocytes 
0.55 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.4 
% 
3.3-12.1 
Neutrophils 
3.74 
10^9/L 
1.5-6.75 
Page 876


SIGA TECHNOLOGIES, INC.  
Page 80 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:08 (9) 
Neutrophils/ 
Leukocytes 
57.1 
% 
39.1-77.2 
Platelets 
277 
10^9/L 
140-400 
9020 
47/F/BL 
Screening 21AUG2019 
10:37 (-14) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.9 
% 
0-1.4 
Eosinophils 
0.24 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
4.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
329 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
31.9 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
96.9 
fL 
72.2-99.1 
Page 877


SIGA TECHNOLOGIES, INC.  
Page 81 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
Screening 21AUG2019 
10:37 (-14) 
Erythrocytes 
3.85 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.0 
% 
11.1-17.3 
Hematocrit 
0.373 fraction 
of 1 
0.335-0.444 
Hemoglobin 
123 
g/L 
108-150 
Leukocytes 
5.4 
10^9/L 
3.1-9.7 
Lymphocytes 
1.75 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
32.6 
% 
13.9-48.3 
Monocytes 
0.44 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.2 
% 
3.3-12.1 
Neutrophils 
2.89 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
53.9 
% 
39.1-77.2 
Page 878


SIGA TECHNOLOGIES, INC.  
Page 82 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
Screening 21AUG2019 
10:37 (-14) 
Platelets 
204 
10^9/L 
140-400 
Check-in 03SEP2019 
08:56 (-1) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.20 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
32.8 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
97.4 
fL 
72.2-99.1 
Erythrocytes 
3.76 
10^12/L 
L NCS 
3.84-5.28 
Page 879


SIGA TECHNOLOGIES, INC.  
Page 83 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
Check-in 03SEP2019 
08:56 (-1) 
Erythrocytes 
Distribution Width 
14.5 
% 
11.1-17.3 
Hematocrit 
0.366 fraction 
of 1 
0.335-0.444 
Hemoglobin 
123 
g/L 
108-150 
Leukocytes 
5.6 
10^9/L 
3.1-9.7 
Lymphocytes 
1.90 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
33.9 
% 
13.9-48.3 
Monocytes 
0.44 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.9 
% 
3.3-12.1 
Neutrophils 
3.03 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.1 
% 
39.1-77.2 
Platelets 
198 
10^9/L 
140-400 
Page 880


SIGA TECHNOLOGIES, INC.  
Page 84 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:31 (4) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.22 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
4.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
334 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
32.6 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
97.7 
fL 
72.2-99.1 
Erythrocytes 
3.79 
10^12/L 
L NCS 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.0 
% 
11.1-17.3 
Page 881


SIGA TECHNOLOGIES, INC.  
Page 85 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:31 (4) 
Hematocrit 
0.370 fraction 
of 1 
0.335-0.444 
Hemoglobin 
124 
g/L 
108-150 
Leukocytes 
5.2 
10^9/L 
3.1-9.7 
Lymphocytes 
1.67 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
31.8 
% 
13.9-48.3 
Monocytes 
0.43 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.2 
% 
3.3-12.1 
Neutrophils 
2.89 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
55.2 
% 
39.1-77.2 
Platelets 
197 
10^9/L 
140-400 
Page 882


SIGA TECHNOLOGIES, INC.  
Page 86 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:06 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.9 
% 
0-1.4 
Eosinophils 
0.18 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
329 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
32.2 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
97.7 
fL 
72.2-99.1 
Erythrocytes 
3.80 
10^12/L 
L NCS 
3.84-5.28 
Erythrocytes 
Distribution Width 
14.5 
% 
11.1-17.3 
Page 883


SIGA TECHNOLOGIES, INC.  
Page 87 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:06 (8) 
Hematocrit 
0.372 fraction 
of 1 
0.335-0.444 
Hemoglobin 
122 
g/L 
108-150 
Leukocytes 
4.7 
10^9/L 
3.1-9.7 
Lymphocytes 
1.27 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
27.3 
% 
13.9-48.3 
Monocytes 
0.37 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.9 
% 
3.3-12.1 
Neutrophils 
2.80 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
60.1 
% 
39.1-77.2 
Platelets 
211 
10^9/L 
140-400 
Page 884


SIGA TECHNOLOGIES, INC.  
Page 88 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:13 (9) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.18 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
331 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
32.3 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
97.5 
fL 
72.2-99.1 
Erythrocytes 
3.78 
10^12/L 
L NCS 
3.84-5.28 
Erythrocytes 
Distribution Width 
14.5 
% 
11.1-17.3 
Page 885


SIGA TECHNOLOGIES, INC.  
Page 89 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:13 (9) 
Hematocrit 
0.369 fraction 
of 1 
0.335-0.444 
Hemoglobin 
122 
g/L 
108-150 
Leukocytes 
4.9 
10^9/L 
3.1-9.7 
Lymphocytes 
1.64 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
33.2 
% 
13.9-48.3 
Monocytes 
0.42 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.4 
% 
3.3-12.1 
Neutrophils 
2.68 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.2 
% 
39.1-77.2 
Platelets 
209 
10^9/L 
140-400 
9021 
39/F/BL 
Screening 21AUG2019 
10:44 (-14) 
Basophils 
0.07 
10^9/L 
0-0.08 
Page 886


SIGA TECHNOLOGIES, INC.  
Page 90 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
Screening 21AUG2019 
10:44 (-14) 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.25 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
314 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
23.7 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
75.6 
fL 
72.2-99.1 
Erythrocytes 
4.91 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
20.1 
% 
H NCS 
11.1-17.3 
Hematocrit 
0.371 fraction 
of 1 
0.335-0.444 
Hemoglobin 
116 
g/L 
108-150 
Page 887


SIGA TECHNOLOGIES, INC.  
Page 91 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
Screening 21AUG2019 
10:44 (-14) 
Leukocytes 
7.8 
10^9/L 
3.1-9.7 
Lymphocytes 
2.90 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
37.3 
% 
13.9-48.3 
Monocytes 
0.58 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.5 
% 
3.3-12.1 
Neutrophils 
3.97 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
51.1 
% 
39.1-77.2 
Platelets 
393 
10^9/L 
140-400 
Check-in 03SEP2019 
09:00 (-1) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Page 888


SIGA TECHNOLOGIES, INC.  
Page 92 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
Check-in 03SEP2019 
09:00 (-1) 
Eosinophils 
0.26 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
319 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
24.2 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
75.8 
fL 
72.2-99.1 
Erythrocytes 
4.78 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
20.4 
% 
H NCS 
11.1-17.3 
Hematocrit 
0.362 fraction 
of 1 
0.335-0.444 
Hemoglobin 
116 
g/L 
108-150 
Leukocytes 
9.7 
10^9/L 
3.1-9.7 
Page 889


SIGA TECHNOLOGIES, INC.  
Page 93 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
Check-in 03SEP2019 
09:00 (-1) 
Lymphocytes 
3.78 
10^9/L 
H NCS 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
38.8 
% 
13.9-48.3 
Monocytes 
0.65 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.7 
% 
3.3-12.1 
Neutrophils 
4.96 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
51.1 
% 
39.1-77.2 
Platelets 
403 
10^9/L 
H NCS 
140-400 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:34 (4) 
Basophils 
0.09 
10^9/L 
H NCS 
0-0.08 
Basophils/ 
Leukocytes 
1.1 
% 
0-1.4 
Eosinophils 
0.21 
10^9/L 
0-0.35 
Page 890


SIGA TECHNOLOGIES, INC.  
Page 94 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:34 (4) 
Eosinophils/ 
Leukocytes 
2.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
322 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
24.6 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
76.5 
fL 
72.2-99.1 
Erythrocytes 
4.88 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
20.9 
% 
H NCS 
11.1-17.3 
Hematocrit 
0.373 fraction 
of 1 
0.335-0.444 
Hemoglobin 
120 
g/L 
108-150 
Leukocytes 
8.2 
10^9/L 
3.1-9.7 
Lymphocytes 
3.20 
10^9/L 
H NCS 
0.8-2.91 
Page 891


SIGA TECHNOLOGIES, INC.  
Page 95 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:34 (4) 
Lymphocytes/ 
Leukocytes 
38.9 
% 
13.9-48.3 
Monocytes 
0.57 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.9 
% 
3.3-12.1 
Neutrophils 
4.17 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
50.6 
% 
39.1-77.2 
Platelets 
432 
10^9/L 
H NCS 
140-400 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:09 (8) 
Basophils 
0.08 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.1 
% 
0-1.4 
Eosinophils 
0.21 
10^9/L 
0-0.35 
Page 892


SIGA TECHNOLOGIES, INC.  
Page 96 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:09 (8) 
Eosinophils/ 
Leukocytes 
3.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
317 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
24.5 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
77.3 
fL 
72.2-99.1 
Erythrocytes 
4.77 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
21.1 
% 
H NCS 
11.1-17.3 
Hematocrit 
0.369 fraction 
of 1 
0.335-0.444 
Hemoglobin 
117 
g/L 
108-150 
Leukocytes 
7.3 
10^9/L 
3.1-9.7 
Lymphocytes 
2.43 
10^9/L 
0.8-2.91 
Page 893


SIGA TECHNOLOGIES, INC.  
Page 97 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:09 (8) 
Lymphocytes/ 
Leukocytes 
33.5 
% 
13.9-48.3 
Monocytes 
0.45 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.2 
% 
3.3-12.1 
Neutrophils 
4.08 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
56.3 
% 
39.1-77.2 
Platelets 
379 
10^9/L 
140-400 
Day 9 
12SEP2019 
08:09 (9) 
Basophils 
0.09 
10^9/L 
H NCS 
0-0.08 
Basophils/ 
Leukocytes 
1.2 
% 
0-1.4 
Eosinophils 
0.19 
10^9/L 
0-0.35 
Page 894


SIGA TECHNOLOGIES, INC.  
Page 98 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:09 (9) 
Eosinophils/ 
Leukocytes 
2.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
323 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
25.0 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
77.5 
fL 
72.2-99.1 
Erythrocytes 
4.86 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
21.2 
% 
H NCS 
11.1-17.3 
Hematocrit 
0.376 fraction 
of 1 
0.335-0.444 
Hemoglobin 
121 
g/L 
108-150 
Leukocytes 
7.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.15 
10^9/L 
0.8-2.91 
Page 895


SIGA TECHNOLOGIES, INC.  
Page 99 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:09 (9) 
Lymphocytes/ 
Leukocytes 
29.1 
% 
13.9-48.3 
Monocytes 
0.45 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.1 
% 
3.3-12.1 
Neutrophils 
4.52 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
61.1 
% 
39.1-77.2 
Platelets 
382 
10^9/L 
140-400 
9022 
31/M/W 
Screening 21AUG2019 
11:05 (-14) 
Basophils 
0.09 
10^9/L 
H NCS 
0-0.08 
Basophils/ 
Leukocytes 
1.5 
% 
H NCS 
0-1.4 
Eosinophils 
0.05 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
0.9 
% 
0-6.1 
Page 896


SIGA TECHNOLOGIES, INC.  
Page 100 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
Screening 21AUG2019 
11:05 (-14) 
Ery. Mean Corpuscular 
HGB Concentration 
341 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
82.2 
fL 
76.5-97.5 
Erythrocytes 
5.27 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.3 
% 
11.8-15.5 
Hematocrit 
0.433 fraction 
of 1 
0.387-0.507 
Hemoglobin 
147 
g/L 
128-174 
Leukocytes 
5.9 
10^9/L 
3.1-9.7 
Lymphocytes 
2.43 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
41.0 
% 
13.9-48.3 
Monocytes 
0.61 
10^9/L 
0.15-0.75 
Page 897


SIGA TECHNOLOGIES, INC.  
Page 101 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
Screening 21AUG2019 
11:05 (-14) 
Monocytes/ 
Leukocytes 
10.3 
% 
3.3-12.1 
Neutrophils 
2.75 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
46.4 
% 
39.1-77.2 
Platelets 
264 
10^9/L 
140-400 
Check-in 03SEP2019 
09:54 (-1) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.09 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
346 
g/L 
320-354 
Page 898


SIGA TECHNOLOGIES, INC.  
Page 102 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
Check-in 03SEP2019 
09:54 (-1) 
Ery. Mean Corpuscular 
Hemoglobin 
28.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
81.0 
fL 
76.5-97.5 
Erythrocytes 
5.06 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.4 
% 
11.8-15.5 
Hematocrit 
0.410 fraction 
of 1 
0.387-0.507 
Hemoglobin 
142 
g/L 
128-174 
Leukocytes 
7.7 
10^9/L 
3.1-9.7 
Lymphocytes 
2.75 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
35.6 
% 
13.9-48.3 
Monocytes 
0.69 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.0 
% 
3.3-12.1 
Page 899


SIGA TECHNOLOGIES, INC.  
Page 103 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
Check-in 03SEP2019 
09:54 (-1) 
Neutrophils 
4.12 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
53.4 
% 
39.1-77.2 
Platelets 
254 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:44 (4) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.07 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
345 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.0 
pg 
25-33.6 
Page 900


SIGA TECHNOLOGIES, INC.  
Page 104 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:44 (4) 
Ery. Mean Corpuscular 
Volume 
81.3 
fL 
76.5-97.5 
Erythrocytes 
5.49 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.3 
% 
11.8-15.5 
Hematocrit 
0.446 fraction 
of 1 
0.387-0.507 
Hemoglobin 
154 
g/L 
128-174 
Leukocytes 
7.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.88 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
39.9 
% 
13.9-48.3 
Monocytes 
0.65 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.0 
% 
3.3-12.1 
Neutrophils 
3.55 
10^9/L 
1.5-6.75 
Page 901


SIGA TECHNOLOGIES, INC.  
Page 105 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:44 (4) 
Neutrophils/ 
Leukocytes 
49.2 
% 
39.1-77.2 
Platelets 
282 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:12 (8) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.1 
% 
0-1.4 
Eosinophils 
0.07 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
341 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.9 
pg 
25-33.6 
Page 902


SIGA TECHNOLOGIES, INC.  
Page 106 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:12 (8) 
Ery. Mean Corpuscular 
Volume 
81.8 
fL 
76.5-97.5 
Erythrocytes 
5.45 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.3 
% 
11.8-15.5 
Hematocrit 
0.446 fraction 
of 1 
0.387-0.507 
Hemoglobin 
152 
g/L 
128-174 
Leukocytes 
6.3 
10^9/L 
3.1-9.7 
Lymphocytes 
2.51 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
39.8 
% 
13.9-48.3 
Monocytes 
0.59 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.4 
% 
3.3-12.1 
Neutrophils 
3.07 
10^9/L 
1.5-6.75 
Page 903


SIGA TECHNOLOGIES, INC.  
Page 107 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:12 (8) 
Neutrophils/ 
Leukocytes 
48.7 
% 
39.1-77.2 
Platelets 
277 
10^9/L 
140-400 
Day 9 
12SEP2019 
08:12 (9) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.2 
% 
0-1.4 
Eosinophils 
0.06 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
345 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.1 
pg 
25-33.6 
Page 904


SIGA TECHNOLOGIES, INC.  
Page 108 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:12 (9) 
Ery. Mean Corpuscular 
Volume 
81.6 
fL 
76.5-97.5 
Erythrocytes 
5.24 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.3 
% 
11.8-15.5 
Hematocrit 
0.427 fraction 
of 1 
0.387-0.507 
Hemoglobin 
147 
g/L 
128-174 
Leukocytes 
5.8 
10^9/L 
3.1-9.7 
Lymphocytes 
2.12 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
36.6 
% 
13.9-48.3 
Monocytes 
0.51 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.8 
% 
3.3-12.1 
Neutrophils 
3.02 
10^9/L 
1.5-6.75 
Page 905


SIGA TECHNOLOGIES, INC.  
Page 109 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:12 (9) 
Neutrophils/ 
Leukocytes 
52.3 
% 
39.1-77.2 
Platelets 
275 
10^9/L 
140-400 
9024 
20/M/BL 
Screening 23AUG2019 
10:48 (-12) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.12 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
88.4 
fL 
76.5-97.5 
Page 906


SIGA TECHNOLOGIES, INC.  
Page 110 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
Screening 23AUG2019 
10:48 (-12) 
Erythrocytes 
5.28 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.8 
% 
11.8-15.5 
Hematocrit 
0.467 fraction 
of 1 
0.387-0.507 
Hemoglobin 
157 
g/L 
128-174 
Leukocytes 
8.8 
10^9/L 
3.1-9.7 
Lymphocytes 
2.77 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
31.5 
% 
13.9-48.3 
Monocytes 
0.57 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.4 
% 
3.3-12.1 
Neutrophils 
5.27 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
60.1 
% 
39.1-77.2 
Page 907


SIGA TECHNOLOGIES, INC.  
Page 111 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
Screening 23AUG2019 
10:48 (-12) 
Platelets 
337 
10^9/L 
140-400 
Check-in 03SEP2019 
09:18 (-1) 
Basophils 
0.09 
10^9/L 
H NCS 
0-0.08 
Basophils/ 
Leukocytes 
0.9 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
346 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.5 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
88.1 
fL 
76.5-97.5 
Erythrocytes 
4.80 
10^12/L 
4.28-6.03 
Page 908


SIGA TECHNOLOGIES, INC.  
Page 112 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
Check-in 03SEP2019 
09:18 (-1) 
Erythrocytes 
Distribution Width 
13.9 
% 
11.8-15.5 
Hematocrit 
0.423 fraction 
of 1 
0.387-0.507 
Hemoglobin 
146 
g/L 
128-174 
Leukocytes 
9.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.75 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
29.2 
% 
13.9-48.3 
Monocytes 
0.55 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.9 
% 
3.3-12.1 
Neutrophils 
5.91 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
62.9 
% 
39.1-77.2 
Platelets 
355 
10^9/L 
140-400 
Page 909


SIGA TECHNOLOGIES, INC.  
Page 113 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:40 (4) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
343 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.5 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.1 
fL 
76.5-97.5 
Erythrocytes 
5.29 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.0 
% 
11.8-15.5 
Page 910


SIGA TECHNOLOGIES, INC.  
Page 114 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:40 (4) 
Hematocrit 
0.471 fraction 
of 1 
0.387-0.507 
Hemoglobin 
161 
g/L 
128-174 
Leukocytes 
8.6 
10^9/L 
3.1-9.7 
Lymphocytes 
2.93 
10^9/L 
H NCS 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
34.0 
% 
13.9-48.3 
Monocytes 
0.72 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.3 
% 
3.3-12.1 
Neutrophils 
4.75 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
55.1 
% 
39.1-77.2 
Platelets 
371 
10^9/L 
140-400 
Page 911


SIGA TECHNOLOGIES, INC.  
Page 115 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:15 (8) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.9 
% 
0-1.4 
Eosinophils 
0.12 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
344 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.5 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
88.6 
fL 
76.5-97.5 
Erythrocytes 
5.06 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.6 
% 
11.8-15.5 
Page 912


SIGA TECHNOLOGIES, INC.  
Page 116 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:15 (8) 
Hematocrit 
0.449 fraction 
of 1 
0.387-0.507 
Hemoglobin 
154 
g/L 
128-174 
Leukocytes 
7.5 
10^9/L 
3.1-9.7 
Lymphocytes 
2.45 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
32.6 
% 
13.9-48.3 
Monocytes 
0.57 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.6 
% 
3.3-12.1 
Neutrophils 
4.32 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
57.4 
% 
39.1-77.2 
Platelets 
339 
10^9/L 
140-400 
Page 913


SIGA TECHNOLOGIES, INC.  
Page 117 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:15 (9) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.9 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
345 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.5 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
88.4 
fL 
76.5-97.5 
Erythrocytes 
5.18 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.6 
% 
11.8-15.5 
Page 914


SIGA TECHNOLOGIES, INC.  
Page 118 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:15 (9) 
Hematocrit 
0.458 fraction 
of 1 
0.387-0.507 
Hemoglobin 
158 
g/L 
128-174 
Leukocytes 
7.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.22 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
30.9 
% 
13.9-48.3 
Monocytes 
0.57 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.0 
% 
3.3-12.1 
Neutrophils 
4.24 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
58.8 
% 
39.1-77.2 
Platelets 
350 
10^9/L 
140-400 
9025 
50/M/W 
Screening 23AUG2019 
10:59 (-26) 
Basophils 
0.04 
10^9/L 
0-0.08 
Page 915


SIGA TECHNOLOGIES, INC.  
Page 119 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
Screening 23AUG2019 
10:59 (-26) 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.17 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
333 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
25.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
77.7 
fL 
76.5-97.5 
Erythrocytes 
5.21 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.1 
% 
11.8-15.5 
Hematocrit 
0.405 fraction 
of 1 
0.387-0.507 
Hemoglobin 
135 
g/L 
128-174 
Page 916


SIGA TECHNOLOGIES, INC.  
Page 120 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
Screening 23AUG2019 
10:59 (-26) 
Leukocytes 
5.9 
10^9/L 
3.1-9.7 
Lymphocytes 
1.57 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
26.4 
% 
13.9-48.3 
Monocytes 
0.40 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.7 
% 
3.3-12.1 
Neutrophils 
3.77 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
63.4 
% 
39.1-77.2 
Platelets 
227 
10^9/L 
140-400 
Check-in 17SEP2019 
09:06 (-1) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Page 917


SIGA TECHNOLOGIES, INC.  
Page 121 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
Check-in 17SEP2019 
09:06 (-1) 
Eosinophils 
0.29 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
4.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
329 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
25.4 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
77.1 
fL 
76.5-97.5 
Erythrocytes 
5.24 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.3 
% 
11.8-15.5 
Hematocrit 
0.404 fraction 
of 1 
0.387-0.507 
Hemoglobin 
133 
g/L 
128-174 
Leukocytes 
6.8 
10^9/L 
3.1-9.7 
Page 918


SIGA TECHNOLOGIES, INC.  
Page 122 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
Check-in 17SEP2019 
09:06 (-1) 
Lymphocytes 
1.63 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
23.9 
% 
13.9-48.3 
Monocytes 
0.43 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.4 
% 
3.3-12.1 
Neutrophils 
4.41 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.8 
% 
39.1-77.2 
Platelets 
239 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:25 (4) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.18 
10^9/L 
0-0.35 
Page 919


SIGA TECHNOLOGIES, INC.  
Page 123 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:25 (4) 
Eosinophils/ 
Leukocytes 
2.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
334 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
25.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
76.9 
fL 
76.5-97.5 
Erythrocytes 
5.42 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.6 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.417 fraction 
of 1 
0.387-0.507 
Hemoglobin 
139 
g/L 
128-174 
Leukocytes 
8.0 
10^9/L 
3.1-9.7 
Lymphocytes 
1.63 
10^9/L 
0.8-2.91 
Page 920


SIGA TECHNOLOGIES, INC.  
Page 124 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:25 (4) 
Lymphocytes/ 
Leukocytes 
20.2 
% 
13.9-48.3 
Monocytes 
0.43 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.3 
% 
3.3-12.1 
Neutrophils 
5.76 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
71.6 
% 
39.1-77.2 
Platelets 
272 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:00 (8) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.14 
10^9/L 
0-0.35 
Page 921


SIGA TECHNOLOGIES, INC.  
Page 125 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:00 (8) 
Eosinophils/ 
Leukocytes 
2.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
329 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
25.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
77.9 
fL 
76.5-97.5 
Erythrocytes 
5.41 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.6 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.421 fraction 
of 1 
0.387-0.507 
Hemoglobin 
139 
g/L 
128-174 
Leukocytes 
7.2 
10^9/L 
3.1-9.7 
Lymphocytes 
1.46 
10^9/L 
0.8-2.91 
Page 922


SIGA TECHNOLOGIES, INC.  
Page 126 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:00 (8) 
Lymphocytes/ 
Leukocytes 
20.3 
% 
13.9-48.3 
Monocytes 
0.39 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.4 
% 
3.3-12.1 
Neutrophils 
5.18 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
71.7 
% 
39.1-77.2 
Platelets 
247 
10^9/L 
140-400 
Day 9 
26SEP2019 
08:00 (9) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.12 
10^9/L 
0-0.35 
Page 923


SIGA TECHNOLOGIES, INC.  
Page 127 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 9 
26SEP2019 
08:00 (9) 
Eosinophils/ 
Leukocytes 
1.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
330 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
25.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
77.5 
fL 
76.5-97.5 
Erythrocytes 
5.35 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.6 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.415 fraction 
of 1 
0.387-0.507 
Hemoglobin 
137 
g/L 
128-174 
Leukocytes 
6.8 
10^9/L 
3.1-9.7 
Lymphocytes 
1.35 
10^9/L 
0.8-2.91 
Page 924


SIGA TECHNOLOGIES, INC.  
Page 128 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 9 
26SEP2019 
08:00 (9) 
Lymphocytes/ 
Leukocytes 
19.9 
% 
13.9-48.3 
Monocytes 
0.45 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.6 
% 
3.3-12.1 
Neutrophils 
4.84 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
71.3 
% 
39.1-77.2 
Platelets 
246 
10^9/L 
140-400 
9033 
32/M/W 
Screening 29AUG2019 
09:53 (-6) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.07 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
0.9 
% 
0-6.1 
Page 925


SIGA TECHNOLOGIES, INC.  
Page 129 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
Screening 29AUG2019 
09:53 (-6) 
Ery. Mean Corpuscular 
HGB Concentration 
345 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.3 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.9 
fL 
76.5-97.5 
Erythrocytes 
5.06 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.7 
% 
11.8-15.5 
Hematocrit 
0.445 fraction 
of 1 
0.387-0.507 
Hemoglobin 
154 
g/L 
128-174 
Leukocytes 
7.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.45 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
33.0 
% 
13.9-48.3 
Monocytes 
0.63 
10^9/L 
0.15-0.75 
Page 926


SIGA TECHNOLOGIES, INC.  
Page 130 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
Screening 29AUG2019 
09:53 (-6) 
Monocytes/ 
Leukocytes 
8.5 
% 
3.3-12.1 
Neutrophils 
4.23 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
56.9 
% 
39.1-77.2 
Platelets 
227 
10^9/L 
140-400 
Check-in 03SEP2019 
09:15 (-1) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.06 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
0.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
339 
g/L 
320-354 
Page 927


SIGA TECHNOLOGIES, INC.  
Page 131 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
Check-in 03SEP2019 
09:15 (-1) 
Ery. Mean Corpuscular 
Hemoglobin 
29.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.8 
fL 
76.5-97.5 
Erythrocytes 
5.10 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.8 
% 
11.8-15.5 
Hematocrit 
0.448 fraction 
of 1 
0.387-0.507 
Hemoglobin 
152 
g/L 
128-174 
Leukocytes 
7.7 
10^9/L 
3.1-9.7 
Lymphocytes 
2.50 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
32.5 
% 
13.9-48.3 
Monocytes 
0.65 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.5 
% 
3.3-12.1 
Page 928


SIGA TECHNOLOGIES, INC.  
Page 132 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
Check-in 03SEP2019 
09:15 (-1) 
Neutrophils 
4.44 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
57.8 
% 
39.1-77.2 
Platelets 
238 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:48 (4) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.08 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
0.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
345 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.2 
pg 
25-33.6 
Page 929


SIGA TECHNOLOGIES, INC.  
Page 133 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:48 (4) 
Ery. Mean Corpuscular 
Volume 
87.6 
fL 
76.5-97.5 
Erythrocytes 
5.09 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.9 
% 
11.8-15.5 
Hematocrit 
0.446 fraction 
of 1 
0.387-0.507 
Hemoglobin 
154 
g/L 
128-174 
Leukocytes 
8.3 
10^9/L 
3.1-9.7 
Lymphocytes 
2.68 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
32.2 
% 
13.9-48.3 
Monocytes 
0.52 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.3 
% 
3.3-12.1 
Neutrophils 
4.99 
10^9/L 
1.5-6.75 
Page 930


SIGA TECHNOLOGIES, INC.  
Page 134 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:48 (4) 
Neutrophils/ 
Leukocytes 
60.0 
% 
39.1-77.2 
Platelets 
245 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:18 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.07 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
0.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.8 
pg 
25-33.6 
Page 931


SIGA TECHNOLOGIES, INC.  
Page 135 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:18 (8) 
Ery. Mean Corpuscular 
Volume 
88.7 
fL 
76.5-97.5 
Erythrocytes 
5.18 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.8 
% 
11.8-15.5 
Hematocrit 
0.459 fraction 
of 1 
0.387-0.507 
Hemoglobin 
154 
g/L 
128-174 
Leukocytes 
7.5 
10^9/L 
3.1-9.7 
Lymphocytes 
2.74 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
36.8 
% 
13.9-48.3 
Monocytes 
0.51 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.8 
% 
3.3-12.1 
Neutrophils 
4.10 
10^9/L 
1.5-6.75 
Page 932


SIGA TECHNOLOGIES, INC.  
Page 136 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:18 (8) 
Neutrophils/ 
Leukocytes 
55.0 
% 
39.1-77.2 
Platelets 
247 
10^9/L 
140-400 
Day 9 
12SEP2019 
08:18 (9) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.07 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
344 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.1 
pg 
25-33.6 
Page 933


SIGA TECHNOLOGIES, INC.  
Page 137 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:18 (9) 
Ery. Mean Corpuscular 
Volume 
87.4 
fL 
76.5-97.5 
Erythrocytes 
5.34 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.5 
% 
11.8-15.5 
Hematocrit 
0.467 fraction 
of 1 
0.387-0.507 
Hemoglobin 
161 
g/L 
128-174 
Leukocytes 
7.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.50 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
34.7 
% 
13.9-48.3 
Monocytes 
0.39 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.3 
% 
3.3-12.1 
Neutrophils 
4.20 
10^9/L 
1.5-6.75 
Page 934


SIGA TECHNOLOGIES, INC.  
Page 138 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:18 (9) 
Neutrophils/ 
Leukocytes 
58.3 
% 
39.1-77.2 
Platelets 
258 
10^9/L 
140-400 
9043 
22/M/BL 
Screening 11SEP2019 
09:38 (-7) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.08 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
337 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.4 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
84.2 
fL 
76.5-97.5 
Page 935


SIGA TECHNOLOGIES, INC.  
Page 139 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
Screening 11SEP2019 
09:38 (-7) 
Erythrocytes 
5.18 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.3 
% 
11.8-15.5 
Hematocrit 
0.436 fraction 
of 1 
0.387-0.507 
Hemoglobin 
147 
g/L 
128-174 
Leukocytes 
3.7 
10^9/L 
3.1-9.7 
Lymphocytes 
1.04 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
28.1 
% 
13.9-48.3 
Monocytes 
0.44 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
11.9 
% 
3.3-12.1 
Neutrophils 
2.14 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
57.5 
% 
39.1-77.2 
Page 936


SIGA TECHNOLOGIES, INC.  
Page 140 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
Screening 11SEP2019 
09:38 (-7) 
Platelets 
260 
10^9/L 
140-400 
Check-in 17SEP2019 
09:06 (-1) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
342 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
84.0 
fL 
76.5-97.5 
Erythrocytes 
5.22 
10^12/L 
4.28-6.03 
Page 937


SIGA TECHNOLOGIES, INC.  
Page 141 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
Check-in 17SEP2019 
09:06 (-1) 
Erythrocytes 
Distribution Width 
12.4 
% 
11.8-15.5 
Hematocrit 
0.439 fraction 
of 1 
0.387-0.507 
Hemoglobin 
150 
g/L 
128-174 
Leukocytes 
3.9 
10^9/L 
3.1-9.7 
Lymphocytes 
1.10 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
28.3 
% 
13.9-48.3 
Monocytes 
0.54 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
13.9 
% 
H NCS 
3.3-12.1 
Neutrophils 
2.11 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.5 
% 
39.1-77.2 
Platelets 
236 
10^9/L 
140-400 
Page 938


SIGA TECHNOLOGIES, INC.  
Page 142 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:28 (4) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.12 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
341 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
84.1 
fL 
76.5-97.5 
Erythrocytes 
5.71 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.3 
% 
11.8-15.5 
Page 939


SIGA TECHNOLOGIES, INC.  
Page 143 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:28 (4) 
Hematocrit 
0.481 fraction 
of 1 
0.387-0.507 
Hemoglobin 
164 
g/L 
128-174 
Leukocytes 
3.8 
10^9/L 
3.1-9.7 
Lymphocytes 
1.38 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
36.2 
% 
13.9-48.3 
Monocytes 
0.53 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
13.9 
% 
H NCS 
3.3-12.1 
Neutrophils 
1.77 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
46.3 
% 
39.1-77.2 
Platelets 
251 
10^9/L 
140-400 
Day 4 
23SEP2019 
10:02 (6), R 
Basophils 
0.02 
10^9/L 
0-0.08 
Page 940


SIGA TECHNOLOGIES, INC.  
Page 144 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 4 
23SEP2019 
10:02 (6), R 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
344 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.5 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
82.8 
fL 
76.5-97.5 
Erythrocytes 
5.52 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.0 
% 
11.8-15.5 
Hematocrit 
0.457 fraction 
of 1 
0.387-0.507 
Hemoglobin 
157 
g/L 
128-174 
Page 941


SIGA TECHNOLOGIES, INC.  
Page 145 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 4 
23SEP2019 
10:02 (6), R 
Leukocytes 
4.0 
10^9/L 
3.1-9.7 
Lymphocytes 
1.16 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
28.6 
% 
13.9-48.3 
Monocytes 
0.57 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
14.1 
% 
H NCS 
3.3-12.1 
Neutrophils 
2.21 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.6 
% 
39.1-77.2 
Platelets 
260 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:32 (8) 
Basophils 
0.03 
10^9/L 
0-0.08 
Page 942


SIGA TECHNOLOGIES, INC.  
Page 146 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:32 (8) 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.13 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
340 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.4 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
83.6 
fL 
76.5-97.5 
Erythrocytes 
5.69 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.1 
% 
11.8-15.5 
Hematocrit 
0.476 fraction 
of 1 
0.387-0.507 
Page 943


SIGA TECHNOLOGIES, INC.  
Page 147 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:32 (8) 
Hemoglobin 
162 
g/L 
128-174 
Leukocytes 
4.7 
10^9/L 
3.1-9.7 
Lymphocytes 
1.37 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
29.5 
% 
13.9-48.3 
Monocytes 
0.67 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
14.3 
% 
H NCS 
3.3-12.1 
Neutrophils 
2.46 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
52.9 
% 
39.1-77.2 
Platelets 
242 
10^9/L 
140-400 
Day 9 
26SEP2019 
08:11 (9) 
Basophils 
0.02 
10^9/L 
0-0.08 
Page 944


SIGA TECHNOLOGIES, INC.  
Page 148 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 9 
26SEP2019 
08:11 (9) 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
346 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
83.4 
fL 
76.5-97.5 
Erythrocytes 
5.35 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.4 
% 
11.8-15.5 
Hematocrit 
0.446 fraction 
of 1 
0.387-0.507 
Hemoglobin 
154 
g/L 
128-174 
Page 945


SIGA TECHNOLOGIES, INC.  
Page 149 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 9 
26SEP2019 
08:11 (9) 
Leukocytes 
3.8 
10^9/L 
3.1-9.7 
Lymphocytes 
1.16 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
30.3 
% 
13.9-48.3 
Monocytes 
0.58 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
15.2 
% 
H NCS 
3.3-12.1 
Neutrophils 
1.97 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
51.4 
% 
39.1-77.2 
Platelets 
234 
10^9/L 
140-400 
9046 
34/M/BL 
Screening 13SEP2019 
09:12 (-5) 
Basophils 
0.09 
10^9/L 
H NCS 
0-0.08 
Basophils/ 
Leukocytes 
2.7 
% 
H NCS 
0-1.4 
Page 946


SIGA TECHNOLOGIES, INC.  
Page 150 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
Screening 13SEP2019 
09:12 (-5) 
Eosinophils 
0.15 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
4.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
328 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.2 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
92.1 
fL 
76.5-97.5 
Erythrocytes 
4.40 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.7 
% 
11.8-15.5 
Hematocrit 
0.405 fraction 
of 1 
0.387-0.507 
Hemoglobin 
133 
g/L 
128-174 
Leukocytes 
3.3 
10^9/L 
3.1-9.7 
Page 947


SIGA TECHNOLOGIES, INC.  
Page 151 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
Screening 13SEP2019 
09:12 (-5) 
Lymphocytes 
1.14 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
34.1 
% 
13.9-48.3 
Monocytes 
0.36 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.8 
% 
3.3-12.1 
Neutrophils 
1.60 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
48.1 
% 
39.1-77.2 
Platelets 
175 
10^9/L 
140-400 
Check-in 17SEP2019 
09:05 (-1) 
Basophils 
0.09 
10^9/L 
H NCS 
0-0.08 
Basophils/ 
Leukocytes 
2.8 
% 
H NCS 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Page 948


SIGA TECHNOLOGIES, INC.  
Page 152 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
Check-in 17SEP2019 
09:05 (-1) 
Eosinophils/ 
Leukocytes 
3.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
326 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.1 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
92.5 
fL 
76.5-97.5 
Erythrocytes 
4.45 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.6 
% 
11.8-15.5 
Hematocrit 
0.412 fraction 
of 1 
0.387-0.507 
Hemoglobin 
134 
g/L 
128-174 
Leukocytes 
3.2 
10^9/L 
3.1-9.7 
Lymphocytes 
1.09 
10^9/L 
0.8-2.91 
Page 949


SIGA TECHNOLOGIES, INC.  
Page 153 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
Check-in 17SEP2019 
09:05 (-1) 
Lymphocytes/ 
Leukocytes 
34.3 
% 
13.9-48.3 
Monocytes 
0.36 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
11.4 
% 
3.3-12.1 
Neutrophils 
1.54 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
48.3 
% 
39.1-77.2 
Platelets 
188 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:31 (4) 
Basophils 
0.09 
10^9/L 
H NCS 
0-0.08 
Basophils/ 
Leukocytes 
2.6 
% 
H NCS 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.5 
% 
0-6.1 
Page 950


SIGA TECHNOLOGIES, INC.  
Page 154 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:31 (4) 
Ery. Mean Corpuscular 
HGB Concentration 
328 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.1 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
91.9 
fL 
76.5-97.5 
Erythrocytes 
4.67 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.5 
% 
11.8-15.5 
Hematocrit 
0.429 fraction 
of 1 
0.387-0.507 
Hemoglobin 
141 
g/L 
128-174 
Leukocytes 
3.3 
10^9/L 
3.1-9.7 
Lymphocytes 
1.32 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
39.7 
% 
13.9-48.3 
Monocytes 
0.45 
10^9/L 
0.15-0.75 
Page 951


SIGA TECHNOLOGIES, INC.  
Page 155 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:31 (4) 
Monocytes/ 
Leukocytes 
13.5 
% 
H NCS 
3.3-12.1 
Neutrophils 
1.35 
10^9/L 
L NCS 
1.5-6.75 
Neutrophils/ 
Leukocytes 
40.8 
% 
39.1-77.2 
Platelets 
201 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:06 (8) 
Basophils 
0.08 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
2.4 
% 
H NCS 
0-1.4 
Eosinophils 
0.13 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
327 
g/L 
320-354 
Page 952


SIGA TECHNOLOGIES, INC.  
Page 156 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:06 (8) 
Ery. Mean Corpuscular 
Hemoglobin 
30.3 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
92.5 
fL 
76.5-97.5 
Erythrocytes 
4.69 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.4 
% 
11.8-15.5 
Hematocrit 
0.434 fraction 
of 1 
0.387-0.507 
Hemoglobin 
142 
g/L 
128-174 
Leukocytes 
3.2 
10^9/L 
3.1-9.7 
Lymphocytes 
1.12 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
34.6 
% 
13.9-48.3 
Monocytes 
0.43 
10^9/L 
0.15-0.75 
Page 953


SIGA TECHNOLOGIES, INC.  
Page 157 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:06 (8) 
Monocytes/ 
Leukocytes 
13.3 
% 
H NCS 
3.3-12.1 
Neutrophils 
1.48 
10^9/L 
L NCS 
1.5-6.75 
Neutrophils/ 
Leukocytes 
45.8 
% 
39.1-77.2 
Platelets 
195 
10^9/L 
140-400 
Day 9 
26SEP2019 
08:06 (9) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
2.2 
% 
H NCS 
0-1.4 
Eosinophils 
0.13 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
4.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
325 
g/L 
320-354 
Page 954


SIGA TECHNOLOGIES, INC.  
Page 158 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 9 
26SEP2019 
08:06 (9) 
Ery. Mean Corpuscular 
Hemoglobin 
30.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
92.4 
fL 
76.5-97.5 
Erythrocytes 
4.67 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.5 
% 
11.8-15.5 
Hematocrit 
0.432 fraction 
of 1 
0.387-0.507 
Hemoglobin 
140 
g/L 
128-174 
Leukocytes 
3.1 
10^9/L 
3.1-9.7 
Lymphocytes 
0.84 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
27.4 
% 
13.9-48.3 
Monocytes 
0.52 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
17.1 
% 
H NCS 
3.3-12.1 
Page 955


SIGA TECHNOLOGIES, INC.  
Page 159 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 9 
26SEP2019 
08:06 (9) 
Neutrophils 
1.50 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
49.1 
% 
39.1-77.2 
Platelets 
196 
10^9/L 
140-400 
9051 
34/M/BL 
Screening 19SEP2019 
09:10 (-13) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.1 
pg 
25-33.6 
Page 956


SIGA TECHNOLOGIES, INC.  
Page 160 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
Screening 19SEP2019 
09:10 (-13) 
Ery. Mean Corpuscular 
Volume 
89.8 
fL 
76.5-97.5 
Erythrocytes 
5.20 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.5 
% 
11.8-15.5 
Hematocrit 
0.467 fraction 
of 1 
0.387-0.507 
Hemoglobin 
157 
g/L 
128-174 
Leukocytes 
5.8 
10^9/L 
3.1-9.7 
Lymphocytes 
2.10 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
36.1 
% 
13.9-48.3 
Monocytes 
0.51 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.7 
% 
3.3-12.1 
Neutrophils 
3.06 
10^9/L 
1.5-6.75 
Page 957


SIGA TECHNOLOGIES, INC.  
Page 161 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
Screening 19SEP2019 
09:10 (-13) 
Neutrophils/ 
Leukocytes 
52.6 
% 
39.1-77.2 
Platelets 
195 
10^9/L 
140-400 
Check-in 01OCT2019 
09:01 (-1) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.13 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
337 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.2 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.7 
fL 
76.5-97.5 
Page 958


SIGA TECHNOLOGIES, INC.  
Page 162 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
Check-in 01OCT2019 
09:01 (-1) 
Erythrocytes 
4.98 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.5 
% 
11.8-15.5 
Hematocrit 
0.447 fraction 
of 1 
0.387-0.507 
Hemoglobin 
151 
g/L 
128-174 
Leukocytes 
5.1 
10^9/L 
3.1-9.7 
Lymphocytes 
1.80 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
35.6 
% 
13.9-48.3 
Monocytes 
0.40 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.9 
% 
3.3-12.1 
Neutrophils 
2.70 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
53.4 
% 
39.1-77.2 
Page 959


SIGA TECHNOLOGIES, INC.  
Page 163 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
Check-in 01OCT2019 
09:01 (-1) 
Platelets 
206 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:40 (4) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.1 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.5 
fL 
76.5-97.5 
Erythrocytes 
5.39 
10^12/L 
4.28-6.03 
Page 960


SIGA TECHNOLOGIES, INC.  
Page 164 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:40 (4) 
Erythrocytes 
Distribution Width 
13.6 
% 
11.8-15.5 
Hematocrit 
0.483 fraction 
of 1 
0.387-0.507 
Hemoglobin 
162 
g/L 
128-174 
Leukocytes 
6.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.38 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
38.3 
% 
13.9-48.3 
Monocytes 
0.59 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.5 
% 
3.3-12.1 
Neutrophils 
3.06 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
49.2 
% 
39.1-77.2 
Platelets 
248 
10^9/L 
140-400 
Page 961


SIGA TECHNOLOGIES, INC.  
Page 165 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:15 (8) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.12 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.9 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
88.9 
fL 
76.5-97.5 
Erythrocytes 
5.27 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.3 
% 
11.8-15.5 
Page 962


SIGA TECHNOLOGIES, INC.  
Page 166 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:15 (8) 
Hematocrit 
0.468 fraction 
of 1 
0.387-0.507 
Hemoglobin 
157 
g/L 
128-174 
Leukocytes 
4.9 
10^9/L 
3.1-9.7 
Lymphocytes 
2.01 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
41.3 
% 
13.9-48.3 
Monocytes 
0.51 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.4 
% 
3.3-12.1 
Neutrophils 
2.20 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
45.1 
% 
39.1-77.2 
Platelets 
246 
10^9/L 
140-400 
Page 963


SIGA TECHNOLOGIES, INC.  
Page 167 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:15 (9) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.07 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
339 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.1 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
88.8 
fL 
76.5-97.5 
Erythrocytes 
5.16 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.3 
% 
11.8-15.5 
Page 964


SIGA TECHNOLOGIES, INC.  
Page 168 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:15 (9) 
Hematocrit 
0.458 fraction 
of 1 
0.387-0.507 
Hemoglobin 
155 
g/L 
128-174 
Leukocytes 
4.6 
10^9/L 
3.1-9.7 
Lymphocytes 
1.63 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
35.5 
% 
13.9-48.3 
Monocytes 
0.48 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.6 
% 
3.3-12.1 
Neutrophils 
2.38 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
51.8 
% 
39.1-77.2 
Platelets 
244 
10^9/L 
140-400 
9052 
42/M/BL 
Screening 21SEP2019 
13:12 (-11) 
Basophils 
0.02 
10^9/L 
0-0.08 
Page 965


SIGA TECHNOLOGIES, INC.  
Page 169 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
Screening 21SEP2019 
13:12 (-11) 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.04 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
0.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.2 
fL 
76.5-97.5 
Erythrocytes 
5.09 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.9 
% 
11.8-15.5 
Hematocrit 
0.439 fraction 
of 1 
0.387-0.507 
Hemoglobin 
148 
g/L 
128-174 
Page 966


SIGA TECHNOLOGIES, INC.  
Page 170 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
Screening 21SEP2019 
13:12 (-11) 
Leukocytes 
5.5 
10^9/L 
3.1-9.7 
Lymphocytes 
2.10 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
38.4 
% 
13.9-48.3 
Monocytes 
0.40 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.3 
% 
3.3-12.1 
Neutrophils 
2.90 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
53.0 
% 
39.1-77.2 
Platelets 
192 
10^9/L 
140-400 
Check-in 01OCT2019 
09:15 (-1) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Page 967


SIGA TECHNOLOGIES, INC.  
Page 171 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
Check-in 01OCT2019 
09:15 (-1) 
Eosinophils 
0.03 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
0.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.7 
fL 
76.5-97.5 
Erythrocytes 
5.15 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.9 
% 
11.8-15.5 
Hematocrit 
0.447 fraction 
of 1 
0.387-0.507 
Hemoglobin 
150 
g/L 
128-174 
Leukocytes 
4.8 
10^9/L 
3.1-9.7 
Page 968


SIGA TECHNOLOGIES, INC.  
Page 172 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
Check-in 01OCT2019 
09:15 (-1) 
Lymphocytes 
2.27 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
47.0 
% 
13.9-48.3 
Monocytes 
0.40 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.2 
% 
3.3-12.1 
Neutrophils 
2.10 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
43.6 
% 
39.1-77.2 
Platelets 
207 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:44 (4) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.05 
10^9/L 
0-0.35 
Page 969


SIGA TECHNOLOGIES, INC.  
Page 173 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:44 (4) 
Eosinophils/ 
Leukocytes 
1.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.5 
fL 
76.5-97.5 
Erythrocytes 
5.02 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.9 
% 
11.8-15.5 
Hematocrit 
0.434 fraction 
of 1 
0.387-0.507 
Hemoglobin 
146 
g/L 
128-174 
Leukocytes 
5.1 
10^9/L 
3.1-9.7 
Lymphocytes 
2.34 
10^9/L 
0.8-2.91 
Page 970


SIGA TECHNOLOGIES, INC.  
Page 174 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:44 (4) 
Lymphocytes/ 
Leukocytes 
46.2 
% 
13.9-48.3 
Monocytes 
0.40 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.9 
% 
3.3-12.1 
Neutrophils 
2.24 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
44.4 
% 
39.1-77.2 
Platelets 
202 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:19 (8) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.2 
% 
0-1.4 
Eosinophils 
0.15 
10^9/L 
0-0.35 
Page 971


SIGA TECHNOLOGIES, INC.  
Page 175 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:19 (8) 
Eosinophils/ 
Leukocytes 
2.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
340 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.2 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
85.9 
fL 
76.5-97.5 
Erythrocytes 
4.91 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.7 
% 
11.8-15.5 
Hematocrit 
0.422 fraction 
of 1 
0.387-0.507 
Hemoglobin 
143 
g/L 
128-174 
Leukocytes 
5.2 
10^9/L 
3.1-9.7 
Lymphocytes 
1.81 
10^9/L 
0.8-2.91 
Page 972


SIGA TECHNOLOGIES, INC.  
Page 176 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:19 (8) 
Lymphocytes/ 
Leukocytes 
34.8 
% 
13.9-48.3 
Monocytes 
0.52 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.1 
% 
3.3-12.1 
Neutrophils 
2.66 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
51.2 
% 
39.1-77.2 
Platelets 
195 
10^9/L 
140-400 
Day 9 
10OCT2019 
08:19 (9) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Page 973


SIGA TECHNOLOGIES, INC.  
Page 177 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:19 (9) 
Eosinophils/ 
Leukocytes 
2.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
338 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.2 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.3 
fL 
76.5-97.5 
Erythrocytes 
4.95 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.0 
% 
11.8-15.5 
Hematocrit 
0.427 fraction 
of 1 
0.387-0.507 
Hemoglobin 
145 
g/L 
128-174 
Leukocytes 
4.2 
10^9/L 
3.1-9.7 
Lymphocytes 
1.81 
10^9/L 
0.8-2.91 
Page 974


SIGA TECHNOLOGIES, INC.  
Page 178 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:19 (9) 
Lymphocytes/ 
Leukocytes 
43.1 
% 
13.9-48.3 
Monocytes 
0.39 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.2 
% 
3.3-12.1 
Neutrophils 
1.87 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
44.5 
% 
39.1-77.2 
Platelets 
200 
10^9/L 
140-400 
9056 
31/F/BL 
Screening 24SEP2019 
10:06 (-8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.20 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.1 
% 
0-6.1 
Page 975


SIGA TECHNOLOGIES, INC.  
Page 179 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
Screening 24SEP2019 
10:06 (-8) 
Ery. Mean Corpuscular 
HGB Concentration 
328 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
29.2 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
88.9 
fL 
72.2-99.1 
Erythrocytes 
4.40 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.1 
% 
11.1-17.3 
Hematocrit 
0.391 fraction 
of 1 
0.335-0.444 
Hemoglobin 
129 
g/L 
108-150 
Leukocytes 
6.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.29 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
35.6 
% 
13.9-48.3 
Monocytes 
0.37 
10^9/L 
0.15-0.75 
Page 976


SIGA TECHNOLOGIES, INC.  
Page 180 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
Screening 24SEP2019 
10:06 (-8) 
Monocytes/ 
Leukocytes 
5.7 
% 
3.3-12.1 
Neutrophils 
3.52 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.9 
% 
39.1-77.2 
Platelets 
273 
10^9/L 
140-400 
Check-in 01OCT2019 
09:26 (-1) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
314-348 
Page 977


SIGA TECHNOLOGIES, INC.  
Page 181 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
Check-in 01OCT2019 
09:26 (-1) 
Ery. Mean Corpuscular 
Hemoglobin 
29.5 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
88.1 
fL 
72.2-99.1 
Erythrocytes 
4.42 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.0 
% 
11.1-17.3 
Hematocrit 
0.390 fraction 
of 1 
0.335-0.444 
Hemoglobin 
131 
g/L 
108-150 
Leukocytes 
4.5 
10^9/L 
3.1-9.7 
Lymphocytes 
1.74 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
38.4 
% 
13.9-48.3 
Monocytes 
0.30 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.5 
% 
3.3-12.1 
Page 978


SIGA TECHNOLOGIES, INC.  
Page 182 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
Check-in 01OCT2019 
09:26 (-1) 
Neutrophils 
2.37 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
52.3 
% 
39.1-77.2 
Platelets 
294 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:25 (4) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.14 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
334 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
29.7 
pg 
22.9-33.9 
Page 979


SIGA TECHNOLOGIES, INC.  
Page 183 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:25 (4) 
Ery. Mean Corpuscular 
Volume 
88.9 
fL 
72.2-99.1 
Erythrocytes 
4.53 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.3 
% 
11.1-17.3 
Hematocrit 
0.403 fraction 
of 1 
0.335-0.444 
Hemoglobin 
135 
g/L 
108-150 
Leukocytes 
4.3 
10^9/L 
3.1-9.7 
Lymphocytes 
1.90 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
44.5 
% 
13.9-48.3 
Monocytes 
0.27 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.4 
% 
3.3-12.1 
Neutrophils 
1.93 
10^9/L 
1.5-6.75 
Page 980


SIGA TECHNOLOGIES, INC.  
Page 184 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:25 (4) 
Neutrophils/ 
Leukocytes 
45.1 
% 
39.1-77.2 
Platelets 
304 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:03 (8) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.21 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
4.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
340 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
30.1 
pg 
22.9-33.9 
Page 981


SIGA TECHNOLOGIES, INC.  
Page 185 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:03 (8) 
Ery. Mean Corpuscular 
Volume 
88.4 
fL 
72.2-99.1 
Erythrocytes 
4.55 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.3 
% 
11.1-17.3 
Hematocrit 
0.402 fraction 
of 1 
0.335-0.444 
Hemoglobin 
137 
g/L 
108-150 
Leukocytes 
5.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.34 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
44.8 
% 
13.9-48.3 
Monocytes 
0.38 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.3 
% 
3.3-12.1 
Neutrophils 
2.27 
10^9/L 
1.5-6.75 
Page 982


SIGA TECHNOLOGIES, INC.  
Page 186 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:03 (8) 
Neutrophils/ 
Leukocytes 
43.4 
% 
39.1-77.2 
Platelets 
319 
10^9/L 
140-400 
Day 9 
10OCT2019 
08:00 (9) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
337 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
30.0 
pg 
22.9-33.9 
Page 983


SIGA TECHNOLOGIES, INC.  
Page 187 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:00 (9) 
Ery. Mean Corpuscular 
Volume 
89.0 
fL 
72.2-99.1 
Erythrocytes 
4.30 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.1 
% 
11.1-17.3 
Hematocrit 
0.382 fraction 
of 1 
0.335-0.444 
Hemoglobin 
129 
g/L 
108-150 
Leukocytes 
4.4 
10^9/L 
3.1-9.7 
Lymphocytes 
1.81 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
41.5 
% 
13.9-48.3 
Monocytes 
0.30 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.9 
% 
3.3-12.1 
Neutrophils 
2.08 
10^9/L 
1.5-6.75 
Page 984


SIGA TECHNOLOGIES, INC.  
Page 188 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:00 (9) 
Neutrophils/ 
Leukocytes 
47.6 
% 
39.1-77.2 
Platelets 
299 
10^9/L 
140-400 
9057 
29/F/W 
Screening 25SEP2019 
16:27 (-7) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.08 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
329 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
27.8 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
84.5 
fL 
72.2-99.1 
Page 985


SIGA TECHNOLOGIES, INC.  
Page 189 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
Screening 25SEP2019 
16:27 (-7) 
Erythrocytes 
4.91 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.5 
% 
11.1-17.3 
Hematocrit 
0.415 fraction 
of 1 
0.335-0.444 
Hemoglobin 
136 
g/L 
108-150 
Leukocytes 
7.2 
10^9/L 
3.1-9.7 
Lymphocytes 
1.94 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
26.9 
% 
13.9-48.3 
Monocytes 
0.50 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.9 
% 
3.3-12.1 
Neutrophils 
4.66 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.6 
% 
39.1-77.2 
Page 986


SIGA TECHNOLOGIES, INC.  
Page 190 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
Screening 25SEP2019 
16:27 (-7) 
Platelets 
333 
10^9/L 
140-400 
Check-in 01OCT2019 
09:22 (-1) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.07 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
28.3 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
84.1 
fL 
72.2-99.1 
Erythrocytes 
4.64 
10^12/L 
3.84-5.28 
Page 987


SIGA TECHNOLOGIES, INC.  
Page 191 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
Check-in 01OCT2019 
09:22 (-1) 
Erythrocytes 
Distribution Width 
13.4 
% 
11.1-17.3 
Hematocrit 
0.390 fraction 
of 1 
0.335-0.444 
Hemoglobin 
131 
g/L 
108-150 
Leukocytes 
7.3 
10^9/L 
3.1-9.7 
Lymphocytes 
1.51 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
20.7 
% 
13.9-48.3 
Monocytes 
0.44 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.0 
% 
3.3-12.1 
Neutrophils 
5.27 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
72.0 
% 
39.1-77.2 
Platelets 
320 
10^9/L 
140-400 
Page 988


SIGA TECHNOLOGIES, INC.  
Page 192 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:28 (4) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.09 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
345 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
29.0 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
84.0 
fL 
72.2-99.1 
Erythrocytes 
4.69 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.1 
% 
11.1-17.3 
Page 989


SIGA TECHNOLOGIES, INC.  
Page 193 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:28 (4) 
Hematocrit 
0.394 fraction 
of 1 
0.335-0.444 
Hemoglobin 
136 
g/L 
108-150 
Leukocytes 
7.3 
10^9/L 
3.1-9.7 
Lymphocytes 
1.85 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
25.3 
% 
13.9-48.3 
Monocytes 
0.50 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.9 
% 
3.3-12.1 
Neutrophils 
4.84 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
66.2 
% 
39.1-77.2 
Platelets 
361 
10^9/L 
140-400 
Page 990


SIGA TECHNOLOGIES, INC.  
Page 194 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:03 (8) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.09 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
340 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
28.6 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
84.1 
fL 
72.2-99.1 
Erythrocytes 
4.72 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.3 
% 
11.1-17.3 
Page 991


SIGA TECHNOLOGIES, INC.  
Page 195 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:03 (8) 
Hematocrit 
0.396 fraction 
of 1 
0.335-0.444 
Hemoglobin 
135 
g/L 
108-150 
Leukocytes 
7.1 
10^9/L 
3.1-9.7 
Lymphocytes 
1.45 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
20.4 
% 
13.9-48.3 
Monocytes 
0.42 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.9 
% 
3.3-12.1 
Neutrophils 
5.13 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
72.1 
% 
39.1-77.2 
Platelets 
356 
10^9/L 
140-400 
Page 992


SIGA TECHNOLOGIES, INC.  
Page 196 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:03 (9) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.09 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
340 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
29.0 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
85.1 
fL 
72.2-99.1 
Erythrocytes 
4.84 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.2 
% 
11.1-17.3 
Page 993


SIGA TECHNOLOGIES, INC.  
Page 197 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:03 (9) 
Hematocrit 
0.412 fraction 
of 1 
0.335-0.444 
Hemoglobin 
140 
g/L 
108-150 
Leukocytes 
6.6 
10^9/L 
3.1-9.7 
Lymphocytes 
1.51 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
23.0 
% 
13.9-48.3 
Monocytes 
0.43 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.5 
% 
3.3-12.1 
Neutrophils 
4.50 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
68.4 
% 
39.1-77.2 
Platelets 
353 
10^9/L 
140-400 
9058 
32/M/W 
Screening 26SEP2019 
09:26 (-20) 
Basophils 
0.07 
10^9/L 
0-0.08 
Page 994


SIGA TECHNOLOGIES, INC.  
Page 198 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
Screening 26SEP2019 
09:26 (-20) 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.09 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
315 
g/L 
L NCS 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
19.2 
pg 
L NCS 
25-33.6 
Ery. Mean Corpuscular 
Volume 
60.9 
fL 
L NCS 
76.5-97.5 
Erythrocytes 
6.73 
10^12/L 
H NCS 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.7 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.409 fraction 
of 1 
0.387-0.507 
Hemoglobin 
129 
g/L 
128-174 
Page 995


SIGA TECHNOLOGIES, INC.  
Page 199 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
Screening 26SEP2019 
09:26 (-20) 
Leukocytes 
6.7 
10^9/L 
3.1-9.7 
Lymphocytes 
1.81 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
27.0 
% 
13.9-48.3 
Monocytes 
0.56 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.4 
% 
3.3-12.1 
Neutrophils 
4.17 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
62.3 
% 
39.1-77.2 
Platelets 
245 
10^9/L 
140-400 
Check-in 15OCT2019 
09:07 (-1) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.9 
% 
0-1.4 
Page 996


SIGA TECHNOLOGIES, INC.  
Page 200 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
Check-in 15OCT2019 
09:07 (-1) 
Eosinophils 
0.08 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
312 
g/L 
L NCS 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
19.0 
pg 
L NCS 
25-33.6 
Ery. Mean Corpuscular 
Volume 
60.9 
fL 
L NCS 
76.5-97.5 
Erythrocytes 
6.66 
10^12/L 
H NCS 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.6 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.406 fraction 
of 1 
0.387-0.507 
Hemoglobin 
127 
g/L 
L NCS 
128-174 
Leukocytes 
5.8 
10^9/L 
3.1-9.7 
Page 997


SIGA TECHNOLOGIES, INC.  
Page 201 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
Check-in 15OCT2019 
09:07 (-1) 
Lymphocytes 
1.85 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
31.7 
% 
13.9-48.3 
Monocytes 
0.43 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.4 
% 
3.3-12.1 
Neutrophils 
3.42 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
58.7 
% 
39.1-77.2 
Platelets 
252 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:32 (4) 
Basophils 
0.08 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.2 
% 
0-1.4 
Eosinophils 
0.08 
10^9/L 
0-0.35 
Page 998


SIGA TECHNOLOGIES, INC.  
Page 202 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:32 (4) 
Eosinophils/ 
Leukocytes 
1.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
316 
g/L 
L NCS 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
19.4 
pg 
L NCS 
25-33.6 
Ery. Mean Corpuscular 
Volume 
61.5 
fL 
L NCS 
76.5-97.5 
Erythrocytes 
6.60 
10^12/L 
H NCS 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.8 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.406 fraction 
of 1 
0.387-0.507 
Hemoglobin 
128 
g/L 
128-174 
Leukocytes 
7.0 
10^9/L 
3.1-9.7 
Lymphocytes 
2.14 
10^9/L 
0.8-2.91 
Page 999


SIGA TECHNOLOGIES, INC.  
Page 203 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:32 (4) 
Lymphocytes/ 
Leukocytes 
30.7 
% 
13.9-48.3 
Monocytes 
0.55 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.9 
% 
3.3-12.1 
Neutrophils 
4.12 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
59.1 
% 
39.1-77.2 
Platelets 
238 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:29 (8) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.09 
10^9/L 
0-0.35 
Page 1000


SIGA TECHNOLOGIES, INC.  
Page 204 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:29 (8) 
Eosinophils/ 
Leukocytes 
1.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
317 
g/L 
L NCS 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
19.2 
pg 
L NCS 
25-33.6 
Ery. Mean Corpuscular 
Volume 
60.8 
fL 
L NCS 
76.5-97.5 
Erythrocytes 
6.59 
10^12/L 
H NCS 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.6 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.401 fraction 
of 1 
0.387-0.507 
Hemoglobin 
127 
g/L 
L NCS 
128-174 
Leukocytes 
6.0 
10^9/L 
3.1-9.7 
Lymphocytes 
1.94 
10^9/L 
0.8-2.91 
Page 1001


SIGA TECHNOLOGIES, INC.  
Page 205 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:29 (8) 
Lymphocytes/ 
Leukocytes 
32.4 
% 
13.9-48.3 
Monocytes 
0.46 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.6 
% 
3.3-12.1 
Neutrophils 
3.47 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
57.8 
% 
39.1-77.2 
Platelets 
236 
10^9/L 
140-400 
Day 9 
24OCT2019 
08:08 (9) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.08 
10^9/L 
0-0.35 
Page 1002


SIGA TECHNOLOGIES, INC.  
Page 206 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:08 (9) 
Eosinophils/ 
Leukocytes 
1.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
308 
g/L 
L NCS 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
18.9 
pg 
L NCS 
25-33.6 
Ery. Mean Corpuscular 
Volume 
61.4 
fL 
L NCS 
76.5-97.5 
Erythrocytes 
6.82 
10^12/L 
H NCS 
4.28-6.03 
Erythrocytes 
Distribution Width 
16.0 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.419 fraction 
of 1 
0.387-0.507 
Hemoglobin 
129 
g/L 
128-174 
Leukocytes 
5.7 
10^9/L 
3.1-9.7 
Lymphocytes 
1.72 
10^9/L 
0.8-2.91 
Page 1003


SIGA TECHNOLOGIES, INC.  
Page 207 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:08 (9) 
Lymphocytes/ 
Leukocytes 
30.0 
% 
13.9-48.3 
Monocytes 
0.47 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.2 
% 
3.3-12.1 
Neutrophils 
3.42 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
59.6 
% 
39.1-77.2 
Platelets 
258 
10^9/L 
140-400 
9061 
21/F/BL 
Screening 26SEP2019 
11:06 (-20) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.9 
% 
0-1.4 
Eosinophils 
0.18 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.8 
% 
0-6.1 
Page 1004


SIGA TECHNOLOGIES, INC.  
Page 208 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
Screening 26SEP2019 
11:06 (-20) 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
28.0 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
83.5 
fL 
72.2-99.1 
Erythrocytes 
4.46 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.0 
% 
11.1-17.3 
Hematocrit 
0.372 fraction 
of 1 
0.335-0.444 
Hemoglobin 
125 
g/L 
108-150 
Leukocytes 
6.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.16 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
33.8 
% 
13.9-48.3 
Monocytes 
0.48 
10^9/L 
0.15-0.75 
Page 1005


SIGA TECHNOLOGIES, INC.  
Page 209 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
Screening 26SEP2019 
11:06 (-20) 
Monocytes/ 
Leukocytes 
7.5 
% 
3.3-12.1 
Neutrophils 
3.51 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
55.0 
% 
39.1-77.2 
Platelets 
296 
10^9/L 
140-400 
Check-in 15OCT2019 
09:01 (-1) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.44 
10^9/L 
H NCS 
0-0.35 
Eosinophils/ 
Leukocytes 
6.7 
% 
H NCS 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
327 
g/L 
314-348 
Page 1006


SIGA TECHNOLOGIES, INC.  
Page 210 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
Check-in 15OCT2019 
09:01 (-1) 
Ery. Mean Corpuscular 
Hemoglobin 
27.6 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
84.4 
fL 
72.2-99.1 
Erythrocytes 
4.41 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
14.6 
% 
11.1-17.3 
Hematocrit 
0.372 fraction 
of 1 
0.335-0.444 
Hemoglobin 
122 
g/L 
108-150 
Leukocytes 
6.5 
10^9/L 
3.1-9.7 
Lymphocytes 
2.40 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
37.0 
% 
13.9-48.3 
Monocytes 
0.52 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.0 
% 
3.3-12.1 
Page 1007


SIGA TECHNOLOGIES, INC.  
Page 211 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
Check-in 15OCT2019 
09:01 (-1) 
Neutrophils 
3.09 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
47.6 
% 
39.1-77.2 
Platelets 
296 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:35 (4) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.25 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
328 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
27.4 
pg 
22.9-33.9 
Page 1008


SIGA TECHNOLOGIES, INC.  
Page 212 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:35 (4) 
Ery. Mean Corpuscular 
Volume 
83.5 
fL 
72.2-99.1 
Erythrocytes 
4.57 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
14.6 
% 
11.1-17.3 
Hematocrit 
0.381 fraction 
of 1 
0.335-0.444 
Hemoglobin 
125 
g/L 
108-150 
Leukocytes 
6.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.44 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
38.2 
% 
13.9-48.3 
Monocytes 
0.43 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.8 
% 
3.3-12.1 
Neutrophils 
3.21 
10^9/L 
1.5-6.75 
Page 1009


SIGA TECHNOLOGIES, INC.  
Page 213 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:35 (4) 
Neutrophils/ 
Leukocytes 
50.3 
% 
39.1-77.2 
Platelets 
318 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:06 (8) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.9 
% 
0-1.4 
Eosinophils 
0.21 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
333 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
27.8 
pg 
22.9-33.9 
Page 1010


SIGA TECHNOLOGIES, INC.  
Page 214 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:06 (8) 
Ery. Mean Corpuscular 
Volume 
83.5 
fL 
72.2-99.1 
Erythrocytes 
4.45 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
14.2 
% 
11.1-17.3 
Hematocrit 
0.372 fraction 
of 1 
0.335-0.444 
Hemoglobin 
124 
g/L 
108-150 
Leukocytes 
6.6 
10^9/L 
3.1-9.7 
Lymphocytes 
2.12 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
32.2 
% 
13.9-48.3 
Monocytes 
0.56 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.4 
% 
3.3-12.1 
Neutrophils 
3.65 
10^9/L 
1.5-6.75 
Page 1011


SIGA TECHNOLOGIES, INC.  
Page 215 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:06 (8) 
Neutrophils/ 
Leukocytes 
55.3 
% 
39.1-77.2 
Platelets 
305 
10^9/L 
140-400 
Day 9 
24OCT2019 
08:03 (9) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.18 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
325 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
27.5 
pg 
22.9-33.9 
Page 1012


SIGA TECHNOLOGIES, INC.  
Page 216 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:03 (9) 
Ery. Mean Corpuscular 
Volume 
84.6 
fL 
72.2-99.1 
Erythrocytes 
4.64 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
14.6 
% 
11.1-17.3 
Hematocrit 
0.393 fraction 
of 1 
0.335-0.444 
Hemoglobin 
128 
g/L 
108-150 
Leukocytes 
6.1 
10^9/L 
3.1-9.7 
Lymphocytes 
2.05 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
33.6 
% 
13.9-48.3 
Monocytes 
0.55 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.9 
% 
3.3-12.1 
Neutrophils 
3.29 
10^9/L 
1.5-6.75 
Page 1013


SIGA TECHNOLOGIES, INC.  
Page 217 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:03 (9) 
Neutrophils/ 
Leukocytes 
53.8 
% 
39.1-77.2 
Platelets 
324 
10^9/L 
140-400 
9062 
33/M/BL 
Screening 30SEP2019 
10:25 (-2) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.07 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
332 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.2 
fL 
76.5-97.5 
Page 1014


SIGA TECHNOLOGIES, INC.  
Page 218 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
Screening 30SEP2019 
10:25 (-2) 
Erythrocytes 
4.98 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.4 
% 
11.8-15.5 
Hematocrit 
0.430 fraction 
of 1 
0.387-0.507 
Hemoglobin 
143 
g/L 
128-174 
Leukocytes 
5.5 
10^9/L 
3.1-9.7 
Lymphocytes 
1.50 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
27.1 
% 
13.9-48.3 
Monocytes 
0.58 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.6 
% 
3.3-12.1 
Neutrophils 
3.35 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
60.7 
% 
39.1-77.2 
Page 1015


SIGA TECHNOLOGIES, INC.  
Page 219 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
Screening 30SEP2019 
10:25 (-2) 
Platelets 
211 
10^9/L 
140-400 
Check-in 01OCT2019 
09:29 (-1) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.05 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
0.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
330 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.4 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.0 
fL 
76.5-97.5 
Erythrocytes 
4.83 
10^12/L 
4.28-6.03 
Page 1016


SIGA TECHNOLOGIES, INC.  
Page 220 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
Check-in 01OCT2019 
09:29 (-1) 
Erythrocytes 
Distribution Width 
14.1 
% 
11.8-15.5 
Hematocrit 
0.416 fraction 
of 1 
0.387-0.507 
Hemoglobin 
137 
g/L 
128-174 
Leukocytes 
5.9 
10^9/L 
3.1-9.7 
Lymphocytes 
1.60 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
27.3 
% 
13.9-48.3 
Monocytes 
0.63 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.8 
% 
3.3-12.1 
Neutrophils 
3.56 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
60.8 
% 
39.1-77.2 
Platelets 
230 
10^9/L 
140-400 
Page 1017


SIGA TECHNOLOGIES, INC.  
Page 221 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:31 (4) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.07 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
333 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.3 
fL 
76.5-97.5 
Erythrocytes 
5.09 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.1 
% 
11.8-15.5 
Page 1018


SIGA TECHNOLOGIES, INC.  
Page 222 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:31 (4) 
Hematocrit 
0.439 fraction 
of 1 
0.387-0.507 
Hemoglobin 
146 
g/L 
128-174 
Leukocytes 
5.8 
10^9/L 
3.1-9.7 
Lymphocytes 
1.61 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
27.7 
% 
13.9-48.3 
Monocytes 
0.56 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.6 
% 
3.3-12.1 
Neutrophils 
3.55 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
61.0 
% 
39.1-77.2 
Platelets 
244 
10^9/L 
140-400 
Page 1019


SIGA TECHNOLOGIES, INC.  
Page 223 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:06 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.07 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
338 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.1 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.1 
fL 
76.5-97.5 
Erythrocytes 
5.07 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.0 
% 
11.8-15.5 
Page 1020


SIGA TECHNOLOGIES, INC.  
Page 224 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:06 (8) 
Hematocrit 
0.437 fraction 
of 1 
0.387-0.507 
Hemoglobin 
148 
g/L 
128-174 
Leukocytes 
6.3 
10^9/L 
3.1-9.7 
Lymphocytes 
2.17 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
34.6 
% 
13.9-48.3 
Monocytes 
0.59 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.4 
% 
3.3-12.1 
Neutrophils 
3.41 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.2 
% 
39.1-77.2 
Platelets 
240 
10^9/L 
140-400 
Page 1021


SIGA TECHNOLOGIES, INC.  
Page 225 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:06 (9) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.06 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
337 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.0 
fL 
76.5-97.5 
Erythrocytes 
4.99 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.8 
% 
11.8-15.5 
Page 1022


SIGA TECHNOLOGIES, INC.  
Page 226 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:06 (9) 
Hematocrit 
0.430 fraction 
of 1 
0.387-0.507 
Hemoglobin 
145 
g/L 
128-174 
Leukocytes 
5.4 
10^9/L 
3.1-9.7 
Lymphocytes 
1.50 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
27.7 
% 
13.9-48.3 
Monocytes 
0.54 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.0 
% 
3.3-12.1 
Neutrophils 
3.30 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
61.0 
% 
39.1-77.2 
Platelets 
236 
10^9/L 
140-400 
9063 
35/M/W 
Screening 30SEP2019 
09:38 (-2) 
Basophils 
0.03 
10^9/L 
0-0.08 
Page 1023


SIGA TECHNOLOGIES, INC.  
Page 227 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
Screening 30SEP2019 
09:38 (-2) 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.22 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
343 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.1 
fL 
76.5-97.5 
Erythrocytes 
5.00 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.8 
% 
11.8-15.5 
Hematocrit 
0.445 fraction 
of 1 
0.387-0.507 
Hemoglobin 
153 
g/L 
128-174 
Page 1024


SIGA TECHNOLOGIES, INC.  
Page 228 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
Screening 30SEP2019 
09:38 (-2) 
Leukocytes 
7.3 
10^9/L 
3.1-9.7 
Lymphocytes 
1.88 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
25.8 
% 
13.9-48.3 
Monocytes 
0.54 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.4 
% 
3.3-12.1 
Neutrophils 
4.63 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
63.4 
% 
39.1-77.2 
Platelets 
315 
10^9/L 
140-400 
Check-in 01OCT2019 
08:48 (-1) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.3 
% 
0-1.4 
Page 1025


SIGA TECHNOLOGIES, INC.  
Page 229 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
Check-in 01OCT2019 
08:48 (-1) 
Eosinophils 
0.27 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.5 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.5 
fL 
76.5-97.5 
Erythrocytes 
5.03 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.9 
% 
11.8-15.5 
Hematocrit 
0.450 fraction 
of 1 
0.387-0.507 
Hemoglobin 
151 
g/L 
128-174 
Leukocytes 
7.9 
10^9/L 
3.1-9.7 
Page 1026


SIGA TECHNOLOGIES, INC.  
Page 230 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
Check-in 01OCT2019 
08:48 (-1) 
Lymphocytes 
2.25 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
28.6 
% 
13.9-48.3 
Monocytes 
0.62 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.9 
% 
3.3-12.1 
Neutrophils 
4.71 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
59.8 
% 
39.1-77.2 
Platelets 
307 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:34 (4) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.20 
10^9/L 
0-0.35 
Page 1027


SIGA TECHNOLOGIES, INC.  
Page 231 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:34 (4) 
Eosinophils/ 
Leukocytes 
3.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
338 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.2 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.2 
fL 
76.5-97.5 
Erythrocytes 
5.07 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.8 
% 
11.8-15.5 
Hematocrit 
0.452 fraction 
of 1 
0.387-0.507 
Hemoglobin 
153 
g/L 
128-174 
Leukocytes 
6.7 
10^9/L 
3.1-9.7 
Lymphocytes 
2.13 
10^9/L 
0.8-2.91 
Page 1028


SIGA TECHNOLOGIES, INC.  
Page 232 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:34 (4) 
Lymphocytes/ 
Leukocytes 
31.7 
% 
13.9-48.3 
Monocytes 
0.57 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.5 
% 
3.3-12.1 
Neutrophils 
3.78 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
56.3 
% 
39.1-77.2 
Platelets 
332 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:09 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.17 
10^9/L 
0-0.35 
Page 1029


SIGA TECHNOLOGIES, INC.  
Page 233 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:09 (8) 
Eosinophils/ 
Leukocytes 
2.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.9 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.1 
fL 
76.5-97.5 
Erythrocytes 
5.26 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.9 
% 
11.8-15.5 
Hematocrit 
0.469 fraction 
of 1 
0.387-0.507 
Hemoglobin 
157 
g/L 
128-174 
Leukocytes 
7.3 
10^9/L 
3.1-9.7 
Lymphocytes 
2.43 
10^9/L 
0.8-2.91 
Page 1030


SIGA TECHNOLOGIES, INC.  
Page 234 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:09 (8) 
Lymphocytes/ 
Leukocytes 
33.1 
% 
13.9-48.3 
Monocytes 
0.56 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.7 
% 
3.3-12.1 
Neutrophils 
4.13 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
56.4 
% 
39.1-77.2 
Platelets 
357 
10^9/L 
140-400 
Day 9 
10OCT2019 
08:09 (9) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.14 
10^9/L 
0-0.35 
Page 1031


SIGA TECHNOLOGIES, INC.  
Page 235 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:09 (9) 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
342 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.4 
fL 
76.5-97.5 
Erythrocytes 
5.22 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.7 
% 
11.8-15.5 
Hematocrit 
0.466 fraction 
of 1 
0.387-0.507 
Hemoglobin 
160 
g/L 
128-174 
Leukocytes 
7.4 
10^9/L 
3.1-9.7 
Lymphocytes 
1.95 
10^9/L 
0.8-2.91 
Page 1032


SIGA TECHNOLOGIES, INC.  
Page 236 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:09 (9) 
Lymphocytes/ 
Leukocytes 
26.3 
% 
13.9-48.3 
Monocytes 
0.56 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.5 
% 
3.3-12.1 
Neutrophils 
4.75 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
63.9 
% 
39.1-77.2 
Platelets 
347 
10^9/L 
140-400 
9069 
41/F/BL 
Screening 30SEP2019 
11:19 (-16) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.23 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.5 
% 
0-6.1 
Page 1033


SIGA TECHNOLOGIES, INC.  
Page 237 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
Screening 30SEP2019 
11:19 (-16) 
Ery. Mean Corpuscular 
HGB Concentration 
319 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
24.8 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
77.7 
fL 
72.2-99.1 
Erythrocytes 
5.05 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.7 
% 
11.1-17.3 
Hematocrit 
0.392 fraction 
of 1 
0.335-0.444 
Hemoglobin 
125 
g/L 
108-150 
Leukocytes 
6.5 
10^9/L 
3.1-9.7 
Lymphocytes 
1.93 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
29.7 
% 
13.9-48.3 
Monocytes 
0.50 
10^9/L 
0.15-0.75 
Page 1034


SIGA TECHNOLOGIES, INC.  
Page 238 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
Screening 30SEP2019 
11:19 (-16) 
Monocytes/ 
Leukocytes 
7.6 
% 
3.3-12.1 
Neutrophils 
3.78 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
58.2 
% 
39.1-77.2 
Platelets 
243 
10^9/L 
140-400 
Check-in 15OCT2019 
12:32 (-1) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.20 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
318 
g/L 
314-348 
Page 1035


SIGA TECHNOLOGIES, INC.  
Page 239 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
Check-in 15OCT2019 
12:32 (-1) 
Ery. Mean Corpuscular 
Hemoglobin 
25.1 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
78.8 
fL 
72.2-99.1 
Erythrocytes 
4.73 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.3 
% 
11.1-17.3 
Hematocrit 
0.373 fraction 
of 1 
0.335-0.444 
Hemoglobin 
119 
g/L 
108-150 
Leukocytes 
6.6 
10^9/L 
3.1-9.7 
Lymphocytes 
1.79 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
26.9 
% 
13.9-48.3 
Monocytes 
0.51 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.7 
% 
3.3-12.1 
Page 1036


SIGA TECHNOLOGIES, INC.  
Page 240 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
Check-in 15OCT2019 
12:32 (-1) 
Neutrophils 
4.11 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
61.8 
% 
39.1-77.2 
Platelets 
250 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:35 (4) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.21 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
318 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
24.7 
pg 
22.9-33.9 
Page 1037


SIGA TECHNOLOGIES, INC.  
Page 241 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:35 (4) 
Ery. Mean Corpuscular 
Volume 
77.7 
fL 
72.2-99.1 
Erythrocytes 
4.75 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.3 
% 
11.1-17.3 
Hematocrit 
0.369 fraction 
of 1 
0.335-0.444 
Hemoglobin 
117 
g/L 
108-150 
Leukocytes 
7.5 
10^9/L 
3.1-9.7 
Lymphocytes 
1.92 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
25.8 
% 
13.9-48.3 
Monocytes 
0.61 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.1 
% 
3.3-12.1 
Neutrophils 
4.68 
10^9/L 
1.5-6.75 
Page 1038


SIGA TECHNOLOGIES, INC.  
Page 242 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:35 (4) 
Neutrophils/ 
Leukocytes 
62.8 
% 
39.1-77.2 
Platelets 
245 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:17 (8) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.20 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
321 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
25.2 
pg 
22.9-33.9 
Page 1039


SIGA TECHNOLOGIES, INC.  
Page 243 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:17 (8) 
Ery. Mean Corpuscular 
Volume 
78.4 
fL 
72.2-99.1 
Erythrocytes 
4.72 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.3 
% 
11.1-17.3 
Hematocrit 
0.370 fraction 
of 1 
0.335-0.444 
Hemoglobin 
119 
g/L 
108-150 
Leukocytes 
6.9 
10^9/L 
3.1-9.7 
Lymphocytes 
2.12 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
30.5 
% 
13.9-48.3 
Monocytes 
0.62 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.0 
% 
3.3-12.1 
Neutrophils 
3.95 
10^9/L 
1.5-6.75 
Page 1040


SIGA TECHNOLOGIES, INC.  
Page 244 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:17 (8) 
Neutrophils/ 
Leukocytes 
56.9 
% 
39.1-77.2 
Platelets 
248 
10^9/L 
140-400 
Day 9 
24OCT2019 
08:06 (9) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.19 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
317 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
24.6 
pg 
22.9-33.9 
Page 1041


SIGA TECHNOLOGIES, INC.  
Page 245 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:06 (9) 
Ery. Mean Corpuscular 
Volume 
77.5 
fL 
72.2-99.1 
Erythrocytes 
4.72 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
15.2 
% 
11.1-17.3 
Hematocrit 
0.365 fraction 
of 1 
0.335-0.444 
Hemoglobin 
116 
g/L 
108-150 
Leukocytes 
7.4 
10^9/L 
3.1-9.7 
Lymphocytes 
1.80 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
24.2 
% 
13.9-48.3 
Monocytes 
0.62 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.3 
% 
3.3-12.1 
Neutrophils 
4.78 
10^9/L 
1.5-6.75 
Page 1042


SIGA TECHNOLOGIES, INC.  
Page 246 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:06 (9) 
Neutrophils/ 
Leukocytes 
64.3 
% 
39.1-77.2 
Platelets 
239 
10^9/L 
140-400 
9073 
40/M/BL 
Screening 04OCT2019 
13:56 (-12) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.17 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
334 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.2 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.5 
fL 
76.5-97.5 
Page 1043


SIGA TECHNOLOGIES, INC.  
Page 247 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
Screening 04OCT2019 
13:56 (-12) 
Erythrocytes 
4.80 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.0 
% 
11.8-15.5 
Hematocrit 
0.420 fraction 
of 1 
0.387-0.507 
Hemoglobin 
140 
g/L 
128-174 
Leukocytes 
7.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.15 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
28.9 
% 
13.9-48.3 
Monocytes 
0.60 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.1 
% 
3.3-12.1 
Neutrophils 
4.47 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
60.3 
% 
39.1-77.2 
Page 1044


SIGA TECHNOLOGIES, INC.  
Page 248 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
Screening 04OCT2019 
13:56 (-12) 
Platelets 
242 
10^9/L 
140-400 
Check-in 15OCT2019 
09:18 (-1) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
332 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.9 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.2 
fL 
76.5-97.5 
Erythrocytes 
4.64 
10^12/L 
4.28-6.03 
Page 1045


SIGA TECHNOLOGIES, INC.  
Page 249 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
Check-in 15OCT2019 
09:18 (-1) 
Erythrocytes 
Distribution Width 
13.5 
% 
11.8-15.5 
Hematocrit 
0.405 fraction 
of 1 
0.387-0.507 
Hemoglobin 
134 
g/L 
128-174 
Leukocytes 
7.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.50 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
34.6 
% 
13.9-48.3 
Monocytes 
0.63 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.6 
% 
3.3-12.1 
Neutrophils 
3.91 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
53.9 
% 
39.1-77.2 
Platelets 
223 
10^9/L 
140-400 
Page 1046


SIGA TECHNOLOGIES, INC.  
Page 250 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:41 (4) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
332 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.3 
fL 
76.5-97.5 
Erythrocytes 
4.83 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.1 
% 
11.8-15.5 
Page 1047


SIGA TECHNOLOGIES, INC.  
Page 251 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:41 (4) 
Hematocrit 
0.417 fraction 
of 1 
0.387-0.507 
Hemoglobin 
138 
g/L 
128-174 
Leukocytes 
6.9 
10^9/L 
3.1-9.7 
Lymphocytes 
2.67 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
38.8 
% 
13.9-48.3 
Monocytes 
0.47 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.9 
% 
3.3-12.1 
Neutrophils 
3.52 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
51.2 
% 
39.1-77.2 
Platelets 
225 
10^9/L 
140-400 
Page 1048


SIGA TECHNOLOGIES, INC.  
Page 252 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:16 (8) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.19 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
331 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.2 
fL 
76.5-97.5 
Erythrocytes 
5.00 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.3 
% 
11.8-15.5 
Page 1049


SIGA TECHNOLOGIES, INC.  
Page 253 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:16 (8) 
Hematocrit 
0.436 fraction 
of 1 
0.387-0.507 
Hemoglobin 
144 
g/L 
128-174 
Leukocytes 
7.1 
10^9/L 
3.1-9.7 
Lymphocytes 
2.89 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
40.7 
% 
13.9-48.3 
Monocytes 
0.49 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.9 
% 
3.3-12.1 
Neutrophils 
3.49 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
49.2 
% 
39.1-77.2 
Platelets 
246 
10^9/L 
140-400 
Page 1050


SIGA TECHNOLOGIES, INC.  
Page 254 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:16 (9) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
330 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.1 
fL 
76.5-97.5 
Erythrocytes 
4.88 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.2 
% 
11.8-15.5 
Page 1051


SIGA TECHNOLOGIES, INC.  
Page 255 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:16 (9) 
Hematocrit 
0.425 fraction 
of 1 
0.387-0.507 
Hemoglobin 
140 
g/L 
128-174 
Leukocytes 
6.9 
10^9/L 
3.1-9.7 
Lymphocytes 
2.70 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
38.9 
% 
13.9-48.3 
Monocytes 
0.53 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.7 
% 
3.3-12.1 
Neutrophils 
3.49 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
50.4 
% 
39.1-77.2 
Platelets 
233 
10^9/L 
140-400 
9077 
37/F/W 
Screening 05OCT2019 
13:15 (-11) 
Basophils 
0.04 
10^9/L 
0-0.08 
Page 1052


SIGA TECHNOLOGIES, INC.  
Page 256 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
Screening 05OCT2019 
13:15 (-11) 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.18 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
29.3 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
87.4 
fL 
72.2-99.1 
Erythrocytes 
4.40 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.0 
% 
11.1-17.3 
Hematocrit 
0.385 fraction 
of 1 
0.335-0.444 
Hemoglobin 
129 
g/L 
108-150 
Page 1053


SIGA TECHNOLOGIES, INC.  
Page 257 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
Screening 05OCT2019 
13:15 (-11) 
Leukocytes 
5.3 
10^9/L 
3.1-9.7 
Lymphocytes 
1.62 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
30.6 
% 
13.9-48.3 
Monocytes 
0.39 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.4 
% 
3.3-12.1 
Neutrophils 
3.06 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
57.8 
% 
39.1-77.2 
Platelets 
313 
10^9/L 
140-400 
Check-in 15OCT2019 
09:28 (-1) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Page 1054


SIGA TECHNOLOGIES, INC.  
Page 258 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
Check-in 15OCT2019 
09:28 (-1) 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
338 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
29.0 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
85.6 
fL 
72.2-99.1 
Erythrocytes 
4.51 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.0 
% 
11.1-17.3 
Hematocrit 
0.386 fraction 
of 1 
0.335-0.444 
Hemoglobin 
131 
g/L 
108-150 
Leukocytes 
5.9 
10^9/L 
3.1-9.7 
Page 1055


SIGA TECHNOLOGIES, INC.  
Page 259 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
Check-in 15OCT2019 
09:28 (-1) 
Lymphocytes 
1.66 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
27.9 
% 
13.9-48.3 
Monocytes 
0.51 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.6 
% 
3.3-12.1 
Neutrophils 
3.64 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
61.2 
% 
39.1-77.2 
Platelets 
330 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:37 (4) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Page 1056


SIGA TECHNOLOGIES, INC.  
Page 260 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:37 (4) 
Eosinophils/ 
Leukocytes 
1.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
337 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
29.0 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
86.0 
fL 
72.2-99.1 
Erythrocytes 
4.64 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.0 
% 
11.1-17.3 
Hematocrit 
0.399 fraction 
of 1 
0.335-0.444 
Hemoglobin 
134 
g/L 
108-150 
Leukocytes 
6.0 
10^9/L 
3.1-9.7 
Lymphocytes 
1.99 
10^9/L 
0.8-2.91 
Page 1057


SIGA TECHNOLOGIES, INC.  
Page 261 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:37 (4) 
Lymphocytes/ 
Leukocytes 
32.9 
% 
13.9-48.3 
Monocytes 
0.50 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.3 
% 
3.3-12.1 
Neutrophils 
3.40 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
56.4 
% 
39.1-77.2 
Platelets 
331 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:12 (8) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Page 1058


SIGA TECHNOLOGIES, INC.  
Page 262 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:12 (8) 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
339 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
29.5 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
86.9 
fL 
72.2-99.1 
Erythrocytes 
4.45 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.0 
% 
11.1-17.3 
Hematocrit 
0.387 fraction 
of 1 
0.335-0.444 
Hemoglobin 
131 
g/L 
108-150 
Leukocytes 
5.2 
10^9/L 
3.1-9.7 
Lymphocytes 
1.55 
10^9/L 
0.8-2.91 
Page 1059


SIGA TECHNOLOGIES, INC.  
Page 263 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:12 (8) 
Lymphocytes/ 
Leukocytes 
30.0 
% 
13.9-48.3 
Monocytes 
0.39 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.6 
% 
3.3-12.1 
Neutrophils 
3.11 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
60.0 
% 
39.1-77.2 
Platelets 
314 
10^9/L 
140-400 
Day 9 
24OCT2019 
08:12 (9) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Page 1060


SIGA TECHNOLOGIES, INC.  
Page 264 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:12 (9) 
Eosinophils/ 
Leukocytes 
2.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
330 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
28.5 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
86.3 
fL 
72.2-99.1 
Erythrocytes 
4.54 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.0 
% 
11.1-17.3 
Hematocrit 
0.392 fraction 
of 1 
0.335-0.444 
Hemoglobin 
129 
g/L 
108-150 
Leukocytes 
5.1 
10^9/L 
3.1-9.7 
Lymphocytes 
1.52 
10^9/L 
0.8-2.91 
Page 1061


SIGA TECHNOLOGIES, INC.  
Page 265 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:12 (9) 
Lymphocytes/ 
Leukocytes 
29.8 
% 
13.9-48.3 
Monocytes 
0.37 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.2 
% 
3.3-12.1 
Neutrophils 
3.06 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
60.1 
% 
39.1-77.2 
Platelets 
330 
10^9/L 
140-400 
9080 
41/F/BL 
Screening 08OCT2019 
11:46 (-8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.18 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.9 
% 
0-6.1 
Page 1062


SIGA TECHNOLOGIES, INC.  
Page 266 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
Screening 08OCT2019 
11:46 (-8) 
Ery. Mean Corpuscular 
HGB Concentration 
341 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
32.3 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
94.8 
fL 
72.2-99.1 
Erythrocytes 
4.40 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.8 
% 
11.1-17.3 
Hematocrit 
0.417 fraction 
of 1 
0.335-0.444 
Hemoglobin 
142 
g/L 
108-150 
Leukocytes 
6.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.48 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
38.8 
% 
13.9-48.3 
Monocytes 
0.46 
10^9/L 
0.15-0.75 
Page 1063


SIGA TECHNOLOGIES, INC.  
Page 267 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
Screening 08OCT2019 
11:46 (-8) 
Monocytes/ 
Leukocytes 
7.1 
% 
3.3-12.1 
Neutrophils 
3.24 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
50.7 
% 
39.1-77.2 
Platelets 
305 
10^9/L 
140-400 
Check-in 15OCT2019 
09:30 (-1) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.20 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
340 
g/L 
314-348 
Page 1064


SIGA TECHNOLOGIES, INC.  
Page 268 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
Check-in 15OCT2019 
09:30 (-1) 
Ery. Mean Corpuscular 
Hemoglobin 
32.1 
pg 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
94.6 
fL 
72.2-99.1 
Erythrocytes 
4.13 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.4 
% 
11.1-17.3 
Hematocrit 
0.391 fraction 
of 1 
0.335-0.444 
Hemoglobin 
133 
g/L 
108-150 
Leukocytes 
7.7 
10^9/L 
3.1-9.7 
Lymphocytes 
2.72 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
35.4 
% 
13.9-48.3 
Monocytes 
0.64 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.4 
% 
3.3-12.1 
Page 1065


SIGA TECHNOLOGIES, INC.  
Page 269 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
Check-in 15OCT2019 
09:30 (-1) 
Neutrophils 
4.07 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
53.1 
% 
39.1-77.2 
Platelets 
283 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:46 (4) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.34 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
4.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
31.7 
pg 
22.9-33.9 
Page 1066


SIGA TECHNOLOGIES, INC.  
Page 270 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:46 (4) 
Ery. Mean Corpuscular 
Volume 
94.6 
fL 
72.2-99.1 
Erythrocytes 
4.75 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.8 
% 
11.1-17.3 
Hematocrit 
0.449 fraction 
of 1 
H NCS 
0.335-0.444 
Hemoglobin 
150 
g/L 
108-150 
Leukocytes 
8.1 
10^9/L 
3.1-9.7 
Lymphocytes 
3.24 
10^9/L 
H NCS 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
40.0 
% 
13.9-48.3 
Monocytes 
0.50 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.2 
% 
3.3-12.1 
Neutrophils 
3.99 
10^9/L 
1.5-6.75 
Page 1067


SIGA TECHNOLOGIES, INC.  
Page 271 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:46 (4) 
Neutrophils/ 
Leukocytes 
49.2 
% 
39.1-77.2 
Platelets 
313 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:21 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.20 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
341 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
32.3 
pg 
22.9-33.9 
Page 1068


SIGA TECHNOLOGIES, INC.  
Page 272 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:21 (8) 
Ery. Mean Corpuscular 
Volume 
94.5 
fL 
72.2-99.1 
Erythrocytes 
4.42 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.3 
% 
11.1-17.3 
Hematocrit 
0.418 fraction 
of 1 
0.335-0.444 
Hemoglobin 
143 
g/L 
108-150 
Leukocytes 
7.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.78 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
37.7 
% 
13.9-48.3 
Monocytes 
0.57 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.7 
% 
3.3-12.1 
Neutrophils 
3.78 
10^9/L 
1.5-6.75 
Page 1069


SIGA TECHNOLOGIES, INC.  
Page 273 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:21 (8) 
Neutrophils/ 
Leukocytes 
51.3 
% 
39.1-77.2 
Platelets 
303 
10^9/L 
140-400 
Day 9 
24OCT2019 
08:21 (9) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
344 
g/L 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
32.3 
pg 
22.9-33.9 
Page 1070


SIGA TECHNOLOGIES, INC.  
Page 274 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:21 (9) 
Ery. Mean Corpuscular 
Volume 
93.9 
fL 
72.2-99.1 
Erythrocytes 
4.11 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
13.2 
% 
11.1-17.3 
Hematocrit 
0.386 fraction 
of 1 
0.335-0.444 
Hemoglobin 
133 
g/L 
108-150 
Leukocytes 
6.9 
10^9/L 
3.1-9.7 
Lymphocytes 
2.55 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
37.1 
% 
13.9-48.3 
Monocytes 
0.62 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.1 
% 
3.3-12.1 
Neutrophils 
3.51 
10^9/L 
1.5-6.75 
Page 1071


SIGA TECHNOLOGIES, INC.  
Page 275 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:21 (9) 
Neutrophils/ 
Leukocytes 
51.0 
% 
39.1-77.2 
Platelets 
283 
10^9/L 
140-400 
9081 
49/M/BL 
Screening 10OCT2019 
12:25 (-20) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.19 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
333 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
88.9 
fL 
76.5-97.5 
Page 1072


SIGA TECHNOLOGIES, INC.  
Page 276 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
Screening 10OCT2019 
12:25 (-20) 
Erythrocytes 
5.05 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.1 
% 
11.8-15.5 
Hematocrit 
0.449 fraction 
of 1 
0.387-0.507 
Hemoglobin 
150 
g/L 
128-174 
Leukocytes 
6.6 
10^9/L 
3.1-9.7 
Lymphocytes 
2.06 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
31.3 
% 
13.9-48.3 
Monocytes 
0.69 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.5 
% 
3.3-12.1 
Neutrophils 
3.60 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.7 
% 
39.1-77.2 
Page 1073


SIGA TECHNOLOGIES, INC.  
Page 277 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
Screening 10OCT2019 
12:25 (-20) 
Platelets 
286 
10^9/L 
140-400 
Check-in 29OCT2019 
10:08 (-1) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.17 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
325 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.1 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.3 
fL 
76.5-97.5 
Erythrocytes 
5.02 
10^12/L 
4.28-6.03 
Page 1074


SIGA TECHNOLOGIES, INC.  
Page 278 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
Check-in 29OCT2019 
10:08 (-1) 
Erythrocytes 
Distribution Width 
14.2 
% 
11.8-15.5 
Hematocrit 
0.448 fraction 
of 1 
0.387-0.507 
Hemoglobin 
146 
g/L 
128-174 
Leukocytes 
6.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.01 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
32.4 
% 
13.9-48.3 
Monocytes 
0.73 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
11.7 
% 
3.3-12.1 
Neutrophils 
3.25 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
52.5 
% 
39.1-77.2 
Platelets 
294 
10^9/L 
140-400 
Page 1075


SIGA TECHNOLOGIES, INC.  
Page 279 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 4 
02NOV2019 
07:27 (4) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.19 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
333 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.2 
fL 
76.5-97.5 
Erythrocytes 
4.87 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.9 
% 
11.8-15.5 
Page 1076


SIGA TECHNOLOGIES, INC.  
Page 280 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 4 
02NOV2019 
07:27 (4) 
Hematocrit 
0.434 fraction 
of 1 
0.387-0.507 
Hemoglobin 
145 
g/L 
128-174 
Leukocytes 
6.6 
10^9/L 
3.1-9.7 
Lymphocytes 
2.34 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
35.3 
% 
13.9-48.3 
Monocytes 
0.65 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.8 
% 
3.3-12.1 
Neutrophils 
3.39 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
51.1 
% 
39.1-77.2 
Platelets 
284 
10^9/L 
140-400 
Page 1077


SIGA TECHNOLOGIES, INC.  
Page 281 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
06NOV2019 
07:00 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.17 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
330 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.7 
fL 
76.5-97.5 
Erythrocytes 
4.90 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.9 
% 
11.8-15.5 
Page 1078


SIGA TECHNOLOGIES, INC.  
Page 282 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
06NOV2019 
07:00 (8) 
Hematocrit 
0.440 fraction 
of 1 
0.387-0.507 
Hemoglobin 
145 
g/L 
128-174 
Leukocytes 
6.0 
10^9/L 
3.1-9.7 
Lymphocytes 
1.90 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
31.7 
% 
13.9-48.3 
Monocytes 
0.64 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.7 
% 
3.3-12.1 
Neutrophils 
3.24 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.0 
% 
39.1-77.2 
Platelets 
304 
10^9/L 
140-400 
Page 1079


SIGA TECHNOLOGIES, INC.  
Page 283 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 9 
07NOV2019 
07:00 (9) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.17 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
333 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
89.3 
fL 
76.5-97.5 
Erythrocytes 
4.88 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.2 
% 
11.8-15.5 
Page 1080


SIGA TECHNOLOGIES, INC.  
Page 284 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 9 
07NOV2019 
07:00 (9) 
Hematocrit 
0.436 fraction 
of 1 
0.387-0.507 
Hemoglobin 
145 
g/L 
128-174 
Leukocytes 
5.8 
10^9/L 
3.1-9.7 
Lymphocytes 
1.89 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
32.3 
% 
13.9-48.3 
Monocytes 
0.60 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
10.3 
% 
3.3-12.1 
Neutrophils 
3.15 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
53.9 
% 
39.1-77.2 
Platelets 
308 
10^9/L 
140-400 
9086 
36/M/BL 
Screening 11OCT2019 
10:03 (-5) 
Basophils 
0.01 
10^9/L 
0-0.08 
Page 1081


SIGA TECHNOLOGIES, INC.  
Page 285 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
Screening 11OCT2019 
10:03 (-5) 
Basophils/ 
Leukocytes 
0.2 
% 
0-1.4 
Eosinophils 
0.03 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
0.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
325 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
85.4 
fL 
76.5-97.5 
Erythrocytes 
5.25 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.5 
% 
11.8-15.5 
Hematocrit 
0.449 fraction 
of 1 
0.387-0.507 
Hemoglobin 
146 
g/L 
128-174 
Page 1082


SIGA TECHNOLOGIES, INC.  
Page 286 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
Screening 11OCT2019 
10:03 (-5) 
Leukocytes 
4.9 
10^9/L 
3.1-9.7 
Lymphocytes 
1.77 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
35.9 
% 
13.9-48.3 
Monocytes 
0.41 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.4 
% 
3.3-12.1 
Neutrophils 
2.71 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.9 
% 
39.1-77.2 
Platelets 
219 
10^9/L 
140-400 
Check-in 15OCT2019 
09:28 (-1) 
Basophils 
0.01 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.3 
% 
0-1.4 
Page 1083


SIGA TECHNOLOGIES, INC.  
Page 287 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
Check-in 15OCT2019 
09:28 (-1) 
Eosinophils 
0.03 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
0.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.9 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
83.4 
fL 
76.5-97.5 
Erythrocytes 
5.08 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.6 
% 
H NCS 
11.8-15.5 
Hematocrit 
0.424 fraction 
of 1 
0.387-0.507 
Hemoglobin 
142 
g/L 
128-174 
Leukocytes 
4.1 
10^9/L 
3.1-9.7 
Page 1084


SIGA TECHNOLOGIES, INC.  
Page 288 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
Check-in 15OCT2019 
09:28 (-1) 
Lymphocytes 
1.71 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
41.4 
% 
13.9-48.3 
Monocytes 
0.34 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.3 
% 
3.3-12.1 
Neutrophils 
2.04 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
49.3 
% 
39.1-77.2 
Platelets 
214 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:40 (4) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.03 
10^9/L 
0-0.35 
Page 1085


SIGA TECHNOLOGIES, INC.  
Page 289 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:40 (4) 
Eosinophils/ 
Leukocytes 
0.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
333 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
84.2 
fL 
76.5-97.5 
Erythrocytes 
5.35 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.3 
% 
11.8-15.5 
Hematocrit 
0.450 fraction 
of 1 
0.387-0.507 
Hemoglobin 
150 
g/L 
128-174 
Leukocytes 
4.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.04 
10^9/L 
0.8-2.91 
Page 1086


SIGA TECHNOLOGIES, INC.  
Page 290 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:40 (4) 
Lymphocytes/ 
Leukocytes 
46.0 
% 
13.9-48.3 
Monocytes 
0.41 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.2 
% 
3.3-12.1 
Neutrophils 
1.94 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
43.7 
% 
39.1-77.2 
Platelets 
224 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:15 (8) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.04 
10^9/L 
0-0.35 
Page 1087


SIGA TECHNOLOGIES, INC.  
Page 291 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:15 (8) 
Eosinophils/ 
Leukocytes 
0.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
332 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
28.2 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
85.1 
fL 
76.5-97.5 
Erythrocytes 
5.38 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.2 
% 
11.8-15.5 
Hematocrit 
0.458 fraction 
of 1 
0.387-0.507 
Hemoglobin 
152 
g/L 
128-174 
Leukocytes 
4.7 
10^9/L 
3.1-9.7 
Lymphocytes 
2.07 
10^9/L 
0.8-2.91 
Page 1088


SIGA TECHNOLOGIES, INC.  
Page 292 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:15 (8) 
Lymphocytes/ 
Leukocytes 
43.6 
% 
13.9-48.3 
Monocytes 
0.38 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.9 
% 
3.3-12.1 
Neutrophils 
2.24 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
47.3 
% 
39.1-77.2 
Platelets 
218 
10^9/L 
140-400 
Day 9 
24OCT2019 
08:15 (9) 
Basophils 
0.01 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.3 
% 
0-1.4 
Eosinophils 
0.04 
10^9/L 
0-0.35 
Page 1089


SIGA TECHNOLOGIES, INC.  
Page 293 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:15 (9) 
Eosinophils/ 
Leukocytes 
1.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
329 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
84.0 
fL 
76.5-97.5 
Erythrocytes 
5.42 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
15.2 
% 
11.8-15.5 
Hematocrit 
0.455 fraction 
of 1 
0.387-0.507 
Hemoglobin 
150 
g/L 
128-174 
Leukocytes 
4.4 
10^9/L 
3.1-9.7 
Lymphocytes 
1.85 
10^9/L 
0.8-2.91 
Page 1090


SIGA TECHNOLOGIES, INC.  
Page 294 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:15 (9) 
Lymphocytes/ 
Leukocytes 
42.0 
% 
13.9-48.3 
Monocytes 
0.36 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.1 
% 
3.3-12.1 
Neutrophils 
2.14 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
48.6 
% 
39.1-77.2 
Platelets 
220 
10^9/L 
140-400 
9087 
34/F/BL 
Screening 11OCT2019 
09:47 (-5) 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.10 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.1 
% 
0-6.1 
Page 1091


SIGA TECHNOLOGIES, INC.  
Page 295 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
Screening 11OCT2019 
09:47 (-5) 
Ery. Mean Corpuscular 
HGB Concentration 
308 
g/L 
L NCS 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
21.8 
pg 
L NCS 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
70.9 
fL 
L NCS 
72.2-99.1 
Erythrocytes 
4.76 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
19.2 
% 
H NCS 
11.1-17.3 
Hematocrit 
0.337 fraction 
of 1 
0.335-0.444 
Hemoglobin 
104 
g/L 
L NCS G1 
108-150 
Leukocytes 
9.1 
10^9/L 
3.1-9.7 
Lymphocytes 
2.10 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
23.1 
% 
13.9-48.3 
Monocytes 
0.78 
10^9/L 
H NCS 
0.15-0.75 
Page 1092


SIGA TECHNOLOGIES, INC.  
Page 296 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
Screening 11OCT2019 
09:47 (-5) 
Monocytes/ 
Leukocytes 
8.6 
% 
3.3-12.1 
Neutrophils 
6.08 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
66.9 
% 
39.1-77.2 
Platelets 
367 
10^9/L 
140-400 
Check-in 15OCT2019 
09:17 (-1) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.23 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
309 
g/L 
L NCS 
314-348 
Page 1093


SIGA TECHNOLOGIES, INC.  
Page 297 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
Check-in 15OCT2019 
09:17 (-1) 
Ery. Mean Corpuscular 
Hemoglobin 
21.5 
pg 
L NCS 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
69.8 
fL 
L NCS 
72.2-99.1 
Erythrocytes 
4.82 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
19.0 
% 
H NCS 
11.1-17.3 
Hematocrit 
0.336 fraction 
of 1 
0.335-0.444 
Hemoglobin 
104 
g/L 
L NCS G1 
108-150 
Leukocytes 
9.6 
10^9/L 
3.1-9.7 
Lymphocytes 
2.70 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
28.1 
% 
13.9-48.3 
Monocytes 
0.82 
10^9/L 
H NCS 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.6 
% 
3.3-12.1 
Page 1094


SIGA TECHNOLOGIES, INC.  
Page 298 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
Check-in 15OCT2019 
09:17 (-1) 
Neutrophils 
5.82 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
60.6 
% 
39.1-77.2 
Platelets 
399 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:43 (4) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.21 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
307 
g/L 
L NCS 
314-348 
Ery. Mean Corpuscular 
Hemoglobin 
21.5 
pg 
L NCS 
22.9-33.9 
Page 1095


SIGA TECHNOLOGIES, INC.  
Page 299 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:43 (4) 
Ery. Mean Corpuscular 
Volume 
70.1 
fL 
L NCS 
72.2-99.1 
Erythrocytes 
4.76 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
18.6 
% 
H NCS 
11.1-17.3 
Hematocrit 
0.334 fraction 
of 1 
L NCS 
0.335-0.444 
Hemoglobin 
102 
g/L 
L NCS G1 
108-150 
Leukocytes 
10.4 
10^9/L 
H NCS 
3.1-9.7 
Lymphocytes 
2.43 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
23.3 
% 
13.9-48.3 
Monocytes 
0.83 
10^9/L 
H NCS 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.0 
% 
3.3-12.1 
Neutrophils 
6.91 
10^9/L 
H NCS 
1.5-6.75 
Page 1096


SIGA TECHNOLOGIES, INC.  
Page 300 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:43 (4) 
Neutrophils/ 
Leukocytes 
66.3 
% 
39.1-77.2 
Platelets 
407 
10^9/L 
H NCS 
140-400 
Day 4 
20OCT2019 
07:04 (5), R 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.20 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Leukocytes 
10.7 
10^9/L 
H NCS 
3.1-9.7 
Lymphocytes 
2.75 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
25.8 
% 
13.9-48.3 
Monocytes 
0.96 
10^9/L 
H NCS 
0.15-0.75 
Page 1097


SIGA TECHNOLOGIES, INC.  
Page 301 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 4 
20OCT2019 
07:04 (5), R 
Monocytes/ 
Leukocytes 
8.9 
% 
3.3-12.1 
Neutrophils 
6.72 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
62.9 
% 
39.1-77.2 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:18 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.19 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
311 
g/L 
L NCS 
314-348 
Page 1098


SIGA TECHNOLOGIES, INC.  
Page 302 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:18 (8) 
Ery. Mean Corpuscular 
Hemoglobin 
21.8 
pg 
L NCS 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
70.1 
fL 
L NCS 
72.2-99.1 
Erythrocytes 
4.88 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
18.0 
% 
H NCS 
11.1-17.3 
Hematocrit 
0.342 fraction 
of 1 
0.335-0.444 
Hemoglobin 
107 
g/L 
L NCS 
108-150 
Leukocytes 
9.1 
10^9/L 
3.1-9.7 
Lymphocytes 
2.69 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
29.7 
% 
13.9-48.3 
Monocytes 
0.75 
10^9/L 
0.15-0.75 
Page 1099


SIGA TECHNOLOGIES, INC.  
Page 303 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:18 (8) 
Monocytes/ 
Leukocytes 
8.2 
% 
3.3-12.1 
Neutrophils 
5.40 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
59.6 
% 
39.1-77.2 
Platelets 
437 
10^9/L 
H NCS 
140-400 
Day 9 
24OCT2019 
08:18 (9) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.16 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
310 
g/L 
L NCS 
314-348 
Page 1100


SIGA TECHNOLOGIES, INC.  
Page 304 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:18 (9) 
Ery. Mean Corpuscular 
Hemoglobin 
21.7 
pg 
L NCS 
22.9-33.9 
Ery. Mean Corpuscular 
Volume 
69.9 
fL 
L NCS 
72.2-99.1 
Erythrocytes 
4.78 
10^12/L 
3.84-5.28 
Erythrocytes 
Distribution Width 
17.8 
% 
H NCS 
11.1-17.3 
Hematocrit 
0.334 fraction 
of 1 
L NCS 
0.335-0.444 
Hemoglobin 
104 
g/L 
L NCS G1 
108-150 
Leukocytes 
9.0 
10^9/L 
3.1-9.7 
Lymphocytes 
2.42 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
26.9 
% 
13.9-48.3 
Monocytes 
0.84 
10^9/L 
H NCS 
0.15-0.75 
Monocytes/ 
Leukocytes 
9.3 
% 
3.3-12.1 
Page 1101


SIGA TECHNOLOGIES, INC.  
Page 305 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:18 (9) 
Neutrophils 
5.55 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
61.6 
% 
39.1-77.2 
Platelets 
420 
10^9/L 
H NCS 
140-400 
9089 
29/M/BL 
Screening 14OCT2019 
09:26 (-2) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.35 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
4.6 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.6 
pg 
25-33.6 
Page 1102


SIGA TECHNOLOGIES, INC.  
Page 306 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
Screening 14OCT2019 
09:26 (-2) 
Ery. Mean Corpuscular 
Volume 
82.2 
fL 
76.5-97.5 
Erythrocytes 
5.17 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.5 
% 
11.8-15.5 
Hematocrit 
0.425 fraction 
of 1 
0.387-0.507 
Hemoglobin 
142 
g/L 
128-174 
Leukocytes 
7.6 
10^9/L 
3.1-9.7 
Lymphocytes 
2.22 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
29.0 
% 
13.9-48.3 
Monocytes 
0.66 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.6 
% 
3.3-12.1 
Neutrophils 
4.35 
10^9/L 
1.5-6.75 
Page 1103


SIGA TECHNOLOGIES, INC.  
Page 307 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
Screening 14OCT2019 
09:26 (-2) 
Neutrophils/ 
Leukocytes 
57.0 
% 
39.1-77.2 
Platelets 
184 
10^9/L 
140-400 
Check-in 15OCT2019 
08:52 (-1) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.27 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
330 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
26.9 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
81.7 
fL 
76.5-97.5 
Page 1104


SIGA TECHNOLOGIES, INC.  
Page 308 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
Check-in 15OCT2019 
08:52 (-1) 
Erythrocytes 
5.14 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.1 
% 
11.8-15.5 
Hematocrit 
0.419 fraction 
of 1 
0.387-0.507 
Hemoglobin 
138 
g/L 
128-174 
Leukocytes 
7.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.16 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
29.9 
% 
13.9-48.3 
Monocytes 
0.57 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.9 
% 
3.3-12.1 
Neutrophils 
4.19 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
57.9 
% 
39.1-77.2 
Page 1105


SIGA TECHNOLOGIES, INC.  
Page 309 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
Check-in 15OCT2019 
08:52 (-1) 
Platelets 
184 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:49 (4) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.6 
% 
0-1.4 
Eosinophils 
0.28 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.3 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
331 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.3 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
82.4 
fL 
76.5-97.5 
Erythrocytes 
5.32 
10^12/L 
4.28-6.03 
Page 1106


SIGA TECHNOLOGIES, INC.  
Page 310 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:49 (4) 
Erythrocytes 
Distribution Width 
14.7 
% 
11.8-15.5 
Hematocrit 
0.438 fraction 
of 1 
0.387-0.507 
Hemoglobin 
145 
g/L 
128-174 
Leukocytes 
8.5 
10^9/L 
3.1-9.7 
Lymphocytes 
2.83 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
33.1 
% 
13.9-48.3 
Monocytes 
0.69 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.1 
% 
3.3-12.1 
Neutrophils 
4.69 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
54.9 
% 
39.1-77.2 
Platelets 
212 
10^9/L 
140-400 
Page 1107


SIGA TECHNOLOGIES, INC.  
Page 311 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:24 (8) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.26 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.4 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
335 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.8 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
82.9 
fL 
76.5-97.5 
Erythrocytes 
5.22 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.1 
% 
11.8-15.5 
Page 1108


SIGA TECHNOLOGIES, INC.  
Page 312 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:24 (8) 
Hematocrit 
0.433 fraction 
of 1 
0.387-0.507 
Hemoglobin 
145 
g/L 
128-174 
Leukocytes 
7.6 
10^9/L 
3.1-9.7 
Lymphocytes 
2.46 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
32.4 
% 
13.9-48.3 
Monocytes 
0.62 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.2 
% 
3.3-12.1 
Neutrophils 
4.21 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
55.5 
% 
39.1-77.2 
Platelets 
201 
10^9/L 
140-400 
Page 1109


SIGA TECHNOLOGIES, INC.  
Page 313 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:24 (9) 
Basophils 
0.04 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.5 
% 
0-1.4 
Eosinophils 
0.27 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
331 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
27.3 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
82.4 
fL 
76.5-97.5 
Erythrocytes 
5.23 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.3 
% 
11.8-15.5 
Page 1110


SIGA TECHNOLOGIES, INC.  
Page 314 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:24 (9) 
Hematocrit 
0.431 fraction 
of 1 
0.387-0.507 
Hemoglobin 
143 
g/L 
128-174 
Leukocytes 
7.2 
10^9/L 
3.1-9.7 
Lymphocytes 
2.45 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
34.1 
% 
13.9-48.3 
Monocytes 
0.60 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.3 
% 
3.3-12.1 
Neutrophils 
3.83 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
53.3 
% 
39.1-77.2 
Platelets 
204 
10^9/L 
140-400 
9092 
24/M/W 
Screening 14OCT2019 
09:33 (-2) 
Basophils 
0.02 
10^9/L 
0-0.08 
Page 1111


SIGA TECHNOLOGIES, INC.  
Page 315 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
Screening 14OCT2019 
09:33 (-2) 
Basophils/ 
Leukocytes 
0.2 
% 
0-1.4 
Eosinophils 
0.18 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.2 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
337 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.9 
fL 
76.5-97.5 
Erythrocytes 
4.98 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.6 
% 
11.8-15.5 
Hematocrit 
0.438 fraction 
of 1 
0.387-0.507 
Hemoglobin 
148 
g/L 
128-174 
Page 1112


SIGA TECHNOLOGIES, INC.  
Page 316 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
Screening 14OCT2019 
09:33 (-2) 
Leukocytes 
8.4 
10^9/L 
3.1-9.7 
Lymphocytes 
1.73 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
20.7 
% 
13.9-48.3 
Monocytes 
0.62 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.5 
% 
3.3-12.1 
Neutrophils 
5.80 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
69.5 
% 
39.1-77.2 
Platelets 
245 
10^9/L 
140-400 
Check-in 15OCT2019 
09:13 (-1) 
Basophils 
0.01 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.2 
% 
0-1.4 
Page 1113


SIGA TECHNOLOGIES, INC.  
Page 317 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
Check-in 15OCT2019 
09:13 (-1) 
Eosinophils 
0.26 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.1 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.4 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.5 
fL 
76.5-97.5 
Erythrocytes 
4.80 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.3 
% 
11.8-15.5 
Hematocrit 
0.420 fraction 
of 1 
0.387-0.507 
Hemoglobin 
141 
g/L 
128-174 
Leukocytes 
8.5 
10^9/L 
3.1-9.7 
Page 1114


SIGA TECHNOLOGIES, INC.  
Page 318 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
Check-in 15OCT2019 
09:13 (-1) 
Lymphocytes 
2.07 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
24.4 
% 
13.9-48.3 
Monocytes 
0.69 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
8.1 
% 
3.3-12.1 
Neutrophils 
5.43 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.2 
% 
39.1-77.2 
Platelets 
239 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:52 (4) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.3 
% 
0-1.4 
Eosinophils 
0.12 
10^9/L 
0-0.35 
Page 1115


SIGA TECHNOLOGIES, INC.  
Page 319 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:52 (4) 
Eosinophils/ 
Leukocytes 
1.8 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
339 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.3 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
86.3 
fL 
76.5-97.5 
Erythrocytes 
4.89 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.7 
% 
11.8-15.5 
Hematocrit 
0.422 fraction 
of 1 
0.387-0.507 
Hemoglobin 
143 
g/L 
128-174 
Leukocytes 
6.8 
10^9/L 
3.1-9.7 
Lymphocytes 
1.78 
10^9/L 
0.8-2.91 
Page 1116


SIGA TECHNOLOGIES, INC.  
Page 320 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:52 (4) 
Lymphocytes/ 
Leukocytes 
26.3 
% 
13.9-48.3 
Monocytes 
0.45 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.7 
% 
3.3-12.1 
Neutrophils 
4.39 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.9 
% 
39.1-77.2 
Platelets 
233 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:27 (8) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.3 
% 
0-1.4 
Eosinophils 
0.14 
10^9/L 
0-0.35 
Page 1117


SIGA TECHNOLOGIES, INC.  
Page 321 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:27 (8) 
Eosinophils/ 
Leukocytes 
1.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
344 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
30.0 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
87.2 
fL 
76.5-97.5 
Erythrocytes 
5.03 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.2 
% 
11.8-15.5 
Hematocrit 
0.438 fraction 
of 1 
0.387-0.507 
Hemoglobin 
151 
g/L 
128-174 
Leukocytes 
7.3 
10^9/L 
3.1-9.7 
Lymphocytes 
1.80 
10^9/L 
0.8-2.91 
Page 1118


SIGA TECHNOLOGIES, INC.  
Page 322 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:27 (8) 
Lymphocytes/ 
Leukocytes 
24.7 
% 
13.9-48.3 
Monocytes 
0.46 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
6.3 
% 
3.3-12.1 
Neutrophils 
4.87 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
66.9 
% 
39.1-77.2 
Platelets 
247 
10^9/L 
140-400 
Day 9 
24OCT2019 
08:27 (9) 
Basophils 
0.02 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.3 
% 
0-1.4 
Eosinophils 
0.11 
10^9/L 
0-0.35 
Page 1119


SIGA TECHNOLOGIES, INC.  
Page 323 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:27 (9) 
Eosinophils/ 
Leukocytes 
1.7 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
342 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
29.4 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
85.8 
fL 
76.5-97.5 
Erythrocytes 
5.02 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
14.5 
% 
11.8-15.5 
Hematocrit 
0.431 fraction 
of 1 
0.387-0.507 
Hemoglobin 
148 
g/L 
128-174 
Leukocytes 
6.9 
10^9/L 
3.1-9.7 
Lymphocytes 
1.88 
10^9/L 
0.8-2.91 
Page 1120


SIGA TECHNOLOGIES, INC.  
Page 324 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:27 (9) 
Lymphocytes/ 
Leukocytes 
27.5 
% 
13.9-48.3 
Monocytes 
0.39 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.7 
% 
3.3-12.1 
Neutrophils 
4.45 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.9 
% 
39.1-77.2 
Platelets 
256 
10^9/L 
140-400 
9095 
42/M/W 
Screening 17OCT2019 
13:31 (-13) 
Basophils 
0.11 
10^9/L 
H NCS 
0-0.08 
Basophils/ 
Leukocytes 
1.2 
% 
0-1.4 
Eosinophils 
0.14 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
1.5 
% 
0-6.1 
Page 1121


SIGA TECHNOLOGIES, INC.  
Page 325 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
Screening 17OCT2019 
13:31 (-13) 
Ery. Mean Corpuscular 
HGB Concentration 
343 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
31.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
92.0 
fL 
76.5-97.5 
Erythrocytes 
4.94 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.8 
% 
11.8-15.5 
Hematocrit 
0.455 fraction 
of 1 
0.387-0.507 
Hemoglobin 
156 
g/L 
128-174 
Leukocytes 
9.1 
10^9/L 
3.1-9.7 
Lymphocytes 
1.18 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
13.0 
% 
L NCS 
13.9-48.3 
Monocytes 
0.26 
10^9/L 
0.15-0.75 
Page 1122


SIGA TECHNOLOGIES, INC.  
Page 326 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
Screening 17OCT2019 
13:31 (-13) 
Monocytes/ 
Leukocytes 
2.9 
% 
L NCS 
3.3-12.1 
Neutrophils 
7.40 
10^9/L 
H NCS 
1.5-6.75 
Neutrophils/ 
Leukocytes 
81.4 
% 
H NCS 
39.1-77.2 
Platelets 
253 
10^9/L 
140-400 
Screening 23OCT2019 
14:43 (-7), 
R 
Basophils 
0.03 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.4 
% 
0-1.4 
Eosinophils 
0.28 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.3 
% 
0-6.1 
Leukocytes 
8.3 
10^9/L 
3.1-9.7 
Lymphocytes 
1.87 
10^9/L 
0.8-2.91 
Page 1123


SIGA TECHNOLOGIES, INC.  
Page 327 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
Screening 23OCT2019 
14:43 (-7), 
R 
Lymphocytes/ 
Leukocytes 
22.4 
% 
13.9-48.3 
Monocytes 
0.60 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
7.2 
% 
3.3-12.1 
Neutrophils 
5.56 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
66.7 
% 
39.1-77.2 
Check-in 29OCT2019 
08:52 (-1) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
1.0 
% 
0-1.4 
Eosinophils 
0.25 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.8 
% 
0-6.1 
Page 1124


SIGA TECHNOLOGIES, INC.  
Page 328 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
Check-in 29OCT2019 
08:52 (-1) 
Ery. Mean Corpuscular 
HGB Concentration 
340 
g/L 
320-354 
Ery. Mean Corpuscular 
Hemoglobin 
31.6 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
93.0 
fL 
76.5-97.5 
Erythrocytes 
4.83 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.7 
% 
11.8-15.5 
Hematocrit 
0.449 fraction 
of 1 
0.387-0.507 
Hemoglobin 
153 
g/L 
128-174 
Leukocytes 
6.5 
10^9/L 
3.1-9.7 
Lymphocytes 
1.63 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
25.2 
% 
13.9-48.3 
Monocytes 
0.39 
10^9/L 
0.15-0.75 
Page 1125


SIGA TECHNOLOGIES, INC.  
Page 329 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
Check-in 29OCT2019 
08:52 (-1) 
Monocytes/ 
Leukocytes 
6.1 
% 
3.3-12.1 
Neutrophils 
4.12 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
63.9 
% 
39.1-77.2 
Platelets 
242 
10^9/L 
140-400 
TPOXX 
600 mg 
Day 4 
02NOV2019 
07:31 (4) 
Basophils 
0.05 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.7 
% 
0-1.4 
Eosinophils 
0.24 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
3.0 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
336 
g/L 
320-354 
Page 1126


SIGA TECHNOLOGIES, INC.  
Page 330 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 4 
02NOV2019 
07:31 (4) 
Ery. Mean Corpuscular 
Hemoglobin 
31.3 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
93.2 
fL 
76.5-97.5 
Erythrocytes 
5.00 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.8 
% 
11.8-15.5 
Hematocrit 
0.466 fraction 
of 1 
0.387-0.507 
Hemoglobin 
157 
g/L 
128-174 
Leukocytes 
8.1 
10^9/L 
3.1-9.7 
Lymphocytes 
2.32 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
28.6 
% 
13.9-48.3 
Monocytes 
0.46 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.7 
% 
3.3-12.1 
Page 1127


SIGA TECHNOLOGIES, INC.  
Page 331 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 4 
02NOV2019 
07:31 (4) 
Neutrophils 
5.03 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
62.1 
% 
39.1-77.2 
Platelets 
265 
10^9/L 
140-400 
Day 8 - 
12 Hours 
Postdose 
06NOV2019 
07:06 (8) 
Basophils 
0.07 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.9 
% 
0-1.4 
Eosinophils 
0.24 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
343 
g/L 
320-354 
Page 1128


SIGA TECHNOLOGIES, INC.  
Page 332 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
06NOV2019 
07:06 (8) 
Ery. Mean Corpuscular 
Hemoglobin 
31.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
92.6 
fL 
76.5-97.5 
Erythrocytes 
4.88 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
13.1 
% 
11.8-15.5 
Hematocrit 
0.452 fraction 
of 1 
0.387-0.507 
Hemoglobin 
155 
g/L 
128-174 
Leukocytes 
8.4 
10^9/L 
3.1-9.7 
Lymphocytes 
2.22 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
26.5 
% 
13.9-48.3 
Monocytes 
0.42 
10^9/L 
0.15-0.75 
Page 1129


SIGA TECHNOLOGIES, INC.  
Page 333 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
06NOV2019 
07:06 (8) 
Monocytes/ 
Leukocytes 
5.0 
% 
3.3-12.1 
Neutrophils 
5.44 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.8 
% 
39.1-77.2 
Platelets 
283 
10^9/L 
140-400 
Day 9 
07NOV2019 
07:06 (9) 
Basophils 
0.06 
10^9/L 
0-0.08 
Basophils/ 
Leukocytes 
0.8 
% 
0-1.4 
Eosinophils 
0.21 
10^9/L 
0-0.35 
Eosinophils/ 
Leukocytes 
2.9 
% 
0-6.1 
Ery. Mean Corpuscular 
HGB Concentration 
341 
g/L 
320-354 
Page 1130


SIGA TECHNOLOGIES, INC.  
Page 334 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 9 
07NOV2019 
07:06 (9) 
Ery. Mean Corpuscular 
Hemoglobin 
31.7 
pg 
25-33.6 
Ery. Mean Corpuscular 
Volume 
93.0 
fL 
76.5-97.5 
Erythrocytes 
4.88 
10^12/L 
4.28-6.03 
Erythrocytes 
Distribution Width 
12.7 
% 
11.8-15.5 
Hematocrit 
0.454 fraction 
of 1 
0.387-0.507 
Hemoglobin 
155 
g/L 
128-174 
Leukocytes 
7.5 
10^9/L 
3.1-9.7 
Lymphocytes 
2.01 
10^9/L 
0.8-2.91 
Lymphocytes/ 
Leukocytes 
26.9 
% 
13.9-48.3 
Monocytes 
0.40 
10^9/L 
0.15-0.75 
Monocytes/ 
Leukocytes 
5.3 
% 
3.3-12.1 
Page 1131


SIGA TECHNOLOGIES, INC.  
Page 335 of 335 
SIGA-246-022  
Listing 16.2.8.1  
Laboratory Results - Hematology  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020801.SAS  Executed: 21JAN2020 23:07  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 9 
07NOV2019 
07:06 (9) 
Neutrophils 
4.79 
10^9/L 
1.5-6.75 
Neutrophils/ 
Leukocytes 
64.2 
% 
39.1-77.2 
Platelets 
273 
10^9/L 
140-400 
 
Page 1132


SIGA TECHNOLOGIES, INC.  
Page 1 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
 
Screening 19JUL2019 
12:06 (-26) 
Alanine 
Aminotransferase 
34 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
42 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
24 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
20.7 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.50 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
3.81 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
86.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
179.6 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
27 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
33 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.77 
mmol/L 
 
 
3-6.44 
 
Page 1133


SIGA TECHNOLOGIES, INC.  
Page 2 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
 
Screening 19JUL2019 
12:06 (-26) 
HDL Cholesterol 
0.91 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
1.92 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 168 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
2.17 
mmol/L 
 
G1 
0-4.52 
 
 
 
 
 
 
Urate 
351 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 13AUG2019 
09:44 (-1) 
Alanine 
Aminotransferase 
29 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
37 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
21.2 
umol/L 
 
 
3.2-28.9 
 
Page 1134


SIGA TECHNOLOGIES, INC.  
Page 3 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
 
Check-in 13AUG2019 
09:44 (-1) 
Blood Urea Nitrogen 
4.64 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
92.8 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
33 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
35 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.05 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 150 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
79 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
333 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:54 (4) 
Alanine 
Aminotransferase 
27 
IU/L 
 
 
7-56 
 
Page 1135


SIGA TECHNOLOGIES, INC.  
Page 4 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:54 (4) 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
37 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
23.6 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.32 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.45 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
94.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
32 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
36 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.83 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 150 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
Page 1136


SIGA TECHNOLOGIES, INC.  
Page 5 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:54 (4) 
Protein 
83 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
141 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
345 
umol/L 
 
 
173-494 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:25 (8) 
Alanine 
Aminotransferase 
26 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
42 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
20.5 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.68 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.45 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
92.8 
umol/L 
 
 
56.6-114.9 
 
Page 1137


SIGA TECHNOLOGIES, INC.  
Page 6 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:25 (8) 
Gamma Glutamyl 
 Transferase 
32 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
33 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.83 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 135 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.29 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
79 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
141 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
321 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
22AUG2019 
09:25 (9) 
Alanine 
Aminotransferase 
28 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
43 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
Page 1138


SIGA TECHNOLOGIES, INC.  
Page 7 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:25 (9) 
Bilirubin 
16.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.50 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
95.5 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
33 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
36 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 160 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
83 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
321 
umol/L 
 
 
173-494 
 
Page 1139


SIGA TECHNOLOGIES, INC.  
Page 8 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
 
Screening 19JUL2019 
12:02 (-26) 
Alanine 
Aminotransferase 
23 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
66 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.96 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.95 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
68.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
265.5 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
42 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.49 
mmol/L 
 
 
3-6.44 
 
Page 1140


SIGA TECHNOLOGIES, INC.  
Page 9 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
 
Screening 19JUL2019 
12:02 (-26) 
HDL Cholesterol 
1.24 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.67 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 200 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
135 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
2.28 
mmol/L 
 
G1 
0-4.52 
 
 
 
 
 
 
Urate 
363 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 13AUG2019 
10:01 (-1) 
Alanine 
Aminotransferase 
23 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
67 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.3 
umol/L 
 
 
3.2-28.9 
 
Page 1141


SIGA TECHNOLOGIES, INC.  
Page 10 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
 
Check-in 13AUG2019 
10:01 (-1) 
Blood Urea Nitrogen 
5.93 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.25 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
80.4 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
38 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.61 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 223 
IU/L 
H NCS  
82-216 
 
 
 
 
 
 
Phosphate 
0.94 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
416 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:49 (4) 
Alanine 
Aminotransferase 
26 
IU/L 
 
 
7-56 
 
Page 1142


SIGA TECHNOLOGIES, INC.  
Page 11 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:49 (4) 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
63 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.9 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.11 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
77.8 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
36 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
32 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.11 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 223 
IU/L 
H NCS  
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.5 
mmol/L 
 
 
3.5-5 
 
Page 1143


SIGA TECHNOLOGIES, INC.  
Page 12 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:49 (4) 
Protein 
76 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
446 
umol/L 
 
 
173-494 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:24 (8) 
Alanine 
Aminotransferase 
32 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
74 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.36 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
75.1 
umol/L 
 
 
56.6-114.9 
 
Page 1144


SIGA TECHNOLOGIES, INC.  
Page 13 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:24 (8) 
Gamma Glutamyl 
 Transferase 
34 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.94 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 216 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
135 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
446 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
22AUG2019 
09:27 (9) 
Alanine 
Aminotransferase 
31 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
72 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
Page 1145


SIGA TECHNOLOGIES, INC.  
Page 14 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:27 (9) 
Bilirubin 
8.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.14 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
74.3 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
33 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
32 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.05 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 202 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.90 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.5 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
76 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
134 
mmol/L 
 
G1 
132-145 
 
 
 
 
 
 
Urate 
434 
umol/L 
 
 
173-494 
 
Page 1146


SIGA TECHNOLOGIES, INC.  
Page 15 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
 
Screening 23JUL2019 
10:05 (-22) 
Alanine 
Aminotransferase 
44 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
64 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
36 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.86 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.20 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
107 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.51 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
76.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
227.7 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
16 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
19 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.44 
mmol/L 
 
G1 
3-6.44 
 
Page 1147


SIGA TECHNOLOGIES, INC.  
Page 16 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
 
Screening 23JUL2019 
10:05 (-22) 
HDL Cholesterol 
0.88 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.95 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 173 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.5 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
59 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.47 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
458 
umol/L 
 
G1 
173-494 
 
 
 
 
Check-in 13AUG2019 
09:35 (-1) 
Alanine 
Aminotransferase 
36 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
39 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
75 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
33 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.2 
umol/L 
 
 
3.2-28.9 
 
Page 1148


SIGA TECHNOLOGIES, INC.  
Page 17 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
 
Check-in 13AUG2019 
09:35 (-1) 
Blood Urea Nitrogen 
3.21 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.10 
mmol/L 
L NCS  
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
69.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
19 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.33 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 160 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.97 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
58 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
440 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:27 (4) 
Alanine 
Aminotransferase 
54 
IU/L 
 
 
7-56 
 
Page 1149


SIGA TECHNOLOGIES, INC.  
Page 18 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:27 (4) 
Albumin 
42 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
73 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
37 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.28 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
77.8 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
20 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
21 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.11 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 143 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.94 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.4 
mmol/L 
 
 
3.5-5 
 
Page 1150


SIGA TECHNOLOGIES, INC.  
Page 19 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:27 (4) 
Protein 
63 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
464 
umol/L 
 
G1 
173-494 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:02 (8) 
Alanine 
Aminotransferase 
45 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
83 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
27 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.6 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.93 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
107 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
73.4 
umol/L 
 
 
56.6-114.9 
 
Page 1151


SIGA TECHNOLOGIES, INC.  
Page 20 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:02 (8) 
Gamma Glutamyl 
 Transferase 
20 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
18 
g/L 
L NCS  
19-39 
 
 
 
 
 
 
Glucose 
5.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 130 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
59 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
458 
umol/L 
 
G1 
173-494 
 
 
 
 
Day 9 
22AUG2019 
09:02 (9) 
Alanine 
Aminotransferase 
44 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
81 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
28 
IU/L 
 
 
10-40 
 
Page 1152


SIGA TECHNOLOGIES, INC.  
Page 21 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:02 (9) 
Bilirubin 
10.4 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.00 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.18 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
72.5 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
20 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
19 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.33 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 141 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.94 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
60 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
446 
umol/L 
 
 
173-494 
 
Page 1153


SIGA TECHNOLOGIES, INC.  
Page 22 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
 
Screening 31JUL2019 
10:20 (-14) 
Alanine 
Aminotransferase 
18 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
88 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
14.0 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.14 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
5.26 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
68.1 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
251.8 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
38 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.33 
mmol/L 
 
 
3-6.44 
 
Page 1154


SIGA TECHNOLOGIES, INC.  
Page 23 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
 
Screening 31JUL2019 
10:20 (-14) 
HDL Cholesterol 
1.45 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
3.50 
mmol/L 
 
G1 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 162 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
71 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
134 
mmol/L 
 
G1 
132-145 
 
 
 
 
 
 
Triglycerides 
0.70 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
416 
umol/L 
H NCS  
119-345 
 
 
 
 
Check-in 13AUG2019 
09:32 (-1) 
Alanine 
Aminotransferase 
14 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
101 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.7 
umol/L 
 
 
3.2-21.7 
 
Page 1155


SIGA TECHNOLOGIES, INC.  
Page 24 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
 
Check-in 13AUG2019 
09:32 (-1) 
Blood Urea Nitrogen 
2.78 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
26 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
69.0 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
33 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.38 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 161 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
71 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
345 
umol/L 
 
 
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:31 (4) 
Alanine 
Aminotransferase 
15 
IU/L 
 
 
4-45 
 
Page 1156


SIGA TECHNOLOGIES, INC.  
Page 25 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:31 (4) 
Albumin 
37 
g/L 
L NCS G1 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
92 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.8 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.18 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
26 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
68.1 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
31 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.72 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 150 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.36 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
Page 1157


SIGA TECHNOLOGIES, INC.  
Page 26 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:31 (4) 
Protein 
66 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
404 
umol/L 
H NCS  
119-345 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:06 (8) 
Alanine 
Aminotransferase 
17 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
37 
g/L 
L NCS G1 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
98 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.9 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.93 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
69.0 
umol/L 
 
 
39.8-93.7 
 
Page 1158


SIGA TECHNOLOGIES, INC.  
Page 27 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:06 (8) 
Gamma Glutamyl 
 Transferase 
32 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.44 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 153 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.42 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
63 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
381 
umol/L 
H NCS  
119-345 
 
 
 
 
Day 9 
22AUG2019 
09:07 (9) 
Alanine 
Aminotransferase 
19 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
38 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
103 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
Page 1159


SIGA TECHNOLOGIES, INC.  
Page 28 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:07 (9) 
Bilirubin 
9.9 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.32 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.25 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
65.4 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
33 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.61 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 163 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
67 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
135 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
381 
umol/L 
H NCS  
119-345 
 
Page 1160


SIGA TECHNOLOGIES, INC.  
Page 29 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
 
Screening 06AUG2019 
10:31 (-8) 
Alanine 
Aminotransferase 
48 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
46 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
23 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.9 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
3.57 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
102.5 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
166.3 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
24 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.05 
mmol/L 
 
 
3-6.44 
 
Page 1161


SIGA TECHNOLOGIES, INC.  
Page 30 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
 
Screening 06AUG2019 
10:31 (-8) 
HDL Cholesterol 
0.85 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
1.89 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 200 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.83 
mmol/L 
 
G1 
0-4.52 
 
 
 
 
 
 
Urate 
399 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 13AUG2019 
09:53 (-1) 
Alanine 
Aminotransferase 
38 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
52 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.4 
umol/L 
 
 
3.2-28.9 
 
Page 1162


SIGA TECHNOLOGIES, INC.  
Page 31 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
 
Check-in 13AUG2019 
09:53 (-1) 
Blood Urea Nitrogen 
5.32 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
106.1 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
22 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 187 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
404 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:35 (4) 
Alanine 
Aminotransferase 
33 
IU/L 
 
 
7-56 
 
Page 1163


SIGA TECHNOLOGIES, INC.  
Page 32 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:35 (4) 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
43 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.14 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
102.5 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
23 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.22 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 183 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.4 
mmol/L 
 
 
3.5-5 
 
Page 1164


SIGA TECHNOLOGIES, INC.  
Page 33 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:35 (4) 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
410 
umol/L 
 
 
173-494 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:10 (8) 
Alanine 
Aminotransferase 
44 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
47 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
22 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.5 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.43 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
105.2 umol/L 
 
 
56.6-114.9 
 
Page 1165


SIGA TECHNOLOGIES, INC.  
Page 34 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:10 (8) 
Gamma Glutamyl 
 Transferase 
23 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.83 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 166 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.26 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
399 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
22AUG2019 
09:13 (9) 
Alanine 
Aminotransferase 
56 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
50 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
24 
IU/L 
 
 
10-40 
 
Page 1166


SIGA TECHNOLOGIES, INC.  
Page 35 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:13 (9) 
Bilirubin 
9.7 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.32 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
106.1 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.94 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 182 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.00 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
387 
umol/L 
 
 
173-494 
 
Page 1167


SIGA TECHNOLOGIES, INC.  
Page 36 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
 
Screening 12AUG2019 
11:07 (-2) 
Alanine 
Aminotransferase 
16 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
39 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
74 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.7 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.39 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.58 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
101.7 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
162.2 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
27 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
22 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.61 
mmol/L 
 
 
3-6.44 
 
Page 1168


SIGA TECHNOLOGIES, INC.  
Page 37 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
 
Screening 12AUG2019 
11:07 (-2) 
HDL Cholesterol 
0.73 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.54 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 167 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.84 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
61 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
2.90 
mmol/L 
 
G1 
0-4.52 
 
 
 
 
 
 
Urate 
422 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 13AUG2019 
09:39 (-1) 
Alanine 
Aminotransferase 
16 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
38 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
74 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
4.3 
umol/L 
 
 
3.2-28.9 
 
Page 1169


SIGA TECHNOLOGIES, INC.  
Page 38 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
 
Check-in 13AUG2019 
09:39 (-1) 
Blood Urea Nitrogen 
3.07 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
108.7 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
26 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
21 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.88 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 158 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
59 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
387 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:33 (4) 
Alanine 
Aminotransferase 
20 
IU/L 
 
 
7-56 
 
Page 1170


SIGA TECHNOLOGIES, INC.  
Page 39 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:33 (4) 
Albumin 
39 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
61 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
6 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.4 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.36 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
106.1 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
28 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
21 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.94 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 148 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.36 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
Page 1171


SIGA TECHNOLOGIES, INC.  
Page 40 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:33 (4) 
Protein 
60 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
399 
umol/L 
 
 
173-494 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:08 (8) 
Alanine 
Aminotransferase 
23 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
71 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
7 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.4 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.14 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
113.2 umol/L 
 
 
56.6-114.9 
 
Page 1172


SIGA TECHNOLOGIES, INC.  
Page 41 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:08 (8) 
Gamma Glutamyl 
 Transferase 
30 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
21 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.66 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 148 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.26 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.4 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
63 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
410 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
22AUG2019 
09:10 (9) 
Alanine 
Aminotransferase 
23 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
73 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
Page 1173


SIGA TECHNOLOGIES, INC.  
Page 42 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:10 (9) 
Bilirubin 
9.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.25 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
111.4 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
31 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
23 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.61 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 155 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.4 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
66 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
410 
umol/L 
 
 
173-494 
 
Page 1174


SIGA TECHNOLOGIES, INC.  
Page 43 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
 
Screening 12AUG2019 
11:08 (-23) 
Alanine 
Aminotransferase 
12 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
72 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.0 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.75 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
6.84 
mmol/L 
H NCS G2 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
75.1 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
182.7 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
13 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
32 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.16 
mmol/L 
 
 
3-6.44 
 
Page 1175


SIGA TECHNOLOGIES, INC.  
Page 44 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
 
Screening 12AUG2019 
11:08 (-23) 
HDL Cholesterol 
1.81 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
4.45 
mmol/L 
H NCS G2 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 114 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.24 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
309 
umol/L 
 
 
119-345 
 
 
 
 
Check-in 03SEP2019 
09:04 (-1) 
Alanine 
Aminotransferase 
11 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
38 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
66 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.2 
umol/L 
 
 
3.2-21.7 
 
Page 1176


SIGA TECHNOLOGIES, INC.  
Page 45 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
 
Check-in 03SEP2019 
09:04 (-1) 
Blood Urea Nitrogen 
5.07 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.13 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
70.7 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
13 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.05 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 107 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.90 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
65 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
309 
umol/L 
 
 
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:25 (4) 
Alanine 
Aminotransferase 
13 
IU/L 
 
 
4-45 
 
Page 1177


SIGA TECHNOLOGIES, INC.  
Page 46 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:25 (4) 
Albumin 
38 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
58 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
7 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.7 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
6.18 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.15 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
73.4 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
12 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.05 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 121 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
Page 1178


SIGA TECHNOLOGIES, INC.  
Page 47 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:25 (4) 
Protein 
67 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
339 
umol/L 
 
 
119-345 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:00 (8) 
Alanine 
Aminotransferase 
15 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
64 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.7 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.86 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
75.1 
umol/L 
 
 
39.8-93.7 
 
Page 1179


SIGA TECHNOLOGIES, INC.  
Page 48 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:00 (8) 
Gamma Glutamyl 
 Transferase 
13 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 127 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
315 
umol/L 
 
 
119-345 
 
 
 
 
Day 9 
12SEP2019 
08:05 (9) 
Alanine 
Aminotransferase 
15 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
64 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
Page 1180


SIGA TECHNOLOGIES, INC.  
Page 49 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:05 (9) 
Bilirubin 
9.1 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.39 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
76.0 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
14 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 129 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
315 
umol/L 
 
 
119-345 
 
Page 1181


SIGA TECHNOLOGIES, INC.  
Page 50 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
 
Screening 15AUG2019 
17:21 (-20) 
Alanine 
Aminotransferase 
25 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
40 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
26 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
5.18 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
90.2 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
182.0 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
32 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
20 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.49 
mmol/L 
 
 
3-6.44 
 
Page 1182


SIGA TECHNOLOGIES, INC.  
Page 51 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
 
Screening 15AUG2019 
17:21 (-20) 
HDL Cholesterol 
0.93 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
3.55 
mmol/L 
 
G1 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 151 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.26 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
64 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.53 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
512 
umol/L 
H NCS G1 
173-494 
 
 
 
 
Check-in 03SEP2019 
11:40 (-1) 
Alanine 
Aminotransferase 
23 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
42 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
14 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
23 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.8 
umol/L 
 
 
3.2-28.9 
 
Page 1183


SIGA TECHNOLOGIES, INC.  
Page 52 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
 
Check-in 03SEP2019 
11:40 (-1) 
Blood Urea Nitrogen 
5.68 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
99.9 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
34 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
20 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.44 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 177 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
67 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
506 
umol/L 
H NCS G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:32 (4) 
Alanine 
Aminotransferase 
25 
IU/L 
 
 
7-56 
 
Page 1184


SIGA TECHNOLOGIES, INC.  
Page 53 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:32 (4) 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
41 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
26 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.50 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
91.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
34 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
22 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 147 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.42 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
Page 1185


SIGA TECHNOLOGIES, INC.  
Page 54 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:32 (4) 
Protein 
65 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
458 
umol/L 
 
G1 
173-494 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:03 (8) 
Alanine 
Aminotransferase 
27 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
47 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
25 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.39 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
93.7 
umol/L 
 
 
56.6-114.9 
 
Page 1186


SIGA TECHNOLOGIES, INC.  
Page 55 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:03 (8) 
Gamma Glutamyl 
 Transferase 
36 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
22 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.49 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 150 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.32 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.4 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
68 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
141 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
446 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
12SEP2019 
08:08 (9) 
Alanine 
Aminotransferase 
27 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
49 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
27 
IU/L 
 
 
10-40 
 
Page 1187


SIGA TECHNOLOGIES, INC.  
Page 56 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:08 (9) 
Bilirubin 
9.9 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.86 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
93.7 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
37 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
22 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 150 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.5 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
68 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
452 
umol/L 
 
G1 
173-494 
 
Page 1188


SIGA TECHNOLOGIES, INC.  
Page 57 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
 
Screening 21AUG2019 
10:37 (-14) 
Alanine 
Aminotransferase 
16 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
38 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
76 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.5 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.36 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.30 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
61.9 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
216.4 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
14 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
Page 1189


SIGA TECHNOLOGIES, INC.  
Page 58 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
 
Screening 21AUG2019 
10:37 (-14) 
HDL Cholesterol 
1.24 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
2.59 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 109 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
69 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.02 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
327 
umol/L 
 
 
119-345 
 
 
 
 
Check-in 03SEP2019 
08:56 (-1) 
Alanine 
Aminotransferase 
11 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
39 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
69 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.5 
umol/L 
 
 
3.2-21.7 
 
Page 1190


SIGA TECHNOLOGIES, INC.  
Page 59 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
 
Check-in 03SEP2019 
08:56 (-1) 
Blood Urea Nitrogen 
5.75 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.25 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
66.3 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
13 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
33 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 127 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.7 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
135 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
357 
umol/L 
H NCS  
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:31 (4) 
Alanine 
Aminotransferase 
12 
IU/L 
 
 
4-45 
 
Page 1191


SIGA TECHNOLOGIES, INC.  
Page 60 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:31 (4) 
Albumin 
37 
g/L 
L NCS G1 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
61 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.5 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.86 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
106 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
68.1 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
13 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
33 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.83 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 108 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
Page 1192


SIGA TECHNOLOGIES, INC.  
Page 61 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:31 (4) 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
393 
umol/L 
H NCS  
119-345 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:06 (8) 
Alanine 
Aminotransferase 
14 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
38 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
69 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.4 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.21 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
66.3 
umol/L 
 
 
39.8-93.7 
 
Page 1193


SIGA TECHNOLOGIES, INC.  
Page 62 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:06 (8) 
Gamma Glutamyl 
 Transferase 
14 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
33 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.38 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 111 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.7 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
71 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
375 
umol/L 
H NCS  
119-345 
 
 
 
 
Day 9 
12SEP2019 
08:13 (9) 
Alanine 
Aminotransferase 
13 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
72 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
22 
IU/L 
 
 
10-40 
 
Page 1194


SIGA TECHNOLOGIES, INC.  
Page 63 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:13 (9) 
Bilirubin 
7.0 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.07 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
64.5 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
15 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
32 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.22 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 115 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.97 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.5 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
351 
umol/L 
H NCS  
119-345 
 
Page 1195


SIGA TECHNOLOGIES, INC.  
Page 64 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
 
Screening 21AUG2019 
10:44 (-14) 
Alanine 
Aminotransferase 
18 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
91 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
4.8 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.43 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
5.72 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
63.6 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
203.7 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
31 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.72 
mmol/L 
 
 
3-6.44 
 
Page 1196


SIGA TECHNOLOGIES, INC.  
Page 65 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
 
Screening 21AUG2019 
10:44 (-14) 
HDL Cholesterol 
1.09 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
4.14 
mmol/L 
 
G2 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 179 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.23 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
135 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.08 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
387 
umol/L 
H NCS  
119-345 
 
 
 
 
Check-in 03SEP2019 
09:00 (-1) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
86 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
15 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
3.2 
umol/L 
 
 
3.2-21.7 
 
Page 1197


SIGA TECHNOLOGIES, INC.  
Page 66 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
 
Check-in 03SEP2019 
09:00 (-1) 
Blood Urea Nitrogen 
3.71 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.45 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
65.4 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
30 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.11 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 176 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.23 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
76 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
458 
umol/L 
H NCS G1 
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:34 (4) 
Alanine 
Aminotransferase 
25 
IU/L 
 
 
4-45 
 
Page 1198


SIGA TECHNOLOGIES, INC.  
Page 67 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:34 (4) 
Albumin 
46 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
73 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.5 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.75 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
69.8 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
28 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.33 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 170 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.39 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
Page 1199


SIGA TECHNOLOGIES, INC.  
Page 68 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:34 (4) 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
482 
umol/L 
H NCS G1 
119-345 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:09 (8) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
72 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.2 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.03 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
66.3 
umol/L 
 
 
39.8-93.7 
 
Page 1200


SIGA TECHNOLOGIES, INC.  
Page 69 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:09 (8) 
Gamma Glutamyl 
 Transferase 
27 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.88 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 150 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.26 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
464 
umol/L 
H NCS G1 
119-345 
 
 
 
 
Day 9 
12SEP2019 
08:09 (9) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
77 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
Page 1201


SIGA TECHNOLOGIES, INC.  
Page 70 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:09 (9) 
Bilirubin 
5.3 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.25 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
75.1 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
28 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.27 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 167 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
452 
umol/L 
H NCS G1 
119-345 
 
Page 1202


SIGA TECHNOLOGIES, INC.  
Page 71 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
 
Screening 21AUG2019 
11:05 (-14) 
Alanine 
Aminotransferase 
40 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
60 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
14.4 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.64 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.66 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
83.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
275.4 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
32 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
Page 1203


SIGA TECHNOLOGIES, INC.  
Page 72 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
 
Screening 21AUG2019 
11:05 (-14) 
HDL Cholesterol 
0.93 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.62 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 189 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.23 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
67 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
2.45 
mmol/L 
 
G1 
0-4.52 
 
 
 
 
 
 
Urate 
494 
umol/L 
 
G1 
173-494 
 
 
 
 
Check-in 03SEP2019 
09:54 (-1) 
Alanine 
Aminotransferase 
45 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
54 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
26 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
14.5 
umol/L 
 
 
3.2-28.9 
 
Page 1204


SIGA TECHNOLOGIES, INC.  
Page 73 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
 
Check-in 03SEP2019 
09:54 (-1) 
Blood Urea Nitrogen 
4.28 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.20 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
82.2 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
33 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 215 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.23 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
68 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
464 
umol/L 
 
G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:44 (4) 
Alanine 
Aminotransferase 
61 
IU/L 
H NCS  
7-56 
 
Page 1205


SIGA TECHNOLOGIES, INC.  
Page 74 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:44 (4) 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
57 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
7 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
31 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
20.5 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.78 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
82.2 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
36 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.22 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 203 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.42 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
Page 1206


SIGA TECHNOLOGIES, INC.  
Page 75 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:44 (4) 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
589 
umol/L 
H NCS G1 
173-494 
 
 
 
 
Day 4 
08SEP2019 
07:42 (5), R 
Alanine 
Aminotransferase 
58 
IU/L 
H NCS  
7-56 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
27 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
19.3 
umol/L 
 
 
3.2-28.9 
 
 
 
 
Day 4 
09SEP2019 
08:07 (6), R 
Alanine 
Aminotransferase 
58 
IU/L 
H NCS  
7-56 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
28 
IU/L 
 
 
10-40 
 
 
 
 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:12 (8) 
Alanine 
Aminotransferase 
55 
IU/L 
 
 
7-56 
 
Page 1207


SIGA TECHNOLOGIES, INC.  
Page 76 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:12 (8) 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
59 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
26 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
19.2 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.43 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
82.2 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
35 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.94 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 192 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.52 
mmol/L 
 
 
0.68-1.52 
 
Page 1208


SIGA TECHNOLOGIES, INC.  
Page 77 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:12 (8) 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
571 
umol/L 
H NCS G1 
173-494 
 
 
 
 
Day 9 
12SEP2019 
08:12 (9) 
Alanine 
Aminotransferase 
53 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
58 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
25 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
17.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.71 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.25 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
Page 1209


SIGA TECHNOLOGIES, INC.  
Page 78 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:12 (9) 
Creatinine 
84.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
35 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.27 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 186 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.23 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
577 
umol/L 
H NCS G1 
173-494 
 
9024 
20/M/BL 
 
Screening 23AUG2019 
10:48 (-12) 
Alanine 
Aminotransferase 
26 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
114 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
Page 1210


SIGA TECHNOLOGIES, INC.  
Page 79 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
 
Screening 23AUG2019 
10:48 (-12) 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
106 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.01 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
79.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
248.1 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
60 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.88 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.17 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.67 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 171 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.5 
mmol/L 
 
 
3.5-5 
 
Page 1211


SIGA TECHNOLOGIES, INC.  
Page 80 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
 
Screening 23AUG2019 
10:48 (-12) 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
0.41 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
333 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 03SEP2019 
09:18 (-1) 
Alanine 
Aminotransferase 
20 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
106 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.2 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.50 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
80.4 
umol/L 
 
 
56.6-114.9 
 
Page 1212


SIGA TECHNOLOGIES, INC.  
Page 81 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
 
Check-in 03SEP2019 
09:18 (-1) 
Gamma Glutamyl 
 Transferase 
43 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
24 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.05 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 163 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
68 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
357 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:40 (4) 
Alanine 
Aminotransferase 
42 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
49 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
121 
IU/L 
H NCS  
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
29 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.8 
umol/L 
 
 
3.2-28.9 
 
Page 1213


SIGA TECHNOLOGIES, INC.  
Page 82 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:40 (4) 
Blood Urea Nitrogen 
3.14 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.53 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
83.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
56 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.88 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 172 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.26 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
78 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
339 
umol/L 
 
 
173-494 
 
Page 1214


SIGA TECHNOLOGIES, INC.  
Page 83 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:15 (8) 
Alanine 
Aminotransferase 
56 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
124 
IU/L 
H NCS  
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
29 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
13.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.00 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.48 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
87.5 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
64 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.88 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 139 
IU/L 
 
 
82-216 
 
Page 1215


SIGA TECHNOLOGIES, INC.  
Page 84 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:15 (8) 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
339 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
12SEP2019 
08:15 (9) 
Alanine 
Aminotransferase 
54 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
127 
IU/L 
H NCS  
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
25 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.43 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
Page 1216


SIGA TECHNOLOGIES, INC.  
Page 85 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:15 (9) 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
87.5 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
66 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.11 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 137 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
339 
umol/L 
 
 
173-494 
 
9025 
50/M/W 
 
Screening 23AUG2019 
10:59 (-26) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
57 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
7 
mmol/L 
 
 
6-17 
 
Page 1217


SIGA TECHNOLOGIES, INC.  
Page 86 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
 
Screening 23AUG2019 
10:59 (-26) 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.82 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.12 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
76.9 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
176.7 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
20 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.38 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
0.75 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.72 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 132 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
Page 1218


SIGA TECHNOLOGIES, INC.  
Page 87 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
 
Screening 23AUG2019 
10:59 (-26) 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.41 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
286 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 17SEP2019 
09:06 (-1) 
Alanine 
Aminotransferase 
19 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
56 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.53 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
77.8 
umol/L 
 
 
56.6-114.9 
 
Page 1219


SIGA TECHNOLOGIES, INC.  
Page 88 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
 
Check-in 17SEP2019 
09:06 (-1) 
Gamma Glutamyl 
 Transferase 
20 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.83 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 137 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
274 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:25 (4) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
56 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.9 
umol/L 
 
 
3.2-28.9 
 
Page 1220


SIGA TECHNOLOGIES, INC.  
Page 89 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:25 (4) 
Blood Urea Nitrogen 
4.53 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
85.7 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
23 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.94 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 121 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.4 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
76 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
327 
umol/L 
 
 
173-494 
 
Page 1221


SIGA TECHNOLOGIES, INC.  
Page 90 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:00 (8) 
Alanine 
Aminotransferase 
23 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
54 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.3 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.43 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
84.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.66 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 113 
IU/L 
 
 
82-216 
 
Page 1222


SIGA TECHNOLOGIES, INC.  
Page 91 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:00 (8) 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.5 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
321 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
26SEP2019 
08:00 (9) 
Alanine 
Aminotransferase 
24 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
59 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.71 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
Page 1223


SIGA TECHNOLOGIES, INC.  
Page 92 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 9 
26SEP2019 
08:00 (9) 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
82.2 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.61 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 119 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.5 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
321 
umol/L 
 
 
173-494 
 
9033 
32/M/W 
 
Screening 29AUG2019 
09:53 (-6) 
Alanine 
Aminotransferase 
26 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
66 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
Page 1224


SIGA TECHNOLOGIES, INC.  
Page 93 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
 
Screening 29AUG2019 
09:53 (-6) 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
6.32 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.43 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
61.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
319.6 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
28 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.38 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
0.91 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.05 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 201 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.42 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.6 
mmol/L 
 
 
3.5-5 
 
Page 1225


SIGA TECHNOLOGIES, INC.  
Page 94 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
 
Screening 29AUG2019 
09:53 (-6) 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
3.23 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
488 
umol/L 
 
G1 
173-494 
 
 
 
 
Check-in 03SEP2019 
09:15 (-1) 
Alanine 
Aminotransferase 
20 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
64 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
6.46 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
61.0 
umol/L 
 
 
56.6-114.9 
 
Page 1226


SIGA TECHNOLOGIES, INC.  
Page 95 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
 
Check-in 03SEP2019 
09:15 (-1) 
Gamma Glutamyl 
 Transferase 
30 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.05 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 162 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.97 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
71 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
500 
umol/L 
H NCS G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:48 (4) 
Alanine 
Aminotransferase 
20 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
55 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.0 
umol/L 
 
 
3.2-28.9 
 
Page 1227


SIGA TECHNOLOGIES, INC.  
Page 96 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:48 (4) 
Blood Urea Nitrogen 
5.11 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.25 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
64.5 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
29 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 158 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.39 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
518 
umol/L 
H NCS G1 
173-494 
 
Page 1228


SIGA TECHNOLOGIES, INC.  
Page 97 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:18 (8) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
59 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
14.5 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.25 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
69.8 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
34 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.49 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 156 
IU/L 
 
 
82-216 
 
Page 1229


SIGA TECHNOLOGIES, INC.  
Page 98 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:18 (8) 
Phosphate 
1.49 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
494 
umol/L 
 
G1 
173-494 
 
 
 
 
Day 9 
12SEP2019 
08:18 (9) 
Alanine 
Aminotransferase 
23 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
50 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
63 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
13.5 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.89 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
Page 1230


SIGA TECHNOLOGIES, INC.  
Page 99 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:18 (9) 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
71.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
35 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 162 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.29 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
80 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
488 
umol/L 
 
G1 
173-494 
 
9043 
22/M/BL 
 
Screening 11SEP2019 
09:38 (-7) 
Alanine 
Aminotransferase 
25 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
36 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
Page 1231


SIGA TECHNOLOGIES, INC.  
Page 100 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
 
Screening 11SEP2019 
09:38 (-7) 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
2.96 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
3.89 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
94.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
243.5 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
30 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.30 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.20 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 154 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.90 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
Page 1232


SIGA TECHNOLOGIES, INC.  
Page 101 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
 
Screening 11SEP2019 
09:38 (-7) 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
0.82 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
452 
umol/L 
 
G1 
173-494 
 
 
 
 
Check-in 17SEP2019 
09:06 (-1) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
39 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.9 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.61 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.48 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
99.9 
umol/L 
 
 
56.6-114.9 
 
Page 1233


SIGA TECHNOLOGIES, INC.  
Page 102 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
 
Check-in 17SEP2019 
09:06 (-1) 
Gamma Glutamyl 
 Transferase 
27 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 171 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
535 
umol/L 
H NCS G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:28 (4) 
Alanine 
Aminotransferase 
25 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
48 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
42 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.3 
umol/L 
 
 
3.2-28.9 
 
Page 1234


SIGA TECHNOLOGIES, INC.  
Page 103 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:28 (4) 
Blood Urea Nitrogen 
3.28 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.58 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
93.7 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
27 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.66 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 147 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
470 
umol/L 
 
G1 
173-494 
 
Page 1235


SIGA TECHNOLOGIES, INC.  
Page 104 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:32 (8) 
Alanine 
Aminotransferase 
31 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
37 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.5 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.28 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.58 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
87.5 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
28 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.49 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 147 
IU/L 
 
 
82-216 
 
Page 1236


SIGA TECHNOLOGIES, INC.  
Page 105 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:32 (8) 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
428 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
26SEP2019 
08:11 (9) 
Alanine 
Aminotransferase 
30 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
40 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.4 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.78 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.45 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
Page 1237


SIGA TECHNOLOGIES, INC.  
Page 106 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 9 
26SEP2019 
08:11 (9) 
Chloride 
98 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
87.5 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
26 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.33 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 143 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.94 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
71 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
135 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
434 
umol/L 
 
 
173-494 
 
9046 
34/M/BL 
 
Screening 13SEP2019 
09:12 (-5) 
Alanine 
Aminotransferase 
12 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
43 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
Page 1238


SIGA TECHNOLOGIES, INC.  
Page 107 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
 
Screening 13SEP2019 
09:12 (-5) 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.07 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
106 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
3.86 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
97.2 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
163.3 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
16 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
22 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.33 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.11 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.54 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 141 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
Page 1239


SIGA TECHNOLOGIES, INC.  
Page 108 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
 
Screening 13SEP2019 
09:12 (-5) 
Protein 
64 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
0.45 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
369 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 17SEP2019 
09:05 (-1) 
Alanine 
Aminotransferase 
12 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
41 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.96 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
98.1 
umol/L 
 
 
56.6-114.9 
 
Page 1240


SIGA TECHNOLOGIES, INC.  
Page 109 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
 
Check-in 17SEP2019 
09:05 (-1) 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
24 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 140 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.97 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
67 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
315 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:31 (4) 
Alanine 
Aminotransferase 
12 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
36 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.7 
umol/L 
 
 
3.2-28.9 
 
Page 1241


SIGA TECHNOLOGIES, INC.  
Page 110 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:31 (4) 
Blood Urea Nitrogen 
3.82 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
98.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
25 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.00 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 125 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
68 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
357 
umol/L 
 
 
173-494 
 
Page 1242


SIGA TECHNOLOGIES, INC.  
Page 111 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:06 (8) 
Alanine 
Aminotransferase 
13 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
34 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
8 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.93 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.48 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
98.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
18 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
24 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.94 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 124 
IU/L 
 
 
82-216 
 
Page 1243


SIGA TECHNOLOGIES, INC.  
Page 112 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
25SEP2019 
08:06 (8) 
Phosphate 
1.23 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
357 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
26SEP2019 
08:06 (9) 
Alanine 
Aminotransferase 
11 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
39 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.3 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.96 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
Page 1244


SIGA TECHNOLOGIES, INC.  
Page 113 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 9 
26SEP2019 
08:06 (9) 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
94.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
25 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.00 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 128 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
363 
umol/L 
 
 
173-494 
 
9051 
34/M/BL 
 
Screening 19SEP2019 
09:10 (-13) 
Alanine 
Aminotransferase 
31 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
33 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
Page 1245


SIGA TECHNOLOGIES, INC.  
Page 114 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
 
Screening 19SEP2019 
09:10 (-13) 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.2 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.78 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.25 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
6.58 
mmol/L 
H NCS G2 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
91.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
184.4 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
54 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
19 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.45 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
4.27 
mmol/L 
H NCS G2 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 215 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.87 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
Page 1246


SIGA TECHNOLOGIES, INC.  
Page 115 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
 
Screening 19SEP2019 
09:10 (-13) 
Protein 
63 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
141 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.84 
mmol/L 
 
G1 
0-4.52 
 
 
 
 
 
 
Urate 
363 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 01OCT2019 
09:01 (-1) 
Alanine 
Aminotransferase 
37 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
38 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.89 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.18 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
88.4 
umol/L 
 
 
56.6-114.9 
 
Page 1247


SIGA TECHNOLOGIES, INC.  
Page 116 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
 
Check-in 01OCT2019 
09:01 (-1) 
Gamma Glutamyl 
 Transferase 
64 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
20 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 209 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
62 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
393 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:40 (4) 
Alanine 
Aminotransferase 
40 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
49 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
40 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.6 
umol/L 
 
 
3.2-28.9 
 
Page 1248


SIGA TECHNOLOGIES, INC.  
Page 117 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:40 (4) 
Blood Urea Nitrogen 
4.21 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
91.9 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
69 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
25 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.38 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 215 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.32 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
387 
umol/L 
 
 
173-494 
 
Page 1249


SIGA TECHNOLOGIES, INC.  
Page 118 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:15 (8) 
Alanine 
Aminotransferase 
40 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
44 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
22 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.6 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.71 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
94.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
65 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
25 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.05 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 222 
IU/L 
H NCS  
82-216 
 
Page 1250


SIGA TECHNOLOGIES, INC.  
Page 119 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:15 (8) 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
71 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
375 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
10OCT2019 
08:15 (9) 
Alanine 
Aminotransferase 
42 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
44 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
22 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.9 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.43 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
Page 1251


SIGA TECHNOLOGIES, INC.  
Page 120 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:15 (9) 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
94.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
64 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
25 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 223 
IU/L 
H NCS  
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
387 
umol/L 
 
 
173-494 
 
9052 
42/M/BL 
 
Screening 21SEP2019 
13:12 (-11) 
Alanine 
Aminotransferase 
12 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
49 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
Page 1252


SIGA TECHNOLOGIES, INC.  
Page 121 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
 
Screening 21SEP2019 
13:12 (-11) 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.7 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.25 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.38 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
110.5 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
131.8 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
13 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
32 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.32 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.64 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 179 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
Page 1253


SIGA TECHNOLOGIES, INC.  
Page 122 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
 
Screening 21SEP2019 
13:12 (-11) 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
0.93 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
327 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 01OCT2019 
09:15 (-1) 
Alanine 
Aminotransferase 
19 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
49 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.18 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
109.6 umol/L 
 
 
56.6-114.9 
 
Page 1254


SIGA TECHNOLOGIES, INC.  
Page 123 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
 
Check-in 01OCT2019 
09:15 (-1) 
Gamma Glutamyl 
 Transferase 
14 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
32 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.66 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 184 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.78 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
309 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:44 (4) 
Alanine 
Aminotransferase 
16 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
46 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.2 
umol/L 
 
 
3.2-28.9 
 
Page 1255


SIGA TECHNOLOGIES, INC.  
Page 124 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:44 (4) 
Blood Urea Nitrogen 
4.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
108.7 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
13 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
34 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.38 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 171 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
79 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
327 
umol/L 
 
 
173-494 
 
Page 1256


SIGA TECHNOLOGIES, INC.  
Page 125 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:19 (8) 
Alanine 
Aminotransferase 
16 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
53 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.2 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.78 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
118.5 umol/L 
H NCS  
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
14 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
34 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.22 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 176 
IU/L 
 
 
82-216 
 
Page 1257


SIGA TECHNOLOGIES, INC.  
Page 126 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:19 (8) 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
78 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
339 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
10OCT2019 
08:19 (9) 
Alanine 
Aminotransferase 
17 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
53 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.9 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.93 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
Page 1258


SIGA TECHNOLOGIES, INC.  
Page 127 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:19 (9) 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
114.9 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
15 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
36 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 166 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.97 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
79 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
351 
umol/L 
 
 
173-494 
 
9056 
31/F/BL 
 
Screening 24SEP2019 
10:06 (-8) 
Alanine 
Aminotransferase 
14 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
49 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
Page 1259


SIGA TECHNOLOGIES, INC.  
Page 128 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
 
Screening 24SEP2019 
10:06 (-8) 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
4.6 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.21 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.66 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
57.5 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
241.5 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
21 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.05 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.11 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
3.00 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 125 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.90 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.6 
mmol/L 
 
 
3.5-5 
 
Page 1260


SIGA TECHNOLOGIES, INC.  
Page 129 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
 
Screening 24SEP2019 
10:06 (-8) 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.18 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
422 
umol/L 
H NCS  
119-345 
 
 
 
 
Check-in 01OCT2019 
09:26 (-1) 
Alanine 
Aminotransferase 
15 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
51 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.2 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.21 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
69.8 
umol/L 
 
 
39.8-93.7 
 
Page 1261


SIGA TECHNOLOGIES, INC.  
Page 130 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
 
Check-in 01OCT2019 
09:26 (-1) 
Gamma Glutamyl 
 Transferase 
22 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 120 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
71 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
434 
umol/L 
H NCS  
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:25 (4) 
Alanine 
Aminotransferase 
14 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
47 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.7 
umol/L 
 
 
3.2-21.7 
 
Page 1262


SIGA TECHNOLOGIES, INC.  
Page 131 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:25 (4) 
Blood Urea Nitrogen 
4.07 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
73.4 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
22 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.33 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 108 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.00 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
446 
umol/L 
H NCS  
119-345 
 
Page 1263


SIGA TECHNOLOGIES, INC.  
Page 132 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:03 (8) 
Alanine 
Aminotransferase 
17 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
56 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.4 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.07 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.50 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
76.9 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
24 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.94 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 111 
IU/L 
 
 
82-216 
 
Page 1264


SIGA TECHNOLOGIES, INC.  
Page 133 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:03 (8) 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
446 
umol/L 
H NCS  
119-345 
 
 
 
 
Day 9 
10OCT2019 
08:00 (9) 
Alanine 
Aminotransferase 
15 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
52 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.5 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
Page 1265


SIGA TECHNOLOGIES, INC.  
Page 134 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:00 (9) 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
76.0 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
23 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.72 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 103 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.00 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
446 
umol/L 
H NCS  
119-345 
 
9057 
29/F/W 
 
Screening 25SEP2019 
16:27 (-7) 
Alanine 
Aminotransferase 
25 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
70 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
Page 1266


SIGA TECHNOLOGIES, INC.  
Page 135 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
 
Screening 25SEP2019 
16:27 (-7) 
Aspartate 
 Aminotransferase 
22 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.3 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.64 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
6.53 
mmol/L 
H NCS G2 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
45.1 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
328.9 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
26 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
0.93 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
3.68 
mmol/L 
 
G1 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 115 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
Page 1267


SIGA TECHNOLOGIES, INC.  
Page 136 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
 
Screening 25SEP2019 
16:27 (-7) 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
4.19 
mmol/L 
 
G2 
0-4.52 
 
 
 
 
 
 
Urate 
327 
umol/L 
 
 
119-345 
 
 
 
 
Check-in 01OCT2019 
09:22 (-1) 
Alanine 
Aminotransferase 
20 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
70 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.2 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
2.93 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
46.0 
umol/L 
 
 
39.8-93.7 
 
Page 1268


SIGA TECHNOLOGIES, INC.  
Page 137 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
 
Check-in 01OCT2019 
09:22 (-1) 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.22 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 114 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.97 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
321 
umol/L 
 
 
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:28 (4) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
67 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
15 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.3 
umol/L 
 
 
3.2-21.7 
 
Page 1269


SIGA TECHNOLOGIES, INC.  
Page 138 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:28 (4) 
Blood Urea Nitrogen 
3.93 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
24 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
47.7 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
32 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.66 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 103 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.36 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
363 
umol/L 
H NCS  
119-345 
 
Page 1270


SIGA TECHNOLOGIES, INC.  
Page 139 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:03 (8) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
71 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.8 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.28 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
49.5 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
26 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
32 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.27 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 96 
IU/L 
 
 
82-216 
 
Page 1271


SIGA TECHNOLOGIES, INC.  
Page 140 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:03 (8) 
Phosphate 
1.29 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
345 
umol/L 
 
 
119-345 
 
 
 
 
Day 9 
10OCT2019 
08:03 (9) 
Alanine 
Aminotransferase 
22 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
78 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
14 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.6 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.00 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
Page 1272


SIGA TECHNOLOGIES, INC.  
Page 141 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:03 (9) 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
52.2 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
29 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
34 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.00 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 99 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
78 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
351 
umol/L 
H NCS  
119-345 
 
9058 
32/M/W 
 
Screening 26SEP2019 
09:26 (-20) 
Alanine 
Aminotransferase 
39 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
72 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
Page 1273


SIGA TECHNOLOGIES, INC.  
Page 142 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
 
Screening 26SEP2019 
09:26 (-20) 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.3 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
6.66 
mmol/L 
H NCS G2 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
84.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
192.6 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
23 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.72 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.45 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
4.77 
mmol/L 
H NCS G2 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 85 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.23 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
Page 1274


SIGA TECHNOLOGIES, INC.  
Page 143 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
 
Screening 26SEP2019 
09:26 (-20) 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
0.95 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
345 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 15OCT2019 
09:07 (-1) 
Alanine 
Aminotransferase 
34 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
56 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.11 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
75.1 
umol/L 
 
 
56.6-114.9 
 
Page 1275


SIGA TECHNOLOGIES, INC.  
Page 144 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
 
Check-in 15OCT2019 
09:07 (-1) 
Gamma Glutamyl 
 Transferase 
23 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.27 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 82 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.29 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
345 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:32 (4) 
Alanine 
Aminotransferase 
33 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
53 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.6 
umol/L 
 
 
3.2-28.9 
 
Page 1276


SIGA TECHNOLOGIES, INC.  
Page 145 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:32 (4) 
Blood Urea Nitrogen 
5.39 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
76.9 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
24 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 82 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.42 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
351 
umol/L 
 
 
173-494 
 
Page 1277


SIGA TECHNOLOGIES, INC.  
Page 146 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:29 (8) 
Alanine 
Aminotransferase 
32 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
61 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.9 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.39 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
77.8 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.83 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 75 
IU/L 
L NCS  
82-216 
 
Page 1278


SIGA TECHNOLOGIES, INC.  
Page 147 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:29 (8) 
Phosphate 
1.32 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
351 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
24OCT2019 
08:08 (9) 
Alanine 
Aminotransferase 
33 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
48 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
63 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
6.46 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
Page 1279


SIGA TECHNOLOGIES, INC.  
Page 148 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:08 (9) 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
86.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 85 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.23 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.5 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
363 
umol/L 
 
 
173-494 
 
9061 
21/F/BL 
 
Screening 26SEP2019 
11:06 (-20) 
Alanine 
Aminotransferase 
13 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
66 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
Page 1280


SIGA TECHNOLOGIES, INC.  
Page 149 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
 
Screening 26SEP2019 
11:06 (-20) 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
3.1 
umol/L 
L NCS  
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.00 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
3.24 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
55.7 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
278.7 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
14 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.88 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
0.88 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
1.94 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 147 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.39 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
Page 1281


SIGA TECHNOLOGIES, INC.  
Page 150 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
 
Screening 26SEP2019 
11:06 (-20) 
Protein 
69 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
141 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
0.93 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
309 
umol/L 
 
 
119-345 
 
 
 
 
Check-in 15OCT2019 
09:01 (-1) 
Alanine 
Aminotransferase 
14 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
60 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
4.1 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.11 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.25 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
60.1 
umol/L 
 
 
39.8-93.7 
 
Page 1282


SIGA TECHNOLOGIES, INC.  
Page 151 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
 
Check-in 15OCT2019 
09:01 (-1) 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.66 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 167 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.29 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
69 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
321 
umol/L 
 
 
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:35 (4) 
Alanine 
Aminotransferase 
12 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
54 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
14 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.2 
umol/L 
 
 
3.2-21.7 
 
Page 1283


SIGA TECHNOLOGIES, INC.  
Page 152 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:35 (4) 
Blood Urea Nitrogen 
3.96 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
60.1 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
18 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.61 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 146 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.52 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
71 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
351 
umol/L 
H NCS  
119-345 
 
Page 1284


SIGA TECHNOLOGIES, INC.  
Page 153 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:06 (8) 
Alanine 
Aminotransferase 
13 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
61 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.7 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.71 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
61.9 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.66 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 135 
IU/L 
 
 
82-216 
 
Page 1285


SIGA TECHNOLOGIES, INC.  
Page 154 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:06 (8) 
Phosphate 
1.42 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
69 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
315 
umol/L 
 
 
119-345 
 
 
 
 
Day 9 
24OCT2019 
08:03 (9) 
Alanine 
Aminotransferase 
14 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
64 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.8 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.93 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
Page 1286


SIGA TECHNOLOGIES, INC.  
Page 155 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:03 (9) 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
68.1 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
18 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.61 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 157 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.29 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.7 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
333 
umol/L 
 
 
119-345 
 
9062 
33/M/BL 
 
Screening 30SEP2019 
10:25 (-2) 
Alanine 
Aminotransferase 
39 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
78 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
Page 1287


SIGA TECHNOLOGIES, INC.  
Page 156 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
 
Screening 30SEP2019 
10:25 (-2) 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.3 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.39 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
3.44 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
84.9 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
207.4 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
58 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.11 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
0.93 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
1.79 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 175 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.4 
mmol/L 
 
 
3.5-5 
 
Page 1288


SIGA TECHNOLOGIES, INC.  
Page 157 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
 
Screening 30SEP2019 
10:25 (-2) 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.60 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
404 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 01OCT2019 
09:29 (-1) 
Alanine 
Aminotransferase 
37 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
76 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.6 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.60 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
88.4 
umol/L 
 
 
56.6-114.9 
 
Page 1289


SIGA TECHNOLOGIES, INC.  
Page 158 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
 
Check-in 01OCT2019 
09:29 (-1) 
Gamma Glutamyl 
 Transferase 
57 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.49 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 159 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
399 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:31 (4) 
Alanine 
Aminotransferase 
31 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
77 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.5 
umol/L 
 
 
3.2-28.9 
 
Page 1290


SIGA TECHNOLOGIES, INC.  
Page 159 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:31 (4) 
Blood Urea Nitrogen 
4.21 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
99.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
48 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.38 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 126 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
404 
umol/L 
 
 
173-494 
 
Page 1291


SIGA TECHNOLOGIES, INC.  
Page 160 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:06 (8) 
Alanine 
Aminotransferase 
31 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
89 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.36 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
109.6 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
43 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.11 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 131 
IU/L 
 
 
82-216 
 
Page 1292


SIGA TECHNOLOGIES, INC.  
Page 161 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:06 (8) 
Phosphate 
1.45 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
399 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
10OCT2019 
08:06 (9) 
Alanine 
Aminotransferase 
32 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
90 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.46 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
Page 1293


SIGA TECHNOLOGIES, INC.  
Page 162 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:06 (9) 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
99.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
44 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.83 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 129 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.5 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
404 
umol/L 
 
 
173-494 
 
9063 
35/M/W 
 
Screening 30SEP2019 
09:38 (-2) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
53 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
14 
mmol/L 
 
 
6-17 
 
Page 1294


SIGA TECHNOLOGIES, INC.  
Page 163 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
 
Screening 30SEP2019 
09:38 (-2) 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.2 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.82 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
63.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
253.2 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.14 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.43 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 135 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.32 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.5 
mmol/L 
 
 
3.5-5 
 
Page 1295


SIGA TECHNOLOGIES, INC.  
Page 164 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
 
Screening 30SEP2019 
09:38 (-2) 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
2.71 
mmol/L 
 
G1 
0-4.52 
 
 
 
 
 
 
Urate 
268 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 01OCT2019 
08:48 (-1) 
Alanine 
Aminotransferase 
23 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
51 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.43 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.25 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
70.7 
umol/L 
 
 
56.6-114.9 
 
Page 1296


SIGA TECHNOLOGIES, INC.  
Page 165 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
 
Check-in 01OCT2019 
08:48 (-1) 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.38 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 143 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.26 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
333 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:34 (4) 
Alanine 
Aminotransferase 
19 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
47 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
46 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.3 
umol/L 
 
 
3.2-28.9 
 
Page 1297


SIGA TECHNOLOGIES, INC.  
Page 166 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 4 
05OCT2019 
07:34 (4) 
Blood Urea Nitrogen 
4.75 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
76.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
24 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 103 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.45 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
76 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
416 
umol/L 
 
 
173-494 
 
Page 1298


SIGA TECHNOLOGIES, INC.  
Page 167 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:09 (8) 
Alanine 
Aminotransferase 
14 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
48 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
54 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.1 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.45 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
99 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
86.6 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
24 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.66 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 109 
IU/L 
 
 
82-216 
 
Page 1299


SIGA TECHNOLOGIES, INC.  
Page 168 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
09OCT2019 
08:09 (8) 
Phosphate 
1.45 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
79 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
399 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
10OCT2019 
08:09 (9) 
Alanine 
Aminotransferase 
13 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
50 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
56 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.6 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.71 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
Page 1300


SIGA TECHNOLOGIES, INC.  
Page 169 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 9 
10OCT2019 
08:09 (9) 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
84.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
33 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 122 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.36 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
83 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
399 
umol/L 
 
 
173-494 
 
9069 
41/F/BL 
 
Screening 30SEP2019 
11:19 (-16) 
Alanine 
Aminotransferase 
15 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
113 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
Page 1301


SIGA TECHNOLOGIES, INC.  
Page 170 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
 
Screening 30SEP2019 
11:19 (-16) 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.4 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.68 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.79 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
59.2 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
263.4 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
18 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.72 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
0.88 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
3.32 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 237 
IU/L 
H NCS  
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
Page 1302


SIGA TECHNOLOGIES, INC.  
Page 171 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
 
Screening 30SEP2019 
11:19 (-16) 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.29 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
303 
umol/L 
 
 
119-345 
 
 
 
 
Check-in 15OCT2019 
12:32 (-1) 
Alanine 
Aminotransferase 
15 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
108 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.7 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.46 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
67.2 
umol/L 
 
 
39.8-93.7 
 
Page 1303


SIGA TECHNOLOGIES, INC.  
Page 172 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
 
Check-in 15OCT2019 
12:32 (-1) 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 233 
IU/L 
H NCS  
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
69 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
315 
umol/L 
 
 
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:35 (4) 
Alanine 
Aminotransferase 
15 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
94 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.6 
umol/L 
 
 
3.2-21.7 
 
Page 1304


SIGA TECHNOLOGIES, INC.  
Page 173 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:35 (4) 
Blood Urea Nitrogen 
3.18 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
60.1 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.05 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 226 
IU/L 
H NCS  
82-216 
 
 
 
 
 
 
Phosphate 
1.39 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
309 
umol/L 
 
 
119-345 
 
Page 1305


SIGA TECHNOLOGIES, INC.  
Page 174 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:17 (8) 
Alanine 
Aminotransferase 
14 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
102 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.2 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.61 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
62.8 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
18 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.66 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 205 
IU/L 
 
 
82-216 
 
Page 1306


SIGA TECHNOLOGIES, INC.  
Page 175 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:17 (8) 
Phosphate 
1.29 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
135 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
303 
umol/L 
 
 
119-345 
 
 
 
 
Day 9 
24OCT2019 
08:06 (9) 
Alanine 
Aminotransferase 
13 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
92 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.1 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.21 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.20 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
Page 1307


SIGA TECHNOLOGIES, INC.  
Page 176 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:06 (9) 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
65.4 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.11 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 204 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
69 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
303 
umol/L 
 
 
119-345 
 
9073 
40/M/BL 
 
Screening 04OCT2019 
13:56 (-12) 
Alanine 
Aminotransferase 
22 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
40 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
31 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
14 
mmol/L 
 
 
6-17 
 
Page 1308


SIGA TECHNOLOGIES, INC.  
Page 177 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
 
Screening 04OCT2019 
13:56 (-12) 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.61 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
26 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.04 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
87.5 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
221.7 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
20 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.38 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.01 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.38 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 143 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.55 
mmol/L 
H NCS  
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
Page 1309


SIGA TECHNOLOGIES, INC.  
Page 178 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
 
Screening 04OCT2019 
13:56 (-12) 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
141 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.42 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
381 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 15OCT2019 
09:18 (-1) 
Alanine 
Aminotransferase 
21 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
38 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
30 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.2 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.36 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.15 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
86.6 
umol/L 
 
 
56.6-114.9 
 
Page 1310


SIGA TECHNOLOGIES, INC.  
Page 179 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
 
Check-in 15OCT2019 
09:18 (-1) 
Gamma Glutamyl 
 Transferase 
24 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.94 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 148 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.71 
mmol/L 
H NCS  
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
64 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
369 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:41 (4) 
Alanine 
Aminotransferase 
23 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
38 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
29 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.7 
umol/L 
 
 
3.2-28.9 
 
Page 1311


SIGA TECHNOLOGIES, INC.  
Page 180 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:41 (4) 
Blood Urea Nitrogen 
3.82 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.25 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
84.0 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
23 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.88 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 133 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.65 
mmol/L 
H NCS  
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
66 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
142 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
452 
umol/L 
 
G1 
173-494 
 
Page 1312


SIGA TECHNOLOGIES, INC.  
Page 181 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:16 (8) 
Alanine 
Aminotransferase 
22 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
33 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.2 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.36 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
93.7 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
24 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.55 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 131 
IU/L 
 
 
82-216 
 
Page 1313


SIGA TECHNOLOGIES, INC.  
Page 182 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:16 (8) 
Phosphate 
1.81 
mmol/L 
H NCS  
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
141 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
440 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
24OCT2019 
08:16 (9) 
Alanine 
Aminotransferase 
22 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
30 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.2 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.25 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.25 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
Page 1314


SIGA TECHNOLOGIES, INC.  
Page 183 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:16 (9) 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
96.4 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
22 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.83 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 140 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.42 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
68 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
428 
umol/L 
 
 
173-494 
 
9077 
37/F/W 
 
Screening 05OCT2019 
13:15 (-11) 
Alanine 
Aminotransferase 
39 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
83 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
Page 1315


SIGA TECHNOLOGIES, INC.  
Page 184 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
 
Screening 05OCT2019 
13:15 (-11) 
Aspartate 
 Aminotransferase 
25 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
4.4 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.00 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
98 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.58 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
54.8 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
249.1 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
19 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.94 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.37 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
2.90 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 149 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
Page 1316


SIGA TECHNOLOGIES, INC.  
Page 185 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
 
Screening 05OCT2019 
13:15 (-11) 
Protein 
71 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
134 
mmol/L 
 
G1 
132-145 
 
 
 
 
 
 
Triglycerides 
0.69 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
286 
umol/L 
 
 
119-345 
 
 
 
 
Check-in 15OCT2019 
09:28 (-1) 
Alanine 
Aminotransferase 
18 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
83 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.3 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.78 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
58.3 
umol/L 
 
 
39.8-93.7 
 
Page 1317


SIGA TECHNOLOGIES, INC.  
Page 186 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
 
Check-in 15OCT2019 
09:28 (-1) 
Gamma Glutamyl 
 Transferase 
14 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.61 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 136 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
69 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
135 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
280 
umol/L 
 
 
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:37 (4) 
Alanine 
Aminotransferase 
11 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
79 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
11 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.1 
umol/L 
 
 
3.2-21.7 
 
Page 1318


SIGA TECHNOLOGIES, INC.  
Page 187 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:37 (4) 
Blood Urea Nitrogen 
4.43 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.53 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
61.0 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
14 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.77 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 126 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
309 
umol/L 
 
 
119-345 
 
Page 1319


SIGA TECHNOLOGIES, INC.  
Page 188 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:12 (8) 
Alanine 
Aminotransferase 
10 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
86 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
6 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
11 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.4 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.39 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.48 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
58.3 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
13 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.61 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 116 
IU/L 
 
 
82-216 
 
Page 1320


SIGA TECHNOLOGIES, INC.  
Page 189 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:12 (8) 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
280 
umol/L 
 
 
119-345 
 
 
 
 
Day 9 
24OCT2019 
08:12 (9) 
Alanine 
Aminotransferase 
11 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
86 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.5 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.11 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.50 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
Page 1321


SIGA TECHNOLOGIES, INC.  
Page 190 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:12 (9) 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
59.2 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
12 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
25 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.83 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 127 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.90 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
69 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
286 
umol/L 
 
 
119-345 
 
9080 
41/F/BL 
 
Screening 08OCT2019 
11:46 (-8) 
Alanine 
Aminotransferase 
18 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
56 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
Page 1322


SIGA TECHNOLOGIES, INC.  
Page 191 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
 
Screening 08OCT2019 
11:46 (-8) 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.4 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.46 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.95 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
76.9 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
162.6 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
15 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.49 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.50 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
3.16 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 184 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.03 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
Page 1323


SIGA TECHNOLOGIES, INC.  
Page 192 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
 
Screening 08OCT2019 
11:46 (-8) 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
0.64 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
393 
umol/L 
H NCS  
119-345 
 
 
 
 
Check-in 15OCT2019 
09:30 (-1) 
Alanine 
Aminotransferase 
15 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
41 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
60 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.4 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.75 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.33 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
85.7 
umol/L 
 
 
39.8-93.7 
 
Page 1324


SIGA TECHNOLOGIES, INC.  
Page 193 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
 
Check-in 15OCT2019 
09:30 (-1) 
Gamma Glutamyl 
 Transferase 
14 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.61 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 173 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.97 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
68 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
404 
umol/L 
H NCS  
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:46 (4) 
Alanine 
Aminotransferase 
17 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
59 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.1 
umol/L 
 
 
3.2-21.7 
 
Page 1325


SIGA TECHNOLOGIES, INC.  
Page 194 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:46 (4) 
Blood Urea Nitrogen 
4.46 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
73.4 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
32 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.94 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 172 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
76 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
351 
umol/L 
H NCS  
119-345 
 
Page 1326


SIGA TECHNOLOGIES, INC.  
Page 195 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:21 (8) 
Alanine 
Aminotransferase 
22 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
68 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.3 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.25 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
77.8 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
18 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.05 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 177 
IU/L 
 
 
82-216 
 
Page 1327


SIGA TECHNOLOGIES, INC.  
Page 196 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:21 (8) 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
327 
umol/L 
 
 
119-345 
 
 
 
 
Day 9 
24OCT2019 
08:21 (9) 
Alanine 
Aminotransferase 
22 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
60 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.4 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.32 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.20 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
Page 1328


SIGA TECHNOLOGIES, INC.  
Page 197 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:21 (9) 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
78.7 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
15 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.33 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 176 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.84 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
133 
mmol/L 
 
G1 
132-145 
 
 
 
 
 
 
Urate 
333 
umol/L 
 
 
119-345 
 
9081 
49/M/BL 
 
Screening 10OCT2019 
12:25 (-20) 
Alanine 
Aminotransferase 
31 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
94 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
Page 1329


SIGA TECHNOLOGIES, INC.  
Page 198 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
 
Screening 10OCT2019 
12:25 (-20) 
Aspartate 
 Aminotransferase 
23 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.2 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.07 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.45 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.82 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
90.2 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
271.4 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
29 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
34 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.00 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.27 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
3.08 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 209 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.4 
mmol/L 
 
 
3.5-5 
 
Page 1330


SIGA TECHNOLOGIES, INC.  
Page 199 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
 
Screening 10OCT2019 
12:25 (-20) 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.02 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
416 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 29OCT2019 
10:08 (-1) 
Alanine 
Aminotransferase 
27 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
88 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.7 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.46 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.53 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
96.4 
umol/L 
 
 
56.6-114.9 
 
Page 1331


SIGA TECHNOLOGIES, INC.  
Page 200 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
 
Check-in 29OCT2019 
10:08 (-1) 
Gamma Glutamyl 
 Transferase 
29 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.49 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 190 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.07 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
76 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
434 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
02NOV2019 
07:27 (4) 
Alanine 
Aminotransferase 
28 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
86 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.3 
umol/L 
 
 
3.2-28.9 
 
Page 1332


SIGA TECHNOLOGIES, INC.  
Page 201 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 4 
02NOV2019 
07:27 (4) 
Blood Urea Nitrogen 
4.71 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
98.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
27 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
30 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.22 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 178 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.29 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
446 
umol/L 
 
 
173-494 
 
Page 1333


SIGA TECHNOLOGIES, INC.  
Page 202 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
06NOV2019 
07:00 (8) 
Alanine 
Aminotransferase 
29 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
86 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.4 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.25 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.45 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
97.2 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
27 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.11 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 169 
IU/L 
 
 
82-216 
 
Page 1334


SIGA TECHNOLOGIES, INC.  
Page 203 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
06NOV2019 
07:00 (8) 
Phosphate 
1.23 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
428 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
07NOV2019 
07:00 (9) 
Alanine 
Aminotransferase 
29 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
86 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
22 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.11 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
26 
mmol/L 
 
 
22-34 
 
Page 1335


SIGA TECHNOLOGIES, INC.  
Page 204 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 9 
07NOV2019 
07:00 (9) 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
95.5 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
26 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
32 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.44 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 173 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
428 
umol/L 
 
 
173-494 
 
9086 
36/M/BL 
 
Screening 11OCT2019 
10:03 (-5) 
Alanine 
Aminotransferase 
11 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
72 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
Page 1336


SIGA TECHNOLOGIES, INC.  
Page 205 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
 
Screening 11OCT2019 
10:03 (-5) 
Aspartate 
 Aminotransferase 
11 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.5 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.78 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.50 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
6.06 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
98.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
183.5 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
32 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
35 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.44 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
0.88 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
4.53 
mmol/L 
H NCS G2 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 125 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
Page 1337


SIGA TECHNOLOGIES, INC.  
Page 206 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
 
Screening 11OCT2019 
10:03 (-5) 
Protein 
79 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
142 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.44 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
529 
umol/L 
H NCS G1 
173-494 
 
 
 
 
Check-in 15OCT2019 
09:28 (-1) 
Alanine 
Aminotransferase 
11 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
63 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
11 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.6 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.14 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
105 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
104.3 umol/L 
 
 
56.6-114.9 
 
Page 1338


SIGA TECHNOLOGIES, INC.  
Page 207 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
 
Check-in 15OCT2019 
09:28 (-1) 
Gamma Glutamyl 
 Transferase 
29 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
31 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.22 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 126 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
142 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
523 
umol/L 
H NCS G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:40 (4) 
Alanine 
Aminotransferase 
10 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
66 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
11 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.2 
umol/L 
 
 
3.2-28.9 
 
Page 1339


SIGA TECHNOLOGIES, INC.  
Page 208 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:40 (4) 
Blood Urea Nitrogen 
3.89 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.53 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
33 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
101.7 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
29 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
34 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 117 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
78 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
144 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
518 
umol/L 
H NCS G1 
173-494 
 
Page 1340


SIGA TECHNOLOGIES, INC.  
Page 209 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:15 (8) 
Alanine 
Aminotransferase 
12 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
76 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
12 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.82 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.53 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
33 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
101.7 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
29 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
35 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
4.66 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 117 
IU/L 
 
 
82-216 
 
Page 1341


SIGA TECHNOLOGIES, INC.  
Page 210 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:15 (8) 
Phosphate 
1.32 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
79 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
142 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
488 
umol/L 
 
G1 
173-494 
 
 
 
 
Day 9 
24OCT2019 
08:15 (9) 
Alanine 
Aminotransferase 
13 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
73 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
11 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.5 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.18 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.45 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
Page 1342


SIGA TECHNOLOGIES, INC.  
Page 211 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:15 (9) 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
107.9 umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
28 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
34 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.11 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 123 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
78 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
482 
umol/L 
 
G1 
173-494 
 
9087 
34/F/BL 
 
Screening 11OCT2019 
09:47 (-5) 
Alanine 
Aminotransferase 
13 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
39 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
85 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
Page 1343


SIGA TECHNOLOGIES, INC.  
Page 212 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
 
Screening 11OCT2019 
09:47 (-5) 
Aspartate 
 Aminotransferase 
15 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
4.8 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
2.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
27 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.17 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
61.0 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Creatinine Clearance 
224.9 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
28 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
34 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.22 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.35 
mmol/L 
 
 
0.88-2.36 
 
 
 
 
 
 
LDL Cholesterol 
2.54 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 173 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.26 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.2 
mmol/L 
 
 
3.5-5 
 
Page 1344


SIGA TECHNOLOGIES, INC.  
Page 213 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
 
Screening 11OCT2019 
09:47 (-5) 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
135 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
0.61 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
410 
umol/L 
H NCS  
119-345 
 
 
 
 
Check-in 15OCT2019 
09:17 (-1) 
Alanine 
Aminotransferase 
16 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
81 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
24 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
5.1 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
2.25 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
61.9 
umol/L 
 
 
39.8-93.7 
 
Page 1345


SIGA TECHNOLOGIES, INC.  
Page 214 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
 
Check-in 15OCT2019 
09:17 (-1) 
Gamma Glutamyl 
 Transferase 
30 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
33 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.38 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 178 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.36 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
75 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
136 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
416 
umol/L 
H NCS  
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:43 (4) 
Alanine 
Aminotransferase 
13 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
39 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
65 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
16 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.5 
umol/L 
 
 
3.2-21.7 
 
Page 1346


SIGA TECHNOLOGIES, INC.  
Page 215 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:43 (4) 
Blood Urea Nitrogen 
2.82 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
57.5 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
31 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
33 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.44 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 139 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.32 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
345 
umol/L 
 
 
119-345 
 
Page 1347


SIGA TECHNOLOGIES, INC.  
Page 216 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:18 (8) 
Alanine 
Aminotransferase 
25 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
81 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.3 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.25 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.48 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
60.1 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
46 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
35 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.33 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 138 
IU/L 
 
 
82-216 
 
Page 1348


SIGA TECHNOLOGIES, INC.  
Page 217 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:18 (8) 
Phosphate 
1.49 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.6 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
77 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
321 
umol/L 
 
 
119-345 
 
 
 
 
Day 9 
24OCT2019 
08:18 (9) 
Alanine 
Aminotransferase 
27 
IU/L 
 
 
4-45 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
38-49 
 
 
 
 
 
 
Alkaline Phosphatase 
79 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
23 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.3 
umol/L 
 
 
3.2-21.7 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.32 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
Page 1349


SIGA TECHNOLOGIES, INC.  
Page 218 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:18 (9) 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
61.9 
umol/L 
 
 
39.8-93.7 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
46 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
33 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.27 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 145 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
76 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
134 
mmol/L 
 
G1 
132-145 
 
 
 
 
 
 
Urate 
321 
umol/L 
 
 
119-345 
 
9089 
29/M/BL 
 
Screening 14OCT2019 
09:26 (-2) 
Alanine 
Aminotransferase 
28 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
47 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
Page 1350


SIGA TECHNOLOGIES, INC.  
Page 219 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
 
Screening 14OCT2019 
09:26 (-2) 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
7.4 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.46 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
33 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
5.57 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
85.7 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
195.5 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
27 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.11 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
0.88 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
3.08 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 150 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.32 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
Page 1351


SIGA TECHNOLOGIES, INC.  
Page 220 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
 
Screening 14OCT2019 
09:26 (-2) 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
3.48 
mmol/L 
 
G2 
0-4.52 
 
 
 
 
 
 
Urate 
375 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 15OCT2019 
08:52 (-1) 
Alanine 
Aminotransferase 
27 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
47 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
81.3 
umol/L 
 
 
56.6-114.9 
 
Page 1352


SIGA TECHNOLOGIES, INC.  
Page 221 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
 
Check-in 15OCT2019 
08:52 (-1) 
Gamma Glutamyl 
 Transferase 
27 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 136 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.23 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
69 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
381 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:49 (4) 
Alanine 
Aminotransferase 
26 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
47 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
20 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.9 
umol/L 
 
 
3.2-28.9 
 
Page 1353


SIGA TECHNOLOGIES, INC.  
Page 222 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:49 (4) 
Blood Urea Nitrogen 
4.18 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
33 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
90.2 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
27 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.27 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 132 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
410 
umol/L 
 
 
173-494 
 
Page 1354


SIGA TECHNOLOGIES, INC.  
Page 223 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:24 (8) 
Alanine 
Aminotransferase 
25 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
51 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.4 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.50 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
91.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
26 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.00 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 121 
IU/L 
 
 
82-216 
 
Page 1355


SIGA TECHNOLOGIES, INC.  
Page 224 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:24 (8) 
Phosphate 
1.36 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
393 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
24OCT2019 
08:24 (9) 
Alanine 
Aminotransferase 
25 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
46 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
49 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
9.6 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
4.89 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.38 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
Page 1356


SIGA TECHNOLOGIES, INC.  
Page 225 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:24 (9) 
Chloride 
99 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
93.7 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
25 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
27 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.11 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 133 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.20 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
73 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
137 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
393 
umol/L 
 
 
173-494 
 
9092 
24/M/W 
 
Screening 14OCT2019 
09:33 (-2) 
Alanine 
Aminotransferase 
18 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
38 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
90 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
Page 1357


SIGA TECHNOLOGIES, INC.  
Page 226 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
 
Screening 14OCT2019 
09:33 (-2) 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
8.7 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
2.32 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.28 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
4.66 
mmol/L 
 
 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
70.7 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
338.3 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
62 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
24 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.27 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.45 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
2.67 
mmol/L 
 
 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 165 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.94 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.9 
mmol/L 
 
 
3.5-5 
 
Page 1358


SIGA TECHNOLOGIES, INC.  
Page 227 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
 
Screening 14OCT2019 
09:33 (-2) 
Protein 
62 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.21 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
404 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 15OCT2019 
09:13 (-1) 
Alanine 
Aminotransferase 
17 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
37 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
99 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
18 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
6.3 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
2.71 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.23 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
29 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
71.6 
umol/L 
 
 
56.6-114.9 
 
Page 1359


SIGA TECHNOLOGIES, INC.  
Page 228 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
 
Check-in 15OCT2019 
09:13 (-1) 
Gamma Glutamyl 
 Transferase 
59 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
22 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.61 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 158 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.16 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.0 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
59 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
381 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:52 (4) 
Alanine 
Aminotransferase 
18 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
39 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
79 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.7 
umol/L 
 
 
3.2-28.9 
 
Page 1360


SIGA TECHNOLOGIES, INC.  
Page 229 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:52 (4) 
Blood Urea Nitrogen 
3.57 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.30 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
103 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
67.2 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
52 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
25 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.38 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 150 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.26 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
64 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
139 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
476 
umol/L 
 
G1 
173-494 
 
Page 1361


SIGA TECHNOLOGIES, INC.  
Page 230 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:27 (8) 
Alanine 
Aminotransferase 
18 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
42 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
97 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.0 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.18 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
30 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
68.1 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
51 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
28 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.16 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 153 
IU/L 
 
 
82-216 
 
Page 1362


SIGA TECHNOLOGIES, INC.  
Page 231 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:27 (8) 
Phosphate 
1.36 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.1 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
434 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
24OCT2019 
08:27 (9) 
Alanine 
Aminotransferase 
20 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
95 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
21 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.5 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
3.11 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
28 
mmol/L 
 
 
22-34 
 
Page 1363


SIGA TECHNOLOGIES, INC.  
Page 232 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:27 (9) 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
69.8 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
49 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.44 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 170 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
3.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
135 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
434 
umol/L 
 
 
173-494 
 
9095 
42/M/W 
 
Screening 17OCT2019 
13:31 (-13) 
Alanine 
Aminotransferase 
16 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
45 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
76 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
13 
mmol/L 
 
 
6-17 
 
Page 1364


SIGA TECHNOLOGIES, INC.  
Page 233 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
 
Screening 17OCT2019 
13:31 (-13) 
Aspartate 
 Aminotransferase 
14 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
12.8 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.14 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.43 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Cholesterol 
6.06 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
 
 
Creatinine 
73.4 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Creatinine Clearance 
246.0 mL/min 
 
 
90-N/A 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
15 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.38 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
 
 
HDL Cholesterol 
1.32 
mmol/L 
 
 
0.65-2.46 
 
 
 
 
 
 
LDL Cholesterol 
4.22 
mmol/L 
 
G2 
0.96-4.22 
 
 
 
 
 
 
Lactate Dehydrogenase 151 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.97 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.7 
mmol/L 
 
 
3.5-5 
 
Page 1365


SIGA TECHNOLOGIES, INC.  
Page 234 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
 
Screening 17OCT2019 
13:31 (-13) 
Protein 
74 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Triglycerides 
1.13 
mmol/L 
 
 
0-4.52 
 
 
 
 
 
 
Urate 
393 
umol/L 
 
 
173-494 
 
 
 
 
Check-in 29OCT2019 
08:52 (-1) 
Alanine 
Aminotransferase 
16 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
66 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
9 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
13 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
11.6 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.68 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
31 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
104 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
79.6 
umol/L 
 
 
56.6-114.9 
 
Page 1366


SIGA TECHNOLOGIES, INC.  
Page 235 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
 
Check-in 29OCT2019 
08:52 (-1) 
Gamma Glutamyl 
 Transferase 
13 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
25 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.88 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 142 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.00 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.3 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
69 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
387 
umol/L 
 
 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
02NOV2019 
07:31 (4) 
Alanine 
Aminotransferase 
20 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
71 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
11 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
13.3 
umol/L 
 
 
3.2-28.9 
 
Page 1367


SIGA TECHNOLOGIES, INC.  
Page 236 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 4 
02NOV2019 
07:31 (4) 
Blood Urea Nitrogen 
5.36 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
102 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
76.9 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
14 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
5.83 
mmol/L 
 
 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 129 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
1.10 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.8 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
404 
umol/L 
 
 
173-494 
 
Page 1368


SIGA TECHNOLOGIES, INC.  
Page 237 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
06NOV2019 
07:06 (8) 
Alanine 
Aminotransferase 
27 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
44 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
71 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
12 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
17 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
13.5 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.32 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.40 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
32 
mmol/L 
 
 
22-34 
 
 
 
 
 
 
Chloride 
101 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
80.4 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
17 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
26 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.33 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 120 
IU/L 
 
 
82-216 
 
Page 1369


SIGA TECHNOLOGIES, INC.  
Page 238 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
06NOV2019 
07:06 (8) 
Phosphate 
1.13 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
4.7 
mmol/L 
 
 
3.5-5 
 
 
 
 
 
 
Protein 
70 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
140 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
393 
umol/L 
 
 
173-494 
 
 
 
 
Day 9 
07NOV2019 
07:06 (9) 
Alanine 
Aminotransferase 
30 
IU/L 
 
 
7-56 
 
 
 
 
 
 
Albumin 
43 
g/L 
 
 
37-55 
 
 
 
 
 
 
Alkaline Phosphatase 
70 
IU/L 
 
 
20-116 
 
 
 
 
 
 
Anion Gap 
10 
mmol/L 
 
 
6-17 
 
 
 
 
 
 
Aspartate 
 Aminotransferase 
19 
IU/L 
 
 
10-40 
 
 
 
 
 
 
Bilirubin 
10.4 
umol/L 
 
 
3.2-28.9 
 
 
 
 
 
 
Blood Urea Nitrogen 
5.21 
mmol/L 
 
 
1.79-9.28 
 
 
 
 
 
 
Calcium 
2.35 
mmol/L 
 
 
2.13-2.58 
 
 
 
 
 
 
Carbon Dioxide 
33 
mmol/L 
 
 
22-34 
 
Page 1370


SIGA TECHNOLOGIES, INC.  
Page 239 of 239 
SIGA-246-022  
Listing 16.2.8.2  
Laboratory Results — Serum Chemistry  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020802.SAS  Executed: 21JAN2020 23:08  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 9 
07NOV2019 
07:06 (9) 
Chloride 
100 
mmol/L 
 
 
96-108 
 
 
 
 
 
 
Creatinine 
78.7 
umol/L 
 
 
56.6-114.9 
 
 
 
 
 
 
Gamma Glutamyl 
 Transferase 
18 
IU/L 
 
 
5-85 
 
 
 
 
 
 
Globulin 
29 
g/L 
 
 
19-39 
 
 
 
 
 
 
Glucose 
6.11 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
 
 
Lactate Dehydrogenase 122 
IU/L 
 
 
82-216 
 
 
 
 
 
 
Phosphate 
0.97 
mmol/L 
 
 
0.68-1.52 
 
 
 
 
 
 
Potassium 
5.1 
mmol/L 
H NCS  
3.5-5 
 
 
 
 
 
 
Protein 
72 
g/L 
 
 
57-88 
 
 
 
 
 
 
Sodium 
138 
mmol/L 
 
 
132-145 
 
 
 
 
 
 
Urate 
399 
umol/L 
 
 
173-494 
 
 
Page 1371


SIGA TECHNOLOGIES, INC.  
Page 1 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
 
Screening 19JUL2019 
11:12 (-26) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Dk Yellow  
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.027 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
Page 1372


SIGA TECHNOLOGIES, INC.  
Page 2 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
08:26 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Dk Yellow  
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.028 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.0 
 
 
 
5-7.5 
 
Page 1373


SIGA TECHNOLOGIES, INC.  
Page 3 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
 
Screening 19JUL2019 
11:13 (-26) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.027 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
Page 1374


SIGA TECHNOLOGIES, INC.  
Page 4 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
TPOXX 
600 mg 
Day 9 
22AUG2019 
08:25 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.011 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
Page 1375


SIGA TECHNOLOGIES, INC.  
Page 5 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
 
Screening 23JUL2019 
09:37 (-22) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.019 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1376


SIGA TECHNOLOGIES, INC.  
Page 6 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 9 
22AUG2019 
08:04 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.019 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
7.0 
 
 
 
5-7.5 
 
Page 1377


SIGA TECHNOLOGIES, INC.  
Page 7 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
 
Screening 31JUL2019 
10:29 (-14) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.020 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
Page 1378


SIGA TECHNOLOGIES, INC.  
Page 8 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
08:08 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.021 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
Page 1379


SIGA TECHNOLOGIES, INC.  
Page 9 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
 
Screening 06AUG2019 
11:05 (-8) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.003 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
Page 1380


SIGA TECHNOLOGIES, INC.  
Page 10 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
08:12 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.006 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
Page 1381


SIGA TECHNOLOGIES, INC.  
Page 11 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
 
Screening 12AUG2019 
10:12 (-2) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.016 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1382


SIGA TECHNOLOGIES, INC.  
Page 12 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
TPOXX 
600 mg 
Day 9 
22AUG2019 
08:10 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.016 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
7.0 
 
 
 
5-7.5 
 
Page 1383


SIGA TECHNOLOGIES, INC.  
Page 13 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
 
Screening 12AUG2019 
10:26 (-23) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.022 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1384


SIGA TECHNOLOGIES, INC.  
Page 14 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:02 (9) 
Bacteria 
51-100 
/HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
Over 20 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
1+ 
 
A NCS  
Negative 
 
 
 
 
 
 
Specific Gravity 
1.024 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
Page 1385


SIGA TECHNOLOGIES, INC.  
Page 15 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:02 (9) 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
9019 
41/M/BL 
 
Screening 15AUG2019 
16:33 (-20) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
Page 1386


SIGA TECHNOLOGIES, INC.  
Page 16 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
 
Screening 15AUG2019 
16:33 (-20) 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.006 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:06 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
Page 1387


SIGA TECHNOLOGIES, INC.  
Page 17 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:06 (9) 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.020 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
9020 
47/F/BL 
 
Screening 21AUG2019 
10:03 (-14) 
Clarity 
Clear 
 
 
 
Clear 
 
Page 1388


SIGA TECHNOLOGIES, INC.  
Page 18 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
 
Screening 21AUG2019 
10:03 (-14) 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.006 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
Page 1389


SIGA TECHNOLOGIES, INC.  
Page 19 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:08 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.016 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1390


SIGA TECHNOLOGIES, INC.  
Page 20 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
 
Screening 21AUG2019 
10:05 (-14) 
Bacteria 
0-20 
/HPF 
 
 
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Trace 
 
A NCS  
Negative 
 
 
 
 
 
 
Specific Gravity 
1.014 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
Page 1391


SIGA TECHNOLOGIES, INC.  
Page 21 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
 
Screening 21AUG2019 
10:05 (-14) 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:19 (9) 
Bacteria 
51-100 
/HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
6-10 
/LPF 
A NCS  
0 
Hyaline casts
seen. 
 
 
 
 
 
Clarity 
Cloudy 
 
A NCS  
Clear 
 
 
 
 
 
 
Color 
Dk Yellow  
 
 
Yellow,Dk 
Yellow 
 
Page 1392


SIGA TECHNOLOGIES, INC.  
Page 22 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:19 (9) 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
Over 20 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Trace 
 
A NCS  
Negative 
 
 
 
 
 
 
Specific Gravity 
1.034 
 
H NCS  
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 3-5 
/HPF 
A NCS  
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Trace 
 
A NCS  
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
Page 1393


SIGA TECHNOLOGIES, INC.  
Page 23 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:19 (9) 
pH 
5.0 
 
 
 
5-7.5 
 
9022 
31/M/W 
 
Screening 21AUG2019 
11:12 (-14) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.022 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
Page 1394


SIGA TECHNOLOGIES, INC.  
Page 24 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
 
Screening 21AUG2019 
11:12 (-14) 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:13 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.012 
 
 
 
1.002-1.03 
 
Page 1395


SIGA TECHNOLOGIES, INC.  
Page 25 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:13 (9) 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
9024 
20/M/BL 
 
Screening 23AUG2019 
10:02 (-12) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
Page 1396


SIGA TECHNOLOGIES, INC.  
Page 26 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
 
Screening 23AUG2019 
10:02 (-12) 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.025 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.0 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:17 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
Page 1397


SIGA TECHNOLOGIES, INC.  
Page 27 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:17 (9) 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.017 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
9025 
50/M/W 
 
Screening 23AUG2019 
10:10 (-26) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
Page 1398


SIGA TECHNOLOGIES, INC.  
Page 28 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
 
Screening 23AUG2019 
10:10 (-26) 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.020 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
7.0 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
26SEP2019 
07:07 (9) 
Bacteria 
0-20 
/HPF 
 
 
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
Page 1399


SIGA TECHNOLOGIES, INC.  
Page 29 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 9 
26SEP2019 
07:07 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
1+ 
 
A NCS  
Negative 
 
 
 
 
 
 
Specific Gravity 
1.023 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
Page 1400


SIGA TECHNOLOGIES, INC.  
Page 30 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
TPOXX 
600 mg 
Day 9 
26SEP2019 
07:07 (9) 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.0 
 
 
 
5-7.5 
 
9033 
32/M/W 
 
Screening 29AUG2019 
09:03 (-6) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
Page 1401


SIGA TECHNOLOGIES, INC.  
Page 31 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
 
Screening 29AUG2019 
09:03 (-6) 
Specific Gravity 
1.018 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.0 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:21 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
Page 1402


SIGA TECHNOLOGIES, INC.  
Page 32 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
07:21 (9) 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.022 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
9043 
22/M/BL 
 
Screening 11SEP2019 
08:45 (-7) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
Page 1403


SIGA TECHNOLOGIES, INC.  
Page 33 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
 
Screening 11SEP2019 
08:45 (-7) 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.022 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Unschedule
d 
- 8.01 
23SEP2019 
10:29 (6) 
Bacteria 
0-20 
/HPF 
 
 
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
Page 1404


SIGA TECHNOLOGIES, INC.  
Page 34 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Unschedule
d 
- 8.01 
23SEP2019 
10:29 (6) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.002 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
Page 1405


SIGA TECHNOLOGIES, INC.  
Page 35 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Unschedule
d 
- 8.01 
23SEP2019 
10:29 (6) 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
7.0 
 
 
 
5-7.5 
 
 
 
 
Day 9 
26SEP2019 
07:05 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
Page 1406


SIGA TECHNOLOGIES, INC.  
Page 36 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 9 
26SEP2019 
07:05 (9) 
Specific Gravity 
1.024 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
9046 
34/M/BL 
 
Screening 13SEP2019 
08:22 (-5) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
Page 1407


SIGA TECHNOLOGIES, INC.  
Page 37 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
 
Screening 13SEP2019 
08:22 (-5) 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.023 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
26SEP2019 
07:08 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
Page 1408


SIGA TECHNOLOGIES, INC.  
Page 38 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
TPOXX 
600 mg 
Day 9 
26SEP2019 
07:08 (9) 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.011 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
9051 
34/M/BL 
 
Screening 19SEP2019 
08:40 (-13) 
Bacteria 
0-20 
/HPF 
 
 
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
Page 1409


SIGA TECHNOLOGIES, INC.  
Page 39 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
 
Screening 19SEP2019 
08:40 (-13) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Positive  
A NCS  
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.016 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
Page 1410


SIGA TECHNOLOGIES, INC.  
Page 40 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
 
Screening 19SEP2019 
08:40 (-13) 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:16 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
Page 1411


SIGA TECHNOLOGIES, INC.  
Page 41 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:16 (9) 
Specific Gravity 
1.015 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
9052 
42/M/BL 
 
Screening 21SEP2019 
12:33 (-11) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
Page 1412


SIGA TECHNOLOGIES, INC.  
Page 42 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
 
Screening 21SEP2019 
12:33 (-11) 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.021 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:20 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
Page 1413


SIGA TECHNOLOGIES, INC.  
Page 43 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:20 (9) 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.021 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
9056 
31/F/BL 
 
Screening 24SEP2019 
09:20 (-8) 
Clarity 
Clear 
 
 
 
Clear 
 
Page 1414


SIGA TECHNOLOGIES, INC.  
Page 44 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
 
Screening 24SEP2019 
09:20 (-8) 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.017 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1415


SIGA TECHNOLOGIES, INC.  
Page 45 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:08 (9) 
Bacteria 
51-100 
/HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
1-2 
/LPF 
A NCS  
0 
Hyaline casts
seen. 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
6-10 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Trace 
 
A NCS  
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.027 
 
 
 
1.002-1.03 
 
Page 1416


SIGA TECHNOLOGIES, INC.  
Page 46 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:08 (9) 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
6-10 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
9057 
29/F/W 
 
Screening 25SEP2019 
15:56 (-7) 
Bacteria 
51-100 
/HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Dk Yellow  
 
 
Yellow,Dk 
Yellow 
 
Page 1417


SIGA TECHNOLOGIES, INC.  
Page 47 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
 
Screening 25SEP2019 
15:56 (-7) 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
11-20 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Positive  
A NCS  
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.027 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
Page 1418


SIGA TECHNOLOGIES, INC.  
Page 48 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
 
Screening 25SEP2019 
15:56 (-7) 
pH 
5.5 
 
 
 
5-7.5 
 
 
 
 
Screening 30SEP2019 
10:10 (-2), 
R 
Bacteria 
None Seen /HPF 
 
 
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
Page 1419


SIGA TECHNOLOGIES, INC.  
Page 49 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
 
Screening 30SEP2019 
10:10 (-2), 
R 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.004 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:08 (9) 
Bacteria 
Over 100 /HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
Page 1420


SIGA TECHNOLOGIES, INC.  
Page 50 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:08 (9) 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Positive  
A NCS  
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.026 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
Page 1421


SIGA TECHNOLOGIES, INC.  
Page 51 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:08 (9) 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
 
 
 
Day 9 
11OCT2019 
10:33 (10), 
R 
Bacteria 
0-20 
/HPF 
 
 
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
Page 1422


SIGA TECHNOLOGIES, INC.  
Page 52 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
TPOXX 
600 mg 
Day 9 
11OCT2019 
10:33 (10), 
R 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.002 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
9058 
32/M/W 
 
Screening 26SEP2019 
08:59 (-20) 
Clarity 
Clear 
 
 
 
Clear 
 
Page 1423


SIGA TECHNOLOGIES, INC.  
Page 53 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
 
Screening 26SEP2019 
08:59 (-20) 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.008 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1424


SIGA TECHNOLOGIES, INC.  
Page 54 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:09 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.030 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1425


SIGA TECHNOLOGIES, INC.  
Page 55 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
 
Screening 26SEP2019 
10:16 (-20) 
Bacteria 
51-100 
/HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
11-20 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase 1+ 
 
A NCS  
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
1+ 
 
A NCS  
Negative 
 
 
 
 
 
 
Specific Gravity 
1.029 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
Page 1426


SIGA TECHNOLOGIES, INC.  
Page 56 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
 
Screening 26SEP2019 
10:16 (-20) 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
11-20 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:09 (9) 
Bacteria 
Over 100 /HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
Page 1427


SIGA TECHNOLOGIES, INC.  
Page 57 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:09 (9) 
Epithelial Cells 
Over 20 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase 1+ 
 
A NCS  
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.026 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
21-50 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1428


SIGA TECHNOLOGIES, INC.  
Page 58 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 9 
31OCT2019 
18:11 (16), 
R 
Bacteria 
Over 100 /HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Cloudy 
 
A NCS  
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
11-20 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Ketones 
Trace 
 
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase 1+ 
 
A NCS  
Negative 
 
 
 
 
 
 
Nitrite 
Positive  
A NCS  
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.029 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
Page 1429


SIGA TECHNOLOGIES, INC.  
Page 59 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
TPOXX 
600 mg 
Day 9 
31OCT2019 
18:11 (16), 
R 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
11-20 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
9062 
33/M/BL 
 
Screening 30SEP2019 
10:35 (-2) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
Page 1430


SIGA TECHNOLOGIES, INC.  
Page 60 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
 
Screening 30SEP2019 
10:35 (-2) 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.003 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
7.0 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:11 (9) 
Bacteria 
0-20 
/HPF 
 
 
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Cloudy 
 
A NCS  
Clear 
 
Page 1431


SIGA TECHNOLOGIES, INC.  
Page 61 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:11 (9) 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Trace 
 
A NCS  
Negative 
 
 
 
 
 
 
Specific Gravity 
1.010 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Trace 
 
A NCS  
Negative 
 
Page 1432


SIGA TECHNOLOGIES, INC.  
Page 62 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:11 (9) 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
7.0 
 
 
 
5-7.5 
 
9063 
35/M/W 
 
Screening 30SEP2019 
08:58 (-2) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.013 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
Page 1433


SIGA TECHNOLOGIES, INC.  
Page 63 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
 
Screening 30SEP2019 
08:58 (-2) 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.0 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:10 (9) 
Bacteria 
21-50 
/HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
0-5 
/HPF 
 
 
0-5 
 
Page 1434


SIGA TECHNOLOGIES, INC.  
Page 64 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 9 
10OCT2019 
07:10 (9) 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Trace 
 
A NCS  
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.021 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
6-10 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
Page 1435


SIGA TECHNOLOGIES, INC.  
Page 65 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 9 
14OCT2019 
09:54 (13), 
R 
Bacteria 
None Seen /HPF 
 
 
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.020 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
Page 1436


SIGA TECHNOLOGIES, INC.  
Page 66 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
TPOXX 
600 mg 
Day 9 
14OCT2019 
09:54 (13), 
R 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
9069 
41/F/BL 
 
Screening 30SEP2019 
10:15 (-16) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
Page 1437


SIGA TECHNOLOGIES, INC.  
Page 67 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
 
Screening 30SEP2019 
10:15 (-16) 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.012 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:10 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
Page 1438


SIGA TECHNOLOGIES, INC.  
Page 68 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:10 (9) 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.018 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
9073 
40/M/BL 
 
Screening 04OCT2019 
13:25 (-12) 
Clarity 
Clear 
 
 
 
Clear 
 
Page 1439


SIGA TECHNOLOGIES, INC.  
Page 69 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
 
Screening 04OCT2019 
13:25 (-12) 
Color 
Dk Yellow  
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.026 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
Page 1440


SIGA TECHNOLOGIES, INC.  
Page 70 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:18 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.021 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
Page 1441


SIGA TECHNOLOGIES, INC.  
Page 71 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
 
Screening 05OCT2019 
13:19 (-11) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.007 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
Page 1442


SIGA TECHNOLOGIES, INC.  
Page 72 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:15 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.018 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1443


SIGA TECHNOLOGIES, INC.  
Page 73 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
 
Screening 08OCT2019 
11:11 (-8) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.005 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1444


SIGA TECHNOLOGIES, INC.  
Page 74 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:23 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.020 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
Page 1445


SIGA TECHNOLOGIES, INC.  
Page 75 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
 
Screening 10OCT2019 
11:34 (-20) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Dk Yellow  
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.025 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1446


SIGA TECHNOLOGIES, INC.  
Page 76 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
TPOXX 
600 mg 
Day 9 
07NOV2019 
06:02 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.023 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
Page 1447


SIGA TECHNOLOGIES, INC.  
Page 77 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
 
Screening 11OCT2019 
08:56 (-5) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.022 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.0 
 
 
 
5-7.5 
 
Page 1448


SIGA TECHNOLOGIES, INC.  
Page 78 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:19 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.017 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1449


SIGA TECHNOLOGIES, INC.  
Page 79 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
 
Screening 11OCT2019 
10:02 (-5) 
Bacteria 
0-20 
/HPF 
 
 
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
6-10 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase 1+ 
 
A NCS  
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.009 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
Page 1450


SIGA TECHNOLOGIES, INC.  
Page 80 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
 
Screening 11OCT2019 
10:02 (-5) 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
6-10 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:20 (9) 
Bacteria 
51-100 
/HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Cloudy 
 
A NCS  
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
Page 1451


SIGA TECHNOLOGIES, INC.  
Page 81 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:20 (9) 
Epithelial Cells 
11-20 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase 1+ 
 
A NCS  
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.009 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
11-20 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
Page 1452


SIGA TECHNOLOGIES, INC.  
Page 82 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 9 
07NOV2019 
10:36 (23), 
R 
Bacteria 
21-50 
/HPF 
A NCS  
None 
Seen,0-20 
 
 
 
 
 
 
Casts 
0 
/LPF 
 
 
0 
 
 
 
 
 
 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Crystals 
0 
/HPF 
 
 
0 
 
 
 
 
 
 
Epithelial Cells 
6-10 
/HPF 
A NCS  
0-5 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.001 
 
L NCS  
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
Page 1453


SIGA TECHNOLOGIES, INC.  
Page 83 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 9 
07NOV2019 
10:36 (23), 
R 
Urine Erythrocytes 0-2 
/HPF 
 
 
0-2 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Leukocytes 
0-5 
/HPF 
 
 
0-5 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
9089 
29/M/BL 
 
Screening 14OCT2019 
08:52 (-2) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
Page 1454


SIGA TECHNOLOGIES, INC.  
Page 84 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
 
Screening 14OCT2019 
08:52 (-2) 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.025 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
 
 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:24 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
Page 1455


SIGA TECHNOLOGIES, INC.  
Page 85 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:24 (9) 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.026 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
9092 
24/M/W 
 
Screening 14OCT2019 
08:56 (-2) 
Clarity 
Clear 
 
 
 
Clear 
 
Page 1456


SIGA TECHNOLOGIES, INC.  
Page 86 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
 
Screening 14OCT2019 
08:56 (-2) 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.013 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.0 
 
 
 
5-7.5 
 
Page 1457


SIGA TECHNOLOGIES, INC.  
Page 87 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 9 
24OCT2019 
07:32 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.013 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
Page 1458


SIGA TECHNOLOGIES, INC.  
Page 88 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
 
Screening 17OCT2019 
13:05 (-13) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Dk Yellow  
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.027 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
1.69 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
6.5 
 
 
 
5-7.5 
 
Page 1459


SIGA TECHNOLOGIES, INC.  
Page 89 of 89 
SIGA-246-022  
Listing 16.2.8.3  
Laboratory Results — Urinalysis  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020803.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
TPOXX 
600 mg 
Day 9 
07NOV2019 
06:08 (9) 
Clarity 
Clear 
 
 
 
Clear 
 
 
 
 
 
 
Color 
Yellow 
 
 
 
Yellow,Dk 
Yellow 
 
 
 
 
 
 
Ketones 
Negative  
 
 
Negative,Tr  
ace 
 
 
 
 
 
 
Leukocyte Esterase Negative  
 
 
Negative 
 
 
 
 
 
 
Nitrite 
Negative  
 
 
Negative 
 
 
 
 
 
 
Occult Blood 
Negative  
 
 
Negative 
 
 
 
 
 
 
Specific Gravity 
1.022 
 
 
 
1.002-1.03 
 
 
 
 
 
 
Urine Bilirubin 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Glucose 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urine Protein 
Negative  
 
 
Negative 
 
 
 
 
 
 
Urobilinogen 
0.34 
umol/dL 
 
 
0.34-1.69 
 
 
 
 
 
 
pH 
5.5 
 
 
 
5-7.5 
 
 
Page 1460


SIGA TECHNOLOGIES, INC.  
Page 1 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
 
Screening 19JUL2019 
11:12 (-26) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 19JUL2019 
12:06 (-26) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.2 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
Page 1461


SIGA TECHNOLOGIES, INC.  
Page 2 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
 
Check-in 13AUG2019 
09:00 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9002 
48/M/W 
 
Screening 19JUL2019 
11:13 (-26) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
Page 1462


SIGA TECHNOLOGIES, INC.  
Page 3 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
 
Screening 19JUL2019 
11:13 (-26) 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 19JUL2019 
12:02 (-26) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.9 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 13AUG2019 
09:11 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
Page 1463


SIGA TECHNOLOGIES, INC.  
Page 4 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9002 
48/M/W 
 
Check-in 13AUG2019 
09:11 (-1) 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9005 
40/M/W 
 
Screening 23JUL2019 
09:37 (-22) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
Page 1464


SIGA TECHNOLOGIES, INC.  
Page 5 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
 
Screening 23JUL2019 
09:37 (-22) 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 23JUL2019 
10:05 (-22) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
6.1 
% 
H NCS 4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 13AUG2019 
08:56 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
Page 1465


SIGA TECHNOLOGIES, INC.  
Page 6 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
 
Check-in 13AUG2019 
08:56 (-1) 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9009 
21/F/BL 
 
Screening 31JUL2019 
10:20 (-14) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.0 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Screening 31JUL2019 
10:29 (-14) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
Page 1466


SIGA TECHNOLOGIES, INC.  
Page 7 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
 
Screening 31JUL2019 
10:29 (-14) 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 13AUG2019 
08:52 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
Page 1467


SIGA TECHNOLOGIES, INC.  
Page 8 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9009 
21/F/BL 
 
Check-in 13AUG2019 
08:52 (-1) 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 13AUG2019 
09:32 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
9012 
34/M/BL 
 
Screening 06AUG2019 
10:31 (-8) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
4.6 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Screening 06AUG2019 
11:05 (-8) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
Page 1468


SIGA TECHNOLOGIES, INC.  
Page 9 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
 
Screening 06AUG2019 
11:05 (-8) 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 13AUG2019 
09:20 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
Page 1469


SIGA TECHNOLOGIES, INC.  
Page 10 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
 
Check-in 13AUG2019 
09:20 (-1) 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9015 
29/M/BL 
 
Screening 12AUG2019 
10:12 (-2) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 12AUG2019 
11:07 (-2) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
Page 1470


SIGA TECHNOLOGIES, INC.  
Page 11 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9015 
29/M/BL 
 
Screening 12AUG2019 
11:07 (-2) 
Hemoglobin A1C 
5.7 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 13AUG2019 
08:47 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
Page 1471


SIGA TECHNOLOGIES, INC.  
Page 12 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
 
Screening 12AUG2019 
10:26 (-23) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 12AUG2019 
11:08 (-23) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.3 
% 
 
4-6 
 
Page 1472


SIGA TECHNOLOGIES, INC.  
Page 13 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9016 
48/F/W 
 
Screening 12AUG2019 
11:08 (-23) 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 03SEP2019 
08:31 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 03SEP2019 
09:04 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
Page 1473


SIGA TECHNOLOGIES, INC.  
Page 14 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
 
Screening 15AUG2019 
16:33 (-20) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 15AUG2019 
17:21 (-20) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
Page 1474


SIGA TECHNOLOGIES, INC.  
Page 15 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
 
Screening 15AUG2019 
17:29 (-20) 
Hemoglobin A1C 
5.0 
% 
 
4-6 
 
 
 
 
Check-in 03SEP2019 
11:14 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9020 
47/F/BL 
 
Screening 21AUG2019 
10:03 (-14) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
Page 1475


SIGA TECHNOLOGIES, INC.  
Page 16 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
 
Screening 21AUG2019 
10:03 (-14) 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 21AUG2019 
10:37 (-14) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.0 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
Page 1476


SIGA TECHNOLOGIES, INC.  
Page 17 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9020 
47/F/BL 
 
Check-in 03SEP2019 
08:26 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 03SEP2019 
08:56 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
9021 
39/F/BL 
 
Screening 21AUG2019 
10:05 (-14) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
Page 1477


SIGA TECHNOLOGIES, INC.  
Page 18 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
 
Screening 21AUG2019 
10:05 (-14) 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 21AUG2019 
10:44 (-14) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.8 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
Page 1478


SIGA TECHNOLOGIES, INC.  
Page 19 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
 
Check-in 03SEP2019 
08:29 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 03SEP2019 
09:00 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
9022 
31/M/W 
 
Screening 21AUG2019 
11:05 (-14) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.8 
% 
 
4-6 
 
Page 1479


SIGA TECHNOLOGIES, INC.  
Page 20 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
 
Screening 21AUG2019 
11:05 (-14) 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Screening 21AUG2019 
11:12 (-14) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 03SEP2019 
09:49 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
Page 1480


SIGA TECHNOLOGIES, INC.  
Page 21 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
 
Check-in 03SEP2019 
09:49 (-1) 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9024 
20/M/BL 
 
Screening 23AUG2019 
10:02 (-12) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
Page 1481


SIGA TECHNOLOGIES, INC.  
Page 22 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
 
Screening 23AUG2019 
10:02 (-12) 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 23AUG2019 
10:48 (-12) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.2 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 03SEP2019 
08:42 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
Page 1482


SIGA TECHNOLOGIES, INC.  
Page 23 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9024 
20/M/BL 
 
Check-in 03SEP2019 
08:42 (-1) 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9025 
50/M/W 
 
Screening 23AUG2019 
10:10 (-26) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
Page 1483


SIGA TECHNOLOGIES, INC.  
Page 24 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9025 
50/M/W 
 
Screening 23AUG2019 
10:59 (-26) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.9 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 17SEP2019 
08:40 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
Page 1484


SIGA TECHNOLOGIES, INC.  
Page 25 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
 
Screening 29AUG2019 
09:03 (-6) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 29AUG2019 
09:53 (-6) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.9 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
Page 1485


SIGA TECHNOLOGIES, INC.  
Page 26 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9033 
32/M/W 
 
Check-in 03SEP2019 
08:39 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9043 
22/M/BL 
 
Screening 11SEP2019 
08:45 (-7) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
Page 1486


SIGA TECHNOLOGIES, INC.  
Page 27 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
 
Screening 11SEP2019 
08:45 (-7) 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 11SEP2019 
09:38 (-7) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.6 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 17SEP2019 
08:38 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
Page 1487


SIGA TECHNOLOGIES, INC.  
Page 28 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
 
Check-in 17SEP2019 
08:38 (-1) 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9046 
34/M/BL 
 
Screening 13SEP2019 
08:22 (-5) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
Page 1488


SIGA TECHNOLOGIES, INC.  
Page 29 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
 
Screening 13SEP2019 
08:22 (-5) 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 13SEP2019 
09:12 (-5) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
4.4 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 17SEP2019 
08:42 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
Page 1489


SIGA TECHNOLOGIES, INC.  
Page 30 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9046 
34/M/BL 
 
Check-in 17SEP2019 
08:42 (-1) 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9051 
34/M/BL 
 
Screening 19SEP2019 
08:40 (-13) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
Page 1490


SIGA TECHNOLOGIES, INC.  
Page 31 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9051 
34/M/BL 
 
Screening 19SEP2019 
09:10 (-13) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.7 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 01OCT2019 
08:22 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
Page 1491


SIGA TECHNOLOGIES, INC.  
Page 32 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
 
Screening 21SEP2019 
12:33 (-11) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 21SEP2019 
13:12 (-11) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
6.0 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
Page 1492


SIGA TECHNOLOGIES, INC.  
Page 33 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9052 
42/M/BL 
 
Check-in 01OCT2019 
08:25 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9056 
31/F/BL 
 
Screening 24SEP2019 
09:20 (-8) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
Page 1493


SIGA TECHNOLOGIES, INC.  
Page 34 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
 
Screening 24SEP2019 
09:20 (-8) 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 24SEP2019 
10:06 (-8) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.7 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 01OCT2019 
08:55 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
Page 1494


SIGA TECHNOLOGIES, INC.  
Page 35 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9056 
31/F/BL 
 
Check-in 01OCT2019 
08:55 (-1) 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 01OCT2019 
09:26 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
9057 
29/F/W 
 
Screening 25SEP2019 
15:56 (-7) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
Page 1495


SIGA TECHNOLOGIES, INC.  
Page 36 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
 
Screening 25SEP2019 
15:56 (-7) 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 25SEP2019 
16:27 (-7) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.5 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
Page 1496


SIGA TECHNOLOGIES, INC.  
Page 37 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9057 
29/F/W 
 
Check-in 01OCT2019 
08:23 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 01OCT2019 
09:22 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
9058 
32/M/W 
 
Screening 26SEP2019 
08:59 (-20) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
Page 1497


SIGA TECHNOLOGIES, INC.  
Page 38 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
 
Screening 26SEP2019 
08:59 (-20) 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 26SEP2019 
09:26 (-20) 
Erythrocyte Cell Morphology Abnormal  
A NCS Normal 
2+ 
Microcytosis
, 
Unrequested 
Test 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.5 
% 
 
4-6 
 
Page 1498


SIGA TECHNOLOGIES, INC.  
Page 39 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
 
Screening 26SEP2019 
09:26 (-20) 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
08:27 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
Page 1499


SIGA TECHNOLOGIES, INC.  
Page 40 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
 
Check-in 15OCT2019 
09:07 (-1) 
Erythrocyte Cell Morphology Abnormal  
A NCS Normal 
2+ 
Microcytosis
, 
Unrequested 
Test 
 
 
TPOXX 
600 
mg 
Day 4 
19OCT2019 
07:32 (4) 
Erythrocyte Cell Morphology Abnormal  
A NCS Normal 
2+ 
Microcytosis
, 
Unrequested 
Test 
 
 
 
Day 8 - 12 
Hours 
Postdose 
23OCT2019 
08:29 (8) 
Erythrocyte Cell Morphology Abnormal  
A NCS Normal 
2+ 
Microcytosis
, 
Unrequested 
Test 
Page 1500


SIGA TECHNOLOGIES, INC.  
Page 41 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
TPOXX 
600 
mg 
Day 9 
24OCT2019 
08:08 (9) 
Erythrocyte Cell Morphology Abnormal  
A NCS Normal 
2+ 
Microcytosis
, 
Unrequested 
Test 
9061 
21/F/BL 
 
Screening 26SEP2019 
10:16 (-20) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
Page 1501


SIGA TECHNOLOGIES, INC.  
Page 42 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
 
Screening 26SEP2019 
11:06 (-20) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.4 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
08:34 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
Page 1502


SIGA TECHNOLOGIES, INC.  
Page 43 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9061 
21/F/BL 
 
Check-in 15OCT2019 
08:34 (-1) 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
09:01 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
9062 
33/M/BL 
 
Screening 30SEP2019 
10:25 (-2) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.6 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Screening 30SEP2019 
10:35 (-2) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
Page 1503


SIGA TECHNOLOGIES, INC.  
Page 44 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
 
Screening 30SEP2019 
10:35 (-2) 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 01OCT2019 
09:25 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
Page 1504


SIGA TECHNOLOGIES, INC.  
Page 45 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9062 
33/M/BL 
 
Check-in 01OCT2019 
09:25 (-1) 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9063 
35/M/W 
 
Screening 30SEP2019 
08:58 (-2) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 30SEP2019 
09:38 (-2) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
Page 1505


SIGA TECHNOLOGIES, INC.  
Page 46 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9063 
35/M/W 
 
Screening 30SEP2019 
09:38 (-2) 
Hemoglobin A1C 
4.9 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 01OCT2019 
08:19 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
Page 1506


SIGA TECHNOLOGIES, INC.  
Page 47 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
 
Screening 30SEP2019 
10:15 (-16) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 30SEP2019 
11:19 (-16) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.7 
% 
 
4-6 
 
Page 1507


SIGA TECHNOLOGIES, INC.  
Page 48 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9069 
41/F/BL 
 
Screening 30SEP2019 
11:19 (-16) 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
11:40 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
12:32 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
Page 1508


SIGA TECHNOLOGIES, INC.  
Page 49 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
 
Screening 04OCT2019 
13:25 (-12) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 04OCT2019 
13:56 (-12) 
HIV-1 Antibody 
Nonreacti
ve 
 
 
Nonreactive  
Page 1509


SIGA TECHNOLOGIES, INC.  
Page 50 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
 
Screening 04OCT2019 
13:56 (-12) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
*** SENT 
TO LAB 
 
A NCS Negative 
Sample sent 
to LabCorp 
for 
confirmatory 
testing. 
 
 
 
 
 
HIV-2 Antibody 
Nonreacti
ve 
 
 
Nonreactive  
 
 
 
 
 
HIV1-RNA 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
6.0 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
08:53 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
Page 1510


SIGA TECHNOLOGIES, INC.  
Page 51 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9073 
40/M/BL 
 
Check-in 15OCT2019 
08:53 (-1) 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9077 
37/F/W 
 
Screening 05OCT2019 
13:15 (-11) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.5 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
Page 1511


SIGA TECHNOLOGIES, INC.  
Page 52 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
 
Screening 05OCT2019 
13:19 (-11) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
09:25 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
Page 1512


SIGA TECHNOLOGIES, INC.  
Page 53 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9077 
37/F/W 
 
Check-in 15OCT2019 
09:25 (-1) 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
09:28 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
9080 
41/F/BL 
 
Screening 08OCT2019 
11:11 (-8) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
Page 1513


SIGA TECHNOLOGIES, INC.  
Page 54 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
 
Screening 08OCT2019 
11:11 (-8) 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 08OCT2019 
11:46 (-8) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.5 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
08:58 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
Page 1514


SIGA TECHNOLOGIES, INC.  
Page 55 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9080 
41/F/BL 
 
Check-in 15OCT2019 
08:58 (-1) 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
09:30 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
9081 
49/M/BL 
 
Screening 10OCT2019 
11:34 (-20) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
Page 1515


SIGA TECHNOLOGIES, INC.  
Page 56 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
 
Screening 10OCT2019 
11:34 (-20) 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 10OCT2019 
12:25 (-20) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
6.2 
% 
H NCS 4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 29OCT2019 
09:47 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
Page 1516


SIGA TECHNOLOGIES, INC.  
Page 57 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9081 
49/M/BL 
 
Check-in 29OCT2019 
09:47 (-1) 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9086 
36/M/BL 
 
Screening 11OCT2019 
08:56 (-5) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
Page 1517


SIGA TECHNOLOGIES, INC.  
Page 58 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
 
Screening 11OCT2019 
08:56 (-5) 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 11OCT2019 
10:03 (-5) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.7 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
09:03 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
Page 1518


SIGA TECHNOLOGIES, INC.  
Page 59 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
 
Check-in 15OCT2019 
09:03 (-1) 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9087 
34/F/BL 
 
Screening 11OCT2019 
09:47 (-5) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
 
 
 
 
 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.3 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Screening 11OCT2019 
10:02 (-5) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
Page 1519


SIGA TECHNOLOGIES, INC.  
Page 60 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
 
Screening 11OCT2019 
10:02 (-5) 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
08:43 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
Page 1520


SIGA TECHNOLOGIES, INC.  
Page 61 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
 
Check-in 15OCT2019 
08:43 (-1) 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
09:17 (-1) 
Choriogonadotropin Beta 
Less than 
5.0 
IU/L 
 
Less than 
5.0 
 
9089 
29/M/BL 
 
Screening 14OCT2019 
08:52 (-2) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
Page 1521


SIGA TECHNOLOGIES, INC.  
Page 62 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9089 
29/M/BL 
 
Screening 14OCT2019 
09:26 (-2) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.8 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 15OCT2019 
08:28 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
Page 1522


SIGA TECHNOLOGIES, INC.  
Page 63 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
 
Screening 14OCT2019 
08:56 (-2) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 14OCT2019 
09:33 (-2) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.6 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
Page 1523


SIGA TECHNOLOGIES, INC.  
Page 64 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
 
Check-in 15OCT2019 
08:48 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
9095 
42/M/W 
 
Screening 17OCT2019 
13:05 (-13) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
 
 
 
 
 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
Page 1524


SIGA TECHNOLOGIES, INC.  
Page 65 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
 
Screening 17OCT2019 
13:05 (-13) 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
 
 
Screening 17OCT2019 
13:31 (-13) 
HIV-1/2 Antibody + 
 HIV-1 p24 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hemoglobin A1C 
5.3 
% 
 
4-6 
 
 
 
 
 
 
Hepatitis B Virus Surface 
 Antigen 
Negative  
 
Negative 
 
 
 
 
 
 
Hepatitis C Virus Antibody 
Negative  
 
Negative 
 
 
 
 
Check-in 29OCT2019 
08:27 (-1) 
3,4-methylenedioxy 
 methamphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Amphetamine 
Negative  
 
Negative 
 
 
 
 
 
 
Barbiturates 
Negative  
 
Negative 
 
Page 1525


SIGA TECHNOLOGIES, INC.  
Page 66 of 66 
SIGA-246-022  
Listing 16.2.8.4  
Laboratory Results — Other  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020804.SAS  Executed: 21JAN2020 23:09  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result 
Units 
Flag 
[1] 
Reference 
Range 
Comments 
9095 
42/M/W 
 
Check-in 29OCT2019 
08:27 (-1) 
Benzodiazepine 
Negative  
 
Negative 
 
 
 
 
 
 
Cannabinoids 
Negative  
 
Negative 
 
 
 
 
 
 
Cocaine 
Negative  
 
Negative 
 
 
 
 
 
 
Ethanol 
Negative  
 
Negative 
 
 
 
 
 
 
Opiate 
Negative  
 
Negative 
 
 
 
 
 
 
Oxycodone 
Negative  
 
Negative 
 
 
Page 1526


SIGA TECHNOLOGIES, INC.  
Page 1 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9001 
41/M/BL 
 
Screening 19JUL2019 
12:06 (-26) 
Triglycerides 
2.17 
mmol/L 
 
G1 
0-4.52 
 
9002 
48/M/W 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:49 (4) 
Glucose 
6.11 
mmol/L 
 
G1 
3-6.44 
 
 
 
TPOXX 
600 mg 
Day 9 
22AUG2019 
09:27 (9) 
Sodium 
134 
mmol/L 
 
G1 
132-145 
 
 
 
 
Screening 19JUL2019 
12:02 (-26) 
Triglycerides 
2.28 
mmol/L 
 
G1 
0-4.52 
 
9005 
40/M/W 
 
Screening 23JUL2019 
10:05 (-22) 
Glucose 
6.44 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
Check-in 13AUG2019 
09:35 (-1) 
Glucose 
6.33 
mmol/L 
 
G1 
3-6.44 
 
 
 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:27 (4) 
Glucose 
6.11 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
Screening 23JUL2019 
10:05 (-22) 
Urate 
458 
umol/L 
 
G1 
173-494 
 
Page 1527


SIGA TECHNOLOGIES, INC.  
Page 2 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9005 
40/M/W 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:27 (4) 
Urate 
464 
umol/L 
 
G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:02 (8) 
Urate 
458 
umol/L 
 
G1 
173-494 
 
9009 
21/F/BL 
TPOXX 
600 mg 
Day 4 
17AUG2019 
08:31 (4) 
Albumin 
37 
g/L 
L NCS G1 
38-49 
 
 
 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
21AUG2019 
09:06 (8) 
Albumin 
37 
g/L 
L NCS G1 
38-49 
 
 
 
 
Screening 31JUL2019 
10:20 (-14) 
Cholesterol 
5.26 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
Screening 31JUL2019 
10:20 (-14) 
LDL Cholesterol 
3.50 
mmol/L 
 
G1 
0.96-4.22 
 
 
 
 
Screening 31JUL2019 
10:20 (-14) 
Sodium 
134 
mmol/L 
 
G1 
132-145 
 
Page 1528


SIGA TECHNOLOGIES, INC.  
Page 3 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9012 
34/M/BL 
 
Screening 06AUG2019 
10:31 (-8) 
Triglycerides 
1.83 
mmol/L 
 
G1 
0-4.52 
 
9015 
29/M/BL 
 
Screening 12AUG2019 
11:07 (-2) 
Triglycerides 
2.90 
mmol/L 
 
G1 
0-4.52 
 
9016 
48/F/W 
 
Screening 12AUG2019 
11:08 (-23) 
Cholesterol 
6.84 
mmol/L 
H NCS G2 
2.2-6.22 
 
 
 
 
Screening 12AUG2019 
11:08 (-23) 
LDL Cholesterol 
4.45 
mmol/L 
H NCS G2 
0.96-4.22 
 
9019 
41/M/BL 
 
Screening 15AUG2019 
17:21 (-20) 
Cholesterol 
5.18 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
Screening 15AUG2019 
17:21 (-20) 
LDL Cholesterol 
3.55 
mmol/L 
 
G1 
0.96-4.22 
 
 
 
 
Screening 15AUG2019 
17:21 (-20) 
Urate 
512 
umol/L 
H NCS G1 
173-494 
 
 
 
 
Check-in 03SEP2019 
11:40 (-1) 
Urate 
506 
umol/L 
H NCS G1 
173-494 
 
Page 1529


SIGA TECHNOLOGIES, INC.  
Page 4 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9019 
41/M/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:32 (4) 
Urate 
458 
umol/L 
 
G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:08 (9) 
Urate 
452 
umol/L 
 
G1 
173-494 
 
9020 
47/F/BL 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:31 (4) 
Albumin 
37 
g/L 
L NCS G1 
38-49 
 
9021 
39/F/BL 
 
Screening 21AUG2019 
10:44 (-14) 
Cholesterol 
5.72 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
Check-in 03SEP2019 
09:00 (-1) 
Glucose 
6.11 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
Screening 21AUG2019 
10:44 (-14) 
LDL Cholesterol 
4.14 
mmol/L 
 
G2 
0.96-4.22 
 
 
 
 
Check-in 03SEP2019 
09:00 (-1) 
Urate 
458 
umol/L 
H NCS G1 
119-345 
 
 
 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:34 (4) 
Urate 
482 
umol/L 
H NCS G1 
119-345 
 
Page 1530


SIGA TECHNOLOGIES, INC.  
Page 5 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9021 
39/F/BL 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:09 (8) 
Urate 
464 
umol/L 
H NCS G1 
119-345 
 
 
 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:09 (9) 
Urate 
452 
umol/L 
H NCS G1 
119-345 
 
9022 
31/M/W 
 
Screening 21AUG2019 
11:05 (-14) 
Triglycerides 
2.45 
mmol/L 
 
G1 
0-4.52 
 
 
 
 
Screening 21AUG2019 
11:05 (-14) 
Urate 
494 
umol/L 
 
G1 
173-494 
 
 
 
 
Check-in 03SEP2019 
09:54 (-1) 
Urate 
464 
umol/L 
 
G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:44 (4) 
Urate 
589 
umol/L 
H NCS G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:12 (8) 
Urate 
571 
umol/L 
H NCS G1 
173-494 
 
Page 1531


SIGA TECHNOLOGIES, INC.  
Page 6 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9022 
31/M/W 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:12 (9) 
Urate 
577 
umol/L 
H NCS G1 
173-494 
 
9033 
32/M/W 
 
Screening 29AUG2019 
09:53 (-6) 
Urate 
488 
umol/L 
 
G1 
173-494 
 
 
 
 
Check-in 03SEP2019 
09:15 (-1) 
Urate 
500 
umol/L 
H NCS G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
07SEP2019 
07:48 (4) 
Urate 
518 
umol/L 
H NCS G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
11SEP2019 
08:18 (8) 
Urate 
494 
umol/L 
 
G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 9 
12SEP2019 
08:18 (9) 
Urate 
488 
umol/L 
 
G1 
173-494 
 
9043 
22/M/BL 
 
Screening 11SEP2019 
09:38 (-7) 
Urate 
452 
umol/L 
 
G1 
173-494 
 
 
 
 
Check-in 17SEP2019 
09:06 (-1) 
Urate 
535 
umol/L 
H NCS G1 
173-494 
 
Page 1532


SIGA TECHNOLOGIES, INC.  
Page 7 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9043 
22/M/BL 
TPOXX 
600 mg 
Day 4 
21SEP2019 
07:28 (4) 
Urate 
470 
umol/L 
 
G1 
173-494 
 
9051 
34/M/BL 
 
Screening 19SEP2019 
09:10 (-13) 
Cholesterol 
6.58 
mmol/L 
H NCS G2 
2.2-6.22 
 
 
 
 
Screening 19SEP2019 
09:10 (-13) 
LDL Cholesterol 
4.27 
mmol/L 
H NCS G2 
0.96-4.22 
 
 
 
 
Screening 19SEP2019 
09:10 (-13) 
Triglycerides 
1.84 
mmol/L 
 
G1 
0-4.52 
 
9057 
29/F/W 
 
Screening 25SEP2019 
16:27 (-7) 
Cholesterol 
6.53 
mmol/L 
H NCS G2 
2.2-6.22 
 
 
 
 
Screening 25SEP2019 
16:27 (-7) 
LDL Cholesterol 
3.68 
mmol/L 
 
G1 
0.96-4.22 
 
 
 
 
Screening 25SEP2019 
16:27 (-7) 
Triglycerides 
4.19 
mmol/L 
 
G2 
0-4.52 
 
9058 
32/M/W 
 
Screening 26SEP2019 
09:26 (-20) 
Cholesterol 
6.66 
mmol/L 
H NCS G2 
2.2-6.22 
 
Page 1533


SIGA TECHNOLOGIES, INC.  
Page 8 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9058 
32/M/W 
 
Screening 26SEP2019 
09:26 (-20) 
LDL Cholesterol 
4.77 
mmol/L 
H NCS G2 
0.96-4.22 
 
9063 
35/M/W 
 
Screening 30SEP2019 
09:38 (-2) 
Triglycerides 
2.71 
mmol/L 
 
G1 
0-4.52 
 
9073 
40/M/BL 
 
Screening 04OCT2019 
13:56 (-12) 
Glucose 
6.38 
mmol/L 
 
G1 
3-6.44 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:41 (4) 
Urate 
452 
umol/L 
 
G1 
173-494 
 
9077 
37/F/W 
 
Screening 05OCT2019 
13:15 (-11) 
Sodium 
134 
mmol/L 
 
G1 
132-145 
 
9080 
41/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:21 (9) 
Sodium 
133 
mmol/L 
 
G1 
132-145 
 
9086 
36/M/BL 
 
Screening 11OCT2019 
10:03 (-5) 
Cholesterol 
6.06 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
Screening 11OCT2019 
10:03 (-5) 
LDL Cholesterol 
4.53 
mmol/L 
H NCS G2 
0.96-4.22 
 
Page 1534


SIGA TECHNOLOGIES, INC.  
Page 9 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9086 
36/M/BL 
 
Screening 11OCT2019 
10:03 (-5) 
Urate 
529 
umol/L 
H NCS G1 
173-494 
 
 
 
 
Check-in 15OCT2019 
09:28 (-1) 
Urate 
523 
umol/L 
H NCS G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:40 (4) 
Urate 
518 
umol/L 
H NCS G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
23OCT2019 
08:15 (8) 
Urate 
488 
umol/L 
 
G1 
173-494 
 
 
 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:15 (9) 
Urate 
482 
umol/L 
 
G1 
173-494 
 
9087 
34/F/BL 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:18 (9) 
Sodium 
134 
mmol/L 
 
G1 
132-145 
 
9089 
29/M/BL 
 
Screening 14OCT2019 
09:26 (-2) 
Cholesterol 
5.57 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
Screening 14OCT2019 
09:26 (-2) 
Triglycerides 
3.48 
mmol/L 
 
G2 
0-4.52 
 
Page 1535


SIGA TECHNOLOGIES, INC.  
Page 10 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9092 
24/M/W 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:52 (4) 
Urate 
476 
umol/L 
 
G1 
173-494 
 
9095 
42/M/W 
 
Screening 17OCT2019 
13:31 (-13) 
Cholesterol 
6.06 
mmol/L 
 
G1 
2.2-6.22 
 
 
 
 
Screening 17OCT2019 
13:31 (-13) 
Glucose 
6.38 
mmol/L 
 
G1 
3-6.44 
 
 
 
TPOXX 
600 mg 
Day 8 - 
12 Hours 
Postdose 
06NOV2019 
07:06 (8) 
Glucose 
6.33 
mmol/L 
 
G1 
3-6.44 
 
 
 
TPOXX 
600 mg 
Day 9 
07NOV2019 
07:06 (9) 
Glucose 
6.11 
mmol/L 
 
G1 
3-6.44 
 
 
 
 
Screening 17OCT2019 
13:31 (-13) 
LDL Cholesterol 
4.22 
mmol/L 
 
G2 
0.96-4.22 
 
9087 
34/F/BL 
 
Screening 11OCT2019 
09:47 (-5) 
Hemoglobin 
104 
g/L 
L NCS G1 
108-150 
 
Page 1536


SIGA TECHNOLOGIES, INC.  
Page 11 of 11 
SIGA-246-022  
Listing 16.2.8.5  
Laboratory Results Meeting Toxicity Grade of 1 or Higher  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
[1] L = Low, H = High, CS = Clinically Significant, NCS = Not Clinically Significant  
[2] G = Grade; Laboratory parameters were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric 
Adverse Events, verions 2.1.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020805.SAS  Executed: 21JAN2020 23:10  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Treat- 
ment 
Visit 
Collection 
Date Time 
(Day) 
Laboratory 
Test 
Result Units 
Flag 
[1] 
Toxicity 
Grade 
[1] 
Reference 
Range 
Comments 
9087 
34/F/BL 
 
Check-in 15OCT2019 
09:17 (-1) 
Hemoglobin 
104 
g/L 
L NCS G1 
108-150 
 
 
 
TPOXX 
600 mg 
Day 4 
19OCT2019 
07:43 (4) 
Hemoglobin 
102 
g/L 
L NCS G1 
108-150 
 
 
 
TPOXX 
600 mg 
Day 9 
24OCT2019 
08:18 (9) 
Hemoglobin 
104 
g/L 
L NCS G1 
108-150 
 
 
Page 1537


SIGA TECHNOLOGIES, INC.  
Page 1 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9001 
41/M/BL 
Screening 
19JUL2019 
11:27 (-26) 
SITTING 154 
85 
57 
14 
36.4 
 
 
Screening 
19JUL2019 
11:34 (-26) R 
SITTING 155 
86 
68 
 
 
 
 
Screening 
19JUL2019 
12:50 (-26) R 
SITTING 138 
100 
60 
 
 
 
 
Check-in 
13AUG2019 
09:38 (-1) 
SITTING 139 
79 
71 
18 
36.2 
 
 
Day 1- 
 Predose 
14AUG2019 
08:28 (1) 
SITTING 169 
99 
66 
20 
36 
 
 
Day 1- 
 Predose 
14AUG2019 
08:35 (1) R 
SITTING 177 
98 
64 
 
 
 
 
Day 1- 
 Predose 
14AUG2019 
08:37 (1) R 
SITTING 150 
98 
64 
 
 
 
 
Day 1- 
 4 Hour Postdose 
14AUG2019 
13:20 (1) 
SITTING 134 
83 
61 
18 
36.3 
Page 1538


SIGA TECHNOLOGIES, INC.  
Page 2 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9001 
41/M/BL 
Day 4- 
 4 Hour Postdose 
17AUG2019 
13:21 (4) 
SITTING 132 
79 
64 
16 
36.2 
 
 
Day 7- 
 Predose 
20AUG2019 
08:45 (7) 
SITTING 162 
95 
68 
20 
35.7 
 
 
Day 7- 
 Predose 
20AUG2019 
08:52 (7) R 
SITTING 158 
96 
72 
 
 
 
 
Day 7- 
 4 Hour Postdose 
20AUG2019 
13:20 (7) 
SITTING 154 
90 
66 
18 
36.5 
 
 
Day 8 
21AUG2019 
09:10 (8) 
SITTING 144 
91 
66 
10 
36.2 
 
 
Day 9 
22AUG2019 
09:20 (9) 
SITTING 131 
80 
71 
16 
36.4 
9002 
48/M/W 
Screening 
19JUL2019 
11:46 (-26) 
SITTING 152 
96 
89 
18 
36.4 
 
 
Screening 
19JUL2019 
11:52 (-26) R 
SITTING 147 
90 
89 
 
 
Page 1539


SIGA TECHNOLOGIES, INC.  
Page 3 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9002 
48/M/W 
Screening 
19JUL2019 
12:48 (-26) R 
SITTING 140 
106 
88 
 
 
 
 
Check-in 
13AUG2019 
09:57 (-1) 
SITTING 137 
77 
98 
18 
36.3 
 
 
Day 1- 
 Predose 
14AUG2019 
08:20 (1) 
SITTING 138 
92 
89 
16 
36.2 
 
 
Day 1- 
 Predose 
14AUG2019 
08:27 (1) R 
SITTING 145 
78 
88 
16 
36.5 
 
 
Day 1- 
 Predose 
14AUG2019 
08:35 (1) R 
SITTING 138 
100 
88 
 
 
 
 
Day 1- 
 4 Hour Postdose 
14AUG2019 
13:21 (1) 
SITTING 182 
82 
81 
18 
35.2 
 
 
Day 1- 
 4 Hour Postdose 
14AUG2019 
13:30 (1) R 
SITTING 160 
100 
80 
 
 
 
 
Day 4- 
 4 Hour Postdose 
17AUG2019 
13:20 (4) 
SITTING 166 
100 
84 
16 
36.4 
Page 1540


SIGA TECHNOLOGIES, INC.  
Page 4 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9002 
48/M/W 
Day 4- 
 4 Hour Postdose 
17AUG2019 
13:26 (4) R 
SITTING 167 
86 
85 
 
 
 
 
Day 4- 
 4 Hour Postdose 
17AUG2019 
13:32 (4) R 
SITTING 162 
100 
88 
 
 
 
 
Day 7- 
 Predose 
20AUG2019 
08:44 (7) 
SITTING 147 
68 
87 
14 
36.2 
 
 
Day 7- 
 4 Hour Postdose 
20AUG2019 
13:22 (7) 
SITTING 152 
77 
79 
16 
35.9 
 
 
Day 8 
21AUG2019 
09:09 (8) 
SITTING 172 
84 
78 
12 
35.1 
 
 
Day 8 
21AUG2019 
09:16 (8) R 
SITTING 160 
78 
76 
 
 
 
 
Day 9 
22AUG2019 
09:19 (9) 
SITTING 144 
88 
85 
16 
36 
9005 
40/M/W 
Screening 
23JUL2019 
09:45 (-22) 
SITTING 139 
86 
63 
16 
35.9 
Page 1541


SIGA TECHNOLOGIES, INC.  
Page 5 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9005 
40/M/W 
Check-in 
13AUG2019 
09:30 (-1) 
SITTING 128 
74 
67 
20 
36.1 
 
 
Day 1- 
 Predose 
14AUG2019 
08:22 (1) 
SITTING 120 
75 
68 
14 
36.2 
 
 
Day 1- 
 4 Hour Postdose 
14AUG2019 
12:57 (1) 
SITTING 112 
72 
69 
18 
36.1 
 
 
Day 4- 
 4 Hour Postdose 
17AUG2019 
12:57 (4) 
SITTING 122 
74 
59 
16 
36.1 
 
 
Day 7- 
 Predose 
20AUG2019 
08:22 (7) 
SITTING 103 
50 
59 
14 
36.4 
 
 
Day 7- 
 4 Hour Postdose 
20AUG2019 
12:57 (7) 
SITTING 106 
72 
63 
18 
36.6 
 
 
Day 8 
21AUG2019 
08:48 (8) 
SITTING 110 
65 
63 
14 
35.9 
 
 
Day 9 
22AUG2019 
08:57 (9) 
SITTING 118 
72 
64 
18 
36.1 
Page 1542


SIGA TECHNOLOGIES, INC.  
Page 6 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9009 
21/F/BL 
Screening 
31JUL2019 
09:57 (-14) 
SITTING 96 
71 
75 
12 
36.4 
 
 
Screening 
31JUL2019 
10:05 (-14) R 
SITTING 94 
74 
79 
 
 
 
 
Screening 
31JUL2019 
11:18 (-14) R 
SITTING 112 
62 
88 
 
 
 
 
Check-in 
13AUG2019 
09:27 (-1) 
SITTING 123 
67 
87 
18 
36.8 
 
 
Day 1- 
 Predose 
14AUG2019 
08:26 (1) 
SITTING 121 
69 
85 
12 
36.3 
 
 
Day 1- 
 4 Hour Postdose 
14AUG2019 
13:01 (1) 
SITTING 98 
57 
79 
14 
35.9 
 
 
Day 4- 
 4 Hour Postdose 
17AUG2019 
13:01 (4) 
SITTING 109 
57 
71 
12 
36.4 
 
 
Day 7- 
 Predose 
20AUG2019 
08:26 (7) 
SITTING 124 
57 
107 
18 
36.4 
Page 1543


SIGA TECHNOLOGIES, INC.  
Page 7 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9009 
21/F/BL 
Day 7- 
 4 Hour Postdose 
20AUG2019 
13:04 (7) 
SITTING 120 
50 
91 
12 
35.9 
 
 
Day 8 
21AUG2019 
08:51 (8) 
SITTING 102 
56 
101 
12 
36.5 
 
 
Day 9 
22AUG2019 
09:01 (9) 
SITTING 105 
56 
88 
16 
36.4 
9012 
34/M/BL 
Screening 
06AUG2019 
10:06 (-8) 
SITTING 121 
75 
68 
14 
36 
 
 
Check-in 
13AUG2019 
09:50 (-1) 
SITTING 113 
70 
77 
16 
36.6 
 
 
Day 1- 
 Predose 
14AUG2019 
08:32 (1) 
SITTING 117 
74 
76 
16 
36.6 
 
 
Day 1- 
 4 Hour Postdose 
14AUG2019 
13:05 (1) 
SITTING 119 
77 
75 
16 
36.2 
 
 
Day 4- 
 4 Hour Postdose 
17AUG2019 
13:05 (4) 
SITTING 115 
75 
68 
14 
35.7 
Page 1544


SIGA TECHNOLOGIES, INC.  
Page 8 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9012 
34/M/BL 
Day 7- 
 Predose 
20AUG2019 
08:30 (7) 
SITTING 121 
76 
68 
18 
36.4 
 
 
Day 7- 
 4 Hour Postdose 
20AUG2019 
13:05 (7) 
SITTING 133 
64 
80 
16 
36.4 
 
 
Day 8 
21AUG2019 
08:55 (8) 
SITTING 128 
64 
69 
14 
36.3 
 
 
Day 9 
22AUG2019 
09:05 (9) 
SITTING 122 
80 
71 
14 
36.6 
9015 
29/M/BL 
Screening 
12AUG2019 
10:57 (-2) 
SITTING 130 
73 
46 
16 
36.6 
 
 
Check-in 
13AUG2019 
09:15 (-1) 
SITTING 129 
74 
50 
12 
35.9 
 
 
Day 1- 
 Predose 
14AUG2019 
08:24 (1) 
SITTING 119 
66 
44 
16 
36.2 
 
 
Day 1- 
 4 Hour Postdose 
14AUG2019 
13:03 (1) 
SITTING 116 
67 
46 
18 
36.3 
Page 1545


SIGA TECHNOLOGIES, INC.  
Page 9 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9015 
29/M/BL 
Day 4- 
 4 Hour Postdose 
17AUG2019 
13:03 (4) 
SITTING 114 
65 
50 
12 
36.5 
 
 
Day 7- 
 Predose 
20AUG2019 
08:28 (7) 
SITTING 113 
59 
44 
12 
36.2 
 
 
Day 7- 
 4 Hour Postdose 
20AUG2019 
13:03 (7) 
SITTING 113 
66 
47 
18 
36.4 
 
 
Day 8 
21AUG2019 
08:53 (8) 
SITTING 108 
63 
57 
12 
36.1 
 
 
Day 9 
22AUG2019 
09:03 (9) 
SITTING 118 
65 
49 
16 
36.4 
9016 
48/F/W 
Screening 
12AUG2019 
11:22 (-23) 
SITTING 149 
85 
88 
16 
36.5 
 
 
Screening 
12AUG2019 
11:29 (-23) R 
SITTING 130 
73 
81 
 
 
 
 
Check-in 
03SEP2019 
08:57 (-1) 
SITTING 138 
64 
87 
14 
36.4 
Page 1546


SIGA TECHNOLOGIES, INC.  
Page 10 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9016 
48/F/W 
Day 1- 
 Predose 
04SEP2019 
07:20 (1) 
SITTING 143 
76 
92 
18 
36.9 
 
 
Day 1- 
 Predose 
04SEP2019 
07:28 (1) R 
SITTING 137 
65 
93 
 
 
 
 
Day 1- 
 4 Hour Postdose 
04SEP2019 
11:55 (1) 
SITTING 125 
72 
82 
12 
35.8 
 
 
Day 4- 
 4 Hour Postdose 
07SEP2019 
11:55 (4) 
SITTING 137 
70 
75 
18 
35.9 
 
 
Day 7- 
 Predose 
10SEP2019 
07:20 (7) 
SITTING 128 
73 
91 
18 
36.3 
 
 
Day 7- 
 4 Hour Postdose 
10SEP2019 
11:55 (7) 
SITTING 143 
71 
71 
18 
36.6 
 
 
Day 8 
11SEP2019 
07:45 (8) 
SITTING 134 
75 
77 
16 
36.7 
 
 
Day 9 
12SEP2019 
07:55 (9) 
SITTING 139 
74 
81 
16 
36.3 
Page 1547


SIGA TECHNOLOGIES, INC.  
Page 11 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9019 
41/M/BL 
Screening 
15AUG2019 
16:58 (-20) 
SITTING 132 
71 
85 
14 
36.3 
 
 
Check-in 
03SEP2019 
11:37 (-1) 
SITTING 137 
78 
88 
16 
36.4 
 
 
Day 1- 
 Predose 
04SEP2019 
07:23 (1) 
SITTING 123 
67 
72 
14 
36.2 
 
 
Day 1- 
 4 Hour Postdose 
04SEP2019 
11:58 (1) 
SITTING 122 
72 
76 
16 
36.1 
 
 
Day 4- 
 4 Hour Postdose 
07SEP2019 
12:04 (4) 
SITTING 129 
76 
71 
16 
36.3 
 
 
Day 7- 
 Predose 
10SEP2019 
07:23 (7) 
SITTING 114 
80 
77 
16 
35.8 
 
 
Day 7- 
 4 Hour Postdose 
10SEP2019 
11:58 (7) 
SITTING 119 
75 
70 
16 
36.5 
 
 
Day 8 
11SEP2019 
07:48 (8) 
SITTING 119 
76 
70 
14 
35.9 
Page 1548


SIGA TECHNOLOGIES, INC.  
Page 12 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9019 
41/M/BL 
Day 9 
12SEP2019 
07:58 (9) 
SITTING 119 
70 
77 
18 
36.3 
9020 
47/F/BL 
Screening 
21AUG2019 
10:32 (-14) 
SITTING 119 
63 
59 
16 
35.9 
 
 
Check-in 
03SEP2019 
08:49 (-1) 
SITTING 137 
62 
53 
18 
36.3 
 
 
Day 1- 
 Predose 
04SEP2019 
07:26 (1) 
SITTING 123 
65 
57 
14 
36.3 
 
 
Day 1- 
 4 Hour Postdose 
04SEP2019 
12:01 (1) 
SITTING 126 
68 
56 
12 
35.9 
 
 
Day 4- 
 4 Hour Postdose 
07SEP2019 
12:01 (4) 
SITTING 130 
63 
51 
18 
36.1 
 
 
Day 7- 
 Predose 
10SEP2019 
07:26 (7) 
SITTING 106 
55 
61 
18 
36.6 
 
 
Day 7- 
 4 Hour Postdose 
10SEP2019 
12:01 (7) 
SITTING 120 
61 
60 
16 
36.4 
Page 1549


SIGA TECHNOLOGIES, INC.  
Page 13 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9020 
47/F/BL 
Day 8 
11SEP2019 
07:51 (8) 
SITTING 122 
71 
59 
14 
36.6 
 
 
Day 9 
12SEP2019 
08:03 (9) 
SITTING 110 
59 
57 
18 
36.4 
9021 
39/F/BL 
Screening 
21AUG2019 
10:19 (-14) 
SITTING 133 
63 
86 
12 
37.4 
 
 
Check-in 
03SEP2019 
08:50 (-1) 
SITTING 114 
55 
88 
14 
37.1 
 
 
Day 1- 
 Predose 
04SEP2019 
07:29 (1) 
SITTING 124 
60 
58 
14 
36.6 
 
 
Day 1- 
 4 Hour Postdose 
04SEP2019 
12:04 (1) 
SITTING 114 
57 
67 
14 
36.4 
 
 
Day 4- 
 4 Hour Postdose 
07SEP2019 
12:04 (4) 
SITTING 126 
59 
69 
16 
36.5 
 
 
Day 7- 
 Predose 
10SEP2019 
07:29 (7) 
SITTING 124 
61 
71 
16 
36.7 
Page 1550


SIGA TECHNOLOGIES, INC.  
Page 14 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9021 
39/F/BL 
Day 7- 
 4 Hour Postdose 
10SEP2019 
12:04 (7) 
SITTING 119 
57 
63 
16 
36.4 
 
 
Day 8 
11SEP2019 
07:54 (8) 
SITTING 127 
60 
73 
18 
36.6 
 
 
Day 9 
12SEP2019 
08:04 (9) 
SITTING 108 
54 
83 
18 
36.6 
9022 
31/M/W 
Screening 
21AUG2019 
10:53 (-14) 
SITTING 127 
69 
83 
16 
36.1 
 
 
Check-in 
03SEP2019 
09:43 (-1) 
SITTING 122 
64 
80 
18 
36.4 
 
 
Day 1- 
 Predose 
04SEP2019 
07:32 (1) 
SITTING 110 
64 
76 
16 
35.7 
 
 
Day 1- 
 4 Hour Postdose 
04SEP2019 
12:07 (1) 
SITTING 119 
67 
77 
12 
36 
 
 
Day 4- 
 4 Hour Postdose 
07SEP2019 
12:13 (4) 
SITTING 116 
66 
77 
18 
36.4 
Page 1551


SIGA TECHNOLOGIES, INC.  
Page 15 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9022 
31/M/W 
Day 7- 
 Predose 
10SEP2019 
07:32 (7) 
SITTING 102 
57 
74 
14 
35.8 
 
 
Day 7- 
 4 Hour Postdose 
10SEP2019 
12:07 (7) 
SITTING 122 
61 
69 
16 
36.1 
 
 
Day 8 
11SEP2019 
07:57 (8) 
SITTING 122 
69 
79 
16 
35.9 
 
 
Day 9 
12SEP2019 
08:07 (9) 
SITTING 119 
59 
80 
16 
36.2 
9024 
20/M/BL 
Screening 
23AUG2019 
10:18 (-12) 
SITTING 108 
72 
94 
18 
36.6 
 
 
Check-in 
03SEP2019 
09:10 (-1) 
SITTING 115 
66 
75 
12 
36.7 
 
 
Day 1- 
 Predose 
04SEP2019 
07:35 (1) 
SITTING 98 
63 
67 
14 
36.3 
 
 
Day 1- 
 Predose 
04SEP2019 
07:41 (1) R 
SITTING 101 
66 
68 
14 
36 
Page 1552


SIGA TECHNOLOGIES, INC.  
Page 16 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9024 
20/M/BL 
Day 1- 
 4 Hour Postdose 
04SEP2019 
12:10 (1) 
SITTING 103 
67 
78 
16 
36 
 
 
Day 4- 
 4 Hour Postdose 
07SEP2019 
12:10 (4) 
SITTING 122 
68 
82 
16 
36.7 
 
 
Day 7- 
 Predose 
10SEP2019 
07:35 (7) 
SITTING 115 
71 
69 
16 
35.9 
 
 
Day 7- 
 4 Hour Postdose 
10SEP2019 
12:10 (7) 
SITTING 121 
72 
75 
12 
36.3 
 
 
Day 8 
11SEP2019 
08:00 (8) 
SITTING 114 
70 
70 
14 
36.2 
 
 
Day 9 
12SEP2019 
08:10 (9) 
SITTING 131 
67 
91 
14 
36.4 
9025 
50/M/W 
Screening 
23AUG2019 
10:29 (-26) 
SITTING 113 
74 
74 
12 
36.8 
 
 
Check-in 
17SEP2019 
09:01 (-1) 
SITTING 133 
82 
72 
18 
37.1 
Page 1553


SIGA TECHNOLOGIES, INC.  
Page 17 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9025 
50/M/W 
Day 1- 
 Predose 
18SEP2019 
07:21 (1) 
SITTING 111 
70 
73 
12 
36.8 
 
 
Day 1- 
 4 Hour Postdose 
18SEP2019 
11:55 (1) 
SITTING 123 
82 
70 
14 
36.7 
 
 
Day 4- 
 4 Hour Postdose 
21SEP2019 
11:55 (4) 
SITTING 122 
69 
69 
18 
36.5 
 
 
Day 7- 
 Predose 
24SEP2019 
07:20 (7) 
SITTING 120 
74 
82 
14 
36.3 
 
 
Day 7- 
 4 Hour Postdose 
24SEP2019 
11:55 (7) 
SITTING 124 
66 
69 
14 
35.8 
 
 
Day 8 
25SEP2019 
07:45 (8) 
SITTING 109 
71 
90 
16 
36.7 
 
 
Day 9 
26SEP2019 
07:55 (9) 
SITTING 101 
58 
85 
14 
36.6 
9033 
32/M/W 
Screening 
29AUG2019 
09:13 (-6) 
SITTING 146 
88 
76 
18 
37.5 
Page 1554


SIGA TECHNOLOGIES, INC.  
Page 18 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9033 
32/M/W 
Screening 
29AUG2019 
09:20 (-6) R 
SITTING 138 
86 
76 
 
 
 
 
Check-in 
03SEP2019 
09:03 (-1) 
SITTING 135 
73 
78 
14 
37.1 
 
 
Day 1- 
 Predose 
04SEP2019 
07:38 (1) 
SITTING 139 
85 
71 
16 
36.6 
 
 
Day 1- 
 4 Hour Postdose 
04SEP2019 
12:13 (1) 
SITTING 134 
87 
60 
12 
36.3 
 
 
Day 4- 
 4 Hour Postdose 
07SEP2019 
12:16 (4) 
SITTING 143 
79 
70 
18 
36.8 
 
 
Day 7- 
 Predose 
10SEP2019 
07:38 (7) 
SITTING 146 
87 
69 
16 
36.8 
 
 
Day 7- 
 4 Hour Postdose 
10SEP2019 
12:13 (7) 
SITTING 143 
84 
60 
16 
37.2 
 
 
Day 8 
11SEP2019 
08:03 (8) 
SITTING 130 
79 
77 
14 
37.2 
Page 1555


SIGA TECHNOLOGIES, INC.  
Page 19 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9033 
32/M/W 
Day 9 
12SEP2019 
08:13 (9) 
SITTING 136 
77 
71 
18 
36.8 
9043 
22/M/BL 
Screening 
11SEP2019 
09:13 (-7) 
SITTING 130 
61 
55 
20 
37.3 
 
 
Check-in 
17SEP2019 
08:58 (-1) 
SITTING 121 
69 
61 
18 
36.7 
 
 
Day 1- 
 Predose 
18SEP2019 
07:23 (1) 
SITTING 132 
71 
62 
14 
36.8 
 
 
Day 1- 
 4 Hour Postdose 
18SEP2019 
11:58 (1) 
SITTING 124 
72 
54 
12 
35.9 
 
 
Day 4- 
 4 Hour Postdose 
21SEP2019 
11:58 (4) 
SITTING 123 
65 
60 
16 
36.3 
 
 
Day 7- 
 Predose 
24SEP2019 
07:23 (7) 
SITTING 124 
71 
67 
18 
36.3 
 
 
Day 7- 
 4 Hour Postdose 
24SEP2019 
11:58 (7) 
SITTING 122 
78 
62 
16 
36.6 
Page 1556


SIGA TECHNOLOGIES, INC.  
Page 20 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9043 
22/M/BL 
Day 8 
25SEP2019 
07:48 (8) 
SITTING 113 
72 
67 
12 
36.5 
 
 
Day 9 
26SEP2019 
07:58 (9) 
SITTING 119 
62 
72 
16 
36.8 
9046 
34/M/BL 
Screening 
13SEP2019 
08:51 (-5) 
SITTING 121 
82 
60 
14 
36.6 
 
 
Check-in 
17SEP2019 
09:02 (-1) 
SITTING 136 
81 
56 
16 
36.8 
 
 
Day 1- 
 Predose 
18SEP2019 
07:26 (1) 
SITTING 122 
82 
55 
14 
36.4 
 
 
Day 1- 
 4 Hour Postdose 
18SEP2019 
12:01 (1) 
SITTING 124 
82 
50 
12 
35.9 
 
 
Day 4- 
 4 Hour Postdose 
21SEP2019 
12:01 (4) 
SITTING 122 
76 
57 
14 
36.4 
 
 
Day 7- 
 Predose 
24SEP2019 
07:26 (7) 
SITTING 118 
68 
62 
16 
36.3 
Page 1557


SIGA TECHNOLOGIES, INC.  
Page 21 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9046 
34/M/BL 
Day 7- 
 4 Hour Postdose 
24SEP2019 
12:03 (7) 
SITTING 131 
73 
53 
16 
36.3 
 
 
Day 8 
25SEP2019 
07:51 (8) 
SITTING 119 
66 
59 
16 
36.2 
 
 
Day 9 
26SEP2019 
08:01 (9) 
SITTING 123 
67 
62 
14 
36.5 
9051 
34/M/BL 
Screening 
19SEP2019 
09:04 (-13) 
SITTING 135 
70 
75 
16 
36.8 
 
 
Check-in 
01OCT2019 
08:58 (-1) 
SITTING 111 
54 
73 
16 
36.9 
 
 
Day 1- 
 Predose 
02OCT2019 
07:35 (1) 
SITTING 127 
73 
71 
16 
36.4 
 
 
Day 1- 
 4 Hour Postdose 
02OCT2019 
12:10 (1) 
SITTING 120 
59 
66 
18 
36.6 
 
 
Day 4- 
 4 Hour Postdose 
05OCT2019 
12:10 (4) 
SITTING 121 
58 
70 
14 
36.7 
Page 1558


SIGA TECHNOLOGIES, INC.  
Page 22 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9051 
34/M/BL 
Day 7- 
 Predose 
08OCT2019 
07:36 (7) 
SITTING 133 
74 
73 
16 
36.6 
 
 
Day 7- 
 4 Hour Postdose 
08OCT2019 
12:10 (7) 
SITTING 122 
72 
63 
16 
36.7 
 
 
Day 8 
09OCT2019 
08:00 (8) 
SITTING 107 
62 
75 
14 
36.4 
 
 
Day 9 
10OCT2019 
08:10 (9) 
SITTING 127 
68 
78 
16 
37.2 
9052 
42/M/BL 
Screening 
21SEP2019 
13:00 (-11) 
SITTING 145 
91 
63 
12 
36.4 
 
 
Screening 
21SEP2019 
13:06 (-11) R 
SITTING 158 
85 
70 
 
 
 
 
Screening 
30SEP2019 
12:29 (-2) R 
SITTING 134 
76 
71 
 
 
 
 
Check-in 
01OCT2019 
08:58 (-1) 
SITTING 148 
83 
80 
14 
36.9 
Page 1559


SIGA TECHNOLOGIES, INC.  
Page 23 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9052 
42/M/BL 
Check-in 
01OCT2019 
09:04 (-1) R 
SITTING 143 
94 
87 
 
 
 
 
Check-in 
01OCT2019 
09:09 (-1) R 
SITTING 132 
60 
88 
 
 
 
 
Day 1- 
 Predose 
02OCT2019 
07:32 (1) 
SITTING 156 
84 
94 
12 
36.6 
 
 
Day 1- 
 Predose 
02OCT2019 
07:38 (1) R 
SITTING 141 
84 
87 
 
 
 
 
Day 1- 
 Predose 
02OCT2019 
07:45 (1) R 
SITTING 144 
92 
84 
 
 
 
 
Day 1- 
 4 Hour Postdose 
02OCT2019 
12:14 (1) 
SITTING 141 
79 
75 
18 
36.5 
 
 
Day 4- 
 4 Hour Postdose 
05OCT2019 
12:14 (4) 
SITTING 145 
84 
70 
16 
36.8 
 
 
Day 7- 
 Predose 
08OCT2019 
07:39 (7) 
SITTING 130 
73 
77 
16 
36.6 
Page 1560


SIGA TECHNOLOGIES, INC.  
Page 24 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9052 
42/M/BL 
Day 7- 
 4 Hour Postdose 
08OCT2019 
12:14 (7) 
SITTING 151 
87 
69 
12 
36.6 
 
 
Day 8 
09OCT2019 
08:04 (8) 
SITTING 126 
79 
84 
14 
36.4 
 
 
Day 9 
10OCT2019 
08:14 (9) 
SITTING 149 
82 
73 
12 
36.6 
9056 
31/F/BL 
Screening 
24SEP2019 
09:27 (-8) 
SITTING 114 
61 
84 
16 
36.5 
 
 
Check-in 
01OCT2019 
09:23 (-1) 
SITTING 120 
65 
85 
16 
37 
 
 
Day 1- 
 Predose 
02OCT2019 
07:20 (1) 
SITTING 125 
70 
86 
18 
36.6 
 
 
Day 1- 
 4 Hour Postdose 
02OCT2019 
11:55 (1) 
SITTING 122 
65 
80 
14 
36.1 
 
 
Day 4- 
 4 Hour Postdose 
05OCT2019 
11:55 (4) 
SITTING 136 
64 
80 
12 
36.2 
Page 1561


SIGA TECHNOLOGIES, INC.  
Page 25 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9056 
31/F/BL 
Day 7- 
 Predose 
08OCT2019 
07:20 (7) 
SITTING 121 
62 
91 
14 
37.1 
 
 
Day 7- 
 4 Hour Postdose 
08OCT2019 
11:55 (7) 
SITTING 131 
67 
88 
14 
37.2 
 
 
Day 8 
09OCT2019 
07:45 (8) 
SITTING 126 
63 
89 
10 
36.5 
 
 
Day 9 
10OCT2019 
07:55 (9) 
SITTING 125 
59 
89 
12 
36.9 
9057 
29/F/W 
Screening 
25SEP2019 
16:09 (-7) 
SITTING 115 
71 
80 
14 
36.1 
 
 
Check-in 
01OCT2019 
09:19 (-1) 
SITTING 116 
57 
68 
14 
36.3 
 
 
Day 1- 
 Predose 
02OCT2019 
07:23 (1) 
SITTING 118 
66 
85 
16 
36.5 
 
 
Day 1- 
 4 Hour Postdose 
02OCT2019 
11:58 (1) 
SITTING 147 
64 
80 
12 
36 
Page 1562


SIGA TECHNOLOGIES, INC.  
Page 26 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9057 
29/F/W 
Day 4- 
 4 Hour Postdose 
05OCT2019 
11:58 (4) 
SITTING 112 
68 
76 
12 
36.3 
 
 
Day 7- 
 Predose 
08OCT2019 
07:23 (7) 
SITTING 115 
58 
86 
14 
36.5 
 
 
Day 7- 
 4 Hour Postdose 
08OCT2019 
11:58 (7) 
SITTING 109 
66 
75 
10 
36.3 
 
 
Day 8 
09OCT2019 
07:48 (8) 
SITTING 116 
70 
89 
12 
36.5 
 
 
Day 9 
10OCT2019 
07:58 (9) 
SITTING 119 
67 
88 
14 
36.7 
9058 
32/M/W 
Screening 
26SEP2019 
09:05 (-20) 
SITTING 118 
64 
73 
12 
36.2 
 
 
Check-in 
15OCT2019 
09:01 (-1) 
SITTING 123 
57 
68 
16 
36.7 
 
 
Day 1- 
 Predose 
16OCT2019 
07:20 (1) 
SITTING 130 
59 
66 
14 
35.7 
Page 1563


SIGA TECHNOLOGIES, INC.  
Page 27 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9058 
32/M/W 
Day 1- 
 4 Hour Postdose 
16OCT2019 
12:05 (1) 
SITTING 127 
58 
69 
14 
36.4 
 
 
Day 4- 
 4 Hour Postdose 
19OCT2019 
12:02 (4) 
SITTING 107 
47 
71 
16 
36.7 
 
 
Day 7- 
 Predose 
22OCT2019 
07:27 (7) 
SITTING 107 
53 
71 
10 
35.9 
 
 
Day 7- 
 4 Hour Postdose 
22OCT2019 
12:02 (7) 
SITTING 111 
53 
70 
16 
36.7 
 
 
Day 8 
23OCT2019 
08:02 (8) 
SITTING 130 
58 
65 
14 
35.7 
 
 
Day 9 
24OCT2019 
08:02 (9) 
SITTING 108 
55 
69 
12 
36.4 
9061 
21/F/BL 
Screening 
26SEP2019 
10:44 (-20) 
SITTING 115 
64 
75 
16 
36.7 
 
 
Check-in 
15OCT2019 
08:56 (-1) 
SITTING 124 
57 
81 
14 
37.1 
Page 1564


SIGA TECHNOLOGIES, INC.  
Page 28 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9061 
21/F/BL 
Day 1- 
 Predose 
16OCT2019 
07:23 (1) 
SITTING 116 
72 
72 
10 
36.6 
 
 
Day 1- 
 4 Hour Postdose 
16OCT2019 
11:58 (1) 
SITTING 120 
60 
75 
12 
36.4 
 
 
Day 4- 
 4 Hour Postdose 
19OCT2019 
11:58 (4) 
SITTING 84 
52 
75 
16 
36.7 
 
 
Day 4- 
 4 Hour Postdose 
19OCT2019 
12:05 (4) R 
SITTING 108 
59 
78 
16 
36.9 
 
 
Day 7- 
 Predose 
22OCT2019 
07:23 (7) 
SITTING 100 
61 
85 
14 
36.6 
 
 
Day 7- 
 4 Hour Postdose 
22OCT2019 
11:58 (7) 
SITTING 111 
58 
75 
14 
37.2 
 
 
Day 8 
23OCT2019 
07:48 (8) 
SITTING 114 
66 
82 
14 
36.4 
 
 
Day 9 
24OCT2019 
07:59 (9) 
SITTING 123 
80 
92 
12 
36.8 
Page 1565


SIGA TECHNOLOGIES, INC.  
Page 29 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9062 
33/M/BL 
Screening 
30SEP2019 
10:07 (-2) 
SITTING 118 
61 
79 
14 
36.2 
 
 
Check-in 
01OCT2019 
09:15 (-1) 
SITTING 134 
81 
78 
18 
36.3 
 
 
Day 1- 
 Predose 
02OCT2019 
07:26 (1) 
SITTING 122 
65 
76 
14 
36.4 
 
 
Day 1- 
 4 Hour Postdose 
02OCT2019 
12:01 (1) 
SITTING 129 
76 
74 
14 
36.2 
 
 
Day 4- 
 4 Hour Postdose 
05OCT2019 
12:01 (4) 
SITTING 125 
70 
78 
10 
36.4 
 
 
Day 7- 
 Predose 
08OCT2019 
07:26 (7) 
SITTING 121 
57 
80 
14 
36.3 
 
 
Day 7- 
 4 Hour Postdose 
08OCT2019 
12:05 (7) 
SITTING 132 
72 
74 
12 
36.4 
 
 
Day 8 
09OCT2019 
07:51 (8) 
SITTING 118 
67 
85 
10 
36.4 
Page 1566


SIGA TECHNOLOGIES, INC.  
Page 30 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9062 
33/M/BL 
Day 9 
10OCT2019 
08:01 (9) 
SITTING 120 
56 
75 
14 
36.1 
9063 
35/M/W 
Screening 
30SEP2019 
09:21 (-2) 
SITTING 154 
80 
77 
12 
36.8 
 
 
Screening 
30SEP2019 
09:28 (-2) R 
SITTING 141 
82 
91 
 
 
 
 
Check-in 
01OCT2019 
08:45 (-1) 
SITTING 135 
83 
76 
16 
36.4 
 
 
Day 1- 
 Predose 
02OCT2019 
07:29 (1) 
SITTING 140 
78 
84 
14 
36.4 
 
 
Day 1- 
 4 Hour Postdose 
02OCT2019 
12:05 (1) 
SITTING 129 
76 
70 
14 
36 
 
 
Day 4- 
 4 Hour Postdose 
05OCT2019 
12:04 (4) 
SITTING 133 
67 
78 
10 
37.2 
 
 
Day 7- 
 Predose 
08OCT2019 
07:29 (7) 
SITTING 119 
71 
73 
16 
36.3 
Page 1567


SIGA TECHNOLOGIES, INC.  
Page 31 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9063 
35/M/W 
Day 7- 
 4 Hour Postdose 
08OCT2019 
12:06 (7) 
SITTING 145 
63 
74 
12 
36.4 
 
 
Day 8 
09OCT2019 
07:54 (8) 
SITTING 123 
68 
82 
14 
35.8 
 
 
Day 9 
10OCT2019 
08:04 (9) 
SITTING 126 
72 
79 
12 
36.4 
9069 
41/F/BL 
Screening 
30SEP2019 
10:52 (-16) 
SITTING 142 
71 
72 
12 
36.1 
 
 
Screening 
30SEP2019 
11:05 (-16) R 
SITTING 154 
72 
68 
 
 
 
 
Check-in 
15OCT2019 
12:18 (-1) 
SITTING 133 
90 
77 
16 
36.4 
 
 
Day 1- 
 Predose 
16OCT2019 
07:26 (1) 
SITTING 137 
65 
67 
16 
36.1 
 
 
Day 1- 
 4 Hour Postdose 
16OCT2019 
12:01 (1) 
SITTING 162 
77 
71 
14 
36 
Page 1568


SIGA TECHNOLOGIES, INC.  
Page 32 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9069 
41/F/BL 
Day 1- 
 4 Hour Postdose 
16OCT2019 
12:09 (1) R 
SITTING 153 
82 
71 
 
 
 
 
Day 4- 
 4 Hour Postdose 
19OCT2019 
12:10 (4) 
SITTING 140 
65 
70 
18 
36.2 
 
 
Day 7- 
 Predose 
22OCT2019 
07:26 (7) 
SITTING 131 
85 
75 
16 
36.8 
 
 
Day 7- 
 4 Hour Postdose 
22OCT2019 
12:03 (7) 
SITTING 133 
63 
70 
12 
35.9 
 
 
Day 8 
23OCT2019 
07:51 (8) 
SITTING 138 
64 
71 
14 
36.8 
 
 
Day 9 
24OCT2019 
08:01 (9) 
SITTING 138 
65 
83 
12 
36.6 
9073 
40/M/BL 
Screening 
04OCT2019 
13:51 (-12) 
SITTING 129 
77 
80 
16 
36.6 
 
 
Check-in 
15OCT2019 
09:14 (-1) 
SITTING 125 
68 
78 
18 
36.4 
Page 1569


SIGA TECHNOLOGIES, INC.  
Page 33 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9073 
40/M/BL 
Day 1- 
 Predose 
16OCT2019 
07:29 (1) 
SITTING 142 
67 
79 
12 
35.9 
 
 
Day 1- 
 Predose 
16OCT2019 
07:36 (1) R 
SITTING 130 
68 
73 
 
 
 
 
Day 1- 
 4 Hour Postdose 
16OCT2019 
12:11 (1) 
SITTING 124 
67 
78 
14 
36.2 
 
 
Day 4- 
 4 Hour Postdose 
19OCT2019 
12:11 (4) 
SITTING 133 
76 
70 
8 
36.3 
 
 
Day 7- 
 Predose 
22OCT2019 
07:36 (7) 
SITTING 130 
73 
79 
16 
35.8 
 
 
Day 7- 
 4 Hour Postdose 
22OCT2019 
12:11 (7) 
SITTING 117 
73 
67 
16 
36.3 
 
 
Day 8 
23OCT2019 
08:01 (8) 
SITTING 123 
71 
81 
14 
36.3 
 
 
Day 9 
24OCT2019 
08:11 (9) 
SITTING 122 
58 
77 
16 
36.7 
Page 1570


SIGA TECHNOLOGIES, INC.  
Page 34 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9077 
37/F/W 
Screening 
05OCT2019 
13:01 (-11) 
SITTING 129 
77 
71 
12 
36.4 
 
 
Check-in 
15OCT2019 
08:52 (-1) 
SITTING 150 
91 
78 
 
35.9 
 
 
Check-in 
15OCT2019 
08:58 (-1) R 
SITTING 136 
80 
77 
12 
36.1 
 
 
Day 1- 
 Predose 
16OCT2019 
07:32 (1) 
SITTING 123 
76 
78 
14 
36.3 
 
 
Day 1- 
 4 Hour Postdose 
16OCT2019 
12:07 (1) 
SITTING 131 
81 
73 
12 
36 
 
 
Day 4- 
 4 Hour Postdose 
19OCT2019 
12:07 (4) 
SITTING 131 
78 
72 
14 
35.9 
 
 
Day 7- 
 Predose 
22OCT2019 
07:32 (7) 
SITTING 120 
77 
77 
14 
36.6 
 
 
Day 7- 
 4 Hour Postdose 
22OCT2019 
12:28 (7) 
SITTING 137 
80 
70 
18 
36.2 
Page 1571


SIGA TECHNOLOGIES, INC.  
Page 35 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9077 
37/F/W 
Day 8 
23OCT2019 
07:57 (8) 
SITTING 131 
83 
82 
16 
35.7 
 
 
Day 9 
24OCT2019 
08:07 (9) 
SITTING 116 
77 
80 
14 
36.4 
9080 
41/F/BL 
Screening 
08OCT2019 
11:38 (-8) 
SITTING 122 
62 
68 
14 
35.7 
 
 
Check-in 
15OCT2019 
09:06 (-1) 
SITTING 119 
63 
68 
14 
36.2 
 
 
Day 1- 
 Predose 
16OCT2019 
07:41 (1) 
SITTING 100 
57 
64 
16 
36.2 
 
 
Day 1- 
 4 Hour Postdose 
16OCT2019 
12:18 (1) 
SITTING 120 
68 
69 
14 
36.3 
 
 
Day 4- 
 4 Hour Postdose 
19OCT2019 
12:23 (4) 
SITTING 127 
60 
77 
16 
36.6 
 
 
Day 7- 
 Predose 
22OCT2019 
07:41 (7) 
SITTING 128 
61 
81 
16 
36 
Page 1572


SIGA TECHNOLOGIES, INC.  
Page 36 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9080 
41/F/BL 
Day 7- 
 4 Hour Postdose 
22OCT2019 
12:16 (7) 
SITTING 121 
67 
75 
14 
36.6 
 
 
Day 8 
23OCT2019 
08:06 (8) 
SITTING 129 
76 
84 
16 
35.9 
 
 
Day 9 
24OCT2019 
08:16 (9) 
SITTING 131 
64 
85 
12 
36.7 
9081 
49/M/BL 
Screening 
10OCT2019 
12:17 (-20) 
SITTING 111 
61 
81 
18 
36.8 
 
 
Check-in 
29OCT2019 
09:41 (-1) 
SITTING 135 
76 
80 
12 
36.4 
 
 
Day 1- 
 Predose 
30OCT2019 
07:22 (1) 
SITTING 137 
72 
90 
16 
36.2 
 
 
Day 1- 
 4 Hour Postdose 
30OCT2019 
11:55 (1) 
SITTING 133 
83 
83 
16 
36.5 
 
 
Day 4- 
 4 Hour Postdose 
02NOV2019 
11:55 (4) 
SITTING 137 
78 
79 
14 
35.8 
Page 1573


SIGA TECHNOLOGIES, INC.  
Page 37 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9081 
49/M/BL 
Day 7- 
 Predose 
05NOV2019 
06:20 (7) 
SITTING 132 
71 
79 
16 
36.3 
 
 
Day 7- 
 4 Hour Postdose 
05NOV2019 
10:55 (7) 
SITTING 134 
71 
73 
14 
35.7 
 
 
Day 8 
06NOV2019 
06:45 (8) 
SITTING 128 
73 
81 
12 
36.4 
 
 
Day 9 
07NOV2019 
06:55 (9) 
SITTING 138 
69 
79 
18 
36.2 
9086 
36/M/BL 
Screening 
11OCT2019 
09:13 (-5) 
SITTING 120 
73 
77 
14 
36.3 
 
 
Check-in 
15OCT2019 
09:25 (-1) 
SITTING 123 
73 
75 
14 
36.4 
 
 
Day 1- 
 Predose 
16OCT2019 
07:35 (1) 
SITTING 121 
77 
75 
10 
36.1 
 
 
Day 1- 
 4 Hour Postdose 
16OCT2019 
12:10 (1) 
SITTING 116 
66 
66 
12 
35.9 
Page 1574


SIGA TECHNOLOGIES, INC.  
Page 38 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9086 
36/M/BL 
Day 4- 
 4 Hour Postdose 
19OCT2019 
12:10 (4) 
SITTING 121 
78 
72 
14 
36.2 
 
 
Day 7- 
 Predose 
22OCT2019 
07:35 (7) 
SITTING 126 
79 
75 
14 
36 
 
 
Day 7- 
 4 Hour Postdose 
22OCT2019 
12:10 (7) 
SITTING 123 
85 
68 
14 
35.7 
 
 
Day 8 
23OCT2019 
08:00 (8) 
SITTING 124 
79 
81 
14 
35.8 
 
 
Day 9 
24OCT2019 
08:10 (9) 
SITTING 120 
74 
79 
12 
35.9 
9087 
34/F/BL 
Screening 
11OCT2019 
09:31 (-5) 
SITTING 149 
76 
87 
20 
36.8 
 
 
Screening 
11OCT2019 
09:39 (-5) R 
SITTING 143 
76 
88 
 
 
 
 
Check-in 
15OCT2019 
08:51 (-1) 
SITTING 150 
88 
91 
14 
37.2 
Page 1575


SIGA TECHNOLOGIES, INC.  
Page 39 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9087 
34/F/BL 
Check-in 
15OCT2019 
08:57 (-1) R 
SITTING 138 
72 
91 
 
 
 
 
Day 1- 
 Predose 
16OCT2019 
07:38 (1) 
SITTING 132 
62 
81 
12 
36.7 
 
 
Day 1- 
 4 Hour Postdose 
16OCT2019 
12:13 (1) 
SITTING 145 
81 
76 
14 
36.6 
 
 
Day 4- 
 4 Hour Postdose 
19OCT2019 
12:15 (4) 
SITTING 136 
69 
78 
14 
36.6 
 
 
Day 7- 
 Predose 
22OCT2019 
07:38 (7) 
SITTING 129 
62 
78 
16 
36.5 
 
 
Day 7- 
 4 Hour Postdose 
22OCT2019 
12:13 (7) 
SITTING 139 
65 
75 
14 
36.5 
 
 
Day 8 
23OCT2019 
08:03 (8) 
SITTING 130 
71 
80 
12 
36.7 
 
 
Day 9 
24OCT2019 
08:13 (9) 
SITTING 116 
58 
80 
16 
36.7 
Page 1576


SIGA TECHNOLOGIES, INC.  
Page 40 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9089 
29/M/BL 
Screening 
14OCT2019 
09:20 (-2) 
SITTING 116 
65 
73 
12 
36.3 
 
 
Check-in 
15OCT2019 
08:49 (-1) 
SITTING 110 
62 
75 
14 
36.4 
 
 
Day 1- 
 Predose 
16OCT2019 
07:45 (1) 
SITTING 112 
73 
71 
12 
36.1 
 
 
Day 1- 
 4 Hour Postdose 
16OCT2019 
12:19 (1) 
SITTING 104 
56 
75 
14 
36.3 
 
 
Day 4- 
 4 Hour Postdose 
19OCT2019 
12:19 (4) 
SITTING 108 
65 
70 
14 
36.1 
 
 
Day 7- 
 Predose 
22OCT2019 
07:44 (7) 
SITTING 106 
54 
64 
16 
36.4 
 
 
Day 7- 
 4 Hour Postdose 
22OCT2019 
12:19 (7) 
SITTING 106 
57 
65 
14 
36.6 
 
 
Day 8 
23OCT2019 
08:09 (8) 
SITTING 103 
68 
74 
12 
36.6 
Page 1577


SIGA TECHNOLOGIES, INC.  
Page 41 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9089 
29/M/BL 
Day 9 
24OCT2019 
08:19 (9) 
SITTING 106 
60 
71 
14 
36.3 
9092 
24/M/W 
Screening 
14OCT2019 
09:24 (-2) 
SITTING 121 
58 
74 
16 
36.3 
 
 
Check-in 
15OCT2019 
09:11 (-1) 
SITTING 134 
63 
61 
16 
36.7 
 
 
Day 1- 
 Predose 
16OCT2019 
07:47 (1) 
SITTING 131 
66 
70 
14 
36.9 
 
 
Day 1- 
 4 Hour Postdose 
16OCT2019 
12:22 (1) 
SITTING 127 
65 
55 
16 
36.6 
 
 
Day 4- 
 4 Hour Postdose 
19OCT2019 
12:22 (4) 
SITTING 128 
67 
50 
18 
36.9 
 
 
Day 7- 
 Predose 
22OCT2019 
07:47 (7) 
SITTING 132 
64 
70 
18 
37 
 
 
Day 7- 
 4 Hour Postdose 
22OCT2019 
12:22 (7) 
SITTING 133 
63 
57 
12 
36.4 
Page 1578


SIGA TECHNOLOGIES, INC.  
Page 42 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9092 
24/M/W 
Day 8 
23OCT2019 
08:12 (8) 
SITTING 136 
72 
57 
14 
36.7 
 
 
Day 9 
24OCT2019 
08:22 (9) 
SITTING 133 
66 
64 
12 
36.9 
9095 
42/M/W 
Screening 
17OCT2019 
13:14 (-13) 
SITTING 136 
82 
76 
14 
36.2 
 
 
Check-in 
29OCT2019 
08:49 (-1) 
SITTING 120 
76 
82 
14 
36.4 
 
 
Day 1- 
 Predose 
30OCT2019 
07:26 (1) 
SITTING 115 
72 
83 
12 
36.8 
 
 
Day 1- 
 4 Hour Postdose 
30OCT2019 
12:01 (1) 
SITTING 129 
70 
79 
14 
36.5 
 
 
Day 4- 
 4 Hour Postdose 
02NOV2019 
12:01 (4) 
SITTING 125 
76 
84 
16 
36.7 
 
 
Day 7- 
 Predose 
05NOV2019 
06:26 (7) 
SITTING 123 
61 
83 
14 
36.4 
Page 1579


SIGA TECHNOLOGIES, INC.  
Page 43 of 43 
SIGA-246-022  
Listing 16.2.8.6  
Vital Sign Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Sys=Systolic, Dias=Diastolic, BP=Blood Pressure, bpm=beats per minute, Resp=Respiration, Temp=Temperature  
R=Repeat  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020806.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Time Point 
Date Time 
(Day) 
Position 
Sys BP 
(mmHg) 
Dias BP 
(mmHg) 
Heart Rate 
(bpm) 
Resp 
Rate 
(bpm) 
Temp 
(C) 
9095 
42/M/W 
Day 7- 
 4 Hour Postdose 
05NOV2019 
11:01 (7) 
SITTING 117 
74 
79 
12 
36.7 
 
 
Day 8 
06NOV2019 
06:51 (8) 
SITTING 106 
66 
86 
14 
36.7 
 
 
Day 9 
07NOV2019 
07:01 (9) 
SITTING 117 
65 
89 
14 
36.6 
 
Page 1580


SIGA TECHNOLOGIES, INC.  
Page 1 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9001 
41/M/BL 
Screening/ 
  19JUL2019 11:47 (-26) 
63 
140 
88 
412 
408 
940 
N 
 
 
 
Check-In/ 
  13AUG2019 09:26 (-1) 
60 
150 
93 
397 
396 
986 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  14AUG2019 13:10 (1) 
56 
156 
93 
396 
400 
1071 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  17AUG2019 13:11 (4) 
61 
147 
90 
401 
399 
980 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  20AUG2019 13:10 (7) 
69 
166 
86 
418 
408 
869 
N 
 
 
 
Day 9/ 
  22AUG2019 09:10 (9) 
63 
158 
92 
402 
399 
951 
N 
 
Page 1581


SIGA TECHNOLOGIES, INC.  
Page 2 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9002 
48/M/W 
Screening/ 
  19JUL2019 11:38 (-26) 
80 
155 
101 
407 
388 
746 
N 
 
 
 
Check-In/ 
  13AUG2019 09:48 (-1) 
93 
163 
97 
413 
384 
645 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  14AUG2019 13:12 (1) 
76 
178 
104 
424 
407 
786 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  17AUG2019 13:10 (4) 
77 
172 
94 
411 
394 
774 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  20AUG2019 13:13 (7) 
75 
173 
92 
406 
392 
800 
N 
 
 
 
Day 9/ 
  22AUG2019 09:09 (9) 
72 
181 
101 
410 
397 
822 
N 
 
Page 1582


SIGA TECHNOLOGIES, INC.  
Page 3 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9005 
40/M/W 
Screening/ 
  23JUL2019 09:58 (-22) 
58 
135 
90 
417 
419 
1020 
N 
 
 
 
Check-In/ 
  13AUG2019 09:21 (-1) 
58 
130 
88 
412 
414 
1021 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  14AUG2019 12:47 (1) 
55 
134 
84 
409 
415 
1087 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  17AUG2019 12:47 (4) 
56 
137 
90 
416 
421 
1064 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  20AUG2019 12:47 (7) 
52 
140 
97 
408 
417 
1151 
N 
 
 
 
Day 9/ 
  22AUG2019 08:47 (9) 
56 
143 
87 
395 
399 
1058 
N 
 
Page 1583


SIGA TECHNOLOGIES, INC.  
Page 4 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9009 
21/F/BL 
Screening/ 
  31JUL2019 09:48 (-14) 
84 
160 
94 
416 
394 
713 
N 
 
 
 
Check-In/ 
  13AUG2019 09:17 (-1) 
91 
147 
94 
433 
404 
659 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  14AUG2019 12:51 (1) 
64 
153 
93 
406 
402 
933 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  17AUG2019 12:51 (4) 
84 
161 
94 
424 
400 
708 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  20AUG2019 12:56 (7) 
83 
146 
94 
407 
385 
717 
N 
 
 
 
Day 9/ 
  22AUG2019 08:51 (9) 
92 
156 
98 
428 
398 
647 
N 
 
Page 1584


SIGA TECHNOLOGIES, INC.  
Page 5 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9012 
34/M/BL 
Screening/ 
  06AUG2019 09:57 (-8) 
73 
203 
84 
421 
407 
817 
AB, NCS 
FIRST DEGREE AV BLOCK
 
 
Check-In/ 
  13AUG2019 09:41 (-1) 
80 
205 
87 
438 
417 
742 
AB, NCS 
FIRST DEGREE AV BLOCK
 
 
Day 1 - 
4 Hour Postdose/ 
  14AUG2019 12:55 (1) 
74 
195 
88 
443 
428 
808 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  17AUG2019 12:55 (4) 
69 
195 
91 
411 
401 
865 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  20AUG2019 12:59 (7) 
73 
199 
97 
420 
406 
818 
N 
 
 
 
Day 9/ 
  22AUG2019 08:55 (9) 
63 
191 
89 
420 
417 
950 
N 
 
Page 1585


SIGA TECHNOLOGIES, INC.  
Page 6 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9015 
29/M/BL 
Screening/ 
  12AUG2019 10:46 (-2) 
47 
216 
109 
386 
402 
1258 
AB, NCS 
SINUS BRADYCARDIA, 
FIRST DEGREE AV BLOCK
 
 
Check-In/ 
  13AUG2019 09:07 (-1) 
47 
219 
111 
380 
395 
1272 
AB, NCS 
SINUS BRADYCARDIA, 
FIRST DEGREE AV BLOCK
 
 
Day 1 - 
4 Hour Postdose/ 
  14AUG2019 12:53 (1) 
48 
211 
108 
365 
379 
1237 
AB, NCS 
SINUS BRADYCARDIA, 
FIRST DEGREE AV BLOCK
 
 
Day 4 - 
4 Hour Postdose/ 
  17AUG2019 12:53 (4) 
50 
220 
105 
363 
374 
1185 
AB, NCS 
FIRST DEGREE AV 
BLOCK, 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 7 - 
4 Hour Postdose/ 
  20AUG2019 12:53 (7) 
50 
215 
109 
366 
377 
1198 
AB, NCS 
FIRST DEGREE AV 
BLOCK, 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 9/ 
  22AUG2019 08:53 (9) 
48 
163 
106 
366 
379 
1230 
AB, NCS 
SINUS BRADYCARDIA, 
NONSPECIFIC T WAVE 
ABNORMALITY 
Page 1586


SIGA TECHNOLOGIES, INC.  
Page 7 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9016 
48/F/W 
Screening/ 
  12AUG2019 10:56 (-23) 
87 
155 
101 
457 
429 
684 
N 
 
 
 
Check-In/ 
  03SEP2019 08:46 (-1) 
89 
161 
94 
455 
425 
667 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  04SEP2019 11:45 (1) 
78 
170 
96 
442 
423 
764 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  07SEP2019 11:45 (4) 
80 
173 
96 
453 
432 
750 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  10SEP2019 11:45 (7) 
71 
174 
96 
438 
426 
844 
N 
 
 
 
Day 9/ 
  12SEP2019 07:45 (9) 
85 
165 
99 
454 
429 
705 
N 
 
Page 1587


SIGA TECHNOLOGIES, INC.  
Page 8 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9019 
41/M/BL 
Screening/ 
  15AUG2019 16:49 (-20) 
76 
178 
76 
422 
405 
789 
N 
 
 
 
Check-In/ 
  03SEP2019 11:26 (-1) 
82 
166 
89 
411 
390 
729 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  04SEP2019 11:48 (1) 
70 
185 
74 
408 
397 
851 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  07SEP2019 11:54 (4) 
63 
176 
84 
407 
403 
945 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  10SEP2019 11:48 (7) 
64 
179 
80 
397 
392 
929 
N 
 
 
 
Day 9/ 
  12SEP2019 07:48 (9) 
71 
178 
73 
400 
389 
838 
N 
 
Page 1588


SIGA TECHNOLOGIES, INC.  
Page 9 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9020 
47/F/BL 
Screening/ 
  21AUG2019 10:23 (-14) 
58 
171 
86 
435 
438 
1034 
N 
 
 
 
Check-In/ 
  03SEP2019 08:40 (-1) 
53 
177 
82 
417 
425 
1116 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  04SEP2019 11:51 (1) 
49 
170 
81 
416 
429 
1217 
AB, NCS 
SINUS BRADYCARDIA 
 
 
Day 4 - 
4 Hour Postdose/ 
  07SEP2019 11:51 (4) 
56 
172 
81 
419 
423 
1054 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  10SEP2019 11:51 (7) 
54 
168 
83 
426 
433 
1091 
N 
 
 
 
Day 9/ 
  12SEP2019 07:54 (9) 
54 
186 
77 
417 
424 
1098 
N 
 
Page 1589


SIGA TECHNOLOGIES, INC.  
Page 10 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9021 
39/F/BL 
Screening/ 
  21AUG2019 10:37 (-14) 
85 
141 
82 
466 
439 
699 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITIES 
 
 
Check-In/ 
  03SEP2019 08:42 (-1) 
76 
151 
84 
464 
446 
786 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 1 - 
4 Hour Postdose/ 
  04SEP2019 11:56 (1) 
60 
143 
86 
463 
462 
984 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 4 - 
4 Hour Postdose/ 
  07SEP2019 11:54 (4) 
64 
158 
83 
449 
444 
932 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 7 - 
4 Hour Postdose/ 
  10SEP2019 11:54 (7) 
57 
152 
90 
435 
438 
1049 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 9/ 
  12SEP2019 07:55 (9) 
74 
160 
85 
444 
429 
810 
N 
 
Page 1590


SIGA TECHNOLOGIES, INC.  
Page 11 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9022 
31/M/W 
Screening/ 
  21AUG2019 10:43 (-14) 
76 
171 
94 
417 
401 
785 
N 
 
 
 
Check-In/ 
  03SEP2019 09:33 (-1) 
78 
169 
93 
441 
421 
760 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  04SEP2019 11:57 (1) 
74 
176 
92 
446 
430 
803 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  07SEP2019 12:03 (4) 
71 
175 
86 
416 
404 
837 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  10SEP2019 11:57 (7) 
67 
179 
90 
434 
426 
893 
N 
 
 
 
Day 9/ 
  12SEP2019 07:57 (9) 
77 
171 
106 
426 
408 
779 
N 
 
Page 1591


SIGA TECHNOLOGIES, INC.  
Page 12 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9024 
20/M/BL 
Screening/ 
  23AUG2019 10:33 (-12) 
66 
156 
88 
367 
360 
896 
AB, NCS 
EARLY REPOLARIZATION 
 
 
Check-In/ 
  03SEP2019 09:02 (-1) 
58 
158 
91 
388 
390 
1033 
AB, NCS 
EARLY REPOLARIZATION 
 
 
Day 1 - 
4 Hour Postdose/ 
  04SEP2019 12:00 (1) 
58 
144 
93 
388 
390 
1030 
AB, NCS 
EARLY REPOLARIZATION 
 
 
Day 4 - 
4 Hour Postdose/ 
  07SEP2019 12:03 (4) 
68 
158 
90 
385 
377 
882 
AB, NCS 
EARLY REPOLARIZATION 
 
 
Day 7 - 
4 Hour Postdose/ 
  10SEP2019 12:00 (7) 
60 
163 
94 
380 
379 
989 
AB, NCS 
EARLY REPOLARIZATION 
 
 
Day 9/ 
  12SEP2019 08:00 (9) 
70 
159 
89 
383 
373 
854 
AB, NCS 
EARLY REPOLARIZATION 
Page 1592


SIGA TECHNOLOGIES, INC.  
Page 13 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9025 
50/M/W 
Screening/ 
  23AUG2019 10:48 (-26) 
60 
157 
93 
397 
396 
989 
N 
 
 
 
Check-In/ 
  17SEP2019 08:53 (-1) 
67 
146 
94 
405 
397 
886 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  18SEP2019 11:46 (1) 
62 
150 
102 
421 
418 
960 
AB, NCS 
SINGLE PVC 
 
 
Unscheduled - 3.01/ 
  18SEP2019 11:47 (1) 
59 
145 
98 
410 
411 
1010 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  21SEP2019 11:46 (4) 
62 
148 
98 
411 
408 
961 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  24SEP2019 11:46 (7) 
64 
142 
101 
420 
415 
934 
N 
 
 
 
Day 9/ 
  26SEP2019 07:45 (9) 
77 
143 
97 
417 
399 
773 
N 
 
Page 1593


SIGA TECHNOLOGIES, INC.  
Page 14 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9033 
32/M/W 
Screening/ 
  29AUG2019 09:43 (-6) 
71 
159 
103 
427 
414 
837 
N 
 
 
 
Check-In/ 
  03SEP2019 08:55 (-1) 
70 
150 
107 
419 
408 
857 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  04SEP2019 12:03 (1) 
57 
155 
107 
428 
431 
1046 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  07SEP2019 12:06 (4) 
65 
141 
102 
416 
410 
911 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  10SEP2019 12:03 (7) 
62 
146 
108 
427 
424 
955 
N 
 
 
 
Day 9/ 
  12SEP2019 08:03 (9) 
67 
172 
108 
426 
417 
890 
N 
 
Page 1594


SIGA TECHNOLOGIES, INC.  
Page 15 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9043 
22/M/BL 
Screening/ 
  11SEP2019 09:04 (-7) 
55 
142 
105 
399 
405 
1088 
N 
 
 
 
Check-In/ 
  17SEP2019 08:50 (-1) 
61 
150 
107 
408 
406 
974 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  18SEP2019 11:48 (1) 
50 
145 
108 
402 
414 
1182 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  21SEP2019 11:48 (4) 
60 
149 
106 
403 
402 
985 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  24SEP2019 11:48 (7) 
64 
152 
106 
424 
419 
934 
N 
 
 
 
Day 9/ 
  26SEP2019 07:48 (9) 
66 
150 
106 
402 
395 
901 
N 
 
Page 1595


SIGA TECHNOLOGIES, INC.  
Page 16 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9046 
34/M/BL 
Screening/ 
  13SEP2019 10:31 (-5) 
68 
211 
113 
396 
388 
880 
AB, NCS 
FIRST DEGREE AV 
BLOCK, 
NCS  NONSPECIFIC 
INTRAVENTRICULAR 
CONDUCTION DELAY, NCS
 
 
Check-In/ 
  17SEP2019 08:53 (-1) 
55 
209 
110 
367 
372 
1074 
AB, NCS 
FIRST DEGREE AV BLOCK
 
 
Day 1 - 
4 Hour Postdose/ 
  18SEP2019 11:51 (1) 
48 
198 
109 
364 
378 
1239 
AB, NCS 
SINUS 
BRADYCARDIA,NCS 
 
 
Day 4 - 
4 Hour Postdose/ 
  21SEP2019 11:51 (4) 
52 
207 
110 
363 
371 
1134 
AB, NCS 
FIRST DEGREE AV 
BLOCK, 
NCS 
 
 
Day 7 - 
4 Hour Postdose/ 
  24SEP2019 11:53 (7) 
51 
201 
109 
365 
375 
1159 
AB, NCS 
FIRST DEGREE AV BLOCK
 
 
Day 9/ 
  26SEP2019 07:54 (9) 
58 
204 
105 
375 
377 
1024 
AB, NCS 
FIRST DEGREE AV BLOCK
Page 1596


SIGA TECHNOLOGIES, INC.  
Page 17 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9051 
34/M/BL 
Screening/ 
  19SEP2019 08:56 (-13) 
61 
160 
88 
413 
411 
979 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Check-In/ 
  01OCT2019 08:50 (-1) 
65 
169 
92 
414 
409 
921 
AB, NCS 
SINUS ARRHYTHMIA, WNL
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 1 - 
4 Hour Postdose/ 
  02OCT2019 12:00 (1) 
65 
170 
90 
427 
421 
920 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY. SINGLE 
PAC. 
 
 
Day 4 - 
4 Hour Postdose/ 
  05OCT2019 12:00 (4) 
61 
171 
90 
400 
398 
971 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 7 - 
4 Hour Postdose/ 
  08OCT2019 12:03 (7) 
60 
170 
89 
393 
393 
1000 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 9/ 
  10OCT2019 08:00 (9) 
72 
167 
90 
405 
393 
827 
AB, NCS 
INFEROLATERAL T WAVE 
ABNORMALITIES 
Page 1597


SIGA TECHNOLOGIES, INC.  
Page 18 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9051 
34/M/BL 
Day 9/ 
  10OCT2019 09:35 (9) R 
72 
170 
91 
403 
391 
833 
AB, NCS 
NONSPECIFIC TWAVE 
ABNORMALITIES. 
9052 
42/M/BL 
Screening/ 
  21SEP2019 12:52 (-11) 
60 
199 
96 
389 
389 
996 
N 
 
 
 
Check-In/ 
  01OCT2019 08:50 (-1) 
87 
168 
91 
422 
397 
689 
AB, NCS 
ARTIFACT NOTED, NO 
NEED FOR REPEAT 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 1 - 
4 Hour Postdose/ 
  02OCT2019 12:04 (1) 
61 
194 
93 
391 
390 
976 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  05OCT2019 12:07 (4) 
64 
192 
90 
385 
380 
933 
N 
 
Page 1598


SIGA TECHNOLOGIES, INC.  
Page 19 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9052 
42/M/BL 
Day 7 - 
4 Hour Postdose/ 
  08OCT2019 12:04 (7) 
66 
194 
96 
386 
380 
900 
N 
 
 
 
Day 9/ 
  10OCT2019 08:04 (9) 
68 
202 
97 
398 
390 
880 
AB, NCS 
FIRST DEGREE AV BLOCK
9056 
31/F/BL 
Screening/ 
  24SEP2019 09:47 (-8) 
76 
166 
85 
407 
390 
781 
N 
 
 
 
Check-In/ 
  01OCT2019 09:15 (-1) 
84 
161 
75 
401 
379 
712 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  02OCT2019 11:45 (1) 
72 
157 
88 
393 
381 
829 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  05OCT2019 11:45 (4) 
77 
159 
86 
390 
374 
771 
N 
 
Page 1599


SIGA TECHNOLOGIES, INC.  
Page 20 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9056 
31/F/BL 
Day 7 - 
4 Hour Postdose/ 
  08OCT2019 11:45 (7) 
86 
156 
77 
404 
381 
697 
N 
 
 
 
Day 9/ 
  10OCT2019 07:45 (9) 
90 
159 
78 
404 
378 
665 
N 
 
9057 
29/F/W 
Check-In/ 
  01OCT2019 09:03 (-1) 
75 
160 
93 
440 
424 
799 
N 
 
 
 
Screening/ 
  01OCT2019 16:21 (-1) 
79 
155 
89 
449 
429 
759 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  02OCT2019 11:48 (1) 
71 
158 
93 
446 
433 
835 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  05OCT2019 11:48 (4) 
68 
166 
90 
427 
418 
879 
N 
 
Page 1600


SIGA TECHNOLOGIES, INC.  
Page 21 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9057 
29/F/W 
Day 7 - 
4 Hour Postdose/ 
  08OCT2019 11:48 (7) 
67 
168 
93 
423 
414 
885 
N 
 
 
 
Day 9/ 
  10OCT2019 07:48 (9) 
83 
153 
94 
439 
416 
719 
N 
 
9058 
32/M/W 
Screening/ 
  26SEP2019 09:17 (-20) 
66 
191 
119 
431 
423 
896 
AB, NCS 
INCOMPLETE RIGHT 
BUNDLE BRANCH BLOCK 
 
 
Check-In/ 
  15OCT2019 08:50 (-1) 
61 
189 
124 
424 
422 
972 
AB, NCS 
RIGHT BUNDLE BRANCH 
BLOCK 
 
 
Day 1 - 
4 Hour Postdose/ 
  16OCT2019 11:52 (1) 
63 
187 
114 
430 
426 
947 
AB, NCS 
INCOMPLETE RIGHT 
BUNDLE BRANCH BLOCK 
 
 
Day 4 - 
4 Hour Postdose/ 
  19OCT2019 11:52 (4) 
64 
186 
112 
419 
414 
927 
AB, NCS 
INCOMPLETE RIGHT 
BUNDLE BRANCH BLOCK 
Page 1601


SIGA TECHNOLOGIES, INC.  
Page 22 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9058 
32/M/W 
Day 7 - 
4 Hour Postdose/ 
  22OCT2019 11:52 (7) 
64 
189 
121 
422 
416 
930 
AB, NCS 
RIGHT BUNDLE BRANCH 
BLOCK 
 
 
Day 9/ 
  24OCT2019 07:53 (9) 
62 
188 
116 
417 
414 
959 
AB, NCS 
INCOMPLETE RIGHT 
BUNDLE BRANCH BLOCK 
9061 
21/F/BL 
Screening/ 
  26SEP2019 10:35 (-20) 
73 
199 
83 
415 
401 
814 
N 
 
 
 
Check-In/ 
  15OCT2019 08:47 (-1) 
74 
192 
87 
410 
396 
809 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  16OCT2019 11:48 (1) 
70 
191 
88 
413 
402 
849 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  19OCT2019 11:48 (4) 
73 
178 
79 
412 
399 
821 
N 
 
Page 1602


SIGA TECHNOLOGIES, INC.  
Page 23 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9061 
21/F/BL 
Day 7 - 
4 Hour Postdose/ 
  22OCT2019 11:48 (7) 
76 
188 
85 
419 
403 
789 
N 
 
 
 
Day 9/ 
  24OCT2019 07:49 (9) 
71 
188 
85 
401 
389 
842 
N 
 
9062 
33/M/BL 
Screening/ 
  30SEP2019 09:53 (-2) 
77 
162 
93 
436 
418 
775 
N 
 
 
 
Check-In/ 
  01OCT2019 09:08 (-1) 
70 
161 
92 
418 
407 
849 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  02OCT2019 11:51 (1) 
68 
160 
88 
432 
422 
874 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  05OCT2019 11:51 (4) 
69 
161 
95 
424 
414 
869 
N 
 
Page 1603


SIGA TECHNOLOGIES, INC.  
Page 24 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9062 
33/M/BL 
Day 7 - 
4 Hour Postdose/ 
  08OCT2019 11:58 (7) 
72 
157 
93 
430 
417 
832 
N 
 
 
 
Day 9/ 
  10OCT2019 07:51 (9) 
70 
167 
89 
411 
401 
856 
N 
 
9063 
35/M/W 
Screening/ 
  30SEP2019 09:14 (-2) 
78 
178 
98 
408 
390 
763 
N 
 
 
 
Check-In/ 
  01OCT2019 08:38 (-1) 
74 
168 
101 
424 
409 
809 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  02OCT2019 11:56 (1) 
66 
177 
98 
408 
400 
899 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  05OCT2019 11:54 (4) 
72 
162 
98 
394 
382 
831 
N 
 
Page 1604


SIGA TECHNOLOGIES, INC.  
Page 25 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9063 
35/M/W 
Day 7 - 
4 Hour Postdose/ 
  08OCT2019 11:59 (7) 
66 
181 
98 
404 
397 
896 
N 
 
 
 
Day 9/ 
  10OCT2019 07:54 (9) 
75 
184 
98 
404 
390 
799 
N 
 
9069 
41/F/BL 
Screening/ 
  30SEP2019 10:36 (-16) 
70 
187 
85 
436 
424 
848 
N 
 
 
 
Check-In/ 
  15OCT2019 12:08 (-1) 
73 
194 
92 
437 
422 
711 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  16OCT2019 11:51 (1) 
70 
174 
89 
425 
414 
855 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  19OCT2019 11:59 (4) 
69 
194 
87 
407 
397 
860 
N 
 
Page 1605


SIGA TECHNOLOGIES, INC.  
Page 26 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9069 
41/F/BL 
Day 7 - 
4 Hour Postdose/ 
  22OCT2019 11:52 (7) 
72 
186 
86 
411 
398 
823 
N 
 
 
 
Day 9/ 
  24OCT2019 07:51 (9) 
76 
194 
86 
409 
393 
789 
N 
 
9073 
40/M/BL 
Screening/ 
  04OCT2019 13:44 (-12) 
72 
158 
106 
427 
414 
828 
N 
 
 
 
Check-In/ 
  15OCT2019 09:06 (-1) 
75 
165 
101 
446 
429 
794 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  16OCT2019 12:01 (1) 
71 
166 
96 
454 
441 
837 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  19OCT2019 12:01 (4) 
67 
166 
95 
454 
445 
888 
N 
 
Page 1606


SIGA TECHNOLOGIES, INC.  
Page 27 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9073 
40/M/BL 
Day 7 - 
4 Hour Postdose/ 
  22OCT2019 12:02 (7) 
69 
166 
93 
436 
426 
868 
N 
 
 
 
Day 9/ 
  24OCT2019 08:01 (9) 
68 
177 
96 
438 
429 
877 
N 
 
9077 
37/F/W 
Screening/ 
  05OCT2019 12:52 (-11) 
67 
142 
94 
432 
424 
884 
N 
 
 
 
Check-In/ 
  15OCT2019 09:16 (-1) 
74 
140 
90 
420 
405 
810 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  16OCT2019 11:57 (1) 
73 
138 
98 
430 
416 
819 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  19OCT2019 11:58 (4) 
71 
166 
94 
437 
424 
840 
N 
 
Page 1607


SIGA TECHNOLOGIES, INC.  
Page 28 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9077 
37/F/W 
Day 7 - 
4 Hour Postdose/ 
  22OCT2019 12:20 (7) 
66 
135 
93 
426 
419 
901 
N 
 
 
 
Day 9/ 
  24OCT2019 07:57 (9) 
74 
162 
92 
429 
414 
808 
N 
 
9080 
41/F/BL 
Screening/ 
  08OCT2019 11:29 (-8) 
66 
139 
82 
431 
423 
898 
N 
 
 
 
Check-In/ 
  15OCT2019 09:26 (-1) 
66 
144 
100 
416 
409 
903 
N 
 
 
 
Day 1 - 
4 Hour Postdose/ 
  16OCT2019 12:10 (1) 
66 
142 
86 
402 
395 
905 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  19OCT2019 12:15 (4) 
80 
136 
81 
419 
399 
744 
N 
 
Page 1608


SIGA TECHNOLOGIES, INC.  
Page 29 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9080 
41/F/BL 
Day 7 - 
4 Hour Postdose/ 
  22OCT2019 12:09 (7) 
72 
126 
80 
399 
387 
824 
N 
 
 
 
Day 9/ 
  24OCT2019 08:06 (9) 
80 
128 
97 
412 
392 
744 
N 
 
9081 
49/M/BL 
Screening/ 
  10OCT2019 11:54 (-20) 
80 
190 
107 
452 
430 
747 
AB, NCS 
LEFT AXIS DEVIATION 
AND NONSPECIFIC 
INTRAVENTRICULAR 
CONDUCTION DELAY OF 
UNCERTAIN 
SIGNIFICANCE. NO 
SIGNS 
OF ACUTE ISCHEMIA OR 
INFARCT 
 
 
Check-In/ 
  29OCT2019 09:32 (-1) 
75 
191 
110 
440 
424 
800 
AB, NCS 
LEFT AXIS DEVIATION 
Page 1609


SIGA TECHNOLOGIES, INC.  
Page 30 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9081 
49/M/BL 
Day 1 - 
4 Hour Postdose/ 
  30OCT2019 11:45 (1) 
74 
193 
109 
442 
426 
805 
AB, NCS 
LEFT AXIS DEVIATION 
 
 
Day 4 - 
4 Hour Postdose/ 
  02NOV2019 11:45 (4) 
72 
194 
109 
442 
428 
830 
AB, NCS 
LEFT AXIS DEVIATION 
 
 
Day 7 - 
4 Hour Postdose/ 
  05NOV2019 10:45 (7) 
66 
197 
108 
428 
421 
901 
AB, NCS 
LEFT AXIS DEVIATION 
 
 
Day 9/ 
  07NOV2019 06:45 (9) 
70 
206 
110 
429 
418 
856 
AB, NCS 
FIRST DEGREE AV 
BLOCK, 
LEFT AXIS DEVIATION 
9086 
36/M/BL 
Screening/ 
  11OCT2019 09:33 (-5) 
77 
216 
112 
446 
428 
773 
AB, NCS 
FIRST DEGREE AV 
BLOCK, 
INCOMPLETE RIGHT 
BUNDLE BRANCH BLOCK 
 
 
Check-In/ 
  15OCT2019 09:17 (-1) 
75 
211 
110 
446 
429 
791 
AB, NCS 
FIRST DEGREE AV BLOCK
Page 1610


SIGA TECHNOLOGIES, INC.  
Page 31 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9086 
36/M/BL 
Day 1 - 
4 Hour Postdose/ 
  16OCT2019 12:00 (1) 
58 
217 
111 
419 
421 
1025 
AB, NCS 
FIRST DEGREE AV 
BLOCK, 
INCOMPLETE RIGHT 
BUNDLE BRANCH BLOCK. 
 
 
Day 4 - 
4 Hour Postdose/ 
  19OCT2019 12:00 (4) 
63 
217 
110 
416 
412 
941 
AB, NCS 
FIRST DEGREE AV BLOCK
 
 
Day 7 - 
4 Hour Postdose/ 
  22OCT2019 12:00 (7) 
60 
217 
110 
422 
421 
985 
AB, NCS 
FIRST DEGREE AV 
BLOCK, 
NCS 
 
 
Day 9/ 
  24OCT2019 08:00 (9) 
73 
221 
108 
433 
418 
815 
AB, NCS 
FIRST DEGREE AV 
BLOCK, 
NCS 
9087 
34/F/BL 
Screening/ 
  11OCT2019 09:14 (-5) 
78 
184 
86 
432 
414 
767 
N 
 
 
 
Check-In/ 
  15OCT2019 09:11 (-1) 
79 
196 
88 
442 
422 
753 
N 
 
Page 1611


SIGA TECHNOLOGIES, INC.  
Page 32 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9087 
34/F/BL 
Day 1 - 
4 Hour Postdose/ 
  16OCT2019 12:06 (1) 
77 
188 
100 
444 
425 
770 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  19OCT2019 12:07 (4) 
76 
188 
88 
430 
413 
783 
AB, NCS 
NONSPECIFIC T-WAVE 
ANORMALITY 
 
 
Day 7 - 
4 Hour Postdose/ 
  22OCT2019 12:03 (7) 
81 
184 
89 
444 
422 
734 
N 
 
 
 
Day 9/ 
  24OCT2019 08:06 (9) 
78 
160 
101 
422 
403 
760 
N 
 
9089 
29/M/BL 
Screening/ 
  14OCT2019 09:08 (-2) 
61 
143 
92 
388 
386 
972 
N 
 
 
 
Check-In/ 
  15OCT2019 08:40 (-1) 
70 
155 
96 
397 
386 
849 
N 
 
Page 1612


SIGA TECHNOLOGIES, INC.  
Page 33 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9089 
29/M/BL 
Day 1 - 
4 Hour Postdose/ 
  16OCT2019 12:09 (1) 
67 
164 
90 
399 
391 
890 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  19OCT2019 12:09 (4) 
63 
152 
91 
393 
389 
941 
N 
 
 
 
Day 7 - 
4 Hour Postdose/ 
  22OCT2019 12:09 (7) 
61 
164 
89 
374 
372 
978 
N 
 
 
 
Day 9/ 
  24OCT2019 08:09 (9) 
66 
164 
91 
382 
375 
898 
N 
 
9092 
24/M/W 
Screening/ 
  14OCT2019 09:14 (-2) 
73 
163 
110 
392 
379 
816 
N 
 
 
 
Check-In/ 
  15OCT2019 09:03 (-1) 
66 
160 
103 
391 
384 
905 
N 
 
Page 1613


SIGA TECHNOLOGIES, INC.  
Page 34 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9092 
24/M/W 
Day 1 - 
4 Hour Postdose/ 
  16OCT2019 12:13 (1) 
55 
160 
108 
390 
395 
1075 
N 
 
 
 
Day 4 - 
4 Hour Postdose/ 
  19OCT2019 12:12 (4) 
54 
152 
113 
395 
401 
1095 
AB, NCS 
INCOMPLETE RIGHT 
BUNDLE BRANCH BLOCK 
 
 
Day 7 - 
4 Hour Postdose/ 
  22OCT2019 12:12 (7) 
54 
158 
112 
381 
388 
1102 
AB, NCS 
INCOMPLETE RIGHT 
BUNDLE BRANCH BLOCK 
 
 
Day 9/ 
  24OCT2019 08:12 (9) 
63 
168 
114 
384 
380 
943 
AB, NCS 
INCOMPLETE RIGHT 
BUNDLE BRANCH BLOCK 
9095 
42/M/W 
Screening/ 
  17OCT2019 12:56 (-13) 
75 
139 
106 
442 
425 
793 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY, NCS 
 
 
Check-In/ 
  29OCT2019 08:40 (-1) 
80 
147 
105 
439 
418 
746 
AB, NCS 
NOSPECIFIC T WAVE 
ABNORMAILITY, NCS 
Page 1614


SIGA TECHNOLOGIES, INC.  
Page 35 of 35 
SIGA-246-022  
Listing 16.2.8.7  
Electrocardiogram Results  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
bpm=beats per minute, msec=milliseconds, Int=Interval  
R=Repeat; N=Normal, AB=Abnormal; CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020807.SAS  Executed: 21JAN2020 23:11  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
ECG Date 
Time (Day) 
Heart 
Rate 
(bpm) 
PR 
Int 
(msec) 
QRS 
Dur 
(msec) 
QTcB 
Int 
(msec) 
QTcF 
Int 
(msec) 
RR 
Int 
(msec) 
Interpretation/ 
Clinically 
Significant 
Abnormal 
Finding 
9095 
42/M/W 
Day 1 - 
4 Hour Postdose/ 
  30OCT2019 11:51 (1) 
71 
150 
99 
425 
413 
834 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 4 - 
4 Hour Postdose/ 
  02NOV2019 11:51 (4) 
77 
151 
100 
411 
429 
770 
AB, NCS 
NONSPECIFIC T WAVE 
ABNORMALITY 
 
 
Day 7 - 
4 Hour Postdose/ 
  05NOV2019 10:51 (7) 
77 
152 
105 
433 
414 
774 
AB, NCS 
SINGLE PVC. 
 
 
Day 9/ 
  07NOV2019 06:51 (9) 
81 
148 
100 
431 
410 
734 
AB, NCS 
NONSPECIFIC T-WAVE 
ABNORMALITY 
 
Page 1615


SIGA TECHNOLOGIES, INC.  
Page 1 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9001 
41/M/BL 
Screening/ 
12AUG2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
13AUG2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1616


SIGA TECHNOLOGIES, INC.  
Page 2 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9001 
41/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
20AUG2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
22AUG2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1617


SIGA TECHNOLOGIES, INC.  
Page 3 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9002 
48/M/W 
Screening/ 
06AUG2019 (-8) 
SKIN 
ABNORMAL, NCS 
MILD SCATTERED TINEA 
VERSICOLOR 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
13AUG2019 (-1) 
SKIN 
ABNORMAL, NCS 
TINEA VERSICOLOR, 
UNCHANGED 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1618


SIGA TECHNOLOGIES, INC.  
Page 4 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9002 
48/M/W 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
20AUG2019 (7) 
SKIN 
ABNORMAL, NCS 
TINEA VERSICOLOR 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
22AUG2019 (9) 
SKIN 
ABNORMAL, NCS 
TINEA VERSICOLOR 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1619


SIGA TECHNOLOGIES, INC.  
Page 5 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9005 
40/M/W 
Screening/ 
23JUL2019 (-22) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
13AUG2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1620


SIGA TECHNOLOGIES, INC.  
Page 6 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9005 
40/M/W 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
20AUG2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
22AUG2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1621


SIGA TECHNOLOGIES, INC.  
Page 7 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9009 
21/F/BL 
Screening/ 
31JUL2019 (-14) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
13AUG2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1622


SIGA TECHNOLOGIES, INC.  
Page 8 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9009 
21/F/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
20AUG2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
22AUG2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1623


SIGA TECHNOLOGIES, INC.  
Page 9 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9012 
34/M/BL 
Screening/ 
06AUG2019 (-8) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
13AUG2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1624


SIGA TECHNOLOGIES, INC.  
Page 10 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9012 
34/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
20AUG2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
22AUG2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1625


SIGA TECHNOLOGIES, INC.  
Page 11 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9015 
29/M/BL 
Screening/ 
12AUG2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
13AUG2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1626


SIGA TECHNOLOGIES, INC.  
Page 12 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9015 
29/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
20AUG2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
22AUG2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1627


SIGA TECHNOLOGIES, INC.  
Page 13 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9016 
48/F/W 
Screening/ 
12AUG2019 (-23) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
03SEP2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1628


SIGA TECHNOLOGIES, INC.  
Page 14 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9016 
48/F/W 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
10SEP2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
12SEP2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1629


SIGA TECHNOLOGIES, INC.  
Page 15 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9019 
41/M/BL 
Screening/ 
23AUG2019 (-12) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
03SEP2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1630


SIGA TECHNOLOGIES, INC.  
Page 16 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9019 
41/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
10SEP2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
12SEP2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1631


SIGA TECHNOLOGIES, INC.  
Page 17 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9020 
47/F/BL 
Screening/ 
21AUG2019 (-14) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
03SEP2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1632


SIGA TECHNOLOGIES, INC.  
Page 18 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9020 
47/F/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
10SEP2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
12SEP2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1633


SIGA TECHNOLOGIES, INC.  
Page 19 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9021 
39/F/BL 
Screening/ 
21AUG2019 (-14) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
03SEP2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1634


SIGA TECHNOLOGIES, INC.  
Page 20 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9021 
39/F/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
10SEP2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
12SEP2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1635


SIGA TECHNOLOGIES, INC.  
Page 21 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9022 
31/M/W 
Screening/ 
21AUG2019 (-14) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
03SEP2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1636


SIGA TECHNOLOGIES, INC.  
Page 22 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9022 
31/M/W 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
10SEP2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
12SEP2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1637


SIGA TECHNOLOGIES, INC.  
Page 23 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9024 
20/M/BL 
Screening/ 
23AUG2019 (-12) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
03SEP2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1638


SIGA TECHNOLOGIES, INC.  
Page 24 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9024 
20/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
10SEP2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
12SEP2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1639


SIGA TECHNOLOGIES, INC.  
Page 25 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9025 
50/M/W 
Screening/ 
23AUG2019 (-26) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
17SEP2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1640


SIGA TECHNOLOGIES, INC.  
Page 26 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9025 
50/M/W 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
24SEP2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
26SEP2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1641


SIGA TECHNOLOGIES, INC.  
Page 27 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9033 
32/M/W 
Screening/ 
29AUG2019 (-6) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
03SEP2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1642


SIGA TECHNOLOGIES, INC.  
Page 28 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9033 
32/M/W 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
10SEP2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
12SEP2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1643


SIGA TECHNOLOGIES, INC.  
Page 29 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9043 
22/M/BL 
Screening/ 
11SEP2019 (-7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
17SEP2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1644


SIGA TECHNOLOGIES, INC.  
Page 30 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9043 
22/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
24SEP2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
26SEP2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1645


SIGA TECHNOLOGIES, INC.  
Page 31 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9046 
34/M/BL 
Screening/ 
13SEP2019 (-5) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
17SEP2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1646


SIGA TECHNOLOGIES, INC.  
Page 32 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9046 
34/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
24SEP2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
26SEP2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1647


SIGA TECHNOLOGIES, INC.  
Page 33 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9051 
34/M/BL 
Screening/ 
30SEP2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
01OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1648


SIGA TECHNOLOGIES, INC.  
Page 34 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9051 
34/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
08OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
10OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1649


SIGA TECHNOLOGIES, INC.  
Page 35 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9052 
42/M/BL 
Screening/ 
30SEP2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
01OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1650


SIGA TECHNOLOGIES, INC.  
Page 36 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9052 
42/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
08OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
10OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1651


SIGA TECHNOLOGIES, INC.  
Page 37 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9056 
31/F/BL 
Screening/ 
26SEP2019 (-6) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
01OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1652


SIGA TECHNOLOGIES, INC.  
Page 38 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9056 
31/F/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
08OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
10OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1653


SIGA TECHNOLOGIES, INC.  
Page 39 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9057 
29/F/W 
Screening/ 
30SEP2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
01OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1654


SIGA TECHNOLOGIES, INC.  
Page 40 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9057 
29/F/W 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
08OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
10OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1655


SIGA TECHNOLOGIES, INC.  
Page 41 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9058 
32/M/W 
Screening/ 
26SEP2019 (-20) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
15OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1656


SIGA TECHNOLOGIES, INC.  
Page 42 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9058 
32/M/W 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
22OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
24OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1657


SIGA TECHNOLOGIES, INC.  
Page 43 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9061 
21/F/BL 
Screening/ 
26SEP2019 (-20) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
15OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1658


SIGA TECHNOLOGIES, INC.  
Page 44 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9061 
21/F/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
22OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
24OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1659


SIGA TECHNOLOGIES, INC.  
Page 45 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9062 
33/M/BL 
Screening/ 
30SEP2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
01OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1660


SIGA TECHNOLOGIES, INC.  
Page 46 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9062 
33/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
08OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
10OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1661


SIGA TECHNOLOGIES, INC.  
Page 47 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9063 
35/M/W 
Screening/ 
30SEP2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
01OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1662


SIGA TECHNOLOGIES, INC.  
Page 48 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9063 
35/M/W 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
08OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
10OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1663


SIGA TECHNOLOGIES, INC.  
Page 49 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9069 
41/F/BL 
Screening/ 
30SEP2019 (-16) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
15OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1664


SIGA TECHNOLOGIES, INC.  
Page 50 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9069 
41/F/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
22OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
24OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1665


SIGA TECHNOLOGIES, INC.  
Page 51 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9073 
40/M/BL 
Screening/ 
14OCT2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
15OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1666


SIGA TECHNOLOGIES, INC.  
Page 52 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9073 
40/M/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
22OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
24OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1667


SIGA TECHNOLOGIES, INC.  
Page 53 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9077 
37/F/W 
Screening/ 
11OCT2019 (-5) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
15OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1668


SIGA TECHNOLOGIES, INC.  
Page 54 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9077 
37/F/W 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
22OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
24OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1669


SIGA TECHNOLOGIES, INC.  
Page 55 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9080 
41/F/BL 
Screening/ 
14OCT2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
15OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
Page 1670


SIGA TECHNOLOGIES, INC.  
Page 56 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9080 
41/F/BL 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
22OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
24OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1671


SIGA TECHNOLOGIES, INC.  
Page 57 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9081 
49/M/BL 
Screening/ 
11OCT2019 (-19) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
ABNORMAL, NCS 
LEFT LOWER LEG 
LYMPHEDEMA 2/2 
SEQUELLAE OF SURGICAL 
REPAIR 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
29OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
ABNORMAL, NCS 
LEFT LEG LYMPHEDEMA 
2/2 SEQUELLAE OF 
SURGICAL REPAIR 
Page 1672


SIGA TECHNOLOGIES, INC.  
Page 58 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9081 
49/M/BL 
Check-in/ 
29OCT2019 (-1) 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
 
 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
05NOV2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
ABNORMAL, NCS 
LEFT LEG LYMPHEDEMA 
UNCHANGED 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
07NOV2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
Page 1673


SIGA TECHNOLOGIES, INC.  
Page 59 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9081 
49/M/BL 
Day 9/ 
07NOV2019 (9) 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
ABNORMAL, NCS 
LEFT LEG LYMPHEDEMA 
2/2 SEQUELLAE OF 
SURGICAL REPAIR- NO 
CHANGE DURING STUDY 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
9086 
36/M/BL 
Screening/ 
11OCT2019 (-5) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
15OCT2019 (-1) 
SKIN 
NORMAL 
 
Page 1674


SIGA TECHNOLOGIES, INC.  
Page 60 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9086 
36/M/BL 
Check-in/ 
15OCT2019 (-1) 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
 
 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
22OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
Page 1675


SIGA TECHNOLOGIES, INC.  
Page 61 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9086 
36/M/BL 
Day 7/ 
22OCT2019 (7) 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
24OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
9087 
34/F/BL 
Screening/ 
11OCT2019 (-5) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
Page 1676


SIGA TECHNOLOGIES, INC.  
Page 62 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9087 
34/F/BL 
Check-in/ 
15OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
 
 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
22OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
Page 1677


SIGA TECHNOLOGIES, INC.  
Page 63 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9087 
34/F/BL 
Day 7/ 
22OCT2019 (7) 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
24OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
9089 
29/M/BL 
Screening/ 
14OCT2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
Page 1678


SIGA TECHNOLOGIES, INC.  
Page 64 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9089 
29/M/BL 
Screening/ 
14OCT2019 (-2) 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
15OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
 
 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
22OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
Page 1679


SIGA TECHNOLOGIES, INC.  
Page 65 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9089 
29/M/BL 
Day 7/ 
22OCT2019 (7) 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
24OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
9092 
24/M/W 
Screening/ 
14OCT2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
Page 1680


SIGA TECHNOLOGIES, INC.  
Page 66 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9092 
24/M/W 
Screening/ 
14OCT2019 (-2) 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
15OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
 
 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
22OCT2019 (7) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
Page 1681


SIGA TECHNOLOGIES, INC.  
Page 67 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9092 
24/M/W 
Day 7/ 
22OCT2019 (7) 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
24OCT2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
9095 
42/M/W 
Screening/ 
28OCT2019 (-2) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
Page 1682


SIGA TECHNOLOGIES, INC.  
Page 68 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9095 
42/M/W 
Screening/ 
28OCT2019 (-2) 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Check-in/ 
29OCT2019 (-1) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 2 
PE All 
NOT DONE 
 
 
 
Day 3 
PE All 
NOT DONE 
 
 
 
Day 4 
PE All 
NOT DONE 
 
 
 
Day 5 
PE All 
NOT DONE 
 
 
 
Day 6 
PE All 
NOT DONE 
 
 
 
Day 7/ 
05NOV2019 (7) 
SKIN 
NORMAL 
 
Page 1683


SIGA TECHNOLOGIES, INC.  
Page 69 of 69 
SIGA-246-022  
Listing 16.2.8.8  
Physical Exam  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
CS=Clinically Significant, NCS=Not clinically significant  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020808.SAS  Executed: 21JAN2020 23:12  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Visit/ 
Exam Date (Day) 
Body System 
Interpretation and 
Significance 
Findings 
9095 
42/M/W 
Day 7/ 
05NOV2019 (7) 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
 
Day 9/ 
07NOV2019 (9) 
SKIN 
NORMAL 
 
 
 
 
HEENT 
NORMAL 
 
 
 
 
PULMONARY 
NORMAL 
 
 
 
 
CARDIOVASCULAR 
NORMAL 
 
 
 
 
ABDOMEN 
NORMAL 
 
 
 
 
LYMPH NODES 
NORMAL 
 
 
 
 
MUSCULOSKELETAL 
NORMAL 
 
 
 
 
NEUROLOGIC SYSTEM 
NORMAL 
 
 
 
 
OTHER 
NOT DONE 
 
 
Page 1684


SIGA TECHNOLOGIES, INC.  
Page 1 of 8 
SIGA-246-022  
Listing 16.2.8.9  
Physical Measurements  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020809.SAS  Executed: 21JAN2020 23:12  
Subject ID 
Age(yrs)/Sex/Race 
Visit 
Date Time (Day) 
Height (cm) 
Weight (kg) 
9001 
41/M/BL 
Screening 
19JUL2019 11:16(-26) 
 
128 
 
 
Check-in 
13AUG2019 09:03(-1) 
174.3 
129.9 
 
 
Day 1 
14AUG2019 07:33(1) 
 
129.6 
 
 
Day 9 
22AUG2019 10:08(9) 
 
126.8 
9002 
48/M/W 
Screening 
19JUL2019 11:18(-26) 
 
160.4 
 
 
Check-in 
13AUG2019 09:17(-1) 
178.5 
159.7 
 
 
Day 1 
14AUG2019 07:17(1) 
 
159.1 
 
 
Day 9 
22AUG2019 10:11(9) 
 
154.9 
9005 
40/M/W 
Screening 
23JUL2019 09:26(-22) 
 
140.9 
 
 
Check-in 
13AUG2019 09:02(-1) 
176.8 
141.9 
 
 
Day 1 
14AUG2019 07:13(1) 
 
140.3 
 
 
Day 9 
22AUG2019 10:16(9) 
 
138.2 
9009 
21/F/BL 
Screening 
31JUL2019 09:33(-14) 
 
138.3 
 
 
Check-in 
13AUG2019 08:53(-1) 
174 
137.2 
 
 
Day 1 
14AUG2019 07:36(1) 
 
136.1 
 
 
Day 9 
22AUG2019 10:05(9) 
 
136.8 
9012 
34/M/BL 
Screening 
06AUG2019 09:34(-8) 
 
130.7 
Page 1685


SIGA TECHNOLOGIES, INC.  
Page 2 of 8 
SIGA-246-022  
Listing 16.2.8.9  
Physical Measurements  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020809.SAS  Executed: 21JAN2020 23:12  
Subject ID 
Age(yrs)/Sex/Race 
Visit 
Date Time (Day) 
Height (cm) 
Weight (kg) 
9012 
34/M/BL 
Check-in 
13AUG2019 09:09(-1) 
177 
130.4 
 
 
Day 1 
14AUG2019 07:29(1) 
 
128.6 
 
 
Day 9 
22AUG2019 10:03(9) 
 
126.4 
9015 
29/M/BL 
Screening 
12AUG2019 10:29(-2) 
 
121.2 
 
 
Check-in 
13AUG2019 09:22(-1) 
195.3 
120.4 
 
 
Day 1 
14AUG2019 07:31(1) 
 
120.1 
 
 
Day 9 
22AUG2019 10:14(9) 
 
115.9 
9016 
48/F/W 
Screening 
12AUG2019 10:30(-23) 
 
143.1 
 
 
Check-in 
03SEP2019 08:26(-1) 
173.6 
144.9 
 
 
Day 1 
04SEP2019 06:04(1) 
 
143.5 
 
 
Day 9 
12SEP2019 09:37(9) 
 
142.7 
9019 
41/M/BL 
Screening 
15AUG2019 16:38(-20) 
 
134.6 
 
 
Check-in 
03SEP2019 11:02(-1) 
181.6 
133.5 
 
 
Day 1 
04SEP2019 06:07(1) 
 
133.1 
 
 
Day 9 
12SEP2019 09:42(9) 
 
131 
9020 
47/F/BL 
Screening 
21AUG2019 10:08(-14) 
 
134.7 
 
 
Check-in 
03SEP2019 08:19(-1) 
164.8 
135 
Page 1686


SIGA TECHNOLOGIES, INC.  
Page 3 of 8 
SIGA-246-022  
Listing 16.2.8.9  
Physical Measurements  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020809.SAS  Executed: 21JAN2020 23:12  
Subject ID 
Age(yrs)/Sex/Race 
Visit 
Date Time (Day) 
Height (cm) 
Weight (kg) 
9020 
47/F/BL 
Day 1 
04SEP2019 06:10(1) 
 
133.7 
 
 
Day 9 
12SEP2019 09:35(9) 
 
133.4 
9021 
39/F/BL 
Screening 
21AUG2019 10:10(-14) 
 
122.5 
 
 
Check-in 
03SEP2019 08:22(-1) 
172.8 
123.4 
 
 
Day 1 
04SEP2019 06:12(1) 
 
122.3 
 
 
Day 9 
12SEP2019 09:34(9) 
 
120.9 
9022 
31/M/W 
Screening 
21AUG2019 10:28(-14) 
 
170.6 
 
 
Check-in 
03SEP2019 09:11(-1) 
177.3 
172.1 
 
 
Day 1 
04SEP2019 06:25(1) 
 
170.2 
 
 
Day 9 
12SEP2019 09:52(9) 
 
165.8 
9024 
20/M/BL 
Screening 
23AUG2019 10:06(-12) 
 
133.8 
 
 
Check-in 
03SEP2019 08:37(-1) 
186.4 
133.3 
 
 
Day 1 
04SEP2019 06:22(1) 
 
133.7 
 
 
Day 9 
12SEP2019 09:46(9) 
 
131.9 
9025 
50/M/W 
Screening 
23AUG2019 10:17(-26) 
 
122.9 
 
 
Check-in 
17SEP2019 08:34(-1) 
175.5 
123.5 
 
 
Day 1 
18SEP2019 06:36(1) 
 
121.1 
Page 1687


SIGA TECHNOLOGIES, INC.  
Page 4 of 8 
SIGA-246-022  
Listing 16.2.8.9  
Physical Measurements  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020809.SAS  Executed: 21JAN2020 23:12  
Subject ID 
Age(yrs)/Sex/Race 
Visit 
Date Time (Day) 
Height (cm) 
Weight (kg) 
9025 
50/M/W 
Day 9 
26SEP2019 08:27(9) 
 
120 
9033 
32/M/W 
Screening 
29AUG2019 09:05(-6) 
 
147.4 
 
 
Check-in 
03SEP2019 08:30(-1) 
172.7 
148 
 
 
Day 1 
04SEP2019 06:19(1) 
 
146.2 
 
 
Day 9 
12SEP2019 09:40(9) 
 
142.6 
9043 
22/M/BL 
Screening 
11SEP2019 08:51(-7) 
 
159.1 
 
 
Check-in 
17SEP2019 08:31(-1) 
186.4 
158.9 
 
 
Day 1 
18SEP2019 06:41(1) 
 
157.1 
 
 
Day 9 
26SEP2019 08:23(9) 
 
156.4 
9046 
34/M/BL 
Screening 
13SEP2019 08:42(-5) 
 
121.6 
 
 
Check-in 
17SEP2019 08:37(-1) 
190.4 
121.3 
 
 
Day 1 
18SEP2019 06:39(1) 
 
120.6 
 
 
Day 9 
26SEP2019 08:20(9) 
 
118.7 
9051 
34/M/BL 
Screening 
19SEP2019 08:44(-13) 
 
129.2 
 
 
Check-in 
01OCT2019 08:25(-1) 
182 
130 
 
 
Day 1 
02OCT2019 06:08(1) 
 
129 
 
 
Day 9 
10OCT2019 08:27(9) 
 
125.6 
Page 1688


SIGA TECHNOLOGIES, INC.  
Page 5 of 8 
SIGA-246-022  
Listing 16.2.8.9  
Physical Measurements  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020809.SAS  Executed: 21JAN2020 23:12  
Subject ID 
Age(yrs)/Sex/Race 
Visit 
Date Time (Day) 
Height (cm) 
Weight (kg) 
9052 
42/M/BL 
Screening 
21SEP2019 12:39(-11) 
 
121.1 
 
 
Check-in 
01OCT2019 08:32(-1) 
179.4 
121.6 
 
 
Day 1 
02OCT2019 06:19(1) 
 
122.9 
 
 
Day 9 
10OCT2019 08:37(9) 
 
120.2 
9056 
31/F/BL 
Screening 
24SEP2019 09:14(-8) 
 
122.4 
 
 
Check-in 
01OCT2019 08:50(-1) 
171 
120.9 
 
 
Day 1 
02OCT2019 05:59(1) 
 
121.4 
 
 
Day 9 
10OCT2019 08:19(9) 
 
120.3 
9057 
29/F/W 
Screening 
25SEP2019 16:01(-7) 
 
127.9 
 
 
Check-in 
01OCT2019 08:43(-1) 
151.2 
127.6 
 
 
Day 1 
02OCT2019 06:01(1) 
 
127.5 
 
 
Day 9 
10OCT2019 08:22(9) 
 
125 
9058 
32/M/W 
Screening 
26SEP2019 08:51(-20) 
 
122.4 
 
 
Check-in 
15OCT2019 08:32(-1) 
185.9 
121.3 
 
 
Day 1 
16OCT2019 06:14(1) 
 
120.6 
 
 
Day 9 
24OCT2019 08:27(9) 
 
119.5 
9061 
21/F/BL 
Screening 
26SEP2019 10:21(-20) 
 
125.3 
Page 1689


SIGA TECHNOLOGIES, INC.  
Page 6 of 8 
SIGA-246-022  
Listing 16.2.8.9  
Physical Measurements  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020809.SAS  Executed: 21JAN2020 23:12  
Subject ID 
Age(yrs)/Sex/Race 
Visit 
Date Time (Day) 
Height (cm) 
Weight (kg) 
9061 
21/F/BL 
Check-in 
15OCT2019 08:27(-1) 
169.8 
127.2 
 
 
Day 1 
16OCT2019 06:06(1) 
 
126.3 
 
 
Day 9 
24OCT2019 08:14(9) 
 
124.5 
9062 
33/M/BL 
Screening 
30SEP2019 09:18(-2) 
 
133.7 
 
 
Check-in 
01OCT2019 08:47(-1) 
173.5 
131.9 
 
 
Day 1 
02OCT2019 06:05(1) 
 
131.5 
 
 
Day 9 
10OCT2019 08:24(9) 
 
130 
9063 
35/M/W 
Screening 
30SEP2019 09:06(-2) 
 
124.5 
 
 
Check-in 
01OCT2019 08:21(-1) 
189 
120.3 
 
 
Day 1 
02OCT2019 06:15(1) 
 
120.3 
 
 
Day 9 
10OCT2019 08:34(9) 
 
115.7 
9069 
41/F/BL 
Screening 
30SEP2019 10:22(-16) 
 
150.9 
 
 
Check-in 
15OCT2019 11:48(-1) 
160 
151.4 
 
 
Day 1 
16OCT2019 06:08(1) 
 
151 
 
 
Day 9 
24OCT2019 08:17(9) 
 
148.4 
9073 
40/M/BL 
Screening 
04OCT2019 13:30(-12) 
 
158.4 
 
 
Check-in 
15OCT2019 08:46(-1) 
182.5 
161.5 
Page 1690


SIGA TECHNOLOGIES, INC.  
Page 7 of 8 
SIGA-246-022  
Listing 16.2.8.9  
Physical Measurements  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020809.SAS  Executed: 21JAN2020 23:12  
Subject ID 
Age(yrs)/Sex/Race 
Visit 
Date Time (Day) 
Height (cm) 
Weight (kg) 
9073 
40/M/BL 
Day 1 
16OCT2019 06:12(1) 
 
159.2 
 
 
Day 9 
24OCT2019 08:43(9) 
 
156.6 
9077 
37/F/W 
Screening 
05OCT2019 12:36(-11) 
 
126.6 
 
 
Check-in 
15OCT2019 08:29(-1) 
167.4 
125.7 
 
 
Day 1 
16OCT2019 06:03(1) 
 
125.2 
 
 
Day 9 
24OCT2019 08:29(9) 
 
124.6 
9080 
41/F/BL 
Screening 
08OCT2019 11:14(-8) 
 
120.6 
 
 
Check-in 
15OCT2019 08:50(-1) 
161.8 
121.2 
 
 
Day 1 
16OCT2019 06:27(1) 
 
120.3 
 
 
Day 9 
24OCT2019 08:46(9) 
 
119.5 
9081 
49/M/BL 
Screening 
10OCT2019 11:37(-20) 
 
218.8 
 
 
Check-in 
29OCT2019 09:09(-1) 
192 
220.4 
 
 
Day 1 
30OCT2019 07:02(1) 
 
219.4 
 
 
Day 9 
07NOV2019 08:01(9) 
 
215.1 
9086 
36/M/BL 
Screening 
11OCT2019 09:02(-5) 
 
140.5 
 
 
Check-in 
15OCT2019 08:55(-1) 
186.4 
139.9 
 
 
Day 1 
16OCT2019 06:20(1) 
 
140 
Page 1691


SIGA TECHNOLOGIES, INC.  
Page 8 of 8 
SIGA-246-022  
Listing 16.2.8.9  
Physical Measurements  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
Day = The presented date — First dose date + 1  
Note: TPOXX 600 mg (3 x 200-mg capsules) was administered orally twice a day on Days 1 to 7, approximately 12 hours (±30 minutes) 
apart.  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l16020809.SAS  Executed: 21JAN2020 23:12  
Subject ID 
Age(yrs)/Sex/Race 
Visit 
Date Time (Day) 
Height (cm) 
Weight (kg) 
9086 
36/M/BL 
Day 9 
24OCT2019 08:32(9) 
 
139 
9087 
34/F/BL 
Screening 
11OCT2019 08:59(-5) 
 
124.3 
 
 
Check-in 
15OCT2019 08:35(-1) 
167.2 
123 
 
 
Day 1 
16OCT2019 06:22(1) 
 
123.3 
 
 
Day 9 
24OCT2019 08:27(9) 
 
121.6 
9089 
29/M/BL 
Screening 
14OCT2019 08:55(-2) 
 
123 
 
 
Check-in 
15OCT2019 08:22(-1) 
167.9 
122 
 
 
Day 1 
16OCT2019 06:30(1) 
 
121.6 
 
 
Day 9 
24OCT2019 08:52(9) 
 
120.1 
9092 
24/M/W 
Screening 
14OCT2019 08:58(-2) 
 
167.8 
 
 
Check-in 
15OCT2019 08:43(-1) 
176.5 
168.6 
 
 
Day 1 
16OCT2019 06:25(1) 
 
166.7 
 
 
Day 9 
24OCT2019 08:40(9) 
 
162.1 
9095 
42/M/W 
Screening 
17OCT2019 12:41(-13) 
 
149.6 
 
 
Check-in 
29OCT2019 08:22(-1) 
176.6 
148.6 
 
 
Day 1 
30OCT2019 06:51(1) 
 
149 
 
 
Day 9 
07NOV2019 08:04(9) 
 
146.9 
 
Page 1692


SIGA TECHNOLOGIES, INC.  
Page 1 of 4 
SIGA-246-022  
Listing 16.2.8.10  
Follow-Up Visit/Call  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l160208010.SAS  Executed: 21JAN2020 22:53  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Type of Follow-Up/
Reason for 
Site Visit 
Contact Made/ 
 If ‘NO’, Reason 
Date of Contact 
Attempt or Visit 
AEs/Medications 
Since Last Visit 
9001 
41/M/BL 
CALL 
YES 
27AUG2019 
NO/NO 
CALL 
YES 
19SEP2019 
NO/NO 
9002 
48/M/W 
CALL 
YES 
27AUG2019 
NO/NO 
CALL 
YES 
19SEP2019 
NO/NO 
9005 
40/M/W 
CALL 
YES 
27AUG2019 
NO/NO 
CALL 
YES 
19SEP2019 
NO/NO 
9009 
21/F/BL 
CALL 
YES 
27AUG2019 
NO/NO 
CALL 
YES 
19SEP2019 
NO/NO 
9012 
34/M/BL 
CALL 
YES 
27AUG2019 
NO/NO 
CALL 
YES 
19SEP2019 
NO/NO 
9015 
29/M/BL 
CALL 
YES 
27AUG2019 
NO/NO 
CALL 
YES 
19SEP2019 
NO/NO 
9016 
48/F/W 
CALL 
YES 
17SEP2019 
NO/NO 
CALL 
YES 
10OCT2019 
NO/NO 
9019 
41/M/BL 
CALL 
YES 
17SEP2019 
NO/NO 
CALL 
YES 
10OCT2019 
NO/NO 
9020 
47/F/BL 
CALL 
YES 
17SEP2019 
NO/NO 
CALL 
YES 
10OCT2019 
NO/NO 
Page 1693


SIGA TECHNOLOGIES, INC.  
Page 2 of 4 
SIGA-246-022  
Listing 16.2.8.10  
Follow-Up Visit/Call  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l160208010.SAS  Executed: 21JAN2020 22:53  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Type of Follow-Up/
Reason for 
Site Visit 
Contact Made/ 
 If ‘NO’, Reason 
Date of Contact 
Attempt or Visit 
AEs/Medications 
Since Last Visit 
9021 
39/F/BL 
CALL 
YES 
17SEP2019 
NO/NO 
CALL 
YES 
10OCT2019 
NO/NO 
9022 
31/M/W 
CALL 
YES 
17SEP2019 
NO/NO 
CALL 
YES 
10OCT2019 
NO/NO 
9024 
20/M/BL 
CALL 
YES 
17SEP2019 
NO/NO 
CALL 
YES 
10OCT2019 
NO/NO 
9025 
50/M/W 
CALL 
YES 
01OCT2019 
NO/YES 
CALL 
YES 
24OCT2019 
NO/NO 
9033 
32/M/W 
CALL 
YES 
17SEP2019 
NO/NO 
CALL 
YES 
10OCT2019 
NO/NO 
9043 
22/M/BL 
CALL 
YES 
01OCT2019 
NO/NO 
CALL 
YES 
24OCT2019 
NO/NO 
9046 
34/M/BL 
CALL 
YES 
01OCT2019 
NO/NO 
CALL 
YES 
24OCT2019 
NO/NO 
9051 
34/M/BL 
CALL 
YES 
15OCT2019 
NO/NO 
CALL 
YES 
07NOV2019 
NO/NO 
9052 
42/M/BL 
CALL 
YES 
15OCT2019 
NO/NO 
CALL 
YES 
07NOV2019 
NO/NO 
Page 1694


SIGA TECHNOLOGIES, INC.  
Page 3 of 4 
SIGA-246-022  
Listing 16.2.8.10  
Follow-Up Visit/Call  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l160208010.SAS  Executed: 21JAN2020 22:53  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Type of Follow-Up/
Reason for 
Site Visit 
Contact Made/ 
 If ‘NO’, Reason 
Date of Contact 
Attempt or Visit 
AEs/Medications 
Since Last Visit 
9056 
31/F/BL 
CALL 
YES 
15OCT2019 
NO/NO 
CALL 
YES 
07NOV2019 
NO/NO 
9057 
29/F/W 
CALL 
YES 
15OCT2019 
NO/NO 
CALL 
YES 
07NOV2019 
NO/NO 
9058 
32/M/W 
CALL 
YES 
29OCT2019 
NO/NO 
CALL 
YES 
21NOV2019 
NO/NO 
9061 
21/F/BL 
CALL 
YES 
29OCT2019 
NO/NO 
CALL 
YES 
21NOV2019 
NO/NO 
9062 
33/M/BL 
CALL 
YES 
15OCT2019 
NO/NO 
CALL 
YES 
07NOV2019 
NO/NO 
9063 
35/M/W 
CALL 
YES 
15OCT2019 
NO/NO 
CALL 
YES 
07NOV2019 
NO/NO 
9069 
41/F/BL 
CALL 
YES 
29OCT2019 
NO/NO 
CALL 
YES 
21NOV2019 
NO/NO 
9073 
40/M/BL 
CALL 
YES 
29OCT2019 
NO/NO 
CALL 
YES 
21NOV2019 
NO/NO 
9077 
37/F/W 
CALL 
YES 
29OCT2019 
NO/NO 
CALL 
YES 
21NOV2019 
NO/NO 
Page 1695


SIGA TECHNOLOGIES, INC.  
Page 4 of 4 
SIGA-246-022  
Listing 16.2.8.10  
Follow-Up Visit/Call  
Safety Population  
 
 
Sex: M=Male, F=Female;  
Race: W=White, BL=Black or African American, AS=Asian, AI=American Indian or Alaska Native, PI=Native Hawaiian or Other Pacific 
Islander, O=Other  
\\wilbtib\wilbtib08\SIGA SGSIGA246022\Trunk\TLF\l160208010.SAS  Executed: 21JAN2020 22:53  
Subject 
ID 
Age(yrs)/ 
Sex/ 
Race 
Type of Follow-Up/
Reason for 
Site Visit 
Contact Made/ 
 If ‘NO’, Reason 
Date of Contact 
Attempt or Visit 
AEs/Medications 
Since Last Visit 
9080 
41/F/BL 
CALL 
YES 
29OCT2019 
NO/NO 
CALL 
YES 
21NOV2019 
NO/NO 
9081 
49/M/BL 
CALL 
YES 
12NOV2019 
NO/NO 
CALL 
YES 
05DEC2019 
NO/NO 
9086 
36/M/BL 
CALL 
YES 
29OCT2019 
NO/NO 
CALL 
YES 
21NOV2019 
NO/NO 
9087 
34/F/BL 
CALL 
YES 
29OCT2019 
NO/NO 
CALL 
YES 
21NOV2019 
NO/NO 
9089 
29/M/BL 
CALL 
YES 
29OCT2019 
NO/NO 
CALL 
YES 
21NOV2019 
NO/NO 
9092 
24/M/W 
CALL 
YES 
29OCT2019 
NO/NO 
CALL 
YES 
21NOV2019 
NO/NO 
9095 
42/M/W 
CALL 
YES 
12NOV2019 
NO/YES 
CALL 
YES 
05DEC2019 
NO/NO 
 
Page 1696


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.3 
CASE REPORT FORMS 
Page 1697


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.3.1 
Case Report Forms for Deaths, Serious Adverse Events, and 
Withdrawals for Adverse Events 
There were no deaths, serious adverse events, or adverse events leading to study 
discontinuation. 
Page 1698


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022 
Clinical Study Report 
16.3.2 
Other Case Report Forms Submitted 
No other case report forms were submitted. 
Page 1699


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022  
Clinical Study Report 
16.4 
INDIVIDUAL SUBJECT DATA LISTINGS 
Please refer to Appendix 16.2 for the data listings. 
Page 1700


SIGA Technologies, Inc.  
TPOXX® 
Protocol No. SIGA-246-022  
Clinical Study Report 
16.5 
BIOANALYTICAL REPORT 
This section contains the following document: 
Bioanalytical Sample Analysis for the Determination of Tecovirimat in Human Plasma by 
HPLC/MS/MS dated 23 January 2020  
Page 1701


 
Confidential 
 
 
 
 
 
Bioanalytical Sample Analysis for the 
Determination of Tecovirimat in 
Human Plasma by HPLC/MS/MS 
Prepared For: 
 
SIGA Technologies, Inc. 
4575 SW Research Way, Suite 110 
Corvallis, Oregon 97333 
 
Prepared By: 
 
Alturas Analytics, Inc. 
1324 Alturas Drive 
Moscow, ID 83843 
 
Alturas Report Number: AD19-982 
Study Number: SIGA-246-022 
IND Number: 69,019 
Version Date: 23 Jan 2020 
Report Status: Final 
 
 
Page 1702


Alturas 
Analytics, Inc. 
Quality Assurance Statement 
Study Number: 
Performed For: 
SIGA-246-022 
SIGA Technologies, Inc. 
Alturas Report Number: AD 19-982 
Study Number: SIGA-246-022 
Version Date: 23 Jan 2020 
Status: Final 
The bioanalytical phase of this study has been inspected by the Alturas Analytics, Inc. Quality 
Assurance Unit. Listed below are the types of inspections conducted, the inspection dates, the 
dates the inspections were reported to the Alturas Analytics, Inc. Principal Investigator and Test 
Facility Management. 
Date Reeorted to 
Type of Inspection 
Inspection Date 
Principal 
Management 
Investigator 
....................... Sample Analysis Plan Review 
22Jul2019 
22 Jul 2019 
23Jul2019 
In-Process Inspection; Sample Sorting 
15 Nov 2019 
15 Nov 2019 
15 Nov 2019 
In-Process Inspection; Curve and QC 
15 Nov 2019 
15 Nov 2019 
18Nov2019 
Pre aration 
Data Audit; Batches 1-18 
18 Dec 2019 
18 Dec 2019 
24 Dec 2019 
Report Audit 
13-14 Jan 2020 
14 Jan 2020 
23 Jan 2020 
The Quality Assurance Unit has confirmed that this repmt accurately describes the Alturas 
Analytics, Inc. methods and Standard Operating Procedures, and that the reported results 
accurately reflect the raw data of the study. 
~
- -
Rachel Walker, B.S. 
Quality Assurance Associate 
Alturas Analytics, Inc. 
Date 
Page 2 of 111 
1324 Alturas Drive I Moscow ID 838431208.883.3400 I www.alturasanalytics.com 
Confidential 
Page 1703


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 3 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Key Personnel 
Principal Investigator: 
 
Jennifer Zimmer, Ph.D. 
 
 
 
Analysts: 
 
Ashley Davie, B.S. 
Winston Slocumb, B.S. 
 
 
 
Quality Control Reviewers: 
 
Timberly Maddox, B.S. 
Rebecca Brainard, B.S. 
 
 
 
Author: 
 
Sara Underwood, B.S. 
 
 
 
Quality Assurance Unit: 
 
David Schumacher, B.S., RQAP-GLP 
Staci Loughney, B.A. 
Rachel Walker, B.S. 
 
 
 
Page 1704


/A 
Alturas 
Analytics, Inc. 
:.:· ! · 
Principal Investigator and GLP Compliance Statement 
Alturas Report Number: AD 19-982 
Study Number: SIGA-246-022 
Version Date: 23 Jan 2020 
Status: Final 
I, the undersigned, hereby declare that the work was performed by me or under my direction and 
that the findings provide a true and accurate record of the results obtained. 
The bioanalytical phase of this study (SIGA-246-022) was performed in compliance with the 
agreed protocol and Alturas Standard Operating Procedures and the study objectives were 
achieved. The bioanalysis was conducted in compliance with applicable provisions of the Food 
and Drug Administration (FDA) Good Laboratory Practice (GLP) Regulations as described in 
the Code of Federal Regulations, 21 CFR Part 58. For any deviations from protocol or 
procedures please see the Study Deviations section of the report. 
Principal Investigator: 
Page 4 of 111 
Confidential 
1324 Alturas Drive I Moscow ID 83843 I 208.883.3400 I www.alturasanalytics.com 
Page 1705


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 5 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
STUDY SCHEDULE 
 
Bioanalytical Sample Analysis for the Determination of Tecovirimat in Human Plasma by 
HPLC/MS/MS 
Bioanalytical Study Phase Initiation Date: 
29 Jul 2019 
 
 
Total Number of Samples Received: 
Primary: 
Duplicate: 
1962 
981 
981 
 
 
Total Number of Samples Analyzed: 
981 
 
 
Analysis Start Date: 
14 Nov 2019 
 
 
Analysis Completion Date: 
06 Dec 2019 
 
 
Draft Report Issue Date: 
16 Jan 2020 
 
 
Final Report Issue Date: 
23 Jan 2020 
 
 
 
Page 1706


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 6 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
List of Abbreviations 
CIMS 
Chemical Inventory Management System 
DMSO 
Dimethyl sulfoxide 
DQC  
Dilution quality control 
IS or Int.Std. 
Internal standard 
ISR  
Incurred sample reanalysis 
HPLC/MS/MS  
Liquid chromatography tandem mass spectrometry  
HQC  
High-level quality control 
LLOQ  
Lower limit of quantitation 
LQC  
Low-level quality control 
MQC  
Mid-level quality control 
mg/mL  
Milligrams per milliliter  
ng/mL  
Nanograms per milliliter 
QC  
Quality control 
SD 
Standard deviation 
SOP  
Standard operating procedure 
ULOQ  
Upper limit of quantitation  
µg/mL  
Micrograms per milliliter  
% Bias 
((experimental value - theoretical value)/theoretical value) x 100 
% CV  
Coefficient of variation x 100 
 
 
 
Page 1707


 
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Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table of Contents 
Section No. 
 
 
 
 
 
 
 
 
 
        Page No. 
Quality Assurance Statement .......................................................................................................... 2 
Key Personnel ................................................................................................................................. 3 
Principal Investigator and GLP Compliance Statement ................................................................. 4 
Study Schedule................................................................................................................................ 5 
List of Abbreviations ...................................................................................................................... 6 
Table of Contents ............................................................................................................................ 7 
List of Tables .................................................................................................................................. 9 
1. 
Summary ............................................................................................................................... 10 
2. 
Materials and Methods .......................................................................................................... 11 
2.1 
Standard Purity.............................................................................................................. 11 
2.2 
Biological Matrix .......................................................................................................... 11 
2.3 
Preparation of Solutions ................................................................................................ 11 
2.3.1 
Stock Solutions ....................................................................................................... 11 
2.3.2 
Working Solutions .................................................................................................. 12 
3. 
Sample Analysis.................................................................................................................... 13 
3.1 
Sample Receipt ............................................................................................................. 13 
3.2 
Summary of Analysis .................................................................................................... 14 
3.3 
Study Sample Results ................................................................................................... 15 
3.4 
Calibration Data ............................................................................................................ 39 
3.5 
Quality Control Samples ............................................................................................... 43 
3.6 
Incurred Sample Reanalysis .......................................................................................... 46 
4. 
Selectivity ............................................................................................................................. 50 
4.1 
Blanks ........................................................................................................................... 50 
4.2 
Carryover ...................................................................................................................... 50 
5. 
Conclusion ............................................................................................................................ 55 
6. 
Archival................................................................................................................................. 55 
7. 
Study Deviations ................................................................................................................... 55 
Page 1708


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Study Number: SIGA-246-022 
Version Date: 23 Jan 2020 
Status: Final 
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8.
Computer Systems ................................................................................................................ 55 
9.
References ............................................................................................................................. 55 
10.
Appendices ........................................................................................................................ 55 
10.1 
Certificates of Analysis ................................................................................................. 56 
10.2 
Representative Chromatograms .................................................................................... 60 
10.3 
Test Method .................................................................................................................. 93 
10.4 
Bioanalytical Sample Analysis Plan ........................................................................... 105 
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Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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List of Tables 
Table No. 
 
 
 
 
 
 
 
 
 
        Page No. 
Table 2-1 
Summary of Reference Standards for SIGA-246-022 .......................................... 11 
Table 2-2 
Blank Biological Matrix for SIGA-246-022 ......................................................... 11 
Table 2-3 
Preparation Dates of Calibration Curve and QC Solutions for SIGA-246-022 .... 12 
Table 3-1 
SIGA-246-022 Human K3DTA Plasma Sample Receipt...................................... 13 
Table 3-2 
Summary of Analytical Batches for Tecovirimat ................................................. 14 
Table 3-3 
Concentration of Tecovirimat in Human Plasma.................................................. 15 
Table 3-4 
Summary of Tecovirimat Reassayed Samples ...................................................... 38 
Table 3-5 
Calibration Curve Data for Tecovirimat in Human K3EDTA Plasma ................. 40 
Table 3-6 
Quality Control Evaluation Data for Tecovirimat in Human Plasma ................... 44 
Table 3-7 
Incurred Sample Reanalysis Data for Tecovirimat in Human Plasma ................. 47 
Table 4-1 
Tecovirimat and ST-247 in Double Blank and Blank + IS Samples in Human 
Plasma ................................................................................................................... 51 
Table 4-2 
Carryover Calculations for Tecovirimat in Human Plasma .................................. 53 
 
 
 
Page 1710


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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1. 
SUMMARY 
This report summarizes the bioanalytical results for the quantitation of TPOXX® (tecovirimat, 
also known as ST-246) in human K3DTA plasma samples for SIGA Technologies, Inc. in 
support of study number SIGA-246-022 entitled “A Post Marketing Study of the Safety, 
Tolerability, and Pharmacokinetics of TPOXX® in Adult Subjects Weighing More than 120 kg.” 
Human K3DTA plasma samples were analyzed for tecovirimat according to Alturas Analytics’ 
Procedure TM19-535 described in the validation report (AV15-ST246-03 Addendum 2). The 
FDA 2018 guidance for industry on Bioanalytical Method Validation was followed for the 
sample analysis procedures throughout the report. 
Acetonitrile precipitation and HPLC/MS/MS were used to determine the concentration of 
tecovirimat from human K3DTA plasma. An aliquot of the extract was injected onto an 
HPLC/MS/MS triple quadrupole mass spectrometer (Sciex API4000). A C18 HPLC column was 
used to separate tecovirimat and the internal standard (IS), ST-247, from interfering compounds 
that may be present in the sample extract. The peak area of the product ion of the compound 
(tecovirimat) was measured against the peak area of the product ion of the IS. A calibration 
curve ranging from 5.00 to 2000 ng/mL (eight concentrations in duplicate) was used to quantify 
tecovirimat in the samples.  
 
 
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Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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2. 
MATERIALS AND METHODS 
2.1 
STANDARD PURITY 
A summary of the reference standards used throughout sample analysis is presented in Table 2-1. 
Purities were corrected for in all calculations. Supporting documentation of the reference 
standard(s), including expiration date, certificates of analysis, and evidence of purity is the 
responsibility of the manufacturer/supplier or Sponsor; see Certificates of Analysis in the 
Appendices. 
Table 2-1 
Summary of Reference Standards for SIGA-246-022 
Reference Standard 
(Synonym) 
Lot Number 
Purity 
Expiration/Retest 
Date 
Batch 
Numbers 
Tpoxx® 
(Tecovirimat, ST-246 Monohydrate) 
20AZ10B-4837 
0.9551 
15 Jan 2020 
1-18 
ST-247 
1244-TRB-4 
1.00 
Not assigned 
1-18 
2.2 
BIOLOGICAL MATRIX 
Blank human plasma was purchased from BioIVT, (Westbury, New York). Table 2-2 
summarizes the lot numbers and receipt dates of the matrices used throughout sample analysis. 
Table 2-2 
Blank Biological Matrix for SIGA-246-022 
Description 
Lot Number 
Receipt Date 
Human K3DTA Plasma 
BRH1353066 
11 Jul 2017 
 
BRH1625452 
30 Jan 2019 
2.3 
PREPARATION OF SOLUTIONS 
A summary of solution preparation dates used throughout sample analysis is presented in Table 
2-3.  
2.3.1 Stock Solutions 
Stock solutions of tecovirimat were prepared in dimethyl sulfoxide (DMSO) and ST-247 was 
prepared in methanol at 1.00 mg/mL. The weight (in milligrams) and other related details for all 
of the solutions were recorded individually for each day of stock solution preparation in Alturas 
Analytics Chemical Inventory Management System (CIMS). Separate stock solutions of 
tecovirimat were weighed and used in the preparation of curve and quality control (QC) working 
Page 1712


 
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Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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solutions and stored at nominal -20 °C. Long term stability of tecovirimat stock solution has 
been demonstrated for up to 285 days at nominal -20 °C; see AV15-ST246-03 Addendum 2.  
2.3.2 Working Solutions 
Standard curve working solutions were prepared by diluting the respective stock solution of 
tecovirimat in DMSO and stored in single-use aliquots at nominal -20 °C. Blank human K3DTA 
plasma was spiked on the day of analysis with the working solutions to yield standard 
concentrations of 5.00, 10.0, 25.0, 100, 350, 700, 1500, and 2000 ng/mL. Long term stability of 
the LLOQ working solution has been demonstrated for up to 56 days at nominal -20 °C; see 
AV15-ST246-03 Addendum 2. 
QC working solutions were prepared by diluting the respective tecovirimat stock solution in 
DMSO and stored in single-use aliquots at nominal -20 °C. QC samples were prepared by 
spiking blank human K3DTA plasma with the QC working solutions to yield concentrations of 
15.0, 150, and 1600 ng/mL. On each day of analysis, QC samples were analyzed with incurred 
samples. Any remaining volume of QC aliquots thawed for analysis were discarded after each 
day of use. 
Table 2-3 
Preparation Dates of Calibration Curve and QC Solutions for 
SIGA-246-022 
Analyte 
Solution Preparation Date 
Plasma 
QC a 
Batch Number(s) 
Stock 
Solution 
Working Solution 
Calibration 
Curve 
QCs 
Tecovirimat 
13 Nov 2019 
13 Nov 2019 
13 Nov 2019 
14 Nov 2019 
15 Nov 2019 
26 Nov 2019 
27 Nov 2019 
28 Nov 2019 
03 Dec 2019 
04 Dec 2019 
05 Dec 2019 
06 Dec 2019 
1 
2-5 
6-8 
9, 10 
11, 12 
13, 14 
16 
17 
15, 18 
a 
= If not prepared on batch extraction date, QC was stored at -70 °C  
 
 
Page 1713


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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3. 
SAMPLE ANALYSIS 
3.1 
SAMPLE RECEIPT 
Study samples were received as shown in Table 3-1. Samples were stored at nominal -70 °C. 
Study samples were analyzed within 24 days from receipt. Long term stability for tecovirimat in 
human plasma has been validated for up to 757 days at nominal -70 °C; see AV15-ST246-03, 
report addendum 3.  
Table 3-1 
SIGA-246-022 Human K3DTA Plasma Sample Receipt 
Date Received 
Sample Count 
Storage Temperature 
(°C) 
Sample Condition 
13 Nov 2019 
981 primary 
-70 ± 10 
Frozen/intact on dry ice 
05 Dec 2019 
981 duplicate 
-70 ± 10 
Frozen/intact on dry ice 
 
 
 
 
Page 1714


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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3.2 
SUMMARY OF ANALYSIS 
Study samples were analyzed in 18 batches in accordance with SOP AA-301, the Bioanalytical 
Sample Analysis Plan, and test method TM19-535. Each batch included at least duplicate QC 
samples at three concentrations within the calibration range. A summary of all analytical batches 
can be found in Table 3-2.  
Table 3-2 
Summary of Analytical Batches for Tecovirimat 
Batch Number 
Extraction Date 
Instrument ID 
Batch Status 
Description of Samples Analyzed 
 
 
 
 
 
1 
14 Nov 2019 
API4000-06 
Accepted 
Incurred samples 
 
 
 
 
 
2 
15 Nov 2019 
API4000-06 
Accepted 
Incurred samples 
 
 
 
 
 
3 
15 Nov 2019 
API4000-06 
Accepted 
Incurred samples 
 
 
 
 
 
4 
15 Nov 2019 
API4000-06 
Accepted 
Incurred samples 
 
 
 
 
 
5 
15 Nov 2019 
API4000-06 
Accepted 
Incurred samples 
 
 
 
 
 
6 
26 Nov 2019 
API4000-04 
Accepted 
Incurred samples 
 
 
 
 
 
7 
26 Nov 2019 
API4000-04 
Accepted 
Incurred samples 
 
 
 
 
 
8 
26 Nov 2019 
API4000-04 
Accepted 
Incurred samples 
 
 
 
 
 
9 
27 Nov 2019 
API4000-04 
Accepted 
Incurred samples 
 
 
 
 
 
10 
27 Nov 2019 
API4000-04 
Accepted 
Incurred samples 
 
 
 
 
 
11 
28 Nov 2019 
API4000-04 
Accepted 
Incurred samples 
 
 
 
 
 
12 
28 Nov 2019 
API4000-04 
Accepted 
Incurred samples 
 
 
 
 
 
13 
03 Dec 2019 
API4000-04 
Accepted 
Incurred samples 
 
 
 
 
 
14 
03 Dec 2019 
API4000-04 
Accepted 
Incurred samples 
 
 
 
 
 
15 
06 Dec 2019 
API4000-06 
Accepted 
Incurred samples 
Reassay samples 
 
 
 
 
 
16 
04 Dec 2019 
API4000-06 
Accepted 
ISR 
 
 
 
 
 
17 
05 Dec 2019 
API4000-06 
Accepted 
ISR 
 
 
 
 
 
18 
06 Dec 2019 
API4000-06 
Accepted 
Incurred samples 
 
 
 
 
 
ISR 
= Incurred sample reanalysis 
 
 
Page 1715


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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3.3 
STUDY SAMPLE RESULTS 
Study sample concentrations are displayed in Table 3-3. Information about reassayed study 
samples is shown in Table 3-4.  
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9001 
1 
0 
1 
LLOQ(<5.00) 
1 
9001 
1 
0.5 
1 
10.8 
1 
9001 
1 
1 
1 
104 
1 
9001 
1 
2 
1 
469 
1 
9001 
1 
4 
1 
1100 
1 
9001 
1 
6 
1 
759 
1 
9001 
1 
8 
1 
397 
1 
9001 
1 
12 
1 
240 
1 
9001 
1 
14 
1 
173 
1 
9001 
2 
16 
5 
485 
1 
9001 
2 
18 
5 
688 
1 
9001 
2 
20 
5 
695 
1 
9001 
2 
24 
5 
455 
1 
9001 
6 
0 
8 
630 
1 
9001 
6 
4 
8 
1580 
1 
9001 
7 
0 
9 
555 
1 
9001 
7 
0.5 
9 
387 
1 
9001 
7 
1 
9 
345 
1 
9001 
7 
2 
9 
603 
1 
9001 
7 
4 
9 
1600 
1 
9001 
7 
6 
9 
1270 
1 
9001 
7 
8 
9 
691 
1 
9001 
7 
12 
9 
481 
1 
9001 
7 
14 
9 
568 
1 
9001 
8 
16 
12 
1020 
1 
9001 
8 
18 
12 
1070 
1 
9001 
8 
20 
12 
717 
1 
9001 
8 
24 
12 
488 
1 
9001 
9 
48 
14 
121 
1 
9002 
1 
0 
1 
LLOQ(<5.00) 
1 
9002 
1 
0.5 
1 
LLOQ(<5.00) 
1 
9002 
1 
1 
1 
33.4 
1 
9002 
1 
2 
1 
323 
1 
9002 
1 
4 
1 
717 
1 
9002 
1 
6 
1 
548 
1 
9002 
1 
8 
1 
355 
1 
9002 
1 
12 
1 
216 
1 
9002 
1 
14 
1 
273 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1716


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9002 
2 
16 
5 
471 
1 
9002 
2 
18 
5 
674 
1 
9002 
2 
20 
5 
865 
1 
9002 
2 
24 
5 
637 
1 
9002 
6 
0 
8 
537 
1 
9002 
6 
4 
8 
1180 
1 
9002 
7 
0 
9 
533 
1 
9002 
7 
0.5 
9 
429 
1 
9002 
7 
1 
9 
410 
1 
9002 
7 
2 
9 
907 
1 
9002 
7 
4 
9 
1290 
1 
9002 
7 
6 
9 
839 
1 
9002 
7 
8 
9 
509 
1 
9002 
7 
12 
9 
567 
1 
9002 
7 
14 
9 
854 
1 
9002 
8 
16 
12 
1140 
1 
9002 
8 
18 
12 
934 
1 
9002 
8 
20 
12 
862 
1 
9002 
8 
24 
12 
624 
1 
9002 
9 
48 
14 
203 
1 
9005 
1 
0 
1 
LLOQ(<5.00) 
1 
9005 
1 
0.5 
1 
22.2 
1 
9005 
1 
1 
1 
164 
1 
9005 
1 
2 
1 
840 
1 
9005 
1 
4 
1 
1080 
1 
9005 
1 
6 
1 
578 
1 
9005 
1 
8 
1 
360 
1 
9005 
1 
12 
1 
233 
1 
9005 
1 
14 
1 
579 
1 
9005 
2 
16 
6 
1110 
1 
9005 
2 
18 
6 
1190 
1 
9005 
2 
20 
6 
811 
1 
9005 
2 
24 
6 
555 
1 
9005 
6 
0 
8 
827 
1 
9005 
6 
4 
8 
1800 
1 
9005 
7 
0 
9 
719 
1 
9005 
7 
0.5 
9 
655 
1 
9005 
7 
1 
9 
572 
1 
9005 
7 
2 
9 
1410 
1 
9005 
7 
4 
15 
2270 
5 
9005 
7 
6 
15 
1170 
1 
9005 
7 
8 
9 
748 
1 
9005 
7 
12 
9 
607 
1 
9005 
7 
14 
9 
1270 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1717


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9005 
8 
16 
12 
1660 
1 
9005 
8 
18 
12 
1490 
1 
9005 
8 
20 
12 
997 
1 
9005 
8 
24 
12 
810 
1 
9005 
9 
48 
14 
314 
1 
9009 
1 
0 
1 
LLOQ(<5.00) 
1 
9009 
1 
0.5 
1 
LLOQ(<5.00) 
1 
9009 
1 
1 
1 
LLOQ(<5.00) 
1 
9009 
1 
2 
1 
72.3 
1 
9009 
1 
4 
1 
523 
1 
9009 
1 
6 
1 
378 
1 
9009 
1 
12 
1 
274 
1 
9009 
1 
14 
1 
346 
1 
9009 
2 
16 
6 
899 
1 
9009 
2 
18 
6 
1520 
1 
9009 
2 
20 
6 
935 
1 
9009 
2 
24 
6 
550 
1 
9009 
6 
0 
8 
750 
1 
9009 
6 
4 
8 
1620 
1 
9009 
7 
0 
9 
650 
1 
9009 
7 
0.5 
9 
516 
1 
9009 
7 
1 
9 
471 
1 
9009 
7 
2 
9 
630 
1 
9009 
7 
4 
9 
1190 
1 
9009 
7 
6 
9 
1030 
1 
9009 
7 
8 
9 
860 
1 
9009 
7 
12 
9 
922 
1 
9009 
7 
14 
9 
962 
1 
9009 
8 
16 
12 
1260 
1 
9009 
8 
18 
12 
1350 
1 
9009 
8 
20 
12 
1070 
1 
9009 
8 
24 
12 
849 
1 
9009 
9 
48 
14 
273 
1 
9012 
1 
0 
1 
LLOQ(<5.00) 
1 
9012 
1 
0.5 
1 
10.7 
1 
9012 
1 
1 
1 
78.9 
1 
9012 
1 
2 
1 
683 
1 
9012 
1 
4 
1 
757 
1 
9012 
1 
6 
1 
657 
1 
9012 
1 
8 
1 
367 
1 
9012 
1 
12 
1 
193 
1 
9012 
1 
14 
1 
265 
1 
9012 
2 
16 
6 
667 
1 
9012 
2 
18 
6 
648 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
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Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9012 
2 
20 
6 
685 
1 
9012 
2 
24 
6 
451 
1 
9012 
6 
0 
8 
815 
1 
9012 
6 
4 
8 
982 
1 
9012 
7 
0 
9 
490 
1 
9012 
7 
0.5 
9 
435 
1 
9012 
7 
1 
9 
354 
1 
9012 
7 
2 
9 
334 
1 
9012 
7 
4 
9 
810 
1 
9012 
7 
6 
9 
1060 
1 
9012 
7 
8 
9 
662 
1 
9012 
7 
12 
9 
424 
1 
9012 
7 
14 
9 
481 
1 
9012 
8 
16 
12 
675 
1 
9012 
8 
18 
12 
979 
1 
9012 
8 
20 
12 
1180 
1 
9012 
8 
24 
12 
603 
1 
9012 
9 
48 
14 
131 
1 
9015 
1 
0 
1 
LLOQ(<5.00) 
1 
9015 
1 
0.5 
1 
5.35 
1 
9015 
1 
1 
1 
69.1 
1 
9015 
1 
2 
1 
212 
1 
9015 
1 
4 
1 
331 
1 
9015 
1 
6 
1 
900 
1 
9015 
1 
8 
1 
544 
1 
9015 
1 
12 
1 
256 
1 
9015 
1 
14 
1 
246 
1 
9015 
2 
16 
6 
393 
1 
9015 
2 
18 
6 
642 
1 
9015 
2 
20 
6 
741 
1 
9015 
2 
24 
6 
507 
1 
9015 
6 
0 
8 
563 
1 
9015 
6 
4 
8 
1320 
1 
9015 
7 
0 
9 
727 
1 
9015 
7 
0.5 
9 
612 
1 
9015 
7 
1 
9 
524 
1 
9015 
7 
2 
9 
618 
1 
9015 
7 
4 
9 
878 
1 
9015 
7 
6 
9 
858 
1 
9015 
7 
8 
9 
612 
1 
9015 
7 
12 
9 
305 
1 
9015 
7 
14 
9 
632 
1 
9015 
8 
16 
12 
746 
1 
9015 
8 
18 
12 
865 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1719


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9015 
8 
20 
12 
742 
1 
9015 
8 
24 
12 
471 
1 
9015 
9 
48 
14 
107 
1 
9016 
1 
0 
1 
LLOQ(<5.00) 
1 
9016 
1 
0.5 
1 
LLOQ(<5.00) 
1 
9016 
1 
1 
1 
91.5 
1 
9016 
1 
2 
1 
205 
1 
9016 
1 
4 
1 
711 
1 
9016 
1 
6 
1 
547 
1 
9016 
1 
8 
1 
408 
1 
9016 
1 
12 
1 
327 
1 
9016 
1 
14 
1 
321 
1 
9016 
2 
16 
6 
528 
1 
9016 
2 
18 
6 
624 
1 
9016 
2 
20 
6 
613 
1 
9016 
2 
24 
6 
534 
1 
9016 
6 
0 
8 
831 
1 
9016 
6 
4 
8 
1700 
1 
9016 
7 
0 
15 
773 
1 
9016 
7 
0.5 
15 
569 
1 
9016 
7 
1 
15 
621 
1 
9016 
7 
2 
15 
870 
1 
9016 
7 
4 
15 
1750 
1 
9016 
7 
6 
15 
1430 
1 
9016 
7 
8 
15 
913 
1 
9016 
7 
12 
15 
811 
1 
9016 
7 
14 
15 
739 
1 
9016 
8 
16 
12 
1090 
1 
9016 
8 
18 
12 
992 
1 
9016 
8 
20 
12 
1180 
1 
9016 
8 
24 
12 
1020 
1 
9016 
9 
48 
14 
205 
1 
9019 
1 
0 
2 
LLOQ(<5.00) 
1 
9019 
1 
0.5 
2 
LLOQ(<5.00) 
1 
9019 
1 
1 
2 
16.6 
1 
9019 
1 
2 
2 
641 
1 
9019 
1 
4 
2 
922 
1 
9019 
1 
6 
2 
771 
1 
9019 
1 
8 
2 
511 
1 
9019 
1 
12 
2 
271 
1 
9019 
1 
14 
2 
225 
1 
9019 
2 
16 
6 
493 
1 
9019 
2 
18 
6 
568 
1 
9019 
2 
20 
6 
761 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1720


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 20 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9019 
2 
24 
6 
417 
1 
9019 
6 
0 
8 
555 
1 
9019 
6 
4 
8 
1210 
1 
9019 
7 
0 
15 
526 
1 
9019 
7 
0.5 
15 
465 
1 
9019 
7 
1 
15 
406 
1 
9019 
7 
2 
15 
617 
1 
9019 
7 
4 
15 
950 
1 
9019 
7 
6 
15 
1130 
1 
9019 
7 
8 
15 
846 
1 
9019 
7 
12 
15 
557 
1 
9019 
7 
14 
15 
650 
1 
9019 
8 
16 
12 
992 
1 
9019 
8 
18 
12 
1020 
1 
9019 
8 
20 
12 
920 
1 
9019 
8 
24 
12 
574 
1 
9019 
9 
48 
14 
130 
1 
9020 
1 
0 
2 
LLOQ(<5.00) 
1 
9020 
1 
0.5 
2 
LLOQ(<5.00) 
1 
9020 
1 
1 
2 
LLOQ(<5.00) 
1 
9020 
1 
2 
2 
25.6 
1 
9020 
1 
4 
2 
740 
1 
9020 
1 
6 
2 
684 
1 
9020 
1 
8 
2 
740 
1 
9020 
1 
12 
2 
444 
1 
9020 
1 
14 
2 
334 
1 
9020 
2 
16 
6 
603 
1 
9020 
2 
18 
6 
801 
1 
9020 
2 
20 
6 
721 
1 
9020 
2 
24 
6 
429 
1 
9020 
6 
0 
8 
550 
1 
9020 
6 
4 
8 
1090 
1 
9020 
7 
0 
15 
506 
1 
9020 
7 
0.5 
15 
506 
1 
9020 
7 
1 
15 
450 
1 
9020 
7 
2 
15 
498 
1 
9020 
7 
4 
15 
1060 
1 
9020 
7 
6 
15 
1110 
1 
9020 
7 
8 
15 
678 
1 
9020 
7 
12 
15 
627 
1 
9020 
7 
14 
15 
610 
1 
9020 
8 
16 
12 
920 
1 
9020 
8 
18 
12 
1010 
1 
9020 
8 
20 
12 
886 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1721


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 21 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9020 
8 
24 
12 
601 
1 
9020 
9 
48 
14 
245 
1 
9021 
1 
0 
2 
LLOQ(<5.00) 
1 
9021 
1 
0.5 
2 
LLOQ(<5.00) 
1 
9021 
1 
1 
2 
21.9 
1 
9021 
1 
2 
2 
774 
1 
9021 
1 
4 
2 
890 
1 
9021 
1 
6 
2 
511 
1 
9021 
1 
8 
2 
292 
1 
9021 
1 
12 
2 
272 
1 
9021 
1 
14 
2 
722 
1 
9021 
2 
16 
6 
748 
1 
9021 
2 
18 
6 
713 
1 
9021 
2 
20 
6 
714 
1 
9021 
2 
24 
6 
336 
1 
9021 
6 
0 
8 
434 
1 
9021 
6 
4 
8 
1330 
1 
9021 
7 
0 
15 
247 
1 
9021 
7 
0.5 
15 
192 
1 
9021 
7 
1 
15 
157 
1 
9021 
7 
2 
15 
451 
1 
9021 
7 
4 
15 
1050 
1 
9021 
7 
6 
15 
459 
1 
9021 
7 
8 
15 
288 
1 
9021 
7 
12 
15 
527 
1 
9021 
7 
14 
15 
638 
1 
9021 
8 
16 
13 
663 
1 
9021 
8 
18 
13 
670 
1 
9021 
8 
20 
13 
532 
1 
9021 
8 
24 
13 
307 
1 
9021 
9 
48 
14 
58.0 
1 
9022 
1 
0 
2 
LLOQ(<5.00) 
1 
9022 
1 
0.5 
2 
LLOQ(<5.00) 
1 
9022 
1 
1 
2 
40.6 
1 
9022 
1 
2 
2 
309 
1 
9022 
1 
4 
2 
624 
1 
9022 
1 
6 
2 
648 
1 
9022 
1 
8 
2 
396 
1 
9022 
1 
12 
2 
304 
1 
9022 
1 
14 
2 
402 
1 
9022 
2 
16 
6 
668 
1 
9022 
2 
18 
6 
632 
1 
9022 
2 
20 
6 
637 
1 
9022 
2 
24 
6 
513 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1722


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 22 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9022 
6 
0 
8 
511 
1 
9022 
6 
4 
8 
1150 
1 
9022 
7 
0 
15 
669 
1 
9022 
7 
0.5 
15 
582 
1 
9022 
7 
1 
15 
581 
1 
9022 
7 
2 
15 
920 
1 
9022 
7 
4 
15 
1170 
1 
9022 
7 
6 
15 
1200 
1 
9022 
7 
8 
15 
727 
1 
9022 
7 
12 
15 
577 
1 
9022 
7 
14 
15 
839 
1 
9022 
8 
16 
13 
1350 
1 
9022 
8 
18 
13 
1300 
1 
9022 
8 
20 
13 
931 
1 
9022 
8 
24 
13 
582 
1 
9022 
9 
48 
14 
148 
1 
9024 
1 
0 
2 
LLOQ(<5.00) 
1 
9024 
1 
0.5 
2 
LLOQ(<5.00) 
1 
9024 
1 
1 
2 
23.5 
1 
9024 
1 
2 
2 
251 
1 
9024 
1 
4 
2 
840 
1 
9024 
1 
6 
2 
885 
1 
9024 
1 
8 
2 
845 
1 
9024 
1 
12 
2 
456 
1 
9024 
1 
14 
2 
328 
1 
9024 
2 
16 
6 
835 
1 
9024 
2 
18 
6 
647 
1 
9024 
2 
20 
6 
1070 
1 
9024 
2 
24 
6 
630 
1 
9024 
6 
0 
8 
921 
1 
9024 
6 
4 
8 
1940 
1 
9024 
7 
0 
15 
862 
1 
9024 
7 
0.5 
15 
711 
1 
9024 
7 
1 
15 
621 
1 
9024 
7 
2 
15 
774 
1 
9024 
7 
4 
15 
1860 
1 
9024 
7 
6 
15 
1440 
1 
9024 
7 
8 
15 
902 
1 
9024 
7 
12 
15 
733 
1 
9024 
7 
14 
15 
1090 
1 
9024 
8 
16 
13 
1300 
1 
9024 
8 
18 
13 
1430 
1 
9024 
8 
20 
13 
1300 
1 
9024 
8 
24 
13 
804 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1723


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 23 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9024 
9 
48 
14 
271 
1 
9025 
1 
0 
2 
LLOQ(<5.00) 
1 
9025 
1 
0.5 
2 
LLOQ(<5.00) 
1 
9025 
1 
1 
2 
LLOQ(<5.00) 
1 
9025 
1 
2 
2 
50.1 
1 
9025 
1 
4 
2 
192 
1 
9025 
1 
6 
2 
628 
1 
9025 
1 
8 
2 
1330 
1 
9025 
1 
12 
2 
758 
1 
9025 
1 
14 
2 
554 
1 
9025 
2 
16 
6 
1050 
1 
9025 
2 
18 
6 
936 
1 
9025 
2 
20 
6 
958 
1 
9025 
2 
24 
6 
1110 
1 
9025 
6 
0 
8 
1200 
1 
9025 
6 
4 
8 
1440 
1 
9025 
7 
0 
18 
1090 
1 
9025 
7 
0.5 
18 
978 
1 
9025 
7 
1 
18 
728 
1 
9025 
7 
2 
18 
884 
1 
9025 
7 
4 
18 
1200 
1 
9025 
7 
6 
18 
1480 
1 
9025 
7 
8 
18 
1210 
1 
9025 
7 
12 
18 
760 
1 
9025 
7 
14 
18 
1060 
1 
9025 
8 
16 
13 
1510 
1 
9025 
8 
18 
13 
1300 
1 
9025 
8 
20 
13 
1170 
1 
9025 
8 
24 
13 
815 
1 
9025 
9 
48 
14 
236 
1 
9033 
1 
0 
2 
LLOQ(<5.00) 
1 
9033 
1 
0.5 
2 
15.5 
1 
9033 
1 
1 
2 
129 
1 
9033 
1 
2 
2 
497 
1 
9033 
1 
4 
2 
574 
1 
9033 
1 
6 
2 
347 
1 
9033 
1 
8 
2 
191 
1 
9033 
1 
12 
2 
160 
1 
9033 
1 
14 
2 
339 
1 
9033 
2 
16 
6 
631 
1 
9033 
2 
18 
6 
528 
1 
9033 
2 
20 
6 
467 
1 
9033 
2 
24 
6 
292 
1 
9033 
6 
0 
8 
356 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1724


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 24 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9033 
6 
4 
8 
1590 
1 
9033 
7 
0 
18 
365 
1 
9033 
7 
0.5 
18 
283 
1 
9033 
7 
1 
18 
402 
1 
9033 
7 
2 
18 
701 
1 
9033 
7 
4 
18 
1160 
1 
9033 
7 
6 
18 
845 
1 
9033 
7 
8 
18 
535 
1 
9033 
7 
12 
18 
463 
1 
9033 
7 
14 
18 
1020 
1 
9033 
8 
16 
13 
916 
1 
9033 
8 
18 
13 
844 
1 
9033 
8 
20 
13 
612 
1 
9033 
8 
24 
13 
411 
1 
9033 
9 
48 
14 
117 
1 
9043 
1 
0 
3 
LLOQ(<5.00) 
1 
9043 
1 
0.5 
3 
LLOQ(<5.00) 
1 
9043 
1 
1 
3 
14.9 
1 
9043 
1 
2 
3 
711 
1 
9043 
1 
4 
3 
909 
1 
9043 
1 
6 
3 
571 
1 
9043 
1 
8 
3 
361 
1 
9043 
1 
14 
3 
269 
1 
9043 
2 
16 
6 
421 
1 
9043 
2 
18 
6 
635 
1 
9043 
2 
20 
6 
1100 
1 
9043 
2 
24 
6 
504 
1 
9043 
6 
0 
8 
958 
1 
9043 
6 
4 
8 
1100 
1 
9043 
7 
0 
18 
840 
1 
9043 
7 
0.5 
18 
451 
1 
9043 
7 
1 
18 
442 
1 
9043 
7 
2 
18 
1050 
1 
9043 
7 
4 
18 
1640 
1 
9043 
7 
6 
18 
1020 
1 
9043 
7 
8 
18 
543 
1 
9043 
7 
12 
18 
501 
1 
9043 
7 
14 
18 
468 
1 
9043 
8 
16 
13 
1120 
1 
9043 
8 
18 
13 
960 
1 
9043 
8 
20 
13 
859 
1 
9043 
8 
24 
13 
570 
1 
9043 
9 
48 
14 
237 
1 
9046 
1 
0 
3 
LLOQ(<5.00) 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1725


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 25 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9046 
1 
0.5 
3 
LLOQ(<5.00) 
1 
9046 
1 
1 
3 
11.8 
1 
9046 
1 
2 
3 
370 
1 
9046 
1 
4 
3 
1030 
1 
9046 
1 
6 
3 
498 
1 
9046 
1 
8 
3 
331 
1 
9046 
1 
12 
3 
265 
1 
9046 
1 
14 
3 
535 
1 
9046 
2 
16 
6 
1090 
1 
9046 
2 
18 
6 
951 
1 
9046 
2 
20 
6 
832 
1 
9046 
2 
24 
6 
506 
1 
9046 
6 
0 
8 
702 
1 
9046 
6 
4 
8 
1440 
1 
9046 
7 
0 
18 
909 
1 
9046 
7 
0.5 
18 
694 
1 
9046 
7 
1 
18 
629 
1 
9046 
7 
2 
18 
721 
1 
9046 
7 
4 
18 
1350 
1 
9046 
7 
6 
18 
833 
1 
9046 
7 
8 
18 
567 
1 
9046 
7 
12 
18 
523 
1 
9046 
7 
14 
18 
1330 
1 
9046 
8 
16 
13 
1470 
1 
9046 
8 
18 
13 
1170 
1 
9046 
8 
20 
13 
1070 
1 
9046 
8 
24 
13 
802 
1 
9046 
9 
48 
14 
264 
1 
9051 
1 
0 
3 
LLOQ(<5.00) 
1 
9051 
1 
0.5 
3 
LLOQ(<5.00) 
1 
9051 
1 
1 
3 
26.7 
1 
9051 
1 
2 
3 
453 
1 
9051 
1 
4 
3 
811 
1 
9051 
1 
6 
3 
232 
1 
9051 
1 
8 
3 
136 
1 
9051 
1 
12 
3 
149 
1 
9051 
1 
14 
3 
171 
1 
9051 
2 
16 
6 
553 
1 
9051 
2 
18 
6 
475 
1 
9051 
2 
20 
6 
409 
1 
9051 
2 
24 
6 
294 
1 
9051 
6 
0 
8 
241 
1 
9051 
6 
4 
8 
816 
1 
9051 
7 
0 
18 
282 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1726


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 26 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9051 
7 
0.5 
18 
239 
1 
9051 
7 
1 
18 
449 
1 
9051 
7 
2 
18 
937 
1 
9051 
7 
4 
18 
1020 
1 
9051 
7 
6 
18 
513 
1 
9051 
7 
8 
18 
285 
1 
9051 
7 
12 
18 
352 
1 
9051 
7 
14 
18 
512 
1 
9051 
8 
16 
13 
641 
1 
9051 
8 
18 
13 
539 
1 
9051 
8 
20 
13 
322 
1 
9051 
8 
24 
13 
284 
1 
9051 
9 
48 
14 
27.9 
1 
9052 
1 
0 
3 
LLOQ(<5.00) 
1 
9052 
1 
0.5 
3 
15.0 
1 
9052 
1 
1 
3 
54.2 
1 
9052 
1 
2 
3 
256 
1 
9052 
1 
4 
3 
556 
1 
9052 
1 
6 
3 
941 
1 
9052 
1 
8 
3 
522 
1 
9052 
1 
12 
3 
346 
1 
9052 
1 
14 
3 
458 
1 
9052 
2 
16 
7 
1040 
1 
9052 
2 
18 
7 
1040 
1 
9052 
2 
20 
7 
958 
1 
9052 
2 
24 
7 
705 
1 
9052 
6 
0 
8 
632 
1 
9052 
6 
4 
8 
1470 
1 
9052 
7 
0 
10 
575 
1 
9052 
7 
0.5 
10 
440 
1 
9052 
7 
1 
10 
450 
1 
9052 
7 
2 
10 
745 
1 
9052 
7 
4 
10 
1930 
1 
9052 
7 
6 
10 
1160 
1 
9052 
7 
8 
10 
750 
1 
9052 
7 
12 
10 
494 
1 
9052 
7 
14 
10 
890 
1 
9052 
8 
16 
13 
1850 
1 
9052 
8 
18 
13 
1310 
1 
9052 
8 
20 
13 
909 
1 
9052 
8 
24 
13 
622 
1 
9052 
9 
48 
14 
146 
1 
9056 
1 
0 
3 
LLOQ(<5.00) 
1 
9056 
1 
0.5 
3 
9.22 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1727


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 27 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9056 
1 
1 
3 
33.0 
1 
9056 
1 
2 
3 
123 
1 
9056 
1 
4 
3 
938 
1 
9056 
1 
6 
3 
519 
1 
9056 
1 
8 
3 
327 
1 
9056 
1 
12 
3 
213 
1 
9056 
1 
14 
3 
158 
1 
9056 
2 
16 
7 
398 
1 
9056 
2 
18 
7 
1140 
1 
9056 
2 
20 
7 
916 
1 
9056 
2 
24 
7 
555 
1 
9056 
6 
0 
8 
738 
1 
9056 
6 
4 
8 
1140 
1 
9056 
7 
0 
10 
653 
1 
9056 
7 
0.5 
10 
458 
1 
9056 
7 
1 
10 
384 
1 
9056 
7 
2 
10 
323 
1 
9056 
7 
4 
10 
901 
1 
9056 
7 
6 
10 
1130 
1 
9056 
7 
8 
10 
794 
1 
9056 
7 
12 
10 
1220 
1 
9056 
7 
14 
10 
853 
1 
9056 
8 
16 
13 
1210 
1 
9056 
8 
18 
13 
1020 
1 
9056 
8 
20 
13 
894 
1 
9056 
8 
24 
13 
707 
1 
9056 
9 
48 
14 
257 
1 
9057 
1 
0 
3 
LLOQ(<5.00) 
1 
9057 
1 
0.5 
3 
LLOQ(<5.00) 
1 
9057 
1 
1 
3 
45.8 
1 
9057 
1 
2 
3 
239 
1 
9057 
1 
4 
3 
489 
1 
9057 
1 
6 
3 
557 
1 
9057 
1 
8 
3 
362 
1 
9057 
1 
12 
3 
210 
1 
9057 
1 
14 
3 
178 
1 
9057 
2 
16 
7 
457 
1 
9057 
2 
18 
7 
451 
1 
9057 
2 
20 
7 
504 
1 
9057 
2 
24 
7 
472 
1 
9057 
6 
0 
8 
618 
1 
9057 
6 
4 
8 
940 
1 
9057 
7 
0 
10 
635 
1 
9057 
7 
0.5 
10 
421 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1728


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 28 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9057 
7 
1 
10 
368 
1 
9057 
7 
2 
10 
512 
1 
9057 
7 
4 
10 
1270 
1 
9057 
7 
6 
10 
931 
1 
9057 
7 
8 
10 
760 
1 
9057 
7 
12 
10 
761 
1 
9057 
7 
14 
10 
797 
1 
9057 
8 
16 
13 
977 
1 
9057 
8 
18 
13 
853 
1 
9057 
8 
20 
13 
913 
1 
9057 
8 
24 
13 
648 
1 
9057 
9 
48 
14 
182 
1 
9058 
1 
0 
3 
LLOQ(<5.00) 
1 
9058 
1 
0.5 
3 
14.0 
1 
9058 
1 
1 
3 
355 
1 
9058 
1 
2 
3 
894 
1 
9058 
1 
4 
3 
881 
1 
9058 
1 
6 
3 
623 
1 
9058 
1 
8 
3 
359 
1 
9058 
1 
12 
3 
192 
1 
9058 
1 
14 
3 
248 
1 
9058 
2 
16 
7 
513 
1 
9058 
2 
18 
7 
588 
1 
9058 
2 
20 
7 
702 
1 
9058 
2 
24 
7 
746 
1 
9058 
6 
0 
8 
573 
1 
9058 
6 
4 
8 
1400 
1 
9058 
7 
0 
10 
645 
1 
9058 
7 
0.5 
10 
488 
1 
9058 
7 
1 
10 
897 
1 
9058 
7 
2 
10 
1710 
1 
9058 
7 
4 
10 
1470 
1 
9058 
7 
6 
10 
1270 
1 
9058 
7 
8 
10 
837 
1 
9058 
7 
12 
10 
621 
1 
9058 
7 
14 
10 
481 
1 
9058 
8 
16 
13 
704 
1 
9058 
8 
18 
13 
854 
1 
9058 
8 
20 
13 
743 
1 
9058 
8 
24 
13 
742 
1 
9058 
9 
48 
14 
141 
1 
9061 
1 
0 
4 
LLOQ(<5.00) 
1 
9061 
1 
0.5 
4 
5.77 
1 
9061 
1 
1 
4 
288 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1729


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 29 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9061 
1 
2 
4 
940 
1 
9061 
1 
4 
4 
965 
1 
9061 
1 
6 
4 
440 
1 
9061 
1 
8 
4 
311 
1 
9061 
1 
12 
4 
325 
1 
9061 
1 
14 
4 
745 
1 
9061 
2 
16 
7 
833 
1 
9061 
2 
24 
7 
448 
1 
9061 
6 
0 
8 
415 
1 
9061 
6 
4 
8 
1020 
1 
9061 
7 
0 
10 
572 
1 
9061 
7 
0.5 
10 
439 
1 
9061 
7 
1 
10 
413 
1 
9061 
7 
2 
10 
606 
1 
9061 
7 
4 
10 
1290 
1 
9061 
7 
6 
10 
1000 
1 
9061 
7 
8 
10 
603 
1 
9061 
7 
12 
10 
554 
1 
9061 
7 
14 
10 
614 
1 
9061 
8 
16 
13 
888 
1 
9061 
8 
18 
13 
936 
1 
9061 
8 
20 
13 
734 
1 
9061 
8 
24 
13 
460 
1 
9061 
9 
48 
14 
129 
1 
9062 
1 
0 
4 
LLOQ(<5.00) 
1 
9062 
1 
0.5 
4 
14.3 
1 
9062 
1 
1 
4 
127 
1 
9062 
1 
2 
4 
609 
1 
9062 
1 
4 
4 
583 
1 
9062 
1 
6 
4 
368 
1 
9062 
1 
8 
4 
232 
1 
9062 
1 
12 
4 
157 
1 
9062 
1 
14 
4 
245 
1 
9062 
2 
16 
7 
467 
1 
9062 
2 
18 
7 
407 
1 
9062 
2 
20 
7 
441 
1 
9062 
2 
24 
7 
370 
1 
9062 
6 
0 
8 
438 
1 
9062 
6 
4 
8 
997 
1 
9062 
7 
0 
10 
462 
1 
9062 
7 
0.5 
10 
386 
1 
9062 
7 
1 
10 
359 
1 
9062 
7 
2 
10 
692 
1 
9062 
7 
4 
10 
941 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1730


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 30 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9062 
7 
6 
10 
1020 
1 
9062 
7 
8 
10 
736 
1 
9062 
7 
12 
10 
647 
1 
9062 
7 
14 
10 
561 
1 
9062 
8 
16 
13 
849 
1 
9062 
8 
18 
13 
901 
1 
9062 
8 
20 
13 
598 
1 
9062 
8 
24 
13 
381 
1 
9062 
9 
48 
14 
128 
1 
9063 
1 
0 
4 
LLOQ(<5.00) 
1 
9063 
1 
0.5 
4 
10.2 
1 
9063 
1 
1 
4 
41.2 
1 
9063 
1 
2 
4 
455 
1 
9063 
1 
4 
4 
762 
1 
9063 
1 
6 
4 
571 
1 
9063 
1 
8 
4 
382 
1 
9063 
1 
12 
4 
170 
1 
9063 
1 
14 
4 
200 
1 
9063 
2 
16 
7 
653 
1 
9063 
2 
18 
7 
674 
1 
9063 
2 
20 
7 
761 
1 
9063 
2 
24 
7 
469 
1 
9063 
6 
0 
8 
532 
1 
9063 
6 
4 
8 
1800 
1 
9063 
7 
0 
10 
687 
1 
9063 
7 
0.5 
10 
539 
1 
9063 
7 
1 
10 
721 
1 
9063 
7 
2 
10 
1860 
1 
9063 
7 
4 
15 
2180 
5 
9063 
7 
6 
15 
1450 
1 
9063 
7 
8 
10 
823 
1 
9063 
7 
12 
10 
635 
1 
9063 
7 
14 
10 
962 
1 
9063 
8 
16 
13 
1440 
1 
9063 
8 
18 
13 
1150 
1 
9063 
8 
20 
13 
955 
1 
9063 
8 
24 
13 
690 
1 
9063 
9 
48 
14 
190 
1 
9069 
1 
0 
4 
LLOQ(<5.00) 
1 
9069 
1 
0.5 
4 
73.2 
1 
9069 
1 
1 
4 
102 
1 
9069 
1 
2 
4 
537 
1 
9069 
1 
4 
4 
957 
1 
9069 
1 
6 
4 
402 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1731


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 31 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9069 
1 
8 
4 
331 
1 
9069 
1 
12 
4 
283 
1 
9069 
1 
14 
4 
629 
1 
9069 
2 
16 
7 
933 
1 
9069 
2 
18 
7 
831 
1 
9069 
2 
20 
7 
592 
1 
9069 
2 
24 
7 
407 
1 
9069 
6 
0 
8 
634 
1 
9069 
6 
4 
8 
1220 
1 
9069 
7 
0 
11 
689 
1 
9069 
7 
0.5 
11 
511 
1 
9069 
7 
1 
11 
472 
1 
9069 
7 
2 
11 
560 
1 
9069 
7 
4 
11 
1270 
1 
9069 
7 
6 
11 
709 
1 
9069 
7 
8 
11 
501 
1 
9069 
7 
12 
11 
543 
1 
9069 
7 
14 
11 
987 
1 
9069 
8 
16 
13 
861 
1 
9069 
8 
18 
13 
772 
1 
9069 
8 
20 
13 
647 
1 
9069 
8 
24 
13 
517 
1 
9069 
9 
48 
14 
232 
1 
9073 
1 
0 
4 
LLOQ(<5.00) 
1 
9073 
1 
0.5 
4 
11.1 
1 
9073 
1 
1 
4 
127 
1 
9073 
1 
2 
4 
702 
1 
9073 
1 
4 
4 
630 
1 
9073 
1 
6 
4 
237 
1 
9073 
1 
8 
4 
225 
1 
9073 
1 
12 
4 
164 
1 
9073 
1 
14 
4 
208 
1 
9073 
2 
16 
7 
504 
1 
9073 
2 
18 
7 
540 
1 
9073 
2 
20 
7 
452 
1 
9073 
2 
24 
7 
294 
1 
9073 
6 
0 
8 
599 
1 
9073 
6 
4 
8 
1290 
1 
9073 
7 
0 
11 
502 
1 
9073 
7 
0.5 
11 
397 
1 
9073 
7 
1 
11 
350 
1 
9073 
7 
2 
11 
847 
1 
9073 
7 
4 
11 
1300 
1 
9073 
7 
6 
11 
931 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1732


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 32 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9073 
7 
8 
11 
637 
1 
9073 
7 
12 
11 
505 
1 
9073 
7 
14 
11 
1030 
1 
9073 
8 
16 
14 
959 
1 
9073 
8 
18 
14 
811 
1 
9073 
8 
20 
14 
696 
1 
9073 
8 
24 
14 
522 
1 
9073 
9 
48 
14 
195 
1 
9077 
1 
0 
4 
LLOQ(<5.00) 
1 
9077 
1 
0.5 
4 
LLOQ(<5.00) 
1 
9077 
1 
1 
4 
15.2 
1 
9077 
1 
2 
4 
586 
1 
9077 
1 
4 
4 
1310 
1 
9077 
1 
6 
4 
810 
1 
9077 
1 
8 
4 
436 
1 
9077 
1 
12 
4 
343 
1 
9077 
1 
14 
4 
694 
1 
9077 
2 
16 
7 
1220 
1 
9077 
2 
18 
7 
1060 
1 
9077 
2 
20 
7 
1100 
1 
9077 
2 
24 
7 
1170 
1 
9077 
6 
0 
8 
1010 
1 
9077 
6 
4 
8 
2000 
1 
9077 
7 
0 
11 
969 
1 
9077 
7 
0.5 
11 
739 
1 
9077 
7 
1 
11 
750 
1 
9077 
7 
2 
11 
847 
1 
9077 
7 
4 
15 
2120 
5 
9077 
7 
6 
15 
1230 
1 
9077 
7 
8 
11 
875 
1 
9077 
7 
12 
11 
925 
1 
9077 
7 
14 
11 
1000 
1 
9077 
8 
16 
14 
1360 
1 
9077 
8 
18 
14 
1290 
1 
9077 
8 
20 
14 
1210 
1 
9077 
8 
24 
14 
1090 
1 
9077 
9 
48 
14 
381 
1 
9080 
1 
0 
4 
LLOQ(<5.00) 
1 
9080 
1 
0.5 
4 
5.31 
1 
9080 
1 
1 
4 
75.1 
1 
9080 
1 
2 
4 
454 
1 
9080 
1 
4 
4 
1130 
1 
9080 
1 
6 
4 
771 
1 
9080 
1 
8 
4 
494 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1733


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 33 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9080 
1 
12 
4 
407 
1 
9080 
1 
14 
4 
269 
1 
9080 
2 
16 
7 
382 
1 
9080 
2 
18 
7 
538 
1 
9080 
2 
20 
7 
771 
1 
9080 
2 
24 
7 
584 
1 
9080 
6 
0 
8 
724 
1 
9080 
6 
4 
8 
1360 
1 
9080 
7 
0 
11 
797 
1 
9080 
7 
0.5 
11 
613 
1 
9080 
7 
1 
11 
481 
1 
9080 
7 
2 
11 
474 
1 
9080 
7 
4 
11 
1120 
1 
9080 
7 
6 
11 
1370 
1 
9080 
7 
8 
11 
886 
1 
9080 
7 
12 
11 
1280 
1 
9080 
7 
14 
11 
1110 
1 
9080 
8 
16 
14 
1500 
1 
9080 
8 
20 
14 
1290 
1 
9080 
8 
24 
14 
1030 
1 
9080 
9 
48 
18 
206 
1 
9081 
1 
0 
5 
LLOQ(<5.00) 
1 
9081 
1 
0.5 
5 
31.4 
1 
9081 
1 
1 
5 
105 
1 
9081 
1 
2 
5 
628 
1 
9081 
1 
4 
5 
527 
1 
9081 
1 
6 
5 
361 
1 
9081 
1 
8 
5 
223 
1 
9081 
1 
12 
5 
152 
1 
9081 
1 
14 
5 
258 
1 
9081 
2 
16 
7 
471 
1 
9081 
2 
18 
7 
473 
1 
9081 
2 
20 
7 
496 
1 
9081 
2 
24 
7 
340 
1 
9081 
6 
0 
8 
471 
1 
9081 
6 
4 
8 
982 
1 
9081 
7 
0 
11 
491 
1 
9081 
7 
0.5 
11 
420 
1 
9081 
7 
1 
11 
409 
1 
9081 
7 
2 
11 
769 
1 
9081 
7 
4 
11 
1030 
1 
9081 
7 
6 
11 
906 
1 
9081 
7 
8 
11 
579 
1 
9081 
7 
12 
11 
491 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1734


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 34 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9081 
7 
14 
11 
851 
1 
9081 
8 
16 
14 
808 
1 
9081 
8 
18 
14 
708 
1 
9081 
8 
20 
14 
638 
1 
9081 
8 
24 
14 
461 
1 
9081 
9 
48 
18 
160 
1 
9086 
1 
0 
5 
LLOQ(<5.00) 
1 
9086 
1 
0.5 
5 
LLOQ(<5.00) 
1 
9086 
1 
1 
5 
21.9 
1 
9086 
1 
2 
5 
215 
1 
9086 
1 
4 
5 
634 
1 
9086 
1 
6 
5 
324 
1 
9086 
1 
8 
5 
154 
1 
9086 
1 
12 
5 
121 
1 
9086 
1 
14 
5 
148 
1 
9086 
2 
16 
7 
240 
1 
9086 
2 
18 
7 
382 
1 
9086 
2 
20 
7 
395 
1 
9086 
2 
24 
7 
215 
1 
9086 
6 
0 
9 
227 
1 
9086 
6 
4 
9 
633 
1 
9086 
7 
0 
11 
339 
1 
9086 
7 
0.5 
11 
230 
1 
9086 
7 
1 
11 
357 
1 
9086 
7 
2 
11 
531 
1 
9086 
7 
4 
11 
690 
1 
9086 
7 
6 
11 
626 
1 
9086 
7 
8 
11 
286 
1 
9086 
7 
12 
11 
265 
1 
9086 
7 
14 
11 
632 
1 
9086 
8 
16 
14 
654 
1 
9086 
8 
18 
14 
548 
1 
9086 
8 
20 
14 
391 
1 
9086 
8 
24 
14 
263 
1 
9086 
9 
48 
18 
114 
1 
9087 
1 
0 
5 
LLOQ(<5.00) 
1 
9087 
1 
0.5 
5 
LLOQ(<5.00) 
1 
9087 
1 
1 
5 
23.4 
1 
9087 
1 
2 
5 
304 
1 
9087 
1 
4 
5 
1160 
1 
9087 
1 
6 
5 
557 
1 
9087 
1 
8 
5 
296 
1 
9087 
1 
12 
5 
177 
1 
9087 
1 
14 
5 
173 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1735


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 35 of 111 
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Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9087 
2 
16 
7 
478 
1 
9087 
2 
18 
7 
867 
1 
9087 
2 
20 
7 
704 
1 
9087 
2 
24 
7 
436 
1 
9087 
6 
0 
9 
474 
1 
9087 
6 
4 
9 
744 
1 
9087 
7 
0 
11 
449 
1 
9087 
7 
0.5 
11 
364 
1 
9087 
7 
1 
11 
329 
1 
9087 
7 
2 
11 
291 
1 
9087 
7 
4 
11 
516 
1 
9087 
7 
6 
11 
751 
1 
9087 
7 
8 
11 
638 
1 
9087 
7 
12 
11 
549 
1 
9087 
7 
14 
11 
712 
1 
9087 
8 
16 
14 
1010 
1 
9087 
8 
18 
14 
868 
1 
9087 
8 
20 
14 
782 
1 
9087 
8 
24 
14 
514 
1 
9087 
9 
48 
18 
121 
1 
9089 
1 
0 
5 
LLOQ(<5.00) 
1 
9089 
1 
0.5 
5 
LLOQ(<5.00) 
1 
9089 
1 
1 
5 
65.9 
1 
9089 
1 
2 
5 
237 
1 
9089 
1 
4 
5 
802 
1 
9089 
1 
6 
5 
649 
1 
9089 
1 
8 
5 
407 
1 
9089 
1 
12 
5 
241 
1 
9089 
1 
14 
5 
252 
1 
9089 
2 
16 
7 
513 
1 
9089 
2 
18 
7 
638 
1 
9089 
2 
20 
7 
698 
1 
9089 
2 
24 
7 
457 
1 
9089 
6 
0 
9 
468 
1 
9089 
6 
4 
9 
941 
1 
9089 
7 
0 
12 
563 
1 
9089 
7 
0.5 
12 
450 
1 
9089 
7 
1 
12 
387 
1 
9089 
7 
2 
12 
355 
1 
9089 
7 
4 
12 
950 
1 
9089 
7 
6 
12 
972 
1 
9089 
7 
8 
12 
566 
1 
9089 
7 
12 
12 
444 
1 
9089 
7 
14 
12 
439 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1736


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 36 of 111 
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Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9089 
8 
16 
14 
786 
1 
9089 
8 
18 
14 
998 
1 
9089 
8 
20 
14 
752 
1 
9089 
8 
24 
14 
480 
1 
9089 
9 
48 
18 
142 
1 
9092 
1 
0 
5 
LLOQ(<5.00) 
1 
9092 
1 
0.5 
5 
26.8 
1 
9092 
1 
1 
5 
196 
1 
9092 
1 
2 
5 
596 
1 
9092 
1 
4 
5 
521 
1 
9092 
1 
6 
5 
439 
1 
9092 
1 
8 
5 
217 
1 
9092 
1 
12 
5 
160 
1 
9092 
1 
14 
5 
300 
1 
9092 
2 
16 
7 
442 
1 
9092 
2 
18 
7 
427 
1 
9092 
2 
20 
7 
484 
1 
9092 
2 
24 
7 
370 
1 
9092 
6 
0 
9 
442 
1 
9092 
6 
4 
9 
1200 
1 
9092 
7 
0 
12 
460 
1 
9092 
7 
0.5 
12 
376 
1 
9092 
7 
1 
12 
590 
1 
9092 
7 
2 
12 
1530 
1 
9092 
7 
4 
12 
1390 
1 
9092 
7 
6 
12 
688 
1 
9092 
7 
8 
12 
444 
1 
9092 
7 
12 
12 
598 
1 
9092 
7 
14 
12 
842 
1 
9092 
8 
16 
14 
960 
1 
9092 
8 
18 
14 
774 
1 
9092 
8 
20 
14 
638 
1 
9092 
8 
24 
14 
270 
1 
9092 
9 
48 
18 
129 
1 
9095 
1 
0 
5 
LLOQ(<5.00) 
1 
9095 
1 
0.5 
5 
LLOQ(<5.00) 
1 
9095 
1 
1 
5 
13.3 
1 
9095 
1 
2 
5 
178 
1 
9095 
1 
4 
5 
697 
1 
9095 
1 
6 
5 
612 
1 
9095 
1 
8 
5 
396 
1 
9095 
1 
12 
5 
331 
1 
9095 
1 
14 
5 
266 
1 
9095 
2 
16 
8 
554 
1 
LLOQ = Lower Limit of Quantitation 
Continued on next page 
Page 1737


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 37 of 111 
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Table 3-3 
Concentration of Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Batch 
Number 
Calculated 
Concentration 
(ng/mL) 
Dilution Factor 
 
 
 
 
 
 
9095 
2 
18 
8 
549 
1 
9095 
2 
20 
8 
582 
1 
9095 
2 
24 
8 
810 
1 
9095 
6 
0 
9 
717 
1 
9095 
6 
4 
9 
1040 
1 
9095 
7 
0 
12 
662 
1 
9095 
7 
0.5 
12 
579 
1 
9095 
7 
1 
12 
318 
1 
9095 
7 
2 
12 
527 
1 
9095 
7 
4 
12 
863 
1 
9095 
7 
6 
12 
1340 
1 
9095 
7 
8 
12 
1030 
1 
9095 
7 
12 
12 
706 
1 
9095 
7 
14 
12 
905 
1 
9095 
8 
16 
14 
1300 
1 
9095 
8 
18 
14 
996 
1 
9095 
8 
20 
14 
976 
1 
9095 
8 
24 
14 
719 
1 
9095 
9 
48 
18 
252 
1 
 
 
Page 1738


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 3-4 
Summary of Tecovirimat Reassayed Samples 
Subject 
Day 
Nominal 
Hour 
Nominal 
Original Conc. 
(ng/mL) 
Original 
Batch No. 
Reason for 
Reassay 
Reassay 
Conc. 
(ng/mL) 
Reassayed 
Batch No. 
Reported 
Conc. 
(ng/mL) 
Reason for 
Reported Conc. 
 
 
 
 
 
 
 
 
 
 
9005 
7 
4 
ULOQ(>2000) 
9 
1 
2270 
15 
2270 
1 
9005 
7 
6 
Follows >ULOQ sample 
9 
2 
1170 
15 
1170 
2 
9063 
7 
4 
ULOQ(>2000) 
10 
1 
2180 
15 
2180 
1 
9063 
7 
6 
Follows >ULOQ sample 
10 
2 
1450 
15 
1450 
2 
9077 
7 
4 
ULOQ(>2000) 
11 
1 
2120 
15 
2120 
1 
9077 
7 
6 
Follows >ULOQ sample 
11 
2 
1230 
15 
1230 
2 
ULOQ = Upper Limit of Quantitation 
 
REASON FOR REASSAY: 
1 
= Sample > ULOQ 
2 
= Sample injected immediately following a >ULOQ sample 
 
REASON FOR REPORTED CONCENTRATION: 
1 
= Original value > ULOQ 
2 
= Original value invalid due to possible carryover 
 
 
Page 1739


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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3.4 
CALIBRATION DATA 
The calibration curve was found to be best modeled by a least-squares linear fit from 5.00 to 
2000 ng/mL for tecovirimat. During method validation, it was found that 1/x2 weighting gave the 
most accurate results for the quantitative analysis of tecovirimat. 
A calibration curve was made with tecovirimat and back-calculated concentrations were 
generated using the derived equation from the weighted least-squares linear regression line of the 
peak area ratios. Per SOP, the accuracy (% bias) for the back-calculated concentrations for each 
standard point should be within 15% (20% at the LLOQ) of the nominal value to be considered 
acceptable. At least 75% of the calibration standards in each batch must meet these accuracy 
criteria in order for the batch to be considered acceptable per SOP. Back-calculated 
concentration values are shown in Table 3-5 together with calibration curve parameters and 
overall precision and accuracy values for the curves.  
 
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Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 3-5 
Calibration Curve Data for Tecovirimat in Human K3EDTA Plasma 
 
Nominal Concentrations 
Calibration Curve Parameters 
Batch 
5.00 
10.0 
25.0 
100 
350 
700 
1500 
2000 
 
 
 
Number 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
A a 
B a 
RSQ b 
 
 
 
 
 
 
 
 
 
 
 
 
1 
5.27 
9.60 
23.3 
102 
329 
820 c 
1590 
2170 
 
 
 
 
4.97 
9.60 
26.0 
95.6 
368 
714 
1410 
1980 
1.13E-02 
6.78E-03 
9.965E-01 
 
 
 
 
 
 
 
 
 
 
 
 
2 
4.93 
10.4 
24.3 
96.7 
352 
752 
1490 
1820 
 
 
 
 
4.78 
11.0 
23.9 
104 
355 
732 
1400 
2020 
1.07E-02 
2.12E-03 
9.964E-01 
 
 
 
 
 
 
 
 
 
 
 
 
3 
5.13 
9.93 
25.9 
97.8 
355 
716 
1530 
2080 
 
 
 
 
5.12 
8.96 
25.2 
92.1 
355 
754 
1380 
2030 
1.05E-02 
4.34E-05 
9.968E-01 
 
 
 
 
 
 
 
 
 
 
 
 
4 
4.89 
9.70 
25.4 
95.5 
508 c 
669 
1500 
1920 
 
 
 
 
5.04 
10.6 
24.4 
101 
340 
779 
1420 
2160 
1.11E-02 
1.22E-03 
9.966E-01 
 
 
 
 
 
 
 
 
 
 
 
 
5 
4.50 
10.0 
23.2 
97.5 
381 
788 
1490 
1940 
 
 
 
 
5.50 
10.1 
26.0 
97.1 
343 
698 
1430 
1920 
1.07E-02 
9.97E-03 
9.949E-01 
 
 
 
 
 
 
 
 
 
 
 
 
6 
5.44 
11.0 
24.5 
103 
345 
690 
1460 
1950 
 
 
 
 
4.66 
8.88 
23.7 
98.2 
391 
712 
1490 
2010 
1.05E-02 
-8.59E-03 
9.951E-01 
 
 
 
 
 
 
 
 
 
 
 
 
7 
5.21 
14.0 c 
25.4 
94.9 
365 
710 
1420 
2590 c 
 
 
 
 
6.74 d 
9.18 
25.0 
95.7 
353 
708 
1540 
2140 
9.68E-03 
-9.70E-03 
9.976E-01 
 
 
 
 
 
 
 
 
 
 
 
 
8 
4.73 
9.76 
26.0 
101 
355 
719 
1490 
2120 
 
 
 
 
5.46 
9.71 
22.7 
95.5 
334 
721 
1520 
2000 
9.88E-03 
3.70E-05 
9.971E-01 
 
 
 
 
 
 
 
 
 
 
 
 
a 
= Linear Regression: y = Ax + B where y is the peak area ratio of Tecovirimat to Int. Std., x is the concentration of Tecovirimat, and A and B are regression constants. 
Regression weighted 1/x2. 
b 
= RSQ = R-Squared 
c 
= >15% (± 15% theoretical). Value excluded from regression and summary statistics. 
d 
= >20% (± 20% theoretical). Value excluded from regression and summary statistics. 
Continued on next page 
Page 1741


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 41 of 111 
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Table 3-5 
Calibration Curve Data for Tecovirimat in Human K3EDTA Plasma 
 
Nominal Concentrations 
Calibration Curve Parameters 
Batch 
5.00 
10.0 
25.0 
100 
350 
700 
1500 
2000 
 
 
 
Number 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
A a 
B a 
RSQ b 
 
 
 
 
 
 
 
 
 
 
 
 
9 
4.92 
10.1 
23.2 
99.4 
358 
714 
1530 
1990 
 
 
 
 
5.20 
12.2 c 
23.4 
97.7 
345 
674 
1660 
2030 
9.81E-03 
-4.48E-03 
9.976E-01 
 
 
 
 
 
 
 
 
 
 
 
 
10 
4.96 
11.5 
24.6 
96.1 
355 
675 
1540 
2140 
 
 
 
 
5.02 
8.98 
23.5 
91.5 
342 
702 
1540 
2150 
9.32E-03 
-8.68E-04 
9.948E-01 
 
 
 
 
 
 
 
 
 
 
 
 
11 
5.70 
9.66 
25.2 
104 
334 
734 
1550 
2100 
 
 
 
 
4.34 
10.3 
23.5 
107 
319 
689 
1520 
1890 
8.81E-03 
8.37E-05 
9.939E-01 
 
 
 
 
 
 
 
 
 
 
 
 
12 
5.39 
10.3 
25.1 
97.7 
337 
717 
1550 
2140 
 
 
 
 
4.54 
9.61 
27.6 
97.5 
185 c 
655 
1460 
1930 
8.51E-03 
4.67E-04 
9.957E-01 
 
 
 
 
 
 
 
 
 
 
 
 
13 
5.19 
10.1 
25.7 
102 
378 
717 
1490 
2050 
 
 
 
 
5.03 
9.19 
23.3 
98.2 
335 
710 
1480 
1960 
9.16E-03 
-4.01E-03 
9.978E-01 
 
 
 
 
 
 
 
 
 
 
 
 
14 
4.67 
8.66 
25.9 
90.5 
340 
751 
1550 
2080 
 
 
 
 
5.69 
9.91 
30.1 c 
92.2 
354 
713 
1610 
1970 
8.93E-03 
-2.68E-03 
9.932E-01 
 
 
 
 
 
 
 
 
 
 
 
 
15 
4.56 
10.9 
24.2 
103 
356 
645 
1240 c 
1750 
 
 
 
 
5.17 
9.92 
26.8 
111 
328 
799 
1370 
1970 
9.80E-03 
-4.42E-04 
9.912E-01 
 
 
 
 
 
 
 
 
 
 
 
 
16 
4.89 
9.46 
26.6 
94.3 
373 
735 
1500 
2070 
 
 
 
 
4.99 
11.0 
24.2 
93.7 
346 
677 
1470 
1950 
9.18E-03 
-5.24E-04 
9.968E-01 
 
 
 
 
 
 
 
 
 
 
 
 
a 
= Linear Regression: y = Ax + B where y is the peak area ratio of Tecovirimat to Int. Std., x is the concentration of Tecovirimat, and A and B are regression constants. 
Regression weighted 1/x2. 
b 
= RSQ = R-Squared 
c 
= >15% (± 15% theoretical). Value excluded from regression and summary statistics. 
Continued on next page 
Page 1742


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 42 of 111 
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Table 3-5 
Calibration Curve Data for Tecovirimat in Human K3EDTA Plasma 
 
Nominal Concentrations 
Calibration Curve Parameters 
Batch 
5.00 
10.0 
25.0 
100 
350 
700 
1500 
2000 
 
 
 
Number 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
(ng/mL) 
A a 
B a 
RSQ b 
 
 
 
 
 
 
 
 
 
 
 
 
17 
5.60 
9.57 
27.0 
96.9 
350 
653 
1410 
1910 
 
 
 
 
4.63 
9.31 
24.0 
104 
382 
716 
1520 
2130 
9.02E-03 
2.22E-03 
9.946E-01 
 
 
 
 
 
 
 
 
 
 
 
 
18 
5.44 
10.4 
24.5 
105 
352 
698 
1460 
1980 
 
 
 
 
4.60 
9.48 
24.6 
110 
337 
652 
1510 
2070 
9.91E-03 
-1.58E-03 
9.965E-01 
 
 
 
 
 
 
 
 
 
 
 
 
Mean 
5.03 
9.91 
24.8 
98.9 
351 
711 
1490 
2010 
9.82E-03 
-5.52E-04 
9.957E-01 
S.D. 
0.356 
0.679 
1.24 
4.97 
16.6 
37.0 
64.5 
100 
 
 
 
%CV 
7.1 
6.9 
5.0 
5.0 
4.7 
5.2 
4.3 
5.0 
 
 
 
%Bias 
0.6 
-0.9 
-0.8 
-1.1 
0.3 
1.6 
-0.7 
0.5 
 
 
 
n 
35 
34 
35 
36 
34 
35 
35 
35 
18 
18 
18 
a 
= Linear Regression: y = Ax + B where y is the peak area ratio of Tecovirimat to Int. Std., x is the concentration of Tecovirimat, and A and B are regression constants. 
Regression weighted 1/x2. 
b 
= RSQ = R-Squared 
 
 
Page 1743


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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3.5 
QUALITY CONTROL SAMPLES 
The QC samples were prepared in human plasma, as described in Section 2.3, extracted 
following the test method (TM19-535), and analyzed along with calibration standards. Two-
thirds (66.7%) of all QC samples must be within 15% of their respective nominal values to meet 
acceptance criteria. In addition, no more than one-half of the QC samples at each level may fail 
these criteria (± 15% of nominal). Dilution QC (DQC) samples were also evaluated in each batch 
that included diluted incurred samples. Two-thirds (66.7%) of the DQC samples must be within 
15% of their respective nominal values to meet run acceptance criteria. The QCs and DQC 
sample results are shown in Table 3-6. 
 
Page 1744


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 3-6 
Quality Control Evaluation Data for Tecovirimat in Human Plasma 
 
Nominal Concentration 
 
LQC 
MQC 
HQC 
DQC a 
Batch Number 
(15.0 ng/mL) 
(150 ng/mL) 
(1600 ng/mL) 
(1600 ng/mL) 
 
 
 
 
 
1 
16.2 
155 
1650 
 
 
15.7 
166 
1490 
 
 
 
 
 
 
2 
17.2 
155 
1600 
 
 
16.1 
146 
1570 
 
 
 
 
 
 
3 
14.6 
169 
1660 
 
 
16.4 
155 
1560 
 
 
 
 
 
 
4 
14.8 
165 
1620 
 
 
17.3 b 
166 
1650 
 
 
 
 
 
 
5 
14.0 
155 
1700 
 
 
13.0 
146 
1680 
 
 
 
 
 
 
6 
15.8 
161 
1500 
 
 
15.0 
193 b 
1870 b 
 
 
 
 
 
 
7 
19.9 b 
160 
1750 
 
 
16.8 
154 
1750 
 
 
 
 
 
 
8 
15.3 
161 
1690 
 
 
14.9 
156 
1570 
 
 
 
 
 
 
9 
16.5 
157 
1580 
 
 
14.8 
148 
1430 
 
 
 
 
 
 
10 
16.5 
150 
1710 
 
 
14.9 
146 
1540 
 
 
 
 
 
 
11 
16.9 
159 
1700 
 
 
16.5 
145 
1640 
 
 
 
 
 
 
12 
16.1 
152 
1600 
 
 
18.3 b 
149 
1880 b 
 
 
 
 
 
 
13 
16.5 
144 
1630 
 
 
15.0 
143 
1510 
 
 
 
 
 
 
14 
12.9 
142 
1490 
 
 
15.3 
142 
1770 
 
 
 
 
 
 
a 
= Dilution QCs undiluted concentration 1600 ng/mL; a 5-fold dilution with blank matrix was performed prior to 
extraction and analysis. 
b 
= Value outside of acceptance criteria (± 15% theoretical) but included in summary statistics. 
Continued on next page 
Page 1745


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 45 of 111 
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Table 3-6 
Quality Control Evaluation Data for Tecovirimat in Human Plasma 
 
Nominal Concentration 
 
LQC 
MQC 
HQC 
DQC a 
Batch Number 
(15.0 ng/mL) 
(150 ng/mL) 
(1600 ng/mL) 
(1600 ng/mL) 
 
 
 
 
 
15 
16.7 
205 b 
1600 
1680 
 
13.8 
141 
1700 
1470 
 
 
 
 
1750 
 
 
 
 
 
16 
16.5 
147 
1550 
 
 
15.0 
155 
1590 
 
 
 
 
 
 
17 
15.8 
147 
1530 
 
 
13.2 
162 
1500 
 
 
 
 
 
 
18 
15.8 
149 
1570 
 
 
15.1 
145 
1650 
 
 
 
 
 
 
Mean 
15.7 
155 
1620 
1630 
S.D. 
1.43 
13.3 
103 
146 
%CV 
9.1 
8.6 
6.4 
9.0 
%Bias 
4.7 
3.3 
1.3 
1.9 
n 
36 
36 
36 
3 
a 
= Dilution QCs undiluted concentration 1600 ng/mL; a 5-fold dilution with blank matrix was performed prior to 
extraction and analysis. 
b 
= Value outside of acceptance criteria (± 15% theoretical) but included in summary statistics. 
 
Page 1746


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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3.6 
INCURRED SAMPLE REANALYSIS 
Incurred sample reanalysis (ISR) was performed in batches 16 and 17 for a total of 116 samples. 
Per SOP, two-thirds (66.7%) of the ISR samples must exhibit a percent difference of less than 
20% from their respective original values to meet acceptance criteria using the equation: 
% 𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷𝐷= 100 ൬𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅𝑅 𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶. −𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂𝑂 𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶.
𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀
൰  
The ISR data for tecovirimat is presented in Table 3-7. The results show that 103 of 116 (88.8%) 
ISR samples pass per Alturas Analytics’ SOP AA-312.  
Page 1747


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 3-7 
Incurred Sample Reanalysis Data for Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Original 
Batch 
Number 
Original 
Concentration 
(ng/mL) 
Repeat 
Batch 
Number 
Repeat 
Concentration 
(ng/mL) 
% 
Difference 
Pass/ 
Fail 
 
 
 
 
 
 
 
 
 
9001 
1 
4h 
1 
1100 
16 
1100 
0.0 
Pass 
9001 
6 
4h 
8 
1580 
16 
1660 
4.9 
Pass 
9001 
7 
1h 
9 
345 
17 
394 
13.3 
Pass 
9001 
8 
18h 
12 
1070 
16 
982 
-8.6 
Pass 
9002 
1 
1h 
1 
33.4 
17 
43.0 
25.1 
Fail 
9002 
1 
12h 
1 
216 
16 
231 
6.7 
Pass 
9002 
7 
4h 
9 
1290 
16 
1310 
1.5 
Pass 
9002 
8 
16h 
12 
1140 
16 
1020 
-11.1 
Pass 
9005 
1 
1h 
1 
164 
16 
173 
5.3 
Pass 
9005 
2 
18h 
6 
1190 
16 
1160 
-2.6 
Pass 
9005 
8 
16h 
12 
1660 
16 
1620 
-2.4 
Pass 
9009 
1 
14h 
1 
346 
17 
424 
20.3 
Fail 
9009 
2 
18h 
6 
1520 
16 
842 
-57.4 
Fail 
9009 
7 
6h 
9 
1030 
16 
1200 
15.2 
Pass 
9012 
7 
6h 
9 
1060 
16 
1020 
-3.8 
Pass 
9015 
6 
4h 
8 
1320 
16 
1220 
-7.9 
Pass 
9016 
8 
24h 
12 
1020 
16 
968 
-5.2 
Pass 
9019 
1 
4h 
2 
922 
17 
901 
-2.3 
Pass 
9019 
1 
12h 
2 
271 
16 
229 
-16.8 
Pass 
9019 
2 
24h 
6 
417 
17 
442 
5.8 
Pass 
9019 
8 
16h 
12 
992 
17 
930 
-6.5 
Pass 
9019 
8 
18h 
12 
1020 
16 
959 
-6.2 
Pass 
9019 
8 
24h 
12 
574 
17 
584 
1.7 
Pass 
9020 
1 
4h 
2 
740 
17 
768 
3.7 
Pass 
9020 
1 
8h 
2 
740 
17 
661 
-11.3 
Pass 
9020 
1 
12h 
2 
444 
17 
454 
2.2 
Pass 
9021 
1 
12h 
2 
272 
16 
249 
-8.8 
Pass 
9022 
2 
18h 
6 
632 
17 
713 
12.0 
Pass 
9022 
2 
20h 
6 
637 
17 
643 
0.9 
Pass 
9024 
1 
2h 
2 
251 
16 
209 
-18.3 
Pass 
9024 
1 
14h 
2 
328 
17 
329 
0.3 
Pass 
9025 
1 
14h 
2 
554 
17 
532 
-4.1 
Pass 
9025 
6 
0h 
8 
1200 
16 
1230 
2.5 
Pass 
9025 
6 
4h 
8 
1440 
16 
1420 
-1.4 
Pass 
9033 
1 
1h 
2 
129 
16 
112 
-14.1 
Pass 
9033 
2 
20h 
6 
467 
17 
482 
3.2 
Pass 
9033 
6 
4h 
8 
1590 
16 
900 
-55.4 
Fail 
9043 
2 
20h 
6 
1100 
16 
1150 
4.4 
Pass 
9043 
6 
4h 
8 
1100 
16 
1060 
-3.7 
Pass 
9046 
1 
4h 
3 
1030 
16 
765 
-29.5 
Fail 
9051 
1 
4h 
3 
811 
17 
720 
-11.9 
Pass 
9051 
1 
6h 
3 
232 
16 
253 
8.7 
Pass 
9051 
2 
18h 
6 
475 
17 
477 
0.4 
Pass 
9052 
1 
2h 
3 
256 
16 
248 
-3.2 
Pass 
9052 
2 
16h 
7 
1040 
16 
946 
-9.5 
Pass 
Continued on next page 
Page 1748


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 3-7 
Incurred Sample Reanalysis Data for Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Original 
Batch 
Number 
Original 
Concentration 
(ng/mL) 
Repeat 
Batch 
Number 
Repeat 
Concentration 
(ng/mL) 
% 
Difference 
Pass/ 
Fail 
 
 
 
 
 
 
 
 
 
9052 
2 
18h 
7 
1040 
16 
903 
-14.1 
Pass 
9052 
2 
24h 
7 
705 
17 
694 
-1.6 
Pass 
9052 
6 
0h 
8 
632 
17 
690 
8.8 
Pass 
9052 
6 
4h 
8 
1470 
16 
1440 
-2.1 
Pass 
9052 
7 
6h 
10 
1160 
16 
1130 
-2.6 
Pass 
9052 
7 
8h 
10 
750 
17 
787 
4.8 
Pass 
9056 
1 
1h 
3 
33.0 
17 
31.6 
-4.3 
Pass 
9056 
1 
6h 
3 
519 
17 
500 
-3.7 
Pass 
9056 
7 
0h 
10 
653 
17 
710 
8.4 
Pass 
9056 
7 
6h 
10 
1130 
16 
1230 
8.5 
Pass 
9056 
7 
12h 
10 
1220 
16 
1060 
-14.0 
Pass 
9057 
1 
4h 
3 
489 
17 
487 
-0.4 
Pass 
9057 
6 
0h 
8 
618 
17 
587 
-5.1 
Pass 
9058 
6 
0h 
8 
573 
17 
616 
7.2 
Pass 
9058 
7 
4h 
10 
1470 
16 
1540 
4.7 
Pass 
9061 
1 
8h 
4 
311 
16 
280 
-10.5 
Pass 
9061 
2 
24h 
7 
448 
17 
386 
-14.9 
Pass 
9061 
6 
0h 
8 
415 
17 
450 
8.1 
Pass 
9061 
6 
4h 
8 
1020 
16 
981 
-3.9 
Pass 
9061 
7 
0h 
10 
572 
17 
550 
-3.9 
Pass 
9061 
7 
1h 
10 
413 
17 
424 
2.6 
Pass 
9061 
7 
6h 
10 
1000 
16 
937 
-6.5 
Pass 
9061 
7 
14h 
10 
614 
17 
626 
1.9 
Pass 
9062 
1 
1h 
4 
127 
16 
123 
-3.2 
Pass 
9062 
1 
8h 
4 
232 
16 
169 
-31.4 
Fail 
9062 
2 
16h 
7 
467 
17 
547 
15.8 
Pass 
9062 
6 
4h 
8 
997 
17 
1110 
10.7 
Pass 
9062 
7 
0h 
10 
462 
17 
501 
8.1 
Pass 
9063 
2 
16h 
7 
653 
17 
1010 
42.9 
Fail 
9063 
7 
0.5h 
10 
539 
17 
556 
3.1 
Pass 
9069 
6 
4h 
8 
1220 
16 
739 
-49.1 
Fail 
9069 
7 
4h 
11 
1270 
16 
1200 
-5.7 
Pass 
9069 
7 
6h 
11 
709 
17 
737 
3.9 
Pass 
9073 
1 
1h 
4 
127 
16 
113 
-11.7 
Pass 
9073 
1 
12h 
4 
164 
16 
179 
8.7 
Pass 
9073 
6 
0h 
8 
599 
17 
633 
5.5 
Pass 
9073 
6 
4h 
8 
1290 
16 
1010 
-24.3 
Fail 
9073 
7 
4h 
11 
1300 
16 
1210 
-7.2 
Pass 
9077 
1 
4h 
4 
1310 
16 
1240 
-5.5 
Pass 
9077 
1 
12h 
4 
343 
17 
357 
4.0 
Pass 
9077 
1 
14h 
4 
694 
17 
611 
-12.7 
Pass 
9077 
2 
16h 
7 
1220 
16 
1170 
-4.2 
Pass 
9077 
2 
18h 
7 
1060 
16 
882 
-18.3 
Pass 
9077 
2 
24h 
7 
1170 
16 
733 
-45.9 
Fail 
9077 
6 
0h 
8 
1010 
16 
1030 
2.0 
Pass 
Continued on next page 
Page 1749


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 3-7 
Incurred Sample Reanalysis Data for Tecovirimat in Human Plasma 
Subject 
Day 
Nominal 
Hour 
Nominal 
Original 
Batch 
Number 
Original 
Concentration 
(ng/mL) 
Repeat 
Batch 
Number 
Repeat 
Concentration 
(ng/mL) 
% 
Difference 
Pass/ 
Fail 
 
 
 
 
 
 
 
 
 
9077 
7 
0.5h 
11 
739 
17 
878 
17.2 
Pass 
9077 
7 
1h 
11 
750 
17 
743 
-0.9 
Pass 
9077 
7 
12h 
11 
925 
17 
919 
-0.7 
Pass 
9077 
7 
14h 
11 
1000 
16 
923 
-8.0 
Pass 
9080 
1 
4h 
4 
1130 
16 
1080 
-4.5 
Pass 
9080 
2 
18h 
7 
538 
17 
521 
-3.2 
Pass 
9080 
7 
2h 
11 
474 
17 
486 
2.5 
Pass 
9081 
2 
24h 
7 
340 
17 
361 
6.0 
Pass 
9081 
7 
0h 
11 
491 
17 
541 
9.7 
Pass 
9086 
1 
8h 
5 
154 
16 
133 
-14.6 
Pass 
9086 
7 
0.5h 
11 
230 
16 
281 
20.0 
Pass 
9087 
1 
4h 
5 
1160 
16 
669 
-53.7 
Fail 
9087 
2 
16h 
7 
478 
17 
373 
-24.7 
Fail 
9087 
2 
20h 
7 
704 
17 
682 
-3.2 
Pass 
9087 
7 
1h 
11 
329 
17 
321 
-2.5 
Pass 
9087 
7 
4h 
11 
516 
17 
577 
11.2 
Pass 
9087 
7 
8h 
11 
638 
17 
669 
4.7 
Pass 
9089 
1 
14h 
5 
252 
16 
260 
3.1 
Pass 
9089 
7 
12h 
12 
444 
17 
442 
-0.5 
Pass 
9092 
1 
8h 
5 
217 
16 
234 
7.5 
Pass 
9092 
1 
12h 
5 
160 
16 
161 
0.6 
Pass 
9092 
6 
4h 
9 
1200 
16 
1190 
-0.8 
Pass 
9092 
7 
2h 
12 
1530 
16 
1480 
-3.3 
Pass 
9095 
6 
4h 
9 
1040 
16 
1080 
3.8 
Pass 
9095 
7 
1h 
12 
318 
16 
447 
33.7 
Fail 
9095 
7 
8h 
12 
1030 
16 
989 
-4.1 
Pass 
 
Page 1750


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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4. 
SELECTIVITY 
4.1 
BLANKS 
Double blank and blank + IS samples in human plasma were analyzed in each batch to determine 
if there were any interfering peaks present during chromatographic analysis. For double blank 
samples to be considered acceptable, the analyte peak area must be less than or equal to 20% and 
the IS peak area must be less than or equal to 5% of the mean of the valid LLOQ curve points. 
For blank + IS samples to be considered acceptable, the peak area ratio must be less than or 
equal to 20% of the mean of the valid LLOQ curve points. No substantial interfering peaks were 
observed that eluted at the retention times of tecovirimat or ST-247 in any of the blank plasma 
samples analyzed during valid sample analysis batches; see Table 4-1.  
4.2 
CARRYOVER 
On each day of analysis a double blank sample was injected after a ULOQ point. If the double 
blank sample had an analyte peak area response less than or equal to 20% of the passing LLOQ 
curve point(s), carryover was not considered to be a factor in that day’s analysis and carryover 
factor (COF) was not evaluated. Carryover met acceptance criteria in all batches; see Table 4-2.  
 
Page 1751


 
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Version Date: 23 Jan 2020 
 
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Table 4-1 
Tecovirimat and ST-247 in Double Blank and Blank + IS Samples in Human Plasma 
Batch 
Number 
Analyte Peak Area 
% Analyte 
Peak Area 
IS Peak Area 
%IS Peak 
Area 
Peak Area Ratio 
% Peak 
Area Ratio 
Double 
Blank 
LLOQ 
Curve 
Values 
Double 
Blank 
LLOQ 
Curve 
Values 
Blank + IS 
LLOQ 
Curve 
Values 
1 
8.05E+00 
2.09E+03 
0.4 
1.75E+01 
3.17E+04 
0.1 
4.06E-04 
6.61E-02 
0.6 
2.33E+03 
3.72E+04 
6.27E-02 
2 
6.30E+00 
1.79E+03 
0.3 
8.76E+01 
3.26E+04 
0.3 
0.00E+00 
5.50E-02 
0.0 
1.92E+03 
3.60E+04 
5.34E-02 
3 
1.09E+01 
1.90E+03 
0.6 
4.04E+02 
3.54E+04 
1.1 
4.14E-04 
5.37E-02 
0.8 
1.92E+03 
3.58E+04 
5.37E-02 
4 
5.95E+00 
2.17E+03 
0.3 
1.32E+02 
3.91E+04 
0.3 
3.96E-04 
5.54E-02 
0.7 
2.22E+03 
3.88E+04 
5.71E-02 
5 
2.87E+01 
2.29E+03 
1.2 
9.94E+01 
3.95E+04 
0.3 
1.08E-04 
5.79E-02 
0.2 
2.51E+03 
3.65E+04 
6.86E-02 
6 
8.19E+01 
2.58E+03 
3.3 
8.41E+00 
5.33E+04 
0.0 
2.26E-03 
4.84E-02 
5.1 
2.40E+03 
5.97E+04 
4.03E-02 
7 
2.64E+01 
2.42E+03 
1.1 
4.20E+00 
5.94E+04 
0.0 
2.41E-04 
4.07E-02 
0.6 
-- a 
-- a 
-- a 
8 
1.13E+02 
2.79E+03 
3.7 
4.55E+01 
5.97E+04 
0.1 
8.21E-04 
4.68E-02 
1.6 
3.42E+03 
6.33E+04 
5.39E-02 
9 
3.78E+01 
2.69E+03 
1.4 
1.47E+01 
6.14E+04 
0.0 
8.24E-04 
4.37E-02 
1.8 
2.70E+03 
5.81E+04 
4.65E-02 
10 
3.78E+01 
2.27E+03 
2.0 
1.47E+01 
4.99E+04 
0.0 
7.41E-04 
4.54E-02 
1.6 
1.51E+03 
3.29E+04 
4.59E-02 
11 
1.89E+01 
2.01E+03 
1.2 
2.52E+01 
4.01E+04 
0.1 
9.59E-04 
5.02E-02 
2.2 
1.19E+03 
3.12E+04 
3.83E-02 
12 
1.05E+01 
1.30E+03 
1.0 
1.89E+01 
2.80E+04 
0.1 
2.15E-03 
4.63E-02 
5.0 
8.91E+02 
2.28E+04 
3.91E-02 
13 
2.73E+01 
2.60E+03 
1.3 
1.68E+01 
5.97E+04 
0.0 
1.12E-03 
4.35E-02 
2.6 
1.58E+03 
3.76E+04 
4.21E-02 
a = Only one valid LLOQ curve point obtained for this batch; see Table 3-5 for details. 
Continued on next page 
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Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 4-1 
Tecovirimat and ST-247 in Double Blank and Blank + IS Samples in Human Plasma 
Batch 
Number 
Analyte Peak Area 
% Analyte 
Peak Area 
IS Peak Area 
%IS Peak 
Area 
Peak Area Ratio 
% Peak 
Area Ratio 
Double 
Blank 
LLOQ 
Curve 
Values 
Double 
Blank 
LLOQ 
Curve 
Values 
Blank + IS 
LLOQ 
Curve 
Values 
14 
1.89E+01 
1.39E+03 
1.1 
1.47E+01 
3.55E+04 
0.0 
6.55E-04 
3.91E-02 
1.5 
2.01E+03 
4.17E+04 
4.81E-02 
15 
2.16E+02 
1.55E+03 
13.4 
3.08E+01 
3.49E+04 
0.1 
4.81E-03 
4.43E-02 
10.2 
1.68E+03 
3.34E+04 
5.02E-02 
16 
7.00E-01 
1.83E+03 
0.0 
8.40E+00 
4.12E+04 
0.0 
1.57E-04 
4.44E-02 
0.4 
1.85E+03 
4.09E+04 
4.52E-02 
17 
3.47E+01 
1.88E+03 
2.0 
3.43E+01 
3.56E+04 
0.1 
3.91E-04 
5.28E-02 
0.8 
1.52E+03 
3.45E+04 
4.40E-02 
18 
1.49E+02 
1.74E+03 
9.0 
3.15E+01 
3.33E+04 
0.1 
2.55E-04 
5.23E-02 
0.5 
1.56E+03 
3.55E+04 
4.40E-02 
 
Page 1753


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
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Table 4-2 
Carryover Calculations for Tecovirimat in Human Plasma 
 
LLOQ 
 
Carryover DoubleBlank 
 
 
Batch Number 
Peak 
Area 
 
Peak 
Area 
 
% 
Carryover 
 
 
 
 
 
 
1 
2090 
 
165 
 
7.4 
 
2330 
 
 
 
 
 
 
 
 
 
 
2 
1790 
 
57.4 
 
3.1 
 
1920 
 
 
 
 
 
 
 
 
 
 
3 
1900 
 
121 
 
6.3 
 
1920 
 
 
 
 
 
 
 
 
 
 
4 
2170 
 
95.2 
 
4.3 
 
2220 
 
 
 
 
 
 
 
 
 
 
5 
2290 
 
131 
 
5.5 
 
2510 
 
 
 
 
 
 
 
 
 
 
6 
2580 
 
28.8 
 
1.2 
 
2400 
 
 
 
 
 
 
 
 
 
 
7 
2420 
 
84.8 
 
3.5 
 
-- a 
 
 
 
 
 
 
 
 
 
 
8 
2790 
 
16.8 
 
0.5 
 
3420 
 
 
 
 
 
 
 
 
 
 
9 
2690 
 
28.7 
 
1.1 
 
2700 
 
 
 
 
 
 
 
 
 
 
10 
2270 
 
18.9 
 
1.0 
 
1510 
 
 
 
 
 
 
 
 
 
 
11 
2010 
 
63.0 
 
3.9 
 
1190 
 
 
 
 
 
 
 
 
 
 
12 
1300 
 
66.5 
 
6.1 
 
891 
 
 
 
 
 
 
 
 
 
 
13 
2600 
 
33.6 
 
1.6 
 
1580 
 
 
 
 
 
 
 
 
 
 
14 
1390 
 
12.6 
 
0.7 
 
2010 
 
 
 
 
 
 
 
 
 
 
15 
1550 
 
169 
 
10.5 
 
1680 
 
 
 
 
 
 
 
 
 
 
a 
= Only one valid LLOQ curve point obtained for this batch; see Table 3-5 for details. 
Continued on next page 
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Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
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Table 4-2 
Carryover Calculations for Tecovirimat in Human Plasma 
 
LLOQ 
 
Carryover DoubleBlank 
 
 
Batch Number 
Peak 
Area 
 
Peak 
Area 
 
% 
Carryover 
16 
1830 
 
180 
 
9.8 
 
1850 
 
 
 
 
 
 
 
 
 
 
17 
1880 
 
151 
 
8.9 
 
1520 
 
 
 
 
 
 
 
 
 
 
18 
1740 
 
218 
 
13.2 
 
1560 
 
 
 
 
 
 
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5. 
CONCLUSION 
The calibration curves and QC sample data from the reported batches indicate that the method 
met the acceptance criteria for these batches. 
6. 
ARCHIVAL 
All raw data, documentation, records and a signed copy of the final report are archived at Alturas 
Analytics, Inc. for a period of at least five years in accordance with Alturas’ SOPs.  
7. 
STUDY DEVIATIONS 
No deviations were noted in this study. 
8. 
COMPUTER SYSTEMS 
All data were acquired using Analyst version 1.6 or higher and all calculations were performed 
with Watson version 7.5 SP1 or higher and Microsoft Excel 2010. Per Alturas Analytics’ SOP 
AA-217, three significant figures are reported for all concentrations and percentages are reported 
to one decimal place. 
9. 
REFERENCES 
1. Alturas Analytics, Inc. Validation Study: AV15-ST246-03 Addendum 2, “Addendum 
2 to HPLC/MS/MS Assay Validation for the Determination of ST-246, M4, M5, and 
TFMBA from Human Plasma.” 
2. Alturas Analytics, Inc. Validation Study: AV15-ST246-03, “ Addendum 3 to 
HPLC/MS/MS Assay Validation for the Determination of ST-246, M4, M5, and 
TFMBA from Human Plasma.”  
3. Food and Drug Administration. Guidance for Industry: Bioanalytical Method 
Validation. Silver Spring, MD: US Department of Health and Human Services, FDA, 
Center for Drug Evaluation and Research; 2018. 
10. 
APPENDICES 
Page 1756


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 56 of 111 
Confidential 
 
 
 
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10.1 CERTIFICATES OF ANALYSIS 
 
Page 1757


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 57 of 111 
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Page 1758


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 58 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Page 1759


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 59 of 111 
Confidential 
 
 
 
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Note: Spectral data on file at Alturas Analytics, Inc. 
Page 1760


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 60 of 111 
Confidential 
 
 
 
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10.2 REPRESENTATIVE CHROMATOGRAMS 
Representative chromatograms are attached below from batch 4 for tecovirimat in human 
K3DTA plasma. Attached are the blanks, standards, QCs, and 63 incurred sample 
chromatograms; which is greater than 5% of the total samples analyzed for this study. Study 
samples are named using the naming convention below: 
 
4 
019 
SIGA-246-022 
085P813 
9061 
A 
Day 1 0h 
PLM-1 
1 
 
 
 
 
 
 
 
 
 
Batch 
Number 
Sample 
Number 
Study Number 
Custom 
ID 
Subject 
Treatment 
ID 
Time 
Matrix-
Replicate 
Dilution 
Factor 
 
 
Page 1761


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 61 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Created with Analyst Reporter 
 
 
Batch 4: Tecovirimat (ST-246) in Human K3EDTA Plasma  
Data File Name 
SIGA-246-022\B4.wiff 
Result Table 
SIGA-246-022_B4.rdb 
Acquisition Method 
ST-246_HumanK3.dam 
Algorithm Used 
MQL 
Project 
AlturasData\SIG 
Instrument Name 
API 4000 
  
Sample Name: 
4 005 SIGA-246-022 Double Blank 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 10:09:09 AM 
Sample Type: 
Quality Control 
Vial Position: 
5 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
5.950000067e+000 
1.323716667e+002 
Peak Area Ratio: 
 
4.49e-002 
 
 
Sample Name: 
4 006 SIGA-246-022 Blank IS 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 10:14:43 AM 
Sample Type: 
Quality Control 
Vial Position: 
6 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.610000007e+001 
4.063853514e+004 
Peak Area Ratio: 
 
3.96e-004 
 
 
 
 
Page 1762


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 62 of 111 
Confidential 
 
 
 
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Sample Name: 
4 007 SIGA-246-022 STD 1 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 10:20:17 AM 
Sample Type: 
Standard 
Vial Position: 
7 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.166140001e+003 
3.911700295e+004 
Peak Area Ratio: 
 
5.54e-002 
 
 
Sample Name: 
4 008 SIGA-246-022 STD 2 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 10:25:50 AM 
Sample Type: 
Standard 
Vial Position: 
8 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.416379997e+003 
4.062092150e+004 
Peak Area Ratio: 
 
1.09e-001 
 
 
Sample Name: 
4 009 SIGA-246-022 LQC 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 10:31:24 AM 
Sample Type: 
Quality Control 
Vial Position: 
9 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
6.338338337e+003 
3.839296556e+004 
Peak Area Ratio: 
 
1.65e-001 
 
Page 1763


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 63 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 010 SIGA-246-022 STD 3 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 10:36:57 AM 
Sample Type: 
Standard 
Vial Position: 
10 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.132302833e+004 
4.001269170e+004 
Peak Area Ratio: 
 
2.83e-001 
 
 
Sample Name: 
4 011 SIGA-246-022 STD 4 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 10:42:29 AM 
Sample Type: 
Standard 
Vial Position: 
11 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.225579169e+004 
3.989837236e+004 
Peak Area Ratio: 
 
1.06e+000 
 
 
Sample Name: 
4 012 SIGA-246-022 MQC 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 10:48:02 AM 
Sample Type: 
Quality Control 
Vial Position: 
12 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
6.966962328e+004 
3.809022073e+004 
Peak Area Ratio: 
 
1.83e+000 
 
Page 1764


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 64 of 111 
Confidential 
 
 
 
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Sample Name: 
4 013 SIGA-246-022 STD 5 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 10:53:35 AM 
Sample Type: 
Standard 
Vial Position: 
13 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.120005999e+005 
3.762778318e+004 
Peak Area Ratio: 
 
5.63e+000 
 
 
Sample Name: 
4 014 SIGA-246-022 STD 6 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 10:59:10 AM 
Sample Type: 
Standard 
Vial Position: 
14 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.911011198e+005 
3.928978321e+004 
Peak Area Ratio: 
 
7.41e+000 
 
 
Sample Name: 
4 015 SIGA-246-022 HQC 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 11:04:44 AM 
Sample Type: 
Quality Control 
Vial Position: 
15 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
6.319176504e+005 
3.526737816e+004 
Peak Area Ratio: 
 
1.79e+001 
 
Page 1765


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 65 of 111 
Confidential 
 
 
 
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Sample Name: 
4 016 SIGA-246-022 STD 7 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 11:10:17 AM 
Sample Type: 
Standard 
Vial Position: 
16 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
6.523013345e+005 
3.918546228e+004 
Peak Area Ratio: 
 
1.66e+001 
 
 
Sample Name: 
4 017 SIGA-246-022 STD 8 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 11:15:51 AM 
Sample Type: 
Standard 
Vial Position: 
17 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
8.255530467e+005 
3.889533000e+004 
Peak Area Ratio: 
 
2.12e+001 
 
 
Sample Name: 
4 018 SIGA-246-022 CO DB 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 11:21:24 AM 
Sample Type: 
Quality Control 
Vial Position: 
18 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
9.520000160e+001 
5.950333361e+001 
Peak Area Ratio: 
 
1.60e+000 
 
Page 1766


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 66 of 111 
Confidential 
 
 
 
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Sample Name: 
4 019 SIGA-246-022 085P813 9061 A Day 1 0h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 11:26:58 AM 
Sample Type: 
Unknown 
Vial Position: 
19 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.120000021e+001 
3.768111551e+004 
Peak Area Ratio: 
 
2.97e-004 
 
 
Sample Name: 
4 020 SIGA-246-022 085P814 9061 A Day 1 0.5h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 11:32:33 AM 
Sample Type: 
Unknown 
Vial Position: 
20 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.531200003e+003 
3.884336603e+004 
Peak Area Ratio: 
 
6.52e-002 
 
 
Sample Name: 
4 021 SIGA-246-022 085P815 9061 A Day 1 1h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 11:38:07 AM 
Sample Type: 
Unknown 
Vial Position: 
21 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.237124034e+005 
3.869524475e+004 
Peak Area Ratio: 
 
3.20e+000 
 
Page 1767


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 67 of 111 
Confidential 
 
 
 
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Sample Name: 
4 022 SIGA-246-022 085P816 9061 A Day 1 2h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 11:43:40 AM 
Sample Type: 
Unknown 
Vial Position: 
22 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.073956565e+005 
3.910999266e+004 
Peak Area Ratio: 
 
1.04e+001 
 
 
Sample Name: 
4 023 SIGA-246-022 085P817 9061 A Day 1 4h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 11:49:14 AM 
Sample Type: 
Unknown 
Vial Position: 
23 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.153275002e+005 
3.885607379e+004 
Peak Area Ratio: 
 
1.07e+001 
 
 
Sample Name: 
4 024 SIGA-246-022 085P818 9061 A Day 1 6h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 11:54:48 AM 
Sample Type: 
Unknown 
Vial Position: 
24 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.876873751e+005 
3.847659143e+004 
Peak Area Ratio: 
 
4.88e+000 
 
Page 1768


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 68 of 111 
Confidential 
 
 
 
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Sample Name: 
4 025 SIGA-246-022 085P819 9061 A Day 1 8h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:00:21 PM 
Sample Type: 
Unknown 
Vial Position: 
25 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.216227883e+005 
3.532737671e+004 
Peak Area Ratio: 
 
3.44e+000 
 
 
Sample Name: 
4 026 SIGA-246-022 085P820 9061 A Day 1 12h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:05:55 PM 
Sample Type: 
Unknown 
Vial Position: 
26 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.248485251e+005 
3.468694154e+004 
Peak Area Ratio: 
 
3.60e+000 
 
 
Sample Name: 
4 027 SIGA-246-022 085P821 9061 A Day 1 14h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:11:31 PM 
Sample Type: 
Unknown 
Vial Position: 
27 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
3.309478300e+005 
4.006866606e+004 
Peak Area Ratio: 
 
8.26e+000 
 
Page 1769


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 69 of 111 
Confidential 
 
 
 
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Sample Name: 
4 028 SIGA-246-022 085P610 9062 A Day 1 0h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:17:06 PM 
Sample Type: 
Unknown 
Vial Position: 
28 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.586666667e+001 
3.606442810e+004 
Peak Area Ratio: 
 
1.27e-003 
 
 
Sample Name: 
4 029 SIGA-246-022 085P611 9062 A Day 1 0.5h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:22:39 PM 
Sample Type: 
Unknown 
Vial Position: 
29 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
5.751781669e+003 
3.611766623e+004 
Peak Area Ratio: 
 
1.59e-001 
 
 
Sample Name: 
4 030 SIGA-246-022 085P612 9062 A Day 1 1h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:28:13 PM 
Sample Type: 
Unknown 
Vial Position: 
30 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.961209000e+004 
3.514948914e+004 
Peak Area Ratio: 
 
1.41e+000 
 
Page 1770


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 70 of 111 
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Sample Name: 
4 031 SIGA-246-022 085P613 9062 A Day 1 2h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:33:48 PM 
Sample Type: 
Unknown 
Vial Position: 
31 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.456151068e+005 
3.640597137e+004 
Peak Area Ratio: 
 
6.75e+000 
 
 
Sample Name: 
4 032 SIGA-246-022 085P614 9062 A Day 1 4h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:39:24 PM 
Sample Type: 
Unknown 
Vial Position: 
32 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
3.088776431e+005 
4.785036711e+004 
Peak Area Ratio: 
 
6.46e+000 
 
 
Sample Name: 
4 033 SIGA-246-022 085P615 9062 A Day 1 6h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:44:57 PM 
Sample Type: 
Unknown 
Vial Position: 
33 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.755102501e+005 
4.307469823e+004 
Peak Area Ratio: 
 
4.07e+000 
 
Page 1771


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 71 of 111 
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Sample Name: 
4 034 SIGA-246-022 085P616 9062 A Day 1 8h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:50:31 PM 
Sample Type: 
Unknown 
Vial Position: 
34 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
9.641593839e+004 
3.754572217e+004 
Peak Area Ratio: 
 
2.57e+000 
 
 
Sample Name: 
4 035 SIGA-246-022 085P617 9062 A Day 1 12h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 12:56:05 PM 
Sample Type: 
Unknown 
Vial Position: 
35 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
7.025529495e+004 
4.033016607e+004 
Peak Area Ratio: 
 
1.74e+000 
 
 
Sample Name: 
4 036 SIGA-246-022 LQC 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:01:38 PM 
Sample Type: 
Quality Control 
Vial Position: 
36 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
7.604598334e+003 
3.939302108e+004 
Peak Area Ratio: 
 
1.93e-001 
 
Page 1772


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 72 of 111 
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Sample Name: 
4 037 SIGA-246-022 085P618 9062 A Day 1 14h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:07:13 PM 
Sample Type: 
Unknown 
Vial Position: 
37 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.006860800e+005 
3.704987913e+004 
Peak Area Ratio: 
 
2.72e+000 
 
 
Sample Name: 
4 038 SIGA-246-022 085P639 9063 A Day 1 0h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:12:47 PM 
Sample Type: 
Unknown 
Vial Position: 
38 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
8.369833373e+001 
3.605918192e+004 
Peak Area Ratio: 
 
2.32e-003 
 
 
Sample Name: 
4 039 SIGA-246-022 085P640 9063 A Day 1 0.5h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:18:23 PM 
Sample Type: 
Unknown 
Vial Position: 
39 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.109446668e+003 
3.600564543e+004 
Peak Area Ratio: 
 
1.14e-001 
 
Page 1773


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 73 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 040 SIGA-246-022 085P641 9063 A Day 1 1h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:23:57 PM 
Sample Type: 
Unknown 
Vial Position: 
40 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.844668501e+004 
4.031398692e+004 
Peak Area Ratio: 
 
4.58e-001 
 
 
Sample Name: 
4 041 SIGA-246-022 085P642 9063 A Day 1 2h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:29:32 PM 
Sample Type: 
Unknown 
Vial Position: 
41 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.925715284e+005 
3.822959459e+004 
Peak Area Ratio: 
 
5.04e+000 
 
 
Sample Name: 
4 042 SIGA-246-022 085P643 9063 A Day 1 4h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:35:06 PM 
Sample Type: 
Unknown 
Vial Position: 
42 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
3.335186215e+005 
3.947829538e+004 
Peak Area Ratio: 
 
8.45e+000 
 
Page 1774


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 74 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 043 SIGA-246-022 085P644 9063 A Day 1 6h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:40:41 PM 
Sample Type: 
Unknown 
Vial Position: 
43 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.290863519e+005 
3.617875974e+004 
Peak Area Ratio: 
 
6.33e+000 
 
 
Sample Name: 
4 044 SIGA-246-022 085P645 9063 A Day 1 8h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:46:15 PM 
Sample Type: 
Unknown 
Vial Position: 
44 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.471833100e+005 
3.480711329e+004 
Peak Area Ratio: 
 
4.23e+000 
 
 
Sample Name: 
4 045 SIGA-246-022 085P646 9063 A Day 1 12h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:51:50 PM 
Sample Type: 
Unknown 
Vial Position: 
45 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
6.700168661e+004 
3.559079725e+004 
Peak Area Ratio: 
 
1.88e+000 
 
Page 1775


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 75 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 046 SIGA-246-022 085P647 9063 A Day 1 14h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 1:57:24 PM 
Sample Type: 
Unknown 
Vial Position: 
46 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
7.855134838e+004 
3.547585935e+004 
Peak Area Ratio: 
 
2.21e+000 
 
 
Sample Name: 
4 047 SIGA-246-022 085P842 9069 A Day 1 0h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:02:59 PM 
Sample Type: 
Unknown 
Vial Position: 
47 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.832833333e+001 
3.488228477e+004 
Peak Area Ratio: 
 
1.39e-003 
 
 
Sample Name: 
4 048 SIGA-246-022 085P843 9069 A Day 1 0.5h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:08:33 PM 
Sample Type: 
Unknown 
Vial Position: 
48 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.918731668e+004 
3.591772033e+004 
Peak Area Ratio: 
 
8.13e-001 
 
Page 1776


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 76 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 049 SIGA-246-022 085P844 9069 A Day 1 1h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:14:07 PM 
Sample Type: 
Unknown 
Vial Position: 
49 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.137511331e+004 
3.652477776e+004 
Peak Area Ratio: 
 
1.13e+000 
 
 
Sample Name: 
4 050 SIGA-246-022 085P845 9069 A Day 1 2h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:19:43 PM 
Sample Type: 
Unknown 
Vial Position: 
50 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.296332667e+005 
3.861520049e+004 
Peak Area Ratio: 
 
5.95e+000 
 
 
Sample Name: 
4 051 SIGA-246-022 085P846 9069 A Day 1 4h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:25:19 PM 
Sample Type: 
Unknown 
Vial Position: 
51 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
3.977427667e+005 
3.752370236e+004 
Peak Area Ratio: 
 
1.06e+001 
 
Page 1777


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 77 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 052 SIGA-246-022 085P847 9069 A Day 1 6h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:30:54 PM 
Sample Type: 
Unknown 
Vial Position: 
52 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.686776399e+005 
3.790002763e+004 
Peak Area Ratio: 
 
4.45e+000 
 
 
Sample Name: 
4 053 SIGA-246-022 085P848 9069 A Day 1 8h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:36:28 PM 
Sample Type: 
Unknown 
Vial Position: 
53 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.340991849e+005 
3.656885932e+004 
Peak Area Ratio: 
 
3.67e+000 
 
 
Sample Name: 
4 054 SIGA-246-022 085P849 9069 A Day 1 12h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:42:02 PM 
Sample Type: 
Unknown 
Vial Position: 
54 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.179335049e+005 
3.757019363e+004 
Peak Area Ratio: 
 
3.14e+000 
 
Page 1778


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 78 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 055 SIGA-246-022 085P850 9069 A Day 1 14h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:47:37 PM 
Sample Type: 
Unknown 
Vial Position: 
55 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.591802699e+005 
3.721035231e+004 
Peak Area Ratio: 
 
6.97e+000 
 
 
Sample Name: 
4 056 SIGA-246-022 085P1074 9073 A Day 1 0h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:53:11 PM 
Sample Type: 
Unknown 
Vial Position: 
56 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.134216667e+002 
3.537143364e+004 
Peak Area Ratio: 
 
3.21e-003 
 
 
Sample Name: 
4 057 SIGA-246-022 085P1075 9073 A Day 1 0.5h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 2:58:45 PM 
Sample Type: 
Unknown 
Vial Position: 
57 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.724604997e+003 
3.803520460e+004 
Peak Area Ratio: 
 
1.24e-001 
 
Page 1779


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 79 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 058 SIGA-246-022 085P1076 9073 A Day 1 1h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 3:04:21 PM 
Sample Type: 
Unknown 
Vial Position: 
58 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
5.117486667e+004 
3.643881337e+004 
Peak Area Ratio: 
 
1.40e+000 
 
 
Sample Name: 
4 059 SIGA-246-022 085P1077 9073 A Day 1 2h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 3:09:55 PM 
Sample Type: 
Unknown 
Vial Position: 
59 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.972803167e+005 
3.819240643e+004 
Peak Area Ratio: 
 
7.78e+000 
 
 
Sample Name: 
4 060 SIGA-246-022 MQC 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 3:15:29 PM 
Sample Type: 
Quality Control 
Vial Position: 
60 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
6.558146503e+004 
3.572575014e+004 
Peak Area Ratio: 
 
1.84e+000 
 
Page 1780


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 80 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 061 SIGA-246-022 085P1078 9073 A Day 1 4h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 3:21:03 PM 
Sample Type: 
Unknown 
Vial Position: 
61 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.971708948e+005 
4.258752647e+004 
Peak Area Ratio: 
 
6.98e+000 
 
 
Sample Name: 
4 062 SIGA-246-022 085P1079 9073 A Day 1 6h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 3:26:39 PM 
Sample Type: 
Unknown 
Vial Position: 
62 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.034520250e+005 
3.934318951e+004 
Peak Area Ratio: 
 
2.63e+000 
 
 
Sample Name: 
4 063 SIGA-246-022 085P1080 9073 A Day 1 8h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 3:32:15 PM 
Sample Type: 
Unknown 
Vial Position: 
63 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
9.278530662e+004 
3.721049632e+004 
Peak Area Ratio: 
 
2.49e+000 
 
Page 1781


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 81 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 064 SIGA-246-022 085P1081 9073 A Day 1 12h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 3:37:52 PM 
Sample Type: 
Unknown 
Vial Position: 
64 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
7.400845000e+004 
4.079889549e+004 
Peak Area Ratio: 
 
1.81e+000 
 
 
Sample Name: 
4 065 SIGA-246-022 085P1082 9073 A Day 1 14h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 3:43:28 PM 
Sample Type: 
Unknown 
Vial Position: 
65 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
9.113383995e+004 
3.959656240e+004 
Peak Area Ratio: 
 
2.30e+000 
 
 
Sample Name: 
4 066 SIGA-246-022 085P900 9077 A Day 1 0h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 3:49:03 PM 
Sample Type: 
Unknown 
Vial Position: 
66 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.940000000e+001 
3.636300060e+004 
Peak Area Ratio: 
 
8.09e-004 
 
Page 1782


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 82 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 067 SIGA-246-022 085P901 9077 A Day 1 0.5h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 3:54:39 PM 
Sample Type: 
Unknown 
Vial Position: 
67 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.894755001e+003 
3.483029373e+004 
Peak Area Ratio: 
 
5.44e-002 
 
 
Sample Name: 
4 068 SIGA-246-022 085P902 9077 A Day 1 1h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:00:14 PM 
Sample Type: 
Unknown 
Vial Position: 
68 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
6.503456667e+003 
3.842387262e+004 
Peak Area Ratio: 
 
1.69e-001 
 
 
Sample Name: 
4 069 SIGA-246-022 085P903 9077 A Day 1 2h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:05:49 PM 
Sample Type: 
Unknown 
Vial Position: 
69 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.458644166e+005 
3.784173399e+004 
Peak Area Ratio: 
 
6.50e+000 
 
Page 1783


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 83 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 070 SIGA-246-022 085P904 9077 A Day 1 4h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:11:25 PM 
Sample Type: 
Unknown 
Vial Position: 
70 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
5.516544900e+005 
3.787288527e+004 
Peak Area Ratio: 
 
1.46e+001 
 
 
Sample Name: 
4 071 SIGA-246-022 085P905 9077 A Day 1 6h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:16:59 PM 
Sample Type: 
Unknown 
Vial Position: 
71 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
3.415605450e+005 
3.806382614e+004 
Peak Area Ratio: 
 
8.97e+000 
 
 
Sample Name: 
4 072 SIGA-246-022 085P906 9077 A Day 1 8h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:22:35 PM 
Sample Type: 
Unknown 
Vial Position: 
72 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.957541650e+005 
4.055055676e+004 
Peak Area Ratio: 
 
4.83e+000 
 
Page 1784


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 84 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 073 SIGA-246-022 085P907 9077 A Day 1 12h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:28:08 PM 
Sample Type: 
Unknown 
Vial Position: 
73 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.471745749e+005 
3.876759627e+004 
Peak Area Ratio: 
 
3.80e+000 
 
 
Sample Name: 
4 074 SIGA-246-022 085P908 9077 A Day 1 14h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:33:44 PM 
Sample Type: 
Unknown 
Vial Position: 
74 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.775353701e+005 
3.611305380e+004 
Peak Area Ratio: 
 
7.69e+000 
 
 
Sample Name: 
4 075 SIGA-246-022 085P987 9080 A Day 1 0h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:39:19 PM 
Sample Type: 
Unknown 
Vial Position: 
75 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.312333340e+001 
3.457199217e+004 
Peak Area Ratio: 
 
6.69e-004 
 
Page 1785


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 85 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 076 SIGA-246-022 085P988 9080 A Day 1 0.5h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:44:54 PM 
Sample Type: 
Unknown 
Vial Position: 
76 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.251326668e+003 
3.752265723e+004 
Peak Area Ratio: 
 
6.00e-002 
 
 
Sample Name: 
4 077 SIGA-246-022 085P989 9080 A Day 1 1h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:50:29 PM 
Sample Type: 
Unknown 
Vial Position: 
77 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
3.148960668e+004 
3.777033985e+004 
Peak Area Ratio: 
 
8.34e-001 
 
 
Sample Name: 
4 078 SIGA-246-022 085P990 9080 A Day 1 2h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 4:56:05 PM 
Sample Type: 
Unknown 
Vial Position: 
78 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.823766151e+005 
3.628993765e+004 
Peak Area Ratio: 
 
5.03e+000 
 
Page 1786


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 86 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 079 SIGA-246-022 085P991 9080 A Day 1 4h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:01:41 PM 
Sample Type: 
Unknown 
Vial Position: 
79 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.745769752e+005 
3.775839848e+004 
Peak Area Ratio: 
 
1.26e+001 
 
 
Sample Name: 
4 080 SIGA-246-022 085P992 9080 A Day 1 6h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:07:16 PM 
Sample Type: 
Unknown 
Vial Position: 
80 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
3.266823899e+005 
3.826602633e+004 
Peak Area Ratio: 
 
8.54e+000 
 
 
Sample Name: 
4 081 SIGA-246-022 085P993 9080 A Day 1 8h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:12:51 PM 
Sample Type: 
Unknown 
Vial Position: 
81 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.998243618e+005 
3.653195906e+004 
Peak Area Ratio: 
 
5.47e+000 
 
Page 1787


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 87 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Sample Name: 
4 082 SIGA-246-022 085P994 9080 A Day 1 12h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:18:26 PM 
Sample Type: 
Unknown 
Vial Position: 
82 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.626782367e+005 
3.604838926e+004 
Peak Area Ratio: 
 
4.51e+000 
 
 
Sample Name: 
4 083 SIGA-246-022 085P995 9080 A Day 1 14h PLM-1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:24:01 PM 
Sample Type: 
Unknown 
Vial Position: 
83 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.116766083e+005 
3.746519073e+004 
Peak Area Ratio: 
 
2.98e+000 
 
 
Sample Name: 
4 084 SIGA-246-022 STD 1 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:29:36 PM 
Sample Type: 
Standard 
Vial Position: 
84 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
2.217508335e+003 
3.884335182e+004 
Peak Area Ratio: 
 
5.71e-002 
 
Page 1788


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 88 of 111 
Confidential 
 
 
 
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Sample Name: 
4 085 SIGA-246-022 STD 2 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:35:12 PM 
Sample Type: 
Standard 
Vial Position: 
85 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.573671667e+003 
3.845554726e+004 
Peak Area Ratio: 
 
1.19e-001 
 
 
Sample Name: 
4 086 SIGA-246-022 STD 3 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:40:48 PM 
Sample Type: 
Standard 
Vial Position: 
86 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.042824833e+004 
3.835186891e+004 
Peak Area Ratio: 
 
2.72e-001 
 
 
Sample Name: 
4 087 SIGA-246-022 STD 4 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:46:23 PM 
Sample Type: 
Standard 
Vial Position: 
87 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
4.189984000e+004 
3.742295120e+004 
Peak Area Ratio: 
 
1.12e+000 
 
Page 1789


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 89 of 111 
Confidential 
 
 
 
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Sample Name: 
4 088 SIGA-246-022 STD 5 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:51:59 PM 
Sample Type: 
Standard 
Vial Position: 
88 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.458986568e+005 
3.873508647e+004 
Peak Area Ratio: 
 
3.77e+000 
 
 
Sample Name: 
4 089 SIGA-246-022 STD 6 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 5:57:35 PM 
Sample Type: 
Standard 
Vial Position: 
89 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
3.167247083e+005 
3.670101155e+004 
Peak Area Ratio: 
 
8.63e+000 
 
 
Sample Name: 
4 090 SIGA-246-022 HQC 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 6:03:10 PM 
Sample Type: 
Quality Control 
Vial Position: 
90 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
6.723723519e+005 
3.673728653e+004 
Peak Area Ratio: 
 
1.83e+001 
 
Page 1790


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 90 of 111 
Confidential 
 
 
 
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Sample Name: 
4 091 SIGA-246-022 STD 7 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 6:08:46 PM 
Sample Type: 
Standard 
Vial Position: 
96 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
6.040107321e+005 
3.844461207e+004 
Peak Area Ratio: 
 
1.57e+001 
 
 
Sample Name: 
4 092 SIGA-246-022 STD 8 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 6:14:20 PM 
Sample Type: 
Standard 
Vial Position: 
92 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
8.259638162e+005 
3.459333597e+004 
Peak Area Ratio: 
 
2.39e+001 
 
 
Sample Name: 
4 093 SIGA-246-022 CO IS 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 6:19:56 PM 
Sample Type: 
Quality Control 
Vial Position: 
93 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
8.683666699e+001 
3.800304029e+004 
Peak Area Ratio: 
 
2.28e-003 
 
Page 1791


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 91 of 111 
Confidential 
 
 
 
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Sample Name: 
4 094 SIGA-246-022 CO ULOQ 1 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 6:25:31 PM 
Sample Type: 
Quality Control 
Vial Position: 
94 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
8.251205287e+005 
3.743170918e+004 
Peak Area Ratio: 
 
2.20e+001 
 
 
Sample Name: 
4 095 SIGA-246-022 CO IS 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 6:31:07 PM 
Sample Type: 
Quality Control 
Vial Position: 
95 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.295850009e+002 
3.885117241e+004 
Peak Area Ratio: 
 
3.34e-003 
 
 
Sample Name: 
4 096 SIGA-246-022 CO ULOQ 2 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 6:36:44 PM 
Sample Type: 
Quality Control 
Vial Position: 
94 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
7.508229683e+005 
3.612323521e+004 
Peak Area Ratio: 
 
2.08e+001 
 
Page 1792


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 92 of 111 
Confidential 
 
 
 
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Sample Name: 
4 097 SIGA-246-022 CO IS 3 1 
Plate Number: 
7 
Acquisition Date: 
11/16/2019 6:42:18 PM 
Sample Type: 
Quality Control 
Vial Position: 
95 
 
Analyte: 
 
IS: 
ST-246 
ST-247 
Analyte Masses: 
IS Masses: 
375.300/283.300 Da 
379.000/287.100 Da 
Analyte Peak Area: 
IS Peak Area: 
1.137500008e+002 
3.864026632e+004 
Peak Area Ratio: 
 
2.94e-003 
 
 
 
Page 1793


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 93 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
10.3 TEST METHOD 
 
 
Page 1794


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 94 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Page 1795


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 95 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Page 1796


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 96 of 111 
Confidential 
 
 
 
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Page 1797


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 97 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
 
Page 1798


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 98 of 111 
Confidential 
 
 
 
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Page 1799


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 99 of 111 
Confidential 
 
 
 
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Page 1800


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 100 of 111 
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Page 1801


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 101 of 111 
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Page 1802


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 102 of 111 
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Page 1803


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 103 of 111 
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Page 1804


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 104 of 111 
Confidential 
 
 
 
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Page 1805


 
Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 105 of 111 
Confidential 
 
 
 
1324 Alturas Drive | Moscow ID 83843 | 208.883.3400 | www.alturasanalytics.com 
10.4 BIOANALYTICAL SAMPLE ANALYSIS PLAN 
 
 
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Alturas Report Number: AD19-982 
 
Study Number: SIGA-246-022 
 
Version Date: 23 Jan 2020 
 
Status: Final 
 
 
Page 106 of 111 
Confidential 
 
 
 
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Alturas Report Number: AD19-982 
Study Number: SIGA-246-022 
Version Date: 23 Jan 2020 
Status: Final 
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Alturas Report Number: AD19-982 
Study Number: SIGA-246-022 
Version Date: 23 Jan 2020 
Status: Final 
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Alturas Report Number: AD19-982 
Study Number: SIGA-246-022 
Version Date: 23 Jan 2020 
Status: Final 
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Alturas Report Number: AD19-982 
Study Number: SIGA-246-022 
Version Date: 23 Jan 2020 
Status: Final 
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Alturas Report Number: AD19-982 
Study Number: SIGA-246-022 
Version Date: 23 Jan 2020 
Status: Final 
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Page 1812