Conditions: Community-acquired Pneumonia
Keywords: Recombinant human plasma gelsolin (rhu-pGSN) Severe community-acquired pneumonia (sCAP) Adjunctive therapy
Allocation: RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 33
Healthy volunteers: no

Brief summary:
A Phase 1b/2a, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Plasma gelsolin (rhu-pGSN) Added to Standard of Care in Subjects Hospitalized for Acute Community-acquired Pneumonia (CAP)

Detailed description:
A total of 32 patients hospitalized with CAP will be randomized sequentially into 4 ascending dosing levels. Each dosing cohort will include 8 subjects randomized 3:1 rhu-pGSN:placebo (6 rhu-pGSN subjects:2 placebo subjects). Patient, caregiver, and sponsor will be blinded to treatment. An unblinded pharmacist will prepare the infusion, but otherwise have no contact with subject.

Dose will be based on actual body weight. Dose escalation will involve 3 dose levels of rhu-pGSN (6, 12, and 24 mg/kg) in patients admitted for CAP. Dose escalation will only occur after post-therapy safety information on all subjects in the prior cohort has been reviewed at Day 7 for the single-dose \[SD\] and multiple-ascending dose \[MAD\] arms. The MAD portion of the study will commence once single doses of 6 mg/kg of rhu-pGSN are shown to be acceptably safe. The first 2 doses must be administered in the hospital, but the third dose can be given in a monitored outpatient setting where appropriate. Discharged subjects will return for follow-up 7 days after the initiation of therapy (Day 7) and on Day 28 for the End-of-Study Visit.

To assess safety and tolerability starting at the initiation of study therapy, subjects will undergo physical examinations (PE; including vital sign measurements), adverse event (AE) assessments, concomitant medication assessments, safety laboratory testing, and electrocardiograms (EKG) completed locally, and other testing as per local custom.

Once informed consent is obtained, the following procedures will be performed:

1. Randomize to currently enrolling treatment arm.
2. Perform PE and document radiographic evidence of pneumonia if not previously completed in preceding 36 hours; calculate Confusion, Urea \>7 mmol/L, Respiratory rate ≥30/min, Blood pressure systolic \<90 or diastolic ≤60, and age ≥65 years (CURB-65), Sequential Organ Failure Assessment (SOFA), and Pneumonia Severity Index (PSI) scores.
3. Obtain blood and sputum cultures, routine/standard labs, and EKG per standard of care (SOC) (if not already performed). The microbiology lab is encouraged to also perform sputum Gram-stains, antigen detection, immunoassay, and genomic diagnostic tests when available.
4. Draw blood for baseline pGSN levels, C-reactive protein (CRP), procalcitonin level, and 10 ml aliquot to be frozen for subsequent biomarker assays.

Screening laboratory and other tests can serve as baseline values for participants (no need to repeat lab tests at entry if done within the prior 36 hours unless dictated by SOC).

Obtain repeat chest x-rays (CXRs), computed tomography (CT) scans, and labs/cultures, etc. during the hospitalization if/when indicated by SOC.

Recalculate CURB-65 and ΔSOFA scores and redraw procalcitonin, pGSN, and biomarker samples on Day 3 or 4 and Day 7.

For the one dose in the SD arm and the first 2 doses in the multiple-dose arms, blood will be drawn within 30 minutes predose, immediately postdose, and 2, 8, 12 and/or 16, and 24 hours (± 30 minutes) after the end of infusion for analysis of plasma for maximum concentration (Cmax), time to maximum concentration (Tmax), terminal half-life (T1/2), area under the curve from time zero to 8 hours (AUC0-8), and area under the curve from time zero to infinity (AUCinf). Sampling at both the 12- and 16-hour time points is encouraged where feasible, but only one of these two times is required. Identical PK sampling is encouraged where feasible, but not required for the third (last) dose.

On Day 28, collect samples for analysis of pGSN levels and antibodies against pGSN.

Arms:
arm 1: Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg v. placebo (NSS) in addition to standard of care arm 2: Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg once per day for 3 days v. placebo (NSS) in addition to standard of care arm 3: Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg once per day for 3 days v. placebo (NSS) in addition to standard of care arm 4: Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg once per day for 3 days v. placebo (NSS) in addition to standard of care

Interventions: intervention 1: Recombinant Human Plasma Gelsolin intervention 2: Normal Saline Placebo
Intervention descriptions: intervention 1: Recombinant human plasma gelsolin lyophilized for reconstitution, reconstituted in sterile water intervention 2: Normal saline in volume equivalent to drug

Protocol document:
Prot_000.pdf: 
BioAegis Therapeutics, Inc. 
 
Clinical Study Protocol 
rhu-pGSN 
 
BTI-201 
Amendment 1 dated 30 April 2018 
1 
Confidential 
 
A PHASE 1B/2A, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-ESCALATION 
STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND 
PHARMACODYNAMICS OF RECOMBINANT HUMAN PLASMA GELSOLIN (RHU-PGSN) 
ADDED TO STANDARD OF CARE IN SUBJECTS HOSPITALIZED FOR ACUTE 
COMMUNITY-ACQUIRED PNEUMONIA (CAP) 
 
Protocol Number: 
BTI-201 
Investigational Product: 
rhu-pGSN 
IND Number: 
120920 
EUDRA CT Number 
N/A 
Development Phase: 
Phase 1b/2a 
Indication Studied: 
Community-acquired pneumonia (CAP) requiring 
hospitalization 
Sponsor Name and Address: 
BioAegis Therapeutics, Inc. (BTI) 
Responsible Medical Officer: 
Mark J. DiNubile, MD FIDSA 
Compliance Statement: 
This study will be conducted in accordance with the 
ethical principles that have their origin in the 
Declaration of Helsinki, clinical research guidelines 
established by the Code of Federal Regulations (Title 
21, CFR Parts 50, 56, and 312), and ICH GCP 
Guidelines. Essential study documents will be archived 
in accordance with applicable regulations. 
Protocol Date: 
30 April 2018  
Version: 
Amendment 1 
 




BioAegis Therapeutics, Inc. 
 
Clinical Study Protocol 
rhu-pGSN 
 
BTI-201 
Amendment 1 dated 30 April 2018 
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Confidential 
 
PROTOCOL ACCEPTANCE FORM 
 
Protocol: 
BTI-201 
Title: 
A Phase 1b/2a, Double-blind, Placebo-controlled, Dose-escalation Study to 
Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of 
Recombinant Human Plasma gelsolin (rhu-pGSN) Added to Standard of 
Care in Subjects Hospitalized for Acute Community-acquired Pneumonia 
(CAP) 
 
Date: 
 
30 April 2018 
 
Amendment: 
 
Amendment 1 
 
 
I have carefully read the BTI-201 protocol and agree that it contains all of the necessary 
information required to conduct this study. I agree to conduct this study as described and 
according to the Declaration of Helsinki, ICH Guidelines for GCP, and all applicable regulatory 
requirements. 
 
  
Investigator’s Signature 
 Date
 
  
Name (printed) 
  
 


BioAegis Therapeutics, Inc. 
 
Clinical Study Protocol 
rhu-pGSN 
 
BTI-201 
Amendment 1 dated 30 April 2018 
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Confidential 
 
1. 
SYNOPSIS  
Name of Sponsor/Company: 
BioAegis Therapeutics Inc. 
Name of Investigational Product: 
Recombinant Human Plasma Gelsolin (rhu-pGSN) 
Name of Active Ingredient: 
rhu-pGSN 
Title of Study:  
A Phase 1b/2a, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, 
Pharmacokinetics, and Pharmacodynamics of Recombinant Human Plasma gelsolin (rhu-pGSN) 
Added to Standard of Care in Subjects Hospitalized for Acute Community-acquired Pneumonia 
(CAP) 
Study center(s): 4-8 sites in Australia 
Studied period (years):  
Estimated date first subject enrolled: July 2018 
Estimated date last subject completed: December 2018 
Phase of development:  
1b/2a 
Objectives:  
 
Primary 
x 
To evaluate the safety and tolerability of single and multiple ascending doses of rhu-pGSN 
administered by once-daily intravenous (IV) push to hospitalized subjects with a primary 
admitting diagnosis of community-acquired pneumonia (CAP) 
x 
To identify the maximum tolerated dose (MTD) or recommended Phase 2b/3 dose  
 
Secondary 
x  To characterize the pharmacokinetic (PK) profile of rhu-pGSN after single or multiple IV 
doses  
 
Exploratory 
x 
To assess the quantitative relationship of pGSN levels at baseline with clinical outcomes, 
changes in prognostic indices and inflammatory biomarkers, and etiologic pathogen type 
x 
To assess the relationship between rhu-pGSN dose and clinical response and changes in 
surrogate biomarkers of efficacy 
 
Immunogenicity: 
x 
To investigate the post-treatment development of antibodies against rhu-pGSN by Day 28 
 
Methodology:  
Each dosing cohort will include 8 subjects randomized 3:1 rhu-pGSN:placebo (6 rhu-pGSN 
subjects:2 placebo subjects).  
Dose will be based on actual body weight. Dose escalation will involve 3 dose levels of rhu-pGSN (6, 
12, and 24 mg/kg) in patients admitted for CAP. Dose escalation will only occur after post-therapy 
safety information on all subjects in the prior cohort has been reviewed at Day 7 for the single-dose 
[SD] and multiple-ascending dose [MAD] arms).  


BioAegis Therapeutics, Inc. 
 
Clinical Study Protocol 
rhu-pGSN 
 
BTI-201 
Amendment 1 dated 30 April 2018 
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Confidential 
 
The MAD portion of the study will commence once single doses of 6 mg/kg of rhu-pGSN are shown 
to be acceptably safe. The first 2 doses must be administered in the hospital, but the third dose can be 
given in a monitored outpatient setting where appropriate. 
Discharged subjects will return for follow-up 7 days after the initiation of therapy (Day 7) and on 
Day 28 for the End-of-Study Visit. 
To assess safety and tolerability starting at the initiation of study therapy, subjects will undergo 
physical examinations (PE; including vital sign measurements), adverse event (AE) assessments, 
concomitant medication assessments, safety laboratory testing, and electrocardiograms (EKG) 
completed locally, and other testing as per local custom.  
Once informed consent is obtained:  
1. Randomize to enrolling treatment arm. 
2. Perform PE and document radiographic evidence of pneumonia if not previously completed 
in preceding 36 hours; calculate Confusion, Urea >7 mmol/L, Respiratory rate ≥30/min, 
Blood pressure systolic <90 or diastolic ≤60, and age ≥65 years (CURB-65), Sequential 
Organ Failure Assessment (SOFA), and Pneumonia Severity Index (PSI) scores. 
3. Obtain blood and sputum cultures, routine/standard labs, and EKG per standard of care 
(SOC) (if not already performed). The microbiology lab is encouraged to also perform 
sputum Gram-stains, antigen detection, immunoassay, and genomic diagnostic tests when 
available. 
4. Draw blood for baseline pGSN levels, C-reactive protein (CRP), procalcitonin level, and 
10 mL aliquot to be frozen for subsequent biomarker assays. 
Screening laboratory and other tests can serve as baseline values for participants (no need to repeat 
lab tests at entry if done within the prior 36 hours unless dictated by SOC). 
Obtain repeat chest x-rays (CXRs), computed tomography (CT) scans, and labs/cultures, etc. during 
the hospitalization if/when indicated by SOC. 
Recalculate CURB-65 and ΔSOFA scores and redraw procalcitonin, pGSN, and biomarker samples 
on Day 3 or 4 and Day 7. 
Doses in the multiple-dose arms should be given at 24-hour (± 60-minute) intervals. For the one dose 
in the SD arm and the first 2 doses in the multiple-dose arms, blood will be drawn within 30 minutes 
predose, and 5-10 minutes after the end of administration, as well as 2, 8, 12 and/or 16, and 24 hours 
after the end of administration (± 30 minutes) for analysis of plasma for maximum concentration 
(Cmax), time to maximum concentration (Tmax), terminal half-life (T1/2), area under the curve from time 
zero to 8 hours (AUC0-8), and area under the curve from time zero to infinity (AUCinf). Sampling at 
both the 12- and 16-hour time points is encouraged where feasible, but only one of these two times is 
required. Identical PK sampling is encouraged on Day 3 where feasible, but not required in the 
multiple-dose arms. In the multiple-dose arms, the sample at 24 hours after the prior dose must be 
drawn before the next dose is given and can serve as the predose sample for the next dose as long as 
administered within the subsequent 30 minutes. 
The syringe, filter, and extension tubing should be connected after disconnecting the IV as close to 
the patient as possible. On Day 28, collect samples for analysis of pGSN levels and antibodies against 
pGSN.  
Number of subjects (enrolled):  
A total of 32 (6 rhu-pGSN and 2 placebo recipients per dose cohort x 4 dosing levels) 
Major inclusion criteria:  
1. Age ≥ 18 years  


BioAegis Therapeutics, Inc. 
 
Clinical Study Protocol 
rhu-pGSN 
 
BTI-201 
Amendment 1 dated 30 April 2018 
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2. Gender: either 
3. Informed consent obtained from subject  
4. Domicile: home, assisted living, rehabilitation facility, or nursing 
home (as long as the prospective participant is capable of 
providing written informed consent) 
5. Duration of infection precipitating hospitalization by history <14 days 
6. Planned or actual admission to hospital with a primary diagnosis of CAP within 24 hours 
of presentation to the hospital 
7. Primary admitting diagnosis of pneumonia supported by a compatible clinical 
presentation with a documented infiltrate consistent with pneumonia on chest 
radiograph or CT, as assessed by the admitting emergency-department (ED), clinic, or 
ward physician or equivalent caregiver 
¾ Recommended (not mandatory) guidance/discretionary criteria defining patients 
with CAP: 
o At least 2 symptoms: difficulty breathing, cough, production of purulent 
sputum, chest pain 
o At least 2 vital sign abnormalities: fever, tachycardia, tachypnea  
o At least one finding of other clinical signs and laboratory abnormalities: 
hypoxemia, clinical evidence of pulmonary consolidation, an elevated total 
white blood cell (WBC) count or leukopenia 
o Chest imaging showing new (or presumed new or worsening) infiltrates  
¾ Receipt of antibiotic treatment prior to presentation does not exclude the patient 
 
Major exclusion criteria: 
1. Pregnant or lactating women 
2. Intubation, vasopressor support, or admission to the intensive care unit (ICU) directly from 
the ED/office (fluids for responsive hypotension is not a reason for exclusion) 
3. Use of any investigational drug in the past 30 days 
4. Hospitalization during the last 30 days  
5. Residence within the last 30 days in long-term care facility where the patient remains 
persistently unable to participate in the routine activities of daily living  
6. Active underlying cancer treated with systemic chemotherapy or radiation therapy during 
the last 30 days 
7. Known or suspected immunosuppressive disease or therapy (including steroid use 
equivalent to prednisone ≥20 mg/day for >7 days or known advanced human 
immunodeficiency virus (HIV) infection with CD4 count ≤200/mm3; specific testing for 
HIV status or CD4 count is not required but can be done at the discretion of the caregivers) 
8. Active congestive heart failure, myocardial infarction, or pulmonary embolism; 
cardiopulmonary arrest in last 30 days 
9. Weight >100 kg  
10. Otherwise unsuitable for study participation in the opinion of the investigator  
 


BioAegis Therapeutics, Inc. 
 
Clinical Study Protocol 
rhu-pGSN 
 
BTI-201 
Amendment 1 dated 30 April 2018 
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Investigational product, dosage and mode of administration:  
Vials containing 200 mg of lyophilized rhu-pGSN will be reconstituted to a volume of 5 mL with 
4.56 mL of sterile water and drawn up into suitably sized syringes as dictated by the dose. 
x 
SD: single IV push at a rate between 5 and 20 mL/min through a standard 0.2-micron 
filter at 6 mg/kg  
x 
MAD: once-daily IV push at a rate between 5 and 20 mL/min through a standard 0.2-
micron filter for 3 days at 6 mg/kg, 12 mg/kg, or 24 mg/kg administered on 3 consecutive 
days approximately 24 hours (± 60 minutes) apart. 
Duration of treatment:  
1 day (SD) or 3 days (MAD) 
Subject screening: within 24 hours of presentation to hospital; enrollment and initiation of study 
treatment begun within 36 hours of presentation. 
Duration of subject participation:  
28 days post-first dose 
Reference therapy, dosage and mode of administration:  
Placebo (dosed at a volume of 0.15, 0.30, or 0.60 mL/kg [depending on the dosing arm] up to 60 mL 
normal saline solution [NSS] via IV push [to match the volume of rhu-pGSN for a patient of that size 
in the specific dosing arm] injected at 5-20 mL/min through a standard 0.2-micron filter)  


BioAegis Therapeutics, Inc. 
 
Clinical Study Protocol 
rhu-pGSN 
 
BTI-201 
Amendment 1 dated 30 April 2018 
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Endpoints/Outcomes: 
Primary 
x 
Incidence, causality, and severity of AEs and SAEs graded according to the National Cancer 
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (or 
equivalent); clinically significant laboratory and/or EKG abnormalities; death irrespective of 
cause; cause of death per investigator, including relationship to study drug; use of 
vasopressors, intubation, or transfer to the ICU or equivalent through Day 7  
Secondary 
x 
PK for rhu-pGSN including, but not limited to: Cmax, Tmax, T1/2, AUC0-8, AUCinf (levels 
measured within 30 minutes predose, 5-10 minutes after the end of administration, and 2, 8, 
12 and/or 16, and 24 hours (± 30 minutes) after each dose (Day 3 sampling in multiple-dose 
arms is optional) 
x 
Incidence, causality, and severity of AEs and serious adverse events (SAEs) graded according 
to the NCI CTCAE version 4.03 (or equivalent); clinically significant laboratory and/or EKG 
abnormalities as required by SOC; death irrespective of cause; cause of death per 
investigator, including relationship to study drug; use of vasopressors, intubation, or transfer 
to the ICU or equivalent through Day 28 (secondary time point) 
Exploratory 
x 
Baseline and sequential pGSN levels 
x 
Clinical outcomes: 28-day survival; ICU days; days on ventilator or pressers; days on 
antibiotics; duration of hospitalization; ΔSOFA and CURB-65 scores 
x 
Temporal profiles of inflammatory biomarkers  
x 
Pathogen type (bacterial; viral; other; unknown) determined per customary work-up at each 
site 
Immunogenicity 
x 
Presence anti-rhu-pGSN antibodies at Day 28 


BioAegis Therapeutics, Inc. 
 
Clinical Study Protocol 
rhu-pGSN 
 
BTI-201 
Amendment 1 dated 30 April 2018 
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Enrollment Procedure: 
After informed consent, subjects with a primary diagnosis of CAP to be admitted to the medical 
wards will be screened for eligibility as soon as possible. Medical history, including concomitant 
medications and current clinical status, will be recorded.  
x 
Pregnancy test (urine/blood) for women of childbearing potential 
x 
A CXR and/or CT of the chest if not previously completed in preceding 36 hours 
x 
If inclusion and exclusion criteria are satisfied, the subject will be enrolled and assigned to a 
baseline risk group CURB-65 ≤3 or >3. Randomization will not be stratified by risk group. 
Screening labs can be used for baseline values. The day of admission will be used as baseline 
(Day 1) for analysis purposes. Subjects will receive rhu-pGSN or placebo at the assigned 
dose within 36 hours of presentation.  
Subject Replacement  
Only subjects missing doses or discontinuing at random (non-informative) before the primary visit on 
Day 7 will be replaced as originally randomized to receive rhu-pGSN or placebo. Safety data from all 
subjects treated with ≥1 dose will be collected. Subjects discontinuing the study after the Day-7 Visit 
will not be replaced. 
Data and Safety Monitoring Board: 
MDN, SO, Clinical Research Organization (CRO) monitor. 
Statistical Methods and Sample Size Rationale for Power Calculations: 
All subjects given ≥1 dose of study drug will be included in the intention-to- treat population; missing 
values will not be imputed but safety data (death and other AEs) will be carried forward. Subjects 
receiving all 3 doses and evaluable at Day 7 will constitute the per-protocol population. The 
expectation is that both populations will be almost identical. 
Results will be summarized via summary statistics separately for each pGSN dose level in the SD and 
in the MAD portions of the trial, and for all placebo subjects pooled. No data will be excluded from 
the summary statistics and analyses, and missing data will not be imputed. 
Demographics and disease-related characteristics will be summarized via counts and percentages of 
subjects for categorical variables, and by N, mean, median, standard deviation, minimum, maximum 
for continuous variables. Summaries will be performed separately by dose group and placebo subjects 
(all placebo subjects combined), and for all study subjects combined. 
AE data will be summarized by counts and proportions of subjects having an AE, each AE type, and 
an AE of each System Organ Class. These summaries will be provided for each dose and placebo (all 
placebo subjects combined). SAEs will be summarized similarly. Reasons for any early 
discontinuations will be summarized similarly. 
Biomarker, clinical outcome, and laboratory data will be summarized via counts and percentages of 
subjects for categorical variables, and by summary statistics (N, mean, median, standard deviation, 
minimum, maximum, 90% confidence intervals, etc.) for baseline, each observed time point, and 
change from baseline at each observed time point for continuous variables. Data will be assessed via 
graphical and Shapiro-Wilk statistic for closeness to normal distribution and if substantial departure is 
observed, transformation (e.g., natural log, reciprocal, square root, ranks) may be employed to derive 
the summary statistics. Details will be in the statistical analysis plan (SAP). 
To complete the PK analyses, plasma specimens will be periodically sampled relative to study drug 
administration and stored frozen for pGSN measurements. For the 1 dose in the SD arm and the first 
2 doses in the MAD arms, blood will be drawn for analysis of Cmax, Cmax, T1/2, AUC0-8, and AUCinf. 
Identical PK sampling is encouraged on Day 3 where feasible (but not required) in the multiple-dose 
arms. 


BioAegis Therapeutics, Inc. 
 
Clinical Study Protocol 
rhu-pGSN 
 
BTI-201 
Amendment 1 dated 30 April 2018 
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Confidential 
 
The immunogenicity will be assessed at the last visit on Day 28 ± 2 days. Antibodies against 
rhu-pGSN will be assayed from frozen specimens to determine whether the investigational product 
induces an antibody response in recipients. 
The table below presents the Minimum Sample Size such that there is 90% probability of observing at 
least 1 AE of a certain type if the TRUE underlying AE rate. 
Sample Size 
TRUE underlying AE rate 
6 (each pGSN dose level) 
32% 
8 (pooled placebo) 
21% 
24 (pooled pGSN) 
10% 
With each sample size presented in the table above, if zero AEs of a certain type are observed, one 
could be "90% confident" the TRUE underlying rate for that AE is at most the rate indicated above. 


BioAegis Therapeutics, Inc. 
 
Clinical Study Protocol 
rhu-pGSN 
 
BTI-201 
Amendment 1 dated 30 April 2018 
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2. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES  
TABLE OF CONTENTS 
PROTOCOL ACCEPTANCE FORM .........................................................................................3 
1. 
SYNOPSIS ............................................................................................................................4 
2. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES ..................11 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS .................................15 
4. 
INTRODUCTION ..............................................................................................................18 
4.1. Community-Acquired Pneumonia ...................................................................................18 
4.2. Current Treatment of CAP ..............................................................................................18 
4.3. Plasma Gelsolin and Treatment of CAP ..........................................................................19 
4.4. Preclinical and Clinical Experience .................................................................................20 
4.4.1. Preclinical Experience .........................................................................................20 
4.4.2. Clinical Experience .............................................................................................21 
4.5. Rationale for Study and Starting Dose ............................................................................22 
5. 
TRIAL OBJECTIVES AND ENDPOINTS .....................................................................23 
5.1. Objectives ........................................................................................................................23 
5.1.1. Primary Objective ................................................................................................23 
5.1.2. Secondary Objectives ..........................................................................................23 
5.1.3. Exploratory Objectives ........................................................................................23 
5.1.4. Immunogenicity Objective ..................................................................................23 
5.2. Endpoints .........................................................................................................................23 
5.2.1. Primary Endpoint .................................................................................................23 
5.2.2. Secondary Endpoints ...........................................................................................23 
5.2.3. Exploratory Endpoints .........................................................................................24 
5.2.4. Immunogenicity Endpoints .................................................................................24 
6. 
INVESTIGATIONAL PLAN ............................................................................................25 
6.1. Overall Study Design ......................................................................................................25 
6.2. Study Enrollment Plan .....................................................................................................25 
6.3. Doses and Schedule of Administration ...........................................................................25 
6.4. Data and Safety Monitoring Board ..................................................................................26 
6.5. Safety Criteria for Stopping Doses ..................................................................................26 
6.5.1. Management of rhu-pGSN Injection-Related Reactions .....................................26 
6.6. Study Duration .................................................................................................................28 
6.7. Total Duration of Subject Participation ...........................................................................28 
6.8. End of Study Definition ...................................................................................................28 
6.9. Criteria for Treatment Discontinuation ...........................................................................28 
6.10. Subject Replacement ..................................................................................................29 
6.11. Criteria for Study Termination ...................................................................................29 


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7. 
STUDY POPULATION .....................................................................................................30 
7.1. Number of Subjects .........................................................................................................30 
7.2. Subject Inclusion Criteria ................................................................................................30 
7.3. Subject Exclusion Criteria ...............................................................................................30 
7.4. Subjects or Partners of Subjects of Reproductive Potential ............................................31 
7.5. Waivers of Inclusion/Exclusion Criteria .........................................................................31 
8. 
DESCRIPTION OF STUDY TREATMENT ..................................................................32 
8.1. Description of Study Drug ...............................................................................................32 
8.2. Method of Assigning Subjects to Treatment Groups ......................................................32 
8.3. Preparation of Study Drug for Administration ................................................................33 
8.4. Subject Monitoring During rhu-pGSN Administration ...................................................33 
8.5. Study Drug Administration .............................................................................................33 
8.6. Shipment of Study Drug ..................................................................................................34 
8.7. Receipt and Storage of Study Drug .................................................................................34 
8.8. Accountability, Handling, and Disposal of Study Drug ..................................................34 
8.9. Concomitant Medications ................................................................................................34 
8.10. Treatment Compliance ................................................................................................35 
8.11. Randomization and Blinding ......................................................................................35 
8.11.1. Unblinding ...........................................................................................................35 
9. 
STUDY ASSESSMENTS ...................................................................................................36 
9.1. Screening Assessments ....................................................................................................43 
9.1.1. HIV Testing .........................................................................................................43 
9.1.2. Confirmation of CAP ..........................................................................................43 
9.1.3. Pregnancy Test ....................................................................................................43 
9.2. Safety Assessments .........................................................................................................43 
9.2.1. Demographic/Medical History ............................................................................43 
9.2.2. Vital Signs ...........................................................................................................43 
9.2.3. Physical Examination ..........................................................................................43 
9.2.4. Outcome Prediction Models ................................................................................44 
9.2.5. Electrocardiogram ...............................................................................................44 
9.2.6. Laboratory Assessments ......................................................................................44 
9.3. Pharmacokinetic Assessments .........................................................................................45 
9.4. Pharmacodynamic Assessments ......................................................................................45 
9.5. Other Assessments ...........................................................................................................45 
10. 
ADVERSE EVENT MANAGEMENT .............................................................................46 
10.1. Definition of Adverse Events .....................................................................................46 
10.1.1. Adverse Event (AE) ............................................................................................46 
10.1.2. Serious Adverse Event (SAE) .............................................................................46 
10.2. Clarifications to Serious Adverse Event Reporting ....................................................46 
10.3. Assessment of Causality .............................................................................................46 
10.4. Assessment of Severity ...............................................................................................47 
10.5. Pregnancy or Drug Exposure during Pregnancy ........................................................48 
10.6. Laboratory Abnormalities ...........................................................................................48 


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10.7. Reporting Adverse Events ..........................................................................................48 
11. 
STATISTICS ......................................................................................................................50 
11.1. General Overview .......................................................................................................50 
11.2. Sample Size and Power Calculations .........................................................................50 
11.3. Analysis Populations ..................................................................................................50 
11.4. Criteria for Evaluation and Statistical Methods ..........................................................50 
11.4.1. Safety ...................................................................................................................50 
11.4.2. Baseline Characteristics .......................................................................................51 
11.4.3. Pharmacokinetics and Immunogenicity ..............................................................51 
11.4.4. Pharmacodynamics ..............................................................................................51 
12. 
DATA RECORDING, RETENTION AND MONITORING ........................................52 
12.1. Case Report Forms .....................................................................................................52 
12.2. Records Retention .......................................................................................................52 
12.3. Data Monitoring ..........................................................................................................52 
12.4. Quality Control and Quality Assurance ......................................................................53 
13. 
REGULATORY, ETHICAL AND LEGAL OBLIGATIONS .......................................54 
13.1. Good Clinical Practice ................................................................................................54 
13.2. Independent Ethics Committee Approval ...................................................................54 
13.3. Regulatory Authority Approval ..................................................................................54 
13.4. Other Required Approvals ..........................................................................................54 
13.5. Informed Consent .......................................................................................................54 
13.6. Subject Confidentiality ...............................................................................................55 
13.7. Disclosure of Information ...........................................................................................55 
14. 
LIST OF REFERENCES ..................................................................................................56 
15. 
APPENDICES ....................................................................................................................58 
APPENDIX A: CURB-65 SCORE .............................................................................................59 
APPENDIX B: MINI-MENTAL STATE EXAM (ABBREVIATED MENTAL 
TEST SCORE) ..........................................................................................................60 
APPENDIX C: PSI (PORT SCORE) .........................................................................................61 
APPENDIX D: SOFA SCORE ...................................................................................................63 
 


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LIST OF TABLES 
Table 1: 
Abbreviations and Specialist Terms ...........................................................................15 
Table 2: 
Summary of deaths .....................................................................................................22 
Table 3: 
Definition of Injection-Related Reactions ..................................................................26 
Table 4: 
Investigational Product ...............................................................................................32 
Table 5: 
Schedule of Assessments: Single-Dose Phase ............................................................37 
Table 6: 
Schedule of Assessments: Multiple-Ascending Dose Phase ......................................40 
Table 7: 
Minimum Sample Size Calculations ..........................................................................50 
 


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3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
The following abbreviations and specialist terms are used in this study protocol. 
Table 1: 
Abbreviations and Specialist Terms  
Abbreviation or Specialist Term 
Explanation 
AE 
Adverse event 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
AUC0-8 
Area under the curve from time zero to 8 hours 
AUCinf 
Area under the curve from time zero to infinity 
BioAegis 
BioAegis Therapeutics, Inc. or Sponsor 
CAP 
Community-acquired pneumonia 
CBC 
Complete blood count 
CDC 
Centers for Disease Control and Prevention 
Cmax 
Maximum concentration 
COPD 
Chronic obstructive pulmonary disease 
CPK 
Creatinine phosphokinase 
CRO 
Contract Research Organization 
CRP 
C-reactive protein 
CTCAE 
Common Terminology Criteria for Adverse Events 
CURB-65 
Confusion, Urea >7 mmol/L, Respiratory rate ≥30/min, 
Blood pressure systolic <90 or diastolic ≤60, and age ≥65 
years 
CXR 
Chest x-ray 
eCRF 
Electronic case report form 
CT 
Computed tomography 
DSMB 
Data and Safety Monitoring Board 
ED 
Emergency department 
EDC 
Electronic data capture 
EKG 
Electrocardiogram 
ELISA 
Enzyme-linked immunosorbent assay 
EOS 
End of Study 
f-actin 
Filamentous actin 
g-actin 
Globular actin 
GCP 
Good Clinical Practice 


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Abbreviation or Specialist Term 
Explanation 
HIV 
Human immunodeficiency virus 
ICH 
International Council for Harmonization of Technical 
Requirements for Pharmaceuticals for Human Use 
ICU 
Intensive Care Unit 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
IRR 
Injection-related reaction 
IUD 
Intrauterine device 
IV 
Intravenous 
IWRS 
Interactive web response system 
LDH 
Lactate dehydrogenase 
MAD 
Multiple-ascending dose 
MMSE 
Mini-Mental State Examination 
MTD 
Maximum tolerated dose 
MV 
Mechanical ventilation 
NCI 
National Cancer Institute 
NSAIDS 
Non-steroidal anti-inflammatory drugs 
NSS 
Normal saline solution 
PD 
pharmacodynamic 
PDF 
Portable document format 
PE 
Physical examination 
PI 
Principal Investigator 
The investigator who leads the study conduct at an 
individual study site.  Every study site has a principal 
investigator. 
PK 
Pharmacokinetics 
PSI 
Pneumonia Severity Index 
rhu-pGSN 
Recombinant human plasma Gelsolin 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Single dose 
SOC 
Standard of care 
SOFA 
Sequential Organ Failure Assessment 
T1/2 
Terminal half-life 


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Abbreviation or Specialist Term 
Explanation 
Tmax 
Time to maximum concentration 
US 
United States 
VP 
Vasopressor 
WBC 
White blood cell 
WHO 
World Health Organization 
 


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4. 
INTRODUCTION 
4.1. 
Community-Acquired Pneumonia 
Pneumonia is an inflammatory condition of the lung primarily affecting the alveoli. It is usually 
caused by infection with viruses or bacteria and less commonly other microorganisms. Certain 
drugs and other conditions such as autoimmune diseases may cause a similar clinical picture. 
Typical symptoms include a cough, chest pain, fever, and difficulty breathing. Diagnostic tools 
include chest x-rays (CXRs), serology, microscopy of a sputum smear and culture of the sputum. 
Treatment depends on the underlying cause. Pneumonia documented or presumed to be viral, 
bacterial or fungal is treated with appropriate agents when available. If the pneumonia is severe, 
the affected person is admitted to hospital. 
According to the World Health Organization (WHO), pneumonia due to infection affects 
approximately 450 million people globally per year, seven percent of the population, and results 
in about 4 million deaths, mostly in third-world countries; however, it remains a serious issue in 
the developed world, as well. In the United States (US), 1.1 million are hospitalized each year, 
resulting in over 52,000 deaths at a ratio of 16.8 deaths per 100,000 (Centers for Disease Control 
and Prevention [CDC], 2010; Kochanek et al, 2015). 
Pneumonia is classified according to the etiologic organism, and where the infection was 
acquired (community or hospital facility). 
Community-acquired pneumonia (CAP) is the most common type of pneumonia, and may be 
caused by pyogenic bacteria, atypical bacteria, viruses or fungi which often cannot be identified 
in real time. CAP may also have non-infectious etiologies, including allergic, immune-mediated, 
toxins, or drugs. CAP occurs throughout the world and is a leading cause of illness and death. 
The following outcome prediction models will be used in the current study:  
x CURB-65:a simple five-point score in which one point is allocated to the presence of 
each of the following: Confusion, Urea >7 mmol/L, Respiratory rate ≥30/min, Blood 
pressure systolic <90 or diastolic ≤60, and age ≥65 years (Appendix A; British Thoracic 
Society, 1987; Neill et al, 1996; Niederman et al, 2001; Lim et al, 2003; Richards et al, 
2011).  
x Pneumonia Severity Index (PSI): calculates the probability of morbidity and mortality 
among patients with CAP (Appendix C; Richards et al, 2011). 
x Sequential Organ Failure Assessment (SOFA): calculates the number and the severity of 
organ dysfunction in six organ systems (respiratory, coagulation, liver, cardiovascular, 
renal, and neurologic) (Appendix D) (Singer et al, 2016). 
4.2. 
Current Treatment of CAP 
CAP antibiotic, anti-fungal or anti-viral agents are administered based on organisms present in 
sputum, bacteriologic culture, serum antibody results or clinical impression of the infecting 
organism until resolution of sepsis and clinical symptoms and radiographic improvement has 
occurred, typically of 5- to 14-days duration. Patients with CURB-65 score ≥3 have an 
unacceptably high mortality despite standard-of-care (SOC) therapy and should be admitted to 


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hospital and may need intensive care (Richards et al, 2011). Any associated organ dysfunction is 
supported in an intensive care unit (ICU) and may include vasopressors and fluids for shock and 
mechanical ventilation for respiratory failure. Oral antibiotic therapy may be continued after 
discharge from hospital. 
4.3. 
Plasma Gelsolin and Treatment of CAP 
Plasma gelsolin is a human protein produced and secreted by virtually every cell type, and it 
circulates at high levels in the blood of healthy individuals. At normal levels of 200-300 mg/L, it 
is the fourth most abundant protein in the circulation. 
The therapeutic protein being developed by BioAegis Therapeutics, Inc. (BioAegis or Sponsor) 
is recombinant human plasma gelsolin (rhu-pGSN) and was formerly referred to as BG9385. It is 
identical to the complete natural protein and is comprised of 755 amino acids. The protein, like 
the natural protein, is non-glycosylated. The protein consists of six repeated domains, which 
make up three distinct actin binding sites, two that bind globular actin (G-actin) and one that 
binds filamentous actin (F-actin). Domain 1 plus the first 10 amino acids of domain 2 of gelsolin 
is the minimal fragment size required for its actin severing activity. Rhu-pGSN contains multiple 
calcium binding sites that regulate its activity. It is a highly conserved protein, as far back as 
drosophila. 
Plasma gelsolin modulates inflammation while at the same time, boosting the body’s ability to 
clear pathogens. It functions through mechanisms quite distinct from anti-inflammatory agents, 
which are antagonists of specific mediators or inhibitors of specific enzymes. Plasma gelsolin 
functions through a pleiotropic mechanism of action, scavenging toxic actin, binding 
inflammatory mediators and enhancing pathogen clearance. pGSN levels decrease markedly in a 
variety of clinical conditions such as acute respiratory distress syndrome, sepsis, major trauma, 
prolonged hyperoxia, malaria, and liver injury. The strength of the correlation between 
magnitude of decline in pGSN and likelihood of mortality is especially striking (Lee et al, 2006; 
2008;  2009; Osborn et al, 2008). Repletion of depressed plasma gelsolin levels with rhu-pGSN 
is expected to benefit patients through four distinct mechanisms that have been described in the 
literature: 
1.  Sequestration of released actin from sites of damage. This sequestration causes local 
depletion of pGSN while leaving large stores of pGSN continuing to circulate in healthy 
individuals. Modest reduction of systemic pGSN levels is then restored after healing is complete 
(Haddad et al, 1990; Lee et al, 1992). 
2.  Prevention of the escape of mediators of inflammation from the local site. Local depletion 
allows appropriate inflammation/healing to proceed while high circulating levels keep the 
mediators local (Bucki et al, 2000; 2005; 2008; 2010). pGSN binds and dampens pro-
inflammatory mediators such as platelet-activating factor, lysophosphatidic acid, and bacterial 
products (Goetzel et al, 2000; Vasconcellos and Lind, 1993; Bucki et al, 2005; Bucki et al, 2008; 
Bucki et al, 2010; Osborn et al, 2007). pGSN can also bind fibronectin (Lind et al, 1984) and 
fibrin (and possibly pro-inflammatory fibrinopeptides) (Smith et al, 1987), and may ‘escort’ or 
delay binding of lysophosphatidic acid and other mediators to their receptors (Goetzel et al, 
2000; Bucki et al, 2010). 


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3.  Enhanced uptake of gram + and gram – bacteria by tissue macrophages. It has been shown 
that actin inhibits bacterial uptake and that pGSN reverses that inhibition. Excess actin in 
seriously ill individuals may account for immune suppression seen in these patients. 
4.  Improved killing of gram + and gram – bacteria by tissue macrophages. This function is 
distinct from the function that enhances bacterial uptake. It has been shown to be mediated by 
induction of NOS3 and is absent in NOS3 knock-out mice (Yang et al, 2015).  
The development of rhu-pGSN was initiated in the 1990s and included development of the 
original E. coli cell bank and conduct of non-clinical and first clinical studies with the protein 
produced from culture of aliquots of this cell bank. BioAegis took over the development of 
rhu-pGSN, established a new E. coli cell line for the production of rhu-pGSN, and implemented 
some improvements in the manufacturing process of the therapeutic protein.  
4.4. 
Preclinical and Clinical Experience 
4.4.1. 
Preclinical Experience 
The preclinical studies of pGSN have revealed no safety concerns related to its mechanism of 
action or formulation. No functional effects on the respiratory system and no systemic toxicity 
attributed to rhu-pGSN or the formulation excipient, 0.1% polysorbate 80 (Tween-80), were 
observed in these studies at the highest achievable doses. No clinically relevant pathological 
effects were evident in rats or monkeys following administration of pGSN or 0.1% polysorbate 
80 vehicle for up to 28 days by inhalation or for 14 days by intravenous (IV) injection. 
Exposures to the lower respiratory tract of rats and monkeys in the repeat-inhalation dose 
toxicity studies were up to approximately 75 and 250 times, respectively, the estimated level at 
the proposed starting dose to be administered to patients with CAP. Based upon the lack of test 
article-related effects, safety margins are estimated to be in excess of 4.5 and 30 times (for rat 
and monkey, respectively) the highest planned clinical dose. 
The pharmacokinetic (PK) profile of rhu-pGSN following inhalation, intratracheal, IV, or oral 
administration is consistent with that of a relatively stable, high molecular weight protein. 
Detectable systemic absorption of rhu-pGSN following inhalation exposure is not extensive. No 
changes in endogenous plasma gelsolin levels were detected using an enzyme-linked 
immunosorbent assay (ELISA) following aerosol administration of pGSN to monkeys at 
presented dose levels up to 9,550 mg/kg. The half-life of rhu-pGSN-related radioactivity in the 
lung was approximately 10 to 16 hours in normal rats and monkeys, respectively, following 
pulmonary exposure. 
Test article-related effects observed following repeat aerosol administration of pGSN under 
conditions of continuous pulmonary exposure was limited to minimal microscopic changes in the 
lungs of monkeys. The microscopic change is attributed to an immunogenic response as 
evidenced by the detection of antibodies to rhu-pGSN. The antibodies appeared to be directed 
against the human-specific epitopes of intact rhu-pGSN and caused no clinical or pathological 
signs of serum sickness. Thus, the immunogenic reaction to rhu-pGSN in monkeys appears to be 
a species-specific response and, therefore, is not considered to be clinically relevant. 
No cardiovascular effects were noted in monkeys receiving pGSN by either inhalation or IV 
administration. 


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No eye or skin irritation was noted in rabbits after acute exposure to the product. 
In summary, the preclinical profile of pGSN suggests that this drug will be well tolerated by 
humans and that the risk of respiratory or systemic toxicity is low.  
4.4.2. 
Clinical Experience 
Rhu-pGSN has been previously evaluated in 3 clinical studies. 
Study 96-900 was a Phase 1, double-blind, randomized, controlled, within-subject, dose-
escalation study in 24 healthy volunteers conducted in the United Kingdom. Patients were dosed 
via nebulization up to a maximum dose of 32 mg given twice per day. Adverse events (AEs) 
were minor and none were consistently attributed to treatment. No formation of antibodies to 
rhu-pGSN was observed.  
Study C96-901 was a randomized, double-blind, placebo-controlled, dose-escalating, tolerability 
study of inhaled rhu-pGSN in 21 patients with cystic fibrosis conducted at one clinical site in 
Canada. Rhu-pGSN or placebo was administered via nebulization at 3.0 mg per day (Day 1 and 
2), 10 mg per day (Day 3 and 4) and 25 mg per day (Day 5 to 9). Sixteen patients were 
randomized to rhu-pGSN and five patients to placebo (randomization ratio 3:1). Rhu-pGSN was 
well tolerated and no safety concerns were raised. No patients withdrew from the study. There 
was no negative effect on pulmonary function. There were no serious adverse events (SAEs) and 
no AEs were considered likely or definitely related to treatment.  
Study CBC-101 was a randomized, double-blind, placebo-controlled, ascending dose, infusion 
trial of the PK of rhu-pGSN in patients with decreased natural gelsolin levels. This Phase 1b/2a 
study was conducted in Hong Kong and enrolled patients admitted to the ICU. Twenty-eight 
patients were enrolled; 21 patients received rhu-pGSN and 7 received placebo. The 4 cohorts 
were treated with ascending doses of rhu-pGSN via IV infusion according to the following 
scheme: 
Cohort 1: Single infusion of 3 mg/kg rhu-pGSN (10 patients) or placebo (3 patients) 
Cohort 2: Single infusion of 6 mg/kg rhu-pGSN (3 patients) or placebo (2 patients) 
Cohort 3: Daily infusion of 6 mg/kg rhu-pGSN for 3 days (6 patients) or placebo (2 patients) 
Cohort 4: Daily infusion of 6 mg/kg rhu-pGSN for 3 days (2 patients with severe multiple organ 
failure) 
The dose escalation over the successive cohorts was supervised by an independent data and 
safety monitoring board (DSMB). The DSMB had to document the safety profile of the drug 
before allowing the study to proceed to a higher dose and/or exposure. No safety concerns 
associated with rhu-pGSN were raised by the DSMB. Seven patients died during the 3-month 
observation period (Table 2); none of the deaths were assessed as related to study treatment. No 
patient who received placebo died. The incidence of death in the rhu-pGSN-treated patients 
(7/21; 33%) is within the limits of expectation for patients admitted in ICU with similar 
diagnoses. However, the incidence of death was lower than expected in the placebo group, most 
probably due to imbalances in multiple baseline clinical prognostic factors in favor of the 
placebo group when compared to the rhu-pGSN group. 


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Table 2: 
Summary of deaths 
Subject Cohort 
Age 
pGSN 
mU/mL 
Admission diagnosis1 
VP 
MV
Day of 
admission 
relative to 
infusion2 
Day of 
death3 
G004 
1 
84 
921 
Fecal peritonitis, 
emergency 
rectosigmoidectomy, 
renal insufficiency 
Yes
Yes 
-10 
5 
G006 
1 
69 
1892 
Pneumonia with 
hepatitis 
No 
Yes 
-10 
3 
G012 
1 
79 
524 
Sigmoid perforation, 
emergency 
rectosigmoidectomy 
No 
No 
-6 
26 
G015 
2 
79 
1161 
Pneumonia, COPD 
Yes
Yes 
-15 
21 
G017 
2 
78 
963 
Peritonitis with terminal 
cholangiocarcinoma 
No 
No 
-10 
16 
G018 
2 
85 
1128 
Pneumonia with renal 
insufficiency 
Yes
Yes 
-10 
66 
G401 
4 
83 
780 
Pneumonia with renal 
insufficiency 
Yes
Yes 
-4 
7 
1 Diagnosis established at ICU admission 
2 Represents the day of hospitalization (irrespective of ICU or not) relative to day of infusion 
3 Day of death relative to first infusion 
COPD = Chronic obstructive pulmonary disease; ICU = Intensive Care Unit; MV = Mechanical 
Ventilation; pGSN = plasma gelsolin; VP = Vasopressor. 
 
4.5. 
Rationale for Study and Starting Dose 
The dosing for this study starts at the highest daily dose evaluated in the CBC-101 study 
performed in Hong Kong, followed by incrementally increased multiple doses for 3 consecutive 
days. The actual dose will be based on actual body weight. The placebo will be the equivalent 
volume on a weight basis of normal saline solution. 
 


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5. 
TRIAL OBJECTIVES AND ENDPOINTS 
5.1. 
Objectives 
5.1.1. 
Primary Objective 
x To evaluate the safety and tolerability of single and multiple ascending doses of rhu-
pGSN administered by once-daily IV push to hospitalized subjects with a primary 
admitting diagnosis of CAP 
x To identify the maximum tolerated dose (MTD) or recommended Phase 2b/3 dose 
5.1.2. 
Secondary Objectives 
x To characterize the PK profile of rhu-pGSN after single or multiple IV doses  
5.1.3. 
Exploratory Objectives 
x To assess the quantitative relationship of pGSN levels at baseline with clinical 
outcomes, changes in prognostic indices and inflammatory biomarkers, and etiologic 
pathogen type 
x To assess the relationship between rhu-pGSN dose and clinical response and changes in 
surrogate biomarkers of efficacy 
5.1.4. 
Immunogenicity Objective 
x To investigate the post-treatment development of antibodies against rhu-pGSN by 
Day 28 
5.2. 
Endpoints 
5.2.1. 
Primary Endpoint 
x Incidence, causality, and severity of AEs and SAEs graded according to the National 
Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 
version 4.03 (or equivalent), clinically significant laboratory and/or electrocardiogram 
(EKG) abnormalities, death irrespective of cause, cause of death per investigator, 
including relationship to study drug; use of vasopressors, intubation, or transfer to the 
ICU or equivalent through Day 7  
5.2.2. 
Secondary Endpoints 
x PK for rhu-pGSN including, but not limited to maximum concentration (Cmax), time to 
maximum concentration (Tmax), terminal half-life (T1/2), area under the curve from time 
zero to 8 hours (AUC0-8), area under the curve from time zero to infinity (AUCinf) (levels 
measured within 30 minutes predose, 5-10 minutes after the end of administration, and 2, 
8, 12 and/or 16, and 24 hours (± 30 minutes) after each dose (Day 3 sampling in multiple-
dose arms is optional) 


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x Incidence, causality, and severity of AEs and SAEs graded according to the NCI CTCAE 
version 4.03 (or equivalent); clinically significant laboratory and/or EKG abnormalities 
as required by SOC; death irrespective of cause; cause of death per investigator, 
including relationship to study drug; use of vasopressors, intubation, or transfer to the 
ICU or equivalent through Day 28 (secondary time point) 
5.2.3. 
Exploratory Endpoints 
x Baseline and sequential pGSN levels 
x Clinical outcomes: 28-day survival; ICU days; days on ventilator or pressers; days on 
antibiotics; duration of hospitalization; ΔSOFA and CURB-65 scores 
x Temporal profiles of inflammatory biomarkers  
x Pathogen type (bacterial; viral; other; unknown) determined per customary work-up at 
each site 
5.2.4. 
Immunogenicity Endpoints 
x Presence of anti-rhu-pGSN antibodies at Day 28 


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6. 
INVESTIGATIONAL PLAN 
6.1. 
Overall Study Design 
Study BTI-201 is a Phase 1b/2a, double-blind, placebo-controlled, dose-escalation study to 
evaluate the safety, PK, and pharmacodynamics of rhu-pGSN added to SOC in subjects 
hospitalized for acute CAP. Each dosing cohort will include 8 subjects randomized 3:1 rhu-
pGSN:placebo (6 rhu-pGSN subjects:2 placebo subjects).  
Dose will be based on actual body weight. Dose escalation will involve 3 dose levels of rhu-
pGSN (6, 12, and 24 mg/kg) in patients admitted for CAP. Dose escalation will only occur after 
post-therapy safety information on all subjects in the prior cohort has been reviewed at Day 7 for 
the single-dose [SD] and multiple-ascending dose [MAD] arms.  
The MAD portion of the study will commence once single doses of 6 mg/kg of rhu-pGSN are 
shown to be acceptably safe. The first 2 doses must be administered in the hospital, but the third 
dose can be given in a monitored outpatient setting where appropriate. 
Discharged subjects will return for follow-up 7 days after the initiation of therapy (Day 7) and on 
Day 28 for the End-of-Study (EOS) Visit. 
To assess safety and tolerability, subjects will undergo physical examinations (PE; including 
vital sign measurements), AE assessments, concomitant medication assessments, safety 
laboratory testing and EKGs (completed locally), and other testing as per local custom. See 
Table 5 and Table 6 for schedules of all study events.  
6.2. 
Study Enrollment Plan 
After informed consent, subjects with a primary diagnosis of CAP to be admitted to the medical 
wards will be screened for eligibility as soon as possible. Medical history, including concomitant 
medications and current clinical status, will be recorded. Initial assessments include:  
x Pregnancy test (urine/blood) for women of childbearing potential  
x A CXR and/or computed tomography (CT) of the chest if not previously completed in 
preceding 36 hours 
x If inclusion and exclusion criteria are satisfied (Section 7.2 and Section 7.3), the subject 
will be enrolled and assigned to a baseline risk group CURB-65 ≤3 or >3. Randomization 
will not be stratified by risk group. Screening labs can be used for baseline values and 
need not be repeated unless the caregivers deem necessary. The day of admission will be 
used as baseline (Day 1) for analysis purposes. Subjects will receive rhu-pGSN or 
placebo at the assigned dose within 36 hours of presentation. 
6.3. 
Doses and Schedule of Administration 
In the SD arm, subjects will receive one dose of rhu-pGSN or placebo on Day 1 as an IV push at 
6 mg/kg.  
In the MAD arms, subjects will receive once-daily doses approximately 24 hours apart of rhu-
pGSN or placebo on Days 1 through 3 as an IV push at 6, 12, or 24 mg/kg. The first 2 doses 


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must be administered in the hospital, but the third dose can be given in a monitored outpatient 
setting where appropriate. 
6.4. 
Data and Safety Monitoring Board 
An DSMB will be established to monitor safety of subjects. The DSMB will be comprised of 
3 members: a representative of the Contract Research Organization (CRO), a representative of 
the Sponsor, and an independent expert in CAP. 
Safety through Day 7 of the study will be evaluated after the completion of each dosing arm to 
determine if it is safe to initiate the next cohort according to the safety criteria for stopping doses 
(Section 6.5).  
Further details will be included in the DSMB charter. 
6.5. 
Safety Criteria for Stopping Doses 
Dosing of rhu-pGSN may be stopped during the study at the discretion of the DSMB. In general, 
doses should not be interrupted for Grade 1 AEs, but treatment to control symptoms should be 
provided, if applicable. 
6.5.1. 
Management of rhu-pGSN Injection-Related Reactions 
Injection-related reactions (IRRs) (Table 3) will be defined according to the NCI-CTCAE, 
version 4.03 or higher. 
Table 3: 
Definition of Injection-Related Reactions 
Adverse 
Event 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
IRR 
Mild transient 
reaction; 
injection 
interruption not 
indicated; 
intervention not 
indicated 
Therapy or injection 
interruption indicated 
but responds 
promptly to 
symptomatic 
treatment (e.g., 
antihistamines, 
NSAIDS, narcotics, 
IV fluids); 
prophylactic 
medications indicated 
for ≤24 hours 
Prolonged (i.e., not rapidly 
responsive to symptomatic 
medication, brief 
interruption of injection, or 
both); recurrence of 
symptoms following initial 
improvement; 
hospitalization indicated 
for clinical sequelae 
Life-
threatening 
consequences; 
urgent 
intervention 
indicated 
Abbreviations: IRR=injection-related reaction; IV=intravenous; NSAIDs=non-steroidal anti-inflammatory drugs.
 


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Management of Grade 1 IRRs 
If a subject presents with a Grade 1 IRR: 
x The injection may be continued; however, the rate may be reduced to 50% at the 
discretion of the Investigator. 
x If the symptoms resolve, the injection can be increased, as tolerated, to the baseline 
rate. 
x The subject may receive appropriate further treatment for IRRs if clinically indicated 
per the site’s standard practice for management of IRRs. 
Management of Grade 2 IRRs 
If a subject presents with a Grade 2 IRR: 
x The injection should be stopped immediately. 
x The subject should receive appropriate further treatment with an antihistamine and/or 
acetaminophen (paracetamol) if clinically indicated per the site’s standard practice for 
management of IRRs. Further medications can be administered if necessary. 
x Once the symptoms have been resolved or reduced to Grade 1, the injection can be 
continued at an injection rate of 50%.  
x If a subject who developed a Grade 2 IRR receives further injections, then 
premedication following the site’s standard practice for premedication for IRR should 
be given before all subsequent injections of rhu-pGSN given at a rate of 50% of the 
original rate. 
Management of Grade 3 IRRs 
If a subject presents with a Grade 3 IRR: 
x The injection should be stopped immediately. 
x The subject must receive appropriate treatment with an antihistamine and/or 
acetaminophen (paracetamol) and/or methylprednisolone (or equivalent) and, if 
necessary, further medications (i.e., epinephrine, bronchodilator). 
x Only after the complete resolution to ≤Grade 1, and after having received appropriate 
prophylactic medication(s) as described above, the injection may be resumed at an 
injection rate of 25%. If, after 1 hour, the subject’s symptoms do not return and vital 
signs are stable, the injection rate may be increased to a maximum of 50%. 
x If, after the resumption of injection, symptoms return (irrespective of grade), the 
injection must be stopped immediately and the injection tubing should be 
disconnected from the subject.  
x Subjects experiencing a Grade 3 IRR may only receive further injections of study 
drug, provided clinically appropriate precautions are undertaken and agreed upon by 
Investigator and Medical Monitor. 


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Management of Grade 4 IRRs 
If a subject presents with a Grade 4 IRR: 
x The injection should be stopped immediately and the injection tubing should be 
disconnected from the subject. 
x The subject should receive appropriate treatment with an antihistamine and/or 
acetaminophen (paracetamol) and/or methylprednisolone (or equivalent) and, if 
necessary, further medications (i.e., epinephrine, bronchodilator). 
x The subject must not receive further injections of rhu-pGSN if rhu-pGSN is judged 
by the Investigator to be the cause of the IRR. 
 
6.6. 
Study Duration 
Subjects in the SD arm of the study will be treated for 1 day. Subjects in the MAD arms of the 
study will be treated for 3 consecutive days.  
Subject screening: within 24 hours of presentation to hospital; enrollment and initiation of study 
treatment within 36 hours of presentation.  
Subjects are followed for safety and efficacy through Day 28 for a total duration of 
approximately 1 month. 
6.7. 
Total Duration of Subject Participation 
Subjects will be observed for 28-days post-first dose. 
6.8. 
End of Study Definition 
End of study (EOS) will be defined as the date the last subject completes the EOS Visit. The 
Sponsor will notify all applicable regulatory agencies in accordance with local requirements 
when the study has ended. 
6.9. 
Criteria for Treatment Discontinuation 
Subjects are free to discontinue their participation in the study at any time and without prejudice 
to further treatment. The Investigator must withdraw any subject from the study if that subject 
requests to be withdrawn, or if it is determined that continuing in the study would result in a 
significant safety risk to the subject. 
The subject's participation in this study may be discontinued for the following reasons: 
x Subject withdrew consent 
x Unacceptable AE 
x Subject is unwilling or unable to continue the study or is lost to follow up 
x Subject is non-compliant with study procedures/study protocol 
x Investigator decides that withdrawal from the study is in the best interest of the subject 


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x Any clinically significant change in subject’s medical condition (at the discretion of the 
Investigator) 
x Sponsor decision to end the study 
If a subject withdraws from the study prematurely, assessments scheduled for the EOS Visit 
should be performed as soon as possible. If a subject refuses further assessment, the subject 
should be contacted for safety evaluations (AE/concomitant medications/potential pregnancy) 
approximately 28 days after study withdrawal. 
If such withdrawal occurs, or if the subject refuses to participate in the EOS Visit, the 
Investigator must determine the primary reason for a subject’s withdrawal from the study and 
record the information on the electronic case report form (eCRF). If the reason for withdrawal is 
an AE, monitoring should continue until the outcome is evident. The specific event or test 
result(s) must be recorded in the eCRF. At the discretion of the Sponsor, subjects may also be 
removed from the study (Section 6.6). 
It should be clearly documented in the source data whether a subject withdrew his/her consent 
and will not enter the follow-up phase, or if a subject withdrew his/her consent for study drug 
treatment but will continue further participation in the study. 
6.10. 
Subject Replacement  
Only subjects missing doses or discontinuing at random (non-informative) before the primary 
visit on Day 7 will be replaced as originally randomized to receive rhu-pGSN or placebo. Safety 
data from all subjects treated with ≥1 dose will be collected. Subjects discontinuing the study 
after the Day-7 Visit will not be replaced. 
6.11. 
Criteria for Study Termination 
The Sponsor reserves the right to discontinue the study at any time for any reason. Such reasons 
may be any of, but not limited to, the following:  
x Occurrence of AEs unknown to date in respect to their nature, severity, and duration, or 
the unexpected incidence of known AEs  
x Medical or ethical reasons affecting the continued performance of the study 
If the study is prematurely terminated, the Investigator is to promptly inform the study subjects 
and Independent Ethics Committee (IEC) and should ensure appropriate follow up for the 
subjects. All procedures and requirements pertaining to the archiving of study documents should 
be followed. All other study materials (e.g., study drug, etc.) must be destroyed or returned to the 
Sponsor. 


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7. 
STUDY POPULATION 
7.1. 
Number of Subjects 
A total of 32 (6 rhu-pGSN and 2 placebo recipients per dose cohort x 4 dosing levels). 
7.2. 
Subject Inclusion Criteria 
1. Age: ≥ 18 years  
2. Gender: Either 
3. Informed consent obtained from subject  
4. Domicile: home, assisted living, rehabilitation facility, or nursing home (as long as the 
prospective participant is capable of providing written informed consent) 
5. Duration of infection precipitating hospitalization by history <14 days  
6. Planned or actual admission to hospital with a primary diagnosis of CAP within 24 hours 
of presentation to the hospital 
7. Primary admitting diagnosis of pneumonia supported by a compatible clinical 
presentation with a documented infiltrate consistent with pneumonia on chest radiograph 
or CT, as assessed by the admitting emergency-department (ED), clinic, or ward 
physician or equivalent caregiver 
¾ Recommended (not mandatory) guidance/discretionary criteria defining patients with 
CAP: 
o At least 2 symptoms: difficulty breathing, cough, production of purulent sputum, 
chest pain 
o At least 2 vital sign abnormalities: fever, tachycardia, tachypnea  
o At least one finding of other clinical signs and laboratory abnormalities: 
hypoxemia, clinical evidence of pulmonary consolidation, an elevated total white 
blood cell (WBC) count or leukopenia 
o Chest imaging showing new (or presumed new or worsening) infiltrates 
¾ Receipt of antibiotic treatment prior to presentation does not exclude the patient. 
7.3. 
Subject Exclusion Criteria 
1. Pregnant or lactating women 
2. Intubation, vasopressor support, or admission to the ICU directly from the ED/office 
(fluids for responsive hypotension is not a reason for exclusion) 
3. Use of any investigational drug in the past 30 days 
4. Hospitalization within the past 30 days 
5. Residence within the last 30 days in long-term care facility where the patient remains 
persistently unable to participate in the routine activities of daily living  


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6. Active underlying cancer treated with systemic chemotherapy or radiation therapy during 
the last 30 days 
7. Known or suspected immunosuppressive disease or therapy (including steroid use 
equivalent to prednisone ≥20 mg/day for >7 days or known advanced human 
immunodeficiency virus (HIV) infection with CD4 count ≤200/mm3; specific testing for 
HIV status or CD4 count is not required but can be done at the discretion of the 
caregivers) 
8. Active congestive heart failure, myocardial infarction, or pulmonary embolism; 
cardiopulmonary arrest in last 30 days 
9. Weight >100 kg  
10. Otherwise unsuitable for study participation in the opinion of the investigator  
7.4. 
Subjects or Partners of Subjects of Reproductive Potential 
Pregnancy is an exclusion criterion and women of childbearing potential (<60 years of age 
and/or post-hysterectomy) must not be considering getting pregnant during the study. Female 
subjects of childbearing potential must have a negative serum or urine pregnancy test within 
36 hours prior to start of study drug. A serum or urine pregnancy test will be performed at the 
EOS Visit. 
Women of childbearing potential must practice an acceptable method of birth control starting at 
screening and continuing at least 4 weeks after the last study treatment. Acceptable methods of 
birth control in this study include: true sexual abstinence (i.e., completely refraining from 
heterosexual intercourse throughout the study), hormonal methods (e.g., “the pill”, hormone 
injections, implants), barrier methods (e.g., condom or diaphragm), intrauterine device (IUD or 
“coil”), or sex exclusively with a sterilized partner. 
Male subjects with a partner who might become pregnant must use reliable forms of 
contraception (i.e., vasectomy, abstinence) during the study starting at screening and for at least 
4 weeks after the last treatment, or an acceptable method of birth control must be used by the 
partner (i.e., oral contraceptive, IUD, hormonal implants, contraceptive injection, or a double-
barrier method). 
Subjects will be instructed to notify the Investigator if pregnancy is discovered either during or 
within 6 months of the last dose of study drug.  
7.5. 
Waivers of Inclusion/Exclusion Criteria 
No waivers of these inclusion or exclusion criteria (Section 7.2 and Section 7.3) will be granted 
by the Investigator and/or the Sponsor or its designee for any subject enrolling into the study.  
 


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8. 
DESCRIPTION OF STUDY TREATMENT  
8.1. 
Description of Study Drug 
Study drug is a recombinant human plasma gelsolin (rhu-pGSN) powder for solution.  
In the SD arm, study drug will be administered as a single IV push at a rate between 5 and 20 
mL/min through a standard 0.2-micron filter at 6 mg/kg.  
In the MAD arms, study drug will be administered as a once-daily IV push at a rate between 5 
and 20 mL/min through a standard 0.2-micron filter for 3 consecutive days approximately 24 
hours apart at 6, 12, or 24 mg/kg.  
rhu-pGSN drug product is provided as a lyophilized powder containing 40 mg/mL rhu-pGSN, 
2% glycine, 4% trehalose, 0.5% arginine, and 0.1% poloxamer 188 in a 10-mM phosphate 
buffer, pH 7. It is provided as a 5 mL fill in 10 mL glass vials to be reconstituted to a volume of 
5 mL with 4.56 mL of sterile water.  
Table 4: 
Investigational Product 
 
Investigational Product 
Product Name: 
rhu-pGSN 
Dosage Form: 
Powder for solution filled as a 5 mL fill in 10 mL glass vials.  
Unit Dose 
rhu-pGSN reconstituted to a volume of 5 mL with 4.56 mL of 
sterile water 
Route of Administration 
Intravenous 
Physical Description 
Lyophilized powder  
Storage Conditions 
2 to 8 °C 
Manufacturer 
Drug Product: Integrity Bio, Inc., Camarillo, CA USA 
 
Vials containing rhu-pGSN study drug will be labeled according to national regulations for 
investigational products. 
8.2. 
Method of Assigning Subjects to Treatment Groups 
Subjects will be randomized in a 3:1 ratio to receive an IV push of rhu-pGSN or placebo (up to 
60 mL normal saline solution [NSS]) during the treatment period. See Section 8.11 for details 
regarding randomization. 


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8.3. 
Preparation of Study Drug for Administration 
The Investigator or designee will be responsible for administering the appropriate dose of IV 
rhu-pGSN to subjects. rhu-pGSN must be stored refrigerated at 2 to 8 °C in its original package 
in an appropriate storage facility accessible only to the pharmacist(s), the Investigator, or a duly 
designated person. 
This person will determine the dose (mg) of rhu-pGSN, calculate the volume of rhu-pGSN 
solution needed, and reconstitute each vial of study drug to a volume of 5 mL with 4.56 mL of 
sterile water. 
The individual rhu-pGSN IV push will be prepared under aseptic conditions and administered at 
the study site according to the directions of the Sponsor, which will be provided in a Pharmacy 
Manual. Any powder remaining in the vial must be discarded. After dilution, administration of 
rhu-pGSN should be initiated as soon as possible (within 4 hours, including no more than 2 
hours at room temperature). Maximum allowed storage times and conditions will be detailed in 
the Pharmacy Manual. 
Placebo (dosed at a volume of 0.15, 0.30, or 0.60 mL/kg (depending on the dosing arm) up to 
60 mL normal saline solution [NSS] via IV push [to match the volume of rhu-pGSN for a patient 
of that size in the specific dosing arm] injected at 5-20 mL/min through a standard 0.2-micron 
filter). 
rhu-pGSN is administered as an IV push. The placebo is NSS and requires no special 
manipulation. The placebo will be the equivalent volume on a weight basis of normal saline 
solution. 
8.4. 
Subject Monitoring During rhu-pGSN Administration 
Vital signs should be measured as outlined in Section 9.2.2. All supportive measures consistent 
with optimal patient care will be provided throughout the study according to institution 
standards. 
Precautions for anaphylaxis should be observed during rhu-pGSN administration. Emergency 
resuscitation equipment and medications should be readily available. Additional supportive 
measures should also be available and may include, but are not limited to, epinephrine, 
antihistamines, corticosteroids, IV fluids, vasopressors, oxygen, bronchodilators, 
diphenhydramine, and acetaminophen (paracetamol). 
8.5. 
Study Drug Administration 
The subject will receive a single IV push at a rate between 5 and 20 mL/min at 6 mg/kg in the 
SD arm. Doses in the MAD arms will be administered as a daily IV push at a rate between 5 and 
20 mL/min at 6, 12, or 24 mg/kg of study drug for 3 days.  The syringe, filter, and extension 
tubing should be connected after disconnecting the IV as close to the patient as possible. 
Subjects are to be monitored for administration site reactions during study drug administration 
and for 1 hour after its completion. Injection-site reactions will be recorded as AEs using the 
appropriate coding terms on the eCRF. 


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8.6. 
Shipment of Study Drug 
Prior to study treatment, study medications will be supplied to the clinical trial site's pharmacy 
by the Sponsor or its designee. 
Shipment of study drug supplies for the study will be accompanied by a shipment form 
describing the contents of the shipment, drug information, and other appropriate documentation. 
The shipment form will assist in maintaining current and accurate inventory records. 
8.7. 
Receipt and Storage of Study Drug 
All study supplies should arrive at the pharmacy in sufficient quantity and in time to enable 
dosing as scheduled. The Investigator must ensure the acknowledgement of receipt of the clinical 
trial material (i.e., study drug and placebo) at the site, including that the material was received in 
good condition.  
The Sponsor or its designee must notify the Investigator/study staff prior to dispatch of drug 
supplies, with the anticipated date of their arrival, addressed to the site’s pharmacy. 
The investigational drug will be stored in the pharmacy, refrigerated at 2 to 8 ºC. The Sponsor 
should be notified for any deviation from the storage conditions. 
8.8. 
Accountability, Handling, and Disposal of Study Drug 
The study site must maintain accurate records documenting dates and amount of study drug 
received. The trial site's pharmacy will be responsible for ensuring the supervision of the storage 
and allocation of these supplies. When a shipment is received, the pharmacist verifies the 
quantities received and the accompanying documentation and provides acknowledgment of 
receipt via the interactive web response system (IWRS).  
Accountability logs will be provided to assist the pharmacist in maintaining current and accurate 
inventory records covering receipt, dispensing, and disposition of the study drug. An unblinded 
study monitor will examine inventory during the study. Accountability records must be readily 
available and may be subject to inspection by regulatory authorities or independent auditors at 
any time.  
Drug administration will be recorded in source documents and in the eCRFs.  
At the end of the study, delivery records of study drug will be reconciled with used / unused 
supplies. A disposition form will be completed to verify that all used, unused or partially used 
supplies have been returned or destroyed following appropriate accountability review by the 
monitor. One copy of all accountability records and the disposition form will be retained by the 
Investigator for the study files. 
8.9. 
Concomitant Medications 
To date, there are no known drug interactions with rhu-pGSN. Because rhu-pGSN has no effect 
on the cytochrome p450 (CYP450) system, subjects may continue their present medications as 
directed by their caregivers. Subjects may receive concomitant medications to treat symptoms, 
AEs, and inter-current illnesses that are medically necessary as standard care. 


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All prior and concomitant medications, including generic name (if possible), and start date if 
known should be documented in the subject's file and in the eCRF. 
8.10. 
Treatment Compliance 
The study drug will be administered by personnel at the study site to ensure compliance. 
8.11. 
Randomization and Blinding 
Following screening, subjects qualified for study entry will be randomized to receive rhu-pGSN 
or placebo during the treatment period. Randomization will be done centrally using the IWRS. 
All eligible subjects will be assigned a randomization number.  
The investigational site team and the subject will be kept blinded to the treatment allocation of 
each participant. Only the designated pharmacist(s) will be unblinded to the treatment allocation. 
The unblinded pharmacist will utilize the IWRS system to randomly assign a treatment 
allocation. The treatment allocation will be available to the unblinded pharmacist(s).  
8.11.1. 
Unblinding 
The unblinded pharmacist(s) will prepare sterile syringes with filters consisting of either 6, 12, or 
24 mg/kg rhu-pGSN or normal saline (Section 8.3) according to the treatment allocation for each 
subject.  
There is no antidote for rhu-pGSN. Unblinding should only be performed if knowledge of the 
treatment assignment will change the planned management of a medical condition. If possible, 
prior to unblinding, the need to unblind should be discussed with the Medical Monitor or 
Sponsor’s Chief Medical Officer; however, this should not delay unblinding if the Investigator 
believes it is necessary. Each case of unblinding will be documented and documentation will be 
stored separately by the unblinded pharmacist.  
Subjects that are unblinded may be withdrawn from the study. The decision to withdraw a 
subject from the study because of unblinding should be discussed with the Sponsor. If the subject 
is withdrawn, the Investigator or designee must record the date and reason for withdrawal on the 
appropriate eCRF for that subject.  
 


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9. 
STUDY ASSESSMENTS 
The procedures and assessments that will be conducted during this study are described in this 
section and summarized in the Schedule of Assessments (Table 5 and Table 6). Detailed 
instructions regarding all laboratory procedures, including collection and handling of samples, 
will be included in the study Laboratory Manual provided by the Sponsor or its designee. 
Written informed consent must be granted by each subject prior to the initiation of any study 
procedure or assessment (other than those considered SOC). 


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Table 5: 
Schedule of Assessments: Single-Dose Phase 
Visit 
Screening 
Baseline/ 
Randomization/ 
Pre-Treatment  
Follow-up days 
Early 
Term/ 
End-of-
Study Visit
Day 
-1 to 0 
1h 
2 
3 or 4 
7 ± 1 
14 ±2 
28 ± 4 
Informed consent 
X 
 
 
 
 
 
 
Eligibility assessment 
X 
 
 
 
 
 
 
Medical history/signs 
and symptoms 
X 
Xi 
 
 
 
 
 
Sputum culturea 
X 
 
 
 
 
 
 
Blood or urine 
pregnancy 
X 
(for women of childbearing 
potential only) 
 
 
 
 
 
X 
Hepatitis B and C, HIV 
Not required 
(could be done at the 
discretion of caregivers) 
 
 
 
 
 
 
Confirmation of CAP 
(CXR or CT) 
X 
 
 
 
 
 
 
PSI score 
X 
 
 
X 
X 
 
X 
SOFA score 
X 
 
 
X 
X 
 
X 
CURB-65 score 
X 
 
 
X 
X 
 
X 
Physical exam 
X 
Xi 
X 
X 
X 
X 
X 
MMSE (Abbreviated 
Mental Test Score) 
X 
Xi 
X 
X 
X 
X 
X 
Vital signs, including 
pulse oximetryb 
X 
X 
X 
X 
X 
X 
X 


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Visit 
Screening 
Baseline/ 
Randomization/ 
Pre-Treatment  
Follow-up days 
Early 
Term/ 
End-of-
Study Visit
Day 
-1 to 0 
1h 
2 
3 or 4 
7 ± 1 
14 ±2 
28 ± 4 
EKGc 
X 
Xi 
 
 
 
 
X 
PK sampling for pGSN 
levelsd  
 
X 
X 
 
 
 
 
CBC with differential 
and reticulocyte count; 
PT/PTT 
X 
Xi 
X 
X 
X 
X 
X 
Comprehensive 
metabolic profile 
(including amylase or 
lipase) 
X 
Xi 
X 
X 
X 
X 
X 
Biomarker sampling e 
 
X 
X 
X 
X 
X 
X 
Anti-rhu-pGSN 
antibody sampling 
(immunogenicity)f 
 
 
 
 
 
 
X 
Study drug 
administrationg 
 
X 
 
 
 
 
 
AEs 
 
X 
X 
X 
X 
X 
X 
Con meds 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: AEs=adverse events; CAP=community-acquired pneumonia; CBC=complete blood count; Con meds=concomitant medications; 
CT=computed tomography; CURB-65=Confusion, Urea >7 mmol/L, Respiratory rate ≥30/min, Blood pressure systolic <90 or diastolic ≤60, and 
age ≥65 years (score); CXR=chest x-ray; EKG=electrocardiogram; HIV=human immunodeficiency virus; MMSE= mini-mental state examination; 
PD=pharmacodynamic; PK=pharmacokinetic; PSI=pneumonia severity index; PT=prothrombin time; PTT=partial thromboplastin time; SOFA= 
sequential organ failure assessment (score); Term=termination. 


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a Collect sputum sample as soon as possible if not collected at the time of hospital admission. The microbiology lab is encouraged to 
also perform sputum Gram-stains, antigen detection, immunoassay, and genomic diagnostic tests when available. If fevers or chills are 
present, 2 sets of blood cultures are recommended at the discretion of the caregivers. 
b Record blood pressure, oral temperature, respiration rate, and heart rate, as well as pulse oximetry. To be measured during study drug 
administration at the following time points: predose, at the end of administration, and 30 minutes after the end of administration. 
c When EKGs are to be collected at the same time point as a blood collection, EKGs should be collected first. Three serial, resting, 
supine 12-lead EKGs are to be conducted within 10 minutes total time. 
d Blood for PK will be drawn within 30 minutes predose, 5-10 minutes after the end of administration, and 2, 8, 12 and/or 16, and 24 
hrs (± 30 minutes) after the end of administration. Sampling at both the 12- and 16-hour time points is encouraged where feasible, but 
only one of these two times is required. The last PK sample (i.e., 24 hours after the end of administration) will occur on Day 2. 
Samples are spun and plasma frozen and sent to a central lab for analysis. 
e A 10-mL aliquot (equal parts serum and plasma) will be frozen for subsequent biomarker analysis including, but not limited to, 
procalcitonin, pGSN, TNFα, TGFβ, IL1β, IL1ra, IL2, IL4, IL6, IL10, IL17a levels and sent to a central lab for analysis. 
f Sample to be sent to a central lab for analysis. 
g Subjects are to be monitored for administration site reactions during study drug administration and for 1 hour after its completion. 
h Day 1 is the first day of study treatment. Baseline tests (including blood draws) should be performed prior to administration of the 
first dose. 
i Test/assessment does not have to be repeated if performed within the prior 36 hours unless dictated by standard of care. 


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Table 6: 
Schedule of Assessments: Multiple-Ascending Dose Phase 
Visit 
Screening 
Baseline/ 
Randomization/ 
Pre-Treatment  
Follow-up days 
Early 
Termination/
End-of-Study 
Visit 
Day 
-1 to 0 
1j 
2 
3 
4 
7 ± 1 
14 ±2 
28 ± 4 
Informed consent 
X 
 
 
 
 
 
 
 
Eligibility assessment 
X 
 
 
 
 
 
 
 
Medical history/ signs and 
symptoms 
X 
Xk 
 
 
 
 
 
 
Sputum culturea 
X 
 
 
 
 
 
 
 
Blood or urine pregnancy 
X 
(for women of 
childbearing 
potential only) 
 
 
 
 
 
 
X 
Hepatitis B and C, HIV 
Not required 
(could be done 
at the discretion 
of caregivers) 
 
 
 
 
 
 
 
Confirmation of CAP (CXR or 
CT) 
X 
 
 
 
 
 
 
 
PSI score 
X 
 
 
 
X 
X 
 
X 
SOFA score 
X 
 
 
 
X 
X 
 
X 
CURB-65 score 
X 
 
 
 
X 
X 
 
X 
Physical exam 
X 
Xk 
X 
X 
X 
X 
X 
X 
MMSE (Abbreviated Mental Test 
Score) 
X 
Xk 
X 
X 
X 
X 
X 
X 


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Visit 
Screening 
Baseline/ 
Randomization/ 
Pre-Treatment  
Follow-up days 
Early 
Termination/
End-of-Study 
Visit 
Day 
-1 to 0 
1j 
2 
3 
4 
7 ± 1 
14 ±2 
28 ± 4 
Vital signs, including pulse 
oximetry b 
X 
X 
X 
X 
X 
X 
X 
X 
EKGc 
X 
Xk 
 
 
 
 
 
X 
PK sampling for pGSN levelsd  
 
X 
X 
Xe 
Xe 
 
 
 
CBC with differential and 
reticulocyte count; PT/PTT 
X 
Xk 
X 
- 
X 
X 
X 
X 
Comprehensive metabolic profile, 
including amylase or lipase 
X 
Xk 
X 
- 
X 
X 
X 
X 
Biomarker sampling f 
 
X 
X 
X 
X 
X 
X 
X 
Anti-rhu-pGSN antibody 
sampling (immunogenicity)g 
 
 
 
 
 
 
 
X 
Study drug administrationh 
 
X 
X 
Xi 
 
 
 
 
AEs 
 
X 
X 
X 
X 
X 
X 
X 
Con meds 
X 
X 
X 
X 
X 
X 
X 
X 
Abbreviations: AEs=adverse events; CAP=community-acquired pneumonia; CBC=complete blood count; Con meds=concomitant medications; 
CT=computed tomography; CURB-65=Confusion, Urea >7 mmol/L, Respiratory rate ≥30/min, Blood pressure systolic <90 or diastolic ≤60, and 
age ≥65 years (score); CXR=chest x-ray; EKG=electrocardiogram; HIV=human immunodeficiency virus; MMSE= mini-mental state examination; 
PD=pharmacodynamic; PK=pharmacokinetic; PSI=pneumonia severity index; PT=prothrombin time; PTT=partial thromboplastin time; SOFA= 
sequential organ failure assessment (score). 
a Collect sputum sample as soon as possible if not collected at the time of hospital admission. The microbiology lab is encouraged to 
also perform sputum Gram-stains, antigen detection, immunoassay, and genomic diagnostic tests when available. If fevers or chills are 
present, 2 sets of blood cultures are recommended at the discretion of the caregivers. 


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b Record blood pressure, oral temperature, respiration rate, and heart rate, as well as pulse oximetry. To be measured during study drug 
administration at the following time points: predose, at the end of administration, and 30 minutes after the end of administration. 
c When EKGs are to be collected at the same time point as a blood collection, EKGs should be collected first. Three serial, resting, 
supine 12-lead EKGs are to be conducted within 10 minutes total time. 
d Doses in the multiple-dose arms should be given at 24-hour (± 60-minute) intervals. Blood for PK will be drawn within 30 minutes 
predose, 5-10 minutes after the end of administration, and 2, 8, 12 and/or 16, and 24 hrs (± 30 minutes) after the end of administration. 
Sampling at both the 12- and 16-hour time points is encouraged where feasible, but only one of these two times is required. In the 
multiple-dose arms, the sample at 24 hours after the prior dose must be drawn before the next dose is given and can serve as the 
predose sample for the next dose as long as administered within the subsequent 30 minutes. Samples are spun and plasma frozen and 
sent to a central lab for analysis. 
e Identical blood collection for PK analysis is encouraged on Day 3 but not required. Where feasible, the last PK sample would occur 
on Day 4 (i.e., 24 hours after the end of administration on Day 3); otherwise, because there is no study drug administered after Day 3, 
no further PK sampling would be done on Day 4. Samples are spun and plasma frozen and sent to a central lab for analysis. 
f A 10-mL aliquot (equal parts serum and plasma) will be frozen for subsequent biomarker analysis including, but not limited to, 
procalcitonin, pGSN, TNFα, TGFβ, IL1β, IL1ra, IL2, IL4, IL6, IL10, IL17a levels and sent to a central lab for analysis. 
g Sample to be sent to a central lab for analysis. 
h Subjects are to be monitored for administration site reactions during study drug administration and for 1 hour after its completion. 
i The third dose of study drug may be given in a monitored outpatient setting where appropriate. 
j Day 1 is the first day of study treatment. Baseline tests (including blood draws) should be performed prior to administration of the 
first dose. 
k Test/assessment does not have to be repeated if performed within the prior 36 hours unless dictated by standard of care. 
 


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9.1. 
Screening Assessments 
Prior to screening, all subjects must provide informed consent for study participation, per 
Section 13.5. The following assessments will be performed according to the time points in the 
Schedule of Assessments tables (Table 5 and Table 6). 
9.1.1. 
HIV Testing 
Subjects are not required to have a negative serology test for HIV to participate in the study. 
Testing could be done at the discretion of caregivers. 
9.1.2. 
Confirmation of CAP 
Subjects are required to have a confirmed CAP diagnosis at screening. If confirmation is not 
available, the subject must undergo testing to confirm CAP. 
9.1.3. 
Pregnancy Test 
All females of childbearing potential are required to have a negative serum or urine pregnancy 
test at screening to participate in the study.  
9.2. 
Safety Assessments 
The following assessments will be performed according to the time points in the Schedule of 
Assessments tables (Table 5 and Table 6). 
9.2.1. 
Demographic/Medical History 
A review of demographic parameters, including age, gender, race and ethnicity will be 
performed at screening.  
Past and present medical history will be recorded. Any ongoing condition or signs and symptoms 
observed prior to the initiation of study treatment should be recorded as medical history.  
9.2.2. 
Vital Signs 
Vital signs will include blood pressure, oral temperature, respiration rate, and heart rate, as well 
as pulse oximetry. Vitals signs will be measured during study drug administration at the 
following time points: predose, at the end of administration, and 30 minutes after the end of 
administration. Significant findings noticed after the start of study drug that meet the definition 
of an AE must be recorded in the eCRF. 
9.2.3. 
Physical Examination 
All physical examinations, including measurement of body weight, will be performed by a study 
physician or designee. Height need only be measured at the screening examination. The initial 
body weight measured at enrollment will be used to calculate rhu-pGSN dosing for all doses (so 
that an individual subject will always receive the same dose). The physical examination includes 
skin, head, ears, eyes, nose, throat, heart, lungs, abdomen, and neurologic system. Additional 
examination may be performed as found relevant by the Investigator. 


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9.2.4. 
Outcome Prediction Models 
The CURB-65 (Appendix A), PSI (Appendix C), and SOFA (Appendix D) tests will be 
administered. The cognitive status of the subject will be informally assessed for incorporation in 
the CURB-65 score by using the mini-mental state examination (MMSE; also referred to as the 
abbreviated mental test score; Appendix B). If the caregivers are concerned about abnormalities 
of cognition, subjects will be further evaluated at the discretion of the caregivers, which may 
involve being asked questions according to the MMSE or similar tool to assess cognitive 
function.  
9.2.5. 
Electrocardiogram 
All EKGs will be conducted and read locally. When EKGs are to be collected at the same time 
point as a blood collection, EKGs should be collected first. Three serial, resting, supine, 12-lead 
EKGs will be conducted within 10 minutes total time. The mean of the triplicate EKG 
measurements performed at screening will serve as the subject’s baseline corrected QT (QTc) 
value for all post-dose comparisons.  
EKG parameters to be evaluated include heart rate, the time from the onset of the P wave to the 
start of the QRS complex (PR), the duration of the entire cardiac cycle, measured in seconds 
(RR), the combination of three of the graphical deflections (QRS complex), the measure of the 
time between the start of the Q wave and the end of the T wave (QT) intervals, and the QT 
interval corrected for heart rate using Fridericia’s formula (QTcF). 
9.2.6. 
Laboratory Assessments 
All routine clinical laboratory assessments will be performed by the hospital laboratory or 
equivalent, when appropriate. Where indicated, handling and shipping clinical laboratory 
samples to a central laboratory will be outlined in the Laboratory Manual.  
Screening laboratory and other tests can serve as baseline values for participants (no need to 
repeat lab tests at entry if done within the prior 36 hours unless dictated by SOC). 
The laboratory evaluations will include: 
1. Hematology: complete blood count with differential white count and reticulocyte count, 
and platelet count; PT/PTT 
2. Comprehensive metabolic profile (including chemistries/electrolytes, TP/albumin, 
BUN/creatinine, C-reactive protein (CRP), lactose dehydrogenase (LDH), creatine 
phosphokinase (CPK), alanine aminotransferase (ALT), aspartate aminotransferase 
(AST), total bilirubin, alkaline phosphatase, and amylase or lipase 
3. Respiratory function (oxygen saturation by pulse oximetry; arterial blood gas tests only at 
the caregiver’s discretion) 
Abnormal laboratory test results considered clinically significant by the Investigator or that 
require treatment should be reported as AEs in the eCRF.  


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9.3. 
Pharmacokinetic Assessments 
For the one dose in the SD arm and the first 2 doses in the MAD arms, blood will be drawn 
within 30 minutes predose, and 5-10 minutes after the end of administration, as well as 2, 8, 12 
and/or 16, and 24 hours after the end of administration (± 30 minutes) for analysis of plasma for 
Cmax, Tmax, T1/2, AUC0-8, AUCinf. Sampling at both the 12- and 16-hour time points is encouraged 
where feasible, but only one of these two times is required. Identical PK sampling is encouraged 
on Day 3 where feasible but not required in the multiple-dose arms. 
9.4. 
Pharmacodynamic Assessments 
A 10-mL aliquot (equal parts serum and plasma spun from 20 mL of whole blood) collected on 
study days indicated in Table 5 and Table 6 will be frozen for subsequent analysis of the 
following: 
x Biomarkers including, but not limited to, procalcitonin, pGSN, TNFα, TGFβ, IL1β, 
IL1ra, IL2, IL4, IL6, IL10, IL17a levels  
9.5. 
Other Assessments 
Other analyses to be performed include: 
o Blood, sputum, and other cultures as clinically indicated (note that a sputum culture is 
mandatory if a sputum specimen can be obtained and blood cultures are strongly 
encouraged at entry into the study) 
o Sputum neutrophil elastase (where feasible at entry and near the conclusion of study 
therapy) 
 
 


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10. 
ADVERSE EVENT MANAGEMENT 
10.1. 
Definition of Adverse Events 
10.1.1. 
Adverse Event (AE) 
An AE is the development of an undesirable medical condition or the worsening of a pre-existing 
medical condition following or during exposure to a pharmaceutical product, whether or not 
considered causally related to the product.  
10.1.2. 
Serious Adverse Event (SAE) 
A serious adverse event (SAE) is an AE occurring during any study phase (i.e., baseline, 
treatment, or follow-up), and at any dose of the investigational product, comparator or placebo, 
that fulfils one or more of the following: 
x Results in death 
x It is immediately life-threatening 
x It requires in-patient hospitalization or prolongation of existing hospitalization 
x It results in persistent or significant disability or incapacity 
x Results in a congenital abnormality or birth defect 
x It is an important medical event that may jeopardize the subject or may require medical 
intervention to prevent one of the outcomes listed above. 
All SAEs that occur after a subject has signed the consent form and has been randomized, 
including before or during treatment and within 28 days following the cessation of treatment, 
whether or not judged to be related to the study, must be recorded on forms provided by the 
Sponsor. 
10.2. 
Clarifications to Serious Adverse Event Reporting 
Death is an outcome of an SAE and not an SAE in itself. When death is an outcome, report the 
event(s) resulting in death as the SAE term (e.g., “pulmonary embolism”). If the cause of death is 
unknown, report “Death, unknown cause” as the SAE term. 
10.3. 
Assessment of Causality 
The relationship of each AE to the study drug administration will be assessed by the Investigator 
after careful consideration of all relevant factors such as (but not limited to) the underlying study 
indication, coexisting disease, concomitant medication, relevant history, pattern of the AE, 
temporal relationship to receipt of the study medication and de-challenge or re-challenge 
according to the following guidelines: 
YES (possible, probably or definitely related): there is a reasonable possibility that the study 
drug caused the event; one or more of the following criteria apply:  
• 
The event follows a reasonable temporal sequence from administration of study drug.  


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• 
The event could not be reasonably attributed to the known characteristics of the subject’s 
clinical state, environment or toxic factors or other modes of therapy administered to the 
subject.  
• 
The event follows a known pattern of response to study drug.  
• 
The event disappears or decreases on cessation or reduction in dose of the study drug. In 
some situations, an AE will not disappear or decrease in intensity upon discontinuation of 
the study drug despite other clear indications of relatedness.  
NO (probably not related or definitely not related): There is no reasonable possibility that the 
study drug caused the event; one or more of the following criteria apply:  
• 
The event does not follow a reasonable temporal sequence from administration of study 
drug.  
• 
The event could be reasonably attributed to the known characteristics of the subject’s 
clinical state, concurrent illness, environment or toxic factor or other modes of therapy 
administered to the subject.  
• 
The event does not follow a known pattern of response to study drug.  
• 
The event does not disappear or decrease on cessation or reduction in dose of the study 
drug, and it does not reappear or worsen when the study drug is re-administered. 
10.4. 
Assessment of Severity 
The severity rating of an AE refers to its intensity. The severity of each AE will be categorized 
using the NCI CTCAE, v 4.03 (or higher). For any term that is not specifically listed in the 
CTCAE scale, intensity should be assigned a grade of 1 through 5 using the following CTCAE 
guidelines: 
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated 
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living 
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization 
or prolongation of hospitalization indicated; disabling; limiting self-care activities of 
daily living 
Grade 4: Life-threatening consequences; urgent intervention indicated 
Grade 5: Death related to AE 
It is important to distinguish between serious and severe AEs. Severity is a measure of intensity 
whereas seriousness is defined by the criteria under Section 10.1.2. An AE of severe intensity 
may not be considered serious. 


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10.5. 
Pregnancy or Drug Exposure during Pregnancy 
If a subject becomes pregnant during the study, administration of study drug is to be 
discontinued immediately. 
Pregnancies must be reported within 24 hours of the Investigator’s knowledge using the 
Sponsor’s pregnancy form.  
Pregnancy in itself is not regarded as an AE or SAE unless there is a suspicion that an 
investigational product may have interfered with the effectiveness of a contraceptive medication. 
The outcome of all pregnancies (spontaneous miscarriage, elective termination, normal birth or 
congenital abnormality) must be followed up and documented even if the subject was 
discontinued from the study. 
All reports of congenital abnormalities/birth defects are SAEs. Spontaneous miscarriages should 
also be reported and handled as SAEs. Elective abortions without complications should not be 
handled as AEs. 
10.6. 
Laboratory Abnormalities 
To the extent possible, all laboratory abnormalities observed during the course of the study will 
be included under a reported AE term describing a clinical syndrome (e.g., elevated BUN and 
creatinine in the setting of an AE of “renal failure”). In these cases (e.g., an AE of renal failure), 
the laboratory abnormality itself (e.g., elevated creatinine) does not need to be recorded as an 
AE.  
If a laboratory abnormality cannot be reported as a clinical syndrome, AND if the laboratory 
abnormality results in a therapeutic intervention (i.e., concomitant medication or therapy), is a 
DLT, or is judged by the Investigator to be of other clinical relevance, then the laboratory 
abnormality should be reported as an AE.  
Subjects experiencing AEs or clinically significant laboratory abnormalities will be assessed and 
appropriate evaluations performed until all parameters have returned to baseline levels or are 
consistent with the subject’s then-current physical condition.  
10.7. 
Reporting Adverse Events 
All AEs, serious and nonserious, will be fully documented on the appropriate eCRF. For each 
AE, the Investigator must provide its duration (start and end dates or ongoing), intensity, 
assessment of causality and whether specific action or therapy was required. 
All AEs that occur from the signing of the informed consent form (ICF) until the first dose of 
study drug should be recorded on the AE eCRF page only if the event was related to a study 
procedure. All other AEs/findings prior to first dose of study drug should be recorded as medical 
history on the applicable eCRF page. All AEs occurring from the first dose of study drug until 
28 days after the last dose of study drug must be recorded on the AE eCRF. 
All SAEs (related and unrelated) must be reported to the Sponsor within 24 hours of the 
Investigator’s knowledge. This should be done by faxing/emailing the completed SAE Report 
Form to the number provided on the SAE Report Form. After the EOS Visit, only new treatment-
related SAEs need to be captured on the AE eCRF and reported to the Sponsor.  


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Investigators must follow subjects with AEs/SAEs until the event has resolved, the condition has 
stabilized, withdrawal of consent, the subject is lost to follow up or death OR until the EOS 
Visit, whichever occurs first. New and ongoing treatment-related SAEs should be followed 
beyond the EOS Visit. If the subject dies, this should be captured as the outcome of the AE 
unless no link between the AE and the subject death can be established, in which case the AE 
will be marked as ongoing and the death will be reported as a separate event. 
If a subject is lost to follow up, this should be captured accordingly within the AE eCRF and on 
the follow up SAE report.  
The Sponsor or designee is responsible for notifying the relevant regulatory authorities of 
applicable suspected unexpected serious adverse reactions (SUSARs) as individual notifications 
or through periodic line listings. It is the Principal Investigator’s responsibility to notify the 
Institutional Review Board (IRB) or IEC of all SAEs that occur at his or her site. Investigators 
will also be notified of all unexpected, serious, drug-related events (7/15 Day Safety Reports) 
that occur during the clinical trial. Each site is responsible for notifying its IRB or IEC of these 
additional SAEs. 


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11. 
STATISTICS 
11.1. 
General Overview 
All subjects given ≥1 dose of study drug will be included in the intention-to- treat population; 
missing values will not be imputed but safety data (death and other AEs) will be carried forward. 
Subjects receiving all 3 doses and evaluable at Day 7 will constitute the per-protocol population. 
The expectation is that both populations will be almost identical. 
Results will be summarized via summary statistics separately for each pGSN dose level in the 
SD and MAD portions of the trial; pooled for all placebo subjects. Additional details will be 
provided in a separate Statistical Analysis Plan (SAP). 
11.2. 
Sample Size and Power Calculations 
The sample size of N=6 rhu-pGSN recipients per dose level and combined placebo in the SD and 
MAD portions of the trial were chosen based on limiting exposure to pGSN in this initial study 
in the current development program. The sample sizes in this trial have the following properties 
in relation to interpretation of AE incidence rates (Table 7). 
Table 7 presents the Minimum Sample Size such that there is 90% probability of observing at 
least 1 AE of a certain type if the TRUE underlying AE rate. 
Table 7: 
Minimum Sample Size Calculations 
Sample Size 
TRUE underlying AE rate 
6 (each pGSN dose level) 
32% 
8 (pooled placebo) 
21% 
24 (pooled pGSN) 
10% 
With each sample size presented in the table above, if zero AEs of a certain type are observed, 
one could be "90% confident" the TRUE underlying rate for that AE is at most the rate indicated 
above. 
11.3. 
Analysis Populations  
No data will be excluded from the summary statistics and analyses, and missing data will not be 
imputed. AEs, including death, will be carried forward. As a sensitivity analysis to the intention-
to-treat population, a per-protocol population excluding subjects who missed doses and/or 
randomly discontinued the study before the primary Day-7 Visit will be analyzed. 
11.4. 
Criteria for Evaluation and Statistical Methods 
11.4.1. 
Safety 
AE data will be summarized by counts and proportions of subjects having an AE, each AE type, 
and an AE of each System Organ Class. These summaries will be provided for each dose and 
placebo (all placebo subjects combined). Serious AEs will be summarized similarly. Reasons for 
any early discontinuations will be summarized similarly. 


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Laboratory data in relation to normal range values will be summarized via counts and 
percentages of subjects below, within, and above the respective normal range, and by summary 
statistics (N, mean, median, standard deviation, minimum, maximum, 90% confidence intervals, 
etc.) for baseline, each observed time point, and change from baseline at each observed time 
point for continuous lab endpoints. 
11.4.2. 
Baseline Characteristics  
Demographics and disease-related characteristics will be summarized via counts and percentages 
of subjects for categorical variables, and by N, mean, median, standard deviation, minimum, 
maximum for continuous variables. Summaries will be performed separately by dose group and 
placebo subjects (all placebo subjects combined), and for all subjects combined. 
11.4.3. 
Pharmacokinetics and Immunogenicity 
To complete the PK analyses, plasma specimens will be periodically sampled relative to study 
drug administration and stored frozen for pGSN measurements. For the 1 dose in the SD arm and 
the first 2 doses in the MAD arms, blood will be drawn within 30 minutes predose, and 5-10 
minutes after the end of administration, as well as 2, 8, 12 and/or 16, and 24 hours  after the end 
of administration (± 30 minutes) for analysis of Cmax, Cmax, T1/2, AUC0-8h, and AUCinf. Identical 
PK sampling is encouraged on Day 3 where feasible (but not required) in the multiple-dose arms. 
Immunogenicity will be assessed at the last visit on Day 28 ± 2 days.  Antibodies against 
rhu-pGSN will be assayed from frozen specimens to determine whether the investigational 
product induces an antibody response in recipients. 
11.4.4. 
Pharmacodynamics 
Biomarker and clinical outcomes will be summarized via counts and percentages of subjects for 
categorical variables, and by summary statistics (N, mean, median, standard deviation, 
minimum, maximum, 90% confidence intervals, etc.) for baseline, each observed time point, and 
change from baseline at each observed time point for continuous variables. Data will be assessed 
via graphical and Shapiro-Wilk statistic for closeness to normal distribution and if substantial 
departure is observed, transformation (e.g., natural log, reciprocal, square root, ranks) may be 
employed to derive the summary statistics. 


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12. 
DATA RECORDING, RETENTION AND MONITORING 
12.1. 
Case Report Forms 
Data will be collected using an electronic data capture (EDC) system at the clinical site. The 
Investigator or designee will record data specified in the protocol using eCRFs. Changes or 
corrections to eCRFs will be made by the Investigator or an authorized member of the study staff 
according to the policies and procedures at the site and the eCRF completion guidelines. 
It is the responsibility of the Investigator to ensure eCRFs are complete and accurate. Following 
review and approval, the Investigator or designee will electronically sign and date the pages. 
This signature certifies that the Investigator has thoroughly reviewed and confirmed all data on 
the eCRF. Regardless of whether this responsibility has been delegated, the Investigator is 
personally responsible for the accuracy and completeness of all data included in the eCRF. 
The Sponsor or designee will provide a portable document format (PDF) file of the eCRFs to the 
site for archiving after all data have been monitored and reconciled. 
12.2. 
Records Retention 
Per Good Clinical Practice (GCP) guidelines regarding records retention, study documents are to 
be retained at the site until at least 2 years after the last approval of a marketing application in an 
International Council for Harmonization of Technical Requirements for Pharmaceuticals for 
Human Use (ICH) region or at least 2 years have elapsed since the formal discontinuation of 
clinical development of study drug. The Sponsor will notify the site of the date when study 
documentation may be destroyed. 
12.3. 
Data Monitoring 
This study will be closely monitored by representatives of the Sponsor throughout its duration. 
Monitoring will include personal visits with the Investigator and study staff as well as 
appropriate communications by telephone, fax, mail, email or use of the EDC system, if 
applicable. It is the responsibility of the monitor to inspect eCRFs at regular intervals throughout 
the study to verify the completeness, accuracy and consistency of the data and to confirm 
adherence to the study protocol and to GCP guidelines. The Investigator agrees to cooperate with 
the monitor to ensure that any problems detected during the course of this study are resolved 
promptly. The Investigator and site will permit study-related monitoring, audits, IEC review and 
regulatory inspection, including direct access to source documents. 
It is understood that study monitors and any other personnel authorized by the Sponsor and/or 
Sponsor representatives may contact and visit the Investigator and will be permitted to inspect all 
study records (including eCRFs and other pertinent data) on request, provided that subject 
confidentiality is maintained and that the inspection is conducted in accordance with local 
regulations. 
Every effort will be made to maintain the anonymity and confidentiality of subjects during this 
study. However, because of the experimental nature of this treatment, the Investigator agrees to 
allow representatives of the Sponsor as well as authorized representatives of regulatory 
authorities to inspect the facilities used in the conduct of this study and to inspect, for purposes 
of verification, the hospital or clinic records of all subjects enrolled in the study. 


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12.4. 
Quality Control and Quality Assurance 
The study site may be audited by a quality assurance representative of the Sponsor or its 
designee for the purpose of monitoring any aspect of the study. The Investigator agrees to allow 
the monitor and/or auditor to inspect the drug storage area, study drug stocks, drug accountability 
records, patient charts and study source documents, and other records relative to study conduct.   
The Investigator should contact the Sponsor or designee immediately if contacted by a regulatory 
agency about an inspection.  


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13. 
REGULATORY, ETHICAL AND LEGAL OBLIGATIONS 
13.1. 
Good Clinical Practice 
The study will be performed in accordance with the protocol, guidelines for GCP established by 
the ICH, and applicable local regulatory requirements and laws. 
13.2. 
Independent Ethics Committee Approval 
The Investigator must inform and obtain approval from the IEC for the conduct of the study at 
named sites, the protocol, informed consent documents and any other written information that 
will be provided to the subjects and any advertisements that will be used. Written approval must 
be obtained prior to recruitment of subjects into the study and shipment of study drug. 
The Investigator is responsible for informing the IEC of any amendment to the protocol in 
accordance with local requirements. Amendments may be implemented only after a copy of the 
approval letter from the IEC has been transmitted to the Sponsor. Amendments that are intended 
to eliminate an apparent immediate hazard to subjects may be implemented prior to receiving 
Sponsor or IEC approval. However, in this case, approval must be obtained as soon as possible 
after implementation. 
Per GCP guidelines, the Investigator will be responsible for ensuring that an annual update is 
provided to the IEC to facilitate continuing review of the study and that the IEC is informed 
about the end of the study. Copies of the update, subsequent approvals and final letter must be 
sent to the Sponsor. 
13.3. 
Regulatory Authority Approval 
The study will be performed in accordance with regional regulatory requirements and will also 
meet all of the requirements of ICH GCP guidance. Amendments to the protocol will be 
submitted to the appropriate regulatory agency/agencies prior to implementation in accordance 
with applicable regulations. 
13.4. 
Other Required Approvals 
In addition to IEC and regulatory authority approval, all other required approvals (e.g. approval 
from the local research and development board or scientific committee) will be obtained prior to 
recruitment of subjects into the study and shipment of study drug. 
13.5. 
Informed Consent 
It is the responsibility of the Investigator (or designee) to obtain written informed consent from 
each subject after adequate explanation of the aims, methods and potential hazards of the study 
and before any study procedures are initiated. The subject should be given the opportunity to ask 
questions and allowed time to consider the information provided.  Each subject should be given a 
copy of the informed consent document and associated materials. The original copy of the signed 
and dated informed consent document must be retained at the site and is subject to inspection by 
representatives of the Sponsor or regulatory authorities; the subject should be given a copy of the 
signed ICF. 


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Substantial changes to the study protocol may necessitate modifications to the informed consent 
document. If an amended informed consent document is issued during a subject’s participation in 
the study, the subject is required to provide written informed consent using the updated consent 
form prior to continuing with study-related activities. 
Subjects unable or unwilling to provide written informed consent will not be enrolled in the 
study. 
13.6. 
Subject Confidentiality 
The Investigator must ensure that subjects’ privacy is maintained. On the eCRF or other 
documents submitted to the Sponsor, subjects will be identified by a subject number or a subject 
number and initials only. Documents that are not submitted to the Sponsor (e.g., signed informed 
consent documents) should be kept in a strictly confidential file by the Principal Investigator. 
The Investigator shall permit authorized representatives of the Sponsor, regulatory authorities 
and IECs to review the portion of the subject’s medical record that is directly related to the study. 
As part of the required content of informed consent documents, the subject must be informed that 
his/her records will be reviewed in this manner. 
13.7. 
Disclosure of Information 
Information concerning the study, patent applications, processes, scientific data or other pertinent 
information is confidential and remains the property of the Sponsor. The Principal Investigator 
may use this information for the purposes of the study only. 
It is understood by the Principal Investigator that the Sponsor will use information obtained in 
this clinical study in connection with the clinical development program, and therefore may 
disclose it as required to other clinical Investigators and to regulatory authorities. In order to 
allow the use of the information derived from this clinical study, the Principal Investigator 
understands that he/she has an obligation to provide complete test results and all data obtained 
during this study to the Sponsor. 
Verbal or written discussion of results prior to study completion and full reporting should only 
be undertaken with written consent from the Sponsor. 


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14. 
LIST OF REFERENCES 
Bucki R, Georges P, Espinassous Q, et al. Inactivation of endotoxin by human plasma gelsolin. 
Biochemistry 2005; 44:9590–7. 
Bucki R, Byfield F, Kulakowska A, et al. Extracellular Gelsolin Binds Lipoteichoic Acid and 
Modulates Cellular Response to Proinflammatory Bacterial Wall Components. J Immunol 2008; 
181:4936- 4944. 
Bucki R, Kulakowska A, Byfield FJ, et al. Plasma gelsolin modulates cellular response to 
sphingosine 1-phosphate. Am J Physiol, Cell Physiol. 2010; 299:C1516–23. 
Centers for Disease Control and Prevention (US). National Center for Health Statistics 2010 
NHDS data file documentation [cited 2017 Feb 28]. Available from: URL: 
https://www.cdc.gov/nchs/nhds/nhds_publications.htm. 
Goetzel EJ, Lee H, Azuma T, et al. Gelsolin Binding and Cellular Presentation of 
Lysophosphatidic Acid. J Biol Chem 2000; 275:14573-8. 
Haddad JG, Harper KD, Guoth M, et al. Angiopathic consequences of saturating the plasma 
scavenger system for actin. Proc Natl Acad Sci USA. 1990; 87:1381-5. 
Kochanek KD, Murphy SL, Xu JQ. Deaths: Final data for 2011. National vital statistics reports; 
vol 63 no 3. Hyattsville, MD: National Center for Health Statistics. 2015. 
Lee WM, Galbraith RM. The extracellular actin-scavenger system and actin toxicity. N Engl J 
Med 1992; 326:1335-41. 
Lee P, Drager L, Stossel T, et al. Relationship of plasma gelsolin levels in outcomes of critically 
ill surgical patients. Ann Surg 2006; 243:399-403. 
Lee PS, Patel S, Christiani DC, et al. Plasma gelsolin depletion and circulating actin in sepsis: a 
pilot study. PLoS ONE 2008; 3:e3712. 
Lee P, Sampath K, Karumanchi S, et al. Plasma Gelsolin and Circulating Actin Correlate with 
Hemodialysis Mortality. J Am Soc Nephrol 2009; 20:1140-8. 
Lim WS, van der Eerden MM, Boersma WG, et al. Defining community acquired pneumonia 
severity on presentation to hospital: an international derivation and validation study. Thorax 
2003; 58:377-82. 
Lind SE, Janmey PA. Human plasma gelsolin binds to fibronectin. J Biol Chem 1984; 
259:13262-6. 
Niederman MS, Mandell LA, Anzueto A, et al. American Thoracic Society and the American 
Thoracic Society: Guidelines for the management of adults with community-acquired 
pneumonia, diagnostic assessment of severity, antimicrobial therapy, and prevention. Am Rev 
Respir Crit Care Med 2001; 163:1730-54.  
Neill AM, Martin IR, Weir R, et al. Community acquired pneumonia: etiology and usefulness of 
severity criteria on admission. Thorax 1996; 51:1010-16. 
Osborn TM, Dahlgren C, Hartwig JH, et al. Modifications of cellular responses to 
lysophosphatidic acid and platelet-activating factor by plasma gelsolin. Am J Physiol Cell 
Physiol 2007; 292:C1323-30.  


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Osborn T, Verdrengh M, Stossel T, et al. Decreased levels of the gelsolin plasma isoform in 
patients with rheumatoid arthritis. Arthritis Res Ther 2008, 10:R117. 
Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions 
for Sepsis and Septic Shock (Sepsis-3). JAMA 2016; 315:801-10. 
Smith DB, Janmey PA, Herbert TJ, et al. Quantitative measurement of plasma gelsolin and its 
incorporation into fibrin clots. J Lab Clin Med 1987;110:189-95. 
The British Thoracic Society and the Public Health Laboratory Service. Community-acquired 
pneumonia in adults in British hospitals in 1982-1983: a survey of etiology, mortality, prognosis 
factors, and outcome. Q J Med 1987; 62:195-220.  
Vasconcellos CA and Lind SE. Coordinated inhibition of actin-induced platelet aggregation by 
plasma gelsolin and vitamin D-binding protein. Blood 1993; 82:3648-57. 
Yang Z, Chiou T, Stossel T, et al. Plasma gelsolin improves lung host defense against 
pneumonia by enhancing macrophage NOS3 function. Am J Physiol Lung Cell Mol Physiol 
2015; 309: L11–L16.  
 


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15. 
APPENDICES 
 


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APPENDIX A: CURB-65 SCORE 
The score is an acronym for each of the risk factors measured. Each risk factor scores one point, 
for a maximum score of 5: 
x 
Confusion of new onset (defined by the Mini-Mental Status Exam Score [Abbreviated 
Mental Test Score; see Appendix B] of 8 or less [2 or more incorrect answers]) 
x 
Blood Urea nitrogen greater than 7 mmol/l (19 mg/dL) 
x 
Respiratory rate of 30 breaths per minute or greater 
x 
Blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less 
x 
Age 65 or older 
 
 


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APPENDIX B: MINI-MENTAL STATE EXAM (ABBREVIATED MENTAL 
TEST SCORE) 
The following questions are put to the patient. Each question correctly answered scores one 
point. A score of 8 or less suggests cognitive impairment at the time of testing, although further 
and more formal tests are necessary to confirm a diagnosis of dementia, delirium or other causes 
of cognitive impairment. 
Question 
Score 
What is your age? (1 point) 
  
What is the time to the nearest hour? (1 point) 
  
Give the patient an address, and ask him or her to repeat it at 
the end of the test. (1 point)  
e.g. 42 West Street 
  
What is the year? (1 point) 
  
What is the name of the office or doctor you are seeing 
today? (1 point) 
  
Can the patient recognize two persons (the doctor, nurse, 
home help, etc.)? (1 point) 
  
What is your date of birth? (day and month sufficient) (1 
point) 
  
In what year was the 9-11 terrorist attack? (1 point)  
(other dates can be used, with a preference for dates some 
time in the past.) 
  
Name the present president of the USA. (1 point) 
Count backwards from 10 down to 1. (1 point) 
  
 
 


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APPENDIX C: PSI (PORT SCORE) 
The Pneumonia Severity Index (PSI) algorithm is detailed below. An online, automated PSI 
calculator is available on the US Agency for Healthcare Research and Quality website. 
Step 1: Stratify to Risk Class I vs. Risk Classes II-V 
Presence of: 
Over 50 years of age 
Yes/No
Altered mental status 
Yes/No
Pulse ≥125/minute 
Yes/No
Respiratory rate >30/minute 
Yes/No
 Systolic blood pressure <90 mm Hg
Yes/No
 Temperature <35 °C or ≥40 °C 
Yes/No
History of: 
 Neoplastic disease 
Yes/No
 Congestive heart failure 
Yes/No
 Cerebrovascular disease 
Yes/No
 Renal disease 
Yes/No
 Liver disease 
Yes/No
  
 If any "Yes", then proceed to Step 2
 If all "No" then assign to Risk Class I
  
Step 2: Stratify to Risk Class II vs III vs IV vs V 
Demographics 
Points Assigned
 If Male 
+Age (yr)
If Female 
+Age (yr) - 10
 Nursing home resident 
+10
Comorbidity 
Neoplastic disease 
+30
Liver disease 
+20
Congestive heart failure 
+10
Cerebrovascular disease 
+10
Renal disease 
+10
Physical Exam Findings 
Altered mental status 
+20
Pulse ≥125/minute 
+10
 Respiratory rate >30/minute 
+20


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Systolic blood pressure <90 mm Hg
+20
Temperature <35 °C or ≥40 °C 
+15
Lab and Radiographic Findings 
Arterial pH <7.35 
+30
Blood urea nitrogen ≥30 mg/dl (9 mmol/liter) +20
Sodium <130 mmol/liter 
+20
Glucose ≥250 mg/dl (14 mmol/liter) 
+10
Hematocrit <30% 
+10
Partial pressure of arterial O2 <60mmHg
+10
 Pleural effusion 
+10
 ∑ <70 = Risk Class II 
 ∑ 71-90 = Risk Class III 
 ∑ 91-130 = Risk Class IV 
 ∑ >130 = Risk Class V 
 
 


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APPENDIX D: SOFA SCORE  
The SOFA score is assessed as below (source: Singer et al, 2016). 
 
 

SAP_001.pdf: 
Protocol Number: BT-201 
 
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Document status: Final SAP Version 2.0 Amendment 1.0 
 
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Page 1 of 44 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
A Phase 1b/2a, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the 
Safety, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Plasma 
gelsolin (rhu-pGSN) Added to Standard of Care in Subjects Hospitalized for Acute 
Community-acquired Pneumonia (CAP) 
 
Protocol No.: BT-201 
Product Code: rhu-pGSN 
 
PREPARED FOR: 
BioAegis Therapeutics, Inc. (BTI) 
 
675 US-1, North Brunswick Township,  
 
NJ 08902,  
 
USA 
 
Phone: +1 203-952-6373 
 
PREPARED BY: 
Novotech (Australia) Pty Ltd 
 
Level 3, 235 Pyrmont Street 
 
Pyrmont, NSW, 2009  
 
Australia  
 
DATE OF ISSUE: 
27 August 2018 (Draft Version 0.1) 
 
19 September 2018 (Draft Version 0.5) 
 
03 October 2018 (Final Draft 0.9) 
 
02 November 2018 (Final 1.0) 
 
03 December 2018 (Final 2.0 Amendment 1.0) 
 
VERSION/STATUS: 
Final 2.0 Amendment 1.0 
 
 
VERSION DATE:  
03 December 2018 
 
AUTHOR:         
Jan Steyn 
 
 
 
 
 


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Page 2 of 44 
SUMMARY OF CHANGES FROM SAP VERSION 1.0 
 
Section 11.2.2 page 25, the following text has been added: 
 
Additionally, counts (%) of number subjects with values out of normal range at each 
scheduled time point will also be presented along with shift tables that will represent the 
changes in normal range categories across post-baseline time points. 
Section 17, the following tables have been added: 
 
No. 
Title 
Analysis 
Population 
 
 
 
14.3.4.1.2.1 
SD: Summary of CBC Shifts from Baseline (Low, Normal, High) 
Safety 
14.3.4.1.2.2 
MAD: Summary of CBC Shifts from Baseline (Low, Normal, High) 
Safety 
14.3.4.2.2.1 
SD: Summary of Coagulation Shifts from Baseline  
(Low, Normal, High) 
Safety 
14.3.4.2.2.2 
MAD: Summary of Coagulation Shifts from Baseline  
(Low, Normal, High) 
Safety 
14.3.4.3.2.1 
SD: Summary of Comprehesive Metabolic Profile Shifts from 
Baseline (Low, Normal, High) 
Safety 
14.3.4.3.2.2 
MAD: Summary of Comprehesive Metabolic Profile Shifts from 
Baseline (Low, Normal, High) 
Safety 
 
 
 
 
Section 18, the following listings have been added: 
 
No. 
Title 
Analysis Population 
 
 
 
16.2.8.1.2.1 
SD: Abnormal CBC 
Intent-to-Treat 
16.2.8.1.2.2 
MAD: Abnormal CBC 
Intent-to-Treat 
16.2.8.2.2.1 
SD: Abnormal Coagulation 
Intent-to-Treat 
16.2.8.2.2.2 
MAD: Abnormal Coagulation 
Intent-to-Treat 
16.2.8.3.2.1 
SD: Abnormal Comprehensive Metabolic Profile 
Intent-to-Treat 
16.2.8.3.2.2 
MAD: Abnormal Comprehensive Metabolic Profile 
Intent-to-Treat 
 
 
 
 
 




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Page 4 of 44 
Table of contents 
 
1. 
INTRODUCTION .................................................................................................................... 8 
2. 
PROJECT OVERVIEW ............................................................................................................ 9 
2.1 
Study Design ............................................................................................................................. 9 
2.2 
Objectives ................................................................................................................................. 9 
2.3 
Sample Size ............................................................................................................................. 10 
2.4 
Randomization ........................................................................................................................ 10 
3. 
STATISTICAL CONSIDERATIONS ......................................................................................... 11 
4. 
ANALYSIS POPULATIONS .................................................................................................... 13 
4.1 
Population Descriptions ......................................................................................................... 13 
5. 
PROTOCOL DEVIATIONS..................................................................................................... 14 
6. 
SUBJECT DISPOSITION ........................................................................................................ 15 
7. 
DEMOGRAPHIC AND BASELINE INFORMATION ................................................................ 16 
7.1 
Demographics ......................................................................................................................... 16 
7.2 
Medical history ....................................................................................................................... 16 
7.3 
Pregnancy Test (Serum and Urine) ......................................................................................... 16 
7.4 
Serology .................................................................................................................................. 16 
7.5 
Other baseline characteristics ................................................................................................ 16 
8. 
STUDY DRUG ADMINISTRATION ........................................................................................ 17 
9. 
PHARMACOKINETICS (PK) .................................................................................................. 18 
9.1 
Definition of variables ............................................................................................................ 18 
9.2 
Biostatistical methods ............................................................................................................ 19 
10. 
PHARMACODYNAMICS (Efficacy) ................................................................................... 22 
10.1 
Definition of variables ............................................................................................................ 22 
10.2 
Biostatistical methods ............................................................................................................ 22 
11. 
SAFETY ............................................................................................................................ 23 
11.1 
Adverse Events ....................................................................................................................... 23 
11.2 
Safety Laboratory Assessments .............................................................................................. 24 
11.3 
Vital Signs Measurements ...................................................................................................... 26 
11.4 
12 - Lead Electrocardiogram (EKG) ......................................................................................... 27 
11.5 
Physical Examinations ............................................................................................................ 27 
11.6 
Outcome Prediction Models .................................................................................................. 27 
11.7 
Concomitant Medications ...................................................................................................... 28 
11.8 
Other safety evaluations ........................................................................................................ 28 
12. 
IMMUNOGENICITY ENDPOINTS ..................................................................................... 30 


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13. 
EXPLORATORY ENDPOINTS ............................................................................................ 31 
14. 
HANDLING OF MISSING DATA........................................................................................ 32 
15. 
CHANGES TO THE PLANNED ANALYSIS .......................................................................... 33 
15.1 
Final Analysis (End of Study) ................................................................................................... 34 
16. 
SOFTWARE ..................................................................................................................... 35 
17. 
TABLES ............................................................................................................................ 36 
18. 
LISTINGS ......................................................................................................................... 39 
19. 
FIGURES .......................................................................................................................... 42 
20. 
APPENDICES ................................................................................................................... 43 
21. 
REFERENCES ................................................................................................................... 44 


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Page 6 of 44 
List of Abbreviations 
Abbreviation 
Description 
AUC0-t 
The area under the plasma concentration-time curve, from time 0 (time of 
dosing) to the last time point with measurable analyte concentration, 
calculated by the log down, linear up trapezoidal method. 
AE 
Adverse Event 
ATC 
Anatomical Therapeutic Class 
AUC0-inf 
The area under the plasma concentration-time curve from time 0 
extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the 
ratio of the last measurable plasma concentration to the elimination rate 
constant (kel). 
AUC0-8 
The area under the plasma concentration-time curve, from time 0 (time of 
dosing) to the 8 hours concentration, calculated by the log down, linear up 
trapezoidal method. 
BLQ 
Below the quantitation limit 
CAP 
Community-Acquired Pneumonia 
CBC 
Complete Blood Count 
Cmax 
Maximum observed concentration 
Cmin 
Minimum observed concentration over the dosing interval. 
CL/F 
Apparent clearance calculated as Dose/AUC0-inf. 
CS 
Clinically Significant 
CSR 
Clinical Study Report 
CV 
Coefficient of variation 
DLT 
Dose Limiting Toxicity 
DN_AUC0-inf 
Dose-normalized AUC0-inf, calculated as AUC0-inf divided by dose. 
DN_AUC0-t 
Dose-normalized AUC0-t, calculated as AUC0-t divided by dose. 
DN_AUC0-8 
Dose-normalized AUC0-8, calculated as AUC0-8 divided by dose. 
DN_Cmax 
Dose-normalized Cmax, calculated as Cmax divided by dose. 
EKG 
Electrocardiogram  
eCRF 
Electronic Case Report Form 
EOS 
End of Study 
GCP 
Good Clinical Practice 
geo CV 
Geometric Coefficient of Variation 
HIV 
Human Immunodeficiency Virus 
ITT 
Intention-to-treat 
IV 
Intravenous 
IWRS 
Interactive web response system 
kel 
Apparent terminal elimination rate constant, calculated by linear regression 
of the terminal linear portion of the log concentration vs. time curve. 
LLQ 
Lower Limit of Quantification 
MAD 
Multiple-Ascending Dose 
MedDRA 
Medical Dictionary for Regulatory Activities 
MMSE 
Mini-Mental State Exam 
N/A 
Not Applicable 
NCS 
Not Clinically Significant 


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Abbreviation 
Description 
NK 
Not Known 
PE 
Physical Examination 
PI 
Principal Investigator 
PK 
Pharmacokinetic 
PP 
Per Protocol 
PSI 
Pneumonia Severity Index 
PT 
Preferred Term 
rhu-pGSN 
Recombinant human plasma Gelsolin 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Single Dose 
SD* 
Standard Deviation 
S.I. 
International System of Units 
SOC* 
Standard of Care 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
t½ 
Apparent elimination half-life, calculated as ln(2)/kel. 
TEAE 
Treatment Emergent Adverse Event 
Tmax 
Time to maximum observed drug concentration. If the maximum value 
occurs at more than one time point, Tmax is defined as the first time point 
with this value. 
Vz/F 
Apparent volume of distribution at the terminal phase, calculated as Dose/ 
(kel × AUC0-inf). 
WHO-DD 
World Health Organization Drug Dictionary 
 
 
 
 


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1. INTRODUCTION 
The following Statistical Analysis Plan (SAP) provides the outline for the statistical analysis of 
the data from the BT-201 study. 
 
The planned analyses identified in this SAP may be included in clinical study reports (CSRs), 
regulatory submissions, or future manuscripts. Also, post hoc exploratory analyses not 
necessarily identified in this SAP may be performed to further examine study data.  Any post 
hoc, or unplanned, exploratory analyses performed will be clearly identified as such in the 
final CSR. 


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2. PROJECT OVERVIEW 
2.1 Study Design 
Study BTI-201 is a Phase 1b/2a, double-blind, placebo-controlled, dose-escalation study to 
evaluate the safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of recombinant 
human plasma gelsolin (rhu-pGSN) added to standard of care (SOC*) in subjects hospitalized 
for acute community-acquired pneumonia (CAP). Each dosing cohort will include 8 subjects 
randomized 3:1 rhu-pGSN:placebo (6 rhu-pGSN subjects:2 placebo subjects). 
There will be 1 single dose cohort (Cohort 1) and 3 multiple dose cohorts (Cohorts 2, 3 and 
4). 
Dose will be based on actual body weight. Dose escalation will involve 3 dose levels of rhu-
pGSN (6, 12, and 24 mg/kg) in patients admitted for CAP. Dose escalation will only occur 
after post-therapy safety information on all subjects in the prior cohort has been reviewed at 
Day 7 for the single-dose (SD) and multiple-ascending dose (MAD*) arms.  
The MAD portion of the study will commence once single doses of 6 mg/kg of rhu-pGSN are 
shown to be acceptably safe. The first 2 doses must be administered in the hospital, but the 
third dose can be given in a monitored outpatient setting where appropriate. 
Discharged subjects will return for follow-up 7 days after the initiation of therapy (Day 7) and 
on Day 28 for the End-of-Study (EOS) Visit. 
To assess safety and tolerability, subjects will undergo physical examinations (PE; including 
vital sign measurements), AE assessments, concomitant medication assessments, safety 
laboratory testing and Electrocardiogram (EKGs - completed locally), and other testing as per 
local custom. 
2.2 Objectives 
2.2.1 Primary objective 
The primary objective of the study will be to evaluate the safety and tolerability of single and 
multiple ascending doses of rhu-pGSN administered by once-daily intravenous (IV) push to 
hospitalized subjects with a primary admitting diagnosis of CAP. 
2.2.2 Secondary objectives 
The secondary objective of the study will be to characterize the PK profile of rhu-pGSN after 
single or multiple IV doses 
2.2.3 Exploratory objective. 
The exploratory objectives of the study will be to investigate the following: 
x 
To assess the quantitative relationship of pGSN levels at baseline with clinical 
outcomes, changes in prognostic indices and inflammatory biomarkers, and etiologic 
pathogen type. 
x 
To assess the relationship between rhu-pGSN dose and clinical response and changes 
in surrogate biomarkers of efficacy. 
2.2.4 Immunogenicity objective. 
The immunogenicity objective of the study will be to investigate the post-treatment 
development of antibodies against rhu-pGSN by Day 28. 


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2.3 Sample Size 
The sample size of N=6 rhu-pGSN recipients per dose level and combined placebo in the SD 
and MAD portions of the trial were chosen based on limiting exposure to pGSN in this initial 
study in the current development program. The sample sizes in this trial have the following 
properties in relation to interpretation of Adverse Events (AEs) incidence rates (Table 1). 
Table 1 presents the Minimum Sample Size such that there is 90% probability of observing at 
least 1 AE of a certain type if the TRUE underlying AE rate. 
Table 1: 
Minimum Sample Size Calculations 
Sample Size 
TRUE underlying AE rate 
6 (each pGSN dose level) 
32% 
8 (pooled placebo) 
21% 
24 (pooled pGSN) 
10% 
With each sample size presented in the table above, if zero AEs of a certain type are 
observed, one could be "90% confident" the TRUE underlying rate for that AE is at most the 
rate indicated above. 
2.4 Randomization 
Following screening, subjects qualified for study entry will be randomized to receive rhu-
pGSN or placebo during the treatment period. Randomization will be done centrally using the 
Interactive web response system (IWRS). All eligible subjects will be assigned a 
randomization number.  
There will be 1 single dose cohort (Cohort 1) and 3 multiple dose cohorts (Cohorts 2, 3 and 
4). Eight subjects will be sequentially randomized to each cohort for a total number 
randomized of 32 subjects. 
Subjects will be randomized in a 3:1 ratio to rhu-pGSN or placebo (6 rhu-pGSN subjects:2 
placebo subjects). 
The investigational site team and the subject will be kept blinded to the treatment allocation of 
each participant. Only the designated pharmacist(s) will be unblinded to the treatment 
allocation. The unblinded pharmacist will utilize the IWRS system to randomly assign a 
treatment allocation. The treatment allocation will be available to the unblinded pharmacist(s).  


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Page 11 of 44 
3. STATISTICAL CONSIDERATIONS 
Data will be handled and processed per the sponsor’s representative (Novotech) Standard 
Operating Procedures (SOPs), which are written based on the principles of good clinical 
practice (GCP). 
All data collected on the eCRFs will be presented in the data listings and will be listed and 
sorted by SD/MAD, treatment, subject number and visit, where applicable. All summaries will 
present the data by SD/MAD (apart from PK summaries), treatment group and overall (total 
subjects), as applicable. In addition, all placebo subjects will be combined into a single 
placebo group for purposes of summarizing the data. 
x 
Continuous variables: Descriptive statistics will include the number of non-missing 
values (N), mean, standard deviation (SD*), median, minimum, maximum.  
The minimum and maximum values will be displayed to the same decimal precision as 
the source data, the arithmetic mean, SD* and median values will be displayed to one 
more decimal than the source data for the specific variable. 
The appropriate precision for derived variables will be determined based on the 
precision of the data on which the derivations are based, and statistics will be 
presented in accordance with the abovementioned rules. 
x 
PK data: For PK data the arithmetic mean, standard deviation, median, minimum, 
maximum, coefficient of variation (CV%), geometric mean and geometric coefficient of 
variation (geo CV%) values will be presented. For the ratio of concentration data to the 
(within 30 minutes) pre-dose concentration on Day 1, the ln(SD*) will also be presented. 
x 
Categorical variables: Descriptive statistics will include frequency counts and 
percentages per category. Percentages will be rounded to one decimal place, with the 
denominator being the number of subjects in the relevant population with non-missing 
data, unless otherwise specified. 
x 
Time to Event Analysis: Through the Kaplan-Meier method, nonparametric estimates of 
the survivor function will be represented by quartile estimates (Q1, Median and Q3) 
along with 95 CIs. Product limit estimates will be presented as part of appendices to the 
study outputs (SAS output). 
x 
Imputation: No missing data will be imputed. 
x 
Baseline: Baseline values will be defined as the last valid, non-missing observation for 
each subject prior to the first dose of study medication. For the PK analysis, baseline 
will be defined as the pre-dose value for each study day. 
x 
Repeat assessments (Safety): No repeat assessments will be included in summary 
presentations (Tables, Figures). Only the original values will be used in summary 
presentations.  All repeat assessments captured in the Electronic Data Capture (EDC) 
system will be presented in the data listings. 
x 
Assessment windows:  All assessments will be included in the data listings and no visit 
windows will be applied to exclude assessments that were performed outside of the 
protocol specified procedure windows. 
x 
Date and time display conventions:  The following display conventions will be applied in 
all outputs where dates and/or times are displayed: 
R Date only:  DDMMMYYYY 
R Date and time:  DDMMMYYYY /HH:MM 


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Page 12 of 44 
If only partial information is available, unknown components of the date or time will be 
presented as ‘NK’ (not known), i.e., ‘2016-NK-NK’.  Times will be reported in military time. 
In the summary tables and figures, treatment groups will be summarized separately for 
SD/MAD, each cohort, combined placebo and overall (all subjects). Study outcomes will be 
summarized as follows: 
x 
For each active dose level (overall):  
R SD Phase: 
 
rhu-pGSN 6 mg/kg 
 
Placebo 
 
Overall 
R MAD Phase 
 
rhu-pGSN 6 mg/kg 
 
rhu-pGSN 12 mg/kg 
 
rhu-pGSN 24 mg/kg 
 
Combined Active 
 
Combined Placebo 
 
Overall 


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Page 13 of 44 
4. ANALYSIS POPULATIONS 
In this study, four analysis populations are defined: Intention-to-treat (ITT), Safety, 
Pharmacokinetic and the Per Protocol populations (PP). 
Furthermore, any additional exploratory analysis not identified in the SAP will be identified in 
the final CSR as exploratory post hoc analyses. This may include the addition of additional 
study populations or subgroups of interest.  
The number and percentage of subjects in each analysis population will be summarized. 
4.1 Population Descriptions 
4.1.1 Intention-to-treat (ITT) population 
The ITT population will be defined as all randomized subjects. Subjects will be analyzed per 
the randomized treatment they received if different from the actual treatment received. 
All disposition, demographic and pharmacodynamic (PD) analyses will be based on the ITT 
population. All listings will be presented by the ITT population. 
4.1.2 Safety population 
The safety population will be defined as all enrolled subjects who received at least one dose 
of the study drug and will be based on actual treatment received. 
If the safety population differs from the ITT population in that subjects received a different 
treatment to that they were randomized, or did not receive treatment whatsoever after 
randomization, the demographic and pharmacodynamic analyses will be repeated for the 
safety population. 
All safety analyses will be based on the safety population. 
4.1.3 Pharmacokinetic (PK) population 
The PK population will comprise all subjects in the safety population who provide adequate 
PK samples to calculate the PK parameters. Subjects with important protocol deviations will 
be assessed on a subject-by-subject basis for inclusion in the PK Population. The PK 
analysis will be conducted using the Pharmacokinetic population. 
4.1.4 Per Protocol (PP) population 
The PP population will comprise all subjects in the safety population excluding subjects who 
missed doses and/or randomly discontinued the study before the primary Day 7 Visit. 
Furthermore, subject that had any relevant important protocol deviations will be excluded 
from the PP population. 
 
 


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5. PROTOCOL DEVIATIONS 
In case protocol deviations/violations are reported, all protocol deviations/violations will be 
listed for each subject in the by-subject data listings. Prior to database lock and during the 
blinded review of database, all protocol deviations/violations will be reviewed and assigned a 
status of important or not. 
Important protocol deviations/violations may include the following, depending on the timing 
and nature of the deviation: 
x 
INFORMED CONSENT DEVIATION: Subject not consented prior to study procedures 
being performed or subject not re-consented to study at next scheduled study visit 
following local approval of an updated PIS-CF. 
x 
ENTRY DEVIATION: Subject enrolled in violation of eligibility criteria. 
x 
WITHDRAWAL DEVIATION: Subject developed withdrawal criteria during the study, 
but were not withdrawn. 
x 
DOSING DEVIATION: Subject received the wrong treatment or incorrect dose of 
investigational product or comparator; Subject received treatment at incorrect timepoint 
in study; Subject received treatment that had not been stored per protocol. 
x 
OPERATIONAL DEVIATION: Informed consent deviations (other than consent not 
being obtained prior to study entry, which would be considered an Entry Deviation), 
IRB/IEC expired approval, significant visit window deviations, or other issues that may 
significantly impact subject safety or data integrity. 
 


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6. SUBJECT DISPOSITION 
Outcomes will be summarized by the treatment groups as specified in section 3. 
6.1.1 Subject disposition 
Subject disposition will be summarized using counts and percentages and will be based on 
the ITT Population.  The number of screened subjects, number and percentage of 
randomized subjects, subjects discontinued from the study as well as the primary reason for 
discontinuation will also be summarized.  
All disposition information collected will be listed together with the date that the subject 
provided informed consent and the date and time of the first study drug administration. 
If the there is a difference between the ITT, Safety populations or the PP population, the 
disposition summary tables will be repeated for that population. 
6.1.2 Analysis Populations 
The number of subjects included in of each of the defined analysis populations will be 
summarized using counts and percentages and will be based on the ITT Population. 
In addition, the inclusion/exclusion of each subject into/from each of the defined analysis 
populations will be listed. 
 


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7. DEMOGRAPHIC AND BASELINE INFORMATION 
Demographic and baseline body measurements will be summarized using the ITT Population 
and may be repeated for the safety population and per protocol populations if different from 
the ITT population. 
All information will be presented by the treatment groups as specified in section 3. 
7.1 Demographics 
7.1.1 Definition of variables 
x 
Age (years); 
x 
Sex; 
x 
Child Bearing Potential; 
x 
Method of Birth Control; 
x 
Race; 
x 
Height (cm); 
x 
Weight (kg); 
7.1.2  Biostatistical methods 
Quantitative and categorical summaries will be presented for demographic variables at the 
screening visit. 
A by-subject data listing for demographic and baseline characteristics will be generated. 
7.2 Medical history 
Past medical history will be coded using the Medical Dictionary for Regulatory Activities, 
(MedDRA - latest version), and will be presented in the by-subject data listings including the 
MedDRA codes. 
7.3 Pregnancy Test (Serum and Urine) 
Pregnancy test results will be included in the by-subject data listings. This includes the 
pregnancy test results at Screening and Day 28/End of Study. 
7.4 Serology 
The following viral detection results (serologies) at Screening will be listed for each subject 
when available: Hepatitis B, Hepatitis C and HIV status. 
7.5 Other baseline characteristics 
Confirmation of CAP (both clinical and radiographic) will be presented in the by-subject data 
listings. 


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8. STUDY DRUG ADMINISTRATION 
Study drug administration results will be presented using the ITT Population. 
A by-subject data listing will be generated for study medication administration. These listings 
will include randomized dose assignment, Date/Time of Injection, Study Drug Administered 
(mL), duration of administrations, reason whole study drug dose was not administered, 
injection interruptions, re-start and reason for any interruptions.  Subjects who receive the 
wrong IP (rhu-pGSN vs. placebo) will be flagged. 


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9. PHARMACOKINETICS (PK) 
All PK summary tables and figures will be based on the PK Population. All listings will be 
based on the Safety Population (Actual Treatment). All analyses will be done by treatment 
group. 
For the 1 dose in the SD arm and the first 2 doses in the MAD arms, blood will be drawn 
within 30 minutes pre-dose, and 5-10 minutes after the end of administration, as well as 2, 8, 
12 and/or 16, and 24 hours after the end of administration (± 30 minutes) for analysis. 
Identical PK sampling is encouraged on Day 3 where feasible (but not required) in the 
multiple-dose arms. 
In this section (section 9): 
x 
The rhu-pGSN treatment group will be referred to the Active treatment group. 
x 
Exogenous pGSN concentrations will be referred to as rhu-pGSN concentrations. 
x 
Endogenous pGSN + Exogenous pGSN (total) will be referred to as pGSN 
9.1 Definition of variables 
The following PK parameters for pGSN will be estimated For Day 1(SD/MAD), Day 2 (MAD) 
and Day 3 (MAD). PK Parameters will only be calculated for the Active (rhu-pGSN) treatment 
group. No PK parameters will be calculated for the Placebo treatment group:  
Day 1: SD/MAD & Day 2/3: MAD 
AUC0-t 
The area under the plasma concentration-time curve, from time 0 (time of 
dosing) to the last time point (24 hours) with measurable analyte 
concentration, calculated by the log down, linear up trapezoidal method. 
AUC0-t will additionally be calculated for the estimated rhu-pGSN profile for 
both the change from pre-dose on each study day and the double-delta 
method. 
AUC0-8 
The area under the plasma concentration-time curve, from time 0 (time of 
dosing) to the 8 hours concentration, calculated by the log down, linear up 
trapezoidal method. 
AUC0-8 will additionally be calculated for the estimated rhu-pGSN profile 
for both the change from pre-dose on each study day and the double-delta 
method. 
AUC0-inf 
The area under the plasma concentration-time curve from time 0 
extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the 
ratio of the last measurable plasma concentration to the elimination rate 
constant (kel). 
Cmax 
Maximum observed concentration. 
Cmax will additionally be calculated for the estimated rhu-pGSN profile for 
both the change from pre-dose on each study day and the double-delta 
method. 
Tmax 
Time to maximum observed drug concentration. If the maximum value 
occurs at more than one time point, Tmax is defined as the first time point 
with this value. 


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kel 
Apparent terminal elimination rate constant calculated by linear regression 
of the terminal linear portion of the log concentration vs. time curve. 
t½ 
Apparent elimination half-life, calculated as ln(2)/kel 
%AUCext 
Percentage of the extrapolated area under the plasma concentration-time 
curve, calculated as 100% * [AUC0-inf - AUC0-t]/ AUC0-inf 
CL/F 
Apparent clearance calculated as Dose/AUC0-inf. 
Vz/F 
Apparent volume of distribution at the terminal phase, calculated as Dose/ 
(kel × AUC0-inf). 
DN_Cmax 
Dose-normalized Cmax, calculated as Cmax divided by dose 
DN_Cmax will additionally be calculated for the estimated rhu-pGSN profile 
for both the change from pre-dose day 1 and the double-delta method.. 
DN_AUC0-inf 
Dose-normalized AUC0-inf, calculated as AUC0-inf divided by dose 
DN_AUC0-t 
Dose-normalized AUC0-t, calculated as AUC0-t divided by dose 
DN_AUC0-t will additionally be calculated for the estimated rhu-pGSN 
profile for both the change from pre-dose on each study day and the 
double-delta method. 
DN_AUC0-8 
Dose-normalized AUC0-24, calculated as AUC0-24 divided by dose 
DN_AUC0-8 will additionally be calculated for the estimated rhu-pGSN 
profile for both the change from pre-dose on each study day and the 
double-delta method. 
9.2 Biostatistical methods 
Plasma pGSN 
Individual plasma pGSN concentrations will be summarized by nominal sampling time. 
Plasma pGSN concentrations that are below the quantitation limit (BQL) will be set to 0 if 
before the first quantifiable concentration, and to ½ the lower level of quantification elsewhere 
for calculation of summary statistics for concentration data at each time point. 
The actual blood sampling dates and times relative to dosing time will be listed by subject and 
nominal sampling time, with time deviations calculated for all subjects with available plasma 
concentration data, including subjects excluded from the PK Population. 
Individual (for each subject) and mean plasma pGSN concentration over time will be 
displayed graphically in linear and semi-logarithmic plot of pGSN concentration versus time.  
The actual collection time will be used for individual plasma pGSN concentration curve and 
the nominal time will be used for plot of mean plasma pGSN concentration curve. 
Plasma concentrations vs. time data will be analyzed using validated PK software (Phoenix 
WinNonlin version 6.3 or higher), by standard non-compartmental model. Actual collection 
time will be used in the calculation of plasma PK parameters. For the calculation of the PK 
parameters, all plasma concentrations that are BLQ prior to the first measurable 


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concentration will be set to ½ the lower level of quantification. The BLQ values that are 
between measurable concentrations will be set to ½ LLOQ. The BLQ values that occur at the 
end of the profile (after the last quantifiable concentration) will also be set to ½ the lower level 
of quantification. 
Ratio of Plasma pGSN 
For subjects that do not have quantifiable pre-dose concentration values on each day, the 
pre-dose value will be set to ½ lower limit of quantification (LLQ). 
Individual plasma pGSN: Day 1, 2 and Day 3 pGSN concentration ratios from each day’s pre-
dose will be summarized by nominal sampling time. 
Plasma pGSN concentrations that are below the quantitation limit (BQL) will be set to ½ the 
lower level of quantification post dose for calculation of summary statistics for concentration 
ratio data at each time point. 
Ratio of Pre-dose and Placebo Adjusted Plasma pGSN 
For the active treatment groups, plasma concentration of pGSN will further be evaluated 
(adjusted) in terms of the mean Placebo pGSN at each time point as well as the pre-dose 
(baseline value) for each study day: 
x 
Pre-dose values on each study day will be presented as recorded; 
x 
Pre-dose values on each study day that are BLQ will be set to ½ LLQ; 
x 
Subsequent BLQ values (post the first quantifiable concentration on each day) will be 
set to ½ LLQ. 
x 
Pre-dose and Placebo Adjusted Concentration  
= (Active Treatment Group natural log Concentration on Day z at Time Point y – Day z 
Pre-dose natural log Concentration) - (Placebo Treatment Group natural log 
Concentration on Day z at Time Point y – Placebo Day z Pre-dose natural log 
Concentration)  [results will be back-transformed to the ratio of ratios scale.] 
Baseline and Placebo corrected Individual plasma pGSN concentrations will be summarized 
by nominal sampling time. 
Analysis of Estimated rhu-pGSN 
This analysis will exclude the placebo treatment group: 
x 
Pre-dose values on each study day will be presented as recorded; 
x 
Pre-dose values on each study day that are BLQ will be set to ½ LLQ; 
x 
Subsequent BLQ values (post the first quantifiable concentration on each day) will be 
set to ½ LLQ. 
x 
Estimated rhu-pGSN concentration  
= concentration on Day z at Time Point y – Day z Pre-dose concentration 
Individual estimated rhu-pGSN concentrations will be summarized by nominal sampling time. 
Geometric summary statistics will not be calculated for estimated rhu-pGSN concentrations, 
as these values could be lower than or equal to 0.  
Estimated Individual (for each subject) and mean estimated plasma rhu-pGSN concentration 
over time will be displayed graphically in linear plots of estimated rhu-pGSN concentration 
versus time.  The actual collection time will be used for individual estimated plasma rhu-
pGSN concentration curve and the nominal time will be used for plot of mean estimated 
plasma rhu-pGSN concentration curve. 


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Estimated plasma concentrations vs. time data will be analyzed using SAS software. Actual 
collection time will be used in the calculation of plasma PK parameters. The following 
parameters (including dose normalized parameters) will be calculated for each study day:  
x 
AUC0-t 
x 
AUC0-8h 
x 
Cmax 
Double Delta Analysis of Estimated rhu-pGSN 
x 
Pre-dose values on each study day will be presented as recorded; 
x 
Pre-dose values on each study day that are BLQ will be set to ½ LLQ; 
x 
Subsequent BLQ values (post the first quantifiable concentration on each day) will be 
set to ½ LLQ. 
x 
Estimated rhu-pGSN will be calculated as follows: 
= (Active Treatment Group Concentration on Day z at Time Point y – Day z Pre-dose 
Concentration) - (Mean Placebo Treatment Group Concentration on Day z at Time 
Point y – Mean Placebo Day z Pre-dose Concentration) 
Estimated rhu-pGSN concentrations will be summarized by nominal sampling time. 
Geometric summary statistics will not be calculated for estimated rhu-pGSN concentrations, 
as these values could be lower than or equal to 0.  
Estimated Individual (for each subject) and mean estimated plasma rhu-pGSN concentration 
over time will be displayed graphically in linear plots of estimated rhu-pGSN concentration 
versus time.  The nominal time will be used for individual estimated plasma rhu-pGSN 
concentration curve and the nominal time will be used for plot of mean estimated plasma rhu-
pGSN concentration curve. 
Estimated rhu-pGSN plasma concentrations vs. time data will be analyzed using SAS 
software. Nominal time will be used in the calculation of plasma PK parameters. The following 
parameters (including dose normalized parameters) will be calculated for each study day:  
x 
AUC0-t 
x 
AUC0-8h 
x 
Cmax 


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10. PHARMACODYNAMICS (EFFICACY) 
All PD summary tables, figures and listings will be based on the ITT Population. All analysis 
will be done by study part (SD/MAD) by each treatment group. 
As a sensitivity analysis, the analysis will be repeated based on the PP population. 
10.1 Definition of variables 
The following biomarkers will be analyzed: 
x 
Procalcitonin; 
x 
pGSN; 
x 
TNFα; 
x 
TGFβ; 
x 
IL1β; 
x 
IL1ra; 
x 
IL2; 
x 
IL4; 
x 
IL6; 
x 
IL10; 
x 
IL17a.` 
10.2 Biostatistical methods 
Biomarker will be summarized via counts and percentages of subjects for categorical 
variables, and by summary statistics for baseline, each observed time point, and ratio from 
baseline at each observed time point for continuous variables (as for the PK analysis with the 
exception of CV% and Geometric CV%) by treatment group and overall. 


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11. SAFETY  
Safety endpoints will be analyzed using the Safety Population. All information will be 
presented by study part, for each treatment group and overall. 
11.1 Adverse Events 
11.1.1 Definition of variables 
x 
Adverse event (AE) 
x 
Serious adverse event (SAE) 
x 
Treatment emergent adverse event (TEAE) 
AEs and SAEs are defined in the study protocol. TEAEs are defined as adverse events that 
occurred or worsened following the first administration of study medication. Adverse events 
that have missing onset dates will be considered treatment-emergent, unless the stop date is 
known to be prior to the first administration of the study medication. 
11.1.2 Biostatistical methods 
All AEs will be coded using MedDRA. 
All AE summaries will be restricted to TEAEs only. Summary tables will include the number of 
subjects (%) experiencing an event and the number of events. Subjects will be counted only 
once at each system organ class (SOC) and preferred term (PT) level of summary. 
The TEAE summaries will include: 
x 
TEAE summary by SOC and PT 
x 
TEAE summary of serious events by SOC and PT 
x 
TEAE summary of deaths by SOC and PT 
x 
TEAE summary by severity (NCI-CTCAE) by SOC and PT 
x 
TEAE summary by causality to Study Drug by SOC and PT 
x 
TEAE summary by causality to Study Procedure by SOC and PT 
x 
TEAE summary of events leading to treatment discontinuation (Drug withdrawn) by 
SOC and PT 
All AEs will be listed and will include verbatim term, PT, SOC, treatment, severity, causality, 
seriousness, and action taken with regards to the study drug. Separate listings will be created 
for SAEs, deaths and events leading to treatment discontinuation (Drug withdrawn). 
Overall survival (time to death in days) will be analyzed through Kaplan-Meier methods and 
censored at the time of the study exit visit. Date of death will be taken as the SAE end date 
for which the outcome is stated to be fatal. Overall survival (days) = Date of event outcome of 
death/ Date of study exit - Date of first study drug administration + 1. 


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11.2 Safety Laboratory Assessments 
Blood samples will be collected at the time points specified in the Schedule of Events (refer to 
the Protocol) to conduct Complete blood count (CBC), Coagulation and Comprehensive 
Metabolic Profile analyses. 
11.2.1 Definition of variables 
The following tests will be performed within each of the specified test panels: 
Complete blood count (CBC): 
x 
Hematocrit (HCT); 
x 
Hemoglobin (HGB); 
x 
Red Blood Cells (RBC) 
x 
White Blood Cells (WBC) with differential (including Eosinophils (EOS), Neutrophils 
(NEUT), Basophils (BASO), Lymphocytes (LYM) and Monocytes (MONO); 
x 
Platelets (PLAT); 
x 
Reticulocyte count 
Coagulation: 
x 
Prothrombin Time (PT) / International Normalized Ratio (INR); 
x 
Partial Thromboplastin Time (PTT). 
Comprehensive Metabolic Profile: 
x 
Albumin (ALB) 
x 
Blood Urea Nitrogen (BUN) 
x 
Creatinine (CREAT) 
x 
C-Reactive Protein (CRP) 
x 
Lactate Dehydrogenase (LDH) 
x 
Creatine phosphokinase (CPK) 
x 
Alanine Aminotransferase (ALT) 
x 
Aspartate Aminotransferase (AST) 
x 
Total Bilirubin (BILI) 
x 
Alkaline Phosphatase (ALP) 
x 
Amylase 
x 
Lipase 
11.2.2 Biostatistical Methods 
All laboratory data collected at scheduled and unscheduled visits will be included in the 
listings, but only results collected as scheduled visits will be included in the summary tables. 
Results for individual parameters may be reported in different units depending on the 
analyzing laboratory.  If required, the results (and the corresponding normal range cut-off 
values) for individual parameters may be converted to International System of Units (S.I.) 
units to summarize the data. 


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For the all parameters where a unit value has been reported, the parameter names that will 
be used in the outputs will comprise of the test name and the unit of measure, for example, 
‘Albumin (g/L)’.  Parameters will be sorted alphabetically within tables and listings. 
For all parameters where a normal range limit value is reported, the normal range will be 
derived based on the available lower and upper limit values and any reported mathematical 
symbols.  If both a lower and upper limit value is available, the normal range will be presented 
as ‘(Lower, Upper)’. 
The reported results for each parameter with a defined normal range will be classified (‘Low’, 
‘Normal’, ‘High’) in relation to the defined normal range limits.  If a result is equal to the 
normal range cut-off value, the result will be considered ‘Normal’. 
The change from baseline values at each post-baseline visit will be calculated for all 
parameters with continuous results (except for specific gravity and pH).  
The decimal precision for each parameter will be based on the maximum number of decimals 
to which the reported result or the normal range limits are presented to in the raw data.  The 
results and normal ranges will be displayed to the same decimal precision in the listings. 
If a result for a parameter that is normally considered continuous is reported as a range (i.e., 
the result for basophils is reported as ‘<0.01’ for a single time point), the result may be 
converted to a numeric value that is smaller than the reported result to contribute to the 
derivations and the summary statistics.  Any conversion rules that are applied will be 
highlighted in the footnotes of the affected tables and listings.  The original reported result 
value will however be included in the listing. 
The laboratory result tables will present summary statistics for each laboratory parameter 
within the specific test panel.  For each parameter, summaries will be presented for the 
baseline and each scheduled post-baseline visit.  In addition, summaries will be presented for 
the change from baseline values at each scheduled post-baseline visit. 
Additionally, counts (%) of number subjects with values out of normal range at each 
scheduled time point will also be presented along with shift tables that will represent the 
changes in normal range categories across post-baseline time points. 
The listings of laboratory parameters will include all the information (fields) collected.  In 
addition, the observations that are used as the baseline record (value) for each parameter will 
be flagged, and the change from baseline values at each post-baseline visit will be presented. 
For all parameters, standardized values will be reported. 


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11.3 Vital Signs Measurements 
11.3.1 Definition of variables 
The following vital signs measurements will be taken at the time points specified in the 
Schedule of Events (refer to the Protocol): 
x 
Heart Rate (beats/min); 
x 
Systolic blood pressure (SBP) (mmHg) 
x 
Diastolic blood pressure (DBP) (mmHg) 
x 
Respiratory rate (breaths/min) 
x 
Temperature (ºC) 
x 
Pulse Oximetry (%) 
x 
Overall Investigator Interpretation 
11.3.2 Biostatistical Methods 
All vital signs data collected at scheduled and unscheduled visits will be included in the 
listings, but only results collected as scheduled visits will be included in the summary tables. 
The parameter names that will be used in the outputs will comprise of the test name and the 
unit of measure, for example, ‘Systolic Blood Pressure (mmHg)’.  Parameters will be sorted in 
the order that the measurements were collected in on the Vital Signs eCRF page within the 
tables and listings. 
The change from baseline to the pre-dose assessment at each post-baseline visit will be 
calculated for all parameters. 
The decimal precision for each parameter will be based on the maximum number of decimals 
to which the results were reported on the eCRF. 
Vital signs measurements will present summary statistics for the results at the baseline and 
each scheduled post-baseline visit for each of the parameters.  In addition, summaries will be 
presented for the change from baseline values at each scheduled post-baseline visit. 
The summary of overall interpretation results table will present counts and percentages for 
the reported results at baseline and each post-baseline visit/time point.  Result categories will 
be ordered as ‘Normal’, ‘Abnormal not clinical significant (NCS)’ and ‘Abnormal clinical 
significant (CS)’. 
The listings of vital signs measurements will include all the information collected. In addition, 
the observations that are used as the baseline record (value) for each parameter will be 
flagged, and the change from baseline values at each post-baseline visit will be presented. 


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11.4 12 - Lead Electrocardiogram (EKG) 
11.4.1 Definition of variables 
The following EKG measurements will be taken at the time points specified in the Schedule of 
Events (refer to the Protocol): 
x 
Heart Rate (beats/min); 
x 
PR Interval (ms) 
x 
QRS Interval (ms) 
x 
QT Interval (sec) 
x 
QTcF Interval (ms) = QT interval /cube root of the RR interval 
x 
Overall Investigator Interpretation 
11.4.2 Biostatistical Methods 
All EKG data collected at scheduled and unscheduled visits will be included in the listings, but 
only results collected as scheduled visits will be included in the summary tables. 
The parameter names that will be used in the outputs will comprise of the test name and the 
unit of measure, for example, ‘Heart Rate (beats/min)’.  Parameters will be sorted in the order 
that the measurements were collected in on the EKG eCRF page within the tables and 
listings. 
For study visits where, multiple EKG measurement are taken, the mean of the measurements 
will be summarized and the worst-case overall investigator interpretation for the multiple 
measurements will be presented. 
The change from baseline to the pre-dose assessment at each post-baseline visit will be 
calculated for all parameters.  
The decimal precision for each parameter will be based on the maximum number of decimals 
to which the results were reported on the eCRF. 
EKG measurements will present summary statistics for the results at the baseline and each 
scheduled post-baseline visit for each of the parameters.  In addition, summaries will be 
presented for the change from baseline values at each scheduled post-baseline visit. 
The summary of overall interpretation results table will present counts and percentages for 
the reported results at baseline and each post-baseline visit/time point.  Result categories will 
be ordered as ‘Normal’, ‘Abnormal NCS’ and ‘Abnormal CS’. 
The listings of EKG measurements will include all the information collected and calculated 
(mean results). In addition, the observations that are used as the baseline record (value) for 
each parameter will be flagged, and the change from baseline values at each post-baseline 
visit will be presented. 
11.5 Physical Examinations 
Physical Examination assessments will be listed for all time points. 
11.6 Outcome Prediction Models 
11.6.1 Definition of variables 
The following outcome prediction models will be taken at the time points specified in the 
Schedule of Events (refer to the Protocol): 
x 
CURB-65 Score; 


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x 
Pneumonia Severity Index (PSI) Score 
x 
Pneumonia Severity Index (PSI) Risk Class 
x 
SOFA Score 
x 
Mini-Mental State Exam (MMSE) Score 
11.6.2 Biostatistical Methods 
All outcome prediction model data collected at scheduled and unscheduled visits will be 
included in the listings, but only results collected as scheduled visits will be included in the 
summary tables. 
The change from baseline to the pre-dose assessment at each post-baseline visit will be 
calculated for all parameters.  
The decimal precision for each parameter will be based on the maximum number of decimals 
to which the results were reported on the eCRF. 
Outcome prediction model scores will present summary statistics for the results at the 
baseline and each scheduled post-baseline visit for each of the parameters.  In addition, 
summaries will be presented for the change from baseline values at each scheduled post-
baseline visit. 
The summary of PSI Risk Class will present counts and percentages for the reported results 
at baseline and each post-baseline visit/time point.  Result categories will be ordered by risk 
class. 
The listings of outcome prediction model data will include all the information collected. In 
addition, the observations that are used as the baseline record (value) for each parameter will 
be flagged, and the change from baseline values at each post-baseline visit will be presented. 
11.7 Concomitant Medications 
Concomitant and prior medications will be coded using World Health Organization Drug 
Dictionary (WHO-DD, September 2015).  
Prior medications are defined as any medication where the use was stopped prior to the first 
administration of the study medication. Prior medications will be listed only. 
Concomitant medications are defined as any medication (other than the study drug) that was 
used at least once after the first administration of the study medication.  Medications that 
were stopped on the same date as the first study drug infusion will be analyzed as 
concomitant medications.  If a clear determination cannot be made (partial medication end 
dates) the medication will be classified as concomitant. 
Concomitant medications will be summarized by WHO-DD Anatomical Therapeutic Chemical 
(ATC) class Level 3, and preferred term using frequency counts and percentages by study 
part and treatment group. Subjects who take the same medication more than once will be 
counted only once for that preferred term.  Subjects will also only be counted once for each 
ATC3 class, regardless of the number of medications they have taken within that class 
11.8 Other safety evaluations 
Hospitalization follow-up will be presented in by-subject listings by study part and treatment 
group. Length of stay in hospital defined as date and time of discharge or date of study exit if 
still hospitalized at the time of death or study exit (censored at 23:59) - date and time of 
Hospitalization admission due to CAP in hours, length of ICU stay and the period of intubation 
in days will be listed and presented through Kaplan-Meier (K-M) methods. 


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The length of stay in ICU and period of intubation analysis will be restricted to subjects that 
stayed in the ICU and were intubated. The event investigated will be the cessation of ICU 
stay and the cessation of intubation. 


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12. IMMUNOGENICITY ENDPOINTS 
All Immunogenicity endpoints will be listed using the safety population by study part and 
treatment.  Specimens from placebo recipients will serve as a negative control. 
Antibodies against rhu-pGSN will be blindly assayed from frozen specimens to determine 
whether the investigational product induces an antibody response in recipients. 


Protocol Number: BT-201 
 
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Document status: Final SAP Version 2.0 Amendment 1.0 
 
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Page 31 of 44 
13. EXPLORATORY ENDPOINTS 
Other analyses to be performed include: 
x 
Blood, sputum, and other cultures as clinically indicated (note that a sputum culture is 
mandatory if a sputum specimen can be obtained and blood cultures are strongly 
encouraged at entry into the study). 
x 
Sputum neutrophil elastase (where feasible at entry and near the conclusion of study 
therapy). 
Exploratory endpoints will be listed only. 


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14. HANDLING OF MISSING DATA 
Missing, unused, or spurious data will be handling in the following manner: 
x 
There will be no imputations or substitution made for missing PD or safety data points; 
x 
For the PK analyses, imputations will be made for missing data points. Please see 
section 9 for more detail. 


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15. CHANGES TO THE PLANNED ANALYSIS 
No planned changes. 


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15.1 Final Analysis (End of Study) 
The final analysis will be conducted after all subjects have completed the study, the clinical 
database has been locked and the analysis populations have been approved. 
The final analysis will be based on the final version of the SAP.  Any deviations from the 
planned analysis will be documented in the CSR. 


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16. SOFTWARE 
The following software will be used to perform the statistical analyses:  
x 
SAS® Version 9.4 or higher (SAS Institute, Cary, North Carolina, USA). 
x 
The following software will be used to perform the PK analysis: Phoenix WinNonlin® 
version 6.3 or higher. 


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17. TABLES 
No. 
Title 
Analysis 
Population 
 
 
 
14.1.1.1 
SD: Summary of Subject Enrolment and Disposition 
Intent-to-Treat 
14.1.1.2 
MAD: Summary of Subject Enrolment and Disposition 
Intent-to-Treat 
14.1.2.1 
SD: Summary of Demographics and Baseline Characteristics 
Intent-to-Treat 
14.1.2.2 
MAD: Summary of Demographics and Baseline Characteristics 
Intent-to-Treat 
14.2.1.1 
Day 1: Summary of Plasma pGSN Concentrations (unit) by Timepoint 
PK 
14.2.1.2 
Day 2: Summary of Plasma pGSN Concentrations (unit) by Timepoint 
PK 
14.2.1.3 
Day 3: Summary of Plasma pGSN Concentrations (unit) by Timepoint 
PK 
14.2.1.4 
Day 1: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint 
PK 
14.2.1.5 
Day 2: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint 
PK 
14.2.1.6 
Day 3: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint 
PK 
14.2.2.1 
Day 1: Summary of Plasma pGSN PK Parameters 
PK 
14.2.2.2 
Day 2: Summary of Plasma pGSN PK Parameters 
PK 
14.2.2.3 
Day 3: Summary of Plasma pGSN PK Parameters 
PK 
14.2.3.1 
Day 1: Summary of Estimated Plasma rhu-pGSN PK Parameters 
PK 
14.2.3.2 
Day 2: Summary of Estimated Plasma rhu-pGSN PK Parameters 
PK 
14.2.3.3 
Day 3: Summary of Estimated Plasma rhu-pGSN PK Parameters 
PK 
14.2.4.1 
SD: Summary of PD Parameters 
Intent-to-Treat 
14.2.4.2 
MAD: Summary of PD Parameters 
Intent-to-Treat 
14.2.5.1 
SD: Summary of PD Parameters 
Per Protocol 
14.2.5.2 
MAD: Summary of PD Parameters 
Per Protocol 
14.3.1.1 
SD: Summary of Concomitant Medication 
Safety 
14.3.1.2 
MAD: Summary of Prior and Concomitant Medication 
Safety 
14.3.3.1.1 
SD: Overall Summary of Treatment-Emergent Adverse Events 
Safety 
14.3.3.1.2 
MAD: Overall Summary of Treatment-Emergent Adverse Events 
Safety 
14.3.3.2.1 
SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT) 
Safety 
14.3.3.2.2 
MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT) 
Safety 
14.3.3.3.1 
SD: Summary of Treatment-Emergent Deaths (Summary by SOC, PT) 
Safety 
14.3.3.3.2 
MAD: Summary of Treatment-Emergent Deaths (Summary by SOC, PT) 
Safety 
 
 
 


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No. 
Title 
Analysis 
Population 
 
 
 
14.3.3.4.1 
SD: Summary of Serious Treatment-Emergent Adverse Events (Summary by SOC, PT) 
Safety 
14.3.3.4.2 
MAD: Summary of Serious Treatment-Emergent Adverse Events (Summary by SOC, PT) 
Safety 
14.3.3.5.1 
SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and NCI-CTCAE Grade) 
Safety 
14.3.3.5.2 
MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and NCI-CTCAE Grade) 
Safety 
14.3.1.6.1 
SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Drug) 
Safety 
14.3.3.6.2 
MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Drug) 
Safety 
14.3.3.7.1 
SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Procedure) 
Safety 
14.3.3.7.2 
MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Procedure) 
Safety 
14.3.3.8.1 
SD: Summary of Treatment-Emergent Adverse Events Leading to Treatment Discontinuation (Summary by SOC, PT) 
Safety 
14.3.3.8.2 
MAD: Summary of Treatment-Emergent Adverse Events Leading to Treatment Discontinuation (Summary by SOC, PT) 
Safety 
14.3.3.9.1 
SD: Summary of Overall Survival 
Safety 
14.3.3.9.2 
MAD: Summary of Overall Survival 
Safety 
14.3.4.1.1.1 SD: Summary of CBC (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.1.1.2 MAD: Summary of CBC (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.1.2.1 SD: Summary of CBC Shifts from Baseline (Low, Normal, High) 
Safety 
14.3.4.1.2.2 MAD: Summary of CBC Shifts from Baseline (Low, Normal, High) 
Safety 
14.3.4.2.1.1 SD: Summary of Coagulation (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.2.1.2 MAD: Summary of Coagulation (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.2.2.1 SD: Summary of Coagulation Shifts from Baseline (Low, Normal, High) 
Safety 
14.3.4.2.2.2 MAD: Summary of Coagulation Shifts from Baseline (Low, Normal, High) 
Safety 
14.3.4.3.1.1 SD: Summary of Comprehesive Metabolic Profile (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.3.1.2 MAD: Summary of Comprehesive Metabolic Profile (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.3.2.1 SD: Summary of Comprehesive Metabolic Profile Shifts from Baseline (Low, Normal, High) 
Safety 
14.3.4.3.2.2 MAD: Summary of Comprehesive Metabolic Profile Shifts from Baseline (Low, Normal, High) 
Safety 
14.3.4.4.1 
SD: Summary of Vital Signs (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.4.2 
MAD: Summary of Vital Signs (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.5.1 
SD: Summary of Vital Signs Interpretation by Timepoint 
Safety 
14.3.4.5.2 
MAD: Summary of Vital Signs Interpretation by Timepoint 
Safety 
14.3.4.6.1 
SD: Summary of Mean EKG (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.6.2 
MAD: Summary of Mean EKG (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 


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No. 
Title 
Analysis 
Population 
 
 
 
14.3.4.7.1 
SD: Summary of EKG Interpretation (Worst) by Timepoint 
Safety 
14.3.4.7.2 
MAD: Summary of EKG Interpretation (Worst) by Timepoint 
Safety 
14.3.4.8.1 
SD: Summary of CURB-65 Score(Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.8.2 
MAD: Summary of CURB-65 Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.9.1 
SD: Summary of PSI Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.9.2 
MAD: Summary of PSI Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.10.1 
SD: Summary of PSI Risk Class by Timepoint 
Safety 
14.3.4.10.2 
MAD: Summary of PSI Risk Class by Timepoint 
Safety 
14.3.4.11.1 
SD: Summary of SOFA Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.11.2 
MAD: Summary of SOFA Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.12.1 
SD: Summary of MMSE Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.12.2 
MAD: Summary of MMSE Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Safety 
14.3.4.13.1 
SD: Summary of Hospitalization 
Safety 
14.3.4.13.2 
MAD: Summary of Hospitalization 
Safety 
 
 
 
 


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18. LISTINGS 
No. 
Title 
Analysis 
Population 
 
 
 
16.2.1.2.1 
SD: Subject Disposition 
Intent-to-Treat 
16.2.1.2.2 
MAD: Subject Disposition 
Intent-to-Treat 
16.2.2.1 
SD: Protocol Deviations 
Intent-to-Treat 
16.2.2.2 
MAD: Protocol Deviations 
Intent-to-Treat 
16.2.3.1 
SD: Analysis Populations 
Intent-to-Treat 
16.2.3.2 
MAD: Analysis Populations 
Intent-to-Treat 
16.2.4.1.1 
SD: Demographics and Baseline Characteristics 
Intent-to-Treat 
16.2.4.1.2 
MAD: Demographics and Baseline Characteristics 
Intent-to-Treat 
16.2.4.2.1 
SD: Viral Serology 
Intent-to-Treat 
16.2.4.2.2 
MAD: Viral Serology 
Intent-to-Treat 
16.2.4.3.1 
SD: Medical History 
Intent-to-Treat 
16.2.4.3.2 
MAD: Medical History 
Intent-to-Treat 
16.2.4.4.1 
SD: Pregnancy Test Results 
Intent-to-Treat 
16.2.4.4.2 
MAD: Pregnancy Test Results 
Intent-to-Treat 
16.2.4.5.1 
SD: Confirmation of CAP 
Intent-to-Treat 
16.2.4.5.2 
MAD: Confirmation of CAP 
Intent-to-Treat 
16.2.4.6.1 
SD: Eligibility Assessment 
Intent-to-Treat 
16.2.4.6.2 
MAD: Eligibility Criteria 
Intent-to-Treat 
16.2.4.7.1 
SD: Prior Medications 
Intent-to-Treat 
16.2.4.7.2 
MAD: Prior Medications 
Intent-to-Treat 
16.2.5.1.1 
SD: Randomization 
Intent-to-Treat 
16.2.5.1.2 
MAD: Randomization 
Intent-to-Treat 
16.2.5.2.1 
SD: Study Drug Administration 
Intent-to-Treat 
16.2.5.2.2 
MAD: Study Drug Administration 
Intent-to-Treat 
16.2.5.3.1 
SD: Study Drug Interruption 
Intent-to-Treat 
16.2.5.3.2 
MAD: Study Drug Interruption 
Intent-to-Treat 
16.2.6.1.1 
SD: Individual pGSN Plasma Concentrations (unit) 
Intent-to-Treat 
 
 
 
 


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No. 
Title 
Analysis 
Population 
 
 
 
16.2.6.1.2 
MAD: Individual pGSN Plasma Concentrations (unit) 
Intent-to-Treat 
16.2.6.2.1 
SD: Individual Estimated Plasma rhu-pGSN Concentrations (unit) 
Intent-to-Treat 
16.2.6.2.2 
MAD: Individual Estimated Plasma rhu-pGSN Plasma Concentrations (unit) 
Intent-to-Treat 
16.2.6.3.1 
SD: Individual pGSN Plasma PK Parameters 
Intent-to-Treat 
16.2.6.3.2 
MAD: Individual pGSN Plasma PK Parameters by Day 
Intent-to-Treat 
16.2.6.4.1 
SD: Individual Estimated Plasma rhu-pGSN Plasma PK Parameters 
Intent-to-Treat 
16.2.6.4.2 
MAD: Individual Estimated Plasma rhu-pGSN Plasma PK Parameters by Day 
Intent-to-Treat 
16.2.6.5.1 
SD: Anti-rhu-pGSN Antibodies 
Intent-to-Treat 
16.2.6.5.2 
MAD: Anti-rhu-pGSN Antibodies 
Intent-to-Treat 
16.2.6.6.1 
SD: Biomarkers 
Intent-to-Treat 
16.2.6.6.2 
MAD: Biomarkers 
Intent-to-Treat 
16.2.6.7.1 
SD: Sputum and Blood Culture 
Intent-to-Treat 
16.2.6.7.2 
MAD: Sputum and Blood Culture 
Intent-to-Treat 
16.2.7.1.1 
SD: Adverse Events 
Intent-to-Treat 
16.2.7.1.2 
MAD: Adverse Events 
Intent-to-Treat 
16.2.7.2.1 
SD: Serious Adverse Events 
Intent-to-Treat 
16.2.7.2.2 
MAD: Serious Adverse Events 
Intent-to-Treat 
16.2.7.3.1 
SD: Adverse Events Leading to Study Medication Discontinuation 
Intent-to-Treat 
16.2.7.3.2 
MAD: Adverse Events Leading to Study Medication Discontinuation 
Intent-to-Treat 
16.2.7.4.1 
SD: Overall Survival 
Intent-to-Treat 
16.2.7.4.2 
MAD: Overall Survival 
Intent-to-Treat 
16.2.8.1.1.1 SD: CBC 
Intent-to-Treat 
16.2.8.1.1.2 MAD: CBC 
Intent-to-Treat 
16.2.8.1.2.1 SD: Abnormal CBC 
Intent-to-Treat 
16.2.8.1.2.2 MAD: Abnormal CBC 
Intent-to-Treat 
16.2.8.2.1.1 SD: Coagulation 
Intent-to-Treat 
16.2.8.2.1.2 MAD: Coagulation 
Intent-to-Treat 
16.2.8.2.2.1 SD: Abnormal Coagulation 
Intent-to-Treat 
16.2.8.2.2.2 MAD: Abnormal Coagulation 
Intent-to-Treat 
16.2.8.3.1.1 SD: Comprehensive Metabolic Profile 
Intent-to-Treat 
16.2.8.3.1.2 MAD: Comprehensive Metabolic Profile 
Intent-to-Treat 


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No. 
Title 
Analysis 
Population 
 
 
 
16.2.8.3.2.1 SD: Abnormal Comprehensive Metabolic Profile 
Intent-to-Treat 
16.2.8.3.2.2 MAD: Abnormal Comprehensive Metabolic Profile 
Intent-to-Treat 
16.2.9.1 
SD: Vital Signs 
Intent-to-Treat 
16.2.9.2 
MAD: Vital Signs 
Intent-to-Treat 
16.2.10.1 
SD: EKG 
Intent-to-Treat 
16.2.10.2 
MAD: EKG 
Intent-to-Treat 
16.2.11.1 
SD: Physical Examination 
Intent-to-Treat 
16.2.11.2 
MAD: Physical Examination 
Intent-to-Treat 
16.2.12.1.1 
SD: Outcome Prediction Models CURB-65 
Intent-to-Treat 
16.2.12.1.2 
MAD: Outcome Prediction Models CURB-65 
Intent-to-Treat 
16.2.12.2.1 
SD: Outcome Prediction Models PSI (Port Score) 
Intent-to-Treat 
16.2.12.2.2 
MAD: Outcome Prediction Models PSI (Port Score) 
Intent-to-Treat 
16.2.12.3.1 
SD: Outcome Prediction Models SOFA Score 
Intent-to-Treat 
16.2.12.3.2 
MAD: Outcome Prediction Models SOFA Score 
Intent-to-Treat 
16.2.12.4.1 
SD: Outcome Prediction Models MMSE Score 
Intent-to-Treat 
16.2.12.4.2 
MAD: Outcome Prediction Models MMSE Score 
Intent-to-Treat 
16.2.13.1 
SD: Concomitant Medications 
Intent-to-Treat 
16.2.13.2 
MAD: Concomitant Medication 
Intent-to-Treat 
16.2.14.1 
SD: Hospitalization Follow-Up 
Intent-to-Treat 
16.2.14.2 
MAD: Hospitalization Follow-Up 
Intent-to-Treat 
 
 
 
 
 
 


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Page 42 of 44 
19. FIGURES 
No. 
Title 
Analysis 
Population 
 
 
 
14.2.1.1 
Individual pGSN Plasma Concentrations (ng/mL) (Linear scale) by Day 
PK 
14.2.1.2 
Individual pGSN Plasma Concentrations (ng/mL) (Semi-logarithmic) by Day 
PK 
14.2.2.1 
Individual Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on the Double Delta Analysis (Linear scale) 
by Day 
PK 
14.2.2.2 
Individual Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on the Double Delta Analysis (Linear scale) 
by Day 
PK 
14.2.3.1 
Mean (+/-SD) pGSN Plasma Concentrations (ng/mL) (Linear scale) by Day 
PK 
14.2.3.2 
Mean (+/-SD) pGSN Plasma Concentrations (ng/mL) based on Changes from Pre-Injection  (Linear scale) by Day (Semi-
logarithmic) by Day 
PK 
14.2.4.1 
Mean (+/-SD) Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on Changes from Pre-Injection  (Linear 
scale) by Day 
PK 
14.2.4.2 
Mean (+/-SD) Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on the Double Delta Analysis (Linear 
scale) by Day 
PK 
14.3.1.1 
SD: Kaplan-Meier Plot of Overall Survival Time 
Safety 
14.3.1.2 
MAD: Kaplan-Meier Plot of Overall Survival Time 
Safety 
14.3.2.1 
SD: Kaplan-Meier Plot of Length of Stay in Hospital (hours) 
Safety 
14.3.2.2 
MAD: Kaplan-Meier Plot of Length of Stay in Hospital (hours) 
Safety 
14.3.3.1 
SD: Kaplan-Meier Plot of Duration of ICU Stay 
Safety 
14.3.3.2 
MAD: Kaplan-Meier Plot of Duration of ICU Stay 
Safety 
14.3.4.1 
SD: Kaplan-Meier Plot of Duration of Intubation 
Safety 
14.3.4.2 
MAD: Kaplan-Meier Plot of Duration of Intubation 
Safety 
 
 
 
 
 
 


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Document status: Final SAP Version 2.0 Amendment 1.0 
 
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Page 43 of 44 
20. APPENDICES 
 
No. 
Title 
Analysis 
Population 
 
 
 
14.3.3.9.1 
SD: Summary of Overall Survival 
Safety 
14.3.3.9.2 
MAD: Summary of Overall Survival 
Safety 
14.3.4.13.1 SD: Summary of Hospitalization 
Safety 
14.3.4.13.2 MAD: Summary of Hospitalization 
Safety 
 
 
 


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Page 44 of 44 
21. REFERENCES 
1) 
Clinical Study Protocol Amendment 1.0, 30 April 2018. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 1 of 82 
 
 
BTI-201: Mock Tables: Table of Contents  
Tables 
 
Table 14.1.1.1 SD: Summary of Subject Enrolment and Disposition .......................................................................................................................................... 6 
Table 14.1.1.2 MAD: Summary of Subject Enrolment and Disposition ....................................................................................................................................... 7 
Table 14.1.2.1 SD: Summary of Demographics and Baseline Characteristics ....................................................................................................................... 8 
Table 14.1.2.2 MAD: Summary of Demographics and Baseline Characteristics .................................................................................................................. 10 
Table 14.2.1.1 Day 1: Summary of Plasma pGSN Concentrations (unit) by Timepoint .................................................................................................. 11 
Table 14.2.1.2 Day 2: Summary of Plasma pGSN Concentrations (unit) by Timepoint .................................................................................................. 13 
Table 14.2.1.3 Day 3: Summary of Plasma pGSN Concentrations (unit) by Timepoint .................................................................................................. 15 
Table 14.2.1.4 Day 1: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint................................................................. 16 
Table 14.2.1.5 Day 2: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint................................................................. 18 
Table 14.2.1.6 Day 3: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint................................................................. 20 
Table 14.2.2.1 Day 1: Summary of Plasma pGSN PK Parameters .................................................................................................................................................... 21 
Table 14.2.2.2 Day 2: Summary of Plasma pGSN PK Parameters .................................................................................................................................................... 22 
Table 14.2.2.3 Day 3: Summary of Plasma pGSN PK Parameters .................................................................................................................................................... 23 
Table 14.2.3.1 Day 1: Summary of Estimated Plasma rhu-pGSN PK Parameters .................................................................................................................. 24 
Table 14.2.3.2 Day 2: Summary of Estimated Plasma rhu-pGSN PK Parameters .................................................................................................................. 25 
Table 14.2.3.3 Day 3: Summary of Estimated Plasma rhu-pGSN PK Parameters .................................................................................................................. 26 
Table 14.2.4.1 SD: Summary of PD Parameters ....................................................................................................................................................................................... 27 
Table 14.2.4.2 MAD: Summary of PD Parameters ..................................................................................................................................................................................... 28 
Table 14.2.5.1 SD: Summary of PD Parameters ....................................................................................................................................................................................... 29 
Table 14.2.5.2 MAD: Summary of PD Parameters ..................................................................................................................................................................................... 30 
Table 14.3.1.1 SD: Summary of Concomitant Medication .................................................................................................................................................................. 31 
Table 14.3.1.2 MAD: Summary of Prior and Concomitant Medication ........................................................................................................................................ 32 
Table 14.3.3.1.1 SD: Overall Summary of Treatment-Emergent Adverse Events ................................................................................................................ 33 
Table 14.3.3.1.2 MAD: Overall Summary of Treatment-Emergent Adverse Events .............................................................................................................. 34 
Table 14.3.3.2.1 SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT) ................................................................................. 35 
Table 14.3.3.2.2 MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT) ............................................................................... 36 
Table 14.3.3.3.1 SD: Summary of Treatment-Emergent Deaths (Summary by SOC, PT) .................................................................................................... 37 
Table 14.3.3.3.2 MAD: Summary of Treatment-Emergent Deaths (Summary by SOC, PT) .................................................................................................. 38 
Table 14.3.3.4.1 SD: Summary of Serious Treatment-Emergent Adverse Events (Summary by SOC, PT) .............................................................. 39 
Table 14.3.3.4.2 MAD: Summary of Serious Treatment-Emergent Adverse Events (Summary by SOC, PT) ............................................................ 40 
Table 14.3.3.5.1 SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and NCI-CTCAE Grade) .................................. 41 
Table 14.3.3.5.2 MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and NCI-CTCAE Grade) ............................... 42 
Table 14.3.1.6.1 SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Drug)........ 43 
Table 14.3.3.6.2 MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Drug) ..... 44 
Table 14.3.3.7.1 SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Procedure)
.............................................................................................................................................................................................................................................................................................. 45 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 2 of 82 
 
Table 14.3.3.7.2 MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study 
Procedure) ...................................................................................................................................................................................................................................................................... 46 
Table 14.3.3.8.1 SD: Summary of Treatment-Emergent Adverse Events Leading to Treatment Discontinuation (Summary by SOC, 
PT) ...................................................................................................................................................................................................................................................................................... 47 
Table 14.3.3.8.2 MAD: Summary of Treatment-Emergent Adverse Events Leading to Treatment Discontinuation (Summary by SOC, 
PT) ...................................................................................................................................................................................................................................................................................... 48 
Table 14.3.3.9.1 SD: Summary of Overall Survival ........................................................................................................................................................................... 49 
Table 14.3.3.9.2 MAD: Summary of Overall Survival ......................................................................................................................................................................... 50 
Table 14.3.4.1.1.1 SD: Summary of CBC (Summary of Actual and Change from Baseline Values) by Timepoint ........................................... 51 
Table 14.3.4.1.1.2 MAD: Summary of CBC (Summary of Actual and Change from Baseline Values) by Timepoint ......................................... 52 
Table 14.3.4.1.2.1 SD: Summary of CBC Shifts from Baseline (Low, Normal, High) .................................................................................................... 53 
Table 14.3.4.1.2.2 MAD: Summary of CBC Shifts from Baseline (Low, Normal, High) .................................................................................................. 54 
Table 14.3.4.2.1.1 SD: Summary of Coagulation (Summary of Actual and Change from Baseline Values) by Timepoint ........................ 55 
Table 14.3.4.2.1.2 MAD: Summary of Coagulation (Summary of Actual and Change from Baseline Values) by Timepoint ...................... 56 
Table 14.3.4.2.2.1 SD: Summary of Coagulation Shifts from Baseline (Low, Normal, High) ................................................................................. 57 
Table 14.3.4.2.2.2 MAD: Summary of Coagulation Shifts from Baseline (Low, Normal, High) ............................................................................... 58 
Table 14.3.4.3.1.1 SD: Summary of Comprehensive Metabolic Profile (Summary of Actual and Change from Baseline Values) by 
Timepoint ........................................................................................................................................................................................................................................................................ 59 
Table 14.3.4.3.1.2 MAD: Summary of Comprehensive Metabolic Profile (Summary of Actual and Change from Baseline Values) by 
Timepoint ........................................................................................................................................................................................................................................................................ 60 
Table 14.3.4.3.2.1 SD: Summary of Comprehensive Metabolic Profile Shifts from Baseline (Low, Normal, High) .................................. 61 
Table 14.3.4.3.2.2 MAD: Summary of Comprehensive Metabolic Profile Shifts from Baseline (Low, Normal, High) ............................... 62 
Table 14.3.4.4.1 SD: Summary of Vital Signs (Summary of Actual and Change from Baseline Values) by Timepoint ............................. 63 
Table 14.3.4.4.2 MAD: Summary of Vital Signs (Summary of Actual and Change from Baseline Values) by Timepoint........................... 64 
Table 14.3.4.5.1 SD: Summary of Vital Signs Interpretation by Timepoint ..................................................................................................................... 65 
Table 14.3.4.5.2 MAD: Summary of Vital Signs Interpretation by Timepoint .................................................................................................................. 66 
Table 14.3.4.6.1 SD: Summary of Mean EKG (Summary of Actual and Change from Baseline Values) by Timepoint .................................... 67 
Table 14.3.4.6.2 MAD: Summary of Mean EKG (Summary of Actual and Change from Baseline Values) by Timepoint .................................. 68 
Table 14.3.4.7.1 SD: Summary of EKG Interpretation (Worst) by Timepoint ..................................................................................................................... 69 
Table 14.3.4.7.2 MAD: Summary of EKG Interpretation (Worst) by Timepoint .................................................................................................................. 70 
Table 14.3.4.8.1 SD: Summary of CURB-65 Score(Summary of Actual and Change from Baseline Values) by Timepoint........................... 71 
Table 14.3.4.8.2 MAD: Summary of CURB-65 Score (Summary of Actual and Change from Baseline Values) by Timepoint ...................... 72 
Table 14.3.4.9.1 SD: Summary of PSI Score (Summary of Actual and Change from Baseline Values) by Timepoint .................................. 73 
Table 14.3.4.9.2 MAD: Summary of PSI Score (Summary of Actual and Change from Baseline Values) by Timepoint ............................... 74 
Table 14.3.4.10.1 SD: Summary of PSI Risk Class by Timepoint ............................................................................................................................................... 75 
Table 14.3.4.10.2 MAD: Summary of PSI Risk Class by Timepoint ............................................................................................................................................. 76 
Table 14.3.4.11.1 SD: Summary of SOFA Score (Summary of Actual and Change from Baseline Values) by Timepoint ............................. 77 
Table 14.3.4.11.2 MAD: Summary of SOFA Score (Summary of Actual and Change from Baseline Values) by Timepoint........................... 78 
Table 14.3.4.12.1 SD: Summary of MMSE Score (Summary of Actual and Change from Baseline Values) by Timepoint ............................. 79 
Table 14.3.4.12.2 MAD: Summary of MMSE Score (Summary of Actual and Change from Baseline Values) by Timepoint........................... 80 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 3 of 82 
 
Table 14.3.4.13.1 SD: Summary of Hospitalization ........................................................................................................................................................................... 81 
Table 14.3.4.13.2 MAD: Summary of Hospitalization ......................................................................................................................................................................... 82 
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 4 of 82 
 
GENERAL COMMENTS 
 
x 
Where a count is 0, the percentage will not be shown (e.g. 0 (0.0%) will be displayed as 0) 
x 
Unless otherwise states, parameters will be listed in alphabetical order 
x 
Percentages and their 95% CI, where appropriate, will be presented to one decimal place 
x 
The minimum and maximum values will be presented to the same number of decimal places as recorded in the electronic Case Report Form (eCRF) 
x 
Mean, median, and SD will be presented to one more decimal place than the raw data 
x 
Percentages will be rounded to one decimal place, with the denominator being the number of subjects in the relevant population with non-missing data, unless 
otherwise specified 
x 
Change from Baseline: 
Change from Baseline will be calculated as: 
ܥ݄ܽ݊݃݁݂ݎ݋݉ܾܽݏ݈݁݅݊݁ൌ݊݁ݓݒ݈ܽݑ݁െܾܽݏ݈݁݅݊݁ݒ݈ܽݑ݁ 
x 
Unscheduled visits will be excluded from summary tables 
x 
Names and order of Treatment Groups 
SD: 
x 
rhu-pGSN 6 mg/kg; 
x 
Placebo; 
x 
Overall. 
MAD: 
x 
rhu-pGSN 6 mg/kg; 
x 
rhu-pGSN 12 mg/kg; 
x 
rhu-pGSN 24 mg/kg; 
x 
Combined Placebo; 
x 
Overall. 
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 5 of 82 
 
x 
Names of visits 
SD: 
x 
Screening 
x 
Day 1 
x 
Day 2 
x 
Day 3/4 
x 
Day 7 
x 
Day 14 
x 
Day 28 / Early Termination (Combined visit for safety and PD) 
MAD: 
x 
Screening 
x 
Day 1 
x 
Day 2 
x 
Day 3 
x 
Day 4 
x 
Day 7 
x 
Day 14 
x 
Day 28 / Early Termination (Combined visit for safety and PD) 
x 
Column widths and text-wrapping may be altered in final output in order to best present the data 
x 
Footnotes may be added/amended if required 
 
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 6 of 82 
 
Table 14.1.1.1 SD: Summary of Subject Enrolment and Disposition 
Protocol: BTI-201 
Intent-to-Treat Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
Number of Subjects Screened 
xx 
xx 
xx 
Number of Screening Failures1 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Number of Subjects Randomized 
xx 
xx 
xx 
Number of Subjects who Completed the Study 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Number of Subjects Discontinued 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Primary Reason for Discontinuation of Study 
 
 
 
Due to Adverse Event 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Subject withdrew consent 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Investigator Decision 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Non-Compliance with the study procedures/protocol 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Any clinically significant change in subject’s medical condition 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Sponsor ended study 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Lost to follow-up 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Other 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Number of Subjects included in the ITT Population 
x (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Number of Subjects included in the Safety Population 
x (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Number of Subjects included in the PK Population 
x (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
Number of Subjects included in the PP Population 
x (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
1Percentages are based on number of subjects screened. 
 
Clinical cut-off date: DDMMMYYYY                                                                                                      
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 7 of 82 
 
Table 14.1.1.2 MAD: Summary of Subject Enrolment and Disposition 
Protocol: BTI-201 
Intent-to-Treat Population 
 
 
Clinical cut-off date: DDMMMYYYY                                                                                                      
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Repeat Table 14.1.1.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 8 of 82 
 
Table 14.1.2.1 SD: Summary of Demographics and Baseline Characteristics 
Protocol: BTI-201 
Intent-to-Treat Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
Age (years) at Screening 
n 
xx 
xx 
xx 
 
Mean 
xx.x 
xx.x 
xx.x 
 
Median 
xx.x 
xx.x 
xx.x 
 
SD 
x.x 
x.x 
xx.x 
 
Minimum 
xx 
xx 
xx 
 
Maximum 
xx 
xx 
xx 
 
 
 
 
Sex n(%) 
Female 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Male 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Race n(%) 
Asian 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Pacific Islander 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Black or African 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Pacific Islander 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Aborigine/Torres Strait Islander 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
White 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Other 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Childbearing Potential n(%)* 
Yes 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
No 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
*Percentages are based on the number of female participants. 
SD: Standard Deviation 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  

 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 9 of 82 
 
Table 14.1.2.1 SD: Summary of Demographics and Baseline Characteristics 
Protocol: BTI-201 
Intent-to-Treat Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
Height (cm) 
n 
xx 
xx 
xx 
 
Mean 
xx.x 
xx.x 
xx.x 
 
Median 
xx.x 
xx.x 
xx.x 
 
SD 
x.x 
x.x 
xx.x 
 
Minimum 
xx 
xx 
xx 
 
Maximum 
xx 
xx 
xx 
 
 
 
 
Weight (kg) 
n 
xx 
xx 
xx 
 
Mean 
xx.x 
xx.x 
xx.x 
 
Median 
xx.x 
xx.x 
xx.x 
 
SD 
x.x 
x.x 
xx.x 
 
Minimum 
xx 
xx 
xx 
 
Maximum 
xx 
xx 
xx 
 
 
 
 
*Percentages are based on the number of female participants. 
SD: Standard Deviation 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 10 of 82 
 
Table 14.1.2.2 MAD: Summary of Demographics and Baseline Characteristics 
Protocol: BTI-201 
Intent-to-Treat Population 
 
 
Clinical cut-off date: DDMMMYYYY                                                                                                      
Program: filepath_name (version x.x), Output: filepath_name   Created: DDMMMYYYY 

 
Programming Note: 
Repeat Table 14.1.2.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 11 of 82 
 
Table 14.2.1.1 Day 1: Summary of Plasma pGSN Concentrations (unit) by Timepoint 
Protocol: BTI-201 
PK Population 
 
Time Point 
 
SD/MAD 
rhu-pGSN 
6 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
12 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
Actual 
Value 
Ratio 
from Pre-
Injection  
Ratio from 
Pre-
Injection/ 
Placebo 
Ratio from 
Pre-
Injection  
Actual 
Value 
Ratio 
from Pre-
Injection  
Ratio from 
Pre-
Injection/ 
Placebo 
Ratio from 
Pre-
Injection  
Actual 
Value 
Ratio  
from Pre-
Injection  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-Injection 
n 
x 
 
 
x 
 
 
x 
 
 
Mean 
x.x 
 
 
x.x 
 
 
x.x 
 
 
Median 
x.x 
 
 
x.x 
 
 
x.x 
 
 
SD 
x.x 
 
 
x.x 
 
 
x.x 
 
 
Minimum 
x 
 
 
x 
 
 
x 
 
 
Maximum 
x 
 
 
x 
 
 
x 
 
 
CV% 
x.x 
 
 
x.x 
 
 
x.x 
 
 
GeoMean 
x.x 
 
 
x.x 
 
 
x.x 
 
 
GeoCV% 
x.x 
 
 
x.x 
 
 
x.x 
 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
5 to 10 mins post 
n 
x 
x 
x 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
ln SD 
 
x.x 
x.x 
 
x.x 
x.x 
 
x.x 
 
GeoMean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
GeoCV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
BLQ 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
…. 
 
 
 
 
 
 
 
 
 
SD: Standard Deviation; GeoMean: Geometric Mean; GeoCV%: Geometric CV%; BLQ: Below Limit of Quantification  
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
Programming Note: Repeat for all timepoints. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 12 of 82 
 
Table 14.2.1.1 Day 1: Summary of Plasma pGSN Concentrations (unit) by Timepoint (continued) 
Protocol: BTI-201 
PK Population 
 
Time Point 
 
MAD 
rhu-pGSN 
24 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
Actual Value 
Ratio from 
Pre-Injection  
Ratio from Pre-
Injection/ 
Placebo Ratio 
from Pre-
Injection  
Actual Value 
Ratio  
from Pre-Injection  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-Injection 
n 
x 
 
 
x 
 
 
Mean 
x.x 
 
 
x.x 
 
 
Median 
x.x 
 
 
x.x 
 
 
SD 
x.x 
 
 
x.x 
 
 
Minimum 
x 
 
 
x 
 
 
Maximum 
x 
 
 
x 
 
 
CV% 
x.x 
 
 
x.x 
 
 
GeoMean 
x.x 
 
 
x.x 
 
 
GeoCV% 
x.x 
 
 
x.x 
 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
 
 
 
 
 
 
5 to 10 mins post 
n 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
 
ln SD 
 
x.x 
x.x 
 
x.x 
 
GeoMean 
x.x 
x.x 
x.x 
x.x 
x.x 
 
GeoCV% 
x.x 
x.x 
x.x 
x.x 
x.x 
 
BLQ 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
…. 
 
 
 
 
 
 
SD: Standard Deviation; GeoMean: Geometric Mean; GeoCV%: Geometric CV%; BLQ: Below Limit of Quantification  
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 
Programming Note: Repeat for all timepoints. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 13 of 82 
 
Table 14.2.1.2 Day 2: Summary of Plasma pGSN Concentrations (unit) by Timepoint 
Protocol: BTI-201 
PK Population 
 
Time Point 
 
MAD 
rhu-pGSN 
6 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
12 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
Actual 
Value 
Ratio 
from Pre-
Injection  
Ratio from 
Pre-
Injection/ 
Placebo 
Ratio from 
Pre-
Injection  
Actual 
Value 
Ratio 
from Pre-
Injection  
Ratio from 
Pre-
Injection/ 
Placebo 
Ratio from 
Pre-
Injection  
Actual 
Value 
Ratio  
from Pre-
Injection  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-Injection 
n 
x 
 
 
x 
 
 
x 
 
 
Mean 
x.x 
 
 
x.x 
 
 
x.x 
 
 
Median 
x.x 
 
 
x.x 
 
 
x.x 
 
 
SD 
x.x 
 
 
x.x 
 
 
x.x 
 
 
Minimum 
x 
 
 
x 
 
 
x 
 
 
Maximum 
x 
 
 
x 
 
 
x 
 
 
CV% 
x.x 
 
 
x.x 
 
 
x.x 
 
 
GeoMean 
x.x 
 
 
x.x 
 
 
x.x 
 
 
GeoCV% 
x.x 
 
 
x.x 
 
 
x.x 
 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
5 to 10 mins post 
n 
x 
x 
x 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
ln SD 
 
x.x 
x.x 
 
x.x 
x.x 
 
x.x 
 
GeoMean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
GeoCV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
BLQ 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
…. 
 
 
 
 
 
 
 
 
 
SD: Standard Deviation; GeoMean: Geometric Mean; GeoCV%: Geometric CV%; BLQ: Below Limit of Quantification  
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  

 
Programming Note: Repeat for all timepoints. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 14 of 82 
 
Table 14.2.1.2 Day 2: Summary of Plasma pGSN Concentrations (unit) by Timepoint (continued) 
Protocol: BTI-201 
PK Population 
 
Time Point 
 
MAD 
rhu-pGSN 
24 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
Actual Value 
Ratio from 
Pre-Injection  
Ratio from Pre-
Injection/ 
Placebo Ratio 
from Pre-
Injection  
Actual Value 
Ratio  
from Pre-Injection  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-Injection 
n 
x 
 
 
x 
 
 
Mean 
x.x 
 
 
x.x 
 
 
Median 
x.x 
 
 
x.x 
 
 
SD 
x.x 
 
 
x.x 
 
 
Minimum 
x 
 
 
x 
 
 
Maximum 
x 
 
 
x 
 
 
CV% 
x.x 
 
 
x.x 
 
 
GeoMean 
x.x 
 
 
x.x 
 
 
GeoCV% 
x.x 
 
 
x.x 
 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
 
 
 
 
 
 
5 to 10 mins post 
n 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
 
ln SD 
 
x.x 
x.x 
 
x.x 
 
GeoMean 
x.x 
x.x 
x.x 
x.x 
x.x 
 
GeoCV% 
x.x 
x.x 
x.x 
x.x 
x.x 
 
BLQ 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
x (xx.x%) 
…. 
 
 
 
 
 
 
SD: Standard Deviation; GeoMean: Geometric Mean; GeoCV%: Geometric CV%; BLQ: Below Limit of Quantification  
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 
Programming Note: Repeat for all timepoints. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 15 of 82 
 
Table 14.2.1.3 Day 3: Summary of Plasma pGSN Concentrations (unit) by Timepoint 
Protocol: BTI-201 
PK Population 
 
 
 
 
Programming Note: Repeat Table 14.2.1.2 for Day 3. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 16 of 82 
 
Table 14.2.1.4 Day 1: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint 
Protocol: BTI-201 
PK Population 
 
Time Point 
 
SD/MAD 
rhu-pGSN 
6 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
12 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
Actual 
Value 
Change 
from Pre-
Injection  
(Change from 
Pre-
Injection)- 
(Mean Placebo 
Change from 
Pre-
Injection)  
Actual 
Value 
Change 
from Pre-
Injection 
(Change from 
Pre-
Injection)- 
(Mean Placebo 
Change from 
Pre-
Injection) 
Actual 
Value 
Change  
from Pre-
Injection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-Injection 
n 
x 
 
 
x 
 
 
x 
 
 
Mean 
x.x 
 
 
x.x 
 
 
x.x 
 
 
Median 
x.x 
 
 
x.x 
 
 
x.x 
 
 
SD 
x.x 
 
 
x.x 
 
 
x.x 
 
 
Minimum 
x 
 
 
x 
 
 
x 
 
 
Maximum 
x 
 
 
x 
 
 
x 
 
 
CV% 
x.x 
 
 
x.x 
 
 
x.x 
 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
5 to 10 mins post 
n 
x 
x 
x 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
x (xx.x%) 
 
…. 
 
 
 
 
 
 
 
 
 
SD: Standard Deviation; BLQ: Below Limit of Quantification  
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  

 
Programming Note: Repeat for all timepoints. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 17 of 82 
 
 
Table 14.2.1.4 Day 1: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint (continued) 
Protocol: BTI-201 
PK Population 
 
Time Point 
 
MAD 
rhu-pGSN 
24 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
Actual Value 
Change from 
Pre-Injection  
(Change from Pre-
Injection)-  
(Mean Placebo 
Change from Pre-
Injection)  
Actual Value 
Change  
from Pre-Injection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-Injection 
n 
x 
 
 
x 
 
 
Mean 
x.x 
 
 
x.x 
 
 
Median 
x.x 
 
 
x.x 
 
 
SD 
x.x 
 
 
x.x 
 
 
Minimum 
x 
 
 
x 
 
 
Maximum 
x 
 
 
x 
 
 
CV% 
x.x 
 
 
x.x 
 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
 
 
 
 
 
 
5 to 10 mins post 
n 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
…. 
 
 
 
 
 
 
SD: Standard Deviation; BLQ: Below Limit of Quantification  
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 

 
Programming Note: Repeat for all timepoints. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 18 of 82 
 
 
Table 14.2.1.5 Day 2: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint 
Protocol: BTI-201 
PK Population 
 
Time Point 
 
MAD 
rhu-pGSN 
6 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
12 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
Actual 
Value 
Change 
from Pre-
Injection  
(Change from 
Pre-
Injection)- 
(Mean Placebo 
Change from 
Pre-
Injection)  
Actual 
Value 
Change 
from Pre-
Injection 
(Change from 
Pre-
Injection)- 
(Mean Placebo 
Change from 
Pre-
Injection) 
Actual 
Value 
Change  
from Pre-
Injection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-Injection 
n 
x 
 
 
x 
 
 
x 
 
 
Mean 
x.x 
 
 
x.x 
 
 
x.x 
 
 
Median 
x.x 
 
 
x.x 
 
 
x.x 
 
 
SD 
x.x 
 
 
x.x 
 
 
x.x 
 
 
Minimum 
x 
 
 
x 
 
 
x 
 
 
Maximum 
x 
 
 
x 
 
 
x 
 
 
CV% 
x.x 
 
 
x.x 
 
 
x.x 
 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
5 to 10 mins post 
n 
x 
x 
x 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
x (xx.x%) 
 
…. 
 
 
 
 
 
 
 
 
 
SD: Standard Deviation; BLQ: Below Limit of Quantification  
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  

 
Programming Note: Repeat for all timepoints. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 19 of 82 
 
Table 14.2.1.5 Day 2: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint (continued) 
Protocol: BTI-201 
PK Population 
 
Time Point 
 
MAD 
rhu-pGSN 
24 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
Actual Value 
Change from 
Pre-Injection  
(Change from 
Pre-Injection)- 
(Mean Placebo 
Change from Pre-
Injection)  
Actual Value 
Change  
from Pre-Injection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-Injection 
n 
x 
 
 
x 
 
 
Mean 
x.x 
 
 
x.x 
 
 
Median 
x.x 
 
 
x.x 
 
 
SD 
x.x 
 
 
x.x 
 
 
Minimum 
x 
 
 
x 
 
 
Maximum 
x 
 
 
x 
 
 
CV% 
x.x 
 
 
x.x 
 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
 
 
 
 
 
 
 
5 to 10 mins post 
n 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
 
BLQ 
x (xx.x%) 
 
 
x (xx.x%) 
 
…. 
 
 
 
 
 
 
SD: Standard Deviation; GeoMean: Geometric Mean; GeoCV%: Geometric CV%; BLQ: Below Limit of Quantification  
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 

 
Programming Note: Repeat for all timepoints. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 20 of 82 
 
Table 14.2.1.6 Day 3: Summary of Estimated Plasma rhu-pGSN Concentrations (unit) by Timepoint 
Protocol: BTI-201 
PK Population 
 
 
 
 
Programming Note: Repeat Table 14.2.1.5 for Day 3. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 21 of 82 
 
Table 14.2.2.1 Day 1: Summary of Plasma pGSN PK Parameters 
Protocol: BTI-201 
PK Population 
 
Parameter (unit) 
 
SD/MAD 
rhu-pGSN 
6 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
12 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
24 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
 
 
 
 
AUC0-t (unit) 
n 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
 
GeoMean 
x.x 
x.x 
x.x 
x.x 
 
GeoCV% 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
Cmax (unit) 
n 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
 
GeoMean 
x.x 
x.x 
x.x 
x.x 
 
GeoCV% 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
SD: Standard Deviation; GeoMean: Geometric Mean; GeoCV%: Geometric CV% 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 
 
 
 
 
 
 
Programming Note: Repeat for all PK parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 22 of 82 
 
 
Table 14.2.2.2 Day 2: Summary of Plasma pGSN PK Parameters 
Protocol: BTI-201 
PK Population 
 
Parameter (unit) 
 
MAD 
rhu-pGSN 
6 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
12 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
24 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
 
 
 
 
AUC0-t (unit) 
n 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
 
GeoMean 
x.x 
x.x 
x.x 
x.x 
 
GeoCV% 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
Cmax (unit) 
n 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
 
GeoMean 
x.x 
x.x 
x.x 
x.x 
 
GeoCV% 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
 
 
SD: Standard Deviation; GeoMean: Geometric Mean; GeoCV%: Geometric CV% 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 
 
 
 
Programming Note: Repeat for all PK parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 23 of 82 
 
Table 14.2.2.3 Day 3: Summary of Plasma pGSN PK Parameters 
Protocol: BTI-201 
PK Population 
 
 
Parameter (unit) 
 
MAD 
rhu-pGSN 
6 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
12 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
24 mg/kg 
(N=xx) 
Placebo 
(N=xx) 
 
 
 
 
 
 
AUC0-t (unit) 
n 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
 
GeoMean 
x.x 
x.x 
x.x 
x.x 
 
GeoCV% 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
Cmax (unit) 
n 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
 
GeoMean 
x.x 
x.x 
x.x 
x.x 
 
GeoCV% 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
 
SD: Standard Deviation; GeoMean: Geometric Mean; GeoCV%: Geometric CV% 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 

 
Programming Note: Repeat for all PK parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 24 of 82 
 
Table 14.2.3.1 Day 1: Summary of Estimated Plasma rhu-pGSN PK Parameters 
Protocol: BTI-201 
PK Population 
 
Parameter (unit) 
 
SD/MAD 
rhu-pGSN 
6 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
12 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
24 mg/kg 
(N=xx) 
Change from 
Pre-Injection 
Double Delta 
Analysis 
Change from 
Pre-Injection 
Double Delta 
Analysis 
Change from 
Pre-Injection 
Double Delta 
Analysis 
 
 
 
 
 
 
 
 
AUC0-t (unit) 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
 
 
Cmax (unit) 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
 
 
SD: Standard Deviation; 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 
 
 
 
 
 

 
Programming Note: Include the following: PK parameters (including dose normalized parameters): 
x 
AUC0-t 
x 
AUC0-8h 
x 
Cmax 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 25 of 82 
 
Table 14.2.3.2 Day 2: Summary of Estimated Plasma rhu-pGSN PK Parameters 
Protocol: BTI-201 
PK Population 
 
Parameter (unit) 
 
MAD 
rhu-pGSN 
6 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
12 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
24 mg/kg 
(N=xx) 
Change from 
Pre-Injection 
Double Delta 
Analysis 
Change from 
Pre-Injection 
Double Delta 
Analysis 
Change from 
Pre-Injection 
Double Delta 
Analysis 
 
 
 
 
 
 
 
 
AUC0-t (unit) 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
 
 
Cmax (unit) 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
 
 
SD: Standard Deviation; 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 
 
 
 
 
 

 
Programming Note: Include the following: PK parameters (including dose normalized parameters): 
x 
AUC0-t 
x 
AUC0-8h 
x 
Cmax 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 26 of 82 
 
Table 14.2.3.3 Day 3: Summary of Estimated Plasma rhu-pGSN PK Parameters 
Protocol: BTI-201 
PK Population 
 
Parameter (unit) 
 
MAD 
rhu-pGSN 
6 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
12 mg/kg 
(N=xx) 
MAD 
rhu-pGSN 
24 mg/kg 
(N=xx) 
Change from 
Pre-Injection 
Double Delta 
Analysis 
Change from 
Pre-Injection 
Double Delta 
Analysis 
Change from 
Pre-Injection 
Double Delta 
Analysis 
 
 
 
 
 
 
 
 
AUC0-t (unit) 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
 
 
Cmax (unit) 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
SD 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Minimum 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
Median 
x 
x 
x 
x 
x 
x 
 
Maximum 
x 
x 
x 
x 
x 
x 
 
CV% 
x.x 
x.x 
x.x 
x.x 
x.x 
x.x 
 
 
 
 
 
 
 
 
SD: Standard Deviation; 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 
 
 
 
 
 

 
Programming Note: Include the following: PK parameters (including dose normalized parameters): 
x 
AUC0-t 
x 
AUC0-8h 
x 
Cmax 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 27 of 82 
 
Table 14.2.4.1 SD: Summary of PD Parameters 
Protocol: BTI-201 
Intent-to-Treat Population 
Parameter 
Visit 
 
rhu-pGSN 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Ratio from 
Baseline1 
Actual 
Value 
Ratio from 
Baseline1 
Actual Value 
Ratio from 
Baseline1 
 
 
 
 
 
 
 
Procalcitonin (unit) 
Baseline1 
n 
x 
 
x 
 
x 
 
 
Mean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Median 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
SD 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Minimum 
x.xx 
 
x.xx 
 
x.xx 
 
 
Maximum 
x.xx 
 
x.xx 
 
x.xx 
 
 
GeoMean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
 
 
 
 
 
 
 
Day 2 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
ln SD 
 
x.xxx 
 
x.xxx 
 
x.xxx 
 
GeoMean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
 
 
 
 
 
 
 
Day 3 or 4 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
ln SD 
 
x.xxx 
 
x.xxx 
 
x.xxx 
 
GeoMean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
Programming Note: Repeat for all PD parameters 
and all scheduled post baseline timepoints. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 28 of 82 
 
Table 14.2.4.2 MAD: Summary of PD Parameters 
Protocol: BTI-201 
Intent-to-Treat Population 

 
Programming Note: 
Repeat Table 14.2.4.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 29 of 82 
 
Table 14.2.5.1 SD: Summary of PD Parameters 
Protocol: BTI-201 
Per Protocol Population 
Parameter 
Visit 
 
rhu-pGSN 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Ratio from 
Baseline1 
Actual 
Value 
Ratio from 
Baseline1 
Actual Value 
Ratio from 
Baseline1 
 
 
 
 
 
 
 
Procalcitonin (unit) 
Baseline1 
n 
x 
 
x 
 
x 
 
 
Mean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Median 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
SD 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Minimum 
x.xx 
 
x.xx 
 
x.xx 
 
 
Maximum 
x.xx 
 
x.xx 
 
x.xx 
 
 
GeoMean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
 
 
 
 
 
 
 
Day 2 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
ln SD 
 
x.xxx 
 
x.xxx 
 
x.xxx 
 
GeoMean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
 
 
 
 
 
 
 
Day 3 or 4 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
ln SD 
 
x.xxx 
 
x.xxx 
 
x.xxx 
 
GeoMean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
Programming Note: Repeat for all PD parameters 
and all scheduled post baseline timepoints. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 30 of 82 
 
Table 14.2.5.2 MAD: Summary of PD Parameters 
Protocol: BTI-201 
Per Protocol Population 

 
Programming Note: 
Repeat Table 14.2.5.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 31 of 82 
 
Table 14.3.1.1 SD: Summary of Concomitant Medication 
Protocol: BTI-201 
Safety Population 
 
Anatomic Therapeutic Classification (ATC3) 
    Preferred Term (PT) 
rhu-pGSN 
6 mg/kg 
(N=xx) 
n (%) M 
Placebo 
(N=xx) 
n (%) M 
Overall 
(N=xx) 
n (%) M 
 
 
 
 
Subjects with at least one Concomitant Medication 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
ATC3/1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
ATC3/2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
ATC3/3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
Note: If a subject has multiple occurrences of a medication, the subject is presented only once in the subject count (N). 
      Occurrences are counted each time in the mentions/Occurrence (M) column. 
      WHO-DD, XXXX 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 32 of 82 
 
Table 14.3.1.2 MAD: Summary of Prior and Concomitant Medication 
Protocol: BTI-201 
Safety Population 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.1.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 33 of 82 
 
Table 14.3.3.1.1 SD: Overall Summary of Treatment-Emergent Adverse Events 
Protocol: BTI-201 
Safety Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
n (%) M 
Placebo 
(N=xx) 
n (%) M 
Overall 
(N=xx) 
n (%) M 
 
 
 
 
Number of subjects reporting at least: 
 
 
 
   One TEAE 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   One NCI-CTEAE Grade 3 TEAE 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   One Serious TEAE 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   One Drug Related TEAE 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   TEAE Leading to Death 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   One Procedure Related TEAE 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   One TEAE leading to study treatment discontinuation 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
Number of subjects reporting TEAEs by NCI-CTEAE Grade 
 
 
 
   Grade 1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Grade 2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Grade 3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Grade 4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Grade 5 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
Number of subjects reporting TEAEs by relationship to study medication 
 
 
 
   Definitely not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Probably not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Possibly Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Probably Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Definitely Related 
 
 
 
 
 
 
 
Number of subjects reporting TEAEs by relationship to study procedure 
 
 
 
   Definitely not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Probably not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Possibly Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Probably Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
   Definitely Related 
 
 
 
 
 
 
 
Note: A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurred or worsened following 
the first administration of study drug. If a subject has multiple occurrences of a TEAE, the subject is presented only once 
in the Patient count (n) column for a given System Organ Class and Preferred Term. Occurrences are counted each time in the 
mentions/occurrence (M) column. Related TEAE = A Possibly , Probably related TEAE or Definitely Related.MedDRA Version xx.x 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 34 of 82 
 
Table 14.3.3.1.2 MAD: Overall Summary of Treatment-Emergent Adverse Events 
Protocol: BTI-201 
Safety Population 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
Programming Note: 
Repeat Table 14.3.3.1.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 35 of 82 
 
Table 14.3.3.2.1 SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT) 
Protocol: BTI-201 
Safety Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
n (%) M 
Placebo 
(N=xx) 
n (%) M 
Overall 
(N=xx) 
n (%) M 
 
 
 
 
Subjects with at least one TEAE 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT5 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
 
Note: A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurred or worsened following 
the first administration of study drug. If a subject has multiple occurrences of a TEAE, the subject is presented only once 
in the Patient count (n) column for a given System Organ Class and Preferred Term. 
Occurrences are counted each time in the mentions/Occurrence (M) column. 
 
MedDRA Version xx.x 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 36 of 82 
 
Table 14.3.3.2.2 MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT) 
Protocol: BTI-201 
Safety Population 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
Programming Note: 
Repeat Table 14.3.3.2.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 37 of 82 
 
Table 14.3.3.3.1 SD: Summary of Treatment-Emergent Deaths (Summary by SOC, PT) 
Protocol: BTI-201 
Safety Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
n (%) M 
Placebo 
(N=xx) 
n (%) M 
Overall 
(N=xx) 
n (%) M 
 
 
 
 
Subjects with at least one TEAE leading to Death 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT5 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
 
Note: A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurred or worsened following 
the first administration of study drug. If a subject has multiple occurrences of a TEAE, the subject is presented only once 
in the Patient count (n) column for a given System Organ Class and Preferred Term. 
Occurrences are counted each time in the mentions/Occurrence (M) column. 
 
MedDRA Version xx.x 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 38 of 82 
 
Table 14.3.3.3.2 MAD: Summary of Treatment-Emergent Deaths (Summary by SOC, PT) 
Protocol: BTI-201 
Safety Population 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
Programming Note: 
Repeat Table 14.3.3.3.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 39 of 82 
 
Table 14.3.3.4.1 SD: Summary of Serious Treatment-Emergent Adverse Events (Summary by SOC, PT) 
Protocol: BTI-201 
Safety Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
n (%) M 
Placebo 
(N=xx) 
n (%) M 
Overall 
(N=xx) 
n (%) M 
 
 
 
 
Subjects with at least one Serious TEAE 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT5 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
 
Note: A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurred or worsened following 
the first administration of study drug. If a subject has multiple occurrences of a TEAE, the subject is presented only once 
in the Patient count (n) column for a given System Organ Class and Preferred Term. 
Occurrences are counted each time in the mentions/Occurrence (M) column. 
 
 MedDRA Version xx.x 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 40 of 82 
 
Table 14.3.3.4.2 MAD: Summary of Serious Treatment-Emergent Adverse Events (Summary by SOC, PT) 
Protocol: BTI-201 
Safety Population 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
Programming Note: 
Repeat Table 14.3.3.4.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
Overall


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 41 of 82 
 
Table 14.3.3.5.1 SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and NCI-CTCAE Grade) 
Protocol: BTI-201 
Safety Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
n (%) M 
Placebo 
(N=xx) 
n (%) M 
Overall 
(N=xx) 
n (%) M 
 
 
 
 
Subjects with at least one TEAE 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Grade 1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Grade 2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Grade 3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Grade 4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Grade 5 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Grade 1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Grade 2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Grade 3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Grade 4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Grade 5 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
 
Note: A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurred or worsened following 
the first administration of study drug. If a subject has multiple occurrences of a TEAE, the subject is presented only once 
in the Patient count (n) column for a given System Organ Class and Preferred Term. 
Occurrences are counted each time in the mentions/Occurrence (M) column. 
 
MedDRA Version xx.x 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 42 of 82 
 
Table 14.3.3.5.2 MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and NCI-CTCAE Grade) 
Protocol: BTI-201 
Safety Population 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 
 
 
Programming Note: 
Repeat Table 14.3.3.5.1 
Include: rhu-pGSN 6 mg/kg 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 43 of 82 
 
Table 14.3.1.6.1 SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Drug) 
Protocol: BTI-201 
Safety Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
n (%) M 
Placebo 
(N=xx) 
n (%) M 
Overall 
(N=xx) 
n (%) M 
 
 
 
 
Subjects with at least one TEAE 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Definitely not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Probably not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Possibly Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Probably Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Definitely Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Definitely not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Probably not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Possibly Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Probably Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Definitely Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
 
Note: A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurred or worsened following 
the first administration of study drug. If a subject has multiple occurrences of a TEAE, the subject is presented only once 
in the Patient count (n) column for a given System Organ Class and Preferred Term. 
Occurrences are counted each time in the mentions/Occurrence (M) column. 
 
MedDRA Version xx.x 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 44 of 82 
 
Table 14.3.3.6.2 MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Drug) 
Protocol: BTI-201 
Safety Population 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
Programming Note: 
Repeat Table 14.3.3.6.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 45 of 82 
 
Table 14.3.3.7.1 SD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Procedure) 
Protocol: BTI-201 
Safety Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
n (%) M 
Placebo 
(N=xx) 
n (%) M 
Overall 
(N=xx) 
n (%) M 
 
 
 
 
Subjects with at least one TEAE 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Definitely not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Probably not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Possibly Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Probably Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Definitely Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Definitely not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Probably not Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Possibly Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Probably Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
       Definitely Related 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
 
Note: A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurred or worsened following 
the first administration of study drug. If a subject has multiple occurrences of a TEAE, the subject is presented only once 
in the Patient count (n) column for a given System Organ Class and Preferred Term. 
Occurrences are counted each time in the mentions/Occurrence (M) column. 
 
MedDRA Version xx.x 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 46 of 82 
 
Table 14.3.3.7.2 MAD: Summary of Treatment-Emergent Adverse Events (Summary by SOC, PT and Relationship to Study Procedure) 
Protocol: BTI-201 
Safety Population 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
Programming Note: 
Repeat Table 14.3.3.7.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 47 of 82 
 
Table 14.3.3.8.1 SD: Summary of Treatment-Emergent Adverse Events Leading to Treatment Discontinuation (Summary by SOC, PT) 
Protocol: BTI-201 
Safety Population 
 
 
rhu-pGSN 
6 mg/kg 
(N=xx) 
n (%) M 
Placebo 
(N=xx) 
n (%) M 
Overall 
(N=xx) 
n (%) M 
 
 
 
 
Subjects with at least one TEAE Leading to Treatment Discontinuation 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
SOC2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT1 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT2 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT3 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT4 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT5 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
    PT6 
xx (xx.x%) xx 
xx (xx.x%) xx 
xx (xx.x%) xx 
 
 
 
 
 
Note: A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurred or worsened following 
the first administration of study drug. If a subject has multiple occurrences of a TEAE, the subject is presented only once 
in the Patient count (n) column for a given System Organ Class and Preferred Term. 
Occurrences are counted each time in the mentions/Occurrence (M) column. 
 
MedDRA Version xx.x 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 48 of 82 
 
Table 14.3.3.8.2 MAD: Summary of Treatment-Emergent Adverse Events Leading to Treatment Discontinuation (Summary by SOC, PT) 
Protocol: BTI-201 
Safety Population 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 
 
 
Programming Note: 
Repeat Table 14.3.3.8.1 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 49 of 82 
 
Table 14.3.3.9.1 SD: Summary of Overall Survival 
Protocol: BTI-201 
Safety Population 
 
 
 
rhu-pGSN:  
6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
 
 
 
 
Deaths 
 
 
 
  Number of Subjects that Died 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  Number of Subjects that did not Die 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
  Survival Time (days) (95% CI1) 
 
 
 
    25th Percentile 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
    Median 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
    75th Percentile 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
 
 
 
 
Note: CI = Confidence Interval; 1Brookmeyer and Crowley method (1982. Log-log transformation);  
      Overall Survival is defined as the difference (in days) between the  
      time of first study drug administration to the date of death + 1 (Include the day of the study drug administration.) 
      Subjects who did not die will be censored at the study exit visit. 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 50 of 82 
 
Table 14.3.3.9.2 MAD: Summary of Overall Survival 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.3.9.1 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 51 of 82 
 
Table 14.3.4.1.1.1 SD: Summary of CBC (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Parameter 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
Hemoglobin (g/L) 
Baseline1 
n 
x 
 
x 
 
x 
 
 
Mean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Median 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
SD 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Minimum 
x.xx 
 
x.xx 
 
x.xx 
 
 
Maximum 
x.xx 
 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
Day 2 
n 
x 
 
x 
 
x 
 
 
Mean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Median 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
SD 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Minimum 
x.xx 
 
x.xx 
 
x.xx 
 
 
Maximum 
x.xx 
 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
Day 3 or 4 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Include all CBC Parameters and all scheduled time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 52 of 82 
 
Table 14.3.4.1.1.2 MAD: Summary of CBC (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.1.1.1 
Include all CBC Parameters and all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 53 of 82 
 
Table 14.3.4.1.2.1 SD: Summary of CBC Shifts from Baseline (Low, Normal, High) 
Protocol: BTI-201 
Safety Population 
 
Parameter 
Result 
Classification 
Baseline1 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Low 
n (%) 
Normal 
n (%) 
High 
n (%) 
Missing  
n (%) 
Total  
n (%) 
 
 
 
 
 
 
 
 
Hemoglobin (g/L) 
Day 2 
Low 
 
 
 
 
 
 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
High 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Missing 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Total 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 3 or 4 
Low 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
High 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Missing 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Total 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note 1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Also Include: Placebo, 
 
Overall 
 
Include all CBC Parameters and all scheduled time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 54 of 82 
 
Table 14.3.4.1.2.2 MAD: Summary of CBC Shifts from Baseline (Low, Normal, High) 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.1.2.1 
Include all CBC Parameters and all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 55 of 82 
 
Table 14.3.4.2.1.1 SD: Summary of Coagulation (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Parameter 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
PT/INR (unit) 
Baseline1 
n 
x 
 
x 
 
x 
 
 
Mean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Median 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
SD 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Minimum 
x.xx 
 
x.xx 
 
x.xx 
 
 
Maximum 
x.xx 
 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
Day 2 
n 
x 
 
x 
 
x 
 
 
Mean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Median 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
SD 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Minimum 
x.xx 
 
x.xx 
 
x.xx 
 
 
Maximum 
x.xx 
 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
Day 3 or 4 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Include all Coagulation Parameters and all scheduled time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 56 of 82 
 
Table 14.3.4.2.1.2 MAD: Summary of Coagulation (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.2.1.1 
Include all Coagulation Parameters and all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 57 of 82 
 
Table 14.3.4.2.2.1 SD: Summary of Coagulation Shifts from Baseline (Low, Normal, High) 
Protocol: BTI-201 
Safety Population 
 
Parameter 
Result 
Classification 
Baseline1 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Low 
n (%) 
Normal 
n (%) 
High 
n (%) 
Missing  
n (%) 
Total  
n (%) 
 
 
 
 
 
 
 
 
PT/INR (unit) 
Day 2 
Low 
 
 
 
 
 
 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
High 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Missing 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Total 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 3 or 4 
Low 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
High 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Missing 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Total 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note 1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
Programming Note: 
Also Include: Placebo, 
 
Overall 
 
Include all Coagulation Parameters and all scheduled time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 58 of 82 
 
 
Table 14.3.4.2.2.2 MAD: Summary of Coagulation Shifts from Baseline (Low, Normal, High) 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.2.2.1 
Include all Coagulation Parameters and all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 59 of 82 
 
Table 14.3.4.3.1.1 SD: Summary of Comprehensive Metabolic Profile (Summary of Actual and Change from Baseline Values) by 
Timepoint 
Protocol: BTI-201 
Safety Population 
 
Parameter 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
Sodium (unit) 
Baseline1 
n 
x 
 
x 
 
x 
 
 
Mean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Median 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
SD 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Minimum 
x.xx 
 
x.xx 
 
x.xx 
 
 
Maximum 
x.xx 
 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
Day 2 
n 
x 
 
x 
 
x 
 
 
Mean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Median 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
SD 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Minimum 
x.xx 
 
x.xx 
 
x.xx 
 
 
Maximum 
x.xx 
 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
Day 3 or 4 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Include all Comprehensive Metabolic Profile Parameters and all 
scheduled time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 60 of 82 
 
Table 14.3.4.3.1.2 MAD: Summary of Comprehensive Metabolic Profile (Summary of Actual and Change from Baseline Values) by 
Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.3.1.1 
Include all Comprehensive Metabolic Profile Parameters and all 
scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 61 of 82 
 
Table 14.3.4.3.2.1 SD: Summary of Comprehensive Metabolic Profile Shifts from Baseline (Low, Normal, High) 
Protocol: BTI-201 
Safety Population 
 
Parameter 
Result 
Classification 
Baseline1 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Low 
n (%) 
Normal 
n (%) 
High 
n (%) 
Missing  
n (%) 
Total  
n (%) 
 
 
 
 
 
 
 
 
Sodium (unit) 
Day 2 
Low 
 
 
 
 
 
 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
High 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Missing 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Total 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 3 or 4 
Low 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
High 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Missing 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Total 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note 1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Also Include: Placebo, 
 
Overall 
 
Include all Comprehensive Metabolic Profile Parameters and all 
scheduled time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 62 of 82 
 
Table 14.3.4.3.2.2 MAD: Summary of Comprehensive Metabolic Profile Shifts from Baseline (Low, Normal, High) 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.3.2.1 
Include all Comprehensive Metabolic Profile Parameters and all 
scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 63 of 82 
 
Table 14.3.4.4.1 SD: Summary of Vital Signs (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Parameter 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Change from 
Baseline1 
Actual 
Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
Systolic blood 
pressure (mmHg) 
Baseline1 
n 
x 
 
x 
 
 
 
Mean 
x.xxx 
 
x.xxx 
 
 
 
 
Median 
x.xxx 
 
x.xxx 
 
 
 
 
SD 
x.xxx 
 
x.xxx 
 
 
 
 
Minimum 
x.xx 
 
x.xx 
 
 
 
 
Maximum 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
 
 
Day 1: End of 
Infusion 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
 
 
 
 
 
 
 
Day 1: 30 mins 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Include all Vital Signs Parameters and all time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 64 of 82 
 
Table 14.3.4.4.2 MAD: Summary of Vital Signs (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.4.1 
Include all Vital Sign Parameters and all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 65 of 82 
 
Table 14.3.4.5.1 SD: Summary of Vital Signs Interpretation by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
 
 
 
 
Baseline1 
n 
xx 
xx 
xx 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Abnormal NCS 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Abnormal CS 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Day 1: 30 mins 
n 
xx 
xx 
xx 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Abnormal NCS 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Abnormal CS 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Day 2 
n 
xx 
xx 
xx 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Abnormal NCS 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Abnormal CS 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
etc. 
etc. 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      NCS = Not Clinically Significant; CS = Clinically Significant. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 66 of 82 
 
Table 14.3.4.5.2 MAD: Summary of Vital Signs Interpretation by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.5.1 
Include all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 67 of 82 
 
Table 14.3.4.6.1 SD: Summary of Mean EKG (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Parameter 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Change from 
Baseline1 
Actual 
Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
Heart Rate (unit) Baseline1 
n 
x 
 
x 
 
 
 
 
Mean 
x.xxx 
 
x.xxx 
 
 
 
 
Median 
x.xxx 
 
x.xxx 
 
 
 
 
SD 
x.xxx 
 
x.xxx 
 
 
 
 
Minimum 
x.xx 
 
x.xx 
 
 
 
 
Maximum 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
 
 
Day 28 / Early 
Termination 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
 
 
 
 
 
 
PR Interval (unit) Baseline1 
n 
x 
 
x 
 
x 
 
 
Mean 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Median 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
SD 
x.xxx 
 
x.xxx 
 
x.xxx 
 
 
Minimum 
x.xx 
 
x.xx 
 
x.xx 
 
 
Maximum 
x.xx 
 
x.xx 
 
x.xx 
 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Include all EKG Parameters and all time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 68 of 82 
 
Table 14.3.4.6.2 MAD: Summary of Mean EKG (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.6.1 
Include all EKG Parameters and all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 69 of 82 
 
Table 14.3.4.7.1 SD: Summary of EKG Interpretation (Worst) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
 
 
 
 
Baseline1 
n 
xx 
xx 
xx 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Abnormal NCS 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Abnormal CS 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Day 28 / Early 
Termination 
n 
xx 
xx 
xx 
 
Normal 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Abnormal NCS 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Abnormal CS 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      NCS = Not Clinically Significant; CS = Clinically Significant. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 70 of 82 
 
Table 14.3.4.7.2 MAD: Summary of EKG Interpretation (Worst) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 
Programming Note: 
Repeat Table 14.3.4.7.1 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 71 of 82 
 
Table 14.3.4.8.1 SD: Summary of CURB-65 Score(Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Change from 
Baseline1 
Actual 
Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
Baseline1 
n 
x 
 
x 
 
 
 
 
Mean 
x.xxx 
 
x.xxx 
 
 
 
 
Median 
x.xxx 
 
x.xxx 
 
 
 
 
SD 
x.xxx 
 
x.xxx 
 
 
 
 
Minimum 
x.xx 
 
x.xx 
 
 
 
 
Maximum 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
 
Day 3 or 4 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
 
 
 
 
 
 
Day 7 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Include all scheduled time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 72 of 82 
 
Table 14.3.4.8.2 MAD: Summary of CURB-65 Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.8.1 
Include all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 73 of 82 
 
Table 14.3.4.9.1 SD: Summary of PSI Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Change from 
Baseline1 
Actual 
Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
Baseline1 
n 
x 
 
x 
 
 
 
 
Mean 
x.xxx 
 
x.xxx 
 
 
 
 
Median 
x.xxx 
 
x.xxx 
 
 
 
 
SD 
x.xxx 
 
x.xxx 
 
 
 
 
Minimum 
x.xx 
 
x.xx 
 
 
 
 
Maximum 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
 
Day 3 or 4 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
 
 
 
 
 
 
Day 7 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Include all scheduled time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 74 of 82 
 
Table 14.3.4.9.2 MAD: Summary of PSI Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.9.1 
Include all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 75 of 82 
 
Table 14.3.4.10.1 SD: Summary of PSI Risk Class by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Visit 
Risk Class 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
 
 
 
 
Baseline1 
n 
xx 
xx 
xx 
 
Class I 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Class II 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Class III 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Class IV 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Class V 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Day 28 / Early Termination 
n 
xx 
xx 
xx 
 
Class I 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Class II 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Class III 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Class IV 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Class V 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      NCS = Not Clinically Significant; CS = Clinically Significant. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 76 of 82 
 
Table 14.3.4.10.2 MAD: Summary of PSI Risk Class by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 
Programming Note: 
Repeat Table 14.3.4.10.1 
Include all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 77 of 82 
 
Table 14.3.4.11.1 SD: Summary of SOFA Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Change from 
Baseline1 
Actual 
Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
Baseline1 
n 
x 
 
x 
 
 
 
 
Mean 
x.xxx 
 
x.xxx 
 
 
 
 
Median 
x.xxx 
 
x.xxx 
 
 
 
 
SD 
x.xxx 
 
x.xxx 
 
 
 
 
Minimum 
x.xx 
 
x.xx 
 
 
 
 
Maximum 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
 
Day 3 or 4 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
 
 
 
 
 
 
Day 7 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Include all scheduled time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 78 of 82 
 
Table 14.3.4.11.2 MAD: Summary of SOFA Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.11.1 
Include all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
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2018-12-03 
 
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Page 79 of 82 
 
Table 14.3.4.12.1 SD: Summary of MMSE Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
Visit 
 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
Actual Value 
Change from 
Baseline1 
Actual 
Value 
Change from 
Baseline1 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
Baseline1 
n 
x 
 
x 
 
 
 
 
Mean 
x.xxx 
 
x.xxx 
 
 
 
 
Median 
x.xxx 
 
x.xxx 
 
 
 
 
SD 
x.xxx 
 
x.xxx 
 
 
 
 
Minimum 
x.xx 
 
x.xx 
 
 
 
 
Maximum 
x.xx 
 
x.xx 
 
 
 
 
 
 
 
 
 
 
Day 3 or 4 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
 
 
 
 
 
 
Day 7 
n 
x 
x 
x 
x 
x 
x 
 
Mean 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Median 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
SD 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
x.xxx 
 
Minimum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
 
Maximum 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
x.xx 
etc. 
 
 
 
 
 
 
 
 
 
 
Note: SD: Standard Deviation 
      1Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
      Unscheduled visits not included in post baseline assessments. 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 
Programming Note: 
Include all scheduled time points. 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 80 of 82 
 
Table 14.3.4.12.2 MAD: Summary of MMSE Score (Summary of Actual and Change from Baseline Values) by Timepoint 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 

 
Programming Note: 
Repeat Table 14.3.4.12.1 
Include all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 81 of 82 
 
Table 14.3.4.13.1 SD: Summary of Hospitalization 
Protocol: BTI-201 
Safety Population 
 
Parameter (Kaplan-Meier Estimates) 
rhu-pGSN: 6 mg/kg 
(N=xx) 
Placebo 
(N=xx)  
Overall 
(N=xx) 
 
 
 
 
Hospital Stay 
 
 
 
  Number of Subjects Discharged 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  Number of Subjects not Discharged 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
  Length of Stay in Hospital (hours) (95% CI1) 
 
 
 
    25th Percentile 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
    Median 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
    75th Percentile 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
 
 
 
 
ICU Stay 
 
 
 
  Number of Subjects in ICU 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  Number of Subjects not in ICU 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
  Length of Stay in ICU (days) (95% CI1) 
 
 
 
    25th Percentile 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
    Median 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
    75th Percentile 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
 
 
 
 
Intubation 
 
 
 
  Number of Subjects Intubated 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  Number of Subjects not Intubated 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
  Length of Intubation (days) (95% CI1) 
 
 
 
    25th Percentile 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
    Median 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
    75th Percentile 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
xx (xx.x, xx.x) 
 
 
 
 
Note: CI = Confidence Interval; 1Brookmeyer and Crowley method (1982. Log-log transformation);  
      Length of stay in hospital is defined as the date and time of discharge/date of study exit (23:59 PM ) -  
      date and time of hospitalization admission due to CAP in hours 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM
 


Protocol No: BTI-201 
Document status: Mock EOS Tables, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 82 of 82 
 
Table 14.3.4.13.2 MAD: Summary of Hospitalization 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
 
 
 
 
Programming Note: 
Repeat Table 14.3.4.13.1 
Include all scheduled time points. 
 
Include: rhu-pGSN 6 mg/kg; 
 
rhu-pGSN 12 mg/kg; 
 
rhu-pGSN 24 mg/kg; 
 
Combined Active; 
 
Combined Placebo; 
 
Overall 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 1 of 83 
 
BTI-201: Mock Listings: Table of Contents 
Listings 
 
Listing 16.2.1.2.1 SD: Subject Disposition ............................................................................................................................................................................................ 6 
Listing 16.2.1.2.2 MAD: Subject Disposition ......................................................................................................................................................................................... 7 
Listing 16.2.2.1 SD: Protocol Deviations ................................................................................................................................................................................................ 7 
Listing 16.2.2.2 MAD: Protocol Deviations .............................................................................................................................................................................................. 9 
Listing 16.2.3.1 SD: Analysis Populations ............................................................................................................................................................................................ 10 
Listing 16.2.3.2 MAD: Analysis Populations .......................................................................................................................................................................................... 11 
Listing 16.2.4.1.1 SD: Demographics and Baseline Characteristics ..................................................................................................................................... 12 
Listing 16.2.4.1.2 MAD: Demographics and Baseline Characteristics ................................................................................................................................... 13 
Listing 16.2.4.2.1 SD: Viral Serology ...................................................................................................................................................................................................... 14 
Listing 16.2.4.2.2 MAD: Viral Serology ................................................................................................................................................................................................... 15 
Listing 16.2.4.3.1 SD: Medical History ................................................................................................................................................................................................... 16 
Listing 16.2.4.3.2 MAD: Medical History ................................................................................................................................................................................................. 17 
Listing 16.2.4.4.1 SD: Pregnancy Test Results ................................................................................................................................................................................... 18 
Listing 16.2.4.4.2 MAD: Pregnancy Test Results ................................................................................................................................................................................ 19 
Listing 16.2.4.5.1 SD: Confirmation of CAP .......................................................................................................................................................................................... 20 
Listing 16.2.4.5.2 MAD: Confirmation of CAP ....................................................................................................................................................................................... 21 
Listing 16.2.4.6.1 SD: Eligibility Assessment ................................................................................................................................................................................... 22 
Listing 16.2.4.6.2 MAD: Eligibility Criteria ..................................................................................................................................................................................... 23 
Listing 16.2.4.7.1 SD: Prior Medications .............................................................................................................................................................................................. 24 
Listing 16.2.4.7.2 MAD: Prior Medications ............................................................................................................................................................................................ 25 
Listing 16.2.5.1.1 SD: Randomization ........................................................................................................................................................................................................ 26 
Listing 16.2.5.1.2 MAD: Randomization ...................................................................................................................................................................................................... 27 
Listing 16.2.5.2.1 SD: Study Drug Administration ........................................................................................................................................................................... 28 
Listing 16.2.5.2.2 MAD: Study Drug Administration ......................................................................................................................................................................... 29 
Listing 16.2.5.3.1 SD: Study Drug Interruption ................................................................................................................................................................................ 30 
Listing 16.2.5.3.2 MAD: Study Drug Interruption .............................................................................................................................................................................. 31 
Listing 16.2.6.1.1 SD: Individual pGSN Plasma Concentrations (unit) .............................................................................................................................. 32 
Listing 16.2.6.1.2 MAD: Individual pGSN Plasma Concentrations (unit) ............................................................................................................................ 33 
Listing 16.2.6.2.1 SD: Individual Estimated Plasma rhu-pGSN Concentrations (unit) ............................................................................................. 34 
Listing 16.2.6.2.2 MAD: Individual Estimated Plasma rhu-pGSN Concentrations (unit) ........................................................................................... 35 
Listing 16.2.6.3.1 SD: Individual pGSN Plasma PK Parameters ................................................................................................................................................. 36 
Listing 16.2.6.3.2 MAD: Individual pGSN Plasma PK Parameters by Day .............................................................................................................................. 37 
Listing 16.2.6.4.1 SD: Individual Estimated Plasma rhu-pGSN PK Parameters ................................................................................................................ 38 
Listing 16.2.6.4.2 MAD: Individual Estimated Plasma rhu-pGSN PK Parameters by Day ............................................................................................. 39 


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Listing 16.2.6.5.1 SD: Anti-rhu-pGSN Antibodies .............................................................................................................................................................................. 40 
Listing 16.2.6.5.2 MAD: Anti-rhu-pGSN Antibodies ........................................................................................................................................................................... 41 
Listing 16.2.6.6.1 SD: Biomarkers ............................................................................................................................................................................................................... 42 
Listing 16.2.6.6.2 MAD: Biomarkers ............................................................................................................................................................................................................. 43 
Listing 16.2.6.7.1 SD: Sputum and Blood Culture .............................................................................................................................................................................. 44 
Listing 16.2.6.7.2 MAD: Sputum and Blood Culture ........................................................................................................................................................................... 45 
Listing 16.2.7.1.1 SD: Adverse Events ...................................................................................................................................................................................................... 46 
Listing 16.2.7.1.2 MAD: Adverse Events ................................................................................................................................................................................................... 47 
Listing 16.2.7.2.1 SD: Serious Adverse Events ................................................................................................................................................................................... 48 
Listing 16.2.7.2.2 MAD: Serious Adverse Events ................................................................................................................................................................................ 49 
Listing 16.2.7.3.1 SD: Adverse Events Leading to Study Medication Discontinuation ............................................................................................. 50 
Listing 16.2.7.3.2 MAD: Adverse Events Leading to Study Medication Discontinuation ........................................................................................... 51 
Listing 16.2.7.4.1 SD: Overall Survival ................................................................................................................................................................................................. 52 
Listing 16.2.7.4.2 MAD: Overall Survival .............................................................................................................................................................................................. 53 
Listing 16.2.8.1.1.1 SD: CBC ........................................................................................................................................................................................................................... 54 
Listing 16.2.8.1.1.2 MAD: CBC ......................................................................................................................................................................................................................... 55 
Listing 16.2.8.1.2.1 SD: Abnormal CBC ...................................................................................................................................................................................................... 56 
Listing 16.2.8.1.2.2 MAD: Abnormal CBC ................................................................................................................................................................................................... 57 
Listing 16.2.8.2.1.1 SD: Coagulation ........................................................................................................................................................................................................ 58 
Listing 16.2.8.2.1.2 MAD: Coagulation ...................................................................................................................................................................................................... 59 
Listing 16.2.8.2.2.1 SD: Abnormal Coagulation ................................................................................................................................................................................... 60 
Listing 16.2.8.2.2.2 MAD: Abnormal Coagulation ................................................................................................................................................................................ 61 
Listing 16.2.8.3.1.1 SD: Comprehensive Metabolic Profile ........................................................................................................................................................ 62 
Listing 16.2.8.3.1.2 MAD: Comprehensive Metabolic Profile ...................................................................................................................................................... 63 
Listing 16.2.8.3.2.1 SD: Abnormal Comprehensive Metabolic Profile ................................................................................................................................... 64 
Listing 16.2.8.3.2.2 MAD: Abnormal Comprehensive Metabolic Profile ................................................................................................................................. 65 
Listing 16.2.9.1 SD: Vital Signs ................................................................................................................................................................................................................. 66 
Listing 16.2.9.2 MAD: Vital Signs ............................................................................................................................................................................................................... 67 
Listing 16.2.10.1 SD: EKG .................................................................................................................................................................................................................................. 68 
Listing 16.2.10.2 MAD: EKG ................................................................................................................................................................................................................................ 69 
Listing 16.2.11.1 SD: Physical Examination .......................................................................................................................................................................................... 70 
Listing 16.2.11.2 MAD: Physical Examination ....................................................................................................................................................................................... 71 
Listing 16.2.12.1.1 SD: Outcome Prediction Models CURB-65 ...................................................................................................................................................... 72 
Listing 16.2.12.1.2 MAD: Outcome Prediction Models CURB-65 .................................................................................................................................................... 73 
Listing 16.2.12.2.1 SD: Outcome Prediction Models PSI (Port Score) ................................................................................................................................. 74 
Listing 16.2.12.2.2 MAD: Outcome Prediction Models PSI (Port Score) .............................................................................................................................. 75 
Listing 16.2.12.3.1 SD: Outcome Prediction Models SOFA Score ............................................................................................................................................... 76 
Listing 16.2.12.3.2 MAD: Outcome Prediction Models SOFA Score ............................................................................................................................................. 77 
Listing 16.2.12.4.1 SD: Outcome Prediction Models MMSE Score ............................................................................................................................................... 78 
Listing 16.2.12.4.2 MAD: Outcome Prediction Models MMSE Score ............................................................................................................................................. 79 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 3 of 83 
Listing 16.2.13.1 SD: Concomitant Medications ................................................................................................................................................................................... 80 
Listing 16.2.13.2 MAD: Concomitant Medication ................................................................................................................................................................................... 81 
Listing 16.2.14.1 SD: Hospitalization Follow-Up .............................................................................................................................................................................. 82 
Listing 16.2.14.2 MAD: Hospitalization Follow-Up ........................................................................................................................................................................... 83 
 

 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 4 of 83 
GENERAL COMMENTS 
x 
Unless otherwise states, parameters will be listed in alphabetical order 
x 
Change from Baseline: 
Change from Baseline will be calculated as: 
ܥ݄ܽ݊݃݁݂ݎ݋݉ܾܽݏ݈݁݅݊݁ൌ݊݁ݓݒ݈ܽݑ݁െܾܽݏ݈݁݅݊݁ݒ݈ܽݑ݁ 
x 
Names and order of Treatment Groups 
SD: 
x 
Cohort 1: rhu-pGSN 6 mg/kg; 
x 
Cohort 1: Placebo 
MAD: 
x 
Cohort 2: rhu-pGSN 6 mg/kg; 
x 
Cohort 2: Placebo 
x 
Cohort 3: rhu-pGSN 12 mg/kg; 
x 
Cohort 3: Placebo 
x 
Cohort 4: rhu-pGSN 24 mg/kg; 
x 
Cohort 4: Placebo 
x 
Names of visits 
SD: 
x 
Screening 
x 
Day 1 
x 
Day 2 
x 
Day 3/4 
x 
Day 7 
x 
Day 14 
x 
Day 28 / Early Termination (Combined visit for safety and efficacy) 
x 
Unscheduled 
MAD: 
x 
Screening 
x 
Day 1 
x 
Day 2 
x 
Day 3 
x 
Day 4 
x 
Day 7 
x 
Day 14 


Protocol No: BTI-201 
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x 
Day 28 / Early Termination (Combined visit for safety and efficacy) 
x 
Unscheduled 
x 
Column widths and text-wrapping may be altered in final output in order to best present the data 
x 
Footnotes may be added/amended if required 

 


Protocol No: BTI-201 
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Page 6 of 83 
Listing 16.2.1.2.1 SD: Subject Disposition 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Final Disposition 
Reason for Discontinuation 
Date of Study Exit  
(DDMMMYYYY) 
Date of Last Contact  
(DDMMMYYYY) 
 
 
 
 
 
XXX 
Withdrawn 
Due to Adverse Event:  
AE#: XXXXXXXXXXXX 
DDMMMYYYY 
DDMMMYYYY 
XXX 
Completed 
 
DDMMMYYYY 
 
XXX 
Completed 
 
DDMMMYYYY 
 
XXX 
Withdrawn 
Other: XXXXXXXXXXXXX 
DDMMMYYYY 
 
etc. 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 7 of 83 
Listing 16.2.1.2.2 MAD: Subject Disposition 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
Programming Note: 
Repeat Listing 16.2.1.2.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 8 of 83 
Listing 16.2.2.1 SD: Protocol Deviations 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Type of Deviation 
Date of Deviation 
(DDMMMYYYY) 
Description of Deviation 
 
 
 
 
 
 
 
 
XXX 
ABCD 
DDMMMYYYY 
ABCD 
 
ABCD 
DDMMMYYYY 
ABCD 
… 
 
 
 
 
 
 
 
 
 
 
 
XXX 
ABCD 
DDMMMYYYY 
ABCD 
 
ABCD 
DDMMMYYYY 
ABCD 
… 
 
 
 
 
 
 
 
 
 
 
 
XXX 
ABCD 
DDMMMYYYY 
ABCD 
 
ABCD 
DDMMMYYYY 
ABCD 
… 
 
 
 
 
 
 
 
 
 
 
 
XXX 
ABCD 
DDMMMYYYY 
ABCD 
XXX 
ABCD 
DDMMMYYYY 
ABCD 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Page x of x 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Listing 16.2.2.2 MAD: Protocol Deviations 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.2.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 10 of 83 
Listing 16.2.3.1 SD: Analysis Populations 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Intent-to-Treat 
Population 
Safety  
Population 
PK  
Population 
Per Protocol  
Population 
 
 
 
 
 
 
 
 
 
 
XXX 
Yes 
Yes 
Yes 
Yes 
XXX 
Yes 
Yes 
Yes 
Yes 
XXX 
Yes 
Yes 
Yes 
Yes 
XXX 
Yes 
Yes 
Yes 
Yes 
XXX 
Yes 
Yes 
Yes 
Yes 
XXX 
Yes 
Yes 
Yes 
Yes 
XXX 
Yes 
Yes 
Yes 
Yes 
 
 
 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
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Page 11 of 83 
Listing 16.2.3.2 MAD: Analysis Populations 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.3.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
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Page 12 of 83 
Listing 16.2.4.1.1 SD: Demographics and Baseline Characteristics 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Date of 
Informed 
Consent 
(DDMMMYYYY) 
Protocol 
Version 
Date of 
Birth 
(DDMMMYYYY) 
Age at 
Informed 
Consent 
Sex 
Child 
Bearing 
Potential 
Contraceptive 
Methods 
Race 
Height 
(cm) 
Weight  
(kg)  
 
 
 
 
 
 
 
 
 
 
 
XXX 
DDMMMYYYY 
Amendment 1  DDMMMYYYY 
xx 
Male 
 
 
White 
xxx 
xx.x 
XXX 
DDMMMYYYY 
Amendment 1  DDMMMYYYY 
xx 
Female 
No 
 
White 
xxx 
xx.x 
XXX 
DDMMMYYYY 
Amendment 1  DDMMMYYYY 
xx 
Male 
 
 
White 
xxx 
xx.x 
XXX 
DDMMMYYYY 
Amendment 1  DDMMMYYYY 
xx 
Female 
Yes 
Hormonal 
methods 
Other: 
XXXXXXXXX 
xxx 
xx.x 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
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Page 13 of 83 
Listing 16.2.4.1.2 MAD: Demographics and Baseline Characteristics 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.4.1.1 for MAD. 


Protocol No: BTI-201 
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Page 14 of 83 
Listing 16.2.4.2.1 SD: Viral Serology 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Visit 
Visit Date  
(DDMMMYYYY 
Test 
Result 
Most Recent 
Viral Load 
(unit) 
Most Recent 
CD4 Count 
(unit) 
 
 
 
 
 
 
 
XXX 
Screening 
DDMMMYYYY 
HIV 
Negative 
xxxxxx 
xxx.x 
 
 
 
Hepatitis B  
Surface Antigen 
Negative 
 
 
 
 
 
Hepatitis C 
Negative 
 
 
 
 
 
 
 
 
 
XXX 
Screening 
DDMMMYYYY 
HIV 
Negative 
xxxxxx 
xxx.x 
 
 
 
Hepatitis B  
Surface Antigen 
Negative 
 
 
 
 
 
Hepatitis C 
Negative 
 
 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 15 of 83 
Listing 16.2.4.2.2 MAD: Viral Serology 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.4.2.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 16 of 83 
Listing 16.2.4.3.1 SD: Medical History 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Condition/  
Body System 
System Organ Class / 
Preferred Term 
Date of 
Diagnosis 
(DDMMMYYYY) 
Resolution Date 
(DDMMMYYYY) 
Concomitant 
Medication 
Taken 
Ongoing 
 
 
 
 
 
 
 
XXX 
XXXXXXXXXXXX/ 
YYYYYYYYYYYY 
XXXXXXXXXX/ YYYYYYYYY/ 
ZZZZZZZZZ 
DDMMMYYYY 
DDMMMYYYY 
No 
No 
 
XXXXXXXXXXXX/ 
YYYYYYYYYYYY 
XXXXXXXXXX/ YYYYYYYYY/ 
ZZZZZZZZZ 
DDMMMYYYY 
DDMMMYYYY 
Yes 
Yes 
… 
 
 
 
 
 
 
XXX 
XXXXXXXXXXXX/ 
YYYYYYYYYYYY 
XXXXXXXXXX/ YYYYYYYYY/ 
ZZZZZZZZZ 
DDMMMYYYY 
DDMMMYYYY 
No 
No 
XXX 
XXXXXXXXXXXX/ 
YYYYYYYYYYYY 
XXXXXXXXXX/ YYYYYYYYY/ 
ZZZZZZZZZ 
DDMMMYYYY 
DDMMMYYYY 
 
 
… 
 
 
 
 
 
 
XXX 
XXXXXXXXXXXX/ 
YYYYYYYYYYYY 
XXXXXXXXXX/ YYYYYYYYY/ 
ZZZZZZZZZ 
DDMMMYYYY 
DDMMMYYYY 
No 
No 
XXX 
XXXXXXXXXXXX/ 
YYYYYYYYYYYY 
XXXXXXXXXX/ YYYYYYYYY/ 
ZZZZZZZZZ 
DDMMMYYYY 
DDMMMYYYY 
No 
No 
 
 
 
 
 
 
 
Note: MedDRA Version XX.X 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 17 of 83 
Listing 16.2.4.3.2 MAD: Medical History 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.4.3.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 18 of 83 
Listing 16.2.4.4.1 SD: Pregnancy Test Results 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Assessment Performed – 
Reason Not Performed 
Visit 
Sample Date/ Time 
(DDMMMYYY/ HH:MM) 
Sample Type 
Result 
 
 
 
 
 
 
XXX 
Yes 
Screening 
DDMMMYYY/ HH:MM 
Serum 
Negative 
 
 
Day 1 
DDMMMYYY/ HH:MM 
Urine 
Negative 
 
 
Day 28 / Early 
Termination 
DDMMMYYY/ HH:MM 
Urine 
Negative 
 
 
 
 
 
 
XXX 
Yes 
Screening 
DDMMMYYY/ HH:MM 
Serum 
Negative 
 
 
Day 1 
DDMMMYYY/ HH:MM 
Urine 
Negative 
 
 
Day 28 / Early 
Termination 
DDMMMYYY/ HH:MM 
Urine 
Negative 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
Yes 
Screening 
DDMMMYYY/ HH:MM 
Serum 
Negative 
 
 
Day 1 
DDMMMYYY/ HH:MM 
Urine 
Negative 
 
 
Day 28 / Early 
Termination 
DDMMMYYY/ HH:MM 
Urine 
Negative 
 
 
 
 
 
 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 19 of 83 
Listing 16.2.4.4.2 MAD: Pregnancy Test Results 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 
 
Programming Note: 
Repeat Listing 16.2.4.4.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 20 of 83 
Listing 16.2.4.5.1 SD: Confirmation of CAP 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject Visit 
Visit Date 
(DDMMMYYY) 
Was there 
clinical 
confirmation 
of CAP 
Was there 
radiological 
confirmation 
of CAP (CXR 
or CT) 
Was CXR or 
CT Scan 
Performed: 
Date 
Performed 
(DDMMMYYY) 
CXR or CT 
Scan 
Findings 
Date and Time of 
presentation to 
the hospital 
(DDMMMYYY/ 
HH:MM) 
Date and Time of 
Hospitalization 
Admission due to 
CAP 
(DDMMMYYY/ 
HH:MM) 
Subject 
Randomized 
 
 
 
 
 
 
 
 
 
 
XXX 
Screening 
DDMMMYYYY 
Yes 
Yes 
Yes: 
DDMMMYYYY 
XXXXXXXXX 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
Yes 
XXX 
Screening 
DDMMMYYYY 
Yes 
Yes 
Yes: 
DDMMMYYYY 
XXXXXXXXX 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
Yes 
XXX 
Screening 
DDMMMYYYY 
Yes 
Yes 
Yes: 
DDMMMYYYY 
XXXXXXXXX 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
Yes 
 
 
 
 
 
 
 
 
 
 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 21 of 83 
Listing 16.2.4.5.2 MAD: Confirmation of CAP 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 
 
Programming Note: 
Repeat Listing 16.2.4.5.2 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 22 of 83 
Listing 16.2.4.6.1 SD: Eligibility Assessment 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Eligibility Assessment 
Date 
(DDMMMYYYY) 
Did the patient meet all 
inclusion criteria? 
Inclusion 
criterion  
not met 
Did the patient meet all 
exclusion criteria? 
Exclusion 
Criterion  
not met 
 
 
 
 
 
 
XXX 
DDMMMYYYY 
Yes 
 
Yes 
 
XXX 
DDMMMYYYY 
Yes 
 
Yes 
 
XXX 
DDMMMYYYY 
Yes 
 
Yes 
 
XXX 
DDMMMYYYY 
Yes 
 
Yes 
 
XXX 
DDMMMYYYY 
Yes 
 
Yes 
 
XXX 
DDMMMYYYY 
Yes 
 
Yes 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 23 of 83 
Listing 16.2.4.6.2 MAD: Eligibility Criteria 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 
 

 
Programming Note: 
Repeat Listing 16.2.4.6.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 24 of 83 
Listing 16.2.4.7.1 SD: Prior Medications 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Number 
CM# 
Drug Name/ATC3/PT 
Indication 
Start Date/ 
Stop Date 
(DDMMMYYYY) 
Ongoing Dose Unit 
Frequency 
Route 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
Pre-existing 
condition: MH# 
DDMMMYYYY / 
DDMMMYYYY 
No 
XX 
Unit 
YYYYYY 
ZZZZZ 
 
2 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
Other: YYYYYY 
DDMMMYYYY / 
DDMMMYYYY 
No 
XX 
Unit 
YYYYYY 
ZZZZZ 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
Other: YYYYYY 
DDMMMYYYY / 
DDMMMYYYY 
No 
XX 
Unit 
YYYYYY 
ZZZZZ 
 
2 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
Other: YYYYYY 
DDMMMYYYY / 
DDMMMYYYY 
No 
XX 
Unit 
YYYYYY 
ZZZZZ 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
Pre-existing 
condition: MH# 
DDMMMYYYY / 
DDMMMYYYY 
No 
XX 
Unit 
YYYYYY 
ZZZZZ 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Prior medications are defined as any medication where the use was stopped prior to the first administration of the study 
medication.  
WHO-DD, xxxxxxxxxx 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 25 of 83 
Listing 16.2.4.7.2 MAD: Prior Medications 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.4.7.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 26 of 83 
Listing 16.2.5.1.1 SD: Randomization 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Date /Time of 
Randomization 
(DDMMMYYYY/ HH:MM) 
Randomization Number 
Date /Time of 
Emergency Unblinding 
(DDMMMYYYY/ HH:MM) 
Reason for Emergency Unblinding 
 
 
 
 
 
XXX 
DDMMMYYYY/ HH:MM 
XXXXX 
 
 
XXX 
DDMMMYYYY/ HH:MM 
XXXXX 
 
 
XXX 
DDMMMYYYY/ HH:MM 
XXXXX 
 
 
XXX 
DDMMMYYYY/ HH:MM 
XXXXX 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXX 
XXX 
DDMMMYYYY/ HH:MM 
XXXXX 
 
 
XXX 
DDMMMYYYY/ HH:MM 
XXXXX 
 
 
 
 
 
 
 
etc. 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 27 of 83 
Listing 16.2.5.1.2 MAD: Randomization 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 
 

 
Programming Note: 
Repeat Listing 16.2.5.1.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 28 of 83 
Listing 16.2.5.2.1 SD: Study Drug Administration 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Visit 
Was Study Drug 
Administered? (If 
no, provide 
reason) 
Start Date/ Time 
of Injection 
(DDMMMYYYY/ HH:MM) 
Stop Date/ Time 
of Injection 
(DDMMMYYYY/ 
HH:MM) 
Study Drug 
Administered 
per Dose 
Prescribed 
Reason not 
Successfully 
Administered 
Volume 
Administered 
(mL) 
Total Duration 
of Injection 
(Including 
Interruptions 
- minutes) 
 
 
 
 
 
 
 
 
XXX 
Day 1 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
Yes 
 
xx 
xx 
XXX 
Day 1 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
Yes 
 
xx 
xx 
XXX 
Day 1 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
No 
XXXXXXXXXXXX 
xx 
 
XXX 
Day 1 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
Yes 
 
xx 
xx 
XXX 
Day 1 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
Yes 
 
xx 
xx 
XXX 
Day 1 
No - XXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 29 of 83 
Listing 16.2.5.2.2 MAD: Study Drug Administration 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
Subject 
Visit 
Was Study Drug 
Administered? (If 
no, provide 
reason) 
Start Date/ Time of 
Injection 
(DDMMMYYYY/ HH:MM) 
Stop Date/ Time 
of Injection 
(DDMMMYYYY/ 
HH:MM) 
Study Drug 
Administered 
per Dose 
Prescribed 
Reason not 
Successfully 
Administered 
Volume 
Administered 
(mL) 
Total Duration 
of Injection 
(Including 
Interruptions 
- minutes) 
 
 
 
 
 
 
 
 
XXX 
Day 1 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
Yes 
 
xx 
xx 
 
Day 2 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
Yes 
 
xx 
xx 
 
Day 3 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
No 
XXXXXXXXXXXX 
xx 
xx 
 
 
 
 
 
 
 
 
XXX 
Day 1 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
Yes 
 
xx 
xx 
 
Day 2 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
Yes 
 
xx 
xx 
 
Day 3 
No - XXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 30 of 83 
Listing 16.2.5.3.1 SD: Study Drug Interruption 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Visit 
Interruption 
Date and Time of 
Interruption 
(DDMMMYYYY/ HH:MM) 
Date and Time of 
Injection Re-start 
(DDMMMYYYY/ HH:MM) 
Reason for Interruption 
 
 
 
 
 
XXX 
Day 1 
1 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
XXX 
Day 1 
1 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
 
2 
 
 
 
XXX 
Day 1 
1 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
XXX 
Day 1 
1 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
XXX 
Day 1 
1 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 31 of 83 
Listing 16.2.5.3.2 MAD: Study Drug Interruption 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Visit 
Interruption 
Date and Time of 
Interruption 
(DDMMMYYYY/ HH:MM) 
Date and Time of 
Injection Re-start 
(DDMMMYYYY/ HH:MM) 
Reason for Interruption 
 
 
 
 
 
XXX 
Day 1 
1 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
XXX 
Day 2 
1 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
XXX 
Day 1 
1 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
XXX 
Day 3 
1 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
XXX 
Day 1 
1 
DDMMMYYYY/ HH:MM 
DDMMMYYYY/ HH:MM 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 32 of 83 
Listing 16.2.6.1.1 SD: Individual pGSN Plasma Concentrations (unit) 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Number 
Day 
Date/Time 
of Dose on 
Dosing Day 
(DDMMMYYYY/ 
HH:MM) 
Sampling Time 
Was PK 
Sample 
Collected? 
Date of  
PK Sample 
Collection 
(DDMMMYYYY) 
Time of 
PK Sample 
Collection 
(HH:MM) 
Time 
Deviation 
Concen-
tration 
(ng/mL) 
Ratio 
from Pre-
Injection 
Day 1 
Ratio 
from Pre-
Injection
/ Placebo 
Ratio 
from Pre-
Injection 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
DDMMMYYYY/ 
HH:MM 
Pre-Injection 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
 
 
YYYYYYYY 
 
 
 
5 to 10 mins 
post 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
X.XX 
X.XX 
 
 
 
 
2 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
8 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
12 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
16 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
24 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
DDMMMYYYY/ 
HH:MM 
Pre-Injection 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
 
 
 
 
 
 
5 to 10 mins 
post 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
X.XX 
X.XX 
YYYYYYYY 
 
 
 
2 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
8 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
12 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
…. 
 
 
16 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
24 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 33 of 83 
Listing 16.2.6.1.2 MAD: Individual pGSN Plasma Concentrations (unit) 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Number 
Day 
Date/Time 
of Dose on 
Dosing Day 
(DDMMMYYYY/ 
HH:MM) 
Sampling Time 
Was PK 
Sample 
Collected? 
Date of  
PK Sample 
Collection 
(DDMMMYYYY) 
Time of 
PK Sample 
Collection 
(HH:MM) 
Time 
Deviation 
Concen-
tration 
(ng/mL) 
Ratio 
from Pre-
Injection 
Day 1 
Ratio 
from Pre-
Injection
/ Placebo 
Ratio 
from Pre-
Injection 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
DDMMMYYYY/ 
HH:MM 
Pre-Injection 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
 
 
YYYYYYYY 
 
 
 
5 to 10 mins 
post 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
X.XX 
X.XX 
 
 
 
 
2 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
8 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
12 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
16 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
24 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 
DDMMMYYYY/ 
HH:MM 
Pre-Injection 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
 
 
 
 
 
 
5 to 10 mins 
post 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
X.XX 
X.XX 
YYYYYYYY 
 
 
 
2 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
8 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
12 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
…. 
 
 
16 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
24 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 34 of 83 
Listing 16.2.6.2.1 SD: Individual Estimated Plasma rhu-pGSN Concentrations (unit) 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Number 
Day 
Date/Time 
of Dose on 
Dosing Day 
(DDMMMYYYY/ 
HH:MM) 
Sampling Time 
Was PK 
Sample 
Collected? 
Date of  
PK Sample 
Collection 
(DDMMMYYYY) 
Time of 
PK Sample 
Collection 
(HH:MM) 
Time 
Deviation 
Concen-
tration 
(ng/mL) 
Change 
from Pre-
Injection 
Day 1 
(Change 
from Pre-
Injection) 
– (Mean 
Placebo 
Change from 
Pre-
Injection) 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
DDMMMYYYY/ 
HH:MM 
Pre-Injection 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
 
 
YYYYYYYY 
 
 
 
5 to 10 mins 
post 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
X.XX 
X.XX 
 
 
 
 
2 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
8 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
12 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
16 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
24 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
DDMMMYYYY/ 
HH:MM 
Pre-Injection 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
 
 
 
 
 
 
5 to 10 mins 
post 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
X.XX 
X.XX 
YYYYYYYY 
 
 
 
2 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
8 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
12 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
…. 
 
 
16 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
24 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 35 of 83 
Listing 16.2.6.2.2 MAD: Individual Estimated Plasma rhu-pGSN Concentrations (unit) 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Number 
Day 
Date/Time 
of Dose on 
Dosing Day 
(DDMMMYYYY/ 
HH:MM) 
Sampling Time 
Was PK 
Sample 
Collected? 
Date of  
PK Sample 
Collection 
(DDMMMYYYY) 
Time of 
PK Sample 
Collection 
(HH:MM) 
Time 
Deviation 
Concen-
tration 
(ng/mL) 
Change 
from Pre-
Injection 
Day 1 
(Change 
from Pre-
Injection) 
– (Mean 
Placebo 
Change from 
Pre-
Injection) 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
DDMMMYYYY/ 
HH:MM 
Pre-Injection 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
 
 
YYYYYYYY 
 
 
 
5 to 10 mins 
post 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
X.XX 
X.XX 
 
 
 
 
2 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
8 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
12 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
16 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
24 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 
DDMMMYYYY/ 
HH:MM 
Pre-Injection 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
 
 
 
 
 
 
5 to 10 mins 
post 
Yes 
DDMMMYYYY 
HH:MM 
xx mins 
XXX 
X.XX 
X.XX 
YYYYYYYY 
 
 
 
2 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
8 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
12 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
…. 
 
 
16 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
24 hours post 
Yes 
DDMMMYYYY 
HH:MM 
xx hours 
XXX 
X.XX 
X.XX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 36 of 83 
Listing 16.2.6.3.1 SD: Individual pGSN Plasma PK Parameters 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Day 1 
Subject 
Number 
AUC0-t 
(unit) 
AUC0-8h 
(unit) 
AUC0-inf 
(unit) 
Cmax 
(unit) 
Tmax 
(unit) 
kel 
(unit) 
t½ 
(unit) 
CL/F 
(unit) 
Vz/F 
(unit) %AUCext DN_AUC0-t DN_AUC0-8 DN_AUC0-inf DN_Cmax 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
…. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 37 of 83 
Listing 16.2.6.3.2 MAD: Individual pGSN Plasma PK Parameters by Day 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Day 1 
Subject 
Number 
AUC0-t 
(unit) 
AUC0-8h 
(unit) 
AUC0-inf 
(unit) 
Cmax 
(unit) 
Tmax 
(unit) 
kel 
(unit) 
t½ 
(unit) 
CL/F 
(unit) 
Vz/F 
(unit) %AUCext DN_AUC0-t DN_AUC0-8 DN_AUC0-inf DN_Cmax 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
…. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 38 of 83 
Listing 16.2.6.4.1 SD: Individual Estimated Plasma rhu-pGSN PK Parameters 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Day 1 
Subject 
Number 
Change from Pre-Injection 
Double Delta Analysis 
AUC0-t 
(unit) 
AUC0-8h 
(unit) 
Cmax 
(unit) 
DN_AUC0-t 
DN_AUC0-8 
DN_Cmax 
AUC0-t 
(unit) 
AUC0-8h 
(unit) 
Cmax (unit) DN_AUC0-t 
DN_AUC0-8 
DN_Cmax 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
 
…. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 39 of 83 
Listing 16.2.6.4.2 MAD: Individual Estimated Plasma rhu-pGSN PK Parameters by Day 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Day 1 
Subject 
Number 
Change from Pre-Injection 
Double Delta Analysis 
AUC0-t 
(unit) 
AUC0-8h 
(unit) 
Cmax 
(unit) 
DN_AUC0-t 
DN_AUC0-8 
DN_Cmax 
AUC0-t 
(unit) 
AUC0-8h 
(unit) 
Cmax (unit) DN_AUC0-t 
DN_AUC0-8 
DN_Cmax 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
XXX 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
 
…. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 

 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 40 of 83 
Listing 16.2.6.5.1 SD: Anti-rhu-pGSN Antibodies 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Listing shell will be updated once data transfer agreement is 
available. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 41 of 83 
Listing 16.2.6.5.2 MAD: Anti-rhu-pGSN Antibodies 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.6.5.1 for MAD. 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 42 of 83 
Listing 16.2.6.6.1 SD: Biomarkers 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Parameter (Unit) 
Study Visit 
Sample Date/ Time 
(DDMMMYYYY/ 
HH:MM) 
Actual 
Value 
Change from 
Baseline 
Reference 
Ranges 
High/ Low  
Flag 
Comments 
 
 
 
 
 
 
 
 
 
XXX 
Procalcitonin (unit) 
Day 1* 
DDMMMYYYY/ HH:MM 
xx 
 
xx, xx 
 
 
 
 
Day 2 
DDMMMYYYY/ HH:MM 
xx 
 
xx, xx 
 
 
 
 
Day 3 
DDMMMYYYY/ HH:MM 
xx 
xx 
xx, xx 
H 
 
 
 
Day 4 
DDMMMYYYY/ HH:MM 
xx 
xx 
xx, xx 
L 
 
 
 
 
 
 
 
 
 
 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: *Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
  L = Below Normal Range, H = Above Normal Range 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 43 of 83 
Listing 16.2.6.6.2 MAD: Biomarkers 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 
 
Programming Note: 
Repeat Listing 16.2.6.6.1 for MAD. 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 44 of 83 
Listing 16.2.6.7.1 SD: Sputum and Blood Culture 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Study Visit 
Sputum Culture 
Collected – Reason 
Not Performed 
Date/Time of 
Collection 
Results 
Gram-Stains 
Antigen  
Detection 
Immunoassay 
Genomic 
Diagnostic Test 
Result 
 
 
 
 
 
 
 
 
 
XXXXX 
Screening 
Yes 
DDMMMYYYY/ 
HH:MM 
 
 
 
 
 
XXXXX 
Screening 
Yes 
DDMMMYYYY/ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 45 of 83 
Listing 16.2.6.7.2 MAD: Sputum and Blood Culture 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 
 
Programming Note: 
Repeat Listing 16.2.6.7.1 for SD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 46 of 83 
Listing 16.2.7.1.1 SD: Adverse Events 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Number 
AE# 
Adverse Event Verbatim/ 
System Organ Class/ 
Preferred Term 
Start Date/  
Stop Date/  
(DDMMMYYYY/ 
DDMMMYYYY) 
SAE 
Severity 
(NCI-
CTCAE) 
Relationship 
to Study Drug 
Relationship 
to Study 
Procedure 
Action 
Taken 
with 
Study 
Drug 
Other 
Action 
Outcome 
TEAE 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
Yes Grade 1 
Possibly 
Related 
Possibly 
Related 
None 
None 
Recovered / 
Resolved 
Yes 
 
2 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
Yes Grade 1 
Definitely 
not Related 
Definitely 
not Related 
None 
None 
Recovered / 
Resolved 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
No 
Grade 1 
Definitely 
not Related 
Definitely 
not Related 
None 
None 
Recovered / 
Resolved 
No 
 
2 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
DDMMMYYYY / 
Ongoing 
No 
Grade 1 
Definitely 
not Related 
Definitely 
not Related 
Drug 
withdrawn None 
Recovered / 
Resolved 
Yes 
 
 
 
 
 
 
 
 
 
 
 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: TEAE = A treatment-emergent adverse event.  
MedDRA Version xx.x 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 47 of 83 
Listing 16.2.7.1.2 MAD: Adverse Events 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.7.1.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 48 of 83 
Listing 16.2.7.2.1 SD: Serious Adverse Events 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subjec
t 
Number AE# 
Adverse Event Verbatim/ 
System Organ Class/ 
Preferred Term 
Start Date/  
Stop Date/  
(DDMMMYYYY/ 
DDMMMYYYY) 
SAE 
Criteria 
Severity 
(NCI-
CTCAE) 
Relationship 
to Study 
Drug 
Relationship 
to Study 
Procedure 
Action 
Taken 
with 
Study 
Drug 
Other 
Action 
Outcome 
TEAE 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYY 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
Is Life 
Threatening Grade 1 
Possibly 
Related 
Possibly 
Related 
None 
None 
Recovered / 
Resolved 
Yes 
 
2 
XXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYY 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
Is Life 
Threatening Grade 1 
Definitely 
not Related 
Definitely 
not Related 
None 
None 
Recovered / 
Resolved 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYY 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
Is Life 
Threatening Grade 1 
Definitely 
not Related 
Definitely 
not Related 
None 
None 
Recovered / 
Resolved 
No 
 
2 
XXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYY 
DDMMMYYYY / 
Ongoing 
Is Life 
Threatening Grade 1 
Definitely 
not Related 
Definitely 
not Related 
Drug 
withdrawn None 
Recovered / 
Resolved 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: TEAE = A treatment-emergent adverse event.  
MedDRA Version xx.x 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 49 of 83 
Listing 16.2.7.2.2 MAD: Serious Adverse Events 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 

 
Programming Note: 
Repeat Listing 16.2.7.2.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 50 of 83 
Listing 16.2.7.3.1 SD: Adverse Events Leading to Study Medication Discontinuation 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Number 
AE# 
Adverse Event Verbatim/ 
System Organ Class/ 
Preferred Term 
Start Date/  
Stop Date/  
(DDMMMYYYY/ 
DDMMMYYYY) 
SAE 
Severity 
(NCI-
CTCAE) 
Relationship 
to Study Drug 
Relationship 
to Study 
Procedure 
Action 
Taken 
with 
Study 
Drug 
Other 
Action 
Outcome 
TEAE 
 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
Yes Grade 1 
Possibly 
Related 
Possibly 
Related 
Drug 
withdrawn 
None 
Recovered / 
Resolved 
Yes 
 
2 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
Yes Grade 1 
Definitely 
not Related 
Definitely 
not Related 
Drug 
withdrawn 
None 
Recovered / 
Resolved 
Yes 
 
 
 
 
 
 
 
 
Drug 
withdrawn 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
DDMMMYYYY/ 
HH:MM 
DDMMMYYYY/ 
HH:MM 
No 
Grade 1 
Definitely 
not Related 
Definitely 
not Related 
Drug 
withdrawn 
None 
Recovered / 
Resolved 
No 
 
2 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
DDMMMYYYY / 
Ongoing 
No 
Grade 1 
Definitely 
not Related 
Definitely 
not Related 
Drug 
withdrawn None 
Recovered / 
Resolved 
Yes 
 
 
 
 
 
 
 
 
 
 
 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: TEAE = A treatment-emergent adverse event.  
MedDRA Version xx.x 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 51 of 83 
Listing 16.2.7.3.2 MAD: Adverse Events Leading to Study Medication Discontinuation 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.7.3.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 52 of 83 
Listing 16.2.7.4.1 SD: Overall Survival 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
 
Subject 
Date of First Study Drug 
Administration 
(DDMMMYYYY) 
Event/Censoring  
Date 
DDMMMYYYY) 
Event or Censoring 
Description 
Days to Event 
 
 
 
 
 
XXX 
DDMMMYYYY 
DDMMMYYYY 
Death 
xxx 
XXX 
DDMMMYYYY 
DDMMMYYYY 
Last assessment date 
xxx 
XXX 
DDMMMYYYY 
DDMMMYYYY 
Last assessment date 
xxx 
XXX 
DDMMMYYYY 
DDMMMYYYY 
Death 
xxx 
 
 
 
 
 
etc. 
 
 
 
 
 
 
 
 
 
Note: Overall Survival is defined as the difference (in days) between the  
      time of first study drug administration to the date of death + 1 (Include the day of the study drug administration.) 
      Subjects who did not die will be censored at the study exit visit. 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 53 of 83 
Listing 16.2.7.4.2 MAD: Overall Survival 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.7.4.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 54 of 83 
Listing 16.2.8.1.1.1 SD: CBC 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Parameter (Unit) 
Study Visit 
Sample Date/ 
Time 
(DDMMMYYYY/ 
HH:MM) 
Actual 
Value 
Change from 
Baseline1 
Reference 
Ranges 
High/ Low  
Flag 
Clinical 
Significance 
Abnormality 
Description 
 
 
 
 
 
 
 
 
 
 
XXX 
Haemoglobin (unit) 
Screening 
DDMMMYYYY/ 
HH:MM 
xx 
 
xx, xx 
 
 
 
 
 
Day 11 
DDMMMYYYY/ 
HH:MM 
xx 
 
xx, xx 
 
 
 
 
 
Day 2 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
H 
NCS 
 
 
 
Day 3 or 4 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
L 
CS 
XXXXXXXXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
  L = Below Normal Range, H = Above Normal Range, NCS = Not Clinically Significant, CS = Clinically Significant. 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 55 of 83 
Listing 16.2.8.1.1.2 MAD: CBC 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.8.1.1.1 for MAD. 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 56 of 83 
Listing 16.2.8.1.2.1 SD: Abnormal CBC 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Parameter (Unit) 
Study Visit 
Sample Date/ 
Time 
(DDMMMYYYY/ 
HH:MM) 
Actual 
Value 
Change from 
Baseline1 
Reference 
Ranges 
High/ Low  
Flag 
Clinical 
Significance 
Abnormality 
Description 
 
 
 
 
 
 
 
 
 
 
XXX 
Haemoglobin (unit) 
Day 2 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
H 
NCS 
 
 
 
Day 3 or 4 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
L 
CS 
XXXXXXXXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
  L = Below Normal Range, H = Above Normal Range, NCS = Not Clinically Significant, CS = Clinically Significant. 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 57 of 83 
Listing 16.2.8.1.2.2 MAD: Abnormal CBC 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.8.1.2.1 for MAD. 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 58 of 83 
Listing 16.2.8.2.1.1 SD: Coagulation 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Parameter (Unit) 
Study Visit 
Sample Date/ 
Time 
(DDMMMYYYY/ 
HH:MM) 
Actual 
Value 
Change from 
Baseline1 
Reference 
Ranges 
High/ Low  
Flag 
Clinical 
Significance 
Abnormality 
Description 
 
 
 
 
 
 
 
 
 
 
XXX 
PT/INR (unit) 
Screening 
DDMMMYYYY/ 
HH:MM 
xx 
 
xx, xx 
 
 
 
 
 
Day 11 
DDMMMYYYY/ 
HH:MM 
xx 
 
xx, xx 
 
 
 
 
 
Day 2 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
H 
NCS 
 
 
 
Day 3 or 4 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
L 
CS 
XXXXXXXXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
  L = Below Normal Range, H = Above Normal Range, NCS = Not Clinically Significant, CS = Clinically Significant. 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 59 of 83 
Listing 16.2.8.2.1.2 MAD: Coagulation 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.8.2.1.1 for MAD. 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 60 of 83 
Listing 16.2.8.2.2.1 SD: Abnormal Coagulation 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Parameter (Unit) 
Study Visit 
Sample Date/ 
Time 
(DDMMMYYYY/ 
HH:MM) 
Actual 
Value 
Change from 
Baseline1 
Reference 
Ranges 
High/ Low  
Flag 
Clinical 
Significance 
Abnormality 
Description 
 
 
 
 
 
 
 
 
 
 
XXX 
PT/INR (unit) 
Day 2 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
H 
NCS 
 
 
 
Day 3 or 4 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
L 
CS 
XXXXXXXXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
  L = Below Normal Range, H = Above Normal Range, NCS = Not Clinically Significant, CS = Clinically Significant. 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 61 of 83 
Listing 16.2.8.2.2.2 MAD: Abnormal Coagulation 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.8.2.2.1 for MAD. 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 62 of 83 
Listing 16.2.8.3.1.1 SD: Comprehensive Metabolic Profile 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Parameter (Unit) 
Study Visit 
Sample Date/ 
Time 
(DDMMMYYYY/ 
HH:MM) 
Actual 
Value 
Change from 
Baseline1 
Reference 
Ranges 
High/ Low  
Flag 
Clinical 
Significance 
Abnormality 
Description 
 
 
 
 
 
 
 
 
 
 
XXX 
Sodium (unit) 
Screening 
DDMMMYYYY/ 
HH:MM 
xx 
 
xx, xx 
 
 
 
 
 
Day 11 
DDMMMYYYY/ 
HH:MM 
xx 
 
xx, xx 
 
 
 
 
 
Day 2 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
H 
NCS 
 
 
 
Day 3 or 4 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
L 
CS 
XXXXXXXXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
  L = Below Normal Range, H = Above Normal Range, NCS = Not Clinically Significant; CS = Clinically Significant. 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 63 of 83 
Listing 16.2.8.3.1.2 MAD: Comprehensive Metabolic Profile 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.8.3.1.1 for MAD. 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 64 of 83 
Listing 16.2.8.3.2.1 SD: Abnormal Comprehensive Metabolic Profile 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Parameter (Unit) 
Study Visit 
Sample Date/ 
Time 
(DDMMMYYYY/ 
HH:MM) 
Actual 
Value 
Change from 
Baseline1 
Reference 
Ranges 
High/ Low  
Flag 
Clinical 
Significance 
Abnormality 
Description 
 
 
 
 
 
 
 
 
 
 
XXX 
Sodium (unit) 
Day 2 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
H 
NCS 
 
 
 
Day 3 or 4 
DDMMMYYYY/ 
HH:MM 
xx 
xx 
xx, xx 
L 
CS 
XXXXXXXXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
  L = Below Normal Range, H = Above Normal Range, NCS = Not Clinically Significant; CS = Clinically Significant. 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 65 of 83 
Listing 16.2.8.3.2.2 MAD: Abnormal Comprehensive Metabolic Profile 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.8.3.2.1 for MAD. 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 66 of 83 
Listing 16.2.9.1 SD: Vital Signs 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subjec
t 
Parameter 
(Unit) 
Assessment 
Performed – 
Reason Not 
Performed 
Study Visit 
Assessment 
Date 
(DDMMMYYYY) 
Timepoint 
Time  
(HH:MM) 
Actual 
Value 
Change 
from 
Baseline1 
Investigator’s 
Overall 
Interpretation 
If Abnormal, 
specify 
 
 
 
 
 
 
 
 
 
 
 
XXX 
Systolic 
Blood 
Pressure 
(mmHg) 
Yes 
Screening 
DDMMMYYYY 
 
HH:MM 
xx 
 
Normal 
 
 
 
Yes 
Day 1 
DDMMMYYYY 
Pre-dose1 
HH:MM 
xx 
 
Abnormal NCS 
XXXXXXXXX 
 
 
 
 
 
End of 
Infusion 
HH:MM 
xx 
xx 
Abnormal NCS 
XXXXXXXXX 
Etc. 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
 
NCS = Not Clinically Significant, CS = Clinically Significant 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 67 of 83 
Listing 16.2.9.2 MAD: Vital Signs 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
Programming Note: Repeat Listing 16.2.9.1.1 for the MAD. 

 
Programming Note: 
Repeat Listing 16.2.9.1 for MAD. 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 68 of 83 
Listing 16.2.10.1 SD: EKG 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subjec
t 
Parameter 
(Unit) 
Assessment 
Performed – 
Reason Not 
Performed Study Visit 
Assessment 
Date 
(DDMMMYYYY) Timepoint 
Time  
(HH:MM) 
Actual 
Value 
Mean  
Actual 
Value 
Mean Change 
from 
Baseline1 
Investigator’s 
Overall 
Interpretation 
Worst 
Investigator’s 
Overall 
Interpretation 
If 
Abnormal, 
specify 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXX 
Heart 
Rate 
(unit) 
Yes 
Screening 
DDMMMYYYY 
EKG 1 
HH:MM 
xx 
 
 
Normal 
 
 
 
 
 
 
 
EKG 2 
HH:MM 
xx 
xx.x 
 
Abnormal NCS 
Abnormal NCS 
XXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Yes 
Day 11 
DDMMMYYYY 
EKG 1 
HH:MM 
xx 
 
 
Abnormal NCS 
 
 
 
 
 
 
 
EKG 2 
HH:MM 
xx 
xx.x 
 
Abnormal NCS 
Abnormal NCS 
XXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Yes 
Day 28 / 
Early 
Termination 
DDMMMYYYY 
EKG 1 
HH:MM 
xx 
 
 
Abnormal NCS 
 
 
 
 
 
 
 
EKG 2 
HH:MM 
xx 
xx.x 
xx.x 
Abnormal CS 
Abnormal NCS 
XXXXXXXXX 
 
 
 
 
 
 
 
 
 
 
 
 
 
etc. 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
 
NCS = Not Clinically Significant, CS = Clinically Significant 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 69 of 83 
Listing 16.2.10.2 MAD: EKG 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 

 
Programming Note: 
Repeat Listing 16.2.10.1 for MAD. 
Include all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 70 of 83 
Listing 16.2.11.1 SD: Physical Examination 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Assessment 
Performed – 
Reason Not 
Performed 
Visit 
Date/Time Physical 
Examination 
performed 
(DDMMMYYYY) 
Body System 
Result 
If Abnormal, 
specify 
 
 
 
 
 
 
 
XXX 
Yes 
Screening 
DDMMMYYYY/ HH:MM 
Skin 
Normal 
 
 
 
 
 
HEENT 
Normal 
 
 
 
 
 
…. 
Abnormal NCS 
ZZZZZZZZZZZZ 
 
 
 
 
Musculoskeletal 
Abnormal NCS 
ZZZZZZZZZZZZ 
 
 
 
 
 
 
 
 
Yes 
Day 1 
DDMMMYYYY/ HH:MM 
Skin 
Normal 
 
 
 
 
 
HEENT 
Normal 
 
 
 
 
 
…. 
Abnormal NCS 
ZZZZZZZZZZZZ 
 
 
 
 
Musculoskeletal 
Abnormal NCS 
ZZZZZZZZZZZZ 
 
 
 
 
 
 
 
 
Yes 
Day 2 
DDMMMYYYY/ HH:MM 
Skin 
Normal 
 
 
 
 
… 
HEENT 
Normal 
 
XXX 
No - 
ZZZZZZZZ 
 
 
…. 
 
 
… 
 
 
 
Musculoskeletal 
Normal 
 
 
 
 
 
 
 
 
Note: NCS = Not Clinically Significant, CS = Clinically Significant 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 71 of 83 
Listing 16.2.11.2 MAD: Physical Examination 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 

 
Programming Note: 
Repeat Listing 16.2.9.11.1 for MAD. 
Include all time points and all parameters. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 72 of 83 
Listing 16.2.12.1.1 SD: Outcome Prediction Models CURB-65 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Study Visit 
Test 
Performed – 
Reason Not 
Performed 
Visit Date 
Confusion of 
New Onset 
Blood Urea 
Nitrogen 
Respiratory 
Rate 
(breaths/min) 
Systolic/ 
Diastolic 
BP (mmHg) 
Age 
(years) 
CURB-65 Score 
Actual 
Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
 
 
 
 
XXXXX 
Screening1 
Yes 
DDMMMYYYY 
xx 
xx (unit) 
xx 
xxx/ xx 
xx 
xx 
 
 
Day 3/4 
Yes 
DDMMMYYYY 
xx 
xx (unit) 
xx 
xxx/ xx 
xx 
xx 
xx 
 
Day 7 
Yes 
DDMMMYYYY 
xx 
xx (unit) 
xx 
xxx/ xx 
xx 
xx 
xx 
 
Day 14 
Yes 
DDMMMYYYY 
xx 
xx (unit) 
xx 
xxx/ xx 
xx 
xx 
xx 
 
Day 28 / 
Early 
Termination 
Yes 
DDMMMYYYY 
xx 
xx (unit) 
xx 
xxx/ xx 
xx 
xx 
xx 
 
 
 
 
 
 
 
 
 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 73 of 83 
Listing 16.2.12.1.2 MAD: Outcome Prediction Models CURB-65 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.12.1.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 74 of 83 
Listing 16.2.12.2.1 SD: Outcome Prediction Models PSI (Port Score) 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Study Visit 
Test Performed – 
Reason Not 
Performed 
Visit Date 
PSI Score 
PSI Class 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
 
XXXXX 
Screening1 
Yes 
DDMMMYYYY 
xx 
 
I 
 
Day 3/4 
Yes 
DDMMMYYYY 
xx 
xx 
II 
 
Day 7 
Yes 
DDMMMYYYY 
xx 
xx 
III 
 
Day 14 
Yes 
DDMMMYYYY 
xx 
xx 
IV 
 
Day 28 / Early 
Termination 
Yes 
DDMMMYYYY 
xx 
xx 
V 
 
 
 
 
 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 75 of 83 
Listing 16.2.12.2.2 MAD: Outcome Prediction Models PSI (Port Score) 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.12.2.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 76 of 83 
Listing 16.2.12.3.1 SD: Outcome Prediction Models SOFA Score 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Study Visit 
Test Performed – 
Reason Not Performed 
Visit Date 
SOFA Score 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
XXXXX 
Screening1 
Yes 
DDMMMYYYY 
xx 
 
 
Day 3/4 
Yes 
DDMMMYYYY 
xx 
xx 
 
Day 7 
Yes 
DDMMMYYYY 
xx 
xx 
 
Day 14 
Yes 
DDMMMYYYY 
xx 
xx 
 
Day 28 / Early 
Termination 
Yes 
DDMMMYYYY 
xx 
xx 
 
 
 
 
 
 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 77 of 83 
Listing 16.2.12.3.2 MAD: Outcome Prediction Models SOFA Score 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.12.3.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 78 of 83 
Listing 16.2.12.4.1 SD: Outcome Prediction Models MMSE Score 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Study Visit 
Test Performed – 
Reason Not Performed 
Visit Date 
MMSE Score 
Actual Value 
Change from 
Baseline1 
 
 
 
 
 
 
XXXXX 
Screening1 
Yes 
DDMMMYYYY 
xx 
 
 
Day 3/4 
Yes 
DDMMMYYYY 
xx 
xx 
 
Day 7 
Yes 
DDMMMYYYY 
xx 
xx 
 
Day 14 
Yes 
DDMMMYYYY 
xx 
xx 
 
Day 28 / Early 
Termination 
Yes 
DDMMMYYYY 
xx 
xx 
 
 
 
 
 
 
etc. 
 
 
 
 
 
 
 
 
 
 
 
Note: 1Baseline. Baseline is defined as the last valid, non-missing assessment prior to first study drug administration. 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 79 of 83 
Listing 16.2.12.4.2 MAD: Outcome Prediction Models MMSE Score 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 

 
Programming Note: 
Repeat Listing 16.2.12.4.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 80 of 83 
Listing 16.2.13.1 SD: Concomitant Medications 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Number 
CM# 
Drug Name/ATC3/PT 
Indication 
Start Date/ 
Stop Date 
(DDMMMYYYY) 
Ongoing Dose Unit 
Frequency 
Route 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
To treat AE: AE# 
DDMMMYYYY / 
DDMMMYYYY 
No 
XX 
Unit 
YYYYYY 
ZZZZZ 
 
2 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
Other: YYYYYY 
DDMMMYYYY / 
DDMMMYYYY 
No 
XX 
Unit 
YYYYYY 
ZZZZZ 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
Other: YYYYYY 
DDMMMYYYY / 
DDMMMYYYY 
No 
XX 
Unit 
YYYYYY 
ZZZZZ 
 
2 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
Other: YYYYYY 
DDMMMYYYY / 
Ongoing 
Yes 
XX 
Unit 
YYYYYY 
ZZZZZ 
 
 
 
 
 
 
 
 
 
 
XXX 
1 
XXXXXXXXXXXXXXXXXXXXXX/ 
ZZZZZZZZZZZZZZZZZZZZZZ/ 
YYYYYYYYYYYYYYYYYYYYYY 
To treat AE: AE# 
DDMMMYYYY / 
DDMMMYYYY 
No 
XX 
Unit 
YYYYYY 
ZZZZZ 
Etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Concomitant medications are medications taken at least once after first study-drug administration.  
WHO-DD, xxxxxxxxxx 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 81 of 83 
Listing 16.2.13.2 MAD: Concomitant Medication 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 
 

 
Programming Note: 
Repeat Listing 16.2.9.13.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 82 of 83 
Listing 16.2.14.1 SD: Hospitalization Follow-Up 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 1: rhu-pGSN 6 mg/kg 
Subject 
Discharged 
from 
Hospital 
Length of Hospital Stay 
ICU Stay 
Intubation 
Administered 
Antibiotics 
Require 
Vasopressors 
Date and Time of 
Hospitalization 
Admission due to 
CAP (DDMMMYYYY/ 
HH:MM) 
Date/ Time of 
Discharge/ Study 
Exit 
(DDMMMYYYY/ 
HH:MM) 
Number 
of 
Hours 
Yes/No 
Number of 
Days 
Yes/No 
Number of 
Days 
 
 
 
 
 
 
 
 
 
 
 
XXX 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
xx 
Yes 
xx 
Yes 
xx 
Yes 
No 
XXX 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
xx 
Yes 
xx 
No 
 
No 
No 
XXX 
Yes 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
xx 
No 
 
No 
 
No 
No 
XXX 
No 
DDMMMYYYY/ HH:MM DDMMMYYYY/ HH:MM 
xx 
No 
 
No 
 
No 
No 
etc. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Length of stay in hospital is defined as the date and time of discharge/date of study exit (23:59 PM) -  
      date and time of hospitalization admission due to CAP in hours 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 


Protocol No: BTI-201 
Document status: Mock EOS Listings, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 83 of 83 
Listing 16.2.14.2 MAD: Hospitalization Follow-Up 
Protocol: BTI-201 
Intent-to-Treat Population 
Cohort 2: rhu-pGSN 6 mg/kg 
 
 
Programming Note: 
Repeat Listing 16.2.14.1 for MAD. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 1 of 18 
 
BTI-201: Mock Figures: Table of Contents 
Figures 
 
Figure 14.2.1.1 Individual pGSN Plasma Concentrations (ng/mL) (Linear scale) by Day .......................................................................................... 3 
Figure 14.2.1.2 Individual pGSN Plasma Concentrations (ng/mL) (Semi-logarithmic) by Day ................................................................................. 4 
Figure 14.2.2.1 Individual Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on Changes from Pre-Injection  
(Linear scale) by Day ....................................................................................................................................................................................................... 5 
Figure 14.2.2.2 Individual Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on the Double Delta Analysis 
(Linear scale) by Day ....................................................................................................................................................................................................... 6 
Figure 14.2.3.1 Mean (+/-SD) pGSN Plasma Concentrations (ng/mL) (Linear scale) by Day...................................................................................... 7 
Figure 14.2.3.2 Mean (+/-SD) pGSN Plasma Concentrations (ng/mL) based on Changes from Pre-Injection  (Linear scale) by Day 
(Semi-logarithmic) by Day .............................................................................................................................................................................................. 8 
Figure 14.2.4.1 Mean (+/-SD) Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on Changes from Pre-Injection  
(Linear scale) by Day ....................................................................................................................................................................................................... 9 
Figure 14.2.4.2 Mean (+/-SD) Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on the Double Delta Analysis 
(Linear scale) by Day ..................................................................................................................................................................................................... 10 
Figure 14.3.1.1 SD: Kaplan-Meier Plot of Overall Survival Time .......................................................................................................................................... 11 
Figure 14.3.1.2 MAD: Kaplan-Meier Plot of Overall Survival Time ........................................................................................................................................ 12 
Figure 14.3.2.1 SD: Kaplan-Meier Plot of Length of Stay in Hospital (hours) ........................................................................................................... 12 
Figure 14.3.2.2 MAD: Kaplan-Meier Plot of Length of Stay in Hospital (hours) ......................................................................................................... 14 
Figure 14.3.3.1 SD: Kaplan-Meier Plot of Duration of ICU Stay ............................................................................................................................................. 14 
Figure 14.3.3.2 MAD: Kaplan-Meier Plot of Duration of ICU Stay .......................................................................................................................................... 16 
Figure 14.3.4.1 SD: Kaplan-Meier Plot of Duration of Intubation ........................................................................................................................................ 17 
Figure 14.3.4.2 MAD: Kaplan-Meier Plot of Duration of Intubation ..................................................................................................................................... 18 
 
 
 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 2 of 18 
 
GENERAL COMMENTS 
 
x 
Names of Treatment Groups: 
SD: 
x 
rhu-pGSN 6 mg/kg. 
 
MAD: 
x 
rhu-pGSN 6 mg/kg; 
x 
rhu-pGSN 12 mg/kg; 
x 
rhu-pGSN 24 mg/kg. 
 
x 
Names of PK sampling times: 
Day 1 (SD and MAD) & Day 3 (MAD) 
x 
Pre-injection 
x 
5 to 10 mins 
x 
2h 
x 
8h 
x 
12h 
x 
16h 
x 
24h 
 
 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 3 of 18 
 
Figure 14.2.1.1 Individual pGSN Plasma Concentrations (ng/mL) (Linear scale) by Day 
Protocol: BTI-201 
PK Populations 
 
Day 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
Programming Note: 
The x-axis will represent the actual study time in hours (0 – 24 hours).  
The y-axis will represent the pGSN Plasma Concentrations (ng/mL). The y-axis will be on the linear scale. 
All subjects will be represented on a single page. Each dose level will be presented as a distinct line type. A separate figure will be created for each Day. SD and MAD 
subjects will be presented on the same page by Day. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 4 of 18 
 
Figure 14.2.1.2 Individual pGSN Plasma Concentrations (ng/mL) (Semi-logarithmic) by Day 
Protocol: BTI-201 
PK Populations 
 
Day 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
Programming Note: 
The x-axis will represent the actual study time in hours (0 – 24 hours).  
The y-axis will represent the pGSN Plasma Concentrations (ng/mL). The y-axis will be on the log scale. 
All subjects will be represented on a single page. Each dose level will be presented as a distinct line type. A separate figure will be created for each Day. SD and MAD 
subjects will be presented on the same page by Day. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 5 of 18 
 
Figure 14.2.2.1 Individual Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on Changes from Pre-Injection  
(Linear scale) by Day 
Protocol: BTI-201 
PK Populations 
 
Day 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
Programming Note: 
The x-axis will represent the actual study time in hours (0 – 24 hours).  
The y-axis will represent the Estimated Plasma rhu-pGSN Concentrations (ng/mL). The y-axis will be on the linear scale. 
All subjects will be represented on a single page. Each dose level will be presented as a distinct line type. A separate figure will be created for each Day. SD and MAD 
subjects will be presented on the same page by Day. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 6 of 18 
 
Figure 14.2.2.2 Individual Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on the Double Delta Analysis 
(Linear scale) by Day 
Protocol: BTI-201 
PK Populations 
 
Day 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
 
Programming Note: 
The x-axis will represent the nominal study time in hours (0 – 24 hours).  
The y-axis will represent the Estimated Plasma rhu-pGSN Concentrations (ng/mL). The y-axis will be on the linear scale. 
All subjects will be represented on a single page. Each dose level will be presented as a distinct line type. A separate figure will be created for each Day. SD and MAD 
subjects will be presented on the same page by Day. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 7 of 18 
 
Figure 14.2.3.1 Mean (+/-SD) pGSN Plasma Concentrations (ng/mL) (Linear scale) by Day 
Protocol: BTI-201 
PK Populations 
 
Day 1 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
Programming Note: 
The x-axis will represent the nominal study time in hours (0 – 24 hours).  
The y-axis will represent the mean pGSN Plasma Concentrations (ng/mL) per Dose level. Whiskers will be included to reflect the SDs. The y-axis will be on the linear 
scale. All treatments will be represented on a single page. Each dose level will be presented as a distinct line type. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 8 of 18 
 
Figure 14.2.3.2 Mean (+/-SD) pGSN Plasma Concentrations (ng/mL) based on Changes from Pre-Injection  
(Linear scale) by Day (Semi-logarithmic) by Day  
Protocol: BTI-201 
PK Populations 
 
Day 1 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
Programming Note: 
The x-axis will represent the nominal study time in hours (0 – 24 hours). 
The y-axis will represent the mean rhu-pGSN Plasma Concentrations (ng/mL) per Dose level. Whiskers will be included to reflect the SDs. The y-axis will be on the log 
scale. All treatments will be represented on a single page. Each dose level will be presented as a distinct line type. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 9 of 18 
 
Figure 14.2.4.1 Mean (+/-SD) Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on Changes from Pre-Injection  
(Linear scale) by Day 
Protocol: BTI-201 
PK Populations 
 
Day 1 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
Programming Note: 
The x-axis will represent the nominal study time in hours (0 – 24 hours).  
The y-axis will represent the mean Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) per Dose level. Whiskers will be included to reflect the SDs. The y-axis 
will be on the linear scale. All treatments will be represented on a single page. Each dose level will be presented as a distinct line type. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 10 of 18 
 
Figure 14.2.4.2 Mean (+/-SD) Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) based on the Double Delta Analysis 
(Linear scale) by Day 
Protocol: BTI-201 
PK Populations 
 
Day 1 
 
 
 
 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM  
 
 
Programming Note: 
The x-axis will represent the nominal study time in hours (0 – 24 hours).  
The y-axis will represent the mean Estimated Plasma rhu-pGSN Plasma Concentrations (ng/mL) per Dose level. Whiskers will be included to reflect the SDs. The y-axis 
will be on the linear scale. All treatments will be represented on a single page. Each dose level will be presented as a distinct line type. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 11 of 18 
 
Figure 14.3.1.1 SD: Kaplan-Meier Plot of Overall Survival Time 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Note: Overall Survival is defined as the difference (in days) between the  
      time of first study drug administration to the date of death + 1 (Include the day of the study drug administration.) 
      Subjects who did not die will be censored at the study exit visit. 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
Programming Note: 
rhu-pGSN and combined Placebo treatments will be presented on one graph. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 12 of 18 
 
Figure 14.3.1.2 MAD: Kaplan-Meier Plot of Overall Survival Time 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Note: Overall Survival is defined as the difference (in days) between the  
      time of first study drug administration to the date of death + 1 (Include the day of the study drug administration.) 
      Subjects who did not die will be censored at the study exit visit. 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
Programming Note: 
rhu-pGSN and combined Placebo treatments will be presented on one graph. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 13 of 18 
 
Figure 14.3.2.1 SD: Kaplan-Meier Plot of Length of Stay in Hospital (hours) 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Note: Length of stay in hospital is defined as the date and time of discharge/date of study exit (23:59 PM ) -  
      date and time of hospitalization admission due to CAP in hours 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
Programming Note: 
rhu-pGSN and combined Placebo treatments will be presented on one graph. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 14 of 18 
 
Figure 14.3.2.2 MAD: Kaplan-Meier Plot of Length of Stay in Hospital (hours) 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
Note: Length of stay in hospital is defined as the date and time of discharge/date of study exit (23:59 PM ) -  
      date and time of hospitalization admission due to CAP in hours 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
Programming Note: 
rhu-pGSN and combined Placebo treatments will be presented on one graph. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 15 of 18 
 
Figure 14.3.3.1 SD: Kaplan-Meier Plot of Duration of ICU Stay 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
Programming Note: 
rhu-pGSN and combined Placebo treatments will be presented on one graph. Only 
include subjects that stayed in the ICU. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 16 of 18 
 
Figure 14.3.3.2 MAD: Kaplan-Meier Plot of Duration of ICU Stay 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
Programming Note: 
rhu-pGSN and combined Placebo treatments will be presented on one graph. Only 
include subjects that stayed in the ICU. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 17 of 18 
 
Figure 14.3.4.1 SD: Kaplan-Meier Plot of Duration of Intubation 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
 
Programming Note: 
rhu-pGSN and combined Placebo treatments will be presented on one graph. Only 
include subjects that were intubated. 


Protocol No: BTI-201 
Document status: Mock EOS Figures, Final V2.0 Amendment V1.0 
2018-12-03 
 
Novotech – Strictly Confidential 
 
Page 18 of 18 
 
Figure 14.3.4.2 MAD: Kaplan-Meier Plot of Duration of Intubation 
Protocol: BTI-201 
Safety Population 
 
 
 
 
 
 
 
Clinical cut-off date: DDMMMYYYY 
Program: filepath_name, Output: filepath_name (version x.x)  Created: DDMMMYYYY HH:MM 
 
Programming Note: 
rhu-pGSN and combined Placebo treatments will be presented on one graph. Only 
include subjects that were intubated.