Clinical trial NCT03052725
Conditions: Eosinophils, Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2017-03-10; Completion date: 2018-02-22
Enrollment: 391 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.

Detailed description:

Arms: arm 1: Reslizumab was administered as 110 mg subcutaneous (sc) injection in the thigh, abdomen, or upper arm(s) once every 4 weeks for a total of 9 doses.
Interventions: intervention 1: reslizumab
Intervention descriptions: intervention 1: Reslizumab was provided in a pre-filled syringe.

Protocol documents:
Prot_000.pdf: 
Clinical Study Protocol
An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in
Patients 12 Years of Age and Older with Severe Eosinophilic Asthma
Study Number C38072-AS-30066
NCT03052725
Protocol Approval Date: 09 December 2016


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SAP_001.pdf: 
Statistical Analysis Plan
An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing 
in Patients 12 Years of Age and Older with Severe Eosinophilic Asthma
Study C38072-AS-30066
NCT03052725
Approval Date: 26 June 2017


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
1
 
Statistical Analysis Plan
Study C38072-AS-30066
An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in
Patients 12 Years of Age and Older with Severe Eosinophilic Asthma
Phase 3
IND number: 101,399;
BLA number: 761033;     EudraCT number: 2016-004661-23
Approval Date: 26 June 2017
Sponsor
Teva Branded Pharmaceutical 
Products R&D, Inc.
41 Moores Road
Frazer, Pennsylvania 19355
United States
Prepared by:
 


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
2
STATISTICAL ANALYSIS PLAN APPROVAL


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
3
TABLE OF CONTENTS
TITLE PAGE...................................................................................................................................1
STATISTICAL ANALYSIS PLAN APPROVAL..........................................................................2
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS..................................................7
INTRODUCTION ...........................................................................................................................9
1.
STUDY OBJECTIVES AND ENDPOINTS..............................................................10
1.1.
Primary and Secondary Study Objectives and Endpoints ..........................................10
1.2.
Exploratory/Other Objectives and Endpoints.............................................................11
2.
STUDY DESIGN .......................................................................................................12
2.1.
General Design ...........................................................................................................12
2.2.
Randomization and Blinding......................................................................................14
2.3.
Data Monitoring Committee.......................................................................................14
2.4.
Sample Size and Power Considerations .....................................................................14
2.5.
Sequence of Planned Analyses ...................................................................................14
2.5.1.
Planned Interim Analyses...........................................................................................14
2.5.2.
Final Analyses and Reporting.....................................................................................15
3.
ANALYSIS SETS ......................................................................................................16
3.1.
Enrolled Analysis Set .................................................................................................16
3.2.
Safety Analysis Set.....................................................................................................16
3.3.
Subgroup Analysis Sets ..............................................................................................16
4.
GENERAL ISSUES FOR DATA ANALYSIS..........................................................17
4.1.
General........................................................................................................................17
4.2.
Specification of Baseline Values................................................................................17
4.2.1.
Diary ...........................................................................................................................17
4.2.2.
Spirometry ..................................................................................................................17
4.2.3.
Patient Reported Outcomes ........................................................................................17
4.2.4.
Oral Corticosteroid Dose ............................................................................................18
4.2.5.
Biomarkers..................................................................................................................18
4.2.6.
Safety..........................................................................................................................18
4.2.7.
ADA............................................................................................................................18
4.3.
Handling Withdrawals and Missing Data...................................................................18
4.4.
Study Days and Visits.................................................................................................18


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
4
5.
STUDY POPULATION.............................................................................................20
5.1.
General........................................................................................................................20
5.2.
Patient Disposition......................................................................................................20
5.3.
Demographics and Baseline Characteristics...............................................................20
5.4.
Medical History ..........................................................................................................20
5.5.
Prior Therapy and Medication....................................................................................21
5.6.
Electrocardiography....................................................................................................21
5.7.
Physical Examinations................................................................................................21
5.8.
Childbearing Potential and Methods of Contraception ..............................................21
5.9.
Study Protocol Violation ............................................................................................21
6.
EFFICACY ANALYSIS ............................................................................................22
6.1.
General........................................................................................................................22
6.2.
Primary Efficacy Endpoint and Analysis ...................................................................22
6.3.
Secondary Efficacy Endpoints and Analysis..............................................................22
6.3.1.
Clinical Asthma Exacerbations and Related Healthcare Utilization..........................22
6.3.1.1.
Definition....................................................................................................................22
6.3.1.2.
Analysis ......................................................................................................................23
6.3.2.
Spirometry ..................................................................................................................23
6.3.2.1.
Definition....................................................................................................................23
6.3.2.2.
Analysis ......................................................................................................................23
6.3.3.
Daily oral corticosteroids dose ...................................................................................24
6.3.3.1.
Definition....................................................................................................................24
6.3.3.2.
Analysis ......................................................................................................................25
6.3.4.
Total reliever bronchodilator medication ...................................................................25
6.3.4.1.
Definition....................................................................................................................25
6.3.4.2.
Analysis ......................................................................................................................25
6.3.5.
Asthma Control Questionnaire ...................................................................................25
6.3.5.1.
Definition....................................................................................................................25
6.3.5.2.
Analysis ......................................................................................................................26
6.3.6.
Asthma Quality of Life Questionnaire for Patients 12 Years and Older....................26
6.3.6.1.
Definition....................................................................................................................26
6.3.6.2.
Analysis ......................................................................................................................26


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
5
7.
MULTIPLE COMPARISONS AND MULTIPLICITY ............................................28
8.
SAFETY ANALYSIS ................................................................................................29
8.1.
General........................................................................................................................29
8.2.
Study Drug Administration.........................................................................................29
8.3.
Adverse Events ...........................................................................................................29
8.3.1.
Adverse Events of Special Interest.............................................................................30
8.3.1.1.
Administration Site Reactions....................................................................................30
8.3.1.2.
Anaphylaxis and Hypersensitivity..............................................................................30
8.3.1.3.
Malignancies...............................................................................................................30
8.3.1.4.
Helminth infections ....................................................................................................30
8.3.1.5.
Muscle Disorders........................................................................................................31
8.3.1.6.
Opportunistic Infections .............................................................................................31
8.4.
Deaths .........................................................................................................................35
8.5.
Clinical Laboratory Tests ...........................................................................................35
8.6.
Physical Examinations................................................................................................38
8.7.
Vital Signs ..................................................................................................................38
8.8.
Electrocardiography....................................................................................................39
8.9.
Concomitant Medications or Therapies......................................................................39
9.
TOLERABILITY VARIABLES AND ANALYSIS..................................................40
10.
PHARMACODYNAMIC ANALYSIS......................................................................41
10.1.
Biomarkers Analysis...................................................................................................41
11.
IMMUNOGENICITY ANALYSIS............................................................................42
12.
PLANNED INTERIM ANALYSIS ...........................................................................43
13.
STATISTICAL SOFTWARE ....................................................................................44
14.
CHANGES TO ANALYSES SPECIFIED IN THE STUDY PROTOCOL..............45
15.
REFERENCES ...........................................................................................................46
16.
APPENDIX.................................................................................................................47


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
6
LIST OF TABLES
Table 1: Definition of Analysis Days for Diary Data....................................................................19
Table 2: Definition of Observed Days for OCS Dose ...................................................................24
Table 3: Conversion of ICS to Fluticasone-Equivalent Doses ......................................................24
Table 4: List of Terms for Opportunistic Infections......................................................................31
Table 5: Criteria for Potentially Clinically Significant Laboratory Values...................................37
Table 6: Criteria for Potentially Clinically Significant Vital Signs...............................................38
Table 7: Changes to the Protocol Specified Analyses ...................................................................45


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
7
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
Abbreviation
Term
ACQ-6
Asthma Control Questionnaire
ADA
Anti-drug Antibody
AE
Adverse Event
ALT
Alanine Aminotransferase
AM
Morning
AQLQ12+
Asthma Quality of Life Questionnaire
AST
Aspartate Aminotransferase
BLA
Biologics License Application
BP
Blood Pressure
CAE
Clinical Asthma Exacerbation
CBC
Complete Blood Count
CPK
Creatine Phosphokinase
CRF
Case Report Form
CSR
Clinical Study Report
DOR
Day of randomization
ECG
Electrocardiogram
EOT
End of Treatment
FDA
Food and Drug Administration
FEV1
Forced Expiratory Volume in 1 Second
HCU
Healthcare Utilization
HEENT
Head, Eyes, Ears, Nose, and Throat
HLGT
High Level Group Term
HLT
High Level Term
ICU
Intensive Care Unit
IMP
investigational medicinal product
IEC
Independent Ethics Committee
IRB
Institutional Review Board
LLT
Low Level Term
MedDRA
Medical Dictionary for Regulatory Activities
NAb
Neutralizing Antibody 
NHANES
National Health and Nutrition Examination Survey
OCS
Oral Corticosteroid


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
8
OL
Open Label
PCS
Potentially Clinically Significant
PD
Pharmacodynamics
PEF
Peak Expiratory Flow
PK
Pharmacokinetics
PM
Evening
PP
Per-Protocol
PT
Preferred Term
SABA
Short-Acting Beta-Agonist
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SAS®
Statistical Analysis Software
sBLA
Supplemental Biologics License Application
sc
Subcutaneous
SCS
Summary of Clinical Safety
SD
Standard Deviation 
SE
Standard Error
SMQ
Standardized MedDRA Query
SOC
System Organ Class
TB
Tuberculosis
ULN
Upper Limit of Normal
US
United States
WHO
World Health Organization


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
9
INTRODUCTION
This Statistical Analysis Plan (SAP) describes the planned analysis and reporting for Teva 
Branded Pharmaceutical Products R&D, Inc. study C38072-AS-30066,  An Open-Label (OL) 
Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age 
and Older with Severe Eosinophilic Asthma, and was written in accordance with SOP
GBP_RD_702 (Statistical Analysis Plan).
The reader of this SAP is encouraged to read the study protocol for details on the conduct of this 
study, the operational aspects of clinical assessments, and the timing for completing the 
participation of a patient in this study. 
The SAP is intended to be in agreement with the protocol, especially with regards to the primary 
and all secondary endpoints and their respective analyses. However, the SAP may contain more 
details regarding these particular points of interest, or other types of analyses (e.g. other 
endpoints). When differences exist in descriptions or explanations provided in the study protocol 
and this Statistical Analysis Plan, the Statistical Analysis Plan prevails; the differences will be 
explained in the Clinical Study Report (CSR).


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
10
1.
STUDY OBJECTIVES AND ENDPOINTS
1.1.
Primary and Secondary Study Objectives and Endpoints
The primary objective of this study is to support the long-term safety of reslizumab 110 mg 
administered subcutaneous (sc) once every 4 weeks in patients 12 years of age and older with 
severe eosinophilic asthma that is inadequately controlled on standard-of-care treatment. 
The primary endpoint is frequency of all adverse events including serious adverse events. 
The secondary safety endpoints for this study include the following:

clinical laboratory test results hematology and chemistry results at baseline and at 
weeks 4 (chemistry only), 8, 24, and 36 or early withdrawal visit

local tolerability at the injection site at approximately 1 hour after study drug 
administration every 4 weeks throughout the study

vital signs measurements every 4 weeks throughout the study

concomitant medication usage every 4 weeks throughout the study
The secondary objective of this study is to evaluate the efficacy of reslizumab 110 mg 
administered sc once every 4 weeks in patients 12 years of age and older with severe 
eosinophilic asthma that is inadequately controlled on standard-of-care treatment.
The secondary efficacy endpoints for this study include the following:

clinical asthma exacerbation (CAE) and healthcare utilization (HCU)-related 
endpoints

frequency of CAEs

frequency of asthma-specific hospital admissions

length of hospital stay and number of Intensive Care Unit (ICU) days

frequency of asthma-specific emergency department visits

frequency of school/work days missed due to asthma

change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second 
(FEV1 ) measured using spirometry at weeks 0, 8, 24, and 36 or early withdrawal visit

change in daily morning ambulatory FEV1 from baseline at each week through week 
36 or early withdrawal, as measured by the handheld spirometry device.

absolute and percent reduction in the daily Oral Corticosteroid (OCS) dose at weeks 
20 and 36 or early withdrawal visit as compared with the dose at baseline (for patients 
on daily OCS at baseline).

change from baseline in total inhalations of reliever bronchodilator medication (eg, 
short-acting beta agonist) measured using weekly averages until week 36 or early 
withdrawal visit.


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
11

change from baseline in Asthma Control Questionnaire (ACQ-6) score performed at 
weeks 0, 8, 24, and 36 or early withdrawal visit

change from baseline in Asthma Quality of Life Questionnaire (AQLQ12+) score 
performed at weeks 0, 8, 24, and 36 or early withdrawal visit
The immunogenicity assessments for this study include the following:

anti-drug antibody (ADA) measurement at baseline and at weeks 8, 24, and 36 or 
early withdrawal visit to evaluate the long-term immunogenicity of sc reslizumab

ADA measurement at the end of study (EOS) visit (19 weeks after the final dose) to 
evaluate immunogenicity after study drug washout
1.2.
Exploratory/Other Objectives and Endpoints
No tertiary or other exploratory endpoints.


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
12
2.
STUDY DESIGN
2.1.
General Design
This is a global, multicenter, OL extension study to obtain additional long-term safety data of
reslizumab treatment administered sc at a fixed dose of 110 mg in patients 12 years of age and 
older with severe eosinophilic asthma.
The study consists of a screening/baseline visit (V1; seamless rollover patients; conducted on the
same day as the end-of-treatment [EOT, week 52 or week 24, respectively] visit for patients who
finished either Study 30025 or 30027) or a standalone screening visit (V0) for patients who did 
not seamlessly rollover from Study 30025 or 30027 (had a gap between placebo-controlled study 
EOT and start of OLE), followed by an OL treatment period, an EOT visit (VEOT), a follow-up 
telephone call (VFU) at 12 weeks after the EOT visit, and an EOS visit (VEOS) for 
immunogenicity testing 19 weeks after the final dose of study drug administration. The duration 
of the OL treatment period will be 9 months (36 weeks).
Study patients will be deemed eligible only if they meet all inclusion criteria and no exclusion
criteria are fulfilled. Patients currently enrolled in Studies 30025 and 30027 will be required to
complete their respective double-blind treatment periods to be eligible for this study. In addition, 
adolescents (patients 12 through <18 years of age) from Study 30025 must also complete the 12-
week early follow-up visit (off study drug) before transferring to this study.
There may be a gap in study drug administration for some patients due to completion of Study 
30025 or 30027 before the initiation of the OL extension study (non-seamless rollover). Patients 
with a gap between the EOT visit for Study 30025 or 30027 will complete a V0 screening visit. 
Adolescents (a patient 12 through <18 years of age) from Study 30025 can complete the V0 
screening visit of Study 30066 the same day as the 12-week early follow-up visit for Study 
30025. Any blood tests completed by adolescents at the 12-week early follow-up visit for Study 
30025 can be used for the V0 screening visit of Study 30066 and do not need to be repeated. Any 
patient who did not rollover seamlessly from Study 30025 or 30027 will participate in a 7-day 
run-in period where baseline measures for asthma control and spirometry will be established. 
This screening assessment and run-in period will be completed within the 2 weeks prior to visit 
1.
During screening/baseline, informed consent (and assent for patients under 18 years of age 
according to local Institutional Review Board/Independent Ethics Committee [IRB/IEC] 
requirements) will be obtained. This will be conducted at the EOT visit of Study 30025 or 30027 
(seamless rollover patients) or at the standalone screening visit (V0) for non-seamless rollover 
patients with a gap in study drug administration (those who have previously completed Study 
30025 or 30027, but are not screened on the same day as the EOT visit.
During the treatment period, patients will receive reslizumab by sc injection at a dosage of 110 
mg every 4 weeks (28 days ±7 days) for 32 weeks in the study center. Patients will return to the 
study center every 4 weeks relative to baseline during OL treatment.
After study drug administration, each patient will remain at the study center for a minimum of 1 
hour for observation. If during post-study drug observation the patient develops clinical


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
13
symptoms, vital signs should be collected and the patient should be assessed for
anaphylaxis/hypersensitivity reactions.
After each administration, the patient will be required to use a study-provided handheld 
electronic diary (eDiary)/spirometry device that will ask questions post-injection to evaluate for 
any new symptoms that may have developed during the 24-hour period after investigational 
medicinal product (IMP) administration. The patient will complete a question regarding new 
symptoms on the eDiary device the evening after the IMP administration and the following 
morning. This is in addition to the peak expiratory flow (PEF; AM and PM), FEV1 measurements 
(AM only), and recording of rescue inhaler use that are performed every day during the treatment 
period.
A full physical examination will be completed at screening and at EOT. Other safety evaluations 
will be performed at every visit when the study drug is administered: adverse event inquiry, vital 
signs measurement, assessment of injection site, concomitant medication use, and urine 
pregnancy test. Additional evaluations, including clinical chemistry, hematology, and ADA 
measurements, will be performed throughout the study according to the schedule of procedures 
and assessments (Table 1 of the protocol). Patients will also be monitored for asthma 
exacerbations throughout the study.
Asthma control measures will be assessed as part of this study to evaluate the long-term effect of 
sc reslizumab. These will include CAE assessment (including healthcare utilization [HCU]), pre-
bronchodilator spirometry, questionnaires (including ACQ-6 and AQLQ12+), and change in 
OCS dose for those on maintenance therapy. Asthma control including asthma exacerbations and 
related HCU will be assessed at every study visit during the treatment period. Spirometry will be 
performed daily through the use of a handheld spirometry device. Concomitant medications will 
be recorded at all visits during the treatment period and will include OCS dose if participants are 
on maintenance corticosteroids. For those patients previously enrolled in Study 30027, 
maintenance prednisone will no longer be provided by the sponsor. In an effort to standardize a 
patient’s maintenance therapy, it is encouraged that the investigators prescribe 
prednisone/prednisolone as the maintenance corticosteroid preparation if deemed necessary.
Patients will have final procedures and assessments performed at the EOT visit. Patients who
withdraw before the completion of the study will have EOT procedures and assessments 
performed at their early withdrawal visit. All patients will have a follow-up telephone assessment 
12 weeks after the EOT visit. The EOT visit includes home pregnancy testing, adverse event 
assessment, and concomitant medication inquiry. There will then be an EOS visit for 
immunogenicity testing 19 weeks after the final dose of study drug.
Measurement of ADAs will be performed on samples collected at baseline and at weeks 8, 24, 
and 36 or early withdrawal visit to evaluate the potential long-term immunogenicity of sc 
reslizumab, and on samples collected at the EOS visit (19 weeks after the final dose) to evaluate 
immunogenicity after study drug washout. A blood sample will also be collected in the event of 
withdrawal from the study or upon observation of any severe hypersensitivity reaction (eg, 
anaphylaxis). An unscheduled sample can also be drawn after a serious adverse event if the 
investigator or sponsor considers appropriate. Drug levels may be measured in the serum 
samples collected for ADAs to help inform ADA analysis. If a patient is found to have a positive 
ADA status after at least 2 doses of study drug in this study, the patient may be scheduled to 


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complete an EOT visit. This testing may be done to enhance early data collection on potential 
washout samples. 
An unscheduled visit may be performed at any time during the study at the patient’s request or as
deemed necessary by the investigator. The date and reason for the unscheduled visit as well as 
any other data obtained (eg, adverse events, concomitant medications and treatments, and results 
from procedures or tests) will be recorded on the case report form (CRF) and noted within the 
patient’s source notes.
Study procedures and assessments with their time points are shown in Table 1 of the protocol
(with non-substantial changes documented in any letters of clarification to the protocol).
2.2.
Randomization and Blinding
This is a non-randomized OL extension study that includes patients who previously completed a 
Teva-sponsored double-blind, placebo-controlled study (Studies 30025 or 30027) of sc 
administration of reslizumab in severe eosinophilic asthma. So, no randomization or blinding 
will be performed.
2.3.
Data Monitoring Committee
There will be no Data Monitoring Committee in this study.
2.4.
Sample Size and Power Considerations
The sample size for this study is not based on power considerations. The sample size is 
determined by the number of patients anticipated to rollover from the 2 double-blind, placebo-
controlled, Phase 3 studies of reslizumab sc (Studies 30025 and 30027).
Approximately 360 patients will be enrolled in this study. The objective of this study is primarily 
safety oriented; therefore, no formal hypothesis testing is planned. Patients completing at least 
the full treatment periods of Studies 30025 and 30027 (or through at least the early follow-up 
visit for adolescents from Study 30025) and meeting the protocol’s inclusion criteria and none of 
the exclusion criteria are eligible for enrollment in this study. It is estimated that the majority of 
patients enrolled in eligible reslizumab safety and efficacy studies will rollover to this study.
2.5.
Sequence of Planned Analyses
2.5.1.
Planned Interim Analyses
There will be a planned data cut will be produced before the supplemental Biologics License 
Application (sBLA) submission. For the purpose of this analysis, a data cut-off will be 
established in accordance with the targeted date of submission and an interim CSR will be 
prepared. All outputs identified in this SAP and planned for the final analysis (Section 2.5.2) will 
be prepared at this time. The interim CSR to support sBLA submission will be based on all data 
accumulated from the study start to December 2017.
An additional planned data cut will be produced before the Day 120 safety update report,
following the sBLA submission. For the purpose of this analysis, a data cut-off will be 
established in accordance with the targeted date of submission and safety data from this study


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will be integrated with safety data from the other studies within the Day 120 report (in this case, 
there will be no separate interim CSR). The summaries provided at the time of this data cut will 
be consistent with those planned for the Summary of Clinical Safety (SCS) in the sBLA.
At the time of each planned interim analysis, no individual patient’s data are considered fully 
locked; therefore interim results are interpreted as preliminary.
2.5.2.
Final Analyses and Reporting
All final, planned analyses identified in this SAP will be performed after the last patient has 
completed the study and the database has been locked. The final study report will include all 
study population, efficacy, safety, and immunogenicity data as specified in the protocol and this 
analysis plan.   


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3.
ANALYSIS SETS
3.1.
Enrolled Analysis Set
The enrolled analysis set will include all enrolled patients, regardless of whether or not a patient 
took any dose of reslizumab. A patient is considered enrolled if informed consent form is 
obtained. The set of enrolled patients will be used for study population summaries.
3.2.
Safety Analysis Set
The safety analysis set will include all patients who received at least 1 dose of reslizumab in this 
study. The primary analysis population for both safety and efficacy summaries will be the safety 
analysis set.
3.3.
Subgroup Analysis Sets
Selected efficacy and safety endpoints including clinical asthma exacerbations, FEV1, 
and 
adverse events will be summarized separately for seamless and non-seamless rollover patients.


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4.
GENERAL ISSUES FOR DATA ANALYSIS
4.1.
General
Descriptive statistics for continuous variables include number of patients (n), mean, standard 
deviation (SD), standard error (SE), median, minimum, and maximum. Descriptive statistics for 
categorical variables include patient counts and percentages, missing categories will be presented 
if necessary.
4.2.
Specification of Baseline Values
Baseline will be defined as the last observed value prior to the first dose of reslizumab in this 
study unless otherwise stated below. 
4.2.1.
Diary
Baseline for diary-based efficacy variables (total reliever bronchodilator medication, 
) will 
be defined as the average of the values over the 7 days preceding the first dose of reslizumab in 
this study. At least 4 out of the 7 expected measurements need to be recorded for each diary 
variable; otherwise the baseline value for that variable will be treated as missing. This definition 
will exclude daily morning ambulatory FEV1 whose baseline value will be derived as outlined in 
Section 4.2.2.
For non-seamless rollovers, baseline will be derived from data collected in this study during 7-
day run-in period prior to Visit 1. For seamless rollovers, baseline will be derived from data 
collected during the 7 days preceding the EOT visit of the previous study (30025 or 30027).
4.2.2.
Spirometry
Pre-bronchodilator FEV1 at pre-specified clinic visits and daily morning ambulatory FEV1 will 
be measured using a handheld device that has combined spirometry and eDiary capabilities.
The baseline value for pre-bronchodilator FEV1 measured at the clinic visits will be the last 
observed value prior to the first dose of reslizumab in this study. The baseline value for daily 
morning ambulatory FEV1 will be defined similarly.
For non-seamless rollovers, baseline will be derived from data collected in this study on or prior 
to Visit 1. For seamless rollovers, baseline will be derived from data collected at the EOT visit of 
the previous study (30025 or 30027).
4.2.3.
Patient Reported Outcomes
The baseline value for patient reported variables (ACQ-6, AQLQ +12) will be the last observed 
value prior to the first dose of reslizumab in this study.
For non-seamless rollovers, baseline will be derived from data collected in this study on or prior 
to Visit 1. For seamless rollovers, baseline will be derived from data collected on the same day 
as the EOT visit of the previous study (30025 or 30027).


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4.2.4.
Oral Corticosteroid Dose
The baseline value will be defined as the OCS dose reported on the day of first dose of 
reslizumab in this study. 
4.2.5.
Biomarkers 
The baseline value for blood eosinophil levels will be the last observed value prior to the first 
dose of reslizumab in this study.
For non-seamless rollovers, baseline will be derived from data collected in this study on or prior 
to Visit 1. For seamless rollovers, baseline will be derived from data collected on the same day 
as the EOT visit of the previous study (30025 or 30027).
4.2.6.
Safety
The baseline value for all visit-based safety assessments (eg, laboratory, vital signs, physical 
examination, ECG) will be the last observed value prior to the first dose of reslizumab in this 
study.
For non-seamless rollovers, baseline will be derived from data collected in this study on or prior 
to Visit 1. For seamless rollovers, baseline will be derived from data collected on the same day 
as the EOT visit of the previous study (30025 or 30027).
4.2.7.
ADA
The baseline value for all ADA status will be the last observed value prior to the first dose of 
reslizumab in the previous double-blind study (30025 or 30027).
For both seamless and non-seamless rollovers, baseline will be derived from data collected on 
the same day as the day of randomization (DOR) visit of the previous study (30025 or 30027).
4.3.
Handling Withdrawals and Missing Data
In general, missing data will not be imputed, unless otherwise specified.
4.4.
Study Days and Visits
Study days will be numbered relative to the first day of study drug administration. The start of 
treatment (day 1) is defined as the date on which a patient takes the first dose of study drug in 
this study. Days will be numbered relative to study start (ie, ..., –2, –1, 1, 2, ...) with day 1 being 
the start of study drug and day –1 being the day before the start of study drug).
For safety-by-visit summaries, if there are multiple assessments at a post-baseline visit then the 
last non-missing assessment at that visit will be used for the summary. This includes assessments 
at the scheduled and unscheduled visits.
For efficacy by-visit summaries, only the assessments at the scheduled visit will be summarized.  
The assessments at unscheduled visits will only be listed. For the purpose of the efficacy 
analysis, assessments collected at an early termination visit will be considered as the next 
scheduled visit for that assessment if at least 3, but no more than 5 weeks, elapsed since the date 
of the last dose of study drug.


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“Endpoint” for safety and efficacy analyses summaries is the time point when the last 
observation was obtained during the treatment period. For patients who completed treatment in 
this study, the treatment period will be defined from the first dose of study drug to the end of 
treatment (week 36) visit. For patients who prematurely discontinue treatment, the treatment 
period will be defined from the first dose of study drug to the last dose of study drug + 4 weeks.
For summaries of diary data and handheld spirometry data, the day used for analysis will consist 
of the evening assessment for the day and the morning assessment for the following day, as 
illustrated in Table 1. Weekly average data will be generated using 7-day window intervals 
derived based on these analysis days.
Table 1: Definition of Analysis Days for Diary Data
Study Period
Diary Day
Study Day
a
Time Point
Baseline
Day -7
-7
PM
-6
AM
Day -6
-6
PM
-5
AM
Day -5 
-5
PM
-4
AM
Day -4
-4
PM
-3
AM
Day -3
-3
PM
-2
AM
Day -2
-2
PM
-1
AM
Day -1
-1
PM
1 (pre-dose)
AM
Treatment
Day 1
1
PM
2
AM
Day 2
2
PM
3
AM
…
..
PM
..
AM
Day 251
251
PM
252
AM
a: Study Day 1 denotes the first dose of study drug; Study Day -1 is the day prior to the first dose of study drug.


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5.
STUDY POPULATION
5.1.
General
The enrolled analysis set (Section 3.1) will be used for all study population summaries, unless 
otherwise specified. Summaries will be presented by double-blind treatment group in the 
previous studies 30025 or 30027 (placebo and reslizumab) and for all patients (ie, total), unless 
otherwise noted. 
For continuous variables, descriptive statistics (number of patients [n], mean, standard deviation 
[SD], standard error [SE], median, minimum, and maximum) will be provided. For categorical 
variables, patient counts and percentages will be provided. Categories for missing data will be 
presented if necessary.
5.2.
Patient Disposition
Data from patients enrolled, patients enrolled but not treated, patients in the safety analysis set,
patients who completed the treatment, patients who completed the study, patients who 
discontinued from treatment, and patients who withdrew from the study will be summarized 
using descriptive statistics. Data from patients who discontinue from the treatment and patients 
who withdrew from the study will also be summarized by reason for withdrawal. The previous 
study from which patients enrolled (30025 or 30027) will also be summarized, along with 
whether the patient was a seamless rollover or non-seamless rollover. This summary will include 
all patients enrolled into this study. The denominator for calculating the percentages will be the 
number of enrolled patients as appropriate.
5.3.
Demographics and Baseline Characteristics
Baseline demographics and baseline characteristics, including spirometry and OCS dose, will be 
summarized using descriptive statistics by previous double-blind treatment group and for all 
patients. 
Age will be calculated based on the date of birth relative to the screening visit (date of informed 
consent in this study). If regional data regulations prohibit collection of a full date of birth, then 
the patient’s age should be recorded on the CRF, if possible. If only a year of birth has been 
collected (and age has not otherwise been reported) then the missing date of birth will be 
imputed as 30 June (30 June YYYY) in order to derive the patient’s age at baseline.
5.4.
Medical History
All medical history abnormalities will be coded using the Medical Dictionary for Regulatory 
Activities (MedDRA); the final version number will be indicated in the summary tables. The 
incidence of medical history abnormalities will be summarized by system organ class (SOC) and 
preferred term (PT). Patients are only counted once in each SOC and once in each PT.
Summaries will be presented by previous double-blind treatment group and for all patients.


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5.5.
Prior Therapy and Medication
Any therapy, medication (including corticosteroids), or procedure a patient has had at screening 
up to the end of the study period, including follow-up, will be recorded on the appropriate CRF. 
Generic or trade name, indication, and dosage will be recorded. The sponsor will encode all 
therapy and medication according to the World Health Organization (WHO) drug dictionary; the 
final version number will be indicated in the summary tables. 
The incidence of prior therapies and medications will be summarized by therapeutic class using 
descriptive statistics by previous double-blind treatment group and for all patients. Patients are 
counted only once in each therapeutic class, and only once in each preferred term. Prior therapies 
and medications will include all medications taken and therapies administered before the first 
day of reslizumab administration in this study.
5.6.
Electrocardiography
Electrocardiogram (ECG) findings (normal, abnormal, and missing) at baseline will be 
summarized using descriptive statistics by previous double-blind treatment group and for all 
patients.
5.7.
Physical Examinations
Patients with at least 1 abnormal finding (overall) and abnormal findings for each category will 
be summarized at baseline by previous double-blind treatment group and for all patients.
5.8.
Childbearing Potential and Methods of Contraception
For female patients, information related to childbearing potential, contraception, and menopause 
will be collected at screening. Information will be provided in the patient data listings.
5.9.
Study Protocol Violation
Patients with at least 1 protocol violation for each category will be summarized by previous
double-blind treatment group and for all patients.


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6.
EFFICACY ANALYSIS
6.1.
General
The safety analysis set (Section 3.2) will be used for all efficacy analyses unless otherwise noted. 
Summaries will be presented by double-blind treatment group in the previous studies 30025 and 
30027 (placebo and reslizumab) and for all patients (ie, total), unless otherwise noted. 
For continuous variables, descriptive statistics (n, mean, SD, SE, median, minimum, and 
maximum) will be provided. For categorical variables, patient counts and percentages will be 
provided. Categories for missing data will be presented if necessary.
6.2.
Primary Efficacy Endpoint and Analysis
There are no pre-specified primary efficacy variables and analyses in this study.
6.3.
Secondary Efficacy Endpoints and Analysis
6.3.1.
Clinical Asthma Exacerbations and Related Healthcare Utilization
6.3.1.1.
Definition
A CAE is defined as a clinically judged deterioration in asthma control, as determined by the 
investigator and evidenced by new or worsening asthma signs or symptoms based on the patient 
history, handheld eDiary/spirometry data, physical examination, and/or ambulatory or clinic visit 
assessment of lung function, and that results in a medical intervention, including at least one of 
the following:

use of systemic corticosteroids (oral or injection) or at least a doubling from a stable
maintenance oral corticosteroid dose for at least 3 days

asthma-specific hospital admission

asthma-specific emergency department visit
Additional medication and/or medical intervention that would satisfy the CAE definition 
occurring within 7 days of the last day of a prior CAE event will be considered as part of the 
same event for analysis purposes.
All asthma exacerbations (mild/moderate/severe) should be recorded on the asthma exacerbation 
CRF. The information on the CRF will be used to determine if an asthma exacerbation meets 
CAE criteria.
The CAE start and stop dates will be collected in order to determine the exacerbation duration. 
The start date of a CAE will be the start date of the initial medical intervention (eg, use of 
systemic corticosteroids [oral or injection] or at least a doubling from a stable maintenance oral 
corticosteroid dose for at least 3 days, asthma-specific hospital admission, or asthma-specific 
emergency department visit, whichever comes first). The stop date is the last day of systemic 
corticosteroids or the last day of an asthma-specific hospitalization or emergency department 
visit, whichever is later. For patients who are on a stable maintenance oral corticosteroid dose 


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and receive at least a doubling of that dose for 3 days, the stop date is when they return to their 
baseline dose. For patients receiving a new use of oral corticosteroid or at least a doubling from 
their stable maintenance oral corticosteroid dose for at least 3 days that did not return to baseline,
the CAE stop date will be the day when they have been on a stable dose for at least 10 days.
6.3.1.2.
Analysis
Summary statistics of frequency of CAEs and related HCU endpoints (asthma-specific hospital 
admissions, asthma-specific emergency department visits, school/work days missed due to 
asthma, and length of hospital stay and number of ICU days) will be provided by previous 
double-blind treatment group and for all patients. The summary will be presented for clinical 
asthma exacerbations recorded during the treatment period. For patients who complete treatment, 
the treatment period will be defined from the first dose of study drug to the end of treatment 
(week 36) visit. For patients who prematurely discontinue treatment, the treatment period will be 
defined from the first dose of study drug to the last dose of study drug + 4 weeks. All events will 
be included in the patient listings. The frequency of CAEs and related HCU endpoints will 
additionally be examined for the subgroups defined in Section 3.3.
6.3.2.
Spirometry
6.3.2.1.
Definition
Pre-bronchodilator (on designated clinic visit days per Table 1 of the protocol;
Screening/Baseline and week 8, 24, and 36 or early withdrawal visit) and daily morning 
ambulatory FEV1 will be measured using the handheld device that has combined spirometry and 
eDiary capabilities. The FEV1 is the volume of air that can be forcibly exhaled from the lungs in 
the first second, measured in liters. The National Health and Nutrition Survey (NHANES) III
reference equations will be used.
6.3.2.2.
Analysis
Summary statistics of actual values and changes from baseline to each scheduled visit in pre-
bronchodilator FEV1 measured using spirometry will be provided by previous double-blind 
treatment group and for all patients. A line graph presenting the mean change from baseline over 
time (at each visit) will be provided for prebronchodilator FEV1 by previous double-blind 
treatment group.
A weekly average of daily morning ambulatory FEV1 (measured by the handheld spirometry 
device) will be derived using 7-day window intervals based on these analysis days (see Table 1
for the definition of analysis days for diary data). The average will be calculated as the sum of all 
values divided by the number of non-missing assessments. There will be no imputation of 
missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in 
the analysis; otherwise the week will be treated as missing.
Summary statistics of actual values and changes from baseline in weekly average of daily 
morning ambulatory FEV1 (measured by the handheld spirometry device) at each week through 
week 36 will be provided by previous double-blind treatment group and for all patients. 
FEV1 will additionally be examined for the subgroups defined in Section 3.3.


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6.3.3.
Daily oral corticosteroids dose
6.3.3.1.
Definition
OCS dose information is collected in Concomitant Medication CRF page. Doses at Week 20 and 
36 will be derived based on the study drug administration visit schedule by comparing OCS 
medication dates with the start date and end date of each visit (Table 2). Daily OCS dose is 
defined as total OCS dose in a day (accounting for reported dose and dose frequency) and 
converting the total daily dose to a prednisone-equivalent dose (Table 3).
For patients on maintenance OCS treatment at baseline, the week 20 and 36 OCS dose and 
corresponding values for absolute and percent change  from baseline will be calculated as 
follows:

Baseline dose = the prescribed OCS dose on the day of first dose of study drug in this 
study (Table 2).

Dose at week 20 (or 36) = mean of all daily OCS doses during the period from week 
16 to week 20 (or from week 32 to week 36) (Table 2). 

Absolute change = maintenance dose – baseline dose

Percent change = 100 x (absolute change / baseline dose)
Table 2: Definition of Observed Days for OCS Dose
Visit period
Start day
Stop day
Baseline Dose
Day of first dose of study drug
N/A
Week 16 to Week 20
Day of W16 Visit + 1 day
Day of W20 Visit
Week 32 to Week 36 
Day of W28 Visit + 1 day
Day of W36 Visit
Table 3: Conversion of ICS to Fluticasone-Equivalent Doses
Inhaled corticosteroid (mcg)
Conversion factor
Fluticasone
1
Fluticasone furoate
2
Mometasone
1.14
Budesonide 
0.625
Ciclesonide
1.56
Beclomethasone
1.25
Triamcinolone
0.25


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6.3.3.2.
Analysis
Summary statistics of absolute and percent change in the daily OCS dose at weeks 20 and 36 as 
compared with the dose at baseline (for patients on daily OCS at baseline) will be provided by
previous double-blind treatment group and for all patients.
6.3.4.
Total reliever bronchodilator medication  
6.3.4.1.
Definition
Total reliever bronchodilator medication use (inhalations/puffs) will be assessed by reviewing 
the eDiary that will be maintained by the patient daily, once in the morning and once in the 
evening. Total reliever use will be derived as the sum of the morning and evening counts.
6.3.4.2.
Analysis
A weekly average of total reliever use will be derived (see Table 1 for the definition of analysis 
days for diary data). The average will be calculated as the sum of all values divided by the 
number of non-missing assessments. There will be no imputation of missing data. At least 4 of 
the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the 
week will be treated as missing.
Summary statistics of actual values and change from baseline in total inhalations of reliever 
bronchodilator medication measured using weekly averages to each week through week 36 will 
be provided by previous double-blind treatment group and for all patients.
6.3.5.
Asthma Control Questionnaire
6.3.5.1.
Definition
The ACQ-6 is a validated asthma assessment tool that has been widely used. There are 6 self-
assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 (higher 
scores are an indication of poorer asthma control), and the total score is the mean of all 
responses. At weeks 0, 8, 24, and 36 (or early withdrawal), the patient answers each of the 6 
questions, identifying the response that best describes how the patient has been during the past 
week.
6.3.5.1.1. Missing data handling and total score calculation
The overall score of the ACQ-6 is derived as the average of the individual item scores; the 
analysis will be based on the available data.
For incomplete data, the following rules will apply:
1. Total score for the visit will not be calculated if Question 1 is left blank, irrespective of 
the completion of the remaining questions.
2. A missing score on post screening questionnaire for Questions 2-6 will be imputed based 
on the total scores from the previous visit, as long as at least 3 out of the 5 questions have 
responses for the current visit (ie, at least half of the remaining questions are answered). 


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The formula is: (total sum of non-missing scores for the current visit / total sum of scores 
for the previous visit for questions answered for the current visit) * (score for the missing 
question on the previous visit)
3. Total score at screening will not be calculated if Question 1 or two or more among 
Questions 2-6 is left blank. A missing score for Questions 2-6 at screening will be 
replaced by an average of the available scores.
6.3.5.2.
Analysis
Summary statistics of actual values and changes from baseline to each scheduled visit in ACQ-6 
score will be provided by previous double-blind treatment group and for all patients. A line 
graph presenting the mean change from baseline over time (at each visit) will be provided for the 
overall score by previous double-blind treatment group.
6.3.6.
Asthma Quality of Life Questionnaire for Patients 12 Years and Older
6.3.6.1.
Definition
The AQLQ +12 is a modified version of the standardized AQLQ (AQLQ[S]), which was 
developed to measure functional impairments experienced by adults ≥17 years of age. The 
AQLQ +12 is valid for patients 12 to 70 years of age and includes 32 questions in 4 domains 
(symptoms, activity limitation, emotional function, and environmental stimuli). Patients will be 
asked to recall their experiences during the previous 2 weeks and score each of the questions on 
a 7-point scale, where 7=not at all limited and 1=totally limited
The 32 questions (items) in the AQLQ +12 are divided into 4 domains:

Activity limitations: Items 1-5, 11, 19, 25, 28, 31, 32

Symptoms: Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30

Emotional function: Items 7, 13, 15, 21, 27

Environmental stimuli: Items 9, 17, 23, 26
6.3.6.1.1. Missing data handling and total score calculation
The overall and domain scores of the AQLQ +12 are derived as the average of the corresponding 
items; the analysis will be based on the available data.
For incomplete data, the overall AQLQ +12 score for a particular visit will not be calculated if 3 
or more responses are missing with no more than 1 per domain. For the symptom and activity 
domain total scores, calculation will require no more than 1 missing item. Total scores for the 
other 2 domains will be regarded as missing if 1 or more item is missing.
6.3.6.2.
Analysis
Summary statistics of actual values and change from baseline to each scheduled visit in the 
overall and domain scores of AQLQ + 12 will be provided by previous double-blind treatment 
group and for all patients. A line graph presenting the mean change from baseline over time (at 
each visit) will be provided for the overall score by previous double-blind treatment group.


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7.
MULTIPLE COMPARISONS AND MULTIPLICITY
There are no pre-specified adjustments for multiplicity applied to this study.


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8.
SAFETY ANALYSIS
8.1.
General
The safety analysis set (Section 3.2) will be used for all safety analyses unless otherwise noted. 
Summaries will be presented by double-blind treatment group in the previous studies 30025 and 
30027 (placebo and reslizumab) and for all patients (ie, total), unless otherwise noted. 
For continuous variables, descriptive statistics (n, mean, SD, SE, median, minimum, and 
maximum) will be provided. For categorical variables, patient counts and percentages will be 
provided. Categories for missing data will be presented if necessary.
8.2.
Study Drug Administration
The exposure to study drug will be characterized by duration of treatment and by the number of 
patients receiving at least 1, 2, 3, etc. injections. Total patient years will also be summarized. The 
summaries will be provided by previous double-blind treatment group and for all patients.
Duration of treatment period is defined separately for patients who completed/discontinued 
treatment.

Completed:
End of treatment (week 36) visit date – first dose date + 1 

Discontinued:
Last dose date – first dose date + 29
For non-seamless rollovers, the length of the “gap” between the end of study drug administration 
from the previous double-blind study to the start of study drug administration in this study will 
also be summarized.
8.3.
Adverse Events
Adverse events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA); the final version number will be indicated in the summary tables. 
On-treatment adverse event summaries will be presented by previous double-blind treatment 
group and for all patients, based on events with onset during the treatment period. If the AE start 
date is missing or partial, the event will be considered on-treatment unless there is evidence to 
the contrary (eg, month and year of AE start is present and is less than the month and year of the 
first dose of study drug). Post-treatment adverse events with onset during the follow-up period 
(ie, AE start date greater than the upper bound of the treatment period, as described in 
Section 4.4 previously) will be summarized separately.
Summaries will be presented by SOC and/or PT for all adverse events (overall and by severity), 
adverse events determined by the investigator to be related to study treatment (overall and by 
severity), serious adverse events, adverse events causing discontinuation from study treatment, 
and non-serious adverse events. Treatment related adverse event summaries will include events 
with missing relationship to study drug. For summaries by severity, patients will be counted at 
the greatest reported severity. Adverse events missing the flag indicating a serious adverse event 
will be excluded from the summary of serious adverse events, but included in the summary of 
non-serious adverse events.


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In addition, adverse events that begin within 24 hours after study drug injection and injection-site 
adverse events (as recorded on the CRF) will each be summarized separately.
A summary for the most common adverse events (incidence ≥2% for all patients) will also be 
presented. Adverse events will additionally be presented for subgroups defined in Section 3.3.
All adverse events, including events with onset prior to the first dose of reslizumab in this study, 
will be included in the patient listings. The mapping of MedDRA dictionary terms for adverse 
event descriptions will also be provided.
8.3.1.
Adverse Events of Special Interest
8.3.1.1.
Administration Site Reactions
Administration site reactions will be defined based on:

MedDRA High Level Group Term (HLGT): Administration Site Reactions
Summaries will be presented by high level term (HLT), preferred term, and previous double-
blind treatment group. Patients will further be assessed on a 4-point Likert scale (none, mild, 
moderate, severe) for several domains of localized injection site tolerability including pain, 
tenderness, erythema, warmth, and swelling. The number and percentage of patients reported for 
each of the levels will be summarized descriptively for each domain by visit.
8.3.1.2.
Anaphylaxis and Hypersensitivity
Anaphylaxis and hypersensitivity events will be defined based on: 

MedDRA SMQ: Anaphylactic Reaction

MedDRA SMQ: Hypersensitivity
Summaries will be presented separately for both the broad (broad+narrow) and narrow preferred 
terms by previous double-blind treatment group.
Adverse events suspected by the investigator to be anaphylaxis events will be summarized by 
preferred term and double-blind treatment group. Supplemental information related to the 
relative timing, clinical manifestation, and treatment of these suspected events will be collected 
in a dedicated CRF and reported in the patient listings.
8.3.1.3.
Malignancies 
Malignancies will be defined based on:

MedDRA SMQ: Malignant Tumors
Summaries will be presented by preferred term and previous double-blind treatment group.
8.3.1.4.
Helminth infections
Helminth infections will be defined based on: 

MedDRA HLGT: Helminthic Disorders


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Summaries will be presented by HLT, preferred term, and previous double-blind treatment 
group.
8.3.1.5.
Muscle Disorders
Muscle disorders will be defined based on:

MedDRA HLGT: Muscle Disorder

MedDRA PT: Blood Creatine Phosphokinase Increased
Summaries will be presented by HLT, preferred term, and previous double-blind treatment 
group.
8.3.1.6.
Opportunistic Infections
Opportunistic infections will be defined based on the following list of terms, derived from the 
preferred term (PT) or low level term (LLT) summarized in Table 4. Food and Drug 
Administration (FDA) terms provided are from the Panel on Opportunistic Infections in HIV-
Infected Adults and Adolescents.
Summaries will be presented by preferred term and previous double-blind treatment group.
Table 4: List of Terms for Opportunistic Infections
Term
Code
Level
List from Panel on 
Opportunistic Infections in 
HIV-Infected Adults and 
Adolescents
If LLT- under which PT 
Acinetobacter infection
10051894
PT
Acinetobacter infection
Acinetobacter bacteraemia
10064965
PT
Acinetobacter infection
Aspergillus infections
10003486
HLT
Aspergillosis
Blastomycosis
10005098
PT
Blastomycosis, extrapulmonary
Epididymitis blastomyces
10015001
PT
Blastomycosis, extrapulmonary
Osteomyelitis blastomyces
10031255
PT
Blastomycosis, extrapulmonary
Burkitt's lymphomas
10006596
HLT
Burkitt's lymphoma
Oesophageal candidiasis
10030154
PT
Candidiasis of esophagus
Cerebral toxoplasmosis
10057854
PT
Toxoplasmosis of brain
Meningitis toxoplasmal
10048848
PT
Toxoplasmosis of brain
Cervix carcinoma
10008342
PT
Cervical cancer invasive
Cervix carcinoma stage II
10008346
PT
Cervical cancer invasive
Cervix carcinoma stage III
10008347
PT
Cervical cancer invasive


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Term
Code
Level
List from Panel on 
Opportunistic Infections in 
HIV-Infected Adults and 
Adolescents
If LLT- under which PT 
Cervix carcinoma stage IV
10008348
PT
Cervical cancer invasive
Coccidioides infections
10009824
HLT
Coccidioidomycosis, 
dissemintaed or extrapulmonary
Cryptococcosis
10011490
PT
Cryptococcosis, extrapulmonary
Cryptococcal fungaemia
10067112
PT
Cryptococcosis, extrapulmonary
Cryptococcal cutaneous infection
10054216
PT
Cryptococcosis, extrapulmonary
Disseminated cryptococcosis
10013439
PT
Cryptococcosis, extrapulmonary
Gastroenteritis cryptococcal
10011485
PT
Cryptococcosis, extrapulmonary
Meningitis cryptococcal
10027209
PT
Cryptococcosis, extrapulmonary
Neurocryptococcosis
10068368
PT
Cryptococcosis, extrapulmonary
Cryptosporidia infections
10011499
HLT
Cryptosporidiosis infection, 
chronic intestinal (> 1 month 
duration)
Cytomegalovirus chorioretinitis
10048843
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus colitis
10048983
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus duodenitis
10049014
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus enteritis
10049074
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus enterocolitis
10049015
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus gastritis
10049016
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus gastroenteritis
10051349
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus gastrointestinal 
infection
10052817
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus gastrointestinal 
ulcer
10075619
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus nephritis
10079095
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)


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Term
Code
Level
List from Panel on 
Opportunistic Infections in 
HIV-Infected Adults and 
Adolescents
If LLT- under which PT 
Cytomegalovirus mucocutaneous 
ulcer
10065036
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus 
myelomeningoradiculitis
10065621
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus myocarditis
10056261
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus oesophagitis
10049018
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus pancreatitis
10049566
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus pericarditis
10056721
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Cytomegalovirus urinary tract 
infection
10051350
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Disseminated cytomegaloviral 
infection
10049075
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Encephalitis cytomegalovirus
10014586
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Pneumonia cytomegaloviral
10035676
PT
Cytomegalovirus disease (other 
than liver, spleen, or nodes)
Hepatitis B
10019731
PT
Hepatitis B
Acute hepatitis B
10059193
PT
Hepatitis B
Chronic hepatitis B
10008910
PT
Hepatitis B
Hepatitis C
10019744
PT
Hepatitis C
Acute hepatitis C
10065051
PT
Hepatitis C
Chronic hepatitis C
10008912
PT
Hepatitis C
Herpes simplex skin chronic 
ulcers
10058426
LLT
Herpes simplex ulcers chronic 
(>1mo)
Under "Herpes dermatitis" PT
Lower respiratory tract herpes 
infection
10019948
PT
Herpes simplex bronchitis
Herpes simplex pneumonia
10065046
PT
Herpes simplex pneumonitis
Pneumonia herpes viral
10035703
PT
Herpes simplex pneumonitis


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Term
Code
Level
List from Panel on 
Opportunistic Infections in 
HIV-Infected Adults and 
Adolescents
If LLT- under which PT 
Herpes simplex oesophagitis
10074242
PT
Herpes simplex oesophagitis
Herpes oesophagitis
10052330
PT
Herpes simplex oesophagitis
Shingles
10040555
LLT
Shingles when 2 distinct episodes 
or more than 1 dermatome
Under "Herpes zoster" PT
Herpes zoster cutaneous 
disseminated
10074297
PT
Shingles when 2 distinct episodes 
or more than 1 dermatome
Herpes zoster disseminated
10065038
PT
Shingles when 2 distinct episodes 
or more than 1 dermatome
Histoplasmosis
10020141
PT
Histoplasmosis extrapulmonary
Histoplasmosis disseminated
10020144
PT
Histoplasmosis disseminated 
Endocarditis histoplasma
10014676
PT
Histoplasmosis disseminated
Histoplasmosis cutaneous
10049142
PT
Histoplasmosis disseminated
Meningitis histoplasma
10027243
PT
Histoplasmosis disseminated
Pericarditis histoplasma
10034489
PT
Histoplasmosis disseminated
Presumed ocular histoplasmosis 
syndrome
10063664
PT
Histoplasmosis disseminated
Retinitis histoplasma
10038912
PT
Histoplasmosis disseminated
HIV wasting syndrome
10050309
PT
Wasting secondary to HIV
Human polyomavirus infection
10057366
PT
Human polyomavirus infection
Immunoblastic lymphoma
10053574
PT
Lymphoma immunoblastic
Isosporiasis
10023076
PT
Isosporiasis, chronic intestinal (> 
1 month’s duration)
Kaposi's sarcomas
10023285
HLT
Kaposi’s sarcoma
Lymphoid interstitial pneumonia
10062997
LLT
Lymphoid interstitial pneumonia
Under " Idiopathic interstitial 
pneumonia " PT
Listeria infections
10024639
HLT
Listeriosis
Atypical mycobacterial 
infections
10003754
HLT
Mycobacterium infections, other 
species or unidentified species, 
disseminated or extrapulmonary 
(eg, M. haemophilium, M. 
fortuitum, or M. marinum)
Nocardia infections
10029443
HLT
Nocardiosis


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Term
Code
Level
List from Panel on 
Opportunistic Infections in 
HIV-Infected Adults and 
Adolescents
If LLT- under which PT 
Pneumocystis jirovecii infection
10073756
PT
Pneumocystis jirovecii infection
Pneumocystis jirovecii 
pneumonia
10073755
PT
Pneumocystis jirovecii infection
Pneumonia recurrent
10066727
LLT
Pneumonia recurrent
Under "Pneumonia" PT
Polyomavirus-associated 
nephropathy
10065381
PT
Polyomavirus (JC virus or BK 
virus)-associated nephropathy 
(including progressive multifocal 
leukoencephalopathy)
JC virus granule cell 
neuronopathy
10074361
PT
Polyomavirus (JC virus or BK 
virus)-associated nephropathy 
(including progressive multifocal 
leukoencephalopathy)
Progressive multifocal
leukoencephalopathy
10036807
PT
Polyomavirus (JC virus or BK 
virus)-associated nephropathy 
(including progressive multifocal 
leukoencephalopathy)
Central nervous system 
lymphoma
10007953
PT
Lymphoma primary of brain
Respiratory moniliasis
10038705
PT
Candidiasis of bronchi
Candidiasis of trachea
10064459
PT
Candidiasis of trachea
Candida pneumonia
10053158
PT
Candidiasis of lungs
Salmonella sepsis
10058878
PT
Salmonella sepsis
Salmonella septicemia
10039445
LLT 
Salmonella septicemia, recurrent
Under "Salmonella sepsis" PT
Salmonella sepsis recurrent
10066745
LLT
Salmonella sepsis if recurrent
Under "Salmonella sepsis" PT
Tuberculous infections
10044756
HLT
Any active TB
Mycobacterium tuberculosis, any 
site, latent or active
8.4.
Deaths
If any patient dies during the study, a listing of deaths will be provided, and all relevant
information will be discussed in the patient narrative included in the CSR.
8.5.
Clinical Laboratory Tests
Clinical laboratory tests (serum chemistry and hematology) will be performed prior to 
reslizumab administration at the time points detailed in Table 1 of the protocol. Clinical 


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laboratory tests will be performed using the central laboratory. Specific laboratory tests to be 
performed are provided in protocol section 7.4.1.
Summary statistics for laboratory tests will be presented at each scheduled visit. Actual values 
and changes from baseline to each visit will be summarized using descriptive statistics. Shifts 
(below, within, and above the normal range) from baseline to each visit will be summarized 
using patient counts and percentages. Shifts from baseline (Grade 0-4) will be provided for 
creatine phosphokinase (CPK) at each visit, based on the following grading scale:

Grade 0: <1.25 x ULN

Grade 1: 1.25 to 1.5 x ULN

Grade 2: 1.6 to 3 x ULN

Grade 3: 3.1 to 10 x ULN

Grade 4: >10 x ULN
For CPK values ≥3.1xULN (Grade 3-4), investigators will collect additional information 
promptly from the patient related to symptoms associated with the elevation and any potential 
alternate causes. This supplemental data will be reported in the patient listings.
The incidence of potentially clinically significant abnormal values will be summarized for 
laboratory data using descriptive statistics with the criteria specified in Table 5; criteria have 
been provided for adults and adolescents separately.
Summaries of potentially clinically significant laboratory values will include all relevant post-
baseline values (including scheduled, unscheduled, and early termination visits). A post-baseline 
laboratory value will be considered potentially clinically significant only if it satisfies the 
specified criteria and is more extreme (farther from the limit) than the baseline value. Listings for 
potentially clinically significant laboratory data will be presented. If any patient has a positive 
pregnancy test, relevant information will be supplied in data listings.
A scatter plot will be provided for the baseline and maximum value for CPK.


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Table 5: Criteria for Potentially Clinically Significant Laboratory Values
Adults (≥18 years)
Adolescents (12 to <18 Years)
Test
Criterion value
Change from baseline
Criterion value
Change from baseline
Serum chemistry
  Alanine aminotransferase
3xULN
Increase >0
3xULN
Increase >0
  Aspartate aminotransferase
3xULN
Increase >0
3xULN
Increase >0
  Alkaline phosphatase
3xULN
Increase >0
3xULN
Increase >0
  Gamma-glutamyl transpeptidase
3xULN
Increase >0
3xULN
Increase >0
  Lactate dehydrogenase
3xULN
Increase >0
3xULN
Increase >0
  Blood urea nitrogen
10.71 mmol/L
Increase >0
10.71 mmol/L
Increase >0
  Creatinine
177 mol/L
Increase >0
177 mol/L
Increase >0
  Uric acid:
Men
625 mol/L
Increase >0
625 mol/L
Increase >0
Women
506 mol/L
Increase >0
506 mol/L
Increase >0
  Bilirubin (total)
34.2 mol/L
Increase >0
34.2 mol/L
Increase >0
  Creatine phosphokinase
Grade 3: 3.1 to 10 x ULN
Grade 4: >10 x ULN
Increase >0
Grade 3: 3.1 to 10 x ULN
Grade 4: >10 x ULN
Increase >0
Hematology
  Hematocrit:
Men
<0.37 L/L
Decrease >0
<0.30 L/L
Decrease >0
Women
<0.32 L/L
Decrease >0
<0.30 L/L
Decrease >0
  Hemoglobin:
Men
115 g/L
Decrease >0
100 g/L
Decrease >0
Women
95 g/L
Decrease >0
100 g/L
Decrease >0
  White blood cell counts
3 x 109/L
Decrease >0
3 x 109/L
Decrease >0
20 x 109/L
Increase >0
20 x 109/L
Increase >0
  Eosinophils
≥1.5 x 109/L
Increase >0
≥1.5 x 109/L
Increase >0
  Absolute neutrophil counts
1 x 109/L
Decrease >0
1 x 109/L
Decrease >0
  Platelet counts
75 x 109/L
Decrease >0
75 x 109/L
Decrease >0
700 x 109/L
Increase >0
700 x 109/L
Increase >0
ULN=upper limit of normal range.
If both the baseline and post-baseline values are beyond the same PCS limit, then the post-baseline value will be considered PCS only if it is more extreme 
(farther from the limit) than the baseline value. If the baseline value is beyond the low PCS limit and the post-baseline value is beyond the high PCS limit (or 
vice-versa), then the post-baseline value will be considered PCS


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8.6.
Physical Examinations
Physical examinations, including height and weight, will be performed at the time points detailed 
in Table 1 of the protocol. 
A full physical examination (performed before spirometry) will include at a minimum the 
following organ systems: general appearance; head, eyes, ears, nose, and throat (HEENT); chest 
and lung; heart; abdomen; musculoskeletal; skin; lymph nodes; and neurological.
Shifts (normal and abnormal) from baseline to each visit will be summarized using patient counts 
and percentages for each category.
8.7.
Vital Signs
Summary statistics for vital signs (blood pressure [BP] (systolic/diastolic), respiratory rate, body 
temperature, and pulse) will be measured at the time points detailed in Table 1 of the protocol.
Actual values and changes from baseline to each visit will be summarized. 
The incidence of potentially clinically significant vital signs will be summarized. Summaries of 
potentially clinically significant values will include all relevant post-baseline values (including 
scheduled, unscheduled, and early termination visits). 
Table 6 specifies the criteria for identifying vital signs as potentially clinically significant for 
adults and adolescents. In order to be identified as potentially clinically significant vital sign, the 
result would need to meet both identified conditions (ie, satisfies the specified criteria and results 
in a change from baseline of at least the magnitude specified). A listing for potentially clinically 
significant vital signs will be presented.  
Table 6: Criteria for Potentially Clinically Significant Vital Signs
Adults (≥18 years)
Adolescents (12 to <18 Years)
Vital Sign
Criterion value
Change from 
baseline
Criterion value
Change from baseline
Heart rate
>100 bpm
Increase of 30
>100 bpm
Increase of 30
<50 bpm
Decrease of 30
<60 bpm
Decrease of 30
Systolic BP
>160 mmHg
Increase of 30
>130 mmHg
Increase of 30
<90 mmHg
Decrease of 30
<90 mmHg
Decrease of 30
Diastolic BP
>100 mmHg
Increase of 12
>85 mmHg
Increase of 12
<50 mmHg
Decrease of 12
<55 mmHg
Decrease of 12
Respiratory rate
>24 breaths/min
Increase of 10
>20 breaths/min
Increase of 10
<6 breaths/min
Not applicable
<10 breaths/min
Not applicable
Temperature
>38.1C
Increase of 1.1
>38.1C
Increase of 1.1
<35.8C
Not applicable
<35.8C
Not applicable


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8.8.
Electrocardiography
Summary statistics for ECG will be measured at the time points detailed in Table 1 of the 
protocol.
Shifts (normal and abnormal) from baseline to week 36 will be summarized using patient counts. 
Summary statistics for ECG variables will be presented at week 36. Actual values and changes 
from baseline to week 36 will be summarized.
The following categorical analyses represent the criteria for potentially clinically significant QTc 
results. Both QTc Bazett and Fridericia interval will be presented using descriptive statistics.

Absolute value at week 36

QTc interval >450 msec

QTc interval >500 msec

Change from baseline to week 36

QTc interval increase >30 msec

QTc interval increase >60 msec

Combined absolute value and change from baseline to week 36

QTc interval >450 msec and QTc interval increase >30 msec

QTc interval >450 msec and QTc interval increase >60 msec

QTc interval >500 msec and QTc interval increase >30 msec

QTc interval >500 msec and QTc interval increase >60 msec
8.9.
Concomitant Medications or Therapies 
All concomitant medications will be coded using the WHO Drug dictionary; the final version 
number will be indicated in the summary tables. The incidence of concomitant medications will 
be summarized by therapeutic class and preferred term. Patients are only counted once in each 
therapeutic class and once in each preferred term.
Concomitant medications include all medications taken while the patient is treated with 
reslizumab in this study. Medications with a start date greater than the upper bound of the 
treatment period (Section 8.2) in this study will be considered post-treatment. Medications will 
be categorized in every period (prior, concomitant, post-treatment) in which it was taken. If the 
medication start/stop date is missing or partial, the medication will be considered concomitant 
unless there is evidence to the contrary (eg, month and year of stop date is present and is less 
than the month and year of the first dose of study drug). 


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9.
TOLERABILITY VARIABLES AND ANALYSIS
Local tolerability at the injection site will be evaluated.
The following procedures/assessments will be performed during and after administration of
study drug:

Patients will be observed for 1 hour after study injection.

Evaluation of injection site for reaction will be performed at approximately 1 hour
after dosing using the injection site CRF. Clinically significant injection site reactions
should be recorded as an adverse event.
Proportion of patients in each domain/response (refer to Section 8.3.1.1 for details on analysis) 
will be summarized by each visit and previous double-blind treatment group.


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10.
PHARMACODYNAMIC ANALYSIS
10.1.
Biomarkers Analysis
The target biomarker endpoint is the blood eosinophil counts at time points detailed in Table 1 of 
the protocol. Summary statistics of actual values, change from baseline, and percent change from 
baseline to each scheduled visit will be provided by previous double-blind treatment group and 
for all patients. A line graph presenting the mean change from baseline over time (at each visit) 
will be provided by previous double-blind treatment group.
All summaries and analyses of other biomarkers (if analyzed) will be explored outside the scope 
of this SAP and reported separately from the clinical study report.


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11.
IMMUNOGENICITY ANALYSIS
The immunogenicity assessments for this study include the following:

ADA measurement at baseline and at weeks 8, 24, and 36 or early withdrawal visit to 
evaluate the long-term immunogenicity of sc reslizumab

ADA measurement at EOS visit (19 weeks after the final dose) to evaluate
immunogenicity after study drug washout
Two types of antibody assay will be performed, an immunogenicity status assay (ADA) and 
neutralizing antibody assay (NAb). For the ADA assay, a screening assessment will be 
performed which produces a positive or negative result. For samples with a positive result, a 
neutralizing antibody assay will be performed, which also produces a positive or negative result; 
a titer value will be obtained to quantify the degree of binding.
A patient will be classified as having a treatment-emergent ADA response if a sample tested 
positive at any of the post-baseline time points but not at the baseline time point, or if the post-
baseline ADA titer increased ≥4-fold from a positive baseline ADA sample (Shankar et al 2014).
In this open-label extension study, the baseline sample data for the purpose of analysis will be 
derived from the pre-dose samples obtained on thethe DOR in the previous study (30025 or 
30027).
Anti-reslizumab antibody data, including neutralizing antibody and titer results for patients who 
have tested ADA positive, will be listed. The number of patients with positive/negative results 
will be summarized at each scheduled visit by previous double-blind treatment group and for all 
patients, if appropriate. ADA status will be correlated with variables of efficacy and safety via
examination of eosinophils and adverse events, respectively, by ADA status (positive, negative).


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12.
PLANNED INTERIM ANALYSIS
There will be a planned data cut with statistical output produced before the sBLA submission 
and a planned data cut with statistical output produced before the Day 120 safety update report
(see Section 2.5.1 for additional details). 


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13.
STATISTICAL SOFTWARE
All data listings, summaries, and statistical analyses will be generated using SAS® version 9.3 or 
later.


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14.
CHANGES TO ANALYSES SPECIFIED IN THE STUDY 
PROTOCOL
Table 7: Changes to the Protocol Specified Analyses
Protocol 
Section
Protocol Description
Change/Rationale
Section 
9.11
There will be a planned data cut with 
statistical output produced before the 
supplemental Biologics License 
Application submission. 
There will be a planned data cut with 
statistical output produced before the 
supplemental Biologics License Application 
submission and a planned data cut with 
statistical output produced before the Day 
120 safety update report. 


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
46
15.
REFERENCES
SAS Institute Inc. 2012. SAS® 9.3 In-Database Products: User’s Guide, 4th ed. Cary, NC: SAS 
Institute Inc.
Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, Quarmby V, Richards 
S, Schneider CK, Subramanyam M, Swanson S, Verthelyi D, Yim S. Assessment and Reporting 
of the Clinical Immunogenicity of Therapeutic Proteins and and Peptides-Harmonized 
Terminology and Tactical Recommendations. AAPS J. 2014;16:658-73.


Open-Label Extension Study–Eosinophilic Asthma
Statistical Analysis Plan
Study C38072-AS-30066
47
16.
APPENDIX
Not applicable.