Conditions: Asthma
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases Additional relevant MeSH terms: Asthma Inflammation Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pathologic Processes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 660
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps. The study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI study.

Detailed description:
This is a Phase IIIb, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and the safety of repeat dosing of benralizumab 30 mg subcutaneous (sc) versus placebo on top of standard of care asthma therapy in patients with severe uncontrolled asthma. Approximately 630 patients with peripheral blood eosinophil counts ≥150 cells/μL will be randomized 2:1 to receive benralizumab 30 mg sc or matched placebo for 24 weeks.

After enrolment, eligible patients will enter an up to 42-day screening/run-in period. Patients who meet eligibility criteria will be randomized 2:1 on Day 0 to receive either benralizumab or placebo every 56 days (every 8 weeks) through Week 16, with end of treatment (EOT) at Day 168 (Week 24). At the completion of the 24-week doubleblind period of the ANDHI study, eligible patients in benralizumab and placebo arm may enter a 56-week open label period (ANDHI in Practice \[ANDHI IP\] substudy), in which concomitant asthma therapies will be tapered as directed by the protocol in those patients who achieve and maintain asthma control (defined as ACQ6 score \<1.5 and no clinically significant asthma exacerbations that required a burst of systemic corticosteroid or a hospitalization due to asthma between reduction visits) with add-on benralizumab.

Arms:
arm 1: Benralizumab (Medi563) Administered subcutaneously at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) In the open label ANDHI IP sub study, all patients will receive benralizumab subcutaneously at Day 168 (Week 24), Day 196 (Week 28), Day 224 (Week 32), Day 280 (Week 40), Day 336 (Week 48), Day 392 (Week 56), Day 448 (Week 64), and Day 504 (Week 72). arm 2: Administered subcutaneously at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days)

Interventions: intervention 1: Benralizumab (Medi-563) intervention 2: Placebo
Intervention descriptions: intervention 1: 30mg Benralizumab administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) In the open label ANDHI IP sub study, all patients will receive benralizumab subcutaneously at Day 168 (Week 24), Day 196 (Week 28), Day 224 (Week 32), Day 280 (Week 40), Day 336 (Week 48), Day 392 (Week 56), Day 448 (Week 64), and Day 504 (Week 72). intervention 2: Placebo administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days)

Protocol document:
SAP_002.pdf: 
Statistical Analysis Plan
Study Code
D3250C00045
Edition Number 3.0
Date
14 Oct 2019
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo 
controlled, Phase 3b Study to Evaluate the Safety and Efficacy of 
Benralizumab 30 mg sc in Patients with Severe Asthma Uncontrolled on 
Standard of Care Treatment (ANDHI)


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
2
TABLE OF CONTENTS
PAGE
TITLE PAGE.......................................................................................................1
TABLE OF CONTENTS.....................................................................................2
LIST OF ABBREVIATIONS ..............................................................................5
AMENDMENT HISTORY..................................................................................8
1.
STUDY DETAILS.............................................................................................12
1.1
Study objectives................................................................................................. 12
1.1.1
Primary objective...............................................................................................12
1.1.2
Secondary objectives..........................................................................................12
1.1.3
Safety objectives................................................................................................13
1.1.4
Exploratory objectives .......................................................................................14
1.2
Study design ...................................................................................................... 14
1.3
Number of subjects ............................................................................................17
2.
ANALYSIS SETS .............................................................................................17
2.1
Definition of analysis sets .................................................................................. 17
2.1.1
All patients analysis set......................................................................................18
2.1.2
Full analysis set..................................................................................................18
2.1.3
Chronic rhinosinusitis with nasal polyposis sub-study analysis set .....................18
2.1.4
Safety analysis set..............................................................................................18
2.2
Violations and deviations ................................................................................... 18
3.
PRIMARY AND SECONDARY VARIABLES.................................................19
3.1
General Definitions............................................................................................ 19
3.1.1
Definition of baseline.........................................................................................19
3.1.2
Change from baseline.........................................................................................20
3.1.3
Visit windows.................................................................................................... 20
3.2
Calculation or derivation of efficacy variables....................................................24
3.2.1
Primary outcome variable ..................................................................................24
3.2.2
Key secondary outcome variable........................................................................ 25
3.2.3
Other secondary outcome variables....................................................................27
3.2.3.1
Pre-bronchodilator forced expiratory volume in first second (pre-BD 
FEV1).................................................................................................................27
3.2.3.2
Asthma control questionnaire 6 (ACQ-6) ........................................................... 27
3.2.3.3
Time to first asthma exacerbation.......................................................................28
3.2.3.4
Peak expiratory flow (PEF) assessment at home.................................................28
3.2.3.5
Short form 36-item health survey, version 2 (SF-36v2) ......................................28


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3.2.3.6
Patient global impression of severity (PGI-S).....................................................30
3.2.3.7
Clinician and patient global impression of change (CGI-C and PGI-C) .............. 31
3.2.3.8
Predominant symptom and impairment assessment (PSIA) ................................32
3.2.3.9
Sino-Nasal outcome test 22 item (SNOT-22) .....................................................33
3.3
Calculation or derivation of safety variables....................................................... 34
3.3.1
Adverse events (AEs)......................................................................................... 34
3.3.2
Laboratory variables .......................................................................................... 35
3.3.3
Vital signs.......................................................................................................... 36
3.3.4
Local ECGs ....................................................................................................... 36
3.3.5
Physical examination .........................................................................................36
3.4
Other asthma control variables........................................................................... 37
3.4.1
Asthma symptom score......................................................................................37
3.4.2
Rescue medication .............................................................................................38
3.4.3
Night-time awakening due to asthma.................................................................. 38
3.4.4
Composition of daily diary measures..................................................................39
4.
ANALYSIS METHODS....................................................................................41
4.1
General principles.............................................................................................. 41
4.1.1
Testing strategy to account for multiplicity considerations .................................42
4.2
Analysis methods...............................................................................................42
4.2.1
Patient disposition..............................................................................................42
4.2.2
Demography data and patient characteristics ...................................................... 42
4.2.3
Prior and concomitant medications.....................................................................43
4.2.4
Study treatments ................................................................................................ 44
4.2.4.1
Exposure............................................................................................................44
4.2.4.2
Compliance........................................................................................................44
4.2.5
Analysis of the primary variable.........................................................................44
4.2.6
Analysis of the key secondary variable...............................................................47
4.2.7
Analysis of the other secondary variables........................................................... 48
4.2.7.1
Pre-bronchodilator forced expiratory volume in first second (pre-BD 
FEV1).................................................................................................................48
4.2.7.2
Asthma control questionnaire 6 (ACQ-6) ...........................................................48
4.2.7.3
Time to first asthma exacerbation.......................................................................49
4.2.7.4
Peak expiratory flow (PEF) assessment at home.................................................49
4.2.7.5
Short form 36-item health survey, version 2 (SF-36v2) ......................................49
4.2.7.6
Patient global impression of severity (PGI-S).....................................................50
4.2.7.7
Clinician and patient global impression of change (CGI-C and PGI-C) .............. 50
4.2.7.8
Predominant symptom and impairment assessment (PSIA) ................................50
4.2.7.9
Sino-Nasal outcome test 22 item (SNOT-22) .....................................................51
4.2.8
Analysis of safety variables................................................................................ 51
4.2.8.1
Adverse events (AEs)......................................................................................... 51
4.2.8.2
Laboratory data.................................................................................................. 52
4.2.8.3
Vital signs.......................................................................................................... 53
4.2.8.4
Local ECGs ....................................................................................................... 54


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
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4.2.8.5
Physical examination .........................................................................................54
4.2.9
Exploratory analyses..........................................................................................54
4.2.9.1
Analysis of biomarker data.................................................................................54
4.2.9.2
Analysis of asthma control assessments..............................................................54
5.
INTERIM ANALYSES .....................................................................................55
6.
CHANGES OF ANALYSIS FROM PROTOCOL .............................................55
7.
REFERENCES ..................................................................................................57
8.
APPENDIX .......................................................................................................59
LIST OF TABLES
Table 1
Visit windows for assessments conducted at every visit of Visit 5-
Visit 11 .................................................................................................21
Table 2
Visit windows for assessments conducted weekly until Visit 6 
(ACQ-6, PGI-S and PGI-C)...................................................................21
Table 3
Weekly windows for home PEF assessments and daily dairy data .........22
Table 4
Threshold values for the SF-36v2 scale and summary measures ............29
Table 5
Vital signs reference ranges...................................................................36
Table 6
Asthma control status based on 7 days previous data.............................40
Table 7
Asthma control status based on previous 4 weeks data ..........................40
LIST OF FIGURES
Figure 1
Study flow chart....................................................................................16


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Edition Number 3.0
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LIST OF ABBREVIATIONS
Abbreviation or 
special term
Explanation
ACQ-6
Asthma Control Questionnaire 6
ALT
Alanine Aminotransferase
AST
Aspartate Aminotransferase
ATC
Anatomical Therapeutic Chemical
ANDHI IP 
ANDHI in Practice 
AE
Adverse Event
BD
bronchodilator
BMI
Body Mass Index
BP
Bodily Pain
CGI-C
Clinician Global Impression of Change
CI
Confidence Interval
CRF
Case Report Form
CSP
Clinical Study Protocol
DAE
AE leading to discontinuation of IP
DL
Direct Likelihood
DRMI
Dropout Reason-based Multiple Imputation
ECG
Electrocardiogram
EOT
End of Treatment
ePRO
electronic PRO
FEV1
Forced Expiratory Volume in first second
GGT
Gamma-GT
GH
General Health Perceptions
ICS
Inhaled Corticosteroids
IP
Investigational Product
IPD
IP Discontinuation
ITT
Intent To Treat
IVRS
Interactive Voice Response system
LSMEANS
Least Square Means
MAR
Missing at Random


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Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
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Abbreviation or 
special term
Explanation
MCID
Minimal Clinically Important Difference
MCMC
Markov Chain Monte Carlo
MCS
Mental Health Component Summary
MedDRA
Medical Dictionary for Regulatory Activities
MH
Mental Health
MMRM
Mixed-effect Model for Repeated Measures
MNAR
Missing Not at Random
NBS
Norm-Based Scoring
NRS
Numeric Rating Scale
OCS
Oral Corticosteroids
PCS
Physical Component Summary
PEF
Peak Expiratory Flow
PF
Physical Functioning
PGI-C
Patient Global Impression of Change
PGI-S
Patient Global Impression of Severity
PRO
Patient Reported Outcome
PSIA
Predominant Symptom and Impairment Assessment
PT
Preferred Term
RE
Role Limitations due to Emotional Problems
REML
Restricted maximum likelihood
RP
Role Limitations due to Physical Health
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
sc
subcutaneously
SF
Social Functioning
SF-36v2
Short Form 36-item Health survey, version 2
SGRQ
Saint George Respiratory Questionnaire
SNOT-22
Sino-Nasal Outcome Test 22 Item
SI
Standard International
SOC
System Organ Class
TBL
Total Bilirubin
ULN
Upper Limit of the Normal


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Edition Number 3.0
Date 14 Oct 2019
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Abbreviation or 
special term
Explanation
VT
Vitality
WHO
World Health Organization


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
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AMENDMENT HISTORY
CCI


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
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CCI


Statistical Analysis Plan 
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Edition Number 3.0
Date 14 Oct 2019
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CCI


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
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CCI


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
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1.
STUDY DETAILS
This is the statistical analysis plan (SAP) for the reporting of the double-blind on-study period 
of study D3250C00045 which is from Visit 1 (enrolment) to Visit 12 (follow-up) inclusive. 
The SAP describes the statistical analyses specified in the clinical study protocol (CSP) for 
this period in more detail; any changes with regards to what is already specified in the CSP 
will be described in Section 6. 
The reporting of the ANDHI in Practice (ANDHI IP) substudy which is from Visit 13 to Visit 
27 (end of study visit) inclusive will be described in a separate analysis plan. This separate 
analysis plan will describe in detail how ANDHI IP will be analyzed standalone. It will also 
include how additional integrated presentations involving the double-blind period of the study 
will be analyzed with ANDHI IP as needed.
In this current SAP the ANDHI IP will only be referenced to show where the cut-off of data is 
between the end of the double-blind on-study period and the start of the ANDHI IP and in 
disposition to show how many patients have entered ANDHI IP.
1.1
Study objectives
1.1.1
Primary objective
Primary Objective:
Outcome Measure:
To determine the effect of benralizumab on the 
rate of asthma exacerbations
The annualized rate of asthma exacerbations between 
benralizumab and placebo (treatment period 
24 weeks)
1.1.2
Secondary objectives
Key Secondary Objectives:
Outcome Measure:
To determine the effect of benralizumab on 
patient-reported disease-specific quality of life
The change from baseline (Visit 4) in Saint George 
Respiratory Questionnaire (SGRQ) to the EOT 
(Day 168/Week 24)


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Edition Number 3.0
Date 14 Oct 2019
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1 PSIA analyses updated from CSP description,  see section 6
1.1.3
Safety objectives
Safety Objectives:
Outcome Measure:
To assess the safety and tolerability of 
benralizumab
Adverse events (AEs), laboratory variables, physical 
examination
Secondary objectives:
Outcome measure:
To determine the effect of benralizumab on 
lung function
The change from baseline (Visit 4) in forced 
expiratory volume in first second (FEV1) over the 
treatment period (up to and including 
Day 168/Week 24)
To determine the effect of benralizumab on 
patient-reported asthma control 
The change from baseline (Visit 4) in Asthma Control 
Questionnaire 6 (ACQ6) to the EOT 
(Day 168/Week 24)
To determine the effect of benralizumab on 
time to first asthma exacerbation
Time to first asthma exacerbation (treatment period 
24 weeks) 
To determine the effect of benralizumab on 
lung function at home
The change from run-in baseline morning peak 
expiratory flow (PEF) to the EOT 
(Day 168/Week 24)
To determine the effect of benralizumab 
general quality of life and health status
The change from baseline (Visit 4) Short Form 36-
item Health survey, version 2 (SF-36v2) to the EOT 
(Day 168/Week 24)
To evaluate patient impression of overall 
asthma severity (patient global impression of 
severity [PGI-S])
The change from baseline (Visit 4) in PGI-S to the 
EOT (Day 168/Week 24)
To evaluate patient impression of change in the 
overall asthma status from baseline as reported 
by the patient (patient global impression of 
change [PGI-C]) and clinician (clinician global 
impression of change [CGI-C])
The degree of change reported by the patient (PGI-C) 
and Investigator (CGI-C) expressed as a proportion of 
each of the 7 possible responses to the EOT
(Day 168/Week 24)
To determine the effect of benralizumab on the 
patient’s predominant symptoms (Predominant 
Symptom and Impairment Assessment; PSIA)
The degree of change reported by the patient in their 
predominant symptom to the EOT 
(Day 168/Week 24)1
To determine the effect of benralizumab on 
disease specific health-related quality of life in 
patients with doctor diagnosed chronic sinusitis 
with nasal polyposis
The change from baseline (Visit 3) in the sino-nasal 
outcome test (SNOT-22) score to the EOT 
(Day 168/Week 24).


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Edition Number 3.0
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1.1.4
Exploratory objectives
1.2
Study design
This is a Phase IIIb, randomized, double-blind, placebo-controlled, parallel-group study 
designed to evaluate the efficacy and the safety of repeat dosing of benralizumab 30 mg 
subcutaneously (sc) versus placebo on top of standard of care asthma therapy in patients with 
severe uncontrolled asthma. The target patient population will consist of male and female 
patients with at least 2 asthma exacerbations while on maintenance inhaled corticosteroids 
(ICS) plus another asthma controller, that required treatment with systemic corticosteroids 
(intramuscular, intravenous, or oral) in the 12 months prior to study enrollment.
Approximately 630 patients with peripheral blood eosinophil counts ≥150 cells/μL will be 
randomized at approximately 275 study centers globally, in a 2:1 ratio to receive 
benralizumab 30 mg sc or matched placebo. Patients will be stratified at randomization by 
previous exacerbations (2 exacerbations in 12 months prior to Visit 1; ≥3 exacerbations in 12 
months prior to Visit 1), maintenance oral corticosteroids (OCS) use (use, non-use), and 
region (North America, rest of world). Approximately 40% of randomized patients are 
expected to have ≥3 exacerbations in 12 months prior to Visit 1.
Therefore, enrollment of patients with only 2 exacerbations in the 12 months prior to Visit 1 
may be halted if this subgroup within a site or region reaches approximately 60% of 
randomized patients.
After initial enrollment and confirmation of entry criteria, patients will proceed to a 
screening/run-in period of up to 42 days to allow adequate time for all of the eligibility criteria 
to be evaluated. Patients who meet specific exclusion criteria (2, 12, 13, 15, 17 or 18 per CSP 
version 1) can be re-screened once at the discretion of the investigator. Patients who meet the 
Exploratory objectives:
Outcome measure:
To determine the effect of eosinophil depletion 
with benralizumab on:
!
Biomarker components of known 
asthma inflammatory pathways or 
airway remodeling (including 
periostin, DPP4, YKL-40 and MMPs)
!
Biomarker surrogates of eosinophilic 
inflammation/activation (including, 
eosinophil granule proteins)
The change from baseline (Visit 4) in circulating 
biomarkers to each pre-specified scheduled 
assessment during the treatment period.
To determine the effect of benralizumab on the 
patient’s level of asthma control based 
standard asthma guidance recommendations
The proportion of patients with well-controlled 
asthma, based on composite diary measures, over 
time.


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eligibility criteria will be randomized to a 24-week treatment period. Either benralizumab or 
placebo will be administered at the study center every 56 days (every 8 weeks) through Week 
16, with a single loading dose at Week 4.  End of treatment (EOT) visit is at Week 24.
Changes to the patient’s usual asthma controller medications are discouraged during the 
treatment period. A follow-up telephone visit for final safety assessments will be conducted at 
Week 26.
Patients with baseline chronic rhinosinusitis with nasal polyposis may elect to participate in a 
sub-study. The rhinosinusitis health status and quality of life of these patients will be assessed 
using the 22-item SNOT 22 completed at on-site visits.
All patients who prematurely discontinue investigational product (IP) should return to the 
study center and complete the procedures described for the premature IP Discontinuation 
(IPD) Visit within 4 weeks ±3 days. At that visit, patients should be encouraged to remain in 
the study and complete all subsequent scheduled study visits, procedures, and assessments 
through study completion. If the patient is not willing to participate further in the study after 
the IPD visit, the patient should be withdrawn from the study and also complete the follow-up 
visit. Withdrawn patients will not be replaced.  
All eligible patients who completed the EOT Visit 11 of the double-blind period may be enrolled 
in the open label ANDHI IP substudy. This ANDHI IP substudy design will be detailed in the 
ANDHI IP SAP.
The study flow chart is shown in Figure 1 (see below). The study plans are presented in 
Tables 1 and 2 of the CSP.


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Edition Number 3.0
Date 14 Oct 2019
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Figure 1
Study flow chart
Patients with a peripheral blood eosinophil count of ≥150 to <300 cells/μL have to fulfill additional clinical criteria described in inclusion criterion 8 
(Section 3.1 of the study protocol), patients with a peripheral blood eosinophil count of ≥300 cells/μL do not need to meet the additional criteria.
ACQ6 asthma control questionnaire 6; Benra benralizumab; EOS eosinophil; EOT end of treatment; EXAC exacerbation; FEV1 forced expiratory volume in 
first second; FU follow-up; ICS inhaled corticosteroid; V visit; WOCBP women of childbearing potential.;  telephone visit.


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
1.3
Number of subjects
The study is powered for the primary objective (to determine the effect of benralizumab on 
asthma exacerbations) through the primary endpoint (annualized rate of asthma exacerbations 
over 24 weeks) as well as for the key secondary objective (to determine the effect of 
benralizumab on patient reported disease-specific quality of life) through the key secondary 
endpoint (the change from baseline to EOT in SGRQ up until and including the Week 24 
visit.).
Previous benralizumab Phase III asthma exacerbation studies (Bleeker et al 2016, Fitzgerald et 
al 2016) indicate that an annual exacerbation rate for the placebo group of 1.25, a 40% 
reduction in exacerbation rate for the benralizumab group, and a common negative binomial 
shape dispersion parameter of 1.2 may be expected.  Results from previous studies also 
indicate that a greater than 4 point difference between treatment groups in the change from 
baseline SGRQ score may be expected, given improvements in related patient reported 
outcomes (PROs) seen in the exacerbation studies as well as the results from mepolizumab 
pivotal trials (Bel et al 2014, Ortega et al 2014).  A difference of 5 points and common 
standard deviation of 19 points was assumed.
Under these assumptions, a 630-patient study randomized in a 2:1 ratio (420 benralizumab: 
210 placebo) has approximately 91% power with respect to the primary endpoint (assessed 
over a 24-week period) and 87% power with respect to the key secondary endpoint, assuming 
a 2-sided 5% significance level in both cases.
The sample size was estimated using nQuery version 8.2.0.0.
The total estimated number of patients to be randomized was updated from approximately 800 
with 1:1 randomization ratio (benralizumab : placebo) to approximately 630 with a 2:1 
randomization (benralizumab : placebo) to mitigate early challenges in recruiting sufficient 
numbers of appropriately severe eosinophilic asthma patients to the study. The change 
preserves the number of patients receiving active benralizumab treatment and reduces the 
number of patients exposed to placebo, while retaining statistical power to detect a treatment 
difference for both asthma exacerbation reduction and SGRQ improvement. The revised 
powering remains consistent with a level that would assure robust conclusions for scientific 
exchange. The revised sample size was not calculated using any current study data to maintain 
the blind.
2.
ANALYSIS SETS
2.1
Definition of analysis sets
The following analysis sets will be used in this study:


Statistical Analysis Plan 
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2.1.1
All patients analysis set
This analysis set will comprise all patients screened for the study and will be used for 
reporting of disposition and screening failures. 
2.1.2
Full analysis set 
All patients randomized and receiving any IP will be included in the full analysis set, 
irrespective of their protocol adherence and continued participation in the study. Patients will 
be analyzed according to their randomized treatment, irrespective of whether or not they have 
prematurely discontinued, according to the intent to treat (ITT) principle.  Patients who 
withdraw consent, and assent when applicable, to participate in the study will be included up 
to the date of their study termination. 
All efficacy data, except SNOT-22, will be summarized and analyzed using the full analysis 
set on an ITT basis. For consistency, demographic and baseline characteristics will also be 
presented using the full analysis set.
2.1.3
Chronic rhinosinusitis with nasal polyposis sub-study analysis set
The chronic rhinosinusitis with nasal polyposis sub-study analysis set is defined as the subset 
of patients with:
! Doctor-diagnosed chronic rhinosinusitis and nasal polyposis included in their medical 
history; who
! Signed informed consent to participate in the sub-study; and 
! Received at least one dose of study IP. 
2.1.4
Safety analysis set
The safety analysis set will include all patients randomized who received any IP. Patients will 
be classified according to the treatment they actually received. A patient who has on one, or 
several occasions, received active treatment will be classified as active (e.g. benralizumab 30 
mg sc). Any deviations from the randomized treatment will be listed and considered when 
interpreting the safety data. All safety analyses will use this analysis set.
2.2
Violations and deviations
Only important protocol deviations will be listed and tabulated in the clinical study report. 
Protocol deviations that may greatly impact the completeness, accuracy, and/or reliability of 
the study data or that may significantly affect a patient’s rights, safety, or well-being will 
include but may not be limited to:


Statistical Analysis Plan 
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Date 14 Oct 2019
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!
Patients who do not meet the inclusion criteria
!
Patients who do not meet the randomization criteria
!
Patients who meet any of the exclusion criteria
!
Patients who use one or more disallowed medication (for any reason, unless 
otherwise specified) during the randomized treatment period. A list of concomitant 
medications for all patients will be provided for team review before each data 
review meeting, for the identification of disallowed medications.
!
Patients who received the incorrect IP or study dose at any time during the 24 week  
treatment period
!
Patients who developed withdrawal criteria (Section 3.11 of the CSP) during the 
study but were not discontinued from IP.
Important protocol deviations will be identified and documented by the study physicians and 
statisticians prior to unblinding of the data. 
3.
PRIMARY AND SECONDARY VARIABLES
3.1
General Definitions
3.1.1
Definition of baseline 
In general, the last measurement prior to the first dose of study treatment will serve as the 
baseline measurement. If time is collected, the assessment performed the same day but at a 
time prior to the first dose of study treatment will be included in the baseline definition. For 
PROs with reflection times of 1 week or more (e.g. the SGRQ, ACQ-6), the time component 
of the definition of baseline (i.e. time of assessment relative to the first dose) will not be 
considered; assessments on the same day as the first dose of study treatment will be used for 
baseline.  If there is no value prior to the first dose of study treatment (or the same day for 
PROs with reflection times ≥ 1 week), then the baseline value will not be imputed and will be 
set to missing.
For information, the planned baseline visit for SGRQ, ACQ-6, SF-36v2, PGI-S and PSIA is 
Visit 4 and for SNOT-22 is Visit 3. For FEV1, the pre-bronchodilator (pre-BD) FEV1
measurement will be used as baseline FEV1. 
Baseline for the Asthma Daily Diary variables will be the mean for data collected over the last 
7 days of the run-in period prior to randomization (as defined in Table 3). If more than 3 daily 
entries (>50%) within that period are missing, then the baseline will be set to missing.


Statistical Analysis Plan 
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Edition Number 3.0
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20
PGI-C and CGI-C are used for an overall evaluation of change compared to randomization 
visit which will be conducted only at post-baseline visits subsequent to Visit 4 (hence there is 
no baseline for these measures). 
For laboratory data and vital signs, baseline will be defined as the latest non-missing 
assessment prior to first dose. If no time is recorded for an assessment, and the assessment 
takes place at Visit 4, this will be assumed to be a pre-dose assessment.  
For physical examination, the baseline visit will be Visit 1.  
3.1.2
Change from baseline
Change from baseline outcome variables are computed as 
(post-baseline value – baseline value). 
Percent change from baseline outcome variables are computed as:
((post-baseline value – baseline value) / (baseline value))*100
If either the post-baseline value or the baseline value is missing, then both change from 
baseline and percent change from baseline value will also be set to missing.  If the baseline 
value is zero, the percent change will be set to missing.
3.1.3
Visit windows
For the exacerbation-related analyses no windows will be applied. 
Summaries of laboratory data will have analysis-defined windows per Table 1 below for 
haematology parameters scheduled to be collected at Visits 5-11.  For laboratory parameters 
not collected at every visit, the adjusted analysis-defined windows will be based on the 
collection schedule in Table 2 of the study protocol, and as described below.  Vital signs will 
be based on the case report form (CRF) visit designation. 
For efficacy endpoints that present visit-based data (patient and clinician reported outcomes, 
spirometry), variables will be summarized based on the scheduled days with adjusted analysis-
defined visit windows. The adjusted analysis-defined windows will be based on the collection 
schedule listed in the protocol and variables will be windowed to the closest scheduled visit 
for that variable. 
Visit windows following baseline will be constructed in such a way that the upper limit of the 
interval falls half way between the two visits (the lower limit of the first post-baseline visit 
will be study day 2). If an even number of days exists between two consecutive visits then the 
upper limit will be taken as the midpoint value minus 1 day. Visit windows are constructed so 
that every observation collected can be allocated to a particular visit. No visit windows will be 
defined for screening visits. 
The adjusted analysis-defined windows for assessments conducted at every visit of Visit 5 -
Visit 11 are summarized in Table 1.   


Statistical Analysis Plan 
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Table 1
Visit windows for assessments conducted at every visit of Visit 5 - Visit 11
Adjusted defined 
window visit*
Scheduled 
study day
Maximum windows
Week 2
15
2 ≤ Study Days ≤ 21
Week 4
29
22 ≤ Study Days ≤ 42
Week 8
57
43 ≤ Study Days ≤ 70
Week 12
85
71 ≤ Study Days ≤ 98
Week 16
113
99 ≤ Study Days ≤ 126
Week 20
141
127 ≤ Study Days ≤ 154
Week 24 
169
155 ≤ Study Days ≤ Visit 11 (EOT) assessment date**
*All data are rewindowed apart from any baseline data. This is to account for any delayed IP during visit 4 
(Week 0) to still be assessed as baseline.
**If no Visit 11 (EOT) assessment then the upper limit is equal to the scheduled study day of 169.
Table 2
Visit windows for assessments conducted weekly until Visit 6 (ACQ-6, PGI-S 
and PGI-C)
Adjusted defined 
window visit*
Scheduled 
study day
Maximum windows
Week 1
8
2 ≤ Study Days ≤ 11
Week 2
15
12 ≤ Study Days ≤ 18
Week 3
22
19 ≤ Study Days ≤ 25
Week 4
29
26 ≤ Study Days ≤ 42
Week 8
57
43 ≤ Study Days ≤ 70
Week 12
85
71 ≤ Study Days ≤ 98
Week 16
113
99 ≤ Study Days ≤ 126
Week 20
141
127 ≤ Study Days ≤ 154
Week 24 
169
155 ≤ Study Days ≤ Visit 11 (EOT) assessment date**
*All data are rewindowed apart from any baseline data. This is to account for any delayed IP during visit 4 
(Week 0) to still be assessed as baseline.
**If no Visit 11 (EOT) assessment then the upper limit is equal to the scheduled study day of 169.


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For assignment of data to adjusted analysis-defined visit windows, study day will be defined 
as follows:
(Date of assessment – date of randomization) +1
By this definition, the day of randomization will be study day 1 and the planned date of Visit 5 
(Week 2) will be study day 15 (=14+1), for example.
If multiple assessments are recorded within a single adjusted visit window, please refer to the 
rules below.
!
If there are 2 or more observations within the same visit window, then the non-
missing observation closest to the scheduled study day will be used in the analysis.
!
If 2 observations are equidistant from the scheduled study day, then the non-missing 
observation with the earlier collection date will be used in the analysis.
!
If 2 observations are collected on the same day then the non-missing observation 
with the earlier collection time will be included in the analysis.
If a visit window does not contain any observations, then the data will remain missing.
For endpoints which are not collected at every visit of Visit 5 – Visit 11, such as SGRQ which 
is assessed only at Visit 6 (Week 4), Visit 8 (Week 12) and Visit 11 (Week 24), the above 
rules will be applied to derive adjusted analysis-defined visit windows based on the protocol-
defined visit schedule for that endpoint.  Similarly for laboratory parameters not collected at 
every visit.
For pre-BD FEV1, the non-missing value with missing or acceptable quality (acceptable or 
borderline quality grade) which is closest to the scheduled visit will be included in the 
analysis. 
Home PEF assessments and daily diary data will be analyzed as weekly means throughout the 
treatment period, using daily diary entries between the scheduled study days contained in
Table 3. Any observation recorded after the morning of Study Day 169 will not be included in 
the analysis but will be listed. 
Table 3
Weekly windows for home PEF assessments and daily dairy data
Adjusted defined 
window visit
Scheduled 
study day
Maximum windows
Baseline
1
Evening of Study Day -7 to the morning of Study Day 1
Week 1
8
Evening of Study Day 1 to the morning of Study Day 8
Week 2
15
Evening of Study Day 8 to the morning of Study Day 15
Week 3
22
Evening of Study Day 15 to the morning of Study Day 22


Statistical Analysis Plan 
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Adjusted defined 
window visit
Scheduled 
study day
Maximum windows
Week 4
29
Evening of Study Day 22 to the morning of Study Day 29
Week 5
36
Evening of Study Day 29 to the morning of Study Day 36
Week 6
43
Evening of Study Day 36 to the morning of Study Day 43
Week 7
50
Evening of Study Day 43 to the morning of Study Day 50
Week 8
57
Evening of Study Day 50 to the morning of Study Day 57
Week 9
64
Evening of Study Day 57 to the morning of Study Day 64
Week 10
71
Evening of Study Day 64 to the morning of Study Day 71
Week 11
78
Evening of Study Day 71 to the morning of Study Day 78
Week 12
85
Evening of Study Day 78 to the morning of Study Day 85
Week 13
92
Evening of Study Day 85 to the morning of Study Day 92
Week 14
99
Evening of Study Day 92 to the morning of Study Day 99
Week 15
106
Evening of Study Day 99 to the morning of Study Day 106
Week 16
113
Evening of Study Day 106 to the morning of Study Day 113
Week 17
120
Evening of Study Day 113 to the morning of Study Day 120
Week 18
127
Evening of Study Day 120 to the morning of Study Day 127
Week 19
134
Evening of Study Day 127 to the morning of Study Day 134
Week 20
141
Evening of Study Day 134 to the morning of Study Day 141
Week 21
148
Evening of Study Day 141 to the morning of Study Day 148
Week 22
155
Evening of Study Day 148 to the morning of Study Day 155
Week 23
162
Evening of Study Day 155 to the morning of Study Day 162
Week 24
169
Evening of Study Day 162 to the morning of Study Day 169
The cut-off for data to be considered as in the double-blind period but not in the ANDHI IP 
(and therefore the end of the on-study period for the double-blind) is as follows:
If a patient transitions directly into ANDHI IP from EOT visit (Week 24) then the cut-off is 
the date of the EOT visit (protocol visit 11) inclusive.
If a patient transitions into ANDHI IP after follow-up visit 12 then the cut-off is the date of 
the day before protocol visit 13.
If a patient does not enter ANDHI IP then for efficacy the cut-off is EOT visit and for safety 
the cut-off is protocol visit 12 inclusive.
Any data that are to be continued to be captured in ANDHI IP such as AEs and exacerbations 
that were ongoing at the time of this cut-off shall remain as ongoing. If an AE or exacerbation 


Statistical Analysis Plan 
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shows as resolved after (and including) the date of Visit 13 but started prior to the date of 
Visit 13 it will be shown as ongoing in the double-blind period.
3.2
Calculation or derivation of efficacy variables
3.2.1
Primary outcome variable 
The annualized rate of asthma exacerbation over the 24-week treatment period will be used as 
the primary efficacy variable. 
An asthma exacerbation will be defined as a worsening of asthma that leads to any of the 
following:
!
Use of systemic corticosteroids (or a temporary increase in a stable OCS 
background dose) for at least 3 days; a single depo-injectable dose of 
corticosteroids will be considered equivalent to a 3-day course of systemic 
corticosteroids.
!
An emergency room/urgent care visit (defined as evaluation and treatment for <24 
hours in an emergency department or urgent care center) due to asthma that 
required systemic corticosteroids (as per above).
!
An inpatient hospitalization (defined as admission to an inpatient facility and/or 
evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.
In order to calculate the number of exacerbations experienced by a patient during the 24-week 
treatment period, the following rules will be applied:
!
The start of an exacerbation is defined as the start date of systemic corticosteroids 
or start date of a temporary increase in a stable oral corticosteroid background dose, 
or start date of hospital admission, whichever occurs the earliest.
!
The end date is defined as the last day of systemic corticosteroids or the last day of 
a temporary increase in a stable oral corticosteroid background dose, or the date of 
discharge from a hospital, whichever occurs the latest.
Two or more exacerbations with the same start date and end date will be counted as one 
exacerbation for the purposes of calculating the number and duration of exacerbations for a 
patient. In the case that one or more exacerbations are recorded as starting or ending during 
another exacerbation, these will be counted as one exacerbation, using the earliest 
exacerbation start date and the latest exacerbation stop date to calculate duration.
Additional systemic corticosteroid treatments, emergency room/urgent care visits requiring 
use of systemic corticosteroids, or inpatient hospitalization due to asthma occurring during an 
exacerbation should not be regarded as a new exacerbation. In order to be counted as a new 
exacerbation it must be preceded by at least 7 days in which none of the criteria are fulfilled. 
If 2 or more exacerbations are recorded less than 7 days apart, these will be counted as one 


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exacerbation, using the earliest exacerbation start date and the latest exacerbation stop date to 
calculate duration.
Maximum treatment period for a patient is approximately 24 weeks; defined as the time from 
randomization to the date of EOT visit (Week 24). For patients who discontinue study 
treatment and remain in the study after the IPD visit, exacerbations will be counted from the 
time of randomization up to and including the date of EOT visit. For a patient lost to follow-
up before EOT visit, the treatment period will be defined as the time from randomization to 
the time point after which an exacerbation could not be assessed. Exacerbations that start after 
EOT visit will not be included in the efficacy assessments but will be listed. If a patient misses 
EOT visit, then any exacerbations that start after the scheduled EOT visit date (i.e. Study Day 
169) will be excluded from efficacy assessments. If an exacerbation is ongoing at EOT visit, 
the exacerbation will be counted in the calculation of annual exacerbation rate, however the 
maximum treatment period will be truncated at the date of EOT visit, as will the duration of 
the exacerbation. 
For the production of summary statistics, the annual exacerbation rate in each treatment group 
will be calculated using the time-based approach below:
Annual Exacerbation Rate = 365.25*Total Number of Exacerbations / Total duration of 
follow-up within the treatment group (days). 
The on-treatment annual exacerbation rate will be calculated similarly, as a sensitivity 
analysis, using only exacerbations and follow-up occurring during the on-treatment period.
3.2.2
Key secondary outcome variable 
The change from baseline in SGRQ total score to the EOT visit (Week 24) is the key 
secondary efficacy variable and is included in the multiple testing strategy. 
The SGRQ is a 50-item PRO instrument developed to measure the health status of patients 
with airway obstruction diseases (Jones et al 1991).  The questionnaire is divided into 2 parts: 
part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 
weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the 
individual’s respiratory condition. The SGRQ yields a total score and 3 domain scores 
(symptoms, activity, and impacts). The total score indicates the impact of disease on overall 
health status.  This total score is expressed as a percentage of overall impairment, in which 
100 represents the worst possible health status and 0 indicates the best possible health status.  
Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater 
impairment. Based on empirical data and interviews with patients, a mean change score of 4 
units is associated with a minimal clinically important difference (MCID). Specific details on 
the scoring algorithms are provided by the developer in a user manual (Jones et al 1991).
When considering the derivation of domain scores (as per Jones et al), and the impact of 
missing items on each domain score, the following items should not be considered as missing 
items if logically skipped (in the context of the patient’s prior responses):


Statistical Analysis Plan 
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Question 6: ‘Length of Worst Attack of Chest Trouble; 
!
If a patient reports no ‘severe or very bad unpleasant attacks of chest trouble’ (Q5), the 
length of worst attack (Q6) will be logically skipped and should be imputed as zero 
with no change to the denominator for the domain / total score(s).
Question 8: 'Wheeze Worse in the Morning’;
!
If Frequency of Wheezing Attacks (Q4) is 'Not at All', 'Wheeze Worse in the Morning' 
(Q8) will be logically skipped and should be imputed as zero with no change to the 
denominator for the domain / total score(s).  
Question 14 (parts 1-4): About your medication: ‘Medication Does Not Help Very Much’, 
‘Embarrassed Using Medication in Public’, ‘Having Side Effects From Medication’, 
‘Medication Interferes With Life a Lot’;
!
If a patient is not taking any relevant medication, all medication questions (Q14) will 
be logically skipped.  Therefore if all 4 responses are missing, all will be imputed as 
zero and the denominator for the domain / total score(s) will not be changed.  If at least 
1 of the 4 are answered, any of the remaining questions not answered will be treated as 
missing.  
Potential health status treatment benefits of benralizumab will be evaluated by comparing the 
change from baseline at Weeks 4, 12 and EOT visit in SGRQ total score. A 4-point threshold 
will be used to define the response:
!
SGRQ total score (Week 4/12/EOT visit – baseline) ≤ -4 → Improvement
!
-4 < SGRQ total score (Week 4/12/EOT visit – baseline) < 4 → No change
!
SGRQ total score (Week 4/12/EOT visit – baseline) ≥ 4 → Deterioration
For the responder analysis of SGRQ, a responder at Weeks 4, 12 and EOT will be defined as a 
patient who had improvement at Weeks 4, 12 or EOT visit respectively (i.e., ≥4-point 
decrease in SGRQ total score at Weeks 4, 12 or EOT visit respectively). Patients who had 
SGRQ total score change defined as no change or deterioration will be considered as non-
responders. If SGRQ total score at Weeks 4, 12 or EOT visit is missing and the patient did not 
complete the study, then the patient will be treated as a non-responder at that visit. For 
patients who complete the study but are missing the SGRQ total score at Week 12 or EOT 
visit, their last evaluable post-baseline score prior to that visit (regardless of analysis-defined 
windows) will be used to define the responder status at that visit. For patients who complete 
the study but are missing the SGRQ total score at Week 4, their score will be treated as 
missing at Week 4.  Patients with a missing baseline score will have missing responder status.
The SGRQ domain (symptoms, activity, impacts) scores will be calculated and summarized to 
evaluate the relative contribution of each domain to the total score. 


Statistical Analysis Plan 
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3.2.3
Other secondary outcome variables 
3.2.3.1
Pre-bronchodilator forced expiratory volume in first second (pre-BD FEV1)
The pre-BD FEV1 will be measured by spirometry at the study center. Section 5.1.2 of the 
CSP contains further details of the spirometry recordings. 
The change from baseline and percent change from baseline to each of the post-randomization 
visits over the treatment period up to and including the EOT visit (Week 24) will be used as 
secondary outcome variables. 
3.2.3.2
Asthma control questionnaire 6 (ACQ-6)
The ACQ-6 is a shortened version of the ACQ that assesses asthma symptoms (nighttime 
waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and short 
acting β2 agonist use) omitting the FEV1 measurement from the original ACQ score.
Patients are asked to recall the status of their asthma during the previous week and respond to 
the symptom and bronchodilator use questions of the ACQ-6, on a 7-point scale. The ACQ-6 
questions are weighted equally and scored from 0 (totally controlled) to 6 (severely 
uncontrolled). The mean ACQ-6 score is computed as the mean of the responses from all the 
items in the questionnaire. If response to any of the questions is missing, the ACQ-6 mean 
score will be missing.
The questionnaire will be completed by the patients using the electronic PRO (ePRO) device 
at the site at Visits 1 and 4 then at the patients’ home thereafter, every 7 days (±2 days) for 28 
days (until Visit 6; Week 4) after which it will be completed every 28 days from Visit 7 
(Week 8) to EOT visit (Week 24).
The outcome variable for the ACQ-6 will be the change in mean score from baseline to each 
of the post-randomization assessments up to and including the EOT visit. 
Asthma control responder status will be evaluated as a supportive analysis. Patients will be 
categorized according to the following limits (Juniper et al 2006), where end of treatment is 
defined as EOT visit:
!
ACQ-6 (End of treatment – baseline) ≤-0.5 → Improvement
!
-0.5 < ACQ-6 (End of treatment – baseline) <0.5 → No change
!
ACQ-6 (End of treatment – baseline) ≥0.5 → Deterioration
An ACQ-6 responder will be defined as a patient who had improvement on ACQ-6, i.e., an 
ACQ-6 responder variable takes value 1 if change from baseline to end of treatment in ACQ-6 
≤-0.5 and 0 otherwise. Patients with missing ACQ-6 score at EOT visit and not completing the 
study will be considered non-responders. For patients who complete the study but are missing 
the ACQ-6 score at EOT visit, their last evaluable post-baseline score (regardless of analysis-


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defined windows) will be used to define the responder status.  Patients with a missing baseline 
score will have missing responder status.
Furthermore, patients will be categorized according to their ACQ-6 defined asthma control 
status at the end of treatment using the following score thresholds (Juniper et al 2006):
!
ACQ-6 (End of treatment) ≤0.75 → Well controlled
!
0.75< ACQ-6 (End of treatment) < 1.5 → Partly controlled
!
ACQ-6 (End of treatment) ≥ 1.5 → Not well controlled
Similarly, for patients who complete the study but are missing the ACQ-6 score at EOT visit, 
their last evaluable post-baseline score (regardless of analysis-defined windows) will be used 
to define the asthma control status.
3.2.3.3
Time to first asthma exacerbation 
Time from randomization to the first asthma exacerbation is a secondary efficacy variable and 
is derived as follows:
Start date of first asthma exacerbation − Date of randomization + 1.
An exacerbation event will be defined in the same way as outlined in Section 3.2.1. The time 
to first asthma exacerbation for patients who do not experience an asthma exacerbation during
the treatment period will be censored at EOT visit (Week 24) for patients who complete the 
study. Patients who withdraw from the study or are lost to follow-up before EOT visit will be 
censored at the last visit date after which an exacerbation could not be assessed.   
3.2.3.4
Peak expiratory flow (PEF) assessment at home
Home PEF testing will be performed by the patient each morning after awakening and before 
taking their morning asthma medications, and each evening. Measurements should be taken at 
approximately the same time each day, and recorded in the Asthma Daily Diary.
Weekly means and change from baseline in weekly means will be calculated for morning PEF 
and evening PEF. The maximum of the 3 measurements performed at every morning and 
evening will used in the calculation of the weekly means. A weekly mean is calculated as the 
sum of all non-missing daily measures/scores over the 7 sequential days divided by the 
number of non-missing daily measures/scores. If more than 3 daily measures/scores (>50%) 
within a period are missing, then the weekly mean for that period will be set to ‘missing’.
3.2.3.5
Short form 36-item health survey, version 2 (SF-36v2) 
The SF-36v2 is a 36-item, self-report survey of functional health and well-being, with 1-week 
recall period (QualityMetric 2011). Responses to 35 of the 36 items are used to compute an 8-
domain profile of functional health and well-being scores. The remaining item, referred to as 
the ‘Health Transition’ item, asks patients to rate how their current state of health compared to 


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their state of health 1 week ago, and is not used to calculate domain scores. The 8-domain 
profile consists of the following subscales: Physical Functioning (PF), Role Limitations due to 
Physical Health (RP), Bodily Pain (BP), General Health Perceptions (GH), Vitality (VT), 
Social Functioning (SF), Role Limitations due to Emotional Problems (RE), and Mental 
Health (MH). Psychometrically-based physical and mental health component summary scores 
(PCS and MCS, respectively) are computed from subscale scores to give a broader metric of 
physical and mental health-related quality of life. Computation will be carried out by Optum.
Norm-based scoring (NBS) is used to calculate the eight SF-36v2 subscales and the two 
component scores. NBS standardizes scale and component scores using the means and 
standard deviations from a U.S. general population normative sample derived from responses 
to the internet-based 2009 QualityMetric PRO Norming Study. 
The norm-based scores in the U.S. general population have been set to have a mean of 50 and 
a standard deviation of 10. By using the NBS method, the data in the current study will be 
scored in relation to U.S. general population norms; therefore, all scores obtained that are 
below 50 can be interpreted as being below the U.S. general population norm while scores 
above 50 can be interpreted as above the U.S. general population norm. PCS and MCS scores 
are each calculated through weighted sums of all 8 scale z-scores. A more detailed description
of this scoring process can be found in the SF-36v2 manual (QualityMetric 2011).
Algorithms that allow for the evaluation of SF-36v2 scale and component summary scores in 
the presence of item-level missing data have been previously developed using a combination 
of Item Response Theory, mean substitution, and regression methods. A more detailed 
description of this scoring process, the Missing Score Estimation, can be found in the SF-36v2 
manual (QualityMetric 2011).
Two types of thresholds have been developed for interpretation of SF-36v2 scores (Table 4).  
The first type is suitable for comparing group mean scores and is generally referred to as the 
MCID.  The second type is suitable for interpreting change at the individual level and is 
referred to as the responder threshold or responder definition (QualityMetric 2011).
Table 4
Threshold values for the SF-36v2 scale and summary measures
SF-36v2 score
Threshold
PCS
MCS
PF
RP
BP
GH
VT
SF
RE
MH
Group 
difference
2
3
3
3
3
2
2
3
4
3
Individual 
change
3.4
4.6
4.3
3.4
6.2
7.2
6.2
6.9
4.5
6.2
BP Bodily Pain; GH General Health Perceptions; MCS mental health component summary; MH Mental Health; 
PCS physical component summary; PF Physical Functioning; RE Emotional Problems; RP Role Limitations due 
to Physical Health; SF Social Functioning; VT Vitality.


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The questionnaire will be completed at on-site visits electronically at Visit 4, Visit 8 (Week 
12) and EOT visit (Week 24).
The outcome variable for the SF-36v2 will be the change in subscale/component summary 
score from baseline to each of the post-randomization assessments up to and including the 
EOT visit.  
Patients will also be categorized according to the domains and threshold values in Table 4, 
where end of treatment is defined as EOT visit:
!
SF-36v2 (End of treatment – baseline) ≥ Threshold value → Improvement
!
–Threshold value < SF-36v2 (End of treatment – baseline) < Threshold value → No 
change
!
SF-36v2 (End of treatment – baseline) ≤ –Threshold value → Deterioration.
An SF-36v2 responder will be defined for each scale and component summary score 
separately, as a patient who had improvement on SF-36v2 using the responder threshold in
Table 4, i.e. an SF-36v2 responder variable based on PF domain takes value 1 if change from 
baseline to end of treatment in SF-36v2 PF score ≥4.3 and 0 otherwise. Patients with missing 
SF-36v2 subscale score at EOT visit and not completing the study will be considered non-
responders when categorizing according to that domain. For patients who complete the study 
but missing a SF-36v2 subscale score at EOT visit, their last evaluable post-baseline score of 
that domain (regardless of analysis-defined windows) will be used to define the corresponding 
responder status.  Patients with a missing baseline score will have missing responder status.
3.2.3.6
Patient global impression of severity (PGI-S)
The PGI-S is a single item designed to capture the patient’s perception of overall symptom 
severity at the time of completion using a 6-point categorical response scale (0=no symptoms, 
5=very severe symptoms). 
This questionnaire will be completed on the ePRO device on-site at Visit 4, then at home 
thereafter, every 7 days for 28 days (until Visit 6; Week 4) and every 28 days from Visit 7 
(Week 8) to EOT visit (Week 24).
The shift in PGI-S response from baseline to post-randomization assessments up to and 
including the EOT visit will be used as a secondary efficacy variable.  
Patients will also be categorized according to the following criteria, where end of treatment is 
defined as EOT visit:


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!
PGI-S (End of treatment – baseline) ≤ -1→ Improvement
!
PGI-S (End of treatment – baseline) = 0 i.e. no change in severity → No change
!
PGI-S (End of treatment – baseline) ≥ 1 → Deterioration
!
PGI-S (Baseline) = 4 or 5 or 6 shifting to PGI-S (End of treatment) = 1 or 2 or 3 → 
Important improvement. 
The proportion of patients with improvement and important improvement will be analyzed 
respectively. Patients with missing PGI-S response at EOT visit and not completing the study 
will be considered as no improvement and no important improvement at end of treatment. For 
patients who complete the study but missing PGI-S response at EOT visit, their last evaluable 
post-baseline response (regardless of analysis-defined windows) will be used to define the 
categories above.  Patients with a missing baseline score will have missing responder status.
3.2.3.7
Clinician and patient global impression of change (CGI-C and PGI-C)
CGI-C and PGI-C instruments are used for an overall evaluation of response to treatment. The 
investigators (clinicians) and patients will be asked to rate the degree of change in the overall 
asthma status compared to the start of treatment, i.e., randomization visit. A 7-point rating 
scale will be used: 1=Very Much Improved; 2=Much Improved; 3=Minimally Improved; 
4=No Changes; 5=Minimally Worse; 6=Much Worse and 7=Very Much Worse.
The CGI-C should be completed before other study assessments and IP administration at all 
on-site visits from Visit 5 (Week 2) to EOT visit (Week 24). PGI-C is completed at home by 
the patient on the ePRO device, every 7 days for 28 days (until Visit 6; Week 4) and every 28 
days from Visit 7 (Week 8) to EOT visit (Week 24).
Patients will also be categorized according to the following responses post-baseline, 
separately for CGI-C and PGI-C:
!
Very much improved, much improved, minimally improved → Improved
!
Very much improved, much improved → Much improved
!
Very much improved → Very much improved
Agreement between CGI-C and PGI-C will be assessed at each visit with both instruments 
planned, where agreement is achieved when both the patient and clinician provide the same 
response (e.g., if both the patient and clinician indicate a response of 1 [very much improved] 
at a particular visit, agreement is achieved for that visit). Agreement will also be assessed for 
categorized responses at those visits. Agreement for EOT visit will be assessed before the 
imputation for missing response, as detailed below, is made. 
The proportion of patients categorized as much improved and very much improved at EOT 
visit will be analyzed for CGI-C and PGI-C. For patients who complete the study but missing 


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response at EOT visit, their last evaluable post-baseline response (regardless of analysis-
defined windows) will be used instead.
3.2.3.8
Predominant symptom and impairment assessment (PSIA)
The objective of this assessment is to capture the degree to which patient-stated bothersome 
symptoms and impairments change over time. This is achieved by generating an 
individualized profile of symptoms and impairments ranked in order of importance by the 
patient (to be performed on-site at Visit 3). The initial PSIA, at Visit 3, (Part 1) asks patients 
to review a list of 8 concepts (including cardinal asthma symptoms, activities, awakenings, 
triggers) and select those which are typically bothersome. Part 2 of the initial PSIA asks 
patients to rank the concepts they selected in Part 1 in order of importance: from most 
important (i.e., value of 1) to least important. The initial PSIA assessment produces a rank 
order list of bothersome concepts which will be evaluated in subsequent administrations. 
Part 3 of the PSIA, administered throughout the study period, will ask the patient to record the 
severity of each selected symptom or impairment using an 11-point numeric rating scale 
(NRS) where ‘0’ = ‘did not experience’ and ‘10’ = ‘worst I can imagine’.
The PSIA administered throughout the study period will be individualized per the patient 
ranking. Every 7 days for the first 16 weeks of the treatment period patients will be asked to 
record the severity of the symptoms/impairments previously selected at Visit 3 using the 11-
point NRS.  During this 16-week period patients were also meant to record the degree to 
which each selected symptom changed since starting treatment using a 7 point change scale 
(e.g. much worse, worse, a little worse, no change, a little better, better, much better). 
However this symptom change was only recorded at week 20 (see Section 6 for further 
details).
The NRS response for the patient’s top ranked symptom or impairment will be collected. The 
change in this score from baseline to each of the post-randomization assessments up to and 
including the EOT visit, will be used as an outcome variable for the PSIA to evaluate the 
degree of change during the treatment period.  This will be repeated for the 2nd and 3rd ranked 
symptoms or impairments.
In addition, the average NRS responses from the patient’s top 3 ranked symptoms and 
impairments will be computed at each visit; if any NRS response is missing, the average score 
will be missing. The change in this average score from baseline to each of the post-
randomization assessments up to and including the EOT visit, will also be used as an outcome 
variable for the PSIA to evaluate the degree of change during the treatment period. 
Additionally, for each of the patient’s top 3 ranked symptoms and impairments, the 7-point 
change scale will be used to define an improvement status for that symptom/impairment at 
week 20 from baseline (week 0): 1=Much Better ; 2=Better; 3=A Little Better; 4=About The 
Same; 5=A Little Worse; 6=Worse and 7=Much Worse.  If the degree of symptom change is 
recorded as “better” or “much better”, it is defined as an “improvement”.  Otherwise it is 
defined as “no improvement”.  A combined response status will also be defined at each 


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assessment: if all the patient’s top 3 ranked symptoms and impairments show an 
“improvement”, the combined response is defined as an “improvement”; otherwise, 
“no/partial improvement”.
3.2.3.9
Sino-Nasal outcome test 22 item (SNOT-22)
Patients with baseline chronic rhinosinusitis with nasal polyposis will participate in a sub-
study as outlined in Section 2.1.3. The rhinosinusitis health status and quality of life of the 
patients will be assessed using the 22-item SNOT-22.
The SNOT-22 is a further modification of the SNOT-20 (Piccirillo et al 2002), where the 
scoring has been simplified by removing the importance rating. In addition to the normal 20-
item version of the SNOT, 2 additional items were measured, nasal blockage, and loss of 
sense of taste and smell. Each of the 22-questions is on a 6-point scale ranging from 0 (no 
problem) to 5 (problem as bad as it can be). The total score is calculated as the sum of the 
responses to all questions answered, with a range from 0 to 110 (higher scores indicate poorer 
outcomes). If response to any of the questions is missing, the total score will be missing. A 
MCID of 8.90 has been established (Hopkins et al 2009).
The questionnaire will be completed at on-site visits electronically at Visit 3, Visit 6 (Week 
4), Visit 8 (Week 12) and EOT visit (Week 24).
The outcome variable for the SNOT-22 will be the change in total score from baseline to each 
of the post-randomization assessments up to and including the EOT visit. 
SNOT-22 responder status will be evaluated as a supportive analysis. Patients will be 
categorized according to the following limits, where end of treatment is defined as EOT visit:
!
SNOT-22 (End of treatment – baseline) ≤ -8.9 → Improvement
!
-8.9 < SNOT-22 (End of treatment – baseline) < 8.9 → No change
!
SNOT-22 (End of treatment – baseline) ≥ 8.9 → Deterioration
An SNOT-22 responder will be defined as a patient who had improvement on SNOT-22, i.e., 
an SNOT-22 responder variable takes value 1 if change from baseline to end of treatment in 
SNOT-22 total score ≤ -8.9 and 0 otherwise. Patients within the nasal polyp sub-study 
analysis set, with missing SNOT-22 total score at EOT visit and not completing the study will 
be considered non-responders. For patients who complete the study but missing SNOT-22 
total score at EOT visit, their last evaluable post-baseline total score (regardless of analysis-
defined windows) will be used to define the responder status.  Patients with a missing baseline 
score will have missing responder status.


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3.3
Calculation or derivation of safety variables
The following safety data will be collected in the double-blind period: reported AEs 
(including serious AEs [SAEs]), hematology, clinical chemistry, urinalysis, vital signs, local 
ECGs, and physical examination. 
All safety measurements will use all available data during this period for analyses, including 
data from unscheduled visits and repeated measurements. No safety data will be imputed. 
Change from baseline to each post-treatment time point where scheduled assessments were 
made will be calculated for relevant measurements. AEs will be summarized by means of 
descriptive statistics and qualitative summaries.
3.3.1
Adverse events (AEs)
Adverse events (including SAEs) experienced by the patients will be collected throughout the 
entire study and will be coded by the AstraZeneca designee using the latest version of the 
Medical Dictionary for Regulatory Activities (MedDRA). 
Adverse event data will be categorized according to their onset date into the following study 
periods:
!
AEs in the pre-treatment period are defined as those with onset before the day of 
first dose of study treatment.
!
AEs in the on-treatment period are defined as those with onset between day of first 
dose of study treatment and scheduled EOT visit or IPD visit for those patients who 
prematurely discontinue study treatment, inclusive. If both EOT and IPD visits are 
missing, then the upper limit of the on-treatment period is defined as the day of last 
dose of study treatment + 56 days. If the upper limit is after the end of on-study 
period then set the upper limit to end of on-study period
!
AEs in the on-study period are defined as those with onset between day of first dose 
of study treatment and up to 
(a) the day of the scheduled follow-up visit, inclusive if the patient does not 
enter ANDHI IP.
(b) the day before the scheduled visit 13 if the patient delays transition into 
ANDHI IP.
(c) the day of the scheduled EOT visit inclusive, if the patient transitions 
directly into ANDHI IP from EOT (visit 11).


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3.3.2
Laboratory variables
Blood samples for determination of clinical chemistry and hematology parameters will be 
taken at the times detailed in the CSP, and will be assessed in a central laboratory. The 
parameters outlined in Section 5.2.1, Tables 4 of the CSP will be collected. 
In summaries, listings and figures, lab results and normal ranges will be presented in the 
Standard International (SI) unit. Eosinophils data will be presented in both SI and 
conventional units (cells/μL) in summaries.
Changes in hematology and clinical chemistry variables between baseline and each post-
baseline assessment will be calculated. Baseline is defined as the last available non-missing 
value measured prior to the first dose of study treatment. The change from baseline is defined 
as the post-baseline visit value minus the baseline visit value. There will be no imputation for 
missing values. For values recorded with a leading greater than or less than (‘>’, ‘<’) symbol, 
the reported numeric value will be used for analysis and the value with the symbol will be 
included in the listings, unless otherwise specified. For example, a value of <0.01 will be 
analyzed as 0.01 and listed as <0.01.   
Absolute values will be compared to the relevant reference range and classified as low (below 
range), normal (within range or on limits) or high (above range). The central laboratory 
reference ranges will be used for laboratory variables. All absolute values falling outside the 
reference ranges will be flagged.
For the purposes of hematology and clinical chemistry shift tables, baseline will be defined as 
the last available non-missing value prior to first dose of study treatment, and maximum or 
minimum value post-baseline will be calculated over the entire post-baseline period, including 
the post-treatment period.
For the liver function tests: Aspartate Aminotransferase (AST), Alanine Aminotransferase 
(ALT), Alkaline phosphatase, Gamma-GT (GGT) and total bilirubin (TBL), the multiple of 
the central laboratory upper limit of the normal (ULN) range will be calculated for each data 
point:
Multiple = Value / ULN,
i.e. if the ALT value was 72 IU/L (ULN 36) then the multiple would be 2.
Patients who meet any of the following criteria at any point during the study will be flagged:


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!
AST ≥ 3x ULN 
!
ALT ≥ 3x ULN 
!
TBL ≥ 2x ULN
3.3.3
Vital signs
Pre-dose vital signs (pulse, systolic blood pressure, diastolic blood pressure, respiration rate, 
and body temperature) will be obtained in accordance with the visit schedule provided in 
Table 2 of the CSP.
Changes in vital signs variables between baseline and each subsequent scheduled assessment 
will be calculated. Baseline is defined as the last value prior to the first dose of study 
treatment. The change from baseline is defined as the post-baseline visit value minus the 
baseline visit value. There will be no imputation for missing values.
Absolute values will be compared to the reference ranges in Table 5 and classified as low 
(below range), normal (within range or on limits) or high (above range). All values (absolute 
and change) falling outside the reference ranges will be flagged. 
Table 5
Vital signs reference ranges
Parameter
Standard Units
Lower Limit
Upper Limit
Diastolic Blood Pressure
mmHg
60
120
Systolic Blood Pressure
mmHg
100
160
Pulse Rate
Beats/min
40
120
Respiratory Rate
Breaths/Min
8
28
Body Temperature
Celsius
36.5
38
Weight 
kg
40
200
Body mass index (BMI) will be calculated from the height and weight as follows:
BMI (kg/m2) = weight (kg) / (height (m)) 2
3.3.4
Local ECGs
The outcome of the overall evaluation is to be recorded as normal/abnormal in the CRF, with 
any abnormalities being recorded as not clinically significant or clinically significant.
3.3.5
Physical examination
Complete and brief physical examinations will be performed at time points specified in 
Section 4, Tables 1 and 2 of the CSP. For the physical examinations only information on 
whether the assessment was performed or not is to be recorded.


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Baseline data will be collected at Visit 1. Any new finding(s) or aggravated existing 
finding(s), judged as clinically significant by the investigator or designee, will be reported as 
an AE.
3.4
Other asthma control variables
Daily diary metrics (rescue medication use, awakenings due to asthma symptoms requiring 
rescue medication, and asthma symptom scores) will be used as additional asthma control 
variables in support of primary analysis, and will be derived from the data collected through 
the ePRO device. Daily diary metrics will be recorded in the Asthma Daily Diary each day 
from the evening of Visit 2 to the morning of Visit 11.
Baseline is defined as the average of the last 7 days before randomization for the daily 
metrics, as defined in Section 3.1.1. Post-randomization periods for the daily diary metrics 
will be defined for the calculation of weekly means using the analysis-defined study windows 
described in Section 3.1.3 and listed in Table 3.  
The post-randomization weekly means for daily diary metrics are calculated as the sum of all 
non-missing daily measures/scores over the 7 day window divided by the number of non-
missing daily measures/scores. If more than 3 daily measures/scores (>50%) within that 
window are missing, then the mean daily measure/score for that period will be set to missing. 
3.4.1
Asthma symptom score
Asthma symptoms during night-time and daytime will be recorded by the patient each 
morning and evening in the Asthma Daily Diary. Symptoms will be recorded using a scale of 
0-3, where 0 indicates no asthma symptoms. Asthma symptom daytime score (recorded in the 
evening), night-time score (recorded in the morning of the next calendar day), and total score 
will be calculated and presented separately. The daily asthma symptom total score will be 
calculated by taking the sum of the daytime score recorded in the evening and the night-time 
score recorded the following morning. If a patient is missing a value for either the daytime or 
night-time asthma symptom score on a given day, then the total score for that day will be set 
to missing. 
Weekly mean scores and change from baseline in weekly mean scores will be calculated for 
total asthma symptom score, daytime asthma symptom score and night-time asthma symptom 
score.  
The number of asthma symptom-free days will be calculated for each patient as the total 
number of days in the 24-week treatment period where the total asthma symptom score is 0. 
The proportion of asthma symptom-free days will be calculated using the total number of days 
with completed asthma symptom score diary during the 24-week treatment period as the 
denominator.


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3.4.2
Rescue medication
The number of times (occasions) rescue medication inhalations and nebulizer treatments taken 
will be recorded by the patient in the Asthma Daily Diary twice daily. Daytime use is recorded 
in the evening and night-time use is recorded in the morning of the next calendar day. Rescue 
medication inhaler usage will be captured as the number of times (occasions) that the patient 
used inhaler irrespective of number of puffs taken. Nebulizer use is the same as one occasion 
of inhaler use. 
The number of times (occasions) rescue medication inhalations and nebulizer treatments 
captured in the Asthma Daily Diary each day will be calculated per patient. If a patient is 
missing a value for either daytime or night-time rescue medication use on a given day, then 
the total rescue medication use for that day will be set to missing.  
Total rescue medication use (inhaler and/or nebulizer), defined as number of times per day 
will be calculated as follows:
Number of daytime inhaler times (recorded in the evening) + number of daytime nebulizer 
times (recorded in the evening) + number of night-time inhaler times (recorded the next 
morning) + number of night-time nebulizer times (recorded the next morning).
Total reliever inhaler use (number of times) per day will be calculated as:
Number of daytime inhaler times (recorded in the evening diary) + number of nighttime 
inhaler times (recorded in the morning diary for next calendar day).
Total nebulizer use (number of times) per day will be calculated as:
Number of daytime nebulizer times (recorded in the evening diary) + number of nighttime 
nebulizer times (recorded in the morning diary for next calendar day).
Weekly mean rescue medication use (average number of times/day) and change from baseline 
in weekly mean rescue medication use will be calculated. If more than 3 daily entries within 
that period are missing, then the average will be set to missing.
3.4.3
Night-time awakening due to asthma
Night-time awakenings due to asthma symptoms and requiring rescue medication use will be 
recorded by the patient in the Asthma Daily Diary each morning by answering the question 
whether he/she woke up during the night due to asthma symptoms by a “yes” or “no” 
response, as well as the follow-up question whether he/she used rescue medication upon 
awakening during the night.
The weekly proportion of nights with nocturnal awakenings for the patient due to asthma and 
requiring rescue medication use out of the nights with non-missing nighttime awakening data 
and the corresponding change from baseline for each post-randomization period will be 
calculated. 


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The weekly proportion will be calculated as the number of times the answers to each of the 
questions (“Did your asthma casue you to wake up during the night?” and “Did you use your 
rescue medication upon awakening during the night?”) over the 7 day window are non-
missing and equal to “Yes”, divided by the number of times the answer to the question “Did 
your asthma cause you to wake up during the night?” is non-missing, and multiplied by 100.  
If more than 3 days have missing answers (>50%) within that window (excluding any missing 
that are logically skipped), then the weekly proportion for that period will be set to missing.
(i.e. if ‘ Did your asthma casue you to wake up during the night?’ is ‘No’, then ‘Did you use 
your rescue medication upon awakening during the night?’ should not be considered missing.)
In addition, the proportion of nights with awakenings independent of rescue medication use 
during the randomized treatment period will also be calculated similarly.
3.4.4
Composition of daily diary measures
Daily diary metrics will be used to determine asthma control status based on the GINA control 
definition (GINA 2018).  Asthma control will be assessed:
!
On a weekly basis using diary data from the previous 7 days (regardless of analysis-
defined windows), from week 1 until week 24 (EOT) (or study discontinuation if 
sooner); and 
!
At weeks 4, 8, 12, 16, 20 and 24 (EOT) based on diary data from the previous 4 
weeks.  
Baseline asthma control status will be determined at week 0 (visit 4) based on the previous 7 
days’ / 4 weeks’ diary data as appropriate.
Asthma control status will be determined in accordance with Table 6 for 7 day assessment and 
Table 7 for 4 week assessment:


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Table 6
Asthma control status based on 7 days previous data
GINA Control Criterion
Asthma Control Status
Daytime symptom score > 0 no more than 
twice in the 7 previous days
Well controlled:
All criteria met and no protocol-defined exacerbation
Partly controlled:
1-2 of these criteria not met and no protocol-defined 
exacerbation
Uncontrolled:
3-4 of these criteria not met and/or ≥ 1 protocol-
defined exacerbation
No nocturnal awakenings due to asthma and 
night-time symptom score = 0 every night in 
the 7 previous days
Total rescue medication use > 0 no more than 
twice in the 7 previous days
Daytime asthma symptom score < 2 every 
day of the 7 previous days
Table 7
Asthma control status based on previous 4 weeks data
GINA Control Criterion
Asthma Control Status
Daytime symptom score > 0 no more than 
twice in each of the 4 previous weeks
Well controlled:
All criteria met and no protocol-defined exacerbation
Partly controlled:
1-2 of these criteria not met and no protocol-defined 
exacerbation
Uncontrolled:
3-4 of these criteria not met and/or ≥ 1 protocol-
defined exacerbation
No nocturnal awakenings due to asthma and 
night-time symptom score = 0 every night in 
each of the 4 previous weeks
Total rescue medication use > 0 no more than 
twice in each of the 4 previous weeks
Daytime asthma symptom score < 2 every 
day in each of the 4 previous weeks
If missing data prevent the asthma control status from being determined, control status will be 
set to missing.  Note that a limited amount of missing data may still allow the control status 
(particularly an uncontrolled status) to be determined.  Patients who withdraw from the study 
prior to EOT will have control status at EOT set to missing.
The time to the first well-controlled week (based on the previous 7 days’ diary data) will also 
be recorded and defined as follows: 


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End date of first asthma well-controlled week (scheduled study date of week  per Table 2) − 
Date of randomization + 1.
The time to first asthma well-controlled week for patients who do not experience an asthma 
well-controlled week during the treatment period will be censored at EOT visit (Week 24) for 
patients who complete the study. Patients who withdraw from the study or are lost to follow-
up before EOT visit will be censored at the last week an asthma well-controlled week is 
assessed.   
An EOT control indicator variable will be created to assess asthma control status based on the 
data collected in the 4 weeks prior to EOT. This variable will be set to 1 if asthma control 
status, assessed over the 4 weeks prior to EOT, is well-controlled and 0 otherwise.   Patients 
with missing EOT control status who do not complete the study will have their control 
indicator variable set to 0.  For patients who complete the study, but are missing EOT control 
status their last available assessment of control (regardless of analysis-defined windows) will 
be used to determine their control indicator variable..
A second EOT control indicator variable will be created following the rules above, except it 
will be set to 1 if asthma control status, assessed over the 4 weeks prior to EOT, is well-
controlled or partly controlled.
4.
ANALYSIS METHODS
4.1
General principles
The analysis of the efficacy endpoints will include all data captured during the 24-week 
double-blind treatment period, defined as the period after randomization at Visit 4 and the 
conclusion of EOT visit, inclusive. This includes data regardless of whether study treatment 
was prematurely discontinued, or delayed, and/or irrespective of protocol adherence, unless 
the patient withdraws consent to study participation. The statistical analyses will compare 
benralizumab to placebo. 
The analysis of safety endpoints will include all data captured during the double-blind on-
study period, defined as the period after first administration of IP at Visit 4 and up to
(a) For patients who do not enter ANDHI IP: the conclusion of the scheduled post-
treatment follow up visit, inclusive for adverse events and concomitant medications. 
For all other safety endpoints the conclusion of the scheduled end of treatment visit.
(b) For patients who transition directly into ANDHI IP: the conclusion of the scheduled 
end of treatment visit for all safety endpoints.
(c) For patients who have delayed transition into ANDHI IP: the day before the date of 
first run-in visit for ANDHI IP, inclusive for adverse events and concomitant 
medications. For all other safety endpoints the conclusion of the scheduled end of 
treatment visit. 


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Statistical models will include stratification factors based on CRF data for previous 
exacerbations, maintenance OCS use at baseline, and region, and not data entered in IVRS 
unless specified otherwise. 
If the number of previous exacerbations is missing from the CRF, the following imputation 
will be applied for the purposes of the statistical modelling: 
!
Previous exacerbations entered in IVRS =2, CRF previous exacerbations = 2;  
!
Previous exacerbations entered in IVRS >=3, CRF previous exacerbations = 3.
P-values will be rounded to 4 decimal places.
4.1.1
Testing strategy to account for multiplicity considerations
To account for multiplicity to test one primary variable and one key secondary variable, the 
following hierarchical testing strategy to control for the overall type-1 error (0.05) will be 
adopted:
!
Initially, test the annualized asthma exacerbation rate at the two-sided 5% 
significance level
!
If annualized asthma exacerbation rate is significant (i.e., the p-value for the 
primary analysis is less than 0.05) then test SGRQ total score change from baseline 
to EOT visit at the two-sided 5% significance level 
4.2
Analysis methods
4.2.1
Patient disposition
Patient disposition will be summarized using the all patients analysis set. The total number of 
patients will be summarized for the following groups: those who enrolled, those who entered 
run-in, and those who were not randomized (and reason). The number and percentage of 
patients within each treatment group will be presented by the following categories: 
randomized, not randomized (and reason), received treatment with study drug, did not receive 
treatment with study drug (and reason), completed treatment with study drug, discontinued 
treatment with study drug (and reason), discontinued treatment with study drug but completed 
study follow-up, completed double-blind period of the study, and withdrawn from double-
blind period of the study (and reason). The number of patients who transitioned into the open 
label ANDHI IP substudy will also be presented.
The number of patients randomized by region, country and center will be summarized by 
treatment group in the full analysis set.
4.2.2
Demography data and patient characteristics
Demography data such as age (as continuous and categorical variable in 3 categories: <50 
years / ≥50 to <65 years / ≥ 65 years), country, gender, race, and ethnicity will be summarized


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by treatment group and for all patients in the full analysis set. Age will be derived from the 
date of informed consent-date of birth, rounded down to the nearest integer. For patients in 
countries where date of birth is not recorded the age as recorded in the CRF will be used.  The 
table will be repeated for patients with screening blood eosinophil count:
!
≥150 -<300 cells/μL and
!
≥300 cells/μL.
Various baseline characteristics will also be summarized by treatment group and for all 
patients in the full analysis set. These include patient characteristics (weight, height and BMI), 
blood eosinophil count at baseline (as continuous and categorical variable in 3 categories: 
<300 cells/μL / ≥300 to <450 cells/μL /  ≥450 cells/μL) and at screening (first assessment with 
blood eosinophil count ≥300 cells/μL before Visit 4 if achieved, otherwise first assessment 
≥150 cells/μL before Visit 4 and categorized as  ≥150 to <300 cells/μL / ≥300 cells/μL; and 
for the former category the additional clinical criteria met for study inclusion (see Inclusion 
Criterion #8 in CSP), and subjects meeting at least 1 of the additional clinical criteria), total 
IgE and Phadiatop, smoking status, medical and surgical histories, lung function data at 
screening (i.e. FEV1, FEV1/FVC, reversibility), PRO and diary data at baseline, home lung 
function (morning and evening PEF) at baseline, and respiratory disease characteristics 
including asthma duration, age at onset of asthma, the number of exacerbations in the previous 
12 months, and the number of exacerbations requiring hospitalizations in the previous 12 
months.  Lung function data at screening, PRO and diary data at baseline and respiratory 
disease characteristics at study entry will be repeated for patients with screening blood 
eosinophil count: 
!
≥150 - <300 cells/μL and 
!
≥300 cells/μL.
Medical and surgical histories will be summarized by MedDRA Preferred Term (PT) within 
MedDRA System Organ Class (SOC).
4.2.3
Prior and concomitant medications
A medication will be classified as a maintenance asthma medication at baseline if it started 
prior to or on the date of randomization and was ongoing after randomization. Maintenance 
asthma medications with a stop date on the date of randomization will be considered as prior 
medication. ICS doses will be converted to their Fluticasone Propionate equivalent in 
micrograms and OCS doses will be converted to their Prednisolone equivalent in milligrams.
A medication will be regarded as prior if it was stopped on or before the date of randomization 
(medication stop date ≤ date of randomization). A medication will be regarded as concomitant 
if the start date is on or after the date of randomization, or if it started prior to the date of 
randomization and was ongoing after the date of randomization. Medications with start date 
after the on-treatment period (as defined for AEs in Section 3.3.1) will not be considered as 


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concomitant. The handling of partial or missing dates for prior and concomitant medications is 
detailed in Appendix II.
The number and percentage of patients taking maintenance asthma medications, including 
ICS/LABA fixed dose combinations, at baseline will be summarized and for those patients 
taking ICS and OCS at baseline, the converted dose will be summarized. The proportion of 
patients taking maintenance OCS at baseline will also be categorized by screening blood 
eosinophil count (≥150 - <300 cells/μL / ≥300 cells/μL).  The number of patients treated with 
ICS at baseline will be summarized by ATC code and preferred term, with total daily dose 
(non-converted) at baseline summarized for each preferred term. 
The number and percentage of patients who take prior medications, will be presented by 
treatment group. Medications will be classified according to the WHO Drug Dictionary 
(WHO DD). The summary table will present data by generic term within ATC code. 
Total number and percentage of days on systemic corticosteroid treatment associated with 
asthma exacerbations and cumulative OCS dose associated with asthma exacerbations during 
the treatment period will be summarized descriptively by treatment group for the full analysis 
set.
4.2.4
Study treatments
4.2.4.1
Exposure
Exposure to IP will be calculated in days as:
Last dose date of IP in double-blind treatment period-first dose date of IP+1,
and will be summarized by treatment group for the safety analysis set.
4.2.4.2
Compliance
Study treatment compliance in the double-blind treatment period will be summarized 
descriptively for the full analysis set and will be calculated as:
(Total doses administered/total doses expected) x 100.
Patients who received no study treatment in the double-blind treatment period will have zero 
compliance.
4.2.5
Analysis of the primary variable
The primary efficacy variable is the annualized rate of asthma exacerbations and the primary 
analysis is to compare the exacerbation rate of benralizumab with placebo based on the full 
analysis set.  
The null hypothesis is that the exacerbation rate on benralizumab is equal to the exacerbation 
rate on placebo. The alternative hypothesis is that the exacerbation rate on benralizumab is not 
equal to the exacerbation rate on placebo, i.e.:


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H0: Rate ratio (benralizumab vs placebo) = 1
Ha: Rate ratio (benralizumab vs placebo) ≠ 1
The exacerbation rate on benralizumab will be compared to the exacerbation rate on placebo 
using a negative binomial model for the primary analysis. The response variable in the model 
will be the number of asthma exacerbations experienced by a patient, over the 24-week 
double-blind treatment period. The model will include covariates of treatment group, region 
(North America/rest of world), number of exacerbations in previous year (count, as a 
continuous variable ) , and maintenance OCS use at baseline (yes/no). Number of 
exacerbations in previous year (count) will not be used as a covariate in the subgroup analysis 
by number of exacerbations in previous year (categorical). The logarithm of the patient’s 
corresponding treatment period will be used as an offset variable in the model to adjust for 
patients having different exposure times during which the events occur.
The estimated treatment effect (i.e., the rate ratio of benralizumab versus placebo), 
corresponding 95% CI, and 2-sided p-value for the rate ratio will be presented. In addition, the 
annual exacerbation rate and the corresponding 95% CI within each treatment group and the 
absolute difference between treatment groups with the corresponding 95% CI will be 
presented. Marginal standardization methods will be used on the model estimates for all 
negative binomial analyses, unless otherwise specified.
The above analysis will be repeated for the following: 
!
Modification of primary endpoint: Exacerbations associated with hospitalization 
and/or emergency room visit
!
Patients with screening blood eosinophil count ≥150 - <300/  μL
!
Patients with screening blood eosinophil count ≥300/  μL
!
Patients with screening blood eosinophil count ≥150 - <400/  μL
!
Patients with screening blood eosinophil count ≥400/  μL
!
Patients with screening blood eosinophil count ≥150 - <500/  μL
!
Patients with screening blood eosinophil count ≥500/  μL
Asthma exacerbation summary statistics will be presented based on the full analysis set by 
treatment group.
Sensitivity analyses 
Sensitivity analyses to assess the robustness of the primary analysis results to missing data as 
outlined in Appendix I may be conducted depending on the amount of missing data due to 
patients who discontinue IP and/or withdraw from the study. 


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In addition, the following analyses will also be performed: 
!
A Poisson regression model taking over dispersion into account will be included as 
a sensitivity analysis for the primary analysis. The correction for potential over 
dispersion will be made by Pearson chi-square. The response variable, covariates 
and offset variable will be the same as described for the primary analysis.  
!
The primary analysis will be repeated where the time at risk (which is included in 
the model as an offset variable) excludes any time during which a patient is having 
an exacerbation (where exacerbation is as detailed in Section 3.3.1 plus 7 days).
Additional sensitivity analyses may be conducted on the primary and key secondary endpoints 
to investigate the sensitivity of the efficacy conclusions upon removal of patient data from:
!
Sites with data anomalies; and/or 
!
Patients with important protocol deviations that may have a direct effect on efficacy 
results (for example: non-qualifying blood eosinophil counts during screening).
Subgroup analyses
To explore the uniformity of the detected overall treatment effect on the primary efficacy 
variable, subgroup analyses and statistical modeling including testing for interaction between 
treatment and covariates will be performed on the full analysis set for the following factors:
!
Gender (male, female)
!
BMI (≤30 kg/m2, >30 kg/m2)
!
Geographic region (North America, rest of world)
!
Number of exacerbations in previous year (2, ≥3 exacerbations)
!
History of nasal polyps (yes, no) 
!
Age at asthma onset (<18, ≥18 years)
!
Screening blood eosinophil counts (≥150 - <300/ μL and ≥300)
!
FVC % predicted at baseline (<65%, ≥65%)
!
Maintenance OCS use at baseline (yes, no)
For each of the subgroup factors in turn, a separate negative binomial regression model will be 
fitted using the same model terms as used for the primary analysis, with additional terms for 
the subgroup main effect and the treatment by subgroup interaction. The p value of the 


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treatment by subgroup interaction will be presented. Similar output will be presented for each 
subgroup as for the primary analysis.
It is important to note that the study has not been designed or powered to assess efficacy 
within any of these pre-defined subgroups, and as such these analyses are considered as 
exploratory. If any model does not converge, sub-groups may be collapsed appropriately.
4.2.6
Analysis of the key secondary variable
Change from baseline in SGRQ total score at EOT visit is a multiplicity protected key 
secondary efficacy variable (Section 4.1.1).
Change from baseline in SGRQ total score at EOT visit will be compared between the 
benralizumab group and the placebo group using a restricted maximum likelihood (REML) 
based on  a mixed-effect model for repeated measures (MMRM) analysis on patients with a 
baseline SGRQ total score and at least one post-randomization SGRQ total score in the full 
analysis set. 
The dependent variable will be the change from baseline in SGRQ total score at post-baseline 
protocol-specified visits (up to the EOT visit). Treatment group will be fitted as the 
explanatory variable, region (North America/rest of world), number of exacerbations in 
previous year, maintenance OCS use at baseline (yes/no), visit, and treatment*visit interaction 
as fixed effects and baseline SGRQ total score as a covariate. The variance-covariance matrix 
will be assumed to be unstructured. If the procedure does not converge then a compound 
symmetric variance-covariance matrix will be used instead. If the procedure still does not 
converge other structures for the matrix will be explored and/or the covariates will be 
explored to see if, for example, changing from counts to categorical data leads to 
convergence,if a covariate should be removed, or if the OM option below should be removed. 
The model is:
Change from baseline in SGRQ total score = Treatment group + baseline SGRQ total score + 
region + maintenance OCS use at baseline + number of exacerbations in previous year + 
visit + treatment*visit
Results will be presented in terms of least square means (LSMEANS), treatment differences 
in LSMEANS, 95% CI and p-values for all visits. The results at EOT visit (Week 24) will be 
of primary interest. The LSMEANS will be calculated using the OM option in the LSMEANS 
statement and the visit by treatment interaction to provide an LSMEAN estimate for each 
scheduled visit.
Sensitivity analyses to assess the robustness of the repeated measures analysis to missing data 
as outlined in Appendix I may be conducted depending on the amount of missing data due to 
patients who discontinue IP and/or withdraw from the study.  


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Subgroup analyses, using the same MMRM model defined above with additional terms for the 
subgroup main effect and the treatment by subgroup interaction, will be conducted for the 
factors previously specified in Section 4.2.5 based on the full analysis set. 
Summary statistics for change from baseline in SGRQ total score and the domain and 
component scores will be produced by treatment group and visit.
The proportion of patients in terms of SGRQ total score response status (improvement, 
deterioration, no change, and missing) at Weeks 4, 12 and EOT will be summarized 
descriptively by treatment group. The corresponding SGRQ total score responder statuses will 
be analyzed using a logistic regression model with covariates of treatment, region (North 
America/rest of world), number of exacerbations in previous year, maintenance OCS use at 
baseline (yes/no) and baseline SGRQ total score. The results of the analyses will be presented 
as odds ratios with associated 95% CIs and 2-sided p-values.
Change from baseline in SGRQ domain scores (symptoms, activity, and impacts) during the 
24-week treatment period will be analyzed separately using a similar model as the above 
MMRM model for change from baseline in SGRQ total score. 
4.2.7
Analysis of the other secondary variables
4.2.7.1
Pre-bronchodilator forced expiratory volume in first second (pre-BD FEV1)
Change from baseline and percent change from baseline in pre-BD FEV1 over the 24-week 
treatment period will be summarized. Change from baseline in pre-BD FEV1 over the 24-
week treatment period will also be analyzed using the same method, MMRM, as for the 
primary analysis of SGRQ total score described in Section 4.2.6, for patients in the full 
analysis set. Included in the model will be the baseline pre-BD FEV1 measurement plus age 
(or age group [in 3 categories as specified in Section 4.2.2] dependent on model 
fit/convergence) and gender. No sensitivity analysis will be performed for this endpoint. 
Subgroup analyses, using the same MMRM model as the primary analysis of this endpoint 
with additional terms for the subgroup main effect and the treatment by subgroup interaction, 
will also be conducted for the factors previously specified in Section 4.2.5 based on the full 
analysis set.   
4.2.7.2
Asthma control questionnaire 6 (ACQ-6)
Change from baseline in ACQ-6 score will be summarized and analyzed using the same 
method, MMRM, as for the primary analysis of SGRQ total score described in Section 4.2.6, 
for patients in the full analysis set. Included in the model will be the baseline ACQ-6 mean 
score. Sensitivity analyses will not be performed. 
Subgroup analyses, using the same MMRM model as the primary analysis of this endpoint 
with additional terms for the subgroup main effect and the treatment by subgroup interaction, 
will also be conducted for the factors previously specified in Section 4.2.5.


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Asthma control responder status based on ACQ-6 at EOT, as defined in Section 3.2.3.2, will 
be analyzed using the same method, logistic regression model, as for SGRQ total score 
responder status described in Section 4.2.6. 
The number and percentage of patients achieving an improvement, no change, or
deterioration, and the number and percentage of patients achieving mean ACQ-6 ≤ 0.75 (Well 
controlled), >0.75 - < 1.5 (Partly controlled) and ≥ 1.5 (Not well controlled) at EOT as defined 
in Section 3.2.3.2 will be summarized by treatment group.
4.2.7.3
Time to first asthma exacerbation
Time to first asthma exacerbation will be analyzed as supportive efficacy variable to the 
primary objective to explore the extent to which treatment with benralizumab delays the time 
to first exacerbation compared with placebo. A Cox proportional hazard model will be fitted 
to data with the covariates of treatment, region (North America/rest of world), number of 
exacerbations in previous year, maintenance OCS use at baseline (yes/no). The model will 
include Efron method for handling ties (TIES=EFRON), and the confidence intervals for 
hazard ratios will be calculated using profile-likelihood confidence limits (RL=PL).
Results of these analyses will be summarized as hazard ratios, 95% confidence intervals and 
p-values for patients in the full analysis set.
Time to first asthma exacerbation will be displayed graphically using a Kaplan-Meier plot.   
4.2.7.4
Peak expiratory flow (PEF) assessment at home
Change from baseline in weekly mean morning and evening PEF will each be summarized 
and analyzed using the same method, MMRM, as for the primary analysis of SGRQ total 
score described in Section 4.2.6, for patients in the full analysis set. Included in the model will 
be the baseline morning and evening PEF. Sensitivity and subgroup analyses will not be 
performed.
4.2.7.5
Short form 36-item health survey, version 2 (SF-36v2)
Change from baseline in SF-36v2 subscale and component summary scores (PF, RP, BP, GH, 
VT, SF, RE, MH, PCS, MCS) will each be summarized and analyzed using the same method, 
MMRM, as for the primary analysis of SGRQ total score described in Section 4.2.6, for 
patients in the full analysis set. Included in the model will be the corresponding baseline score. 
Sensitivity and subgroup analyses will not be performed.
The SF-36v2 responder statuses based on subscale and component summary scores at EOT 
and the responder threshold values, as defined in Section 3.2.3.5, will each be analyzed using 
the same method, logistic regression model, as for SGRQ total score responder status 
described in Section 4.2.6. 


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4.2.7.6
Patient global impression of severity (PGI-S)
The patients’ improvement statuses (improvement, important improvement) based on PGI-S at 
EOT, as defined in Section 3.2.3.6, will each be analyzed using the same method, logistic 
regression model, as for SGRQ total score responder status described in Section 4.2.6, for 
patients in the full analysis set. Included in the model will be the baseline PGI-S response.
The number and percentage of patients in each category of the PGI-S responses will be 
summarized by treatment group and visit, along with a shift table to demonstrate the change 
from baseline in PGI-S categories throughout the treatment period. 
4.2.7.7
Clinician and patient global impression of change (CGI-C and PGI-C)
The CGI-C and PGI-C responses will be summarized by treatment group and visit for patients 
in the full analysis set. The number and percentage of patients will be presented for CGI-C, 
PGI-C, and for agreement in CGI-C and PGI-C responses as described in Section 3.2.3.7.
The number and percentage of patients defined as responders based on categorized responses 
for CGI-C and PGI-C (improved, much improved, very much improved) will also be 
presented by treatment group and visit. 
The CGI-C’s and PGI-C’s responder statuses (much improved, very much improved) at EOT 
will each be analyzed using the same method, logistic regression model, as for SGRQ total 
score responder status described in Section 4.2.6. No baseline response will be included in the 
model. 
4.2.7.8
Predominant symptom and impairment assessment (PSIA)
For each of the PSIA symptom / impairment concepts, the number and percentage of patients 
ranking the concepts 1st through to 8th as well as “Not Scored”, as part of the initial PSIA, 
will be summarized descriptively by treatment group for the full analysis set.
The change from baseline (Visit 4) in severity of each patient’s top ranked 
symptom/impairment, based on NRS responses as defined in Section 3.2.3.8, will be 
summarized and analyzed using the same method, MMRM, as for the primary analysis of 
SGRQ total score described in Section 4.2.6, for patients with a baseline score and at least one 
post-baseline rating in the full analysis set.  The corresponding baseline score will be included 
in the model.  Sensitivity and subgroup analyses will not be performed.  The absolute severity 
at baseline and at each assessment will also be summarized.  This will be repeated for each of 
the 2nd and 3rd ranked symptoms/impairments.
The change from baseline in the average of each patient’s top 3 ranked symptoms and 
impairments will be summarized and analyzed using a MMRM, as above.  The average of the 
patient’s top 3 ranked symptoms and impairments at baseline will be included in the model.  
The absolute average severity at baseline and at each assessment will also be summarized.


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The number and percentage of patients in each category of the change scale responses will be 
summarized descriptively by treatment group at week 20 for each ranked symptom/ 
impairment (ranked 1st, 2nd, 3rd through to 8th).
The number and proportion of patients recording an “improvement” in their top ranked 
symptom/impairment will be summarized by treatment group at week 20, for the full analysis 
set.  95% confidence intervals about the proportions (calculated using the exact Clopper-
Pearson formula) will be presented.  The number of patients in each treatment group with 
missing data at Week 20 will also be reported.  The above analysis will be repeated for the 
2nd and 3rd top ranked symptoms/impairments and for the combined response (based on the 3 
top ranked symptoms and impairments: see Section 3.2.3.8).  Note that when calculating these 
proportions, the denominator will be the number of patients with an assessment of 1, 2 or 3 
ranked (respectively) bothersome symptoms/impairments at Week 20.  This is not consistent 
with other “responder”-type analyses in this study but because change data were not collected 
prior to Week 20 (see Section 6), LOCF imputation for any missing data is not possible.
Improvement status at week 20 for the top ranked symptom/impairment will be analyzed 
using the same method, logistic regression model, as for the SGRQ total score responder 
status described in Section 4.2.6.  No baseline response will be included in the model.  This 
analysis will be repeated for the combined response (based on the 3 top ranked symptoms and 
impairments) at Week 20.
4.2.7.9
Sino-Nasal outcome test 22 item (SNOT-22)
Change from baseline in SNOT-22 total score will be summarized and analyzed using the 
same method, MMRM, as for the primary analysis of SGRQ total score described in Section 
4.2.6, for patients in the chronic rhinosinusitis with nasal polyposis sub-study analysis set. 
Included in the model will be the baseline SNOT-22 total score. Sensitivity and subgroup 
analyses will not be performed.
The SNOT-22 responder status based on SNOT-22 total score at EOT, as defined in Section 
3.2.3.9, will be analyzed using the same method, logistic regression model, as for SGRQ total 
score responder status described in Section 4.2.6. 
The analyses described above will be repeated for patients with SNOT-22 total score at 
baseline >30.
4.2.8
Analysis of safety variables
All safety variables will be summarized using the safety analysis set and data presented
according to treatment received.
4.2.8.1
Adverse events (AEs)
Adverse events will be summarized separately for the on-study and on-treatment periods, as 
defined in Section 3.3.1. All AEs will be listed for each patient, regardless of treatment period. 
All summaries will be presented by treatment group.


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An overall summary table will be produced showing the number and percentage of patients 
with at least 1 AE in any of the following categories: AEs, SAEs, AEs with outcome of death, 
and AEs leading to discontinuation of IP (DAEs). The total number of AEs in the different AE 
categories in terms of AE counts will also be presented (i.e., accounting for multiple 
occurrences of the same event in a patient).  
Adverse events, AEs with outcome of death, SAEs, and DAEs will be summarized by SOC 
and PT assigned to the event by MedDRA. For each PT, the number and percentage of 
patients reporting at least one occurrence will be presented, i.e. for a patient, multiple 
occurrences of an AE will only be counted once. SAEs causing discontinuation of the study 
treatment and SAEs causing discontinuation from the study will also be summarized. 
The number of AEs and SAEs will also be summarized by SOC and PT by MedDRA for the 
on-study and on-treatment periods. For each PT, the number of occurrences will be presented.
The incidence rate of AEs per person-years at risk, calculated as (number of patients reporting 
AE)/ (total period with patients at risk of AE), will also be reported for the on-study and on-
treatment periods. The total period at risk for each patient will be defined as the period from 
first dose of study treatment to the date of the EOT or IPD visit, or day of last dose of study 
treatment + 56 days when both EOT or IPD visits are missing, or end of study date if day of 
last dose of study treatment + 56 days is after end of study date (see Section 3.3.1) for the on-
treatment period; and as the period from first dose of study treatment to the EOT visit, follow-
up visit or scheduled visit  13 (see Section 3.3.1) for the on-study period. Rates will be 
expressed in terms of events per 100 patient-years. 
A summary of the most common (frequency of >5%) AEs and will be presented by PT. AEs, 
SAEs and DAEs will be summarized by preferred term and investigator’s causality 
assessment (related vs. not related) and maximum intensity. If a patient reports multiple 
occurrences of the same AE within the same study period, the maximum intensity will be 
taken as the highest recorded maximum intensity (the order being mild, moderate, and severe). 
Adverse events of injection site reactions (high level term of administration and injection site) 
and hypersensitivity (standardized MedDRA query of hypersensitivity) will be summarized by 
preferred term. Hypersensitivity events will be listed.
Separate listings of patients with AEs, AEs with outcome of death, SAEs, or DAEs will be 
presented.
4.2.8.2
Laboratory data 
All continuous laboratory parameters will be summarized descriptively by absolute value at 
each visit by treatment group, together with the corresponding changes from baseline. All 
parameters will be summarized in SI units, with the exception of blood eosinophil counts 
which will be summarized in both SI and conventional units. Results which are reported from 
the central laboratory in conventional units will be converted to SI units for reporting.


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Central laboratory reference ranges will be used for the identification of abnormalities, and a 
shift table will be produced for each laboratory parameter to display low, normal, high, and 
missing values. The shift tables will present baseline and maximum/minimum post-baseline 
value, as applicable for each parameter and will include patients with both baseline and post-
baseline data.
Shift plots showing each individual patient’s laboratory value at baseline and at 
maximum/minimum post-baseline will be produced for each continuous laboratory variable. If 
any laboratory variables show any unusual features (high or low values or a general shift in 
the data points) at other time points then shift plots of these data may be produced. 
Data for patients who have treatment-emergent changes outside central laboratory reference 
ranges will be presented. A change is treatment-emergent if it occurs during on-treatment 
period as defined in Section 3.3.1. This data presentation will include all visits for this subset 
of patients.  
Maximum post-baseline bilirubin elevations by maximum post-baseline ALT and AST will be 
presented, expressed as multiples of ULN. Bilirubin will be presented in multiples of the 
following ULN ≤1.5, >1.5-2, >2, and AST and ALT will be presented in multiples of the 
following ULN ≤1, >1-3, >3-5, >5-10, >10.  
Maximum post-baseline total bilirubin will be presented (<2 and ≥2 x ULN) against maximum 
post-baseline ALT (<3, ≥3 - <5, ≥5-<10, and ≥10 x ULN), expressed as multiples of ULN.  
This will be repeated to show maximum post-baseline total bilirubin against maximum post-
baseline AST.
Data for patients with ALT or AST ≥3 x ULN, and bilirubin ≥2 x ULN will be presented, 
which will include all visits for this subset of patients. 
For all patients who meet the biochemical criteria for confirmed Hy’s law, a SAE Narrative 
will be produced.  
Any data outside the central laboratory normal reference ranges will be explicitly noted on the 
listings that are produced.
4.2.8.3
Vital signs 
Descriptive statistics and change from baseline for vital signs data will be presented for each 
treatment group by visit. Baseline to maximum post-baseline and baseline to minimum post-
baseline value shift tables will be generated displaying low, normal, high, and missing values, 
as applicable for each parameter and will include patients with both baseline and post-baseline 
data.
All recorded vital signs data will be listed. 


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4.2.8.4
Local ECGs
The investigator’s overall evaluation of ECG (normal or abnormal) will be listed for all 
patients, detailing whether any abnormalities were clinically significant or not. 
A summary table will be produced for baseline ECG evaluation to display normal, abnormal –
not clinically significant, abnormal – clinically significant and not done.  
4.2.8.5
Physical examination
Physical examination data will not be summarized.  
4.2.9
Exploratory analyses
4.2.9.1
Analysis of biomarker data
Summaries and analyses for exploratory biomarkers will be documented in a separate analysis 
plan and will be reported outside the clinical study report in a separate report.  
4.2.9.2
Analysis of asthma control assessments
Exploratory asthma control variables as recorded in daily diaries and defined in Section 3.4
will be reported descriptively. 
Summary statistics will be produced by treatment group and visit for absolute value and 
change from baseline in total asthma symptom score, daytime score, night-time score, total 
rescue medication use (average number of times/day), weekly proportion of nights with 
nocturnal awakenings requiring and independent of rescue medication use. 
The proportion of asthma symptom-free days up to EOT visit will be summarized 
descriptively by treatment group. The number of asthma symptom-free days and asthma 
symptom assessment days will also be presented. 
The number and proportion of patients:
!
Well-controlled;
!
Partly controlled; and
!
Uncontrolled
will be summarized by treatment group and week, based on the previous 7 days of data, from 
week 0 (baseline) until week 24 (EOT), for the full analysis set.  The number of patients in 
each treatment group with missing data at each timepoint will also be reported.  In addition, 
the proportion of patients well-controlled and well-/partly controlled (based on the previous 7 
days of data), with 95% confidence intervals about the proportions (calculated using the exact 
Clopper-Pearson formula) will be presented, by treatment group and week for the full analysis 
set.


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The proportion of patients well-controlled (based on the previous 7 days of data) over time 
(week 0 - week 24) will be analyzed by treatment group using a local regression model (Loess 
method) and Loess curves (with 95% confidence intervals) by treatment group will be 
produced.  This analysis will be repeated for the proportion of patients well-/partly controlled 
over time.
In addition, the number and proportion of patients:
!
Well-controlled; 
!
Partly controlled; and
!
Uncontrolled
at week 0 (baseline), weeks 4, 8, 12, 16, 20 and week 24 (EOT), based on the 4 weeks of data 
prior to each timepoint, will be summarized by treatment group, for the full analysis set.  
Frequency plots by treatment group over time (at weeks 0, 4, 12 and 24 only) will be 
produced.
Time to first well-controlled week (from week 0) based on the previous 7 days’ data will be 
analyzed.  A Cox proportional hazard model will be fitted to the data with the covariates of 
treatment, region (North America/rest of world), number of exacerbations in the previous year 
and maintenance OCS use at baseline (yes/no).  The model will include Efron method for 
handling ties (TIES=EFRON), and the confidence intervals for hazard ratios will be calculated 
using profile-likelihood confidence limits (RL=PL). Results will be summarized as hazard 
ratios, 95% confidence intervals and p-values for patients in the full analysis set.  Time to first 
well-controlled week will be displayed graphically using a Kaplan-Meier plot.
EOT asthma control status will be compared across treatment groups using two separate 
logistic regression models.  The dependent variable in each model will be the EOT control 
indicator variables (based on well-controlled or well-/partly controlled status (see section 
3.4.4), with covariates of treatment, region (North America/rest of world), number of 
exacerbations in the previous year and maintenance OCS use at baseline (yes/no)baseline 
asthma control status (based on the last 4 weeks prior to randomization). 
Results will be presented as odds ratios with associated 95% CIs and 2-sided p-values.
5.
INTERIM ANALYSES
No interim analyses are planned.
6.
CHANGES OF ANALYSIS FROM PROTOCOL
The clarifications and changes that have been made are listed below:


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!
Section 1.1.4: the outcome measure for asthma control is updated to be the 
proportion of patients with well-controlled asthma (instead of the proportion of time 
that the patient’s asthma is well controlled), based on composite diary measures 
over time.
!
Section 1.3: while not a change to the analysis compared to the protocol, it was 
noted that sample size calculations for the primary endpoint in the protocol used a 
12-month follow-up period.  This has been corrected to use a 24-week follow-up 
and the power amended (from 97% to 91%) in Section 1.3.
!
Section 3.1.1:  For PROs with reflection times of 1 week or more (e.g. the SGRQ, 
ACQ-6), the time component of the definition of baseline (i.e. time of assessment 
relative to the first dose) will be waived provided the assessment occurs on the same 
day as the first dose of study treatment.
!
The protocol describes that change for each of the patient’s top 3 ranked symptoms 
and impairments using the 7-point change scale will be collected weekly from week 
1 to week 16 for PSIA to define an improvement status for that ranked 
symptom/impairment. This data collection of patient-perceived change from 
baseline (Visit 4) is important as it is designed to show an early response to 
benralizumab if said early response exists. However, these data were only collected 
at Week 20 due to an error in the set-up of the electronic patient reported outcomes 
system which was not caught until the majority of patients had already enrolled and 
progressed through the study. Therefore, no local regression modeling of 
proportions showing an improvement (Loess method) and Loess curves (with 95% 
confidence intervals) for each of the top 3 symptoms/impairments and top 3 
combined; or time to 1st improvement for each of the top 3 symptoms/impairments 
will be performed. A note to file has been implemented.
!
The main analysis of PSIA data will be the change from baseline in severity scores 
for each of the top 3 ranked symptoms / impairments and for the average of the top 
3 ranked symptoms / impairments.
!
In addition, to investigate and quantify any early response to benralizumab that may 
exist (in the absence of the PSIA change data), SGRQ total score responder 
analyses at Weeks 4 and 12 have been included.
!
The protocol includes responder analyses for the SGRQ subscales, but these will 
not be carried out (as there is no MCID defined for the subscales).
!
SGRQ responder analyses will be performed at Weeks 4 and 12 in addition to EOT. 


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7.
REFERENCES
Bel et al 2014
Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord 
ID. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. New England 
journal of medicine. 2014 Sep 25;371(13):1189-97.
Bleeker et al 2016
Bleecker ER, Fitzgerald JM, Chanez P, Papi A, Weinstein SF, Barker P, et al. Efficacy and 
safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled 
corticosteroids and long-acting β 2-agonists (SIROCCO): a randomized, multicentre, 
placebo-controlled phase 3 trial. The Lancet 2016;388(10056):2115-2127.
Fitzgerald et al 2016
Fitzgerald JM, Bleecker ER, Nair P, Korn S, Ohta K., Lommatzsch M, et al. Benralizumab, an 
anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with 
severe, uncontrolled, eosinophilic asthma (CALIMA): a randomized, double-blind, placebo-
controlled phase 3 trial. The Lancet 2016;388(10056):2128-2141.
GINA 2018
Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2018.
Available from: www.ginasthma.org
Hopkins et al 2009
Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item 
Sinonasal Outcome Test. Clinical otolaryngology. 2009;34(5):447-45.
Jones et al 1991
Jones PW, Quirk FH, Baveystock CM. The St George’s Respiratory Questionnaire. 
RespirMed. 1991;85 Suppl B:25-31.
Juniper et al 2006
Juniper EF, Bousquet J, Abetz L, Bateman ED; GOAL Committee. Identifying 'well-
controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respir 
Med. 2006 Apr;100(4):616-21.
Ortega et al 2014
Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz 
LE, Keene ON, Yancey SW, Chanez P. Mepolizumab treatment in patients with severe 
eosinophilic asthma. New England Journal of Medicine. 2014 Sep 25;371(13):1198-207.
Piccirillo et al 2002
Piccirillo JF, Merritt MG, Richards ML. Psychometric and clinimetric validity of the 20-item 
Sino-Nasal Outcome Test (SNOT-20). Otolaryngology--Head and Neck Surgery. 2002; 
126(1);41-47.


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
58
QualityMetric 2011
QualityMetric, I. User's manual for the SF-36v2 Health Survey (3 ed.). 2011. Lincoln, RI.


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
59
8.
APPENDIX
Appendix I
Accounting for missing data
Accounting for missing data for recurrent events (exacerbation rate endpoint)
In this study some patients dropping out of the study potentially leads to unobserved events.  
The amount of missing data is minimized in this study as patients are encouraged to remain in 
the study after premature discontinuation of IP and complete visits according to the protocol.
This section summarizes how we will describe the pattern of and reasons for missing data 
from the study.  It will also describe how we plan to account for missing data, including both 
the primary and sensitivity analyses to assess the robustness of the treatment effect under 
different underlying assumptions to account for missing data.
Missing data descriptions
Tabular summaries for the percentage of patients by the reason for discontinuation of 
randomized treatment as well as for withdrawal from the study will be presented by treatment 
to describe why patients discontinue from randomized treatment or withdraw from the study.  
The time to discontinuation of randomized treatment and withdrawal from the study will be 
presented using Kaplan Meier plots (overall and split by treatment related/not treatment 
related reason for discontinuation, as defined in Tables 1 and 2). Dependent on these outputs 
additional exploratory analyses may be produced as deemed necessary to further understand 
the pattern of missing data.
Primary analysis under the Treatment Policy Estimand using the Missing at Random (MAR) 
assumption
The primary analysis is under the treatment policy estimand which allows for differences in 
outcomes over the entire study treatment period to reflect the effect of initially assigned 
randomized treatment as well as if subsequent treatments are taken. This primary analysis 
includes all data until patients withdraw from the study regardless of if they discontinue from 
randomized treatment. The primary analysis uses the negative binomial regression model with 
(logarithm of) the observation period as an offset term and assumes that missing data is 
missing at random (MAR) and is a direct likelihood approach (DL). 
Sensitivity analyses under the Treatment Policy Estimand using both MAR and MNAR 
assumptions
To examine the sensitivity of the results of the primary analysis to departures from the 
underlying assumptions, additional analyses will be performed using controlled multiple 
imputation method introduced in [1] and further developed at AstraZeneca [2,3] which allows 
for different underlying assumptions to be used. As with the primary analysis the sensitivity 
analyses include all data until patients withdraw from the study regardless of if they 
discontinue from randomized treatment.  


Statistical Analysis Plan 
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Edition Number 3.0
Date 14 Oct 2019
60
For this method an underlying negative binomial stochastic process for the rate of 
exacerbations is assumed and post study withdrawal counts will be imputed conditional upon 
the observed number of events prior to the withdrawal. This allows various assumptions about 
the missing data to be analyzed by modifying the post-withdrawal model assumption.
The method involves first fitting the primary analysis i.e. negative binomial regression model 
to the observed data and then imputing post-withdrawal counts by sampling from the 
conditional negative binomial probability relating post-withdrawal counts and observed prior-
withdrawal counts based on various assumptions.
(1)
Here 
is number of counts before withdrawal from the study, 
is number of counts after 
withdrawal from the study, 
is the dispersion parameter and which is assumed to be the 
same for different treatment arms, j denotes the treatment arm and i denotes the subject 
identifier. Furthermore
(2)
where 
is the negative binomial distribution (NBD) rate parameter before withdrawal from 
the study, and 
is the rate parameter after withdrawal from the study as determined based 
on various assumptions. 
The imputed number of exacerbations that would have been seen is then combined with the 
observed exacerbations and data is analyzed using the primary analysis methodology (DL). 
This analysis is repeated multiple times and the results combined using Rubin’s formulae [7, 
8].
The following default assumptions that will be used to impute the missing data who withdraw
early from the study are as follows:
a) MAR: Missing counts in each arm are imputed assuming the expected event rate within 
that arm. 
b) Dropout Reason-based Multiple Imputation (DRMI): Missing counts will be imputed 
differently depending on the reason for dropout; counts for patients in the Benralizumab 
arms who dropped out for a treatment related reason are imputed based on the expected 
event rate in the placebo arm, whereas the remaining patients who have dropped out are 
imputed assuming MAR. Treatment related reasons include (1) AEs, (2) Death and (3) 
development of study specified reasons (4) severe non-compliance of protocol  to stop 
active treatments.


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
61
Some reasons for withdrawal are clearer to determine as treatment related (Adverse Events, 
Death, Development of study-specific discontinuation criteria) or non-treatment related 
(Subject lost to follow up, eligibility criteria not fulfilled).  Other reasons are less clear such as 
subject decision and ‘Other’; a review of each patient who withdraws from the study will 
therefore be carried out prior to unblinding the study. The review will include assessment of 
the reason for discontinuation of randomized treatment for those patients who discontinued 
randomized treatment and then withdrew from the study and also free text for when the reason 
for withdrawal or discontinuation of randomized treatment is subject decision or other. Based 
on this review the default assumptions for DRMI as described in b) and table 1 may be 
changed.  A list of these patients and the assumptions made under DRMI will be documented 
prior to unblinding of the study and documented in the BDR comments tracker. 
A summary of reasons for patients withdrawing from the Benralizumab treatment arm and the 
corresponding treatment arm used to calculate the imputation exacerbation rate under MAR 
and DRMI is given in Table 1.
Table 1
Reason for withdrawal
MAR
DRMI
Adverse Event
Benralizumab
Placebo
Development of study-specific 
discontinuation criteria*
Benralizumab
Placebo
Death
Benralizumab
Placebo
Severe non-compliance to 
protocol
Benralizumab
Placebo
Eligibility criteria not fulfilled
Benralizumab
Benralizumab
Subject lost to follow up
Benralizumab
Benralizumab
Subject decision 
Benralizumab
Based on review prior to study 
unblinding
Other
Benralizumab
Based on review prior to study 
unblinding
Note all patients on exacerbation rate in the placebo arm are imputed using the placebo arm rate
*Development of study-specific discontinuation criteria are based on the following:  anaphylactic reaction to the 
IP requiring administration of epinephrine, development of helminth parasitic infestations requiring 
hospitalization, 2 consecutive doses of IP missed or more than 2 scheduled doses of IP are missed during course 
of the study, an asthma-related event requiring mechanical ventilation.
Together with the primary analysis the sensitivity analyses are considered to cover the range 
from realistic to plausible worst case assumptions about missing data.  The MAR multiple 
imputation approach is expected to correspond closely to the primary analysis, and is included 
to allow for comparisons with MNAR assumptions (specifically methods b and c) using the 
same multiple imputation methodology.


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
62
The dropout reason-based multiple imputation (DRMI) approach was selected as the most 
conservative approach based on the fact that placebo patients are receiving standard of care 
and are not expected to change to a substantially more effective treatment after withdrawing 
from study or study treatment. For patients receiving Benralizumab who withdraw from the 
study due to treatment related reasons it is assumed that at worst they would be on the 
standard of care treatment i.e. the placebo arm.  For patients receiving Benralizumab who 
withdraw from the study due to non-treatment related reasons it seems reasonable to assume 
they would be similar to those patients who complete treatment.
On-Treatment Analyses (Efficacy and Effectiveness estimands) 
In addition, primary and sensitivity analyses described previously, two alternative estimands 
will be estimated using only the on initial randomized treatment data:
Efficacy estimand - what would have been the outcome if all patients had stayed on study 
treatment: This will be estimated using the primary analysis method but including only data 
from patients whilst being on initial randomized treatment, and assuming MAR subsequently.  
Effectiveness estimand with assumed loss of effect post discontinuation of Benralizumab: 
This will be estimated using the DRMI controlled imputation approaches including only data 
from patients whilst on treatment.
Therefore, the primary analyses and sensitivity analyses will be repeated including only data 
from patients whilst being on initial randomized treatment i.e. excluding data once patients 
discontinue from randomized treatment.    
A summary of reasons for patients withdrawing from the Benralizumab treatment arm and the 
corresponding treatment arm used to calculate the imputation exacerbation rate under MAR, 
and DRMI are given in Table 2. As for patients who withdraw from the study, a review of 
each patient who discontinued randomized treatment will be carried out prior to unblinding 
the study where the default assumptions for DRMI as described in Table 2 may be changed. 
Again, a list of these patients and the assumptions made under DRMI will be documented 
prior to unblinding of the study.


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
63
Table 2
Reason for discontinuation of 
randomized treatment
MAR
DRMI
Adverse Event
Benralizumab
Placebo
Development of study-specific 
discontinuation criteria*
Benralizumab
Placebo
Severe non-compliance to 
protocol
Benralizumab
Placebo
Subject lost to follow up
Benralizumab
Benralizumab
Subject decision 
Benralizumab
Based on review prior to study 
unblindng
Other
Benralizumab
Based on review prior to study 
unblindng
Note all patients on exacerbation rate in the placebo arm are imputed using the placebo arm rate
*Development of study-specific discontinuation criteria are based on the following:  anaphylactic reaction to the 
IP requiring administration of epinephrine, development of helminth parasitic infestations requiring 
hospitalization, 2 consecutive doses of IP missed or more than 2 scheduled doses of IP are missed during course 
of the study, an asthma-related event requiring mechanical ventilation.
Using on treatment data is easier to interpret as it is not impacted by any subsequent pattern of 
alternative treatments once patients discontinue from randomized treatment. The efficacy 
estimand together with the reason for and timing of why a patient might not tolerate the 
treatment allows for the simplest interpretation as it describes the treatment effect for patients 
who adhere to treatment together with why and when they might not adhere to treatment.  
Sensitivity analyses using the effectiveness estimands under the DRMI allow for alternative 
assumptions to be made based on reasons for discontinuation. 
Overall summary of analyses to account for missing data
A summary of the different analyses to be carried out under different estimands and 
assumptions are described in Table 3.


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3 0Date 14 Oct 2019
Table 3
Treatment Policy Estimand
On-Treatment Analyses 
(Efficacy and Effectiveness estimands)
DL
MAR
DRMI
DL
MAR
DRMI
Population
On-treatment + post-discontinuation of randomized treatment
On-treatment
Estimand
Treatment policy 
(MAR)
Treatment policy 
(MNAR)
Efficacy 
(MAR)
Effectiveness 
(MNAR)
Exacerbation 
rate for 
imputation 
in Benra 
arm**
No explicit 
imputation*
Benra rate 
assumed for all 
reasons for 
withdrawal 
Placebo rate assumed for AEs, 
Death, development of study 
specified reasons to stop active 
treatments and Severe non-
compliance to protocol, 
otherwise Benra rate assumed. 
Reasons are subject to review 
prior to study unblinding
No explicit 
imputation*
Benra rate 
assumed for 
all reasons for 
discontinued 
treatment 
Placebo rate assumed for AEs, 
development of study specified 
reasons to stop active treatments 
and Severe non-compliance to 
protocol, otherwise Benra rate 
assumed. Reasons are subject to 
review prior to study unblinding
Default 
definition 
for
and
based on 
formula (2) 
****.
For all treatment 
arms j=B and P
for reasons above 
otherwise
For all 
treatment arms 
j=B and P
for reasons above 
otherwise
* Implicitly assumes unobserved rate the same as observed 
** All patients on exacerbation rate in the placebo arm are imputed using the placebo arm rate (i.e. 
)
*** P denotes Placebo, B denotes Benralizumab 
**** Note can be over written by review prior to study unblinding`


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
65
Forest plots will be used to show the primary analysis results along with the missing data 
sensitivity and alternative estimand analysis results.
It is noted that if the primary analysis is statistically significant, it is not necessarily expected 
that all sensitivity analyses will also give statistically significant results. If the results of the 
sensitivity analyses provide reasonably similar estimates of the treatment effect to the primary 
analysis, this will be interpreted as providing assurance that neither the lost information nor 
the mechanisms which cause the data to be missing have an important effect on primary 
analysis conclusions. Based on these outputs and the drug’s mechanism of action, the 
plausibility of the assumptions we make about missing data in the different analyses will be 
considered and described in the clinical study report. 
Accounting for missing data for continuous endpoints (SGRQ total score)
Missing data descriptions
In addition to the tables and figures suggested above, plots of change from baseline vs time, 
by dropout pattern (e.g. completers vs non-completers, split by reason for dropout and/or split 
by last available visit) will also be produced.
Primary analysis under the Treatment Policy Estimand using the MAR assumption
As for the primary variable, the primary analysis of the SGRQ total score key secondary 
endpoint includes all data captured during the trial and is therefore considered to be under the 
treatment policy estimand. The Mixed Model Repeated Measures model (MMRM) used is a 
DL approach which is valid under the MAR assumption. 
Sensitivity analysis under the Treatment Policy Estimand using MNAR assumptions
Sensitivity analyses of the repeated measures analyses will be performed for the SGRQ total 
score using controlled sequential multiple imputation methods based on pattern mixture 
models, as described in [5]. 
The method is analogous to the multiple imputation of exacerbation events and the imputation 
process consists of a sequence of MI steps, where each step is intended to impute missing 
values at one time-point only. This model will assume that some pre-specified subset of 
subjects who withdraw from the study have correlations with future (unobserved) visits 
similar to subjects in the placebo arm. As for the exacerbation events, this allows us to assess 
various deviations from the MAR assumption.
The assumptions that will be used to impute the missing data who withdraw early are as 
follows:
a) MAR: Assumes that the trajectory for patients who dropped out in each arm is similar to 
those observed in their own treatment arm


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
66
b) DRMI: Assumes that the trajectory for patients in the Benralizumab arm who dropped out 
for a treatment related reasons (according to the same classification as for the DRMI 
analysis of the primary endpoint) is similar to that of the placebo patients, whereas the 
remaining patients who has dropped out are imputed assuming MAR.
Approach b) can be considered more conservative than the approach for the primary analysis 
because the assumptions mean that as soon as patients withdraw for a treatment related reason, 
they begin to worsen immediately. 
The MNAR imputation is achieved by only using appropriate data at each stage of the 
imputation. Imputation will be done in two steps, the non-monotone (intermediate) missing 
SGRQ total score values will be imputed first (Markov chain Monte Carlo [MCMC] method 
is used to partially impute the data using SAS PROC MI) and then the missing value at each 
visit will be imputed using a sequential regression method (using MONOTONE REG option 
of SAS PROC MI). 
For example, to impute missing values at time t for subjects in the Benralizumab arm, that 
dropped out due to an AE, include only placebo observations up to and including time t, plus 
observations from subjects in the Benralizumab arms, that dropped out due to an AE, up to 
and including time t-1. This is done for each visit, one at a time using observed data, and 
missings just imputed. Placebo missing observations and Benralizumab observations that are 
not missing due to AEs are imputed assuming MAR and follow the pattern of observed 
placebo observations in each treatment arm respectively. 100 imputations will be carried out, 
and a seed of 784088 will be used. The analysis of each of the imputed dataset will be as 
described for the primary analysis in section xxx and these will be combined using SAS 
procedure PROC MIANALYZE. 
On-Treatment Analyses (Efficacy and Effectiveness estimands) 
Analogously to the approach for the primary endpoint, efficacy and effectiveness estimands 
will be estimated using on-treatment data and the methods described above. 
Results for continuous endpoints will be presented as per the recurrent event sensitivity 
analyses.
References
1.
Keene ON, Roger JH, Hartley BF, Kenward MG. Missing data sensitivity analysis for recurrent 
event data using controlled imputation. Pharmaceutical Statistics 2014, 13 258–264.
2.
Wan R, Hirsch I, Gottlow M, Hollis S, Darilay A, Weissfeld L, France L. Controlled imputation 
approach for analyzing missing data in recurrent events due to early discontinuations. 
DIA/FDA Statistics Forum 2015.


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
67
3.
Gottlow M, Hollis S, Wan R, Hirsch I, Darilay A, Weissfeld L, France L. A Simulation study of a 
controlled imputation approach for analyzing missing data in recurrent events due to early 
discontinuations. PSI Annual Conference 2015.
4.
The Panel on Handling Missing Data in Clinical Trials; National Research Council. The 
Prevention and Treatment of Missing Data in Clinical Trials. National Academies Press, 2010.
5.
Guideline on Missing Data in Confirmatory Clinical Trials 2 July 2010 
EMA/CPMP/EWP/1776/99 Rev. 1
6.
AZ guidance (clinical OPI): Guidance on Minimizing the Loss of Patient Data in AstraZeneca 
Clinical Trials, ed 2.0. (LDMS_001_00102309)
7.
Fleming, TR. Addressing Missing Data in Clinical Trials. Ann. Intern. Med. 2011;154:113-117.
8.
Ratitch B, O’Kelly M, Tosiello R. Missing data in clinical trials: from clinical assumptions to 
statistical analysis using pattern mixture models. Pharmaceutical Statistics 2013; 12: 337-347.
9.
Keene ON, Roger JH, Hartley BF, Kenward MG. Missing data sensitivity analysis for recurrent 
event data using controlled imputation. Pharmaceutical Statistics 2014, 13 258–264.
10. Rubin DB. Multiple imputation for nonresponse in surveys. New York: John Wiley & Sons, Inc. 
1987.
11. Barnard J, Rubin DB. Small-sample degrees of freedom with multiple imputation. Biometrika 
1999; 86:948-955.
12. Little RJ, Yosef M, Cain KC, Nan B, Harlow SD. A hot-deck multiple imputation procedure for 
gaps in longitudinal data on recurrent events. Statist. Med., 2008; 27:103-120.
13. Mallinckrodt CH, Lin Q, Lipkovich I, Molenberghs G. A structured approach to choosing 
estimands and estimators in longitudinal clinical trials. Pharmaceutical Statistics 2012, 
11:456–461. 


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
68
Appendix II
Partial dates for prior/concomitant medication and asthma history
Dates missing the day or both the day and month of the year will adhere to the following 
conventions in order to classify prior/concomitant medications:
The missing day of start date of a therapy will be set to the first day of the month that the 
event occurred.
The missing day of end date of a therapy will be set to the last day of the month of the 
occurrence.
If the start date of a therapy is missing both the day and month, the onset date will be set to 
January 1 of the year of onset.
If the end date of a therapy is missing both the day and month, and the year of occurrence is in 
the same year as the year of the end of study date, then set the end date to be equal to end of 
study date otherwise the date will be set to December 31 of the year of occurrence.
If the start date of a therapy has been checked in the eCRF as having started > 3 months prior 
to enrolment, the start date will be set to the earlier of 92 days prior to the date of enrolment 
and the therapy end date (if completed).
If the start date of a therapy is null and has not been checked in the eCRF as having started >3 
months prior to enrolment, and the end date is not a complete date, then the start date will be 
set to the date of the first study visit.
If the start date of a therapy is null and has not been checked in the eCRF as having started >3 
months prior to enrolment, and the end date is a complete date
∀
and the end date is after the date of the first study visit then the start date will 
be set to the date of the first study visit.
∀
otherwise the start date will be set to the end date of the therapy.
If the end date of a therapy is null and the start date is not a complete date then the end date 
will be set to the date of the last study visit.
If the end date of a therapy is null and the start date is a complete date
∀
and the start date is prior to the date of the last study visit then the end date will 
be set to the date of the last study visit.
∀
otherwise, the end date will be set to the start date of the therapy.
The following conventions will be applied for partial dates of asthma diagnosis:


Statistical Analysis Plan 
Study Code D3250C00045
Edition Number 3.0
Date 14 Oct 2019
69
If the  day of  date of asthma diagnosis is missing it will be set to the first day of the month 
that the diagnosis occurred.
If the date of asthma diagnosis is missing both the day and month, and the year of diagnosis is 
in the same year as the year of birth, then set the date to be equal to date of birth (if both the 
day and month of birth are missing then set to January 1 of the year of birth; if the day of birth 
is missing then set to the first day of the month of birth); otherwise the date will be set to 
January 1 of the year of diagnosis.


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Prot_000.pdf: 
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