Clinical trial NCT03206918
Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia Relapsed or Refractory Small Lymphocytic Lymphoma
Keywords: Bruton's tyrosine kinase Chronic lymphocytic leukemia Relapsed/refractory Zanubrutinib
Sponsor: BeiGene
Start date: 2017-03-09; Completion date: 2020-09-10
Enrollment: 91 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a single-arm, open-label, multi-center Phase 2 study in participants with histologically documented CLL/SLL who have relapsed after or refractory to ≥ 1 prior treatment regimen(s). The study is composed of an initial screening phase, a single-arm treatment phase, and a follow-up phase.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Zanubrutinib
Intervention descriptions: intervention 1: Zanubrutinib 160 mg (two - 80 mg white opaque capsules) taken by mouth (PO) twice a day (BID)

Protocol documents:
Prot_001.pdf: 
BGB-3111-205 (NCT03206918)
A Single-Arm, Open-Label, Multicenter Phase 2 Study to 
Evaluate Safety and Efficacy of BGB-3111, a Bruton's 
Tyrosine Kinase (BTK) Inhibitor in Relapsed or Refractory 
Chronic 
Lymphocytic 
Leukemia/Small 
Lymphocytic 
Lymphoma (CLL/SLL)   
Document Type: Clinical Study Protocol
Document Date: Oct 25, 2017


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SAP_000.pdf: 
BGB-3111-205 (NCT03206918)
A Single-Arm, Open-Label, Multicenter Phase 2 Study to 
Evaluate Safety and Efficacy of BGB-3111, a Bruton's 
Tyrosine Kinase (BTK) Inhibitor in Relapsed or Refractory 
Chronic 
Lymphocytic 
Leukemia/Small 
Lymphocytic 
Lymphoma (CLL/SLL)   
Document Type: Statistical Analysis Plan 
Document Date: Mar 16, 2018


BeiGene (Beijing) Co., Ltd 
                       BGB-3111-205 
              (Statistical Analysis Plan) 
 
Version 1.0:  03/16/2018 
Page 1 of 27  
 
 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
Study Protocol 
Number: 
BGB-3111-205 
Study Protocol 
Title: 
A Single-Arm, Open-label, Multicenter Phase 2 Study to Evaluate Safety 
and Efficacy of BGB-3111, a Bruton’s Tyrosine Kinase (BTK) Inhibitor 
in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small 
Lymphocytic Lymphoma (CLL/SLL) 
 
Date: 
March 16, 2018 
Version: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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BeiGene (Beijing) Co., Ltd 
                       BGB-3111-205 
              (Statistical Analysis Plan) 
 
Version 1.0:  03/16/2018 
Page 3 of 27  
 
 
TABLE OF CONTENTS 
1 
INTRODUCTION 
7 
2 
STUDY OVERVIEW 
7 
3 
STUDY OBJECTIVES 
8 
3.1      Primary Objectives 
8 
3.2      Secondary Objectives 
8 
3.3      
 
9 
4 
STUDY ENDPOINTS 
9 
4.1      Primary Endpoints 
9 
4.2      Secondary Endpoints 
9 
4.3      
 
9 
5 
SAMPLE SIZE CONSIDERRATIONS 
10 
6 
STATISTICAL METHODS 
10 
6.1 
Analysis Populations 
10 
6.2 
Data Analysis General Considerations 
10 
6.2.1 
Definitions and Computations 
10 
6.2.2 
Conventions 
11 
6.2.3 
Handling of missing data 
11 
6.2.4 
Adjustments for Covariates 
12 
6.2.5 
Multiple Comparisons/Multiplicity 
12 
6.2.6 
Data Integrity 
12 
6.3 
Subject Characteristics 
12 
6.3.1 
Subject Disposition 
12 
6.3.2 
Protocol Deviations 
12 
6.3.3 
Demographic and Other Baseline Characteristics 
12 
6.3.4 
Prior Anti-Cancer Drug Therapies and Surgeries 
12 
6.3.5 
Prior and Concomitant Medication and Therapy 
13 
6.3.6 
Medical History 
13 
6.4 
Efficacy Analysis 
13 
6.4.1 
Primary Efficacy Analyses 
13 
6.4.2 
Secondary Efficacy Analyses 
14 
6.4.2.1 
Progression-Free Survival 
14 
6.4.2.2 
Duration of response 
15 
6.4.2.3 
Time to Response 
15 
6.4.3 
Subgroup Analyses 
15 
6.4.4 
 
16 
6.5 
Safety Analyses 
16 
6.5.1 
Extent of Exposure 
17 
6.5.2 
Adverse Events 
17 
6.5.2.1 
Exposure-Adjusted Incidence Rates (EAIR) 
18 
6.5.3 
Laboratory Values 
19 
6.5.4 
Vital Signs 
19 
6.5.5 
Electrocardiograms (ECG) 
19 
6.5.6 
ECOG 
19 
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BeiGene (Beijing) Co., Ltd 
     BGB-3111-205 
     (Statistical Analysis Plan) 
Version 1.0:  03/16/2018 
Page 6 of 27 
 
Abbreviation 
Definition 
IRC 
Independent Review Committee 
IRT 
Interactive Response Technology 
iwCLL 
International Workshop on Chronic Lymphocytic Leukemia 
MAR 
Missing at random 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
magnetic resonance imaging 
NCI-CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events 
nPR 
nodular partial response 
ORR 
overall response rate 
 
 
PD 
Progressive disease 
PO 
orally 
PFS 
progression-free survival 
 
 
PR 
partial response 
PR-L 
partial response with lymphocytosis 
PRO 
patient-reported outcome 
R/R 
relapsed or refractory 
SAE 
serious adverse event 
SD 
stable disease 
SE 
Standard error 
SLL 
small lymphocytic lymphoma 
SMC 
Safety Monitoring Committee 
TEAEs 
treatment emergent adverse events 
TTR 
time to response 
ULN 
upper limit of normal 
WHO 
World Health Organization 
C
CI
C
CI
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BeiGene (Beijing) Co., Ltd 
                       BGB-3111-205 
              (Statistical Analysis Plan) 
 
Version 1.0:  03/16/2018 
Page 8 of 27  
 
 
Figure 1 
Schema for Study BGB-3111-205 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 
STUDY OBJECTIVES 
3.1      Primary Objectives  
• 
To evaluate the efficacy of BGB-3111 at a dose of 160 mg PO BID, in subjects with R/R CLL/SLL 
as assessed by an Independent Review Committee (IRC) using the overall response rate according to 
modified International Workshop on CLL (IWCLL) Guidelines (Hallek et al, 2008; Hallek et al, 
2012; Hallek et al, 2013; see Appendix 3) and the Revised Criteria for Response for Malignant 
Lymphoma in subjects with SLL (Cheson et al, 2014; see Appendix 4). 
3.2      Secondary Objectives  
Efficacy: 
• 
To evaluate the efficacy of BGB-3111 as measured by PFS, DOR, and time to response (TTR) by 
IRC 
Confirmed diagnosis of chronic lymphocytic 
leukemia/small lymphocytic lymphoma 
Age ≥18 relapsed or refractory after ≥ 1 prior therapy 
BGB-3111 
160 mg orally twice daily  
1 cycle=28 days 
until disease progression (PD) or intolerable toxicity 
Discontinue 
due to PD 
Safety Follow-up visit (30 days 
after last dose) 
Survival Follow-up every 3 
months 
 
Safety Follow-up visit (30 days 
after last dose) 
Continue efficacy evaluations 
(tumor assessments) until PD 
Survival Follow-up every 3 
months 
Discontinue 
due to reason other than PD 
End of treatment (EOT) 
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                       BGB-3111-205 
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6.2.2 Conventions 
Unless otherwise specified, the following conventions will be applied to all analyses: 
• 1 year = 365.25 days. Number of years is calculated as (days/365.25) rounded up to 1 
significant digit. 
• 1 month = 30.4375 days. Number of months is calculated as (days/30.4375) rounded up to 1 
significant digit. 
• Age will be calculated as the integer part of (date of informed consent – date of birth + 
1)/365.25 
• P-values will be rounded to 4 decimal places.  P-values that round to 0.0000 will be 
presented as ‘< 0.0001’ and p-values that round to 1.000 will be presented as ‘> 0.9999’.   
• Time-to-event or duration of event endpoints will be based on the actual date the radiograph 
was obtained rather than the associated visit date. 
• Missing efficacy or safety data will not be imputed unless otherwise specified. 
• For by-visit observed data analyses, percentages will be calculated based on the number of 
patients with nonmissing data as the denominator, unless otherwise specified. 
• For continuous endpoints, summary statistics will include n, mean, standard deviation, 
median, first and third quartiles and range (minimum and maximum). 
6.2.3 Handling of missing data  
Missing data will not be imputed unless otherwise specified elsewhere in the SAP. Missing dates or 
partially missing dates will be imputed conservatively for adverse events and prior/concomitant 
medications/procedures as provided in Appendix 1. 
When summarizing categorical variables, subjects with missing data are generally included in the 
denominator to calculate percentages unless otherwise specified. When needed, the category of 
“Missing” is created and the number of patients with missing data is presented. 
When summarizing continuous variables, subjects with missing data are not included in calculations. 
No imputations are made. 
By-visit endpoints will be analyzed using observed data, unless otherwise specified. For observed 
data analyses, missing data will not be imputed and only the observed records will be included.  
If the start day of a subsequent anti-cancer therapy is missing, it will be assumed to be the first day of 
the month. 
If only the day of death date is missing, the death will be assumed to be on the first day of the month 
if the last known alive data is earlier. If the last known alive date is later than the first day of the 
month, then the death date will be assumed to be the last known alive date plus 1 day. 
No imputation of AE grades will be performed. TEAEs with missing CTCAE grade will only be 
summarized in the all-grades column. 
If the assessment of the relationship of an AE to study treatments is missing, then the AE is assumed 
to be related to the study treatments in the safety analysis, but no imputation should be done at the 
data level. 
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                       BGB-3111-205 
              (Statistical Analysis Plan) 
 
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6.2.4 Adjustments for Covariates 
No adjustments for covariates are planned for primary and secondary analyses in the study. Baseline 
factors may be used in the model as covariates as supportive analyses for endpoints. 
6.2.5 Multiple Comparisons/Multiplicity 
Not applicable. 
6.2.6 Data Integrity 
Before pre-specified statistical analysis begins, the integrity of the data should be reviewed to assure 
fit-for-purpose.  The data set for analysis should be an accurate and complete representation of the 
subjects' relevant outcomes from the clinical database.  All data should be complete and reviewed 
up to a pre-specified cutoff date.  Consistency checks and appropriate source data verification 
should be complete. 
Assessment for progression and disease response is performed centrally by the IRC. The IRC data 
flow and workflow are described in the IRC charter. 
6.3 
SUBJECT CHARACTERISTICS 
6.3.1 Subject Disposition 
The number (percentage) of subjects screened, treated, discontinued from study drugs and 
discontinued from the study will be summarized. The primary reason for end of treatment (study drug 
discontinuation) and end of study will be summarized by categories.   
6.3.2 Protocol Deviations 
Important protocol deviation criteria will be established and subjects with important protocol 
deviations will be identified and documented before the database lock. Important protocol deviations 
will be summarized for all enrolled patients. They will also be listed by each category. 
6.3.3 Demographic and Other Baseline Characteristics 
Demographic and other baseline characteristics will be summarized using descriptive statistics in the 
safety population. Variables include age (continuous and <65 vs. ≥65), gender, height, weight, cancer 
type, time since diagnosis, prior line(s) of therapy for CLL/SLL, Eastern Cooperative Oncology 
Group (ECOG) performance status, Binet stage, baseline Rai stage, IGHV mutational status, presence 
or absence of disease-related constitutional symptoms, lymphadenopathy, hepatomegaly, 
splenomegaly, Bulky disease (LDi<5 cm vs. ≥5 cm and <10 cm vs. ≥10 cm), cytopenias (yes vs. no), 
β2-microglobulin (≤3 mg/L vs >3 mg/L), blood lymphocytes, % of lymphocyte and tumor cell 
involvement in bone marrow biopsy for CLL and SLL patients respectively, platelet count, 
hemoglobin, neutrophils, serum immunoglobulins, coagulation, del(17p), del(13q), del(11q), trisomy 
12, 
, and other selected hematology and chemistry lab measures.  
  
6.3.4 Prior Anti-Cancer Drug Therapies and Surgeries 
The lines of prior anti-CLL/SLL drug therapies, prior anti-CLL/SLL radiotherapy and prior anti-
CLL/SLL surgeries will be summarized. The therapies and surgeries with the same sequence/regimen 
number are counted as one prior therapy/surgery.  
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                       BGB-3111-205 
              (Statistical Analysis Plan) 
 
Version 1.0:  03/16/2018 
Page 13 of 27  
 
 
6.3.5 Prior and Concomitant Medication and Therapy 
Prior and concomitant medications will be coded using the World Health Organization Drug 
Dictionary (WHO DD) drug codes, and will be further classified to the appropriate Anatomical 
Therapeutic Chemical (ATC) code.  
The number (percentage) of subjects reporting prior and concomitant medications will be summarized 
by ATC medication class and WHO DD preferred term by phase in the safety population. Prior 
medications are defined as medications that started before the first dose date. Concomitant 
medications will be defined as medications that (1) started before the first dose of study drug and were 
continuing at the time of the first dose of study drug, or (2) started on or after the date of the first dose 
of study drug up to 30 days after the subject’s last dose or initiation of a new anti-cancer therapy.  
6.3.6 Medical History 
Medical History will be coded using MedDRA (version 20.0). The number (percentage) of subjects 
reporting a history of any medical condition, as recorded on the CRF, will be summarized by system 
organ class and preferred term in the safety population.  
6.4 
EFFICACY ANALYSIS 
Analysis of efficacy endpoints will be conducted in the safety population, unless otherwise specified.  
6.4.1 Primary Efficacy Analyses 
The primary efficacy endpoint is overall response rate (ORR) according to the IWCLL criteria (Hallek 
et al, 2008; Hallek et al, 2012; Hallek et al, 2013) and 2014 Revision for Malignant Lymphoma in 
subjects with SLL (Cheson et al, 2014), as assessed by IRC. The response and disease progression 
will be centrally reviewed by IRC, which will be the primary source for the ORR analysis. Criteria 
for PD and response categories, as well as the process and convention of the IRC, will be prospectively 
detailed in the IRC charter.  
ORR is defined as the crude proportion of patients who achieve a best overall response (BOR) of CR, 
CRi, nPR, PR or PR-L for CLL patients, and CR, PR for SLL patients, per the IRC prior to initiation 
of subsequent antineoplastic therapy. 
In this population, the ORR in the historical control is assumed to be approximately 32% based on 
recent trials (Furman et al 2014; Sorensen et al 1997). A binomial exact test will be performed to test 
the null hypothesis H0: ORR=0.32 in the safety population using the significance level of 0.025 (1-
sided). If the obtained 1-sided p-value is less than or equal to 0.025, it will be concluded that the single 
agent BGB-3111 statistically significantly increases ORR compared with historical control. 
Therefore, the superiority of single agent BGB-3111 will be demonstrated. 
Associated 2-sided 95% Clopper-Pearson CI of ORR will be calculated to assess the precision of the 
rate estimate.  
Best overall response is defined as the best response recorded from the date of Cycle 1 Day 1 of BGB-
3111 until data cut or start of new anti-cancer treatment. Patients with no post-baseline response 
assessment (due to any reason) will be considered as non-responders. The proportion and its 
corresponding Clopper-Pearson 95% CI for complete response rate will also be presented.  
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The ORR analysis will be conducted no later than 12 months after the first dose of the last dosed 
patient. Sensitivity analyses will be performed for ORR in the patients achieve a BOR of PR or higher 
(i.e. excluding CLL patients with BOR of PR-L). ORR analysis based on investigator assessments 
will also be performed. 
6.4.2 Secondary Efficacy Analyses 
6.4.2.1 Progression-Free Survival 
PFS is defined as the time from Cycle 1 Day 1 of BGB-3111 to the earlier of disease progression or 
death due to any cause: 
PFS = (Disease Progression/Death Date – first dose Date +1) / 30.4375 
For purposes of calculating PFS, the start date for progressive disease is the date at which progression 
was first observed. 
The duration of PFS will be right-censored for patients who met 1 of the following conditions: 1) no 
baseline disease assessments; 2) starting a new anti-cancer therapy before documentation of disease 
progression or death; 3) death or disease progression immediately after more than 1 consecutively 
missed disease assessment visit; and 4) alive without documentation of disease progression before the 
data cutoff date. For such patients, the primary analysis of PFS will be right-censored according to 
the convention described in Table 1. These conventions are based on 2012 国家食品药品监督管理
局《抗肿瘤药物临床试验终点技术指导原则》. 
PFS will be based on the IRC assessments. PFS as assessed by investigator will also be analyzed as 
sensitivity analyses. 
Table 1: Date of Progression or Censoring for Progression-free Survival 
Situation 
Date of Progression or Censoring 
Outcome 
No baseline disease assessments 
Date of first dose 
Censored 
New anti-cancer treatment started before 
documentation of PD or death 
Date of last disease assessment prior to 
or on date of new anti-cancer treatment 
Censored 
Death or PD immediately after more than 
1 
consecutively 
missed 
disease 
assessment visit 
Date of last disease assessment visit 
without documentation of PD that is 
before the first missed visit 
Censored 
Alive and without PD documentation 
Date of last disease assessment 
Censored 
Death or PD between planned disease 
assessments 
Date of death or first disease assessment 
showing PD, whichever occurs first 
Progressed 
Death before first disease assessment 
Date of death 
Progressed 
 
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The distribution of PFS, including median PFS and PFS rate at selected timepoints such as 3 and 6 
months, will be summarized descriptively using the Kaplan-Meier method. The 95% confidence 
interval for median and other quartiles of PFS will be generated by using Brookmeyer method 
(Brookmeyer and Crowley 1982), whereas the 95% confidence interval for PFS rate at selected 
timepoints will be generated by using Greenwood formula (Greenwood 1926). Duration of follow-up 
for PFS will be estimated by reverse Kaplan-Meier method (Schemper and Smith 1996). 
6.4.2.2 Duration of response  
The duration of overall response will be calculated for patients who achieve CR, CRi, nPR, PR, or 
PR-L. For such patients, the duration of overall response is defined as the number of days from the 
earliest date of the start of CR, CRi, nPR, PR, or PR-L, until the first date that progressive disease is 
objectively documented or death due to any cause. 
DOR will be right censored for patients who achieve CR, CRi, nPR, PR, and PR-L based on the 
censoring conventions defined previously for the PFS analysis. The distribution of DOR will be 
summarized descriptively using the same methods used for PFS analysis. Median follow-up for DOR 
will be estimated according to the Kaplan-Meier estimate of potential follow-up also termed “reverse 
Kaplan-Meier” (Schemper and Smith 1996). 
DOR will be based on the IRC assessments. DOR as assessed by investigator will also be analyzed 
as sensitivity analyses. 
6.4.2.3 Time to Response 
Time to response for responders (CR, CRi, nPR, PR, or PR-L) is defined as the time interval between 
Cycle 1 Day 1 and the date of the earliest qualifying response. TTR will be summarized by sample 
statistics such as mean, median and standard deviation for responders only. TTR will be based on the 
IRC assessments. TTR as assessed by investigators and based on patients with a BOR of PR or higher 
for CLL will also be analyzed as sensitivity analyses.    
6.4.3 Subgroup Analyses 
Primary and selected secondary endpoints will be summarized descriptively in the specified 
subgroups, as appropriate. Within group values (rates for ORR/medians for PFS) will be presented in 
forest plots. The example of baseline variables for the subgroup analysis are below: 
• 
Age (< 65 years vs ≥ 65 years) 
• 
Gender (male vs female) 
• 
Histology diagnosis (CLL vs SLL) 
• 
Binet stage (C vs A or B)- 
• 
Rai stage (Stage 0-II vs III-IV) 
• 
ECOG-PS (0 vs ≥1) 
• 
Prior line of therapy for CLL/SLL (1 vs ≥2) 
• 
Refractory to last systemic therapy (Yes vs No) 
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statistics (e.g., n, mean, standard deviation, median, Q1, Q3, minimum, maximum for continuous 
variables; n [%] for categorical variables).   
6.5.1 Extent of Exposure 
Extent of exposure to BGB-3111 will be summarized descriptively as the number of cycles received 
(number and percentage of patients), duration of exposure (date of last study drug administration-date 
of first study drug administration+1) (days), cumulative total dose received per patient (mg), dose 
intensity (mg/day) and relative dose intensity (%). 
For each patient, the relative dose intensity (actual vs planned) of BGB-3111 will be calculated. The 
average relative dose intensity for BGB-3111 will be calculated by summarizing the relative dose 
intensity for individual patients. These results will be provided to determine the presence of any major 
differences for the planned vs actual dose and schedule. 
The number (and percentage) of patients with dose reduction, dose interruption, and drug 
discontinuation will be summarized with the respective reasons. The cycles in which dose 
reduction/interruption occurred will be summarized using descriptive statistics. Frequency of dose 
modifications will be summarized by categories. 
6.5.2 Adverse Events  
AEs will be graded by the investigators using CTCAE v4.03. The AE verbatim descriptions 
(investigator terms from the CRF) will be classified into standardized medical terminology using the 
Medical Dictionary for Regulatory Activities (MedDRA). Adverse events will be coded to the 
MedDRA Version 20.0 or higher lower level term closest to the verbatim term.  The linked MedDRA 
preferred term (PT) and primary system organ class (SOC) are also captured in the database. 
A treatment emergent adverse event (TEAE) is defined as an AE that starts or increases in severity 
on or after the date of the first dose of study drug is administered and within 30 days of the last 
administration of study drug or the start of new anti-cancer therapy, whichever occurs earlier. 
Missing and partially missing AE start dates will be imputed according to the specifications 
described in Appendix 1. Only those AEs that were treatment emergent will be included in 
summary tables.  All AEs, treatment emergent or otherwise, will be presented in subject data 
listings. 
TEAEs will be summarized based on the number and percentage of patients experiencing events by 
MedDRA system organ class and preferred term.  The causal relationship between the occurrence of 
an AE and each treatment will be judged by the investigator. In the event a patient experiences 
repeat episodes of the same AE, then the event with the highest severity grade and/or strongest 
causal relationship to each treatment will be used for purposes of incidence tabulations. 
An overview table, including the incidence of and the number of subjects with TEAEs, treatment-
emergent serious adverse events (SAEs), treatment-related TEAEs, TEAEs with grade 3 or above, 
treatment-related SAEs, TEAEs that led to death, and TEAEs that led to treatment discontinuation, 
dose reduction or dose interruption will be provided. Treatment-related AEs include those events 
considered by the investigator to be related to study drug or with missing assessment of the causal 
relationship. AEs of special interest (AESI) include hemorrhage, major hemorrhage defined as any 
serious or grade ≥ 3 bleeding of any site, or central nervous system (CNS) bleeding of any grade, 
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atrial fibrillation, hypertension, second primary malignancies, diarrhea, tumor lysis syndrome, 
infection, opportunistic infection, neutropenia, thrombocytopenia, and anemia. The AESI categories 
are subject to change if warranted to better represent BGB-3111 safety.    
 
Tabular summaries of the following AE will also be provided: 
• 
TEAEs 
• 
by system organ class  
• 
by preferred term in decreasing frequency 
• 
by AEs of special interest  
• 
SAEs 
• 
by system organ class  
• 
by AEs of special interest  
• 
Treatment-related TEAEs 
• 
TEAEs with grade 3 or above 
• 
TEAEs with fatal outcome 
• 
Treatment-related SAEs 
• 
TEAEs resulting in discontinuation, reduction, or interruption of BGB-3111 
Patient data listings of all AEs will be provided. 
6.5.2.1 Exposure-Adjusted Incidence Rates (EAIR) 
 An exposure adjusted analysis is also planned to analyze AESIs. The analysis restricts on the 
occurrence of the first event per patient and ignores the existence of later (multiple) events as these 
cannot be assumed to occur independent of previous events. 
The incidence rate for a patient is derived from the duration of treatment exposure of that patient. A 
patient’s duration of exposure is given either 1) by the time when the event has occurred (non-
censored data), or 2) by the total duration of treatment in case the patient does not show the adverse 
event of interest (censored data). Depending on whether a patient has an adverse event or not, the 
duration of exposure enters the denominator in its non-censored or censored form, respectively. 
The average EAIR per AESI considers the first event per patient per AESI only, and the corresponding 
exposure time in the denominator: 
𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐸𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴= ∑
𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴,𝑖𝑖
𝑛𝑛
𝑖𝑖=1
∑
𝑡𝑡𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴,𝑖𝑖
𝑛𝑛
𝑖𝑖=1
 
Whereby TEAEAESI,i represents the first TEAE among all AESI TEAEs of patient i and ti as time when 
the TEAE occurs (non-censored data) or total duration of treatment if no event occurs (censored data).     
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10 APPENDIX 
10.1 APPENDIX 1  
IMPUTATION OF MISSING/PARTIALLY MISSING DATES 
Missing data will not be imputed unless otherwise specified. The imputation rule for the safety 
analyses will be used to address the issues with partial dates. When the start date or end date of an 
adverse event is partially missing, the date will be imputed to determine whether the adverse event 
is treatment-emergent. When in doubt, the adverse event will be considered treatment emergent by 
default. The following rules will be applied to impute partial dates for adverse events: 
If start date of an adverse event is partially missing, impute as follows: 
• If both month and day are missing and year = year of treatment start date, then set to 
treatment start date 
• If both month and day are missing and year ≠ year of treatment start date, then set to January 
01 
• If day is missing and month and year = month and year of treatment start date, then set to 
treatment start date 
• If day is missing and month and year ≠ month and year of treatment start date, then set to 
first day of the month 
• If start date is completely missing, set to treatment start date as long as adverse event end 
date is not before treatment start date 
If end date of an adverse event is partially missing, impute as follows: 
• If both month and day are missing, then set to December 31 
• If only day is missing, then set to last day of the month 
• If end date is completely missing, do not impute 
When the start date or end date of a medication is partially missing, the date will be imputed to 
determine whether the medication is prior or concomitant. The following rules will be applied to 
impute partial dates for medications: 
If start date of a medication is partially missing, impute as follows: 
• If both month and day are missing, then set to January 01 
• If only day is missing, then set to the first of the month 
If end date of a medication is partially missing, impute as follows: 
• If both month and day are missing, then set to December 31 
• If only day is missing, then set to last day of the month 
If start date or end date of a medication is completely missing, do not impute. 
 
 
 
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10.2 APPENDIX 2   
CLL RESPONSE DEFINITIONS 
Parameter 
CR/CRi* 
PR/nPR* 
PR With Lymphocytosis 
Progressive Disease* 
Group A 
Lymphadenopathy† 
None > 1.5 cm 
Decrease ≥ 50%b 
Decrease ≥ 50% 
Increase ≥ 50% or new lesionc 
Hepatomegaly 
None 
Decrease ≥ 50% 
Decrease ≥ 50% 
Increase ≥ 50% 
Splenomegaly 
None 
Decrease ≥ 50% 
Decrease ≥ 50% 
Increase ≥ 50% 
Blood lymphocytes 
< 4000/μL 
Decrease ≥ 50% from 
baseline 
Decrease < 50% or increase 
from baseline 
 
Marrow‡ 
Normocellular, < 30% 
lymphocytes, no 
B-lymphoid nodules. 
Hypocellular marrow 
defines CRi. 
50% reduction in marrow 
infiltrate, or B-lymphoid 
nodules. 
Nodular PR (nPR): criteria 
for CR are met in setting of 
B-lymphoid nodules/B-cell 
clusters. 
50% reduction in marrow 
infiltrate, or B-lymphoid 
nodules 
 
Group B 
Platelet count 
> 100,000/μLa 
> 100,000/μL or increase ≥ 
50% over baselinea 
> 100,000/μL or increase ≥ 
50% over baselinea 
Decrease of ≥ 50% from 
baseline secondary to CLL 
Hemoglobin 
> 11.0 g/dLa 
> 11 g/dL or increase ≥ 50% 
over baselinea 
> 11 g/dL or increase ≥ 50% 
over baselinea 
Decrease of > 2 g/dL from 
baseline secondary to CLL 
Neutrophils‡ 
> 1500/μLa 
> 1,500/μL or > 50% 
improvement over baselinea 
> 1,500/μL or > 50% 
improvement over baselinea 
 
Abbreviations: CLL, chronic lymphocytic leukemia; CR, complete remission (response); CRi, CR with incomplete bone marrow recovery; CT, computed 
tomography; PD, disease progression; PR, partial remission (response); SD, stable disease. 
 
Group A criteria define the tumor load, Group B criteria define the function of the hematopoietic system (or marrow). 
CR*: all of the criteria have to be met, and patients must lack disease-related constitutional symptoms and extralymphatic site of disease.  
PR*: at least two of the criteria of group A (lymphadenopathy, splenomegaly, hepatomegaly, or lymphocytes) plus one of the criteria of Group B (platelets, 
hemoglobin, or neutrophils) have to be met. 
 
NOTE: Patients with only one abnormality in Group A at baseline are still assessable for PR. The one Group A parameter must be met (and the other two must 
still be normal), and at least one Group B criteria must be met (Hallek et al, 2013).  
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Partial response with lymphocytosis*: presence of lymphocytosis, plus ≥50% reduction in lymphadenopathy and/or in spleen or liver enlargement, plus one of 
the Group B criteria must be met (Hallek et al, 2012);  
SD: is absence of progressive disease and failure to achieve at least a PR. 
PD* progressive disease: at least one of the above progressive disease criteria has to be met. Transformation to a more aggressive histology (eg, Richter’s 
Syndrome) meets the definition of PD. 
 
NOTE: Isolated elevation of treatment-related lymphocytosis by itself will not be considered PD unless patient becomes symptomatic (Hallek et al, 2012). 
† Sum of the products (SPD) of multiple lymph nodes (as evaluated by CT scans, or by physical examination). 
‡ These parameters are irrelevant for some response categories 
 
a. 
Without need for exogenous growth factors 
b. 
In the sum products of ≤6 lymph nodes or in the largest diameter of the enlarged lymph node(s) detected before therapy and no increase in any 
lymph node or new enlarged lymph nodes 
c. 
An increase of 50% or more in greatest determined diameter of any previous site, minimum 0.5 cm if nodes <2 cm in a single lymph node 
defines PD. An increase from the nadir by ≥ 50% in SPD of multiple targeted lesions. An unequivocal increase in the size of one or more nodal 
or extranodal non-target lesions. 
 
Note:  Temporary withholding of study drug (eg, for drug-related toxicity, surgery, or intercurrent illness) for as little as 7 days can cause a transient 
worsening of disease and/or of constitutional symptoms.  In such circumstances, and if medically appropriate, patients may resume therapy and 
relevant clinical, laboratory, and/or radiologic assessments should be performed to document whether tumor control can be maintained or whether 
actual disease progression has occurred.   
 
BTK inhibition may cause lymphocytosis due to a redistribution of leukemia cells from the lymphoid tissues to the blood.  In such cases, increased blood 
lymphocytosis is not a sign of treatment failure or progressive disease.  The opposite may occur during periods of temporary holds of BTK inhibitors (due to 
adverse events or other reasons), and leukemia cells may redistribute from the blood to lymphoid tissue; this also is not a sign of treatment failure or progressive 
disease. 
 
Isolated increase in lymph nodes and/or splenomegaly during periods of BGB-3111 hold will not be considered as progressive disease unless confirmed by a 
repeat imaging studies at least 6 weeks after restarting study drug administration.  The response category “indeterminate due to BGB-3111 hold” should be 
selected for such instances.  Following the repeat imaging 6 weeks after restarting study drug, response should be in comparison to the imaging at baseline. 
 
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