Clinical trial NCT02343120
Conditions: B-cell Malignancies
Sponsor: BeiGene
Start date: 2014-09-04; Completion date: 2021-03-31
Enrollment: 385 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the safety, tolerability, pharmacokinetic profile and efficacy of BGB-3111 in participants with B-cell lymphoid malignancies.

Detailed description:

Arms: arm 1: Participants were administered up to 320 mg total daily dose of zanubrutinib until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
Interventions: intervention 1: Zanubrutinib
Intervention descriptions: intervention 1: Oral administration by capsule

Protocol documents:
Prot_000.pdf: 
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STATISTICAL ANALYSIS PLAN
Study Protocol 
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A Phase I, Open-Label, Multiple-Dose, Dose Escalation and 
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CONFIDENTIAL
Page 12


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CONFIDENTIAL
Page 13


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Table 1: Planned sample size in Part 2 by diagnosis, sub-diagnosis, prior treatment status, starting dose, and schedule
Part 2 
Cohort
Diagnosis (sub-diagnosis)
Refractory status
Dose/schedule
n
CLL/SLL
WM
MALT
RT
R/R
TN
320 mg 
QD
160 mg 
BID
MCL
FL
MZL
DLBCL
HCL
D

[
[
;
*&%
VXEW\SH
[
DOWHUQDWH
DOWHUQDWH
E

QRQ*&%
VXEW\SH
[
[
F

[
[
[
G

[
[
[
H

[
[
[
[
I

[
[
[
[
[
J

[
[
[
[
K

[
[
[
[
L

!\U
&,56! 
[
[
[
M

[
[
[
[
N

[
;
[
[
[
O

;
[
P

[
[
[
[
;
[
[
[
;
[
[
TOTAL
380
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3
STUDY OBJECTIVES
3.1
PART 1
Primary Objectives
x
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7RGHWHUPLQH53'DQGUHJLPHQRI]DQXEUXWLQLE ZKHQJLYHQFRQWLQXRXVO\RUDOO\
Secondary Objectives
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Exploratory Objectives
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3.2
PART 2
Primary Objectives
x
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Secondary Objectives
x
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CONFIDENTIAL
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CONFIDENTIAL
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4
STUDY ENDPOINTS
4.1
PART 1
Primary Endpoints
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CONFIDENTIAL
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4.2
PART 2
Primary Endpoints
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Secondary Endpoints 
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3. SDUDPHWHUVDVGHVFULEHGIRU3DUWLQFOXGLQJ $8&ODVW$8&LQI &PD[ WPD[W&/)
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4.3
EFFICACY ENDPOINTS FOR POOLED PART1 AND PART2 BY DISEASE TYPE
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CONFIDENTIAL
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5DWHRI9*35RU&5 SHURYHUDOOFRPELQHGDVVHVVPHQW E\,5&
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Exploratory efficacy endpoints
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CONFIDENTIAL
Page 19


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CONFIDENTIAL
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5
SAMPLE SIZE CONSIDERATIONS
Part 1
7KHQXPEHURIGRVHOHYHOVH[DPLQHGDQGWKHHPHUJLQJ]DQXEUXWLQLE WR[LFLWLHVZLOOGHWHUPLQHWKH
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Part 2
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6
STATISTICAL METHODS
6.1
ANALYSIS SETS
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CONFIDENTIAL
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6.2
DATA ANALYSIS GENERAL CONSIDERATIONS
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6.2.1
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6.2.2
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6.2.3
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PATIENT CHARACTERISTICS
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6.3.5
Medical History
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Prior Anti-Cancer Therapies and Surgeries
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6.3.7
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EFFICACY ANALYSIS
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SAFETY ANALYSES
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Vital Signs
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Physical Examination
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CONFIDENTIAL
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9
REFERENCES
%URRNPH\HU5DQG&URZOH\-A confidence interval for the median survival time
%LRPHWULFV
&KHVRQ%'%\UG-&5DL.5HWDO  1RYHO7DUJHWHG$JHQWVDQGWKH1HHGWR5HILQH
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$VVHVVPHQWRI+RGJNLQDQG1RQ+RGJNLQ /\PSKRPD7KH/XJDQR&ODVVLILFDWLRQ-&OLQ2QFRO
±
)OHLVV-/Statistical Methods for Rates and Proportions, Second Edition, 1HZ<RUN
-RKQ:LOH\	6RQV,QF
*UHHQZRRG0The natural duration of cancer 3XEOLFKHDOWKDQGPHGLFDOSDWLHQWV

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CONFIDENTIAL
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6FKHPSHU0DQG6PLWK7/A note on quantifying follow-up in studies of failure time
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CONFIDENTIAL
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Appendix A: WM Response Assessment Methods
Overall Combined Assessment
(Modified Owens 2013)
Overall IgM Assessment
Complete 
Response 
(CR)
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CONFIDENTIAL
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CONFIDENTIAL
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CONFIDENTIAL
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Appendix B: WM International Prognostic Scoring System (IPSS)
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2009;113:4163-4170
CONFIDENTIAL
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BeiGene USA, Inc 
                       BGB-3111-AU-003 
              (SAP appendix for final CSR) 
 
CONFIDENTIAL 
Page 1 
 
 
 
 
STATISTICAL ANALYSIS PLAN APPENDIX 
Study Protocol 
Number: 
BGB-3111-AU-003 
Study Protocol 
Title: 
A Phase I, Open-Label, Multiple-Dose, Dose Escalation and 
Expansion Study to Investigate the Safety and Pharmacokinetics of 
the BTK Inhibitor BGB-3111 in Subjects with B-Cell Lymphoid 
Malignancies 
 
Date: 
Mar 23, 2021 
Version: 
1.0 
 
 
 
 
 
 
 
 
 
 
 
CONFIDENTIAL
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BeiGene USA, Inc 
                       BGB-3111-AU-003 
              (SAP appendix for final CSR) 
 
CONFIDENTIAL 
Page 2 
TABLE OF CONTENTS 
TABLE OF CONTENTS .................................................................................................................2 
LIST OF TABLES ...........................................................................................................................2 
REVISION HISTORY.....................................................................................................................3 
INTRODUCTION ...........................................................................................................................4 
1. 
EFFICACY ANALYSIS SET ......................................................................................4 
2. 
DETERMINATION OF INVESTIGATOR RESPONSE DATE ................................5 
3. 
PFS/DOR EVENT AND CENSORED DATES ..........................................................7 
3.1. 
PFS/DOR censoring reasons .........................................................................................8 
4. 
DETERMINATION OF BASELINE EXTRAMEDULLARY DISEASE 
FOR WM ......................................................................................................................9 
5. 
DETERMINATION OF BASELINE LYMPHADENOPATHY, 
SPLENOMEGALY, AND HEPATOMEGALY FOR CLL/SLL ................................9 
6. 
BONE MARROW INVOLVEMENT AT BASELINE .............................................10 
7. 
EXTRA-NODAL LESION AT BASELINE ..............................................................10 
8. 
REFRACTORY DISEASE ........................................................................................10 
9. 
BEST RESPONSE OF LAST PRIOR REGIMEN ....................................................10 
10. 
DETERMINATION OF ACTUAL DOSE ................................................................11 
11. 
DEFINITION OF RELATIVE DOSE INTENSITY ..................................................11 
12. 
DOSE REDUCTION ..................................................................................................12 
13. 
DOSE INTERRUPTION DUE TO AE ......................................................................12 
14. 
UNKNOWN DATES .................................................................................................13 
15. 
MISSING DATE IMPUTATION RULE ...................................................................13 
16. 
NORMAL RANGE FOR NEUTROPHIL COUNT AND LYMPHOCYTE 
COUNT DERIVED FROM % ...................................................................................15 
 
LIST OF TABLES 
Table 1 
Example ........................................................................................................................5 
Table 2 
Measurements to be considered to derive the timepoint response date ........................6 
 
CONFIDENTIAL
Page 48


BeiGene USA, Inc 
                       BGB-3111-AU-003 
              (SAP appendix for final CSR) 
 
CONFIDENTIAL 
Page 3 
REVISION HISTORY  
Revision  
Effective Date  
Summary of Revisions  
1.0 
23-Mar-2021 
Effective version 
 
 
 
CONFIDENTIAL
Page 49


BeiGene USA, Inc 
                       BGB-3111-AU-003 
              (SAP appendix for final CSR) 
 
CONFIDENTIAL 
Page 4 
INTRODUCTION 
This Statistical Analysis Plan (SAP) appendix provides additional details on the efficacy and 
safety analyses other than those specified in the SAP Version 1.0 (dated on 19 October 2018) for 
the BGB-3111-AU-003 Study (referred to as AU003 in the following sections).  
This document provides the most updated information for safety-related sections and 
summarizes the efficacy-related information based on below 3 disease-specific appendixes:  
x 
SAP appendix for MCL Version 1.0 dated on 01Mar2019.  
x 
SAP appendix for MZL Version 1.0 dated on 09Nov2020. 
x 
SAP appendix for WM Version 2.0 dated on 27Nov2019.  
1. 
EFFICACY ANALYSIS SET  
Per AU003 SAP, the Safety Set, which includes all patients received any dose of zanubrutinib, 
will be the primary analysis set of the final efficacy analysis except for WM patients.  
For clarity of the presentation, Efficacy Evaluable Set defined same as above safety set will be 
referenced and used for the final efficacy analyses except for WM patients. For WM patients, as 
defined in SAP, the final efficacy analyses will be based on the Efficacy Evaluable Set which 
includes all WM patients in the safety set with baseline IgM (or M-protein) >= 5 g/L and with no 
prior exposure to a BTK inhibitor.  
Unless specified otherwise, efficacy analyses will be presented by specific indications, including 
CLL/SLL, WM, MCL, MZL, FL, DLBCL, RT, and HCL. For CLL/SLL, WM, MCL and 
DLBCL, the efficacy will be presented by the following subgroups: 
x CLL/SLL patients will be presented by their status of Del17p status, i.e., Del17p+, 
Del17p- (wild type) and total (including both Del17p+, Del17p- and patients with 
missing Del17p status). 
x WM patients will be presented by treatment naïve (TN) vs. relapsed/refractor (R/R) status 
as presented in the WM specific CSR. 
x MCL patients will be presented by TN vs. R/R status, and within R/R patients, the 
efficacy will be further presented by those treated with 320 mg total daily dose and total 
regardless of the doses received. These are based on those presented in the MCL filing 
specific analyses and CSR. 
x DLBCL patients will be presented by non-GCB DLBCL and GCB DLBCL patients. 
CONFIDENTIAL
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BeiGene USA, Inc 
                       BGB-3111-AU-003 
              (SAP appendix for final CSR) 
 
CONFIDENTIAL 
Page 5 
2. 
DETERMINATION OF INVESTIGATOR RESPONSE DATE 
If investigator assessed timepoint response date can’t be fully cleaned at the final database lock 
and the study team decides to derive the timepoint response date, below principals will be 
followed: 
x Assessment dates of all measurements that could impact the investigator’s determination 
of response will be compared with investigator assessed response date in EDC. (Note: the 
measurements vary by indications and need be confirmed with medical monitor) 
x The last date of the measurements that is on or before the investigator assessed timepoint 
response date will be the derived timepoint response date. If the response is PD, then the 
derived timepoint response date will be the PD date from “Disease Progression” CRF 
page for that corresponding timepoint. 
To determine the timepoint response date, the assessment dates of all measurements that could 
impact the investigator’s determination of response along with the date of the investigator 
response assessment will be placed into a tall skinny file and sorted by Subject and Date. 
Table 1 is an example of how the tall skinny file would look like: 
Table 1 
Example 
Subject 
Assessment 
Date 
Sxxxx-xx-xx 
Target Lesion 
02 June 2017 
  
Non-Target 
02 June 2017 
  
New Lesion 
NA 
 
PET Scan 
03 June 2017 
  
Liver and Spleen Measurements  02 Jun 2017 
 
Bone Marrow 
NA 
 
Study Biopsy 
NA 
  
Investigator Response 
03 Jun 2017 
 
The last assessment date of all considered measurements (Table 2) on or before the Investigator 
Response date will be the derived date associated with the Investigator’s response, except that 
PD date from “Disease Progression” CRF page will be used when the corresponding timepoint 
response is PD. 
The measurements to be considered are listed below for different indications in Table 2. 
 
 
CONFIDENTIAL
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BeiGene USA, Inc 
                       BGB-3111-AU-003 
              (SAP appendix for final CSR) 
 
CONFIDENTIAL 
Page 6 
Table 2 
Measurements to be considered to derive the timepoint response date 
Measurements 
CLL 
WM 
MCL/ 
MZL 
RT & other 
NHL (i.e., FL, 
DLBCL, SLL) 
HCL 
Scan date of (Target Lesions, Non-
Target Lesions, New Lesion) 
X 
X 
X 
X 
X 
PET-CT Scan 
X 
 
X 
X 
X 
Liver and Spleen measurements 
(CT, MRI, PET/CT only in lvr_spl) 
X 
X 
(Spleen 
only) 
X 
(Spleen 
only) 
X 
(Spleen only) 
X 
(Spleen only) 
Physical Examination-Targeted 
(Spleen and Lymph nodes from 
PETAR) 
X 
(Liver also) 
X 
 
X 
X 
Bone Marrow (% tumor cell 
involvement: 2 fields (BMLYMPHO, 
BMGENM) & other morphological 
findings (BMFIND) & BMTUMYN, 
excluding blank/NAs) 
X 
X 
X 
X 
 
Bone Marrow (% Hairy Cell 
Involvement (BMHCL), non-missing 
ones) 
 
 
 
 
X 
Study biopsy 
X 
X 
X 
X 
X 
Serum IgM (non-missing ones, 
excluding Not Done/Not reported/ 
Unknown/Not available/blank) 
 
X 
 
 
 
Serum SPEP (only if serum 
paraprotein was used to determine 
overall response (SIMPROT=1), non-
missing ones)  
 
X 
 
 
 
Serum Immunofixation  
(only if serum paraprotein was used to 
determine overall response, 
Positive/Negative ones, excluding 
NAs/blanks)  
 
X 
 
 
 
Hematology (Hemoglobin, Platelet 
Count, Neutrophils, non-missing ones) 
X 
(Lymphocytes 
also) 
 
 
 
X 
(Hairy Cell 
Count also) 
 
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3. 
PFS/DOR EVENT AND CENSORED DATES  
 Step 1: First check whether there is a PD or death. 
x If yes, go to step 2.  
x If no, go to step 4 
Step 2:  Define PFS event date as earlier date of following two dates and PFS censoring flag=0 
x PD date = Date for the first documented PD from PD form (or IRC raw.RS domain 
for IRC PFS) 
x Death date  
Step 3: Compare PFS event date from step 2 to: 1) new anti-cancer therapy start date and 2) the 
skipped assessment date. 
x If PFS event date > new anti-cancer therapy start date OR the PFS event date > the 
skipped assessment date, 
o PFS censored date = Last disease assessment date prior to the earlier of PFS 
event date and new anticancer therapy start date. 
o PFS censoring flag = 1 
Under protocol version 6.0 or earlier, no regular response assessments (unless PD) were required 
after Week 52 for patients on treatment. To avoid under count of PDs/death that due to lack of 
protocol-defined regular assessments, the patients were assumed to be followed till the end of 
treatment. The potential skipped assessments will be calculated from the maximum of the last 
assessment and the end of treatment dates. Under protocol version 7.0, dated 02 October 2017, 
imaging for response assessment after Week 52 (beginning Week 76) was required to be 
conducted regularly every 24 weeks or when a significant change in response was suspected 
(progressive disease [PD] or upgrade of response), the skipped assessment will be counted from 
the very last assessment date:   
a) For patients with PFS event date within Week 52 (i.e., 365 days) from first dose, the 
skipped assessment date is defined as 6 months from the last disease assessment date 
prior to PFS event. 
b) For patients with PFS event date after Week 52 (i.e., >365 days) from first dose,  
x 
If the last disease assessment date prior to PFS event date was earlier than        
protocol version 7.0 effective date (02 October 2017), the skipped assessment 
date is defined as 12 months from the maximum of (last disease assessment 
date prior to PFS event, and EOT date), assuming the response remains 
unchanged as long as the treatment continues. 
x 
If the last disease assessment date prior to PFS event date was later than 02 
October 2017, the skipped assessment date is defined as 12 months from the 
last disease assessment date prior to PFS event. 
6 months interval ~ 24 weeks + 2 weeks window =182 days 
12 months interval ~48 weeks + 2 weeks window=350 days 
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Step 4: Define PFS censored date as below and PFS censoring flag = 1 
x If no disease assessment at baseline or post-baseline, then PFS censored date = first 
dose date, otherwise PFS censored date = Last disease assessment date  
 
Definition of Last disease assessment date for censored patients and for determining the 
skipped assessment date: 
x Last disease assessment date by Investigator= Last response date (See Section 2) 
where response is evaluable and not PD prior to new anti-cancer therapy start date. 
x Last disease assessment date by IRC= Last non-PD date by IRC if it is prior to new 
anti-cancer therapy start, otherwise last timepoint assessment date prior to new anti-
cancer therapy start date. 
x If all timepoint responses are “Not evaluable” (by Investigator or IRC), then Last 
disease assessment date = Last timepoint assessment date prior to new anti-cancer 
therapy start date. 
3.1. 
PFS/DOR censoring reasons 
Check against the SAP if “>1 missed assessment’ apply. 
1) If subject is CNSR=1 and has no baseline or post baseline response assessment, set to 'No 
baseline/post-baseline assessment'.  
2) Else if subject is CNSR=1 and disease progression or death right after more than one 
missed scheduled disease assessment at the time of data cutoff, set to ‘Progressive 
disease/death after >1 missed assessment'.   
3) Else if subject is CNSR=1 and disease progression or death after new anti-cancer therapy, 
set to ‘Progressive disease/death after non-protocol anti-cancer therapy'.   
4) Else if subject is CNSR=1 and started new anti-cancer therapy and last tumor assessment 
is on or before new anti-cancer therapy at the time of data cutoff, set to “No documented 
progressive disease/death”.  
5) Else if subject is CNSR=1 and started new anti-cancer therapy and last tumor assessment 
is after new anti-cancer therapy at the time of data cutoff, set to “No documented 
progressive disease /death: Non-protocol anti-cancer therapy”.  
6) Else if subject is CNSR=1 and disc study due to patient withdrew consent or lost to 
follow-up, then set to ' No documented progressive disease/death: Withdrew consent/lost 
to follow-up’.  
a. Comment: Only report study discontinuation due to withdrew consent or lost to 
follow up. For other reasons, report as “No documented progressive disease /death” if 
patient does not have PD or death. 
7) Else if subject is CNSR=1 and alive without disease progression at the time of data 
cutoff, set to “No documented progressive disease/death”.  
 
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4. 
DETERMINATION OF BASELINE EXTRAMEDULLARY 
DISEASE FOR WM  
Baseline extramedullary disease (EMD) is defined as “Yes” if any of the below criteria is “Yes”: 
Lymphadenopathy: 
x Lymph Node in raw.TLB [Target Lesions – Baseline]: if any “type of lesion” = 
“Lymph node” with LDi (“longest perpendicular diameter measurement”) >1.5 (cm) 
then “Yes”. 
x Lymph Node in raw.PETAR [Physical Examination – Targeted] or raw.PEB 
[Physical Examination]: if baseline lymph node assessment is “Abnormal” then 
“Yes”. Baseline lymph node is defined as “body system” = “Lymph nodes” with 
“folder” = “WK1D1” from raw.PETAR, if a patient has missing record or missing 
result or non-“Abnormal” result then use “body system”=“Hematologic/Lymphatic” 
with “folder”=”Screening” from raw.PEB. 
Splenomegaly: 
x Spleen in raw.LVR_SPL [Liver and Spleen Measurements]: if spleen is enlarged then 
“Yes”. Baseline is defined per SAP using date of assessment. 
x Spleen in raw.PETAR [Physical Examination – Targeted] or raw.PEB [Physical 
Examination]: if baseline spleen assessment is enlarged then “Yes”. Baseline is 
defined as “folder” = “WK1D1” from raw.PETAR, if a patient has missing record or 
missing result or not enlarged result then use “folder”=”Screening” from raw.PEB. 
Other: 
x Extranodal in raw.TLB [Target Lesions – Baseline]: if any “type of lesion” = 
“Extranodal” with LDi (“longest perpendicular diameter measurement”) >1.0 (cm) 
then “Yes”. 
Otherwise, baseline EMD is “No”. 
5. 
DETERMINATION OF BASELINE LYMPHADENOPATHY, 
SPLENOMEGALY, AND HEPATOMEGALY FOR CLL/SLL  
For CLL/SLL patients,  
x Baseline Lymphadenopathy and Splenomegaly were defined the same as those 
defined above for WM.  
x Baseline Hepatomegaly is defined as “Yes” if any of the below criteria is “Yes”: 
a) Liver in raw.LVR_SPL [Liver and Spleen Measurements]: if liver is enlarged 
then “Yes”. Baseline is defined per SAP using date of assessment. 
b) Liver in raw.PETAR [Physical Examination – Targeted] or raw.PEB [Physical 
Examination]: if baseline liver assessment is enlarged then “Yes”. Baseline is 
defined as “folder” = “WK1D1” from raw.PETAR, if a patient has missing 
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record or missing result or not enlarged result then use “folder”=”Screening” 
from raw.PEB. 
6. 
BONE MARROW INVOLVEMENT AT BASELINE 
Use last bone marrow record on or before the first dose date (from the bone marrow eCRFs) 
x Was there tumor involvement in the bone marrow? (Yes, No, Indeterminate, Not 
Available).  
x If no bone marrow data on or before the first dose date, patient will be counted in Not 
Available. 
x Only patients with this question checked as ‘Yes’ will be considered as with bone 
marrow involvement at baseline. 
7. 
EXTRA-NODAL LESION AT BASELINE 
x Yes, if any lesion in “Target Lesions - Baseline” or “Non-Target Lesions - Baseline” with 
lesion type = “Extranodal”, or bone marrow involvement = “Yes” at baseline per bone 
marrow biopsy/aspiration (see Section 6). 
x No, otherwise. 
8. 
REFRACTORY DISEASE 
Refractory disease is derived from the last regimen of prior anticancer therapy, 
x Yes, if best overall response =”SD” or “PD”. 
x No, if best overall response = “CR” or “PR” (for CLL patients, also consider best overall 
response of “CRi”, “nPR” and “PR-L”). 
x Unknown if best overall response is missing or not evaluable. 
9. 
BEST RESPONSE OF LAST PRIOR REGIMEN 
To determine the best response of last prior regimen, 
x First, pick the maximum regimen number from clinical review spreadsheet of ‘prior 
anticancer therapies’. 
x Then, select the best response among the last regimens. (CR> CRi> VGPR> nPR> PR> 
PR-L> MR> SD> PD>Not evaluable >Not done > Missing) 
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10. 
DETERMINATION OF ACTUAL DOSE 
The actual dose group is determined as follows. 
x Remove all records from raw.sda with non-missing enddate and with enddate-
startdate<=2.  
x Remove all records with dose missed/held, i.e., exreas1 ne “No” and exreas1 ne “”. 
Records with this info missing will be considered as no dose missed/held. 
x Remove all records with missing intended or actual dose, i.e., exdose2 eq “” or sdaad eq 
“”. 
x Remove all records with no actual dose, i.e., sdaad eq “0 mg”. 
For each subject select the record with the earliest start date and use the corresponding value for 
the dose variable as the actual dose received.  
11. 
DEFINITION OF RELATIVE DOSE INTENSITY 
Below steps should be followed to calculate Relative Dose Intensity (RDI): 
1. Determine the first dose date from raw.SDA as the earliest start date among records with 
total dose per day>0. 
2. Determine the treatment end date as the end date of last dosing record from raw.SDA. If 
the end date of last dosing record is after the cutoff date, use the cutoff date. Partial dates 
are imputed as per Section 15.A.7. If this date is completely missing, use the minimum of  
x The end of treatment date from the treatment discontinuation page 
x The start date for the last dosing record with a missing end date + 30 days  
x The data cutoff date 
For patients who have discontinued study treatment, if the last dosing record has a total 
dose per day of zero, then determine the treatment end date as the end date of last non-
zero dosing record from raw.SDA before cutoff date.  
3. Actual total dose: To each day that is between first dose date and treatment end date, 
calculate the total daily dose. Sum over all days to obtain the total dose received. For 
cases where there are dose records that overlap in time assign the smallest non-missing 
total daily dose for the overlapping days. Note that there are some instances where the am 
and pm dose for the same day are recorded as separate entries. These entries need to be 
added together to obtain the total daily dose. 
4. Planned total dose: To each day that is between first dose date and treatment end date, 
assign the total planned daily dose. This will be the same number for every day during 
this period. For Part 1 patients, it is the actual initial total daily dose determined in 
Section 10; for Part 2 patients, it is 320 mg (per day). Calculate the duration of treatment 
as (treatment end date -first dose date +1) and multiply by the total planned daily dose to 
obtain the total expected dose. 
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5. Divide the total dose received by the total expected dose and multiply by 100 to 
determine the relative dose intensity. 
12. 
DOSE REDUCTION  
Below steps should be followed to calculate number of patients with dose reductions: 
1) Select records in raw.SDA where dose change reason ne “” (SDARRPD ne “”). 
2) Among records in step 1, select: 
x For Part 2 patients: total daily dose < original assigned total daily dose (e.g., 160mg 
BID = 320mg). 
x For Part 1 patients: total daily dose < original assigned total daily dose (e.g., 160mg 
BID=320mg) or total daily dose < maximum total daily dose before this record. 
3) Exclude records where dose missed/held reason ne “”. 
4) Exclude records where total daily dose = 0mg or missing. 
5) If dose change reason = “Other” (SDARRPD= “Other”), then only keep those with dose 
reduction duration >= 3 days (EXENDTC1-EXSTDTC1+1>=3). Note if dose change 
reason is adverse event or PI decision, then checking if dose reduction duration is >=3 
days is not needed. 
13. 
DOSE INTERRUPTION DUE TO AE 
To calculate number of patients with dose interruptions due to AE, select records in raw.SDA 
where 
1) sdarmcd = “Adverse Event” AND  
2) total daily dose=0 or 0mg (raw.SDA. sdacalcdose) AND 
3) duration > 1 day (stop date-start date+1 > 1 day; if start/stop date is partial then count it 
as duration > 1 day)  
Note: Some patients had dose held due to same AE as multiple dosing records, those need be 
added up to decide whether it is greater than 1 day. i.e. Among records with 
raw.sda.sdarmcd=”Adverse Event”, look for records where Raw.sda.sdaaedsl2 is not equal to “ “ 
AND raw.sda.sdaaedsl2 are same AND total daily dose=0 or 0mg AND start date of the next 
dosing record is 1 day after the stop date of the previous dosing record (i.e. dates are 
consecutive). 
 
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14. 
UNKNOWN DATES 
Sites used 1900/01/01 to denote an unknown date. 
Sites used xxxx/01/01 to denote and unknown month for some records. 
Sites used xxxx/xx/01/to denote an unknown day for some records. 
 If an end date is before a start date and year is missing for an end date, then impute the end date 
as follows:  
x Start date and end date have the same year and the end date is of the form xxxx/01/01, 
then write the end date as xxxx/unk/un  
x Start date and end date have the same year and month and the end date is of the form 
xxxx/xx/01 then write the end date as xxxx/xx/un  
x End date has the form 1900/01/01 then write the end date as unkn/unk/un 
15. 
MISSING DATE IMPUTATION RULE 
In general, missing or partial dates will not be imputed as data level. The following rules will 
apply for the specific analysis and summary purposes mentioned below only.   
A.1 Prior/Concomitant Medications/Procedures 
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: 
x 
If both month and day are missing or if month is missing and day is 01, then set to 
January 01 
x 
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: 
x 
If both month and day are missing, then set to December 31 
x 
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. 
A.2 Adverse Events 
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 AE is partially missing, the date will be imputed to 
determine whether the AE is treatment emergent. When in doubt, the AE will be considered 
treatment emergent by default. The following rules will be applied to impute partial dates for 
AEs: 
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If start date of an AE is partially missing, impute as follows: 
x If both month and day are missing, then the imputed month and day will be January 01 or 
the first dosing date if they have the same year, whichever is later.  
x If only day is missing, then the imputed day will be the first day of the month or the first 
dosing date if they have the same month and year, whichever is later  
x If start date is completely missing, the imputed day will be the first dosing date as long as 
AE end date is not before the first dosing date.  
If end date of an AE is partially missing, impute as follows: 
x If both month and day are missing, then set to December 31 
x If only day is missing, then set to last day of the month 
If end date is completely missing, do not impute. 
A.3 Deaths 
In case complete death dates are not recorded, impute as follows: 
x If both month and day are missing, then the imputed month and day will be January 01 or 
the last date of the last date of subject known to be alive + 1, whichever is later. 
x If only day is missing, the death will be assumed to be on the first day of the month or the 
last date of subject known to be alive +1, whichever is later.  
A.4 New Anti-cancer therapy 
If the start day of a subsequent anti-cancer therapy is incomplete or missing, impute as follows:  
x If both month and day are missing, then the imputed month and day will be 01Jan or the 
last day of the month for the last adequate disease assessment (refer to #2 derivation of 
investigator response date, use the derived last tumor assessment where the response is 
not NA, NE or not done) if they have the same year. 
x If only day is missing, then the imputed day will be the first day of the month. 
A.5 Diagnosis 
If a diagnosis date is partially missing, impute as follows: 
x If both month and day are missing, then set to January 01 
x If only day is missing, then set to the first of the month 
If a diagnosis date is completely missing, do not impute. 
A.6 Prior Therapy/Response to Prior Therapy 
If a prior therapy or response to prior therapy date is partially missing, impute as follows: 
x If only day is missing, then set to the 15th of the month 
No imputation will be performed for all other types of missing dates. 
 
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A.7 Dose Stop Date 
Sort all dose records by start and stop date and impute the partial missing dose stop date as 
follows:  
x If dose stop date is not the last dosing record, then impute the stop date as start date of 
next dosing record -1. (used when calculating the total dose received) 
x If dose stop date is the last dosing record and partially missing 
o If only day is missing, impute the stop date as the earliest of last day of the month, 
end of treatment date (if end of treatment date is complete), end of study date, 
death date and data cutoff date. 
16. 
NORMAL RANGE FOR NEUTROPHIL COUNT AND 
LYMPHOCYTE COUNT DERIVED FROM % 
When deriving the absolute neutrophil count from a measure reported as %, the percent value is 
multiplied by the total WBC count. The standard normal range from Mosby’s Manual of 
Diagnostic and Laboratory Tests will be used to evaluate the toxicity grade of such neutrophil 
values which is 2.5-8.0 x 10^9/L. The same method will be used for the absolute lymphocyte 
count whose standard normal range is 1.0-4.0 x 10^9/L.  
 
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