Clinical trial NCT04551963
Conditions: B-cell Malignancies
Sponsor: BeiGene
Start date: 2020-11-15; Completion date: 2022-02-21
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to assess the steady-state zanubrutinib pharmacokinetics (PK) when co-administered with moderate and strong cytochrome P450 family 3 subfamily A (CYP3A) inhibitors.

Detailed description:

Arms: arm 1: Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, fluconazole was administered once a day at a dose of 400 mg with zanubrutinib at a reduced dose of 80 mg twice a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg twice a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, diltiazem was administered once a day at a dose of 180 mg with 80 mg zanubrutinib twice a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg twice a day.

Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day. arm 2: Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, voriconazole was administered twice a day at a dose of 200 mg (total daily dose of 400 mg) with zanubrutinib at a reduced dose of 80 mg once a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg once a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, clarithromycin was administered twice a day at a dose of 250 mg (total daily dose of 500 mg) with 80 mg zanubrutinib once a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg once a day.

Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day.
Interventions: intervention 1: Zanubrutinib intervention 2: Fluconazole intervention 3: Diltiazem intervention 4: Voriconazole intervention 5: Clarithromycin
Intervention descriptions: intervention 1: Capsules administered at a dose and frequency as specified in the treatment arm intervention 2: Capsules administered at a dose and frequency as specified in the treatment arm intervention 3: Capsules administered at a dose and frequency as specified in the treatment arm intervention 4: Capsules administered at a dose and frequency as specified in the treatment arm intervention 5: Capsules administered at a dose and frequency as specified in the treatment arm

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
BeiGene USA, Inc 
BGB--113 
     (Statistical Analysis Plan) 
Version 2.0: 07 January 2022 
Page 1 of 26 
STATISTICAL ANALYSIS PLAN 
Study Protocol 
Number: 
BGB-3111-113 
Study Protocol 
Title: 
A Drug–Drug Interaction Study of Zanubrutinib with Moderate/Strong CYP3A 
Inhibitors in Patients with B-Cell Malignancies 
Date: 
07 January 2022 
Version: 
2.0 
DocuSign Envelope ID: C891B1EE-F477-4151-8F0E-EE57E7C0D613
NCT04551963


BeiGene USA, Inc
                  BGB--113
              (Statistical Analysis Plan)
Version 2.0: 07 January 2022
Page 2 of 26
SIGNATURE PAGE
Authors: 
BeiGene USA, Inc.
Signature
Date:  ______________
Approval
BeiGene USA, Inc.
Signature
Date: ________________
BeiGene USA, Inc.
Signature
Date: ________________
Medical Monitor
BeiGene USA, Inc.
Signature
Date: ________________
BeiGene USA, Inc.
Signature
Date: ________________
DocuSign Envelope ID: C891B1EE-F477-4151-8F0E-EE57E7C0D613
07-Jan-2022 | 04:50:17 PST
07-Jan-2022 | 09:23:29 PST
07-Jan-2022 | 05:41:24 PST
07-Jan-2022 | 09:43:42 PST
07-Jan-2022 | 08:36:28 PST


 
BeiGene USA, Inc 
                  BGB--113 
              (Statistical Analysis Plan) 
 
 
 
Version 2.0: 07 January 2022 
Page 3 of 26  
CONFIDENTIAL 
 
TABLE OF CONTENTS 
1 
INTRODUCTION 
7 
2 
STUDY OVERVIEW 
7 
3 
STUDY OBJECTIVES 
9 
3.1 
Primary Objectives 
9 
3.2 
Secondary Objectives 
9 
3.3 
Exploratory Objectives 
9 
4 
STUDY ENDPOINTS 
9 
4.1 
Primary Endpoints 
9 
4.2 
Secondary Endpoints 
9 
4.3 
Exploratory Endpoints 
9 
5 
SAMPLE SIZE CONSIDERATIONS 
10 
6 
STATISTICAL METHODS 
10 
6.1 
Analysis sets 
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 
12 
6.2.4 
Adjustment for Covariates 
12 
6.2.5 
Multiplicity Adjustment 
12 
6.2.6 
Data Integrity 
12 
6.3 
Patient Characteristics 
12 
6.3.1 
Patient Disposition 
12 
6.3.2 
Protocol Deviations 
13 
6.3.3 
Demographic and Other Baseline Characteristics 
13 
6.3.4 
Disease History and Characteristics 
13 
6.3.5 
Prior Antineoplastic Therapies 
14 
6.3.6 
Prior and Concomitant Medications 
14 
6.3.7 
Medical History 
14 
6.4 
Efficacy Analysis 
14 
6.4.1 
Best Response, ORR, and Rate of VGPR or Better 
14 
6.4.2 
Time to Response 
15 
6.4.3 
Subgroup Analyses 
15 
6.5 
Safety Analyses 
15 
6.5.1 
Extent of Exposure 
15 
6.5.2 
Adverse Events 
15 
6.5.3 
Laboratory Values 
17 
6.5.4 
Vital Signs 
17 
6.5.5 
Electrocardiogram (ECG) 
17 
6.5.6 
Eastern Cooperative Oncology Group (ECOG) Performance 
Status 
17 
6.5.7 
Blood Transfusions 
18 
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                  BGB--113 
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Page 4 of 26  
 
 
6.6 
Pharmacokinetic Analyses 
18 
6.6.1 
Calculation of Pharmacokinetic Parameters 
19 
6.6.1.1 
Criteria for the Calculation of Apparent Terminal 
Elimination Rate Constant and Half-life 
19 
6.6.1.2 
Criteria for Calculation and Reporting of Area Under 
the Concentration-time Curve 
19 
6.6.1.3 
Criteria for Handling Below the Limit of Quantification 
or Missing Concentrations for Pharmacokinetic 
Analysis 
20 
6.6.2 
Treatment of Outliers in Pharmacokinetic Analysis 
20 
6.6.3 
Presentation of Pharmacokinetic Data 
20 
6.6.4 
Statistical Methodology for Analysis of Pharmacokinetic 
Parameters 
21 
6.7 
Additional Exploratory Analyses 
22 
7 
INTERIM ANALYSIS 
22 
8 
CHANGES IN THE PLANNED ANALYSIS 
22 
9 
REFERENCES 
23 
10 
APPENDIX 
24 
Appendix A: 
Missing Data Imputation Rule 
24 
Appendix B: 
Sensitivity Analysis for PK Parameters 
26 
 
 
 
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                  BGB--113 
              (Statistical Analysis Plan) 
 
 
 
Version 2.0: 07 January 2022 
Page 5 of 26  
 
 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation  
Definition  
AE  
adverse event  
BID 
twice a day 
BMI 
body mass index 
BTK  
Bruton tyrosine kinase  
CI  
confidence interval  
CLL 
chronic lymphocytic lymphoma 
CR  
complete response  
CSR 
clinical study report 
CT  
computed tomography  
CTCAE  
Common Terminology Criteria for Adverse Events  
CYP3A 
cytochrome P450, family 3, subfamily A 
DDI 
drug-drug interaction 
ECG  
electrocardiogram  
ECOG  
Eastern Cooperative Oncology Group  
eCRF  
electronic case report form  
FDA  
Food and Drug Administration  
HBcAb 
hepatitis B core antibody 
HBsAb 
hepatitis B surface antibody 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HBC 
hepatitis C virus 
MCL 
mantle cell lymphoma 
MedDRA 
Medical Dictionary for Regulatory Activities  
MR 
minor response 
MZL 
marginal zone lymphoma 
NHL 
non-Hodgkin lymphoma 
ORR  
overall response rate  
OS  
overall survival  
PCR 
polymerase chain reaction 
PD  
progressive disease  
PK 
pharmacokinetic 
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                  BGB--113 
              (Statistical Analysis Plan) 
 
 
 
Version 2.0: 07 January 2022 
Page 6 of 26  
 
 
PR  
partial response  
PT  
preferred term  
QD 
once a day 
SAE  
serious adverse event  
SAP 
statistical analysis plan 
SD  
stable disease  
SLL 
small lymphocytic lymphoma 
SOC  
system organ class  
TEAE  
treatment-emergent adverse event  
TTR 
time to response 
VGPR 
very good partial response 
WHO-DD 
World Health Organization Drug Dictionary 
WM 
Waldenström macroglobulinemia 
 
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BeiGene USA, Inc 
                  BGB--113 
              (Statistical Analysis Plan) 
 
 
 
Version 2.0: 07 January 2022 
Page 7 of 26  
 
 
1 
INTRODUCTION 
The purpose of this statistical analysis plan (SAP) version 2.0 is to describe the procedures and 
statistical methods that will be used in the clinical study report (CSR) for study BGB-3111-113, 
titled A Drug–Drug Interaction Study of Zanubrutinib with Moderate/Strong CYP3A Inhibitors 
in Patients with B-Cell Malignancies.  The focus of this SAP is the planned final analyses for the 
clinical and pharmacokinetic (PK) data.  This SAP is based on amendment 2.0 (05 November 
2020) of the protocol.  
2 
STUDY OVERVIEW 
This is a multicenter, Phase 1, open-label, randomized clinical drug-drug interaction (DDI) study 
of zanubrutinib in approximately 30 patients with B-cell malignancies (15 in each arm) to ensure 
that 24 patients (12 in each arm) complete the study.  The study will include a pharmacokinetic 
(PK) study (Arm A and Arm B) in Cycle 1, as part of a Treatment Phase of six treatment cycles. 
Patients who continue to derive clinical benefit from zanubrutinib in the presence of acceptable 
tolerability at the end of the Treatment Phase (6 cycles) will be eligible to continue to receive 
zanubrutinib under a rollover extension study.  Patients will be randomized to Arm A (moderate 
CYP3A inhibitors of fluconazole and diltiazem) or Arm B (strong CYP3A inhibitors of 
voriconazole and clarithromycin) to assess the effects of CYP3A inhibitors on zanubrutinib’s PK 
in Cycle 1.  Efficacy will be investigated during the subsequent treatment cycles and clinical 
safety will be investigated throughout the study. 
The study is composed of an initial Screening phase (up to 28 days), a randomized Treatment 
Phase of 6 cycles including PK assessments in Cycle 1, and a Safety Follow-up phase or rollover 
to a long-term extension study. 
Figure 1 provides the schema for the study. 
Figure 1 
Schema for Study BGB-3111-113 
 
 
 
 
Figure 2 provides the schema for the PK assessments in Cycle 1 as described in amendment 2.0 
of the protocol. 
 
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BeiGene USA, Inc 
                  BGB--113 
              (Statistical Analysis Plan) 
 
 
 
Version 2.0: 07 January 2022 
Page 8 of 26  
 
 
Figure 2 
Schema for PK Assessments in Cycle 1 of Study BGB-3111-113 
 
Arm A: 
 
 
 
Arm B: 
 
Blood samples for PK assessments will be collected during Cycle 1 on Days 3, 10, and 28 at pre-
dose, 0.5, 1, 2, 3, 4, 6, 8, and 10 hours post-dose and on Day 22 at pre-dose.  Under the original 
protocol, there was no pre-dose sample collected on Day 22 and the sample collection on Day 28 
was prescribed to be done on Day 26.  One patient was enrolled under the original protocol. 
For Cycles 2-6, patients in both arms receive zanubrutinib at a dose of 160 mg 
(80 mg x 2 capsules) BID or 320 mg (80 mg x 4 capsules) QD.  Zanubrutinib continues until 
progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, loss to follow-up, 
or end of study participation (completion of 6 cycles), whichever occurs first.   
Response will be based on the investigator’s assessment at the end of Cycles 3 and 6 using 
standard response criteria for each histologic subtype, as described in the protocol.  For patients 
with mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or small lymphocyte 
lymphoma (SLL), response will be assessed and categorized per Lugano Classification for non-
Hodgkin lymphoma (NHL).  For patients with chronic lymphocytic lymphoma (CLL), disease 
response will be determined in accordance with the 2018 International Workshop on Chronic 
Lymphocytic Leukemia guidelines with modification for treatment-related lymphocytosis. 
Response will be evaluated for the Waldenström macroglobulinemia (WM) patients using an 
adaptation of the consensus panel criteria updated at the Sixth International Workshop.  The 
response categories are complete response (CR), very good partial response (VGPR, for WM), 
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BeiGene USA, Inc 
                  BGB--113 
              (Statistical Analysis Plan) 
 
 
 
Version 2.0: 07 January 2022 
Page 9 of 26  
 
 
partial response (PR), minor response (MR, for WM), stable disease, and PD.  For patients with 
WM, quantitative immunoglobulins and ȕ2-microglobulin will be measured on Day 1 of each 
cycle.  Other efficacy measures are described in the protocol.   
All adverse events (AEs) and serious adverse events (SAEs), regardless of relationship to 
zanubrutinib, will be reported until 30 days after the last dose of zanubrutinib. After this period, 
the investigator should report any SAEs that are believed to be related to prior zanubrutinib 
treatment.  
 
3 
STUDY OBJECTIVES 
3.1 PRIMARY OBJECTIVES 
The primary objective of the study is to assess the DDI between zanubrutinib and moderate 
(diltiazem, fluconazole) and strong (clarithromycin, voriconazole) CYP3A inhibitors in patients 
with B-cell malignancies as measured by the steady-state zanubrutinib PK when coadministered 
with moderate and strong CYP3A inhibitors. 
3.2 SECONDARY OBJECTIVES  
The secondary objective is to evaluate the safety and tolerability of zanubrutinib alone and when 
co-administered with moderate and strong CYP3A inhibitors. 
3.3 EXPLORATORY OBJECTIVES 
The exploratory objective is to evaluate the efficacy of zanubrutinib. 
4 
STUDY ENDPOINTS 
4.1 PRIMARY ENDPOINTS 
The primary endpoints are the PK parameters of area under the plasma concentration-time curve 
from zero to the last measurable concentration (AUC0-t), AUC from 0 to 24 hours (AUC0-24h), 
maximum observed plasma concentration (Cmax), time to reach the Cmax (Tmax), and apparent 
terminal elimination half-life (t1/2) as determined by blood samples collection during Cycle 1 on 
Day 3, Day 10, and Day 28.   
4.2 SECONDARY ENDPOINTS 
The secondary endpoints are safety parameters, including adverse events, serious adverse events, 
clinical laboratory tests, physical examinations, and vital signs.  Safety will be measured by the 
incidence, timing, and severity of treatment-emergent AEs (TEAEs, defined in Section 6.2.1) 
according to the National Cancer Institute Common Terminology Criteria for Adverse Events 
Version 5.0 (CTCAE v5.0). 
4.3 EXPLORATORY ENDPOINTS 
The exploratory endpoints are: 
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BeiGene USA, Inc 
                  BGB--113 
              (Statistical Analysis Plan) 
 
 
 
Version 2.0: 07 January 2022 
Page 10 of 26  
 
 
x Overall response rate (ORR), defined as the proportion of patients who achieve a PR or better 
for MCL and MZL patients, and PR with lymphocytosis or better for CLL/SLL patients. For 
WM patients, ORR is defined as the proportion of patients achieving CR, VGPR, PR or MR. 
x Rate of CR or complete metabolic response, defined as the proportion of patients who 
achieve a CR or complete metabolic response. 
x Time to response, defined as time from randomization to the first documentation of response. 
5 
SAMPLE SIZE CONSIDERATIONS 
Up to 30 patients will be enrolled in the study to ensure that 12 patients per arm successfully 
complete Cycle 1.  The sample size chosen for this study was based on precedent set by other PK 
studies of similar nature and was not based on power calculations.  
6 
STATISTICAL METHODS 
6.1 ANALYSIS SETS 
The Safety analysis set includes all patients who are enrolled and receive any dose of 
zanubrutinib. This will be the population of interest for the safety and efficacy analyses.  
The PK Evaluable analysis set will include all patients who received at least 1 dose of 
zanubrutinib and have evaluable PK data (at least 1 PK parameter can be calculated). A patient 
may be excluded from the PK summary statistics and statistical analysis if the patient has an AE 
of vomiting that occurs at or before 2 times the median Tmax of zanubrutinib. 
6.2 DATA ANALYSIS GENERAL CONSIDERATIONS 
6.2.1 
Definitions and Computations 
Enrolled patient: a patient who was approved by the medical monitor or designee and who was 
enrolled by study center personnel in the Interactive Response Technology (IRT) system. 
Study drug: the study drug in this study is zanubrutinib. 
Study day: Study day will be calculated in reference to the date of the first dose of study drug.  
For assessments conducted on or after the date of the first dose of study drug, study day will be 
calculated as (assessment date – date of first dose of study drug + 1).  For assessments conducted 
before the date of the first dose of study drug, study day is calculated as (assessment date – date 
of first dose of study drug). Study day 1 is defined as the date of first dose of study drug.  There 
is no study day 0.  
Treatment follow-up time: The treatment follow-up time (weeks) will be calculated as (date of 
the last dose of study drug – date of first dose of study drug + 1).  For patients on treatment at the 
time of the data cutoff date, the date of the data cutoff will be used.  
Study follow-up time: The study follow-up time (months) will be calculated as (date of end of 
study [or death] – date of first dose of study drug + 1).  For patients on study at the time of the 
data cutoff date, the date of the data cutoff will be used. 
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Baseline: Unless otherwise specified, a baseline value is defined as the last non-missing value 
collected on/before the date of first dose of study drug. 
Unscheduled Visits: Unscheduled measurements will not be included in by-visit table summaries 
and graphs but will contribute to best/worst case value where required (e.g., shift table). Listings 
will include scheduled, unscheduled data. 
Treatment-emergent adverse event (TEAE): An AE that has an onset date on or after the date of 
the first dose of study drug and up to 30 days following study drug discontinuation, or the start of 
new anticancer therapy, whichever comes first.  Worsening of a treatment-emergent AE to Grade 
5 beyond 30 days after last dose of study drug is also considered a treatment-emergent AE, if it is 
prior to new anticancer therapy start. 
Overall response rate (ORR):  For WM, ORR is defined as the proportion of patients achieving a 
CR, VGPR, PR, or MR.  ORR is defined as the proportion of patients who achieve a PR or better 
for MCL and MZL patients, and PR with lymphocytosis or better for CLL/SLL patients. 
Rate of VGPR or better:  For WM, rate of VGPR or better is defined as the proportion of patients 
achieving a CR or VGPR.   
All calculations and analyses will be conducted using SAS version 9.4 or higher. 
Listings will be provided for all data captured in the EDC as well as derived efficacy and 
pharmacokinetic variables.   
6.2.2 
Conventions 
Unless otherwise specified, the following conventions will be applied to all analyses: 
x 1 year = 365.25 days. Number of years is calculated as (days/365.25) rounded up to 1 
significant digit. 
x 1 month = 30.4375 days. Number of months is calculated as (days/30.4375) rounded up to 1 
significant digit. 
x 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’.   
x Missing PK, efficacy, or safety data will not be imputed unless otherwise specified. 
x Time-to-event or duration of event endpoints will be based on the actual date the assessments 
to document response were obtained (e.g., date of IgM assessment) rather than the associated 
visit date. 
x For by-visit observed data analyses, percentages will be calculated based on the number of 
patients with non-missing data as the denominator, unless otherwise specified. 
x For continuous endpoints, summary statistics will include n, mean, standard deviation, 
median, minimum, and maximum.  The first and third quartiles (Q1, Q3) may also be 
provided as appropriate. 
x Notations in the EDC documenting assessments that were delayed or not performed due to 
Covid-19 will be noted in the listings.  No summary of these assessments will be provided. 
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Page 12 of 26  
 
 
x If an investigator states that an adverse event is due to Covid-19, it will be documented in the 
verbatim term.  No summary of specific Covid-19 related adverse events will be provided. 
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 prior/concomitant 
medications/procedures, subsequent antineoplastic therapies, adverse events and deaths.  Specific 
rules for handling of missing or partially missing dates for prior/concomitant 
medications/procedures, subsequent antineoplastic therapies, adverse events, and deaths are 
provided in Appendix A.  
By-visit summaries of variables with missing data will use only non-missing data, not imputed 
one, unless otherwise specified.   
6.2.4 
Adjustment for Covariates 
Not applicable. 
6.2.5 
Multiplicity Adjustment 
Not applicable.  
6.2.6 
Data Integrity 
Before any pre-specified statistical analysis begins, the integrity of the eCRF data and all derived 
values will be reviewed to ensure that the data are accurate and complete up to a pre-specified 
cutoff date.  Consistency checks and appropriate source data verification will be completed. 
6.3 PATIENT CHARACTERISTICS 
6.3.1 
Patient Disposition 
The summary of patient disposition will be based on the Safety Analysis set.  The following 
patient disposition information will be summarized: 
x Number of enrolled patients  
x Number of treated patients  
x Number (%) of treated patients who remain on treatment at time of data cutoff date or 
completion of Cycle 6 
x Number (%) of treated patients who discontinued treatment prior to data cutoff date or 
completion of Cycle 6 
x Reasons that patients discontinued treatment 
x Number (%) of treated patients who remain on study at time of data cutoff date 
x Number (%) of treated patients who discontinued study  
x Reasons that patients discontinued study 
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x Treatment follow-up time (weeks) 
x Study follow-up time (months) 
6.3.2 
Protocol Deviations 
Criteria for important protocol deviations will be established, and patients with important 
protocol deviations will be identified and documented before the database lock.  Important 
protocol deviations will be summarized for all patients in the Safety Analysis set. 
6.3.3 
Demographic and Other Baseline Characteristics 
Demographic and baseline characteristics will be summarized descriptively for patients in the 
Safety Analysis set as follows: 
x Age (years) and age (years) categorized as <65 and 65  
x Sex 
x Race 
x Ethnicity 
x Baseline ECOG performance status 
x Baseline weight (kg) 
x Baseline height (cm) 
x Body mass index (kg/m2) 
x Baseline viral hepatitis B and C serologic markers, including hepatitis B surface antigen 
(HBsAg), hepatitis B core antibody (HBcAb), hepatitis B surface antibody (HBsAb), 
hepatitis B virus (HBV) DNA by polymerase chain reaction (PCR), hepatitis C virus (HCV) 
antibody, and HCV RNA by PCR.  
6.3.4 
Disease History and Characteristics 
Disease history and disease characteristic will be summarized for the Safety Analysis set. These 
include: 
x Disease type and sub-type, including blastic variant form of MCL 
x Time since first diagnosis to Day 1 (months) 
x Stage (Rai) for CLL at screening 
x Stage (Binet) for CLL at screening 
x Stage for NHL at screening 
x Risk group for WM at screening 
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6.3.5 
Prior Antineoplastic Therapies  
The following information related to prior antineoplastic therapy will be summarized for the 
Safety Analysis set: 
x Number of prior systemic therapy regimens and number of prior regimens categorized as 1, 
2, 3, etc. 
x Time from the end of last regimen to Day 1 (months) 
x Reason last regimen ended 
x Best overall response to last regimen 
x Number (%) of patients with prior radiotherapy  
6.3.6 
Prior and Concomitant Medications 
Concomitant medications will be assigned a preferred name using the World Health 
Organization Drug Dictionary (WHO DD) drug codes. Concomitant medications will be further 
coded to the appropriate Anatomical Therapeutic Chemical (ATC) class indicating therapeutic 
classification.  
Prior medications will be defined as medications that stopped before the first dose of study drug. 
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 patient’s last dose.  For the 
purpose of determining if a medication should be noted as a concomitant medication, the 
imputation rules stated in Appendix A will be used. 
The number (percentage) of patients reporting concomitant medications will be summarized by 
ATC medication class and WHO DD preferred name for the Safety Analysis set.  
6.3.7 
Medical History 
Medical history will be mapped to a preferred term (PT) and a system organ class (SOC) using 
the Medical Dictionary for Regulatory Activities (MedDRA) of the version currently in effect at 
BeiGene at the time of the data cutoff date.  The number (percentage) of patients reporting a 
history of any medical condition, as recorded on the CRF, will be summarized by SOC and PT 
for the Safety Analysis set.  
6.4 EFFICACY ANALYSIS 
The population of primary interest for efficacy analyses is the Safety Analysis set.  
6.4.1 
Best Response, ORR, and Rate of VGPR or Better 
The ORR, rate of CR or complete metabolic response, and rate of VGPR or better (for WM) will 
be summarized.  Patients with no post-baseline response assessment (due to any reason) will be 
considered non-responders for these summaries.  Best response (CR, VGPR, PR, MR, SD, PD, 
not evaluated) will be summarized.   
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6.4.2 
Time to Response 
Time to response (TTR) is defined as the time (weeks) from date of first dose of zanubrutinib to 
the earliest qualifying response of MR or better for WM, to first earliest qualifying response of 
PR with lymphocytosis or better for CLL, and to first earliest qualifying response of PR or better 
for other diagnoses. TTR will be summarized by descriptive summary statistics (n, mean, 
standard deviation, median, minimum, maximum) for responders only. 
6.4.3 
Subgroup Analyses 
The summaries of ORR will be provided by diagnosis (type and sub-type of disease). 
6.5 SAFETY ANALYSES 
All safety analyses will be performed based on the Safety Analysis set.  Safety and tolerability 
will be assessed, where applicable, by incidence, severity, change from baseline values, and 
abnormal values for all relevant parameters including AEs, laboratory parameters, vital signs, 
and physical examination. 
6.5.1 Extent of Exposure 
The following variables describing extent of exposure to zanubrutinib will be summarized 
descriptively:  
x Number of treatment cycles received, defined as the total number and percentage of 
treatment cycles in which at least one dose of zanubrutinib is administered  
x Duration of exposure (weeks), defined as the duration (weeks) from the date of the first dose 
to the last dose of zanubrutinib  
x Cumulative total dose received per patient (mg), defined as the cumulative dose (mg) of 
zanubrutinib during the treatment period of the study  
x Actual dose intensity (mg/day), defined as the total dose of zanubrutinib (mg) received by a 
patient divided by the duration of exposure (days)  
x Relative dose intensity (%), defined as the ratio of the actual dose intensity (mg/day) and the 
planned dose intensity (320 mg/day).  
The number (percentage) of patients with dose reduction and drug discontinuation will be 
summarized with the respective reasons. The number of dose reductions/missed doses will be 
summarized.   
Patients who do not receive all the CYP3A inhibitor drug doses as prescribed in the protocol will 
be noted as protocol deviations.   
6.5.2 Adverse Events  
AEs will be graded by the investigators using CTCAE v5.0. Verbatim description of AEs (as 
recorded by the investigator on the eCRF) will be classified into standardized PT and SOC using 
MedDRA. 
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Only those AEs that are treatment-emergent will be included in summary tables.  All AEs, 
treatment-emergent or otherwise, will be presented in patient data listings.  
Treatment-related AEs include those events considered by the investigator to be possibly or 
probably related to zanubrutinib or with missing assessment of the causal relationship. 
An overview table, including the number (and percentage) of patients with at least one TEAE, 
grade 3 or above TEAE, treatment-emergent SAE, treatment-related TEAE, treatment-related 
grade 3 or above TEAE, treatment-related SAE, TEAE and treatment-related TEAE that led to 
death, TEAE and treatment-related TEAE that led to treatment discontinuation, TEAE and 
treatment-related TEAE that led to dose reduction, and TEAE and treatment-related TEAE that 
led to a missed dose will be provided.  
The incidence of TEAEs will be also reported as the number (percentage) of patients with 
TEAEs by SOC and PT.  A patient will be counted only once by the highest severity grade 
according to CTCAE v5.0 within a SOC and PT, even if the patient experiences more than 1 
TEAEs within a specific SOC and PT. 
The number (percentage) of patients with at least one TEAE, grade 3 or above TEAE, treatment-
emergent SAE, treatment-related TEAE, treatment-related grade 3 or above TEAE, treatment-
related SAE, TEAE that led to death, TEAE that led to treatment discontinuation, and TEAE that 
led to dose modification will be summarized by SOC and PT.  All TEAEs, grade 3 and above 
TEAEs, and SAEs will also be summarized by PT in descending order.  All TEAEs, related 
TEAEs, TEAEs that led to treatment discontinuation, and TEAEs that led to a dose modification 
will be summarized by SOC, PT, and highest severity grade.   
The incidence of TEAEs of interest, grade 3 or higher TEAEs of interest, treatment-related 
TEAEs of interest, and treatment-related grade 3 or higher TEAEs of interest will be summarized 
by category and PT.  
The incidence of TEAEs with onset during Cycle 1 will be summarized by SOC and PT.  This 
summary will be provided for each arm and treatment combination at day of onset.  The groups 
for this summary are: 
x Arm A 
zanubrutinib (onset of AE prior to date of first dose of fluconazole [nominally  
 
 
Day 4] or after discontinuation of fluconazole and prior to date of first dose of  
 
 
diltiazem [nominally Days 13-19]) 
o zanubrutinib+fluconazole (onset of AE on or after the date of first dose of 
fluconazole and prior to 3 days after date of last dose of fluconazole [nominally 
Days 4-14]) 
o zanubrutinib+diltiazem (onset of AE on or after date of first dose of diltiazem 
[nominally Day 22] to the end of Cycle 1) 
x Arm B 
zanubrutinib (onset of AE prior to date of first dose of voriconazole [nominally  
 
 
Day 4] or after discontinuation of voriconazole and prior to date of first dose of  
 
 
clarithromycin [nominally Day 13-19]) 
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o zanubrutinib+voriconazole (onset of AE on or after the date of first dose of 
voriconazole and prior to 3 days after date of last dose of voriconazole [nominally 
Day 4-14]) 
o zanubrutinib+clarithromycin (onset of AE on or after date of first dose of 
clarithromycin [nominally Day 22] to the end of Cycle 1) 
Under the original protocol, diltiazem or clarithromycin dosing was to begin on Day 20 rather 
than Day 22.  If the start of the CYP3A inhibitor differs from the prescribed start day, then the 
actual day will be used to define the groups for this summary. 
A summary of the number of deaths and the causes of death, classified by deaths within 30 days 
of last dose of zanubrutinib and deaths more than 30 days after the last dose, will be provided.  
Cause of death will also be summarized. 
Listings of deaths/fatal AEs, serious AEs, AEs leading to dose modification or discontinuation of 
zanubrutinib will be provided. 
6.5.3 Laboratory Values 
Abnormal laboratory values will be flagged and identified as those outside (above or below) the 
normal range.  Descriptive summary statistics (n, mean, standard deviation, median, minimum, 
maximum for continuous variables; n [%] for categorical variables) for hematology and serum 
chemistry laboratory parameters at each visit and their changes from baseline will be provided.  
Baseline values of coagulation parameters will be summarized. 
Laboratory parameters that are graded according to CTCAE v5.0 will be summarized by CTCAE 
grade.  Shift tables will be used to assess the shift of each laboratory parameter from its toxicity 
grade at baseline to the worst post-baseline toxicity grade.  Parameters with CTCAE grading in 
both high and low directions (e.g., calcium, glucose, magnesium, phosphorus, potassium, 
sodium) will be summarized separately.  A listing of all grade 3 or higher laboratory values will 
be provided.   
6.5.4 Vital Signs 
Values of vital signs parameters, including resting diastolic and systolic BP, heart rate, 
temperature, and weight, and changes from baseline will be summarized by visit and assessment 
time. 
6.5.5 Electrocardiogram (ECG) 
A 12-lead electrocardiogram (ECG) will be performed locally in triplicate at screening, at 
protocol-specified visits and timepoints during Cycle 1for all patients and as clinically indicated 
at other timepoints.  The values and change from baseline of ECG parameters will be 
summarized by visit and assessment time.  
6.5.6 Eastern Cooperative Oncology Group (ECOG) Performance Status 
ECOG performance status will be summarized as the number (percentage) of patients with each 
ECOG grade at the screening visit, each visit during study treatment, and at the Safety follow-up 
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visit.  Shift tables assessing the ECOG performance status at baseline versus worst performance 
status on study will be presented. 
6.5.7 
Blood Transfusions 
The number (percentage) of patients reporting one or more blood transfusions will be 
summarized by type of product for the Safety Analysis set.  
6.6 PHARMACOKINETIC ANALYSES 
The following PK parameters will be determined where possible from the plasma concentrations 
of zanubrutinib using noncompartmental methods in validated software program Phoenix 
WinNonlin (Certara, Version 8.1 or higher): 
Parameter 
Unitsa 
Definition 
AUC0-t 
h*ng/mL 
area under the concentration-time curve from time 0 to the time of the 
last quantifiable concentration (Tlast)b 
AUC0-24h 
h*ng/mL 
area under the concentration-time curve from time 0 extrapolated to 
24 hours  
Cmax 
ng/mL 
maximum observed concentration 
Tmax 
H 
time of the maximum observed concentration 
t1/2 
H 
apparent terminal elimination half-life 
a Units are based on concentration units (provided by the bioanalytical lab or preferred units for presentation of PK parameters) 
and dose units used in the study. 
b Area under the concentration-time curve will be calculated using the linear trapezoidal rule for increasing concentrations and 
the logarithmic rule for decreasing concentrations (linear up/log down rule).  
 
The following additional PK parameters may be determined where appropriate. 
Parameter 
Unitsa 
Definition 
%AUCextrap 
% 
percentage of AUC due to extrapolation from the last quantifiable 
concentration to infinity 
Tlast 
H 
time of the last quantifiable concentration 
 
 
 
CL/F 
L/h 
apparent oral clearance 
AUC0-12h 
h*ng/mL 
area under the concentration-time curve from time 0 extrapolated to 
12 hours  
Vz/F 
L 
apparent volume of distribution 
 
Pharmacokinetic analysis will be carried out where possible using actual blood sampling times 
post dose. If an actual time is missing, the sample concentration result will be treated as missing 
unless there is scientific justification to include the result using the nominal time.  
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The parameters Cmax, Tmax and Tlast will be obtained directly from the concentration-time 
profiles. If Cmax occurs at more than 1 timepoint, Tmax will be assigned to the first occurrence of 
Cmax. 
For the calculation of AUC0-12h, AUC will be extrapolated to 12 hours for both the QD and BID 
dose regimens and for the calculation of AUC0-24 , AUC will be extrapolated to 24 hours post 
dose for the QD dose; and  for the BID dose regimen, the AUC 0-24 will be estimated as twice 
that of AUC0-12h. The specific algorithm for the estimation will be documented in the study report. 
6.6.1 
Calculation of Pharmacokinetic Parameters 
6.6.1.1 Criteria for the Calculation of Apparent Terminal Elimination Rate Constant and 
Half-life 
The start of the terminal elimination phase for each patient will be defined by visual inspection 
and generally will be the first point at which there is no systematic deviation from the log-linear 
decline in concentrations. 
The apparent terminal elimination rate constant (Ȝz) will only be calculated when a reliable 
estimate can be obtained using at least 3 data points, preferably not including Cmax, and the 
adjusted coefficient for determination of exponential fit (R2-adj) of the regression line is  0.7. 
Parameters requiring Ȝz for their calculation (eg, AUC0-24h, t1/2, CL/F, and Vz/F) will only be 
calculated if the R2-adj value of the regression line is  0.7. 
The following regression-related diagnostic PK parameters will be determined, when possible: 
Parameter 
Units 
Definition 
Ȝz 
1/h 
apparent terminal elimination rate constant 
Ȝz Upper 
h 
end of exponential fit 
Ȝz Lower 
h 
start of exponential fit 
Ȝz N 
NA 
number of data points included in the log-linear regression 
Ȝz Span Ratio 
NA 
time period over which Ȝz was determined as a ratio of t1/2 
R2-adj 
NA 
adjusted coefficient for determination of exponential fit 
Where possible, the span of time used in the determination of Ȝz (ie, the difference between Ȝz 
Upper and Ȝz Lower) should be  2 half-lives. If the Ȝz Span Ratio is < 2, the robustness of the 
t1/2 values will be discussed in the CSR. 
6.6.1.2 Criteria for Calculation and Reporting of Area Under the Concentration-time 
Curve 
The minimum requirement for the calculation of area under the concentration-time curve (AUC) 
will be the inclusion of at least 3 consecutive concentrations above the lower limit of 
quantification. If there are only 3 consecutive concentrations, at least 1 should follow Cmax.  
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If the extrapolated area is > 30%, AUC0-24h (and derived parameters) may be excluded from the 
summary statistics and statistical analysis at the discretion of the pharmacokineticist.  
If AUC0-24h cannot be determined reliably for all patients and/or treatments, an alternative AUC 
measure, such as AUC to a fixed time point or AUC0-t, may be used in the statistical analysis. 
6.6.1.3 Criteria for Handling Below the Limit of Quantification or Missing 
Concentrations for Pharmacokinetic Analysis 
Plasma concentrations below the limit of quantification (BLQ) will be assigned a value of 0 
before the first measurable concentration and thereafter BLQs will be treated as missing. The 
following rules apply with special situations defined below: 
Ɣ If an entire concentration-time profile is BLQ, it will be excluded from PK analysis. 
Ɣ Where 2 or more consecutive concentrations are BLQ at the end of a profile, the profile 
will be deemed to have terminated and any further quantifiable concentrations will be set 
to missing for the calculation of the PK parameters, unless they are considered to be a 
true characteristic of the profile of the drug. 
6.6.2 Treatment of Outliers in Pharmacokinetic Analysis 
If a value is considered to be anomalous due to being inconsistent with the expected PK profile, 
it may be appropriate to exclude the value from the PK analysis. However, the exclusion of any 
data must have strong justification and will be documented in the CSR. 
6.6.3 
Presentation of Pharmacokinetic Data 
If the actual time of sample collection deviates from the nominal time by more than ± 10%, the 
concentration will be flagged and excluded from the summary statistics. Individual 
concentrations deemed to be anomalous will be flagged in the listings and excluded from the 
summary statistics. 
For PK concentration data the following rules will apply for the summaries and figures: 
Ɣ Values that are BLQ will be set to 0 for the calculation of summary statistics. 
Ɣ Arithmetic mean or median values that are BLQ will be presented as 0. 
Ɣ If any BLQ results (treated as 0) are in a series of summarized data, geometric mean and 
CV% of geometric mean will be reported as not calculated (NC). 
All PK concentrations and parameters, with the exception of diagnostic regression-related PK 
parameters, will be summarized.  The summary tables will include n, arithmetic mean, standard 
deviation, coefficient of variation, median, minimum, and maximum.  For the concentration data 
and all PK parameters except Tmax and Tlast, the geometric mean and geometric coefficient of 
variation (GCV) will be provided.  The GCV is calculated as GCV(%) = [exp(s2) – 1]½ × 100 
where s2 is the sample variance of the ln transformed data.   
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The following figures will be provided: 
Ɣ Mean (+ standard deviation [SD]) PK concentration versus time post dose for each PK 
visit.  The values for each PK visit will be displayed on the same set of axes within each 
arm of the study.   
Ɣ Individual concentration data versus time post dose for each PK collection visit day will be 
provided.  The values for each PK visit will be displayed on the same set of axes within 
each arm of the study.   
Ɣ Mean (+ SD) of the PK parameters for each PK visit within each arm of the study. 
Ɣ Individual values of the PK parameters for each PK visit within each arm of the study  
All figures will be produced on both linear and semi-logarithmic scales. The +SD bars will only 
be displayed on the linear scale.  
6.6.4 
Statistical Methodology for Analysis of Pharmacokinetic Parameters 
Four separate statistical analyses will be conducted in order to investigate the DDI of the 4 
CYP3A inhibitors on the PK of zanubrutinib as evaluated by zanubrutinib Cmax, AUC0-t, and 
AUC0–24h.  The values on Day 3 in the absence of CYP3A inhibitors will be compared to the 
values on Day 10 and Day 28 in the presence of CYP3A inhibitors.  These analyses will be 
performed separately for each treatment arm.  Additional PK parameters may be analyzed as 
needed. 
 
PK analysis 1:  Arm A only 
Compare Day 3 (zanubrutinib alone) to Day 
10 (zanubrutinib + fluconazole) 
PK analysis 2:  Arm A only 
Compare Day 3 (zanubrutinib alone) to Day 
28 (zanubrutinib + diltiazem) 
PK analysis 3:  Arm B only 
Compare Day 3 (zanubrutinib alone) to Day 
10 (zanubrutinib + voriconazole) 
PK analysis 4:  Arm B only 
Compare Day 3 (zanubrutinib alone) to Day 
28 (zanubrutinib + clarithromycin) 
 
The natural log (ln)transformed PK parameters will be analyzed using a mixed model.  The 
model will include treatment as a fixed effect, and patient as a random effect. Each analysis (PK 
analysis 1-4) will be conducted separately in a model with relevant data of test and difference 
(e.g., Parameters from Day 28 will not be included in the statistical model of PK analysis 1). 
For each PK parameter separately, the least squares mean (LSM) for each treatment, difference 
in LSMs between the test and reference treatments, and corresponding 90% confidence interval 
(CI) will be calculated; these values will then be back-transformed to give the geometric least 
square mean (GLSM), ratio of GLSMs for zanubrutinib + CYP3A inhibitor to zanubrutinib alone 
and corresponding 90% CI.  
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Additionally, the pooled estimate (across all treatments) of the within-patient coefficient of 
variation (CVW) will be calculated. The CVW is defined as  
CVW(%) = [exp(MSE) – 1]½ × 100 
where MSE is the residual error from the mixed model. 
An example of the SAS code that will be used is as follows: 
Mixed Model Analysis 
proc mixed data = <data_in>; 
  by param; 
  class trt usubjid; 
  model lpk = trt / cl residual ddfm = kr2; 
  lsmeans trt / cl pdiff = control('1') alpha = 0.1; 
  random usubjid;  
  ods output lsmeans = <data_out>;   
  ods output diffs = <data_out>; 
  ods output covparms = <data_out>; 
run; 
 
6.7 ADDITIONAL EXPLORATORY ANALYSES 
Additional exploratory analyses may be conducted as appropriate.  Any exploratory analyses that 
are performed will be appropriately titled/labeled as exploratory and will be clearly distinguished 
from planned analyses when results are reported in the Clinical Study Report. 
7 
INTERIM ANALYSIS 
No formal interim analyses are planned for this study.  Data from the study will be reviewed by 
the study team on a periodic basis.  Summaries and analyses of subsets of the study data may be 
performed on a periodic basis for study team review, submission to professional meetings, and 
internal decision-making.  
8 
CHANGES IN THE PLANNED ANALYSIS 
The table below summarizes the changes in the planned analyses from SAP 1.0. The changes are 
all made before database lock. 
SAP 
version 
Approval date 
Change made 
from 
Rationale of the change Description of the change 
1.0 
25 March 2021 
Protocol V2.0 
 
 
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SAP 
version 
Approval date 
Change made 
from 
Rationale of the change Description of the change 
2.0 
This version 
SAP V1.0 
Correct the analyses per 
protocol amendment and 
inconsistencies with 
eCRF. Provide more 
details of PK analyses. 
The PK assessment and 
relevant analyses on Day 
26 are changed to Day 28. 
The calculation of AUC0-
12h and AUC0-24h are further 
detailed. The residual plot 
for model diagnosis is 
removed. The summary of 
reasons for missed doses, 
prior stage/prognostic 
factors for WM patients, 
and prior transplants are 
removed. 
9 
REFERENCES 
1. Brookmeyer, B et al. A confidence interval for the median survival time, Biometrics 
1982; 38(1), p29-41.  
2. Brown H, Prescott R.  Applied Mixed Models in Medicine.  Wiley, 1999; Ch 7. 
3. Food and Drug Administration Center for Drug Evaluation Research CDER and Center 
for Biologics Evaluation and Research (2007). FDA Guidance for Industry Clinical Trial 
Endpoints for the Approval of Cancer Drugs and Biologics.  
4. Kalbfleisch, J. D. and Prentice, R. L. (1980), The Statistical Analysis of Failure Time 
Data, New York: John Wiley & Sons.  
5. Keene ON.  The log transformation is special.  Statistics in Medicine 1995; 14: 811-819. 
6. Klein, J. P. and Moeschberger, M. L. (1997), Survival Analysis: Techniques for Censored 
and Truncated Data, New York: Springer-Verlag. 
7. Owen RG, Kyle RA, Stone MJ, et al.  Response assessment in Waldenstrom 
macroglobulinaemia: update from the VIth International Workshop.  Br J Haematol 
2013;160:171-6. 
8. Schemper M., and Smith T.L., (1996), A note on quantifying follow-up in studies of 
failure time, Controlled Clinical Trials, 17: 343-346. 
9. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power 
approach for assessing the equivalence of average bioavailability. Journal of 
Pharmacokinetics 
and 
Biopharmaceutics, 
1987; 
15: 
657-680. 
 
 
 
 
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10 APPENDIX 
Appendix A: Missing Data 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/Therapies/Procedures 
When the start date or end date of a medication/therapy/procedure/transfusion is partially 
missing, the date will be imputed to determine whether the 
medication/therapy/procedure/transfusion is prior or concomitant. The following rules will be 
applied to impute partial dates for medications/therapies/procedures/transfusions: 
If start date of a medication/therapy/procedure/transfusion 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 end date of a medication/therapy/procedure/transfusion 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 
x For prior anticancer therapy, the imputed end date should be the first dose date – 14 at the 
latest after imputation. 
If start date or end date of a medication/therapy/procedure/transfusion 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 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: 
x If both month and day are missing and year = year of treatment start date, then set to 
treatment start date 
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x If both month and day are missing and year  year of treatment start date, then set to 
January 01 
x If day is missing and month and year = month and year of treatment start date, then set to 
treatment start date 
x If day is missing and month and year  month and year of treatment start date, then set to 
first day of the month 
x 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 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 
x If end date is completely missing, do not impute. 
If the imputed AE end date > last known alive date or end of study date, then set to the last 
known alive date or end of study date, whichever occurs first. 
 
A.3 Deaths 
In case only the day of a death date is missing, the death will be assumed to be on the 1st date of 
the month if the last date of patient known to be alive is earlier that the 1st date of the month, 
otherwise the death date will be assumed to be on 1 day after the last date of patient known to be 
alive. 
A.4 Subsequent Antineoplastic Therapies 
If the start date of a subsequent antineoplastic therapy is missing, the start date will be assumed 
to be on the 1st date of the month.  If the imputed start date  end of treatment date, then set to 1 
day after the last treatment date. 
 
 
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Appendix B: Sensitivity Analysis for PK Parameters 
A second method for the statistical analysis of the PK parameters will be performed in order to 
adjust the effect of each CYP3A inhibitor on the pharmacokinetics of the other CYP3A inhibitor 
each patient receives.  Two separate statistical analyses will be conducted, one for each treatment 
arm.  The values on Day 3 in the absence of CYP3A inhibitors will be compared to the values on 
Day 10 and Day 28 in the presence of CYP3A inhibitors.   
 
PK analysis 1:  Arm A only 
Compare Day 3 (zanubrutinib alone) to Day 
10 (zanubrutinib + fluconazole) and Day 28 
(zanubrutinib + diltiazem) 
PK analysis 2:  Arm B only 
Compare Day 3 (zanubrutinib alone) to Day 
10 (zanubrutinib + voriconazole) and Day 28 
(zanubrutinib + clarithromycin) 
 
The SAS code will be essentially the same as for the primary comparisons.  The covariance 
structure will be set to UN for the mixed model analyses.  However, two separate contrasts will 
be provided for the difference in the least squares means for comparison of zanubrutinib to 
zanubrutinib + each CYP3A inhibitor.   
 
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