Conditions: Neoplasms
Keywords: PARP inhibitor niraparib Solid Tumor Zejula
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 236
Healthy volunteers: no

Brief summary:
This is a three stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) and Bioequivalence (BE) of niraparib administered as a tablet formulation compared to the reference capsule formulation currently marketed in the United States. Stage 3 evaluates the effect of a high-fat meal on niraparib pharmacokinetics (PK) following a single dose of the tablet. The Extension Phase of this study is to enable participants enrolled in the study to continue to receive treatment with niraparib tablets if they are tolerating it and, in the Investigator's opinion, may receive benefit.

Detailed description:

Arms:
arm 1: Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase arm 2: Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase arm 3: Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase. arm 4: Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase arm 5: Single dose niraparib tablet with a high fat meal followed by single dose of niraparib tablet in a fasted state. arm 6: Single dose niraparib tablet in a fasted state followed by single dose Niraparib tablet with a high fat meal.

Interventions: intervention 1: Niraparib Tablet intervention 2: Niraparib Capsule
Intervention descriptions: intervention 1: Niraparib tablet formulation intervention 2: Niraparib capsule formulation

Protocol document:
SAP_002.pdf: 
Statistical Analysis Plan
Study ID:  213362
Official Title of Study: An Open-Label, Randomized-Sequence, Multicenter, Single-
Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib 
Tablet Formulation Compared to Niraparib Capsule Formulation in Patients With Advanced 
Solid Tumors
NCT ID: NCT03329001
Date of Document (version 7): 12-July-2023 
Date of Document (version 6): 21-December-2021 


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Protocol No: 3000-01-004 
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Statistical Analysis Plan 
AN OPEN-LABEL, RANDOMIZED-SEQUENCE, MULTICENTER, SINGLE-CROSSOVER 
STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY AND BIOEQUIVALENCE OF 
NIRAPARIB TABLET FORMULATION COMPARED TO NIRAPARIB CAPSULE 
FORMULATION IN PATIENTS WITH ADVANCED SOLID TUMORS 
 
GSK/TESARO Protocol 
Number: 
213362/3000-01-004 
Protocol Version: 
6.0 (Amendment 5) 
Compound Number: 
GSK 3985771, MK-4827 
Study Drug Name:  
Niraparib 
Phase:  
Phase 1 
Methodology:  
Open-Label, Cross-Over 
Sponsor:  
TESARO, GSK Company 
Analysis Plan Date: 
12 July 2023 
Analysis Plan Version:  
Version 7.0 
 
 
Confidentiality Statement 
All information contained in this document is privileged and confidential to TESARO, a wholly 
owned subsidiary of GSK. Any distribution, copying, or disclosure is strictly prohibited without 
prior written approval by TESARO. 


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SPONSOR SIGNATURE PAGE 
 
Protocol Title: 
AN OPEN-LABEL, RANDOMIZED-SEQUENCE, 
MULTICENTER, SINGLE-CROSSOVER STUDY TO 
ASSESS THE RELATIVE BIOAVAILABILITY AND 
BIOEQUIVALENCE OF NIRAPARIB TABLET 
FORMULATION COMPARED TO NIRAPARIB CAPSULE 
FORMULATION IN PATIENTS WITH ADVANCED SOLID 
TUMORS 
Protocol Number: 
3000-01-004 
Sponsor:  
TESARO, a GSK Company 
980 Great West Road 
Brentford 
Middlesex, TW8 9GS 
UK 
By signing this document, I acknowledge that I have read the document and approve of the 
planned statistical analyses described herein. I agree that the planned statistical analyses are 
appropriate for this study, are in accordance with the study objectives, and are consistent with the 
statistical methodology described in the protocol, clinical development plan, and all applicable 
regulatory guidance and guidelines. 
Author: 
Alina Striha 
Principal Statistician 
Plus-Project Ltd. 
Signature:  
 
 
 
Date: 
Approver: 
Wenlei Liu 
Statistics Director 
GSK Company 
Signature:  
 
 
 
Date: 
 
 


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TABLE OF CONTENTS 
SPONSOR SIGNATURE PAGE.................................................................................................................. 2 
TABLE OF CONTENTS .............................................................................................................................. 3 
TABLES INCLUDED IN THE TEXT ......................................................................................................... 5 
FIGURES INCLUDED IN THE TEXT ....................................................................................................... 5 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ............................................................... 6 
1. 
Information from the Study Protocol .................................................................................................... 8 
1.1. 
Introduction and Objectives .......................................................................................................... 8 
1.1.1. 
Introduction ........................................................................................................................... 8 
1.1.2. 
Study Objectives ................................................................................................................... 8 
1.1.3. 
Scope and Revision History .................................................................................................. 9 
1.2. 
Study Design ............................................................................................................................... 14 
1.2.1. 
Synopsis of Study Design ................................................................................................... 14 
1.2.2. 
Randomization Methodology .............................................................................................. 18 
1.2.3. 
Unblinding .......................................................................................................................... 18 
1.2.4. 
Study Procedures................................................................................................................. 18 
1.2.5. 
Efficacy, Safety, and Pharmacokinetic parameters ............................................................. 18 
2. 
Patient Population ............................................................................................................................... 19 
2.1. 
Population Definitions ................................................................................................................ 19 
2.2. 
Protocol Deviations ..................................................................................................................... 19 
3. 
General Statistical Methods ................................................................................................................ 19 
3.1. 
Sample Size Justification ............................................................................................................ 19 
3.2. 
General Methods ......................................................................................................................... 21 
3.3. 
Baseline Definitions .................................................................................................................... 22 
3.4. 
Methods of Pooling Data ............................................................................................................ 22 
3.5. 
Adjustments for Covariates ......................................................................................................... 22 
3.6. 
Multiplicity Adjustment .............................................................................................................. 22 
3.7. 
Subpopulations ............................................................................................................................ 22 
3.8. 
Withdrawals, Drop-outs, Loss to Follow-up ............................................................................... 22 
3.9. 
Missing Data ............................................................................................................................... 22 
3.10. Visit Windows ............................................................................................................................ 23 
3.11. Interim Analysis .......................................................................................................................... 23 
3.12. COVID-19 ................................................................................................................................... 23 


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4. 
Study Analyses .................................................................................................................................... 24 
4.1. 
Patient Disposition ...................................................................................................................... 24 
4.2. 
Demographics, Baseline Characteristics and Medical History ................................................... 24 
4.3. 
Investigator Assessment of Response ......................................................................................... 25 
4.4. 
Safety Evaluation ........................................................................................................................ 25 
4.4.1. 
Treatment Exposure and Compliance ................................................................................. 25 
4.4.2. 
Adverse Events ................................................................................................................... 26 
4.4.3. 
Laboratory Data .................................................................................................................. 29 
4.4.4. 
Vital Signs and Physical Examination ................................................................................ 29 
4.4.5. 
Electrocardiogram ............................................................................................................... 30 
4.4.6. 
Prior and Concomitant Mediations ..................................................................................... 30 
4.4.7. 
Prior and Concomitant Transfusions and Growth Factors .................................................. 31 
4.4.8. 
COVID-19 ........................................................................................................................... 31 
5. 
Changes to Planned Analyses ............................................................................................................. 31 
4.5. 
Changes in v5.0 of the SAP ........................................................................................................ 31 
4.6. 
Changes in v6.0 of the SAP ........................................................................................................ 32 
4.7. 
Changes in v7.0 of the SAP ........................................................................................................ 32 
6. 
Appendix ............................................................................................................................................. 33 
6.1. 
Planned Statistical Tables, Listings, and Figures ........................................................................ 33 
 
 
 


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TABLES INCLUDED IN THE TEXT 
TABLE 1 REVISION HISTORY ....................................................................................................................... 13 
TABLE 2 NCI COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS V4.03 (CTCAE) ..................... 29 
FIGURES INCLUDED IN THE TEXT 
FIGURE 1 STUDY DESIGN: SINGLE-CROSSOVER STUDY ............................................................................. 17 
 
 


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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Definition 
AE(s) 
adverse event(s) 
AESI 
Adverse Events of Special Interest 
ALT 
alanine aminotransferase 
ALP 
alkaline phosphatase 
AML 
Acute Myeloid Leukemia 
AST 
aspartate aminotransferase 
ATC 
Anatomical Therapeutic Chemical 
AUC 
area under the plasma concentration-time curve 
BA 
bioavailability 
BE  
bioequivalence 
BMI 
body mass index 
CI 
confidence interval 
CL/F 
apparent total body clearance  
Cmax 
Maximum observed plasma concentration 
CSR 
clinical study report 
CV 
coefficient of variation 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EOT 
end-of-treatment 
FE 
food effect 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
LLN 
lower limit of normal 
LS mean 
least-squares mean 
MDRP 
Medical Data Review Plan 
MDS 
Myelodysplastic Syndromes 
MedDRA 
Medical Dictionary for Regulatory Activities 
NCI CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events 
PI 
Package Insert 
PK 
pharmacokinetics 
PT 
preferred term 
CCI


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Abbreviation 
Definition 
Q1 
first quartile 
Q3 
third quartile 
QD 
one time per day 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
standard deviation 
SOC 
system organ class 
t1/2 
termination elimination half-life  
TEAE 
treatment-emergent adverse event 
tmax 
Time to reach Cmax 
US 
United States 
ULN 
upper limit of normal 
Vz/F 
apparent terminal volume of distribution  
WHO 
World Health Organization 
 
 


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1. Information from the Study Protocol 
1.1. Introduction and Objectives 
1.1.1. Introduction 
The approved niraparib drug product is an immediate release hard gelatin capsule dosage form that 
contains 100 mg of niraparib per capsule. The labelled starting dose for niraparib is 300 mg. Facilitating 
this dose requires the administration of three 100 mg capsules.  
It is the Sponsor’s intent to introduce a tablet dosage form that provides the 100 mg, 200 mg and 300 mg 
dose in single dose strength tablets to reduce the pill burden on the patients. 
To this end, the Sponsor has developed a tablet dosage form with the specific intent to provide 
comparable performance to the approved capsule dosage form. The formulation and manufacturing 
process of the tablet were selected to produce a tablet with comparable in-vitro performance to the 
capsule.  
This study is an open-label Phase 1 study to evaluate the relative bioavailability (BA) and bioequivalence 
(BE) of niraparib administered as a tablet formulation compared to the reference capsule formulation 
manufactured by the same process as currently marketed in the United States. Specifically, a 300 mg 
niraparib tablet will be compared to three (3) niraparib capsules (3 × 100 mg). In addition, this study will 
evaluate the effect of a high-fat meal on the pharmacokinetics (PK) of the niraparib 300 mg tablet 
formulation (Stage 3). The Extension Phase of this study is to enable patients enrolled in the study to 
continue to receive treatment with niraparib if they are tolerating it and, in the Investigator’s opinion, may 
receive benefit. 
1.1.2. Study Objectives 
The primary objectives of this study are as follows: 
• 
Stage 1: To obtain preliminary assessment of the relative bioavailability of 300 mg niraparib 
administered as a tablet versus capsule formulation and to estimate the intra-subject variability of 
niraparib PK 
• 
Stage 2: To evaluate if the tablet formulation (1 × 300 mg) of niraparib is bioequivalent to the 
capsule formulation (3 × 100 mg) 
• 
Stage 3: To assess the effect of a high-fat meal on niraparib PK following a single 300 mg dose of 
the tablet formulation. 
The secondary objectives of this study are as follows: 
• 
Stage 1, Stage 2, and Stage 3: To evaluate the safety of single dose niraparib when administered as 
a tablet or capsule formulation in patients with advanced solid tumors 
• 
Extension Phase: To evaluate the safety of continuously dosed niraparib in patients with 
advanced solid tumors. 
The exploratory objectives of this study are as follows: 
CCI


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1.1.3. Scope and Revision History 
A separate PK analysis plan will be written to address the PK objectives and data for this study. 
This statistical analysis plan (SAP) is designed to outline the methods to be used in the analyses of 
non-pharmacokinetic study data. Patient populations to be used for analyses, data handling rules, 
statistical methods, and formats for data presentation are identified and provided. The statistical analyses 
and summary tabulations described in this SAP will provide the basis for the results sections of the 
clinical study report (CSR) for this trial. 
The SAP will outline any differences in the currently planned analytical objectives relative to those 
planned in the study protocol. 
The SAP is a living document that will be created during the trial conduct. It will be maintained 
throughout the lifecycle of the trial. Important changes following approval of SAP v1.0 will be tracked in 
this section. 
The following changes have been implemented in the Appendix containing shells of the Planned 
Statistical Tables, Listings and Figures. 
Table/Listing 
Number 
Correction 
Reason for Correction 
Table 14.1.1d 
Footnotes [2] and [3] added to the table and in the 
footer. 
Clarification why two patients have 
been double counted in Screening. 
Table 14.1.3.1c 
Footnote added to the shell. 
Clarification added to the output for 
Extension Phase reporting effort. 
Table 14.1.4d 
Added “Missing” category to Cancer stage and 
Number of prior lines of therapy. 
Data collected has missing 
information on the eCRF. 
Table 14.3.1.1.2d 
Removed “Any COVID-19 related TEAE”. 
Removing a duplicate entry row. 
Table 14.3.1.14d 
Removed “System Organ Class” from the table. 
Line not required for the table in 
question as summary by Preferred 
Term is of interest. 
Table 14.3.1.16.1c 
Table shell added. 
Table added for final study disclosure 
purposes of Extension Phase data. 
Table 14.3.1.16d 
Added footnote: 
“NOTE: Deaths due to progressive disease were 
not collected as adverse events.” 
Added to reflect data collection and 
management process and align with 
Stage 1 and Stage 2 programming 
practice. 
Table 14.3.1.2.1.1d 
Footnote added: 
Note: COVID-19 Case Diagnosis is based on 
WHO Definition as of DDMMMYYYY. 
Added as per reviewer request. 
Table 14.3.1.20d 
Table 14.3.1.21d 
Table 14.3.1.22d 
Footnote [1] updated to: 
“Note: Extension Phase for all Stages of TABLET 
study overlapped with COVID-19 pandemic, with 
all Stage 3 patients commencing treatment for the 
Extension Phase on or after 02JUN2021 placing 
the AE onset during the pandemic, while last 
patient commenced treatment for Stages 1 and 2 
on 14MAY2018 and 05DEC2019, respectively, 
placing their first Extension Phase treatment dose 
administration prior to the start of the pandemic, 
as defined by WHO as of 20MAR2020, with 
Clarification of footnote explaining 
calendar placement of the Stages 1-3 
during COVID-19 pandemic. 
 
 
 
 
 
 
 
 


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Table/Listing 
Number 
Correction 
Reason for Correction 
patients across all Stages ongoing until 
DDMMMYYYY.” 
 
 
Table titles updated to:  
Table 14.3.1.20d Summary of Incidence 
of COVID-19 Related Adverse Events 
Over Time (Safety Population in the 
Stage 3 PK Phase)  
Table 14.3.1.21d Summary of Incidence 
of COVID-19 Related Adverse Events 
Over Time by Gender (Safety Population 
in the Stage 3 PK Phase) 
Table 14.3.1.22d Summary of Incidence 
of COVID-19 Related Adverse Events 
Over Time by Age Group (Safety 
Population in the Stage 3 PK Phase) 
 
 
 
 
Clarification of titles to reflect the 
reporting effort of COVID-19 related 
AE incidence rates. 
Table 14.4.1c 
Summary table of Important Protocol Deviations 
for Open-Label Extension Phase added. 
Added upon request from study team 
for CSR reporting purposes. 
Table 14.4.1d 
Summary table of Important Protocol Deviations 
for the PK Phase Occurring Through End of 
Treatment (Safety Population in the Stage 3 PK 
Phase). 
Footnotes and corresponding references added to 
the table. 
Added upon request from study team 
for CSR reporting purposes. 
 
 
Added upon request for clarification. 
Listing 16.2.2.2c   
Footnote [1] updated to: 
“Note: Extension Phase for all Stages of TABLET 
study overlapped with COVID-19 pandemic, with 
all Stage 3 patients commencing treatment for the 
Extension Phase on or after 02JUN2021 placing 
the AE onset during the pandemic, while last 
patient commenced treatment for Stages 1 and 2 
on 14MAY2018 and 05DEC2019, respectively, 
placing their first Extension Phase treatment dose 
administration prior to the start of the pandemic, 
as defined by WHO as of 20MAR2020, with 
patients across all Stages ongoing until 
DDMMMYYYY. 
Clarification of footnote explaining 
calendar placement of the Stages 1-3 
during COVID-19 pandemic. 
 
Listing 16.2.5.1d 
Added “PK Dose 1” and “PK Dose 2” date 
columns to the listing. 
 
Moved “Patient Number” into header row. 
Added columns to the shells to align 
Stage 3 reported outputs with those 
reported in Stages 1 and 2. 
For readability purposes. 
Listing 16.2.5.3d 
Added “Rel Day [1]” column and [1] footnote: 
“[1] Relative to first dose during the PK Phase.” 
Added to the shells to align Stage 3 
reported outputs with those reported 
in Stages 1 and 2. 
Listing 16.2.5.5d 
Columns “Full Dose Taken?”, “If N, how much 
consumed?”, “Reason for Change”, “Nausea 
within specified time of dose?” removed from the 
listing.  
Columns removed from Stage 3 
listing as not applicable, as per study 
design. 
Listing 16.2.8.1.1d 
and associated 
repeat listings 
Programming note added regarding location of 
“Patient Number” in the outputs. 
Depending on spacing/information 
displayed, “Patient Number” may be 
displayed in the header row after 


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Page 11 of 135 
Table/Listing 
Number 
Correction 
Reason for Correction 
“Treatment Sequence” in order to aid 
readability of the listing. 
Listing 16.2.8.2d 
Removed “Heart Rate” column. 
Data collected under “Pulse” in 
Stage 3, added “Heart Rate” to the 
shells in error. 
Listing 16.2.8.5d 
Added text to footnote: “in the PK Phase” 
Previously missing in error. 
Listing 16.2.9.2c 
Footnote [1] updated to: 
“Note: Extension Phase for all Stages of TABLET 
study overlapped with COVID-19 pandemic, with 
all Stage 3 patients commencing treatment for the 
Extension Phase on or after 02JUN2021 placing 
the AE onset during the pandemic, while last 
patient commenced treatment for Stages 1 and 2 
on 14MAY2018 and 05DEC2019, respectively, 
placing their first Extension Phase treatment dose 
administration prior to the start of the pandemic, 
as defined by WHO as of 20MAR2020, with 
patients across all Stages ongoing until 
DDMMMYYYY. 
Clarification of footnote explaining 
calendar placement of the Stages 1-3 
during COVID-19 pandemic. 
 
Listing 16.2.2c 
Listing updated to include only “Important” 
protocol deviations; title updated to reflect 
change. 
“Protocol Deviation Severity” column dropped. 
Updated upon request from study 
team for CSR reporting purposes. 
 
Obsolete field. 
Listing 16.2.2.1d 
Listing updated to include only “Important” 
protocol deviations; title updated to reflect 
change. 
Updated upon request from study 
team for CSR reporting purposes. 
Section 1.2 
Definition of data cut has been amended. 
Definition changed to reflect study 
reporting requirements upon request 
from study team. 
Table 14.1.1c  
Table has been updated to include Starting Dose 
(100 mg, 200 mg and 300 mg) and categorization 
by Stage (TABLET Stages 1, 2 and 3). 
Updated upon request from study 
team for CSR reporting purposes. 
Table 14.1.10c 
Table added for Extension Phase. 
Added upon request from study team 
for CSR reporting purposes. 
Extension Phase 
tables 
Treatment arm labels updated to be TABLET, 
CAPSULE and OVERALL, for consistency, 
throughout the shells 
Updated for consistency. 
Table 14.3.1.1.1c 
Table shell spelled out for Extension Phase 
reporting effort, including COVID-19 summary 
categories. 
Updated upon request from study 
team for CSR reporting purposes. 
Table 
14.3.1.1.1.1c 
New repeat table added for Extension Phase. 
Added upon request from study team 
for CSR reporting purposes. 
Table 14.3.1.11.1a 
New table added for PK Stage 1.  
Required for plain text summary 
reporting effort. 
Table 14.3.1.11.1b 
New table added for PK Stage 2.  
Required for plain text summary 
reporting effort. 
Table 14.3.1.11.1c 
New table added for Extension Phase. 
Required for plain text summary 
reporting effort. 
Table 14.3.1.11.1d 
New table added for PK Stage 3. 
Required for plain text summary 
reporting effort. 
Table 14.3.1.23.1a 
New table added for PK Stage 1. 
Required for disclosure reporting 
effort. 


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Table/Listing 
Number 
Correction 
Reason for Correction 
Table 14.3.1.23.1b 
New table added for PK Stage 2. 
Required for disclosure reporting 
effort. 
Table 14.3.1.23.1c 
New table added for Extension Phase. 
Required for disclosure reporting 
effort. 
Table 14.3.1.23.1d 
New table added for PK Stage 3. 
Required for disclosure reporting 
effort. 
Table 14.3.1.23.2a 
New table added for PK Stage 1. 
Required for plain text summary 
reporting effort. 
Table 14.3.1.23.2b 
New table added for PK Stage 2. 
Required for plain text summary 
reporting effort. 
Table 14.3.1.23.2c 
New table added for Extension. 
Required for plain text summary 
reporting effort. 
Table 14.3.1.23.2d 
New table added for PK Stage 3. 
Required for plain text summary 
reporting effort. 
Table 14.3.1.14c 
Footnotes omitted as not applicable for Extension 
phase reporting. 
Updated for clarification. 
Table 14.3.1.20c 
Footnote updated to reflect reporting period for 
overall study population in Extension Phase. 
Updated for clarification. 
Table 14.3.1.21c 
Table added for Extension Phase reporting. 
Updated upon request from study 
team for CSR reporting purposes. 
Table 14.3.1.22c 
Table added for Extension Phase reporting. 
Updated upon request from study 
team for CSR reporting purposes. 
Table 14.3.4.1c 
‘Number of Cycles’ changed to ‘Maximum 
number of cycles’. Labels for dose 
interruptions/reductions/re-escalations modified 
for clarity. 
‘Median number of cycles started’, ‘Exposure 
duration (months)’ and ‘Dose intensity’ added to 
output. 
Updated to reflect changes requested 
by study team. 
Table 14.3.4.5.1c 
Table added for Extension Phase reporting. 
Updated upon request from study 
team for CSR reporting purposes. 
Listing 16.2.2.2c 
Listing added for Extension Phase reporting. 
Updated upon request from study 
team for CSR reporting purposes. 
Listing 16.2.5.1.1c 
Listing added for Extension Phase reporting. 
Updated upon request from study 
team for CSR reporting purposes. 
Listing 16.2.5.5c 
“Tablets remaining” and “Was Full Dose Taken?” 
column dropped. 
Data not collected consistently for 
study reporting purposes. 
Listing 16.2.6.1c 
“Visit” column dropped. 
 
“Tumor Type” column added. 
Visit data not collected, only date of 
assessment. 
Added upon request from study team 
for CSR reporting purposes. 
Listing 16.2.7.1c 
Listing shell spelled out for Extension Phase 
reporting effort. 
‘Dose at onset of AE’ variable dropped from 
listing. 
Updated upon request from study 
team for CSR reporting purposes. 
Data not collected consistently for 
production of reliable results. 
Listing 16.2.7.2c  
Listing added for Extension Phase reporting. 
Added upon request from study team 
for CSR reporting purposes 
Listing 16.2.9.2c 
Listing shell spelled out for Extension Phase 
reporting effort. 
Updated upon request from study 
team for CSR reporting purposes. 
Figure 14.3.4.3.1c 
Figure shell added for Extension Phase reporting 
effort. 
Updated upon request from study 
team for CSR reporting purposes. 
 


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Table 1 Revision History 
SAP  
version 
Protocol 
version 
eCRF  
version 
Changes from previous version 
1.0 
2.0 
5.0 (26FEB2018) 
First Draft 
2.0 
4.0 
8.0 (12FEB2019) 
Major changes to this draft of the SAP include the following: 
Incorporate changes based on amended protocol. 
Modify Stage 2 analysis of AEs to accommodate the increase in 
washout time between Period 1 and Period 2 for Stage 2. 
For the Extension Phase, specify that analysis will be performed by 
formulation and overall to accommodate allowance of both tablet 
and capsule formulation in the Extension Phase. 
Define the BA/BE evaluable population and add demographic and 
baseline characteristic summaries for this population. 
Clarify definition of concomitant medications and add additional 
table for Stage 2 to analyze only medications taken during the PK 
collection period. 
Clarifications to mock table and listing shells (e.g., numbering, 
footnotes). 
3.0 
5.0 
10.0 (31JUL2019) 
Major changes to this draft of the SAP include the following: 
• 
Incorporate changes based on amended protocol, 
including: 
o 
Updated numbers of patients enrolled to account 
for non-evaluability. 
o 
Specification of reasons for non-evaluability for 
the analysis of bioequivalence. 
• 
Focus Extension Phase laboratory summaries on select 
laboratory assessments hemoglobin, neutrophils, platelets, 
bilirubin, creatinine, AST, and ALT). 
4.0 
6.0 
11.0 (16APR2020) 
Major changes to this draft of the SAP include the following: 
• 
Incorporate changes based on amended protocol, to 
address the objectives for Stage 3 of the study. 
• 
Addition of sections relating to COVID-19 reporting. 
5.0 
6.0 
13.0 (17MAR2021) 
Primary changes to this draft associated with addition of Important 
Protocol Deviation table and updates to the associated listing to 
reporting effort.  
Minor updates to align Stage 1, 2 and 3 TLFs with shells, and 
associated update to Protocol Deviation reporting, as per the SAP. 


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SAP  
version 
Protocol 
version 
eCRF  
version 
Changes from previous version 
6.0 
6.0 
13.0 (17MAR2021) 
Primary change to this draft of the SAP is change of the data cut for 
reporting of final Stage 3 analysis. 
Minor update to footnotes of Important Protocol Deviation summary 
table. 
Minor update to Section 5 formatting. 
7.0 
6.0 
14.0 (17NOV2021) 
Minor updates to template output/column header and title formatting 
to align with produced output header and title formatting. 
CRF versions updated to align with CRF booklet version upgrades 
starting from SAP version 4.0 onwards.  
COVID-19 related output shell added for Extension phase. 
Definitions of exposure and compliance derivations expanded to 
include dose intensity. 
Additional tables and listings have been added/modified for 
Extension Phase; disclosure and plain language summary reporting 
tables have been added across all study stages. 
Section 3.2 ‘Dose at onset of AE’ has been removed from AE 
listings; output shells added for adverse event reporting in the 
Extension Phase/to cover time between end of PK Phase and start 
of Extension Phase. 
Section 2 updated to include definition for dose intensity in exposure 
table for Extension Phase.  
Section 4.4.2 updated AE classification for PK Period 1 for Stage 3. 
 
 
1.2. Study Design 
1.2.1. Synopsis of Study Design 
This is a multicenter, open-label study in patients with advanced solid tumors. This is a 3-stage, 
randomized-sequence, single-crossover study to assess the relative BA and BE of niraparib tablet 
formulation relative to the capsule formulation. In addition, Stage 3 of the protocol is a single cohort, 
randomized-sequence, 2 period, single dose, crossover study to assess effect of food on the PK of the 
niraparib tablet formulation. 
Pharmacokinetics (PK) Phase: In Stages 1 and 2, patients will be randomized 1:1 to receive tablet 
formulation followed by capsule formulation or capsule formulation followed by tablet formulation. In 
Stage 3, patients will be randomized 1:1 to receive tablet formulation in a fasted state followed by tablet 
taken with a high-fat meal, or by tablet taken with a high-fat meal followed by tablet formulation taken in 
a fasted state. 


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Stage 1: Following an 8-hour fast on Day 1, patients will receive a single dose of the formulation (tablet 
[1 × 300 mg] or capsule [3 × 100 mg]) followed by a 7-day (+1 day) Washout/PK period, followed by a 
dose of the alternate formulation also in a fasted state, followed by a 7-day (+1 day) Washout/PK period 
for Stage 1 of the study followed by a dose of the alternate formulation also in a fasted state, followed by 
a 7-day Washout/PK period. Patients receiving the tablet in the first treatment period will receive the 
capsules in the second treatment period and vice versa (Figure 1). Extensive PK sampling will be carried 
out after niraparib dosing. 
Stage 2: Following an 8-hour fast on Day 1, patients will receive a single dose of the formulation (tablet 
[1 × 300 mg] or capsule [3 × 100 mg]) followed by a 14-day (+/- 4 days) Washout/PK period followed by 
a dose of the alternate formulation also in a fasted state, followed by a 7-day Washout/PK period. Patients 
receiving the tablet in the first treatment period will receive the capsules in the second treatment period 
and vice versa (Figure 1). Extensive PK sampling will be carried out after niraparib dosing. 
Stage 3: In Period 1, patients will receive a single 300 mg niraparib tablet either following a 10-hour fast 
or directly following consumption of a high-fat meal, followed by a 14-day (+4 days) PK sampling and 
Washout period. In Period 2, patients will be crossed over to receive a single 300 mg niraparib tablet in a 
fasted state or with a high-fat meal, followed by a 7-day PK sampling period. All patients will fast for a 
minimum of 4 hours post-dose in both periods. Patients receiving the tablet in the fasted state in the first 
treatment period will receive the tablet with a high-fat meal in the second treatment period and vice versa. 
In the rare instance where a delay of the entire PK Period 2 is needed for any reason beyond the 4 day 
window specified above the site must contact the Sponsor’s medical monitor to discuss the patient 
circumstances, the Sponsor will decide if the patient can continue with PK Period 2 with a delay. 
Similarly, should the laboratory results on Day 15 (D15) (the day of niraparib administration in PK 
Period 2) show changes in organ function such that the original inclusion criteria for laboratory values are 
no longer met, or in the event of a significant change of patient’s clinical status as judged by the 
Investigator, the site must consult with the Sponsor to discuss the patient’s continued participation in PK 
Period 2. Note that sites need not wait for the pre-dose laboratory results to begin PK Period 2, but rather 
consult the Sponsor once the results are available as needed. In Stage 2, patients who experience emesis 
within 9 hours of dosing or who miss a critical PK sample (such as the last PK sample on Day 8 in each 
period) will be discontinued from the PK Phase and will be allowed to be screened for the Extension 
Phase. In Stage 3, patients who experience emesis within 10 hours of dosing will be discontinued from 
the PK Phase and will be allowed to be screened for the Extension Phase. Patients who miss sufficient 
samples to render calculation of AUC unreliable will be discontinued from the PK Phase; those that meet 
other criteria for continued niraparib therapy will be eligible to be screened for the Extension Phase. 
For Stage 1, the PK parameters that will be estimated include area under the plasma concentration-time 
curve from time 0 to the time of the last quantifiable concentration (AUC0-t), area under the plasma 
concentration-time curve from time 0 extrapolated to infinity (AUC0-∞), apparent total body clearance 
(CL/F), maximum observed plasma concentration (Cmax), time to reach Cmax (tmax), termination 
elimination half-life (t1/2), apparent terminal volume of distribution (Vz/F) and BA of tablet formulation 
relative to the capsule formulation based on AUC0-t, AUC0-∞, and Cmax. Relative bioavailability will be 
assessed based on the ratio of geometric least-squares (LS) means of the test (tablet) to reference 


Nira pari b  
Statistical A nal ysis Pla n  
Pr ot oc ol N o: 3 0 0 0 -0 1 -0 0 4  
C o nfi de ntial  
Pa ge 1 6  of 1 3 5  
(ca ps ule). A d diti o nall y, t he p har mac o ki netics of 
 will be deter mi ned 
( Sta ge 1 o nl y). 
F or Sta ge 2, t he sa me P K para meters as a b o ve will be esti mate d. T o c o ncl u de bi oe q ui vale nce, t he 9 0 % 
c o nfi de nce i nter val  ( CI) of t he rati o of ge o metric L S  mea ns of t he test (ta blet) t o refere nce (ca ps ule) 
pr o d uct s h o ul d be wit hi n 0. 8 0 0  –  1 .2 5 0  ( 8 0%  –  1 2 5 %)  f or A U C0 -∞, A U C0 -t, a n d Cma x . 
F or Sta ge 3, t he sa me P K para meters as a b o ve will be esti mate d. I n a d diti o n, t la g, t he ti me fr o m 
a d mi nistrati o n of t he d ose t o t he first q ua ntifia ble c o nce ntrati o n, will be deter mi ne d, a n d t ma x  will be 
c o m pare d bet wee n t he fe d a n d faste d states. T he relati ve bi oa vaila bilit y  of t he 3 0 0 m g nira pari b ta blet 
a d mi nistere d wit h a hi g h -fat meal relati ve t o faste d d osi n g will be base d o n t he rati o of ge o metric L S  
mea ns of A U C 0 -t, A U C0 -∞, a n d Cma x . 
A d dit i o nal P K para meters ma y be esti mate d (e. g., resi d ual area), if dee me d a p pr o priate. 
E xte nsi o n P hase: W he n patie nts c o m plete t he P K P hase of t he st u d y  (at least 7-da ys fr o m t he be gi n ni n g 
of P K Peri o d 2) , t he y ma y be eli gi ble t o partici pate i n t he E xte nsi o n P hase f oll o wi n g re vie w of t he 
E xte nsi o n P hase i ncl usi o n criteria a n d c o m pleti o n of t he re q uire d E xte nsi o n P hase scree ni n g assess me nts. 
T he starti n g d ose of nira pari b i n t he E xte nsi o n P hase will be base d o n t he patie nt’s baseli ne act ual b o d y 
wei g ht or platelet c o u nt. Patie nts wit h a baseli ne act ual b o d y wei g ht of ≥7 7 k g a n d scree ni n g platelet 
c o u nt of ≥1 5 0, 0 0 0/ µ L ( o btai ne d after c o m pleti o n of t he P K P hase, as part of E xte nsi o n P hase scree ni n g) 
will ta ke o ne 3 0 0 m g stre n gt h ta blet or 3 ×  1 0 0 m g ta blet/ca ps ules at eac h d ose a d mi nistrati o n ( o nce a da y 
[Q D ]). Patie nts wit h a baseli ne act ual b o d y wei g ht of < 7 7 k g or scree ni n g platelet c o u nt of < 1 5 0, 0 0 0/ µ L 
will ta ke o ne 2 0 0 m g stre n gt h ta blet or 2 ×  1 0 0 m g ta blet/ca ps ules at eac h d ose a d mi nistrati o n ( Q D). F or 
patie nts w h ose i nitial starti n g d ose is 2 0 0 m g Q D, escalati o n t o 3 0 0 m g Q D is per mitte d after 2 c ycles of 
t hera p y if n o treat me nt i nterr u pti o n or disc o nti n uati o n was re q uire d d uri n g t he first 2 c ycles of E xte nsi o n 
P hase t hera p y a n d after a p pr o val fr o m t he S p o ns or. A d diti o nal d ose m o dificati o ns will n ot be base d u p o n 
c ha n ges i n t he patie nt’s act ual b o d y wei g ht d uri n g st u d y partici pati o n. If la b orat or y val ues at t he 
be gi n ni n g of E xte nsi o n P hase are o utsi de of t he ra n ge s pecifie d i n t he i ncl usi o n criteria, t he patie nt ma y 
c o nti n ue t o partici pate i n t he st u d y o nl y u p o n S p o ns or a p pr o val wit h c o nsi derati o n f or a n a p pr o priatel y 
re d uce d d ose. S h o ul d a patie nt start t he E xte nsi o n P hase at 1 0 0  m g, c o nsi derati o n ma y be gi ve n t o 
escalate t o 2 0 0 m g after 2 c ycles  of  t hera p y if n o treat me nt i nterr u pti o n or disc o nti n uati o n was re q uire d 
d uri n g t he first 2 c ycles of E xte nsi o n P hase t hera p y a n d after a p pr o val fr o m t he S p o ns or.  
Patie nts ha ve u p t o 2 8 da ys ( 2 1 da ys f or Sta ge 3 onl y; u p t o 2 8 da ys ma y be acce pta ble f oll o wi n g 
disc ussi o n bet wee n t he S p o ns or a n d I n vesti gat or) after c o m pleti o n of t he P K P hase t o c o m plete t he 
scree ni n g assess me nts a n d t he E xte nsi o n P hase Scree ni n g Visit.  
A t u m or assess me nt is t o be perf or me d pri or t o t he first d ose of t he E xte nsi o n P hase ( pre -E xte nsi o n 
P hase). T he pre -E xte nsi o n P hase t u m or assess me nt nee d n ot be c o m plete d if t he baseli ne t u m or 
assess me nt was perf or me d ≤ 5 6 da ys bef ore t he first d ose of t he E xte nsi o n P hase. 
T he C ycle 1/ Da y 1 Visit ca n occ ur o n t he sa me da y as t he E xte nsi o n P hase Scree ni n g Visit, de pe n de nt 
u p o n a vaila bilit y of ra di o gra p hic res ults o btai ne d ≤ 5 6  da ys of t he first pla n ne d d ose i n t he E xte nsi o n 
P hase. If t he E xte nsi o n P hase Scree ni n g Visit a n d t h e C ycle 1/ Da y 1 Visit occ ur o n t he sa me da y, t he 
cli nical la b orat or y res ults will be re vie we d b y t he st u d y pers o n nel pri or t o st u d y dr u g a d mi nistrati o n  t o 
C CI


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ensure eligibility. At the Cycle 1/Day 1 Visit, patients will undergo safety assessments and will receive 
study drug supply for the duration of 1 cycle (300 mg or 200 mg tablets of niraparib for QD dosing or 
3 × 100 mg or 2 × 100 mg tablet/capsules of niraparib for QD dosing, depending on availability). It is 
preferred that patients remain on the same formulation (tablet versus capsule) throughout the Extension 
Phase. Patients will return on the first day of every treatment cycle (28 ± 7 days) to receive study drug 
and for safety assessments. Visits will continue approximately every 4 weeks until treatment 
discontinuation. In line with the niraparib United States Package Insert (US PI), dose interruption (no 
longer than 28 days) will be allowed based on adverse events (AEs). In addition, dose reductions to 
200 mg QD and subsequently to 100 mg QD will be allowed based on AEs (please refer to US PI). Any 
dose reductions differing from this must be discussed with the medical monitor. Patients can continue in 
the Extension Phase until the patient meets 1 of the withdrawal criteria. 
End-of-treatment (EOT) and Safety Follow-up Visits: The EOT visit will occur within 7 days of the 
decision to discontinue study drug, for any reason, or completion of the PK Phase for patients who 
participate in the Extension Phase (Stage 3 only), whichever occurs first. Should the first dose of a new 
anti-cancer therapy occur within 14 days of the decision to discontinue study drug, all assessments 
required for the Safety Follow-up visit should occur at the EOT visit and this visit will be considered the 
Safety Follow-up visit. If the first dose of the new anti-cancer therapy occurs >14 days of the decision to 
discontinue study, the Safety Follow-up visit will occur 30 +7 days after the last dose of the study drug, or 
at the start of any new anti-cancer therapy, whichever occur first. 
For Stage 3 of the PK Phase only, the data cut will occur when all patients have completed the PK Phase. 
Data collected up to and including PK EOT visit prior to the data cut will be presented in the FE Stage 3 
PK CSR for all randomized and treated patients. Additionally, the Sponsor will include safety data related 
to the PK Phase, as identified up to Cycle 1/Day 1 of the Extension Phase. 
Figure 1 Study Design: Single-Crossover Study 
 
Stage 2 (completed): 
 


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Stage 1 (completed): 
Abbreviations: PK = pharmacokinetics.  
 
1.2.2. Randomization Methodology 
Randomization will occur centrally using an interactive voice response system/integrated web response 
system. In Stage 1 and Stage 2, patients will be assigned randomly in a 1:1 ratio to a dosing sequence: 
capsule formulation followed by tablet formulation, or vice versa. In Stage 3, patients will be assigned 
randomly in a 1:1 ratio to a dosing sequence: dosing after receiving a high-fat meal (fed) followed by 
dosing after fasting, or vice versa. The period between randomization and Cycle 1/Day 1 should be no 
longer than 5 calendar days. 
1.2.3. Unblinding 
Unblinding is not applicable as this is an open-label study. 
1.2.4. Study Procedures 
Refer to the latest protocol for the schedule of assessments. 
1.2.5. Efficacy, Safety, and Pharmacokinetic parameters 
1.2.5.1. Efficacy parameters 
Investigator assessment of response will occur every 3-cycles while on study or per the Institution’s 
standard practice. 
1.2.5.2. Safety parameters 
Safety parameters to be assessed include: 
• 
Treatment emergent adverse events (TEAE) 
• 
Discontinuations due to AEs 
• 
Physical examination (PE) findings 
• 
Vital signs 
• 
Clinical laboratory results (hematology, chemistry, urinalysis) 
• 
Electrocardiograms (ECG) 
• 
Use of concomitant medications. 
1.2.5.3. PK parameters 
PK parameters and analysis methodology will be addressed in the PK analysis plan. 


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2. Patient Population 
2.1. Population Definitions 
The following patient populations will be evaluated for analyses specified in this SAP. Additional 
populations, relevant to the PK analysis will be defined in the PK analysis plan. 
• 
Safety Population in the Stage 1 PK Phase: All patients who receive any amount of niraparib 
during the Stage 1 PK Phase of the study. 
• 
Safety Population in the Stage 2 PK Phase: All patients who receive any amount of niraparib 
during the Stage 2 PK Phase of the study. 
• 
Safety Population in the Stage 3 PK Phase: All patients who receive any amount of niraparib 
during the Stage 3 PK Phase of the study. 
• 
Safety Population in the Extension Phase: All patients who receive any amount of niraparib in the 
Open-Label Extension Phase of the study. 
• 
BA/BE Evaluable Population: All patients who complete both PK periods and have sufficient PK 
sample collection to accurately estimate PK parameters, without significant niraparib carryover 
(baseline concentration > 5% of Cmax), in both PK Periods. Patients who have significant niraparib 
carryover from Period 1 in Period 2 will be completely excluded from the BA/BE Evaluable 
Population. The terminology BA Evaluable Population will be used for Stage 1 and BE Evaluable 
Population will be used for Stage 2. 
• 
Food effect (FE) Evaluable Population: All patients who complete both PK periods and have 
sufficient PK sample collection to accurately estimate PK parameters in both periods. Patients meeting 
non-evaluability criteria or having significant niraparib carryover (baseline concentration >5% of Cmax) 
will be completely excluded from the FE Population. 
2.2. Protocol Deviations 
Protocol deviations will be assessed and classified as important and/or significant per Sponsor’s SOP. The 
Medical Data Review Plan (MDRP) prospectively identifies classification criteria for important 
deviations. All protocol deviations will be identified, classified and finalized prior to database lock. 
A listing of protocol deviations will be provided for the Stage 1 PK Phase, Stage 2 PK Phase; for Stage 3 
PK Phase and the Open-Label Extension Phase a listing of only “Important” protocol deviations will be 
provided. 
For Stage 3 PK Phase and Open-Label Extension Phase, tables summarizing “Important” protocol 
deviations will be provided. 
3. General Statistical Methods 
3.1. Sample Size Justification 
Stage 1 
No formal sample size calculation was performed for Stage 1. Approximately 24 patients will be enrolled 
in Stage 1. This sample size is considered adequate for preliminary assessment of the relative 
bioavailability of the tablet compared to the capsules and for estimating the intra-subject coefficient of 
variation, after accounting for patient drop-outs and potential carryover.  


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Stage 2 
Based on estimates from Stage 1, 100 BA/BE evaluable patients are required in Stage 2. With 
100 evaluable patients, assuming the intra-subject coefficient of variation (CV) is 25% and the true ratio 
of means is 0.89 (89%), there is at least 90% power to demonstrate the bioequivalence (bioequivalence 
range: 0.80 to 1.250 [80% – 125%], alpha=0.05). Power calculations were also performed under 
alternative assumptions for the CV and mean ratio. Assuming the CV is 30% and the true ratio of means 
is 0.89 (89%), with 100 evaluable patients, there is at least 82% power to demonstrate bioequivalence. 
Assuming the true ratio is 0.90 (90%), the power is 96% and 88% assuming CVs of 25% and 30%, 
respectively.  
The final analysis of bioequivalence will be based on Stage 2 BA/BE evaluable patients only, with a 
target sample size of 100 evaluable patients. Patients may be identified as non-evaluable due to issues 
arising during the study conduct, such as: 
• 
Emesis within 9 hours of dosing,  
• 
Dosing errors,  
• 
Patient did not fast prior to dosing,  
• 
Missing critical PK sample on Day 8,  
• 
Failure to complete both PK periods, and 
• 
Significant changes to the patient medical status that would potentially affect the PK profile as 
determined by the Sponsor in consultation with the Investigator prior to PK data analysis.  
In this patient population, approximately 170 total patients are targeted for enrollment, assuming a 35% 
non-evaluability rate during the study conduct, and an additional 10% non-evaluability rate during PK 
analysis. The non-evaluability rate arising during the study conduct will be continuously monitored by the 
Sponsor and the total number of enrolled patients may be adjusted accordingly with the aim to target the 
resulting sample size of 100 BA/BE evaluable patients.  
Stage 3 
Assuming the true ratio of means is 1 and the intra-subject CV is 20% for AUC0-t and AUC0-∞, with 
16 evaluable patients, there is approximately 83% probability that the 90% CI of the ratio of geometric 
means will be within 0.800 and 1.250 (80% - 125%). Based on the results of a FE study conducted using 
the capsule formulation, an effect of a high-fat meal on Cmax is possible. The sample size of 16 patients is 
deemed adequate to characterize this effect. AUC0-t and AUC0-∞ will be the primary parameters for 
analysis.  
The primary analysis will be based on the FE Evaluable Population as it is the most conservative 
approach, which maximizes the benefits of the crossover design, where each patient serves as their own 
control. Results for the PK Evaluable Population will also be summarized and reported for this study. 
To account for non-evaluable patients, approximately 20 total patients are targeted for enrollment. The 
final analysis will be based on Stage 3 FE evaluable patients only. Patients may be identified as 
non-evaluable due to issues arising during the study conduct, such as: 
• 
Emesis within 10 hours of dosing, 


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• 
Dosing errors, 
• 
Patient did not follow dietary requirements prior to dose and post-dose, 
• 
Failure to complete both PK periods, and 
• 
Significant changes to the patient medical status that would potentially affect the PK profile as 
determined by the Sponsor in consultation with the Investigator prior to PK data analysis.  
Patients who miss critical PK samples or miss sufficient samples to render calculation of AUC unreliable 
will be discontinued from the PK Phase; those that meet other criteria for continued niraparib therapy will 
be eligible to be screened for the Extension Phase. The non-evaluability rate arising during the study 
conduct will be continuously monitored by the Sponsor and the total number of enrolled patients may be 
adjusted accordingly with the aim to target the resulting sample size of 16 evaluable patients. 
3.2. General Methods 
All statistical analyses will be performed using SAS statistical software v9.4 or later, unless otherwise 
noted. All output will be incorporated into Microsoft Word or Excel files, or Adobe Acrobat PDF files, 
sorted and labeled according to the International Council for Harmonisation (ICH) recommendations, and 
formatted to the appropriate page size(s). 
For categorical variables, summary tabulations of the number and percentage of patients within each 
category of the parameter will be presented. Percentages will be based on the patients with a non-missing 
parameter unless missing category is presented. Percentages will be reported to one decimal place. 
Percentages will not be presented for zero counts. 
For continuous variables, the number of patients, mean, standard deviation (SD), median, first quartile 
(Q1), third quartile (Q3), minimum, and maximum values will be presented. Mean, median, Q1, and Q3 
will be reported to 1 more decimal place than the raw data, while the SD will be reported to 2 more 
decimal places than the raw data. 
All data listings that contain an evaluation date will also contain a relative study day. A unique relative 
study day will be calculated for the PK Phase and Extension Phase based on the first date of dosing within 
the respective study phase. Pre-treatment and on-treatment study days are numbered relative to the day of 
the first dose of study drug which is designated as Day 1. The preceding day is Day -1, the day before that 
is Day -2, etc. Post-treatment study days are numbered relative to the first dose and are designated as 
Day +1, Day +2, etc. 
In addition: 
• 
Medical history and AEs will be coded using the most up-to-date version of Medical Dictionary 
for Regulatory Activities (MedDRA).  
• 
Laboratory parameter changes during the Extension Phase for selected laboratory tests will be 
described using shift tables, relative to the National Cancer Institute (NCI) Common Terminology 
Criteria for Adverse Events (CTCAE) v4.03.  
• 
Concomitant medications will be coded using the latest version of the World Health 
Organization’s (WHO) Anatomical Therapeutic Chemical (ATC) classification. 
• 
CIs will be presented to one more decimal place than the raw data. 


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Summaries in the Extension Phase will be performed by formulation and overall, regardless of starting 
dose, unless otherwise specified. The niraparib formulation will be included in the listing for the 
Extension Phase. 
All tables, figures, and listings will include footers at the bottom of the page reflecting the programs used 
to generate the tables, figures, and listings, and date and time of the generation of the output. 
Some minor modifications may be necessary to the planned design of tables, figures, and listings to 
accommodate data collected during the actual study conduct. 
3.3. Baseline Definitions 
For all analyses unless otherwise noted, baseline is defined as the most recent measurement prior to the 
first administration of study drug, for each phase of the study. Baseline can be the same date as first dose, 
given the measurement is expected prior to first dose when only date information is available.  
3.4. Methods of Pooling Data 
Data will be pooled across study sites.  
3.5. Adjustments for Covariates 
No formal statistical analyses that adjust for possible covariate effects are planned for the safety endpoints. 
3.6. Multiplicity Adjustment 
Multiplicity is not adjusted in this study. 
3.7. Subpopulations 
Not applicable. 
3.8. Withdrawals, Drop-outs, Loss to Follow-up 
Patients will not be replaced during Stage 1. During Stage 2 and Stage 3, patients who do not complete 
Period 1 or Period 2, or who are missing PK samples which render the determination of the primary PK 
parameters not possible, will be replaced. After evaluation, patients receiving concomitant medications 
which may affect the final analysis may be replaced. 
3.9. Missing Data 
In general, there will be no imputations made to accommodate missing data points. All data recorded on 
the eCRF will be included in data listings for the CSR. 
When tabulating AE data, partial dates will be handled as follows: 
• 
If the day of the month is missing, the onset day will be set to the first day of the month unless it 
is the same month and year as first study treatment. In this case, in order to conservatively report the 
event as treatment-emergent, the onset date will be assumed to be the date of first study treatment. 
• 
If the onset day and month are both missing, the day and month will be assumed to be January 1, 
unless the event occurred in the same year as the first study treatment. In this case, the event onset will 
be coded to the day of first study treatment in order to conservatively report the event as treatment-
emergent. 


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• 
A missing onset date will be coded as the first day of study treatment. If the resulting onset date is 
after a reported date of resolution, the onset date will be set equal to the date of resolution, after 
considering any required imputation. 
Imputation of partial dates is used only to determine whether an event is treatment-emergent; data listings 
will present the partial date as recorded in the eCRF. 
Partial start dates for prior/concomitant medication, growth factor and transfusion data will be handled in 
the same way as described above for adverse events. Stop dates will be imputed as follows: 
• 
If only day of the month is missing, the end day will be set to the last day of the month.  
• 
If end day and end month are missing, and the year is not missing, then the day and month will be 
set to December 31 (or date of study discontinuation/completion if earlier than December 31).  
• 
If the stop date is completely missing, it will be set to the date of study 
discontinuation/completion. 
• 
If the imputed stop date is greater than the date of study discontinuation/completion then the date 
will be set to the date of study discontinuation/completion. 
3.10. Visit Windows 
By-visit summaries and analyses will be performed by nominal visit. All data will be tabulated per the 
evaluation visit as recorded on the eCRF even if the assessment is outside of the visit window for 
analysis. 
3.11. Interim Analysis 
There will be no interim analysis for this study. 
3.12. COVID-19 
COVID-19 pandemic may impact the conduct of clinical studies. Challenges may arise from quarantines, 
site closures, travel limitations interruptions to the supply chain for the investigational product or other 
considerations if site personnel or patients become infected with COVID-19. These challenges may lead 
to difficulties in meeting protocol specified procedures, including administering or using the 
investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. 
This study was initiated by TESARO, which was subsequently acquired by GSK. Prior to the acquisition, 
protocol deviations were classified using TESARO definitions. The TESARO protocol deviation system 
was decommissioned in May 2020, and thereafter, protocol deviations were classified using GSK 
definitions. 
All protocol deviations collected during the study will be reviewed by the TESARO (for Stage 1 and 
Stage 2) or GSK (for Stage 3 only) study team, as appropriate, in order to identify TESARO 
“Significant”/“Important” protocol deviations and GSK “Important” protocol deviations, respectively. 
Consistent with ICH E3 guidance, only protocol deviations identified as “Important” (GSK) are evaluated 
in the CSR for impact on the Stage 3 primary endpoint. 


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4. Study Analyses 
4.1. Patient Disposition 
A by-patient data listing of patient disposition information will be presented for each phase. 
For the PK Phase (Stage 1, Stage 2, and Stage 3 separately), patient disposition will be tabulated and will 
include the number of patients in each of the following categories: 
• 
Patients screened 
• 
Patients randomized 
• 
Patients treated with each formulation (Stage 1 and 2) 
• 
Patients treated in fed and fasted state (Stage 3) 
• 
Patients in the Safety Population 
• 
Patients completing the PK Phase 
• 
Primary reason for discontinuation from the PK Phase 
• 
Primary reason for discontinuation from the study, for patients who do not continue to the 
Extension Phase. 
For the Open-Label Extension Phase, patient disposition will be tabulated and will include the number of 
patients in each of the following categories: 
• 
Patients treated with at least one dose 
• 
Patients who discontinue treatment and the reason(s) for withdrawal 
• 
Patients who discontinue the study and the reason(s) for withdrawal. 
4.2. Demographics, Baseline Characteristics and Medical History 
Demographics, baseline characteristics, primary cancer history, and medical history information will be 
summarized for the PK Safety Population by sequence and overall (Stage 1, Stage 2 and Stage 3 
separately) and for the Open-Label Extension Phase, using descriptive statistics for the Safety Population. 
No formal statistical comparisons will be performed. Demographics and baseline characteristics will also 
be summarized for the BA for Stage 1, BE Evaluable Population for Stage 2 and FE Evaluable Population 
for Stage 3. 
The demographic and baseline characteristics tables will include the following variables: 
• 
Age at time of screening (years) 
• 
Age categories (18 to <65, 65 to <75, ≥75; and ≥65) 
• 
Sex 
• 
Race (White, Black, Asian, American Indian/Alaska Native, Native Hawaiian or other Pacific 
Islander, Other and Not Reported) 
• 
Ethnicity (Hispanic or Latino, not-Hispanic or Latino, Not Reported and Unknown) 
• 
Baseline weight (in kilograms) 
• 
Baseline height (in centimeters) 
• 
Baseline body mass index (BMI) (kg/m2), calculated using the patient’s height and weight at 
screening [BMI (kg/m2) = weight (kg) / height (m)2] 
• 
Eastern Cooperative Oncology Group (ECOG) performance status at baseline. 


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Primary cancer history will be summarized for the safety population and will include the following 
variables: 
• 
Tumor type 
• 
Time from first diagnosis to informed consent (years) 
• 
Cancer stage (most recent) (Locally advanced, Metastatic) 
• 
Number of prior lines of therapy 
• 
Any prior radiotherapy. 
Prior anti-cancer treatments will be coded using the most current version of the WHO Drug Dictionary. 
The number and percentage of patients reporting the use of at least one preferred term will be reported for 
the Safety Population in the PK Phase (Stage 1, Stage 2 and Stage 3 separately) and the Safety Population 
in the Extension Phase. 
Medical history will be coded using the most current version of MedDRA, and the number and 
percentage of patients experiencing at least one such diagnosis by MedDRA System Organ Class (SOC) 
and preferred term (PT) will be reported for the Safety Population in the PK Phase (Stage 1, Stage 2 and 
Stage 3 separately) and the Safety Population in the Extension Phase. 
Demographics, baseline characteristics, primary cancer history, and medical history information for each 
patient will be provided in data listings. 
4.3. Investigator Assessment of Response 
Investigator assessment of response will be provided in data listings for the Extension Phase. Additional 
descriptive summaries of response may be performed by tumor type. 
4.4. Safety Evaluation 
4.4.1. Treatment Exposure and Compliance 
PK Phase 
The number and percentage of patients receiving capsules and tablets during the PK Phase (Stage 1 and 
Stage 2, separately) will be summarized. For Stage 3, the number of tablets received will be summarized 
by fed/fasted state. 
A by-patient listing of the niraparib treatment data will be produced for the PK Safety Population. 
Extension Phase 
Study treatment exposure and compliance will be summarized by formulation (Capsule; Tablet) and 
overall, including: 
• 
Number and percentage of patients who initiated 1, 2, 3, 4, 5, ≥6 treated cycles (Maximum 
Number of Cycles). 
• 
Median number of cycles started. 
• 
Duration of treatment (months), defined as: 
[last dose date - first dose date in the Extension Phase + 1] / 30.4375. 
• 
Duration on study (months), defined as: 


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[last contact date - first dose date in the Extension Phase + 1] / 30.4375, where last 
contact date is the last visit date or date of death. 
• 
Dose intensity (mg/day), defined as: 
Sum of daily doses consumed / [last dose date - first dose date in Extension Phase + 1] 
• 
Number of patients with at least one dose interruption. 
• 
Number of patients with at least one dose reduction. 
• 
Number of patients with at least one dose re-escalation. 
In addition, the starting niraparib dose for each cycle will be summarized. 
A by-patient listing of the niraparib treatment data will be produced for the Open-Label Extension Phase 
safety population. 
4.4.2. Adverse Events 
All AEs will be classified by SOC and PT using the most up-to-date version of MedDRA. 
Per protocol, all SAEs will be collected from the signing of the ICF for this study through 90 days after 
the last dose of study drug (or until the start of alternate anticancer therapy, whichever occurs first, and 
recorded in the eCRF. 
All AEs, regardless of the source of identification (e.g., physical examination, laboratory assessment, 
ECG, or reported by patient), will be collected and recorded in the eCRF for each patient from the time of 
randomization and/or treatment assignment until 30 days after the last dose of study drug. 
All AEs experienced by a patient, regardless of the suspected causality, will be monitored until the AE or 
SAE has resolved, until AE(s) or SAE(s) have returned to baseline or normal levels, until stabilized with a 
satisfactory explanation for the changes observed, until the patient is lost to follow-up, or until the patient 
has died, starts alternate anti-cancer therapy, or until the patient withdraws consent. 
For analysis, TEAEs will be defined as any AEs collected with a start date on or after the first dose of 
study drug. Any AEs recorded in the database that occur from the time of ICF to first dose will be listed 
only and not included in safety analyses. Pre-existing conditions will be recorded in the eCRF on the 
Medical History or appropriate page. 
The severity of the toxicities will be graded according to the NCI CTCAE v4.03. Within the same 
MedDRA PT, only the most severe AE for each patient will be counted in tabulations by severity. Within 
a MedDRA SOC, patients with more than 1 MedDRA PT will be counted only once for the most severe 
AE reported. 
The Investigator must provide a causality assessment (related or not related) regarding the relationship of 
the event with the study drug and/or study procedure for all AEs. In Stage 1, for analysis of the PK Phase, 
AEs considered related to either tablet or capsule will be considered to be related to study drug. Any AEs 
for which the relationship is missing (for either tablet or capsule during the Stage 1 PK Phase) will be 
considered related to study treatment. During Stage 2 PK Phase, Stage 3 PK Phase and Extension Phase, 
relationship relative to niraparib will be considered. Within the same MedDRA PT, only the AE with the 
highest ranked relationship to treatment for each patient will be counted in tabulations by relationship to 
treatment. Within a MedDRA SOC, patients with more than 1 MedDRA PT will be counted only once for 


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the AE that is most related to treatment. The imputation for a missing relationship will take place prior to 
determining the most related AE within a SOC or PT for a given patient. 
If the start date is missing for an AE and the actual start date cannot be determined from a partial date, the 
AE will be considered treatment-emergent. 
Adverse Events of Special Interest (AESI) for niraparib are the following:  
• 
Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) 
• 
Secondary cancers (new malignancies [other than MDS or AML]) 
• 
Pneumonitis (for Stage 1 and Stage 2 only) 
• 
Embryo-fetal toxicity (for Stage 1 and Stage 2 only). 
AEs will be classified into the following time periods for analysis. 
• 
PK Phase (for Stage 1, Stage 2, and Stage 3 separately): 
o Period 1: Any AE that begins on or after Dose 1 but prior to Dose 2. 
▪ 
For Stage 1, Period 1 will be defined as 7-days post Dose 1 for patients who do not 
receive Dose 2. 
▪ 
For Stage 2 and Stage 3, Period 1 will be defined as 14-days post Dose 1 for patients 
who do not receive Dose 2. 
o Period 2: Any AEs that begins on or after Dose 2 but prior to the end of the PK Phase as 
defined by 7-days post Dose 2. 
o Safety Follow-Up/Extension Screening Period: 
▪ 
For patients not participating in the Extension Phase, AEs that begin after the end of 
the PK Phase. 
▪ 
For patients participating in the Extension Phase, AEs that begin after the end of the 
PK Phase until the date of first dose in the Extension Phase. 
• 
Open-Label Extension Phase: 
o Any AEs that start on or after the first dose in the Extension Phase. 
• 
Any AEs with onset during the PK Phase/Safety Follow-Up/Extension Screening Period and 
ongoing/ resolved during the Extension Phase will be listed separately. 
The analyses indicated below will be performed for each of the above-mentioned phases. 
A high-level overview of TEAEs will be presented in a summary table. This table will include the number 
and percentage of patients for the following categories:  
• 
Any TEAE 
• 
Any related TEAEs 
• 
Any serious TEAEs 
• 
Any related serious TEAEs 
• 
Any TEAEs with CTCAE toxicity grade 3 or above 
• 
Any related TEAEs with CTCAE toxicity grade 3 or above 
• 
Any TEAEs leading to treatment discontinuation 
• 
Any related TEAEs leading to treatment discontinuation 


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• 
Any TEAEs leading to dose interruption 
• 
Any TEAEs leading to dose reduction 
• 
Any TEAEs leading to death. 
The number and percentage of patients reporting a TEAE will be summarized in the following additional 
AE tables. AE tabulations will be ordered in terms of decreasing frequency for SOC (alphabetically for 
SOCs with the same number of AEs reported), and decreasing frequency for PT within SOC 
(alphabetically for PTs with the same number of AEs reported within a SOC) considering the overall rate. 
• 
TEAE by SOC and PT 
• 
Related TEAE by SOC and PT 
• 
Treatment emergent SAEs by SOC and PT 
• 
Related treatment emergent SAEs by SOC and PT 
• 
TEAE with toxicity grade 3 or above by SOC and PT 
• 
Related TEAE with toxicity grade 3 or above by SOC and PT 
• 
TEAEs leading to treatment discontinuation by SOC and PT 
• 
TEAEs leading to dose interruption by SOC and PT (Extension Phase Only) 
• 
TEAEs leading to dose reduction by SOC and PT  
• 
TEAEs leading to death by SOC and PT 
• 
TEAE by PT (sorted by frequency) 
• 
TEAE by SOC, PT, and maximum toxicity grade 
• 
Treatment emergent AESI. 
For Stage 1 and Stage 2 PK Phase, primary tabulations for the PK Phase data will be provided by 
formulation (regardless of period), those occurring during the Follow-up/Extension Screening, and 
overall. In addition, the high-level overview of TEAEs and summary of TEAEs by SOC and PT will be 
summarized by sequence and formulation. For Stage 3 PK Phase, primary tabulations for the PK Phase 
data will be provided by fed/fasted state (regardless of period), and overall. In addition, the high-level 
overview of TEAEs and summary of TEAEs by SOC and PT will be summarized by sequence and 
fed/fasted state. For the Open-Label Extension Phase, data will be summarized by formulation and for all 
patients overall. 
The following by-patient listings will be produced for the PK Phase (Stage 1, Stage 2, and Stage 3 
separately) and the Open-Label Extension Phase: 
• 
All TEAEs 
• 
Treatment emergent SAEs 
• 
All Deaths 
• 
TEAEs leading to dose interruption (Extension Phase Only) 
• 
TEAEs leading to dose reduction 
• 
TEAEs leading to treatment discontinuation 
• 
Any TEAEs with onset during PK Phase (including Safety Follow-Up/Extension Screening 
Period) and ongoing/resolved during Extension Phase. 


Nira pari b  
Statistical A nal ysis Pla n  
Pr ot oc ol N o: 3 0 0 0 -0 1 -0 0 4  
C o nfi de ntial  
Pa ge 2 9  of 1 3 5  
4. 4. 3.  La b orat or y D ata  
La b orat or y assess me nts f or safet y o versi g ht are perf or me d l ocall y at eac h ce nter’s la b orat or y b y mea ns of 
t heir esta blis he d met h o ds. All la b orat or y val ues will be c o n verte d t o SI u nits a n d classifie d as n or mal, 
l o w, or hi g h base d o n n or mal ra n ges s u p plie d b y t he l ocal la b orat ories a n d u p o n e m pl o yi n g 
sta n dar dizati o n. 
A b y -patie nt listi n g of all la b orat or y data will be pr o vi de d, wit h la b orat or y refere nce ra n ges a n d a b n or mal 
val ues hi g hli g hte d, a n d i ncl u di n g ce nter, patie nt i de ntifier, a n d visit f or t he P K P hase  a n d t he E xte nsi o n 
P hase  of t he st u d y.  
F or t he E xte nsi o n P hase , select he mat ol o g y ( he m o gl o bi n, ne utr o p hils a n d platelets) a n d c he mistr y 
( bilir u bi n, creati ni ne , as partate a mi n otra nsferase [ A S T ] a n d ala ni ne a mi n otra nsferase [ A L T ]) will be 
a nal yze d usi n g c ha n ge fr o m baseli ne b y  visit.  
F or t he E xte nsi o n P hase, select he mat ol o g y ( he m o gl o bi n, ne utr o p hils a n d platelets) a n d c he mistr y tests 
( bilir u bi n, creati ni ne , A L T, a n d A S T ), baseli ne a n d p ost -baseli ne res ults will be cate g orize d b y N CI 
C T C A E v 4. 0 3 gra de ( Ta ble 2 ). Shift ta bles will be pr o d uce d b y ma xi m u m p ost -baseli ne gra de . Res ults 
t hat are c o nsi dere d ‘ n or mal’ will be assi g ne d a Gra de 0.  
Ta ble 2  N CI C o m m o n Ter mi n ol o g y Criteri a f or A d verse E v e nts v 4. 0 3 ( C T C A E)  
4. 4. 4.  Vital Si g ns a n d P h ysic al E x a mi nati o n  
Vital si g n meas ure me nts will be prese nte d f or eac h patie nt i n a data listi n g.  
C CI - T hi s s e cti o n c o nt ai n e d Cli ni c al O ut c o m e A s s e s s m e nt d at a c oll e cti o n q u e sti o n n air e s or i n di c e s, w hi c h 
ar e pr ot e ct e d b y t hir d p art y c o p yri g ht l a w s a n d t h er ef or e h a v e b e e n e x cl u d e d.


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Baseline physical examination findings will be presented in a data listing. Any new or changed condition 
will be captured as an adverse event and will be summarized in the AE tables and listings. 
4.4.5. Electrocardiogram 
Standard 12-lead ECGs will be performed locally for patients in the study. Any ECG findings that are 
assessed as clinically significant and are reported as an AE or SAE will be summarized in the AE tables 
and listings. 
All ECG results (i.e., interpretations) for each patient will be provided in a data listing. 
4.4.6. Prior and Concomitant Mediations 
Medications collected at Screening and during the study will be coded using the current version of the 
WHO Drug dictionary. Study treatment, prior anti-cancer treatments for primary cancer, transfusions and 
growth factors are collected and summarized separately. For each of the study phases (Stage 1 PK, 
Stage 2 PK, Stage 3 PK and Extension Phase), medications will be categorized as prior or concomitant 
using the following definitions: 
• 
Prior medications during the PK Phase: any medications which started prior to the first dose date 
of study treatment during the PK Phase. 
• 
Concomitant medications during the PK Phase: any medications being taken on or after the initial 
study treatment dosing date through either the first dose of the Extension Phase or through 30 days 
after the last dose, for those not continuing into the Extension Phase. 
o For Stage 2 PK Phase, concomitant medications will be further identified as those taken 
during the PK collection period, defined by dates of the first PK-draw to last PK-draw. 
• 
Prior medications during the Extension Phase: any medications which started prior to the first 
dose date of study treatment during the Extension Phase. 
• 
Concomitant medications during the Extension Phase: any medications on or after the first 
treatment dosing date in the Extension Phase through 30 days after the last dose of treatment. 
• 
Any concomitant medication taken during PK Phase that were ongoing during the Extension 
Phase will be classified as Both, i.e., concomitant and prior, for the purposes of the Extension Phase. 
Note: medications can be classified as both prior and concomitant. 
Both prior medications and concomitant medications will be summarized by ATC classification drug 
class and WHO preferred name using the number and percentage of patients for each cohort. A patient 
reporting the same medication more than once will be counted only once when calculating the number 
and percentage of patients who received that medication in a given time category (prior or concomitant). 
The summary of concomitant medications will be ordered alphabetically by drug class and then by 
descending frequency of preferred name in total within the drug class. For drugs with the same frequency, 
sorting will be done alphabetically. Summaries will be based on the safety population. 
For PK Stage 2, an additional summary of concomitant medications used during the PK collection period 
will be provided for the BE Evaluable Population. 
For each phase of the study, all prior and concomitant medications will be provided in a by-patient listing 
sorted by patient ID number and administration date in chronological order. 


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4.4.7. Prior and Concomitant Transfusions and Growth Factors 
The number and percentage of patients receiving prior and concomitant growth factors during the PK 
Phase and Extension Phase will be summarized. The data will be classified as prior or concomitant using 
similar logic as provided in Section 4.4.6. 
For each phase of the study, all prior and concomitant transfusions and growth factor use will be provided 
in a by-patient listing sorted by patient ID number and administration date in chronological order. 
4.4.8. COVID-19 
The PK Phase Stage 3 of the trial takes place during COVID-19 pandemic, as a result, some of the trial 
procedures could be impacted in terms of missing visits and/or assessments. Missing protocol required 
data/visits due to COVID-19 must be noted in participant notes and recorded as COVID-19-related 
protocol deviations. 
A summary of the following COVID-19 assessments will be produced: case diagnosis, COVID-19 test 
performed, and results of the COVID-19 test. 
The incidence of COVID-19 related AEs and SAEs will be summarized as part of the safety reporting 
summaries along with COVID-19-related as reasons for treatment discontinuation. 
A listing of all patients with COVID-19 assessments and symptom assessments will be produced and will 
include the following: 
• 
Treatment sequence 
• 
Patient number 
• 
COVID-19 case diagnosis 
• 
COVID-19 test performed 
• 
Result of the COVID-19 test 
• 
Assessments and symptom assessments performed 
• 
Results of the assessments and symptom assessments. 
For PK Phase Stage 3, a separate listing defining “Important” GSK protocol deviations related to 
COVID-19 will be presented. 
For protocol deviation reporting during the Extension Phase, a listing will be produced to present 
TESARO Classification of protocol deviations for patients continuing from Stage 1 and Stage 2, and GSK 
Classification of protocol deviations for patients continuing from Stage 3. 
5. Changes to Planned Analyses 
There is no change between the protocol-defined statistical analyses and those planned in this SAP. 
4.5. Changes in v5.0 of the SAP 
Section 2.2 updated to include a summary tables of Important protocol deviations for Stage 3 PK Phase 
and Open-Label Extension Phases, as well as clarification of associated deviation listings presenting only 
protocol deviations classified as “Important”. 


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4.6. Changes in v6.0 of the SAP 
Section 1.2 updated to reflect the change in PK data cut requirements for final Stage 3 analysis. 
4.7. Changes in v7.0 of the SAP 
Case record form (CRF) versions updated to align with CRF booklet version upgrades starting from SAP 
version 4.0 onwards.  
Section 2 updated to include definition for dose intensity in exposure table for Extension Phase.  
Section 3.2 ‘Dose at onset of AE’ column removed from AE listings. 
Section 4.4.2 updated AE classification for PK Period 1 for Stage 3. 
Table 2 header row labels updated to correct CTCAE version. 
Table numbering and output header formatting updated to reflect the produced outputs. 
Header row labels for Extension Phase updated to TABLET, CAPSULE and OVERALL for consistency. 
Additional tables and listings have been added/modified for Extension Phase; disclosure and plain language 
summary reporting tables added across all study stages.  
All-Cause Mortality table added for final study disclosure reporting purposes of the Extension Phase. 
 
 


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6. Appendix 
6.1. Planned Statistical Tables, Listings, and Figures 
 
TABLE 14.1.1A SUBJECT DISPOSITION IN THE PK PHASE (ALL PATIENTS IN THE STAGE 1 PK PHASE) ........................ 43 
TABLE 14.1.1B SUBJECT DISPOSITION IN THE PK PHASE (ALL PATIENTS IN THE STAGE 2 PK PHASE) ......................... 44 
TABLE 14.1.1C SUBJECT DISPOSITION IN THE EXTENSION PHASE (ALL PATIENTS IN THE EXTENSION PHASE) ............ 45 
TABLE 14.1.1D SUBJECT DISPOSITION IN THE PK PHASE (ALL PATIENTS IN THE STAGE 3 PK PHASE) ........................ 46 
TABLE 14.1.2A DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................................... 47 
TABLE 14.1.2.1A DEMOGRAPHICS (BA EVALUABLE POPULATION IN THE STAGE 1 PK PHASE) ................................... 47 
TABLE 14.1.2.1B DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................................................ 47 
TABLE 14.1.2.2B DEMOGRAPHICS (BE EVALUABLE POPULATION IN THE STAGE 2 PK PHASE).................................... 48 
TABLE 14.1.2C DEMOGRAPHICS (SAFETY POPULATION IN THE EXTENSION PHASE) .................................................... 48 
TABLE 14.1.2.1D DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ................................................ 48 
TABLE 14.1.2.2D DEMOGRAPHICS (FE EVALUABLE POPULATION IN THE STAGE 3 PK PHASE) .................................... 48 
TABLE 14.1.3A BASELINE CHARACTERISTICS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ............................... 49 
TABLE 14.1.3.1A BASELINE CHARACTERISTICS (BA EVALUABLE POPULATION IN THE STAGE 1 PK PHASE) .............. 49 
TABLE 14.1.3.1B BASELINE CHARACTERISTICS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................ 50 
TABLE 14.1.3.2B BASELINE CHARACTERISTICS (BE EVALUABLE POPULATION IN THE STAGE 2 PK PHASE) ............... 50 
TABLE 14.1.3C BASELINE CHARACTERISTICS (SAFETY POPULATION IN THE EXTENSION PHASE) ................................ 50 
TABLE 14.1.3.1D BASELINE CHARACTERISTICS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ............................ 50 
TABLE 14.1.3.2D BASELINE CHARACTERISTICS (FE EVALUABLE POPULATION IN THE STAGE 3 PK PHASE) ............... 50 
TABLE 14.1.4A PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................. 51 
TABLE 14.1.4B PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................................. 51 
TABLE 14.1.4C PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE EXTENSION PHASE) .................................. 51 
TABLE 14.1.4D PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ................................. 51 
TABLE 14.1.5A PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ....................... 52 
TABLE 14.1.5B PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ....................... 52 
TABLE 14.1.5C PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE EXTENSION PHASE) ........................ 52 
TABLE 14.1.5D PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ....................... 52 
TABLE 14.1.6A MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ............................................... 53 
TABLE 14.1.6B MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................................... 53 
TABLE 14.1.6C MEDICAL HISTORY AND PRIOR BLOOD DISORDERS (SAFETY POPULATION IN THE EXTENSION PHASE)
 ............................................................................................................................................................................ 53 
TABLE 14.1.6D MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ............................................... 53 
TABLE 14.1.7A PRIOR MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................. 54 
TABLE 14.1.7B PRIOR MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................. 54 
TABLE 14.1.7C PRIOR MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE EXTENSION PHASE) .................. 54 
TABLE 14.1.7D PRIOR MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ................. 54 
TABLE 14.1.8A CONCOMITANT MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .. 55 
TABLE 14.1.8.1B CONCOMITANT MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) 55 
TABLE 14.1.8.2B CONCOMITANT MEDICATIONS DURING THE PK COLLECTION PERIOD BY ATC AND PT (BE 
EVALUABLE POPULATION IN THE STAGE 2 PK PHASE) ........................................................................................ 55 
TABLE 14.1.8C CONCOMITANT MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE EXTENSION PHASE) .... 55 
TABLE 14.1.8D CONCOMITANT MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .. 56 
TABLE 14.1.9A CONCOMITANT TRANSFUSIONS AND GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 1 PK 
PHASE) ................................................................................................................................................................ 57 
TABLE 14.1.9B CONCOMITANT TRANSFUSIONS AND GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 2 PK 
PHASE) ................................................................................................................................................................ 57 


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TABLE 14.1.9C CONCOMITANT TRANSFUSIONS AND GROWTH FACTORS (SAFETY POPULATION IN THE EXTENSION 
PHASE) ................................................................................................................................................................ 57 
TABLE 14.1.9D CONCOMITANT TRANSFUSIONS AND GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 3 PK 
PHASE) ................................................................................................................................................................ 57 
TABLE 14.1.10C SUMMARY OF INVESTIGATOR-ASSESSED BEST RESPONSE BY TUMOR TYPE (SAFETY POPULATION IN 
THE EXTENSION PHASE) ...................................................................................................................................... 58 
TABLE 14.3.1.1.1A OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS (SAFETY POPULATION IN THE 
STAGE 1 PK PHASE) ............................................................................................................................................ 59 
TABLE 14.3.1.1.1B OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS (SAFETY POPULATION IN THE 
STAGE 2 PK PHASE) ............................................................................................................................................ 59 
TABLE 14.3.1.1.1C OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 60 
TABLE 14.3.1.1.1.1C OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS ONGOING FROM PK PHASE 
(SAFETY POPULATION IN THE EXTENSION PHASE)............................................................................................... 60 
TABLE 14.3.1.1.1D OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) ............................................................................................................................................ 61 
TABLE 14.3.1.1.2A OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SEQUENCE AND PERIOD 
(SAFETY POPULATION IN THE STAGE 1 PK PHASE) ............................................................................................. 62 
TABLE 14.3.1.1.2B OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SEQUENCE AND PERIOD 
(SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................................................................................. 62 
TABLE 14.3.1.1.2D OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SEQUENCE AND PERIOD 
(SAFETY POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................. 63 
TABLE 14.3.1.2.1A SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 1 PK PHASE) ................................................................................................................................. 64 
TABLE 14.3.1.2.1B SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 2 PK PHASE) ................................................................................................................................. 64 
TABLE 14.3.1.2.1C SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE EXTENSION PHASE) .................................................................................................................................. 65 
TABLE 14.3.1.2.1D SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 3 PK PHASE) ................................................................................................................................. 66 
TABLE 14.3.1.2.1.1D SUMMARY OF COVID-19 RELATED ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION IN 
THE STAGE 3 PK PHASE) ..................................................................................................................................... 67 
TABLE 14.3.1.2.2A SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 1 PK PHASE) ................................................................................................................................. 68 
TABLE 14.3.1.2.2B SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 2 PK PHASE) ................................................................................................................................. 68 
TABLE 14.3.1.2.2D SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 3 PK PHASE) ................................................................................................................................. 69 
TABLE 14.3.1.3A SUMMARY OF RELATED TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 1 PK PHASE)
 ............................................................................................................................................................................ 70 
TABLE 14.3.1.3B SUMMARY OF RELATED TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 2 PK PHASE)
 ............................................................................................................................................................................ 70 
TABLE 14.3.1.3C SUMMARY OF RELATED TEAE BY SOC AND PT (SAFETY POPULATION IN THE EXTENSION PHASE) 70 
TABLE 14.3.1.3D SUMMARY OF RELATED TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 3 PK PHASE)
 ............................................................................................................................................................................ 70 
TABLE 14.3.1.4A SUMMARY OF SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) 70 
TABLE 14.3.1.4B SUMMARY OF SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) 70 
TABLE 14.3.1.4C SUMMARY OF SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE EXTENSION PHASE) . 70 
TABLE 14.3.1.4D SUMMARY OF SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) 70 


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TABLE 14.3.1.5A SUMMARY OF RELATED SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 1 PK 
PHASE) ................................................................................................................................................................ 70 
TABLE 14.3.1.5B SUMMARY OF RELATED SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 2 PK 
PHASE) ................................................................................................................................................................ 70 
TABLE 14.3.1.5C SUMMARY OF RELATED SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE EXTENSION 
PHASE) ................................................................................................................................................................ 70 
TABLE 14.3.1.5D SUMMARY OF RELATED SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 3 PK 
PHASE) ................................................................................................................................................................ 70 
TABLE 14.3.1.6A SUMMARY OF TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY POPULATION IN 
THE STAGE 1 PK PHASE) ..................................................................................................................................... 70 
TABLE 14.3.1.6B SUMMARY OF TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY POPULATION IN 
THE STAGE 2 PK PHASE) ..................................................................................................................................... 70 
TABLE 14.3.1.6C SUMMARY OF TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY POPULATION IN 
THE EXTENSION PHASE) ...................................................................................................................................... 70 
TABLE 14.3.1.6D SUMMARY OF TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY POPULATION IN 
THE STAGE 3 PK PHASE) ..................................................................................................................................... 70 
TABLE 14.3.1.7A SUMMARY OF RELATED TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 1 PK PHASE) ............................................................................................................ 70 
TABLE 14.3.1.7B SUMMARY OF RELATED TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 2 PK PHASE) ............................................................................................................ 70 
TABLE 14.3.1.7C SUMMARY OF RELATED TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 70 
TABLE 14.3.1.7D SUMMARY OF RELATED TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 70 
TABLE 14.3.1.8A SUMMARY OF TEAE LEADING TO TREATMENT DISCONTINUATION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 1 PK PHASE) ............................................................................................................ 70 
TABLE 14.3.1.8B SUMMARY OF TEAE LEADING TO TREATMENT DISCONTINUATION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 2 PK PHASE) ............................................................................................................ 70 
TABLE 14.3.1.8C SUMMARY OF TEAE LEADING TO TREATMENT DISCONTINUATION BY SOC AND PT (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 71 
TABLE 14.3.1.8D SUMMARY OF TEAE LEADING TO TREATMENT DISCONTINUATION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 71 
TABLE 14.3.1.9C SUMMARY OF TEAE LEADING TO TREATMENT DOSE INTERRUPTION BY SOC AND PT (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 71 
TABLE 14.3.1.10A SUMMARY OF TEAE LEADING TO TREATMENT DOSE REDUCTION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 1 PK PHASE) ............................................................................................................ 71 
TABLE 14.3.1.10B SUMMARY OF TEAE LEADING TO TREATMENT DOSE REDUCTION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 2 PK PHASE) ............................................................................................................ 71 
TABLE 14.3.1.10C SUMMARY OF TEAE LEADING TO TREATMENT DOSE REDUCTION BY SOC AND PT (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 71 
TABLE 14.3.1.10D SUMMARY OF TEAE LEADING TO TREATMENT DOSE REDUCTION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 71 
TABLE 14.3.1.11A SUMMARY OF TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN THE STAGE 1 
PK PHASE) ........................................................................................................................................................... 71 
TABLE 14.3.1.11B SUMMARY OF TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN THE STAGE 2 
PK PHASE) ........................................................................................................................................................... 71 
TABLE 14.3.1.11C SUMMARY OF TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 71 


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TABLE 14.3.1.11D SUMMARY OF TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN THE STAGE 3 
PK PHASE) ........................................................................................................................................................... 71 
TABLE 14.3.1.11.1A SUMMARY OF RELATED TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN 
THE STAGE 1 PK PHASE) ..................................................................................................................................... 71 
TABLE 14.3.1.11.1B SUMMARY OF RELATED TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN 
THE STAGE 2 PK PHASE) ..................................................................................................................................... 71 
TABLE 14.3.1.11.1C SUMMARY OF RELATED TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN 
THE EXTENSION PHASE) ...................................................................................................................................... 71 
TABLE 14.3.1.11.1D SUMMARY OF RELATED TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN 
THE STAGE 3 PK PHASE) ..................................................................................................................................... 71 
TABLE 14.3.1.12A SUMMARY OF TREATMENT EMERGENT AESI BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 1 PK PHASE) ............................................................................................................................................ 71 
TABLE 14.3.1.12B SUMMARY OF TREATMENT EMERGENT AESI BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 2 PK PHASE) ............................................................................................................................................ 71 
TABLE 14.3.1.12C SUMMARY OF TREATMENT EMERGENT AESI BY SOC AND PT (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 71 
TABLE 14.3.1.12D SUMMARY OF TREATMENT EMERGENT AESI BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) ............................................................................................................................................ 71 
TABLE 14.3.1.23.1A SUMMARY OF NON-SERIOUS TEAE (≥5%) BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 1 PK PHASE) ............................................................................................................................................ 72 
TABLE 14.3.1.23.1B SUMMARY OF NON-SERIOUS TEAE (≥5%) BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 2 PK PHASE) ............................................................................................................................................ 72 
TABLE 14.3.1.23.1C SUMMARY OF NON-SERIOUS TEAE (≥5%) BY SOC AND PT (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 72 
TABLE 14.3.1.23.1D SUMMARY OF NON-SERIOUS TEAE (≥5%) BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) ............................................................................................................................................ 72 
TABLE 14.3.1.23.2A SUMMARY OF RELATED NON-SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 1 PK PHASE) ............................................................................................................................................ 72 
TABLE 14.3.1.23.2B SUMMARY OF RELATED NON-SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 2 PK PHASE) ............................................................................................................................................ 72 
TABLE 14.3.1.23.2C SUMMARY OF RELATED NON-SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 72 
TABLE 14.3.1.23.2D SUMMARY OF RELATED NON-SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) ............................................................................................................................................ 72 
TABLE 14.3.1.13A SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT AND CTCAE TOXICITY 
GRADE (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................................................................. 73 
TABLE 14.3.1.13B SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT AND MAXIMUM 
TOXICITY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................................................................. 73 
TABLE 14.3.1.13C SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT AND MAXIMUM 
TOXICITY (SAFETY POPULATION IN THE EXTENSION PHASE) .............................................................................. 73 
TABLE 14.3.1.13D SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT AND CTCAE TOXICITY 
GRADE (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ................................................................................. 74 
TABLE 14.3.1.14A SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY PT (SAFETY POPULATION IN THE 
STAGE 1 PK PHASE) ............................................................................................................................................ 75 
TABLE 14.3.1.14B SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY PT (SAFETY POPULATION IN THE 
STAGE 2 PK PHASE) ............................................................................................................................................ 75 
TABLE 14.3.1.14C SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY PT (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 75 


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TABLE 14.3.1.14D SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY PT (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) ............................................................................................................................................ 76 
TABLE 14.3.1.15A LISTING OF SERIOUS TEAES DURING PK PHASE (SAFETY POPULATION IN THE STAGE 1 PK PHASE)
 ............................................................................................................................................................................ 77 
TABLE 14.3.1.15B LISTING OF SERIOUS TEAES DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 2 PK 
PHASE) ................................................................................................................................................................ 77 
TABLE 14.3.1.15C LISTING OF SERIOUS TEAES DURING THE EXTENSION PHASE (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 77 
TABLE 14.3.1.15D LISTING OF SERIOUS TEAES DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 3 PK 
PHASE) ................................................................................................................................................................ 77 
TABLE 14.3.1.16A LISTING OF DEATHS DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 1 PK PHASE)... 77 
TABLE 14.3.1.16B LISTING OF DEATHS DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ... 77 
TABLE 14.3.1.16C LISTING OF DEATHS DURING THE EXTENSION PHASE (SAFETY POPULATION IN THE EXTENSION 
PHASE) ................................................................................................................................................................ 78 
TABLE 14.3.1.16D LISTING OF DEATHS DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 3 PK PHASE)... 78 
TABLE 14.3.1.17C LISTING OF TEAE LEADING TO DOSE INTERRUPTION DURING THE EXTENSION PHASE (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 78 
TABLE 14.3.1.17D LISTING OF TEAE LEADING TO DOSE INTERRUPTION DURING THE PK PHASE (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 78 
TABLE 14.3.1.18A LISTING OF TEAE LEADING TO DOSE REDUCTION DURING THE PK PHASE (SAFETY POPULATION IN 
THE STAGE 1 PK PHASE) ..................................................................................................................................... 78 
TABLE 14.3.1.18B LISTING OF TEAE LEADING TO DOSE REDUCTION DURING THE PK PHASE (SAFETY POPULATION IN 
THE STAGE 2 PK PHASE) ..................................................................................................................................... 78 
TABLE 14.3.1.18C LISTING OF TEAE LEADING TO DOSE REDUCTION DURING THE EXTENSION PHASE (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 78 
TABLE 14.3.1.18D LISTING OF TEAE LEADING TO DOSE REDUCTION DURING THE PK PHASE (SAFETY POPULATION IN 
THE STAGE 3 PK PHASE) ..................................................................................................................................... 78 
TABLE 14.3.1.19A LISTING OF TEAE LEADING TO TREATMENT DISCONTINUATION DURING THE PK PHASE (SAFETY 
POPULATION IN THE STAGE 1 PK PHASE) ............................................................................................................ 78 
TABLE 14.3.1.19B LISTING OF TEAE LEADING TO TREATMENT DISCONTINUATION DURING THE PK PHASE (SAFETY 
POPULATION IN THE STAGE 2 PK PHASE) ............................................................................................................ 78 
TABLE 14.3.1.19C LISTING OF TEAE LEADING TO TREATMENT DISCONTINUATION DURING THE EXTENSION PHASE 
(SAFETY POPULATION IN THE EXTENSION PHASE)............................................................................................... 78 
TABLE 14.3.1.19D LISTING OF TEAE LEADING TO TREATMENT DISCONTINUATION DURING THE PK PHASE (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 78 
TABLE 14.3.1.16.1C ALL-CAUSE MORTALITY (SAFETY POPULATION IN THE EXTENSION PHASE) ............................... 79 
TABLE 14.3.1.20D SUMMARY OF INCIDENCE OF COVID-19 RELATED ADVERSE EVENTS OVER TIME (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 80 
TABLE 14.3.1.20C SUMMARY OF INCIDENCE OF COVID-19 RELATED ADVERSE EVENTS OVER TIME (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 81 
TABLE 14.3.1.21D SUMMARY OF INCIDENCE OF COVID-19 RELATED ADVERSE EVENTS OVER TIME BY GENDER 
(SAFETY POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................. 82 
TABLE 14.3.1.22D SUMMARY OF INCIDENCE OF ADVERSE EVENTS OVER TIME BY AGE GROUP (SAFETY POPULATION 
IN THE STAGE 3 PK PHASE) ................................................................................................................................. 82 
TABLE 14.3.1.21C SUMMARY OF INCIDENCE OF COVID-19 RELATED ADVERSE EVENTS OVER TIME BY GENDER  
(SAFETY POPULATION IN THE EXTENSION PHASE)............................................................................................... 83 
TABLE 14.3.1.22C SUMMARY OF INCIDENCE OF ADVERSE EVENTS OVER TIME BY AGE GROUP (SAFETY POPULATION 
IN THE EXTENSION PHASE) .................................................................................................................................. 83 


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TABLE 14.3.4.1A SUMMARY OF STUDY TREATMENT EXPOSURE DURING THE PK PHASE (SAFETY POPULATION IN THE 
STAGE 1 PK PHASE) ............................................................................................................................................ 84 
TABLE 14.3.4.1B SUMMARY OF STUDY TREATMENT EXPOSURE DURING THE PK PHASE (SAFETY POPULATION IN THE 
STAGE 2 PK PHASE) ............................................................................................................................................ 84 
TABLE 14.3.4.1C SUMMARY OF STUDY TREATMENT EXPOSURE DURING THE EXTENSION PHASE (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 85 
TABLE 14.3.4.1D SUMMARY OF STUDY TREATMENT EXPOSURE DURING THE PK PHASE (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) ............................................................................................................................................ 86 
TABLE 14.3.4.2C SUMMARY OF NIRAPARIB DOSE BY CYCLE (SAFETY POPULATION IN THE EXTENSION PHASE) ........ 87 
TABLE 14.3.4.3.1C SUMMARY AND CHANGE FROM BASELINE OF SELECT HEMATOLOGY PARAMETERS BY VISIT 
DURING THE EXTENSION PHASE (SAFETY POPULATION IN THE EXTENSION PHASE) ........................................... 88 
FIGURE 14.3.4.3.1C CHANGE FROM BASELINE (± SE) OF SELECT HEMATOLOGY PARAMETERS OVER TIME (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 89 
TABLE 14.3.4.3.2C SHIFT SUMMARY OF SELECT HEMATOLOGY PARAMETERS DURING THE EXTENSION PHASE 
(SAFETY POPULATION IN THE EXTENSION PHASE)............................................................................................... 90 
TABLE 14.3.4.4.1C SUMMARY AND CHANGE FROM BASELINE OF SELECT CHEMISTRY PARAMETERS BY VISIT DURING 
THE EXTENSION PHASE (SAFETY POPULATION IN THE EXTENSION PHASE) ......................................................... 90 
TABLE 14.3.4.4.2C SHIFT SUMMARY OF SELECT CHEMISTRY PARAMETERS IN MAXIMUM TOXICITY GRADE DURING 
THE EXTENSION PHASE (SAFETY POPULATION IN THE EXTENSION PHASE) ......................................................... 90 
TABLE 14.3.4.4.1D SUMMARY OF COVID-19 ASSESSMENTS FOR PATIENTS WITH SUSPECTED, PROBABLE OR 
CONFIRMED COVID-19 CASE DIAGNOSIS  (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .......................... 91 
TABLE 14.3.4.5.1C SUMMARY OF COVID-19 ASSESSMENTS FOR PATIENTS WITH SUSPECTED, PROBABLE OR 
CONFIRMED COVID-19 CASE DIAGNOSIS  (SAFETY POPULATION IN THE EXTENSION PHASE) ........................... 92 
TABLE 14.4.1C SUMMARY OF IMPORTANT PROTOCOL DEVIATIONS (SAFETY POPULATION IN THE EXTENSION PHASE)
 ............................................................................................................................................................................ 93 
TABLE 14.4.1D SUMMARY OF IMPORTANT PROTOCOL DEVIATIONS FOR THE PK PHASE OCCURRING THROUGH END OF 
TREATMENT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ......................................................................... 94 
LISTING 16.2.1A DISPOSITION FOR PK PHASE (ALL PATIENTS ENROLLED IN THE STAGE 1 PK PHASE) ....................... 96 
LISTING 16.2.1B DISPOSITION FOR PK PHASE (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................... 96 
LISTING 16.2.1C DISPOSITION FOR OPEN-LABEL EXTENSION PHASE (ALL PATIENTS ENROLLED FOR THE EXTENSION 
PHASE) ................................................................................................................................................................ 96 
LISTING 16.2.1D DISPOSITION FOR PK PHASE (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .............................. 96 
LISTING 16.2.1.2A REASONS FOR SCREEN FAILURE (PATIENTS WHO FAILED SCREENING IN THE STAGE 1 PK PHASE) 97 
LISTING 16.2.1.2B REASONS FOR SCREEN FAILURE (PATIENTS WHO FAILED SCREENING IN THE STAGE 2 PK PHASE) 97 
LISTING 16.2.1.2D REASONS FOR SCREEN FAILURE (PATIENTS WHO FAILED SCREENING IN THE STAGE 3 PK PHASE) 97 
LISTING 16.2.2A PROTOCOL DEVIATIONS FOR THE PK PHASE (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ...... 98 
LISTING 16.2.2B PROTOCOL DEVIATION FOR THE PK PHASE (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ........ 98 
LISTING 16.2.2C IMPORTANT PROTOCOL DEVIATIONS FOR THE OPEN-LABEL EXTENSION PHASE (SAFETY POPULATION 
IN THE EXTENSION PHASE) .................................................................................................................................. 99 
LISTING 16.2.2.1D IMPORTANT PROTOCOL DEVIATIONS FOR THE PK PHASE OCCURRING THROUGH END OF 
TREATMENT (SAFETY POPULATION FOR STAGE 3 PK PHASE) ........................................................................... 100 
LISTING 16.2.2.2D GSK PROTOCOL DEVIATIONS RELATED TO COVID-19 (SAFETY POPULATION FOR STAGE 3 PK 
PHASE) .............................................................................................................................................................. 101 
LISTING 16.2.3A STUDY POPULATIONS FOR THE PK PHASE (ALL PATIENTS ENROLLED IN THE STAGE 1 PK PHASE) 103 
LISTING 16.2.3B STUDY POPULATIONS FOR THE PK PHASE (ALL PATIENTS SCREENED IN THE STAGE 2 PK PHASE) . 103 
LISTING 16.2.3C STUDY POPULATIONS FOR THE OPEN-LABEL EXTENSION PHASE (ALL PATIENTS ENROLLED IN THE 
EXTENSION PHASE) ........................................................................................................................................... 104 
LISTING 16.2.3D STUDY POPULATIONS FOR THE PK PHASE (ALL PATIENTS ENROLLED IN THE STAGE 3 PK PHASE) 105 
LISTING 16.2.4.1A DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ............................................ 106 


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LISTING 16.2.4.1B DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................................ 106 
LISTING 16.2.4.1C DEMOGRAPHICS (SAFETY POPULATION IN THE EXTENSION PHASE) ............................................. 106 
LISTING 16.2.4.1D DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ............................................ 106 
LISTING 16.2.4.2A MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ....................................... 107 
LISTING 16.2.4.2B MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ........................................ 107 
LISTING 16.2.4.2C MEDICAL HISTORY (SAFETY POPULATION IN THE EXTENSION PHASE) ......................................... 107 
LISTING 16.2.4.2D MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ....................................... 107 
LISTING 16.2.4.3A PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................ 108 
LISTING 16.2.4.3B PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................ 108 
LISTING 16.2.4.3C PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE EXTENSION PHASE) ................. 108 
LISTING 16.2.4.3D PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ................ 108 
LISTING 16.2.4.4A PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .......................... 109 
LISTING 16.2.4.4B PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) .......................... 109 
LISTING 16.2.4.4C PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE EXTENSION PHASE) ........................... 109 
LISTING 16.2.4.4D PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .......................... 109 
LISTING 16.2.4.5A PRIOR/CONCOMITANT RADIOTHERAPY (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ......... 110 
LISTING 16.2.4.5B PRIOR/CONCOMITANT RADIOTHERAPY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ......... 110 
LISTING 16.2.4.5C PRIOR/CONCOMITANT RADIOTHERAPY (SAFETY POPULATION IN THE EXTENSION PHASE) .......... 110 
LISTING 16.2.4.5D PRIOR/CONCOMITANT RADIOTHERAPY (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ......... 110 
LISTING 16.2.5.1B PRIOR AND CONCOMITANT MEDICATIONS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) .... 111 
LISTING 16.2.5.1C PRIOR AND CONCOMITANT MEDICATIONS (SAFETY POPULATION IN THE EXTENSION PHASE) ..... 111 
LISTING 16.2.5.1D PRIOR AND CONCOMITANT MEDICATIONS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .... 111 
LISTING 16.2.5.1.1C TREATMENT EXPOSURE AND DURATION (SAFETY POPULATION IN THE EXTENSION PHASE) ..... 112 
LISTING 16.2.5.2A PRIOR/CONCOMITANT PROCEDURES DURING PK PHASE (SAFETY POPULATION IN THE STAGE 1 PK 
PHASE) .............................................................................................................................................................. 113 
LISTING 16.2.5.2B PRIOR/CONCOMITANT PROCEDURES DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 2 
PK PHASE) ......................................................................................................................................................... 113 
LISTING 16.2.5.2C PRIOR/CONCOMITANT PROCEDURES DURING THE EXTENSION PHASE (SAFETY POPULATION IN THE 
EXTENSION PHASE) ........................................................................................................................................... 113 
LISTING 16.2.5.2D PRIOR/CONCOMITANT PROCEDURES DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 3 
PK PHASE) ......................................................................................................................................................... 113 
LISTING 16.2.5.3A PRIOR AND CONCOMITANT TRANSFUSIONS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ... 114 
LISTING 16.2.5.3B PRIOR AND CONCOMITANT TRANSFUSIONS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ... 114 
LISTING 16.2.5.3C PRIOR AND CONCOMITANT TRANSFUSIONS (SAFETY POPULATION IN THE EXTENSION PHASE) .... 114 
LISTING 16.2.5.3D PRIOR AND CONCOMITANT TRANSFUSIONS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ... 114 
LISTING 16.2.5.4A PRIOR AND CONCOMITANT GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 1 PK PHASE)
 .......................................................................................................................................................................... 115 
LISTING 16.2.5.4B PRIOR AND CONCOMITANT GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 2 PK PHASE)
 .......................................................................................................................................................................... 115 
LISTING 16.2.5.4C PRIOR AND CONCOMITANT GROWTH FACTORS (SAFETY POPULATION IN THE EXTENSION PHASE)
 .......................................................................................................................................................................... 115 
LISTING 16.2.5.4D PRIOR AND CONCOMITANT GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 3 PK PHASE)
 .......................................................................................................................................................................... 115 
LISTING 16.2.5.5A STUDY TREATMENT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ...................................... 116 
LISTING 16.2.5.5B STUDY TREATMENT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ...................................... 116 
LISTING 16.2.5.5C STUDY TREATMENT (SAFETY POPULATION IN THE EXTENSION PHASE) ....................................... 117 
LISTING 16.2.5.5D STUDY TREATMENT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ...................................... 118 
LISTING 16.2.5.6B SUBSEQUENT ANTI-CANCER THERAPY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ......... 119 
LISTING 16.2.5.6C SUBSEQUENT ANTI-CANCER THERAPY (SAFETY POPULATION IN THE EXTENSION PHASE) .......... 120 


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Page 40 of 135 
LISTING 16.2.5.6D MEAL STATUS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ............................................... 121 
LISTING 16.2.6.1C INVESTIGATOR ASSESSMENT OF RESPONSE (SAFETY POPULATION IN THE EXTENSION PHASE) .... 122 
LISTING 16.2.7.1A ADVERSE EVENTS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ......................................... 123 
LISTING 16.2.7.1B ADVERSE EVENTS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ......................................... 123 
LISTING 16.2.7.1D ADVERSE EVENTS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ......................................... 123 
LISTING 16.2.7.1C ADVERSE EVENTS (SAFETY POPULATION IN THE EXTENSION PHASE) .......................................... 124 
LISTING 16.2.7.2C ADVERSE EVENTS ONGOING FROM PK PHASE (SAFETY POPULATION IN THE EXTENSION PHASE)125 
LISTING 16.2.8.1.1A HEMATOLOGY RESULTS IN THE PK PHASE (SAFETY POPULATION IN THE STAGE 1 PK PHASE). 126 
LISTING 16.2.8.1.1B HEMATOLOGY RESULTS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................. 126 
LISTING 16.2.8.1.1C HEMATOLOGY RESULTS (SAFETY POPULATION IN THE EXTENSION PHASE) .............................. 126 
LISTING 16.2.8.1.1D HEMATOLOGY RESULTS THROUGH THE PK END OF TREATMENT VISIT (SAFETY POPULATION IN 
THE STAGE 3 PK PHASE) ................................................................................................................................... 126 
LISTING 16.2.8.1.2A CHEMISTRY RESULTS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................. 126 
LISTING 16.2.8.1.2B CHEMISTRY RESULTS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................................. 126 
LISTING 16.2.8.1.2C CHEMISTRY RESULTS (SAFETY POPULATION IN THE EXTENSION PHASE) .................................. 126 
LISTING 16.2.8.1.2D CHEMISTRY RESULTS THROUGH THE PK END OF TREATMENT VISIT (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) .......................................................................................................................................... 126 
LISTING 16.2.8.1.3A URINALYSIS RESULTS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................ 126 
LISTING 16.2.8.1.3B URINALYSIS RESULTS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................................ 126 
LISTING 16.2.8.1.3C URINALYSIS RESULTS (SAFETY POPULATION IN THE EXTENSION PHASE) ................................. 126 
LISTING 16.2.8.1.3D URINALYSIS RESULTS THROUGH THE PK END OF TREATMENT VISIT (SAFETY POPULATION IN 
THE STAGE 3 PK PHASE) ................................................................................................................................... 126 
LISTING 16.2.8.1.4C LIVER FUNCTION TESTS – POTENTIAL HY’S LAW CASES (SAFETY POPULATION IN THE 
EXTENSION PHASE) ........................................................................................................................................... 128 
LISTING 16.2.8.2A VITAL SIGNS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................................. 129 
LISTING 16.2.8.2B VITAL SIGNS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................................................. 129 
LISTING 16.2.8.2C VITAL SIGNS (SAFETY POPULATION IN THE EXTENSION PHASE) .................................................. 129 
LISTING 16.2.8.2D VITAL SIGNS THROUGH THE PK END OF TREATMENT VISIT (SAFETY POPULATION IN THE STAGE 3 
PK PHASE) ......................................................................................................................................................... 129 
LISTING 16.2.8.3A ECG RESULTS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ............................................... 130 
LISTING 16.2.8.3B ECG RESULTS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................................... 130 
LISTING 16.2.8.3C ECG RESULTS (SAFETY POPULATION IN THE EXTENSION PHASE) ................................................ 130 
LISTING 16.2.8.3D ECG RESULTS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ............................................... 130 
LISTING 16.2.8.4A ECOG PERFORMANCE STATUS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ..................... 131 
LISTING 16.2.8.4B ECOG PERFORMANCE STATUS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ..................... 131 
LISTING 16.2.8.4C ECOG PERFORMANCE STATUS (SAFETY POPULATION IN THE EXTENSION PHASE) ...................... 131 
LISTING 16.2.8.4D ECOG PERFORMANCE STATUS THROUGH THE PK END OF TREATMENT VISIT (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) .......................................................................................................... 131 
LISTING 16.2.8.5A BASELINE PHYSICAL EXAMINATION FINDINGS (SAFETY POPULATION IN THE STAGE 1 PK PHASE)
 .......................................................................................................................................................................... 132 
LISTING 16.2.8.5B BASELINE PHYSICAL EXAMINATION FINDINGS (SAFETY POPULATION IN THE STAGE 2 PK PHASE)
 .......................................................................................................................................................................... 132 
LISTING 16.2.8.5C BASELINE PHYSICAL EXAMINATION FINDINGS (SAFETY POPULATION IN THE EXTENSION PHASE)
 .......................................................................................................................................................................... 132 
LISTING 16.2.8.5D BASELINE PHYSICAL EXAMINATION FINDINGS (SAFETY POPULATION IN THE STAGE 3 PK PHASE)
 .......................................................................................................................................................................... 132 
LISTING 16.2.8.6A PREGNANCY TEST (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ......................................... 133 
LISTING 16.2.8.6B PREGNANCY TEST (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ......................................... 133 
LISTING 16.2.8.6C PREGNANCY TEST (SAFETY POPULATION IN THE EXTENSION PHASE) .......................................... 133 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 41 of 135 
LISTING 16.2.8.6D PREGNANCY TEST (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ......................................... 133 
LISTING 16.2.9.2D LISTING OF COVID-19 ASSESSMENTS AND SYMPTOM ASSESSMENTS FOR PATIENTS WITH COVID-
19 ADVERSE EVENTS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ......................................................... 134 
LISTING 16.2.9.2C LISTING OF COVID-19 ASSESSMENTS AND SYMPTOM ASSESSMENTS FOR PATIENTS WITH COVID-
19 ADVERSE EVENTS (SAFETY POPULATION IN THE EXTENSION PHASE) .......................................................... 135 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 42 of 135 
TABLES 
General guidelines: 
Tables will be provided for the Stage 1 PK Phase, Stage 2 PK Phase, Stage 3 PK Phase and the Open-Label Extension Phase. 
For the PK Phase (Stage 1, Stage 2 and Stage 3): 
• Treatment=Sequence and Overall, in general. For PK and AE data, please see mock tables. 
• Population=Safety Population in Stage 1 PK (Stage 2 PK or Stage 3 PK) Phase, unless otherwise specified. 
• PK Phase Data: 
o For patients who do not continue to Extension Phase, PK Phase is any data collected. 
o For patients who do continue to Extension Phase, 
▪ 
AEs – prior to first dose in Extension Phase 
▪ 
Prior meds/procedures/etc. – prior to first dose in PK Phase 
▪ 
Concomitant meds – meds prior to first dose in Extension Phase. 
• Assessments (Labs, ECGs, Vitals, ECOG, PE, etc.) – use visit to identify data. 
For the Extension Phase: 
• Treatment=Niraparib Tablet or Capsule (regardless of starting dose); Summarize by Tablet; Capsule; Overall, unless otherwise 
specified. 
• Population=Safety Population in the Open-Label Extension Phase (i.e., those who receive at least 1 dose), unless otherwise specified. 
• Extension Phase Data: 
o For patients who do not continue to Extension Phase, there is no Extension Phase data. 
o For patients who do continue to Extension Phase, 
▪ 
AEs – on or after first dose in Extension Phase 
▪ 
Prior meds/procedures/etc. – prior to first dose in Extension Phase 
▪ 
Concomitant meds – meds on or after the first dose in Extension Phase 
▪ 
Assessments (Labs, ECGs, Vitals, ECOG, PE, etc.) – use visit to identify data. 
Sort order: All AE tabulations, unless otherwise specified, will be ordered in terms of decreasing frequency for SOC (alphabetically for SOCs with 
the same number of AEs reported), and decreasing frequency for PT within SOC (alphabetically for PTs with the same number of AEs reported 
within a SOC) considering the overall rate. 
 


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Statistical Analysis Plan 
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Table 14.1.1a 
Subject Disposition in the PK Phase (All Patients in the Stage 1 PK Phase) 
Parameter 
Statistic Sequence 
TABLET/CAPSULE 
Sequence 
CAPSULE/TABLET 
 
Overall 
Number of Patients  
 
 
 
 
Screened 
n  
-- 
-- 
xx 
Randomized 
n  
x  
x  
x  
Received Tablet 
n  
x  
x  
x  
Received Capsule 
n  
x  
x  
x  
Received Both Tablet and Capsule 
n  
x  
x  
x  
PK Phase Safety Population 
n 
x  
x  
x  
 
 
 
 
 
Completed PK Phase 
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from PK Phase 
n 
x  
x  
x  
   Reason1 
n 
x  
x  
x  
   Reason2 
n 
x  
x 
x  
 
 
 
 
 
Participate in Extension Phase  
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from Study Prior to Entering the Extension 
Phase 
 
 
 
 
   Reason1 
n 
xx  
xx  
xx  
   Reason2 
n 
xx  
xx  
xx  
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Only include DC from study for those patients who do not enter the Extension Phase. 
 
 


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Table 14.1.1b 
Subject Disposition in the PK Phase (All Patients in the Stage 2 PK Phase) 
Parameter 
Statistic 
Sequence 
TABLET/CAPSULE 
Sequence 
CAPSULE/TABLET 
 
Overall 
Number of Patients 
 
 
 
 
Screened 
n  
-- 
-- 
xx 
Randomized 
n  
x  
x  
x  
  Not Treated 
n  
x  
x  
x  
  Received Tablet 
n  
x  
x  
x  
  Received Capsule 
n  
x  
x  
x  
  Received Both Tablet and Capsule 
n  
x  
x  
x  
PK Phase Safety Population 
n 
x  
x  
x  
 
 
 
 
 
Completed PK Phase 
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from PK Phase [1] 
n 
x  
x  
x  
    Reason 1 
n 
x  
x  
x  
    Reason 2 
n 
x  
x  
x  
 
 
 
 
 
Participate in Extension Phase 
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from Study Prior to Entering the Extension Phase 
 
 
 
 
   Reason 1 
n 
xx  
xx  
xx  
   Reason 2 
n 
xx  
xx  
xx  
 
 
 
 
 
 
[1] Includes patients in the Safety Population (i.e., treated patients) only. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Only include DC from study for those patients who do not enter the Extension Phase. 
 
 


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Table 14.1.1c 
Subject Disposition in the Extension Phase (All Patients in the Extension Phase) 
Parameter 
Statistic TABLET 
CAPSULE 
OVERALL 
Number of Patients  
 
 
 
 
Dosed 
n  
xx 
xx 
xx 
By Stage: 
 
 
 
 
Dosed in Stage 1 
n (%) 
xx ( xx.x) 
xx ( xx.x) 
xx ( xx.x) 
Dosed in Stage 2 
n (%) 
xx ( xx.x) 
xx ( xx.x) 
xx ( xx.x) 
Dosed in Stage 3 
n (%) 
xx ( xx.x) 
xx ( xx.x) 
xx ( xx.x) 
 
 
 
 
 
By Starting Dose: 
 
 
 
 
100mg/d 
n (%) 
xx ( xx.x) 
xx ( xx.x) 
xx ( xx.x) 
200mg/d 
n (%) 
xx ( xx.x) 
xx ( xx.x) 
xx ( xx.x) 
300mg/d 
n (%) 
xx ( xx.x) 
xx ( xx.x) 
xx ( xx.x) 
 
 
 
 
 
Discontinued Treatment After Receiving at Least 1 Dose 
n  
xx 
xx 
xx 
   Reason 1 
n  
xx 
xx 
xx 
   Reason 2 
n  
xx 
xx 
xx 
 
 
 
 
 
Discontinued Study 
n  
xx 
xx 
xx 
   Reason 1 
n  
xx 
xx 
xx 
   Reason 2 
n  
xx 
xx 
xx 
 
 
 
 
 
NOTE: The starting dose of 100 mg/day was selected based on Investigator decision. 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


Niraparib 
Statistical Analysis Plan 
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Protocol: XXXXX 
Table 14.1.1d 
Subject Disposition in the PK Phase (All Patients in the Stage 3 PK Phase) 
Parameter 
Statistic 
Sequence 
NIRAPARIB TABLET 
FASTED/FED 
Sequence 
NIRAPARIB TABLET 
FED/FASTED 
 
 
OVERALL 
Number of Patients 
 
 
 
 
Screened [1] 
n  
-- 
-- 
xx 
Randomized 
n  
x  
x  
x  
  Not Treated 
n  
x  
x  
x  
  Received Tablet in Fasted State 
n  
x  
x  
x  
  Received Tablet in Fed State 
n  
x  
x  
x  
  Received Tablet in Both Fasted and Fed State 
n  
x  
x  
x  
PK Phase Safety Population 
n 
x  
x  
x  
 
 
 
 
 
Completed PK Phase 
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from PK Phase [2] 
n 
x  
x  
x  
    Reason 1 
n 
x  
x  
x  
    Reason 2 
n 
x  
x  
x  
 
 
 
 
 
Participate in Extension Phase 
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from Study Prior to Entering the Extension Phase 
 
 
 
 
   Reason 1 
n 
xx  
xx  
xx  
   Reason 2 
n 
xx  
xx  
xx  
 
 
 
 
 
 
[1] Patient xxxxxx-xxxx (Screen Failure ID: XXi) and xxxxxx-xxxx (Screen Failure ID: YYi) re-screened and reconsented after screen 
failure are counted twice in Screening. 
[2] Includes patients in the Safety Population (i.e., treated patients) only. 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
[Programming Note] 
 
XXi/YYi is ID that was SF. 
Programming, please note footnote references changed order in the shell and footer. 
 
 


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Statistical Analysis Plan 
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Table 14.1.2a 
Demographics (Safety Population in the Stage 1 PK Phase) 
Parameter 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Age (yrs) 
n  
xx  
xx  
xx  
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
Age Group 
 
 
 
 
18 -< 65 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
65 -< 75 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
≥ 75 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Missing 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Sex 
 
 
 
 
Male 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Female 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Race 
 
 
 
 
White 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
African American 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Asian 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
American Indian or Alaska Native 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Native Hawaiian or other Pacific Islander 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Other 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Not Reported 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Ethnicity 
 
 
 
 
Hispanic or Latino 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Not Hispanic or Latino 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Unknown 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Not Reported 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for:  
Table 14.1.2.1a Demographics (BA Evaluable Population in the Stage 1 PK Phase) 
Table 14.1.2.1b Demographics (Safety Population in the Stage 2 PK Phase) 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 48 of 135 
Table 14.1.2.2b Demographics (BE Evaluable Population in the Stage 2 PK Phase) 
Table 14.1.2c Demographics (Safety Population in the Extension Phase) 
• 
Summarize Extension Phase Data with columns for TABLET; CAPSULE; OVERALL. 
• 
Add footnote: “Note: Age was collected at PK Phase entry only.” 
 
Table 14.1.2.1d Demographics (Safety Population in the Stage 3 PK Phase) 
Table 14.1.2.2d Demographics (FE Evaluable Population in the Stage 3 PK Phase) 
• 
Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL. 
 
 


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Table 14.1.3a 
Baseline Characteristics (Safety Population in the Stage 1 PK Phase) 
Parameter 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Weight (kg) 
n  
xx  
xx  
xx  
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
Height (cm) 
n  
xx  
xx  
xx  
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
BMI (kg/m2) 
n  
xx  
xx  
xx  
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
ECOG Performance Status 
 
 
 
 
0 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
3 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
4 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Missing 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
ECOG = Eastern Cooperative Oncology Group: 
0=Fully active, able to carry on all pre-disease performance without restriction 
1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 
2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 
3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 
4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.1.3.1a Baseline Characteristics (BA Evaluable Population in the Stage 1 PK Phase) 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 50 of 135 
Table 14.1.3.1b Baseline Characteristics (Safety Population in the Stage 2 PK Phase) 
Table 14.1.3.2b Baseline Characteristics (BE Evaluable Population in the Stage 2 PK Phase) 
Table 14.1.3c Baseline Characteristics (Safety Population in the Extension Phase) 
• 
Summarize Extension Phase Data with columns for TABLET; CAPSULE; OVERALL. 
• 
Add footnote for Extension Phase and relevant reference in the table:  
• 
[1] Only weight and ECOG Performance Status were repeated at Extension Phase entry. 
 
Table 14.1.3.1d Baseline Characteristics (Safety Population in the Stage 3 PK Phase) 
• 
Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
Table 14.1.3.2d Baseline Characteristics (FE Evaluable Population in the Stage 3 PK Phase) 
• 
Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
 
 


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Table 14.1.4a 
Primary Cancer History (Safety Population in the Stage 1 PK Phase) 
Parameter 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Tumor Type 
 
 
 
 
  Xxxxxxxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Xxxxxxxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Xxxxxxxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Time from first diagnosis to informed consent (years) 
n 
xx  
xx  
xx  
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
Cancer Stage (most recent) 
 
 
 
 
  Locally advanced 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Metastatic 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Missing 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Number of prior lines of therapy 
 
 
 
 
  0 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  3 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  4 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  5 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  >=6 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Missing 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Any prior radiotherapy 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
Repeat for: 
Table 14.1.4b Primary Cancer History (Safety Population in the Stage 2 PK Phase) 
Table 14.1.4c Primary Cancer History (Safety Population in the Extension Phase) 
• 
Summarize Extension Phase Data with columns for TABLET; CAPSULE; OVERALL. 
Table 14.1.4d Primary Cancer History (Safety Population in the Stage 3 PK Phase) 
• 
Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 


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Table 14.1.5a 
Prior Anti-Cancer Treatment (Safety Population in the Stage 1 PK Phase) 
Preferred Term 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
 
 
 
 
 
Agent 1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Agent 2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Agent 3 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Sort by decreasing frequency in the OVERALL column. 
Repeat for: 
Table 14.1.5b Prior Anti-Cancer Treatment (Safety Population in the Stage 2 PK Phase) 
Table 14.1.5c Prior Anti-Cancer Treatment (Safety Population in the Extension Phase) 
• 
Summarize Extension Phase Data with columns for TABLET; CAPSULE; OVERALL. 
Table 14.1.5d Prior Anti-Cancer Treatment (Safety Population in the Stage 3 PK Phase) 
• 
Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED AND OVERALL. 
 
 


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Table 14.1.6a 
Medical History (Safety Population in the Stage 1 PK Phase) 
System Organ Class 
Preferred Term 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Any condition 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . .  
 
 
 
 
 
 
 
 
 
SOC2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . . 
 
 
 
 
 
 
 
 
 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Sort alphabetically by SOC/PT. 
Repeat for:  
Table 14.1.6b Medical History (Safety Population in the Stage 2 PK Phase) 
Table 14.1.6c Medical History and Prior Blood Disorders (Safety Population in the Extension Phase) 
• 
Summarize Extension Phase Data with columns for TABLET; CAPSULE; OVERALL. 
• 
Add footnote: “Note: The table summarizes combined data from Medical History and Prior Blood Disorders eCRFs. Duplicate events 
reported across both eCRFs are counted only once per patient in this table.” 
 
Table 14.1.6d Medical History (Safety Population in the Stage 3 PK Phase) 
• 
Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
 
 


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Table 14.1.7a 
Prior Medications by ATC and PT (Safety Population in the Stage 1 PK Phase) 
ATC (Level 3) 
Preferred Term 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Any prior medication 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
ATC1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . .  
 
 
 
 
 
 
 
 
 
ATC2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . . 
 
 
 
 
 
 
 
 
 
 
Note: Prior medications are any medications with a start date earlier than the first dose date of study treatment and are coded using 
WHO Drug Dictionary version YYYYMM. Study treatment, prior anti-cancer treatments for primary cancer, transfusions and growth factors 
are not included. 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
[Programming Notes] 
Sort alphabetically by ATC3 and Preferred Term. If there are uncoded terms due to no ATC level 3 term not being available, add footnote 
for uncoded term: [1] ATC level 3 term is not available through WHO Drug Dictionary. 
 
Repeat for:  
Table 14.1.7b Prior Medications by ATC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.1.7c Prior Medications by ATC and PT (Safety Population in the Extension Phase) 
• 
Summarize Extension Phase Data with columns for TABLET; CAPSULE; OVERALL. 
 
[Programming Notes]  
• 
Footnote – Extension Phase: Prior medications are any medications, other than study treatments and pre-medications for study treatment, 
with a start date earlier than the first dose date of study treatment during the Extension Phase and are coded using WHO Drug Dictionary 
version YYYYMM. 
• 
Prior anti-cancer treatments for primary cancer are not included. 
 
Table 14.1.7d Prior Medications by ATC and PT (Safety Population in the Stage 3 PK Phase) 
• 
Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL. 


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Table 14.1.8a 
Concomitant Medications by ATC and PT (Safety Population in the Stage 1 PK Phase) 
ATC (Level 3) 
Preferred Term 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Any concomitant medication 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
ATC1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . .  
 
 
 
 
 
 
 
 
 
ATC2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . . 
 
 
 
 
 
 
 
 
 
 
Note: Concomitant medications are any medications being taken on or after the initial study treatment dosing date through either the 
first dose of the Extension Phase or through 30 days after the last dose, for those not continuing into the Extension Phase. They are 
coded using WHO Drug Dictionary version YYYYMM. 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Sort alphabetically by ATC3 and Preferred Term. If there are uncoded terms due to no ATC level 3 term not being available, add footnote 
for uncoded term: [1] ATC level 3 term is not available through WHO Drug Dictionary. 
Repeat for:  
Table 14.1.8.1b Concomitant Medications by ATC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.1.8.2b Concomitant Medications During the PK Collection Period by ATC and PT (BE Evaluable Population in the Stage 2 PK 
Phase) 
• 
Footnote: Concomitant medications during the PK collection period are any concomitant medications taken between the first PK-draw 
until the last PK-draw. They are coded using WHO Drug Dictionary version YYYYMM. 
 
Table 14.1.8c Concomitant Medications by ATC and PT (Safety Population in the Extension Phase) 
• 
Summarize Extension Phase Data with columns for TABLET; CAPSULE; OVERALL. 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 56 of 135 
[Programming Notes] 
• 
Footnote – Extension Phase: Concomitant medications are any medications being taken on or after the initial study treatment dosing 
date during the Extension Phase through 30 days after the last dose. They are coded using WHO Drug Dictionary version YYYYMM. 
Table 14.1.8d Concomitant Medications by ATC and PT (Safety Population in the Stage 3 PK Phase) 
• 
Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
• 
Footnote – Stage 3: Concomitant medications are any medications being taken on or after the initial study treatment dosing date 
through either the first dose of the Extension Phase or through 30 days after the last dose, for those not continuing into the Extension 
Phase. They are coded using WHO Drug Dictionary version YYYYMM. 
 
 


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Table 14.1.9a 
Concomitant Transfusions and Growth Factors (Safety Population in the Stage 1 PK Phase) 
Parameter 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Any Concomitant Transfusions  
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Red Blood Cells 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Platelet 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Other 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
Any Concomitant Growth Factors 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
G-CSF 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
GM-CSF 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Recombinant Erythropoietin 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Other 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Note: Concomitant transfusions or growth factors are any transfusion or growth factor given on or after the initial study treatment 
dosing date through either the first dose of the Extension Phase or through 30 days after the last dose for those not continuing into 
the Extension Phase. 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for:  
Table 14.1.9b Concomitant Transfusions and Growth Factors (Safety Population in the Stage 2 PK Phase) 
Table 14.1.9c Concomitant Transfusions and Growth Factors (Safety Population in the Extension Phase) 
• 
Summarize Extension Phase Data with columns for TABLET; CAPSULE; OVERALL. 
[Programming Notes] 
• 
Footnote – Extension Phase: Concomitant transfusions or growth factors are any transfusion or growth factor given on or after the 
initial study treatment dosing date during the Extension Phase through 30 days after the last dose. 
Table 14.1.9d Concomitant Transfusions and Growth Factors (Safety Population in the Stage 3 PK Phase) 
• 
Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
• 
Footnote – Stage 3: Concomitant transfusions or growth factors are any transfusion or growth factor given on or after the initial 
study treatment dosing date through either the first dose of the Extension Phase or through 30 days after the last dose for those not 
continuing into the Extension Phase. 
 


Niraparib 
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Protocol: XXXXX 
Table 14.1.10c 
Summary of Investigator-Assessed Best Response by Tumor Type (Safety Population in the Extension Phase) 
Treatment: <TABLET, CAPSULE> (N=xx) 
Tumor type [1] 
Investigator Assessment 
Complete 
Response (CR) 
Partial 
Response (PR) 
Stable Disease 
(SD) 
Progressive 
Disease (PD) 
Not Evaluable 
(NE) 
Total [2] 
 
 
 
 
 
 
 
Prostate Cancer 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Mesothelioma Malignant 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Duodenal Adenocarcinoma 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Colon Cancer 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Malignant Melanoma 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
... 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other: xxx 
 
 
 
 
 
 
Total 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
N=Number of patients in Safety Population. 
Note: 'Total' represents the number of patients with non-missing investigator assessment. 
[1] The percentages are based on row totals. 
[2] The percentages are based on overall response totals. 
 
Source: Listing 16.2.6.1c.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Present by decreasing order of total frequency of tumor types observed, in the event of tie, sort in alphabetical order. 
If better fit requires taking Treatment out into the header row, split table across pages with each treatment on a new page. 
 
 
 


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Table 14.3.1.1.1a 
Overall Summary of Treatment Emergent Adverse Events (Safety Population in the Stage 1 PK Phase) 
 
TABLET [1] 
(N=xx) 
CAPSULE [2] 
(N=xx) 
FU/Ext Screening 
[3] (N=xx) 
Total [4] 
(N=xx) 
Any Treatment Emergent Adverse Event (TEAE) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Reduction 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Interruption 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib capsules. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for:  
Table 14.3.1.1.1b Overall Summary of Treatment Emergent Adverse Events (Safety Population in the Stage 2 PK Phase) 


Niraparib 
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Table 14.3.1.1.1c 
Overall Summary of Treatment Emergent Adverse Events (Safety Population in the Extension Phase) 
 
TABLET  
(N=xx) 
CAPSULE  
(N=xx) 
OVERALL 
(N=xx) 
Any Treatment Emergent Adverse Event (TEAE) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Reduction 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Interruption 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any COVID-19 related TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Note: This table reports Treatment Emergent Adverse Events (TEAEs) with onset during Extension Phase only. 
 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
[Programming Notes]  
• 
Sort order: All AE tabulations, unless otherwise specified, will be ordered in terms of decreasing frequency for SOC (alphabetically 
for SOCs with the same number of AEs reported), and decreasing frequency for PT within SOC (alphabetically for PTs with the same 
number of AEs reported within a SOC) considering the overall rate. 
 
Repeat for:  
Table 14.3.1.1.1.1c Overall Summary of Treatment Emergent Adverse Events Ongoing from PK Phase (Safety Population in the Extension 
Phase) 
[Programming Notes for Table 14.3.1.1.1.1c]  
Footnote: “Note: This table reports Treatment Emergent Adverse Events (TEAEs) with onset during PK Phase of the study. 
 
This table summarizes data from Listing 16.2.7.2c, please use this listing as source reference in the footnote. 


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Table 14.3.1.1.1d 
Overall Summary of Treatment Emergent Adverse Events (Safety Population in the Stage 3 PK Phase) 
 
NIRAPARIB 
TABLET FASTED [1] 
(N=xx) 
NIRAPARIB 
TABLET FED [2] 
(N=xx) 
FU/Ext 
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any Treatment Emergent Adverse Event (TEAE) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Reduction 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Interruption 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any COVID-19 related TEAE Leading to Treatment 
Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
 


Niraparib 
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Table 14.3.1.1.2a 
Overall Summary of Treatment Emergent Adverse Events by Sequence and Period (Safety Population in the Stage 1 PK Phase) 
 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
TABLET 
Period 1 
(N=xx) 
CAPSULE 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
CAPSULE 
Period 1 
(N=xx) 
TABLET 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
Any Treatment Emergent Adverse Event (TEAE) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Reduction 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Interruption 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE Leading to Treatment 
Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.3.1.1.2b Overall Summary of Treatment Emergent Adverse Events by Sequence and Period (Safety Population in the Stage 2 PK 
Phase) 
 
 


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Table 14.3.1.1.2d 
Overall Summary of Treatment Emergent Adverse Events by Sequence and Period (Safety Population in the Stage 3 PK Phase) 
 
Sequence 
NIRAPARIB TABLET FASTED/FED 
(N=xx) 
Sequence 
NIRAPARIB TABLET FED/FASTED 
(N=xx) 
NIRAPARIB 
TABLET 
FASTED 
Period 1 
(N=xx) 
NIRAPARIB 
TABLET  
FED  
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
NIRAPARIB 
TABLET  
FED 
Period 1 
(N=xx) 
NIRAPARIB 
TABLET FASTED 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
Any Treatment Emergent Adverse Event (TEAE) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE with CTCAE Toxicity Grade ≥ 
3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Reduction 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Interruption 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE Leading to Treatment 
Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any COVID-19 related TEAE Leading to 
Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
 


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Table 14.3.1.2.1a 
Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 1 PK Phase) 
 
System Organ Class 
Preferred Term 
TABLET [1] 
(N=xx) 
CAPSULE [2] 
(N=xx) 
FU/Ext Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib capsules. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For all tables of adverse events by SOC and PT, sort SOCs by descending overall frequency of events reported. Within each SOC, sort PTs 
by descending overall frequency of events reported. 
Table 14.3.1.2.1b Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 2 PK Phase) 
 
 


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Table 14.3.1.2.1c 
Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Extension Phase) 
System Organ Class 
Preferred Term 
TABLET 
(N=xx) 
CAPSULE 
(N=xx) 
OVERALL 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For all tables of adverse events by SOC and PT, sort SOCs by descending overall frequency of events reported. Within each SOC, sort PTs 
by descending overall frequency of events reported. 
 
 


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Statistical Analysis Plan 
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Table 14.3.1.2.1d 
Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 3 PK Phase) 
 
System Organ Class 
Preferred Term 
NIRAPARIB 
TABLET FASTED [1] 
(N=xx) 
NIRAPARIB 
TABLET FED [2] 
(N=xx) 
FU/Ext  
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For all tables of adverse events by SOC and PT, sort SOCs by descending overall frequency of events reported. Within each SOC, sort PTs 
by descending overall frequency of events reported. 


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Table 14.3.1.2.1.1d 
Summary of COVID-19 related Adverse Events by SOC and PT (Safety Population in the Stage 3 PK Phase) 
 
System Organ Class 
Preferred Term 
NIRAPARIB 
TABLET FASTED [1] 
(N=xx) 
NIRAPARIB 
TABLET FED [2] 
(N=xx) 
FU/Ext  
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Note: COVID-19 Case Diagnosis is based on WHO Definition as of DDMMMYYYY. 
[1] Includes COVID-19 related TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes COVID-19 related TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes COVID-19 related TEAEs occurring at any time during the PK Phase.  
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For all tables of adverse events by SOC and PT, sort SOCs by descending overall frequency of events reported. Within each SOC, sort PTs 
by descending overall frequency of events reported. 
Select only COVID-19 related TEAEs. 
 


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Statistical Analysis Plan 
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Table 14.3.1.2.2a 
Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 1 PK Phase) 
 
System Organ Class 
Preferred Term 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
TABLET 
Period 1 
(N=xx) 
CAPSULE 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
CAPSULE 
Period 1 
(N=xx) 
TABLET  
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For tables of adverse events by SOC and PT by sequence and period, sort alphabetically by SOCs and PTs. 
Table 14.3.1.2.2b Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 2 PK Phase) 


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Statistical Analysis Plan 
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Table 14.3.1.2.2d 
Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 3 PK Phase) 
 
Sequence 
NIRAPARIB TABLET FASTED/FED 
(N=xx) 
Sequence 
NIRAPARIB TABLET FED/FASTED 
(N=xx) 
 
System Organ Class 
Preferred Term 
NIRAPARIB 
TABLET FASTED 
Period 1 
(N=xx) 
NIRAPARIB 
TABLET FED 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
NIRAPARIB 
TABLET FASTED 
Period 1 
(N=xx) 
NIRAPARIB 
TABLET FED 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For tables of adverse events by SOC and PT by sequence and period, sort alphabetically by SOCs and PTs. 
 
 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 70 of 135 
Using Mock Shell (Table 14.3.1.2.1a, Table 14.3.1.2.1b, Table 14.3.1.2.1c, Table 14.3.1.2.1d)  
Repeat for: 
Table 14.3.1.3a Summary of Related TEAE by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.3b Summary of Related TEAE by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.3c Summary of Related TEAE by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.3d Summary of Related TEAE by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.4a Summary of Serious TEAE by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.4b Summary of Serious TEAE by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.4c Summary of Serious TEAE by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.4d Summary of Serious TEAE by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.5a Summary of Related Serious TEAE by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.5b Summary of Related Serious TEAE by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.5c Summary of Related Serious TEAE by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.5d Summary of Related Serious TEAE by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.6a Summary of TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.6b Summary of TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.6c Summary of TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.6d Summary of TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.7a Summary of Related TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.7b Summary of Related TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.7c Summary of Related TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.7d Summary of Related TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.8a Summary of TEAE Leading to Treatment Discontinuation by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.8b Summary of TEAE Leading to Treatment Discontinuation by SOC and PT (Safety Population in the Stage 2 PK Phase) 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 71 of 135 
Table 14.3.1.8c Summary of TEAE Leading to Treatment Discontinuation by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.8d Summary of TEAE Leading to Treatment Discontinuation by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.9c Summary of TEAE Leading to Treatment Dose Interruption by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.10a Summary of TEAE Leading to Treatment Dose Reduction by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.10b Summary of TEAE Leading to Treatment Dose Reduction by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.10c Summary of TEAE Leading to Treatment Dose Reduction by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.10d Summary of TEAE Leading to Treatment Dose Reduction by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.11a Summary of TEAE Leading to Death by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.11b Summary of TEAE Leading to Death by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.11c Summary of TEAE Leading to Death by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.11d Summary of TEAE Leading to Death by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.11.1a Summary of Related TEAE Leading to Death by SOC and PT (Safety Population in the Stage 1 PK Phase) 
[Programming notes] – TABLE FOR PLAIN TEXT SUMMARY PURPOSES ONLY. 
Table 14.3.1.11.1b Summary of Related TEAE Leading to Death by SOC and PT (Safety Population in the Stage 2 PK Phase) 
[Programming notes] – TABLE FOR PLAIN TEXT SUMMARY PURPOSES ONLY. 
Table 14.3.1.11.1c Summary of Related TEAE Leading to Death by SOC and PT (Safety Population in the Extension Phase) 
[Programming notes] – TABLE FOR PLAIN TEXT SUMMARY PURPOSES ONLY. 
Table 14.3.1.11.1d Summary of Related TEAE Leading to Death by SOC and PT (Safety Population in the Stage 3 PK Phase) 
[Programming notes] – TABLE FOR PLAIN TEXT SUMMARY PURPOSES ONLY. 
Table 14.3.1.12a Summary of Treatment Emergent AESI by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.12b Summary of Treatment Emergent AESI by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.12c Summary of Treatment Emergent AESI by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.12d Summary of Treatment Emergent AESI by SOC and PT (Safety Population in the Stage 3 PK Phase) 


Niraparib 
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Protocol No: 3000-01-004 
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Page 72 of 135 
Table 14.3.1.23.1a Summary of Non-Serious TEAE (≥5%) by SOC and PT (Safety Population in the Stage 1 PK Phase) 
[Programming notes] – TABLE FOR DISCLOSURE PURPOSES ONLY. 
Table 14.3.1.23.1b Summary of Non-Serious TEAE (≥5%) by SOC and PT (Safety Population in the Stage 2 PK Phase) 
[Programming notes] – TABLE FOR DISCLOSURE PURPOSES ONLY.  
Table 14.3.1.23.1c Summary of Non-Serious TEAE (≥5%) by SOC and PT (Safety Population in the Extension Phase) 
[Programming notes] – TABLE FOR DISCLOSURE PURPOSES ONLY.  
Table 14.3.1.23.1d Summary of Non-Serious TEAE (≥5%) by SOC and PT (Safety Population in the Stage 3 PK Phase) 
[Programming notes] – TABLE FOR DISCLOSURE PURPOSES ONLY.  
Table 14.3.1.23.2a Summary of Related Non-Serious TEAE by SOC and PT (Safety Population in the Stage 1 PK Phase) 
[Programming notes] – TABLE FOR PLAIN TEXT SUMMARY PURPOSES ONLY. 
Table 14.3.1.23.2b Summary of Related Non-Serious TEAE by SOC and PT (Safety Population in the Stage 2 PK Phase) 
[Programming notes] – TABLE FOR PLAIN TEXT SUMMARY PURPOSES ONLY. 
Table 14.3.1.23.2c Summary of Related Non-Serious TEAE by SOC and PT (Safety Population in the Extension Phase) 
[Programming notes] – TABLE FOR PLAIN TEXT SUMMARY PURPOSES ONLY. 
Table 14.3.1.23.2d Summary of Related Non-Serious TEAE by SOC and PT (Safety Population in the Stage 3 PK Phase) 
[Programming notes] – TABLE FOR PLAIN TEXT SUMMARY PURPOSES ONLY. 
 


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Table 14.3.1.13a 
Summary of Treatment Emergent Adverse Events by SOC and PT and CTCAE Toxicity Grade (Safety Population in the Stage 1 PK Phase) 
 
System Organ Class 
Preferred Term 
TABLET [1] 
(N=xx) 
CAPSULE [2] 
(N=xx) 
FU/Ext  
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  Grade 1 
 
 
 
 
  ... 
 
 
 
 
  Grade 5 
 
 
 
 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  Grade 1 
 
 
 
 
  ... 
 
 
 
 
  Grade 5 
 
 
 
 
 
 
 
 
 
 PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  Grade 1 
 
 
 
 
  ... 
 
 
 
 
  Grade 5 
 
 
 
 
... 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib capsules. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.3.1.13b Summary of Treatment Emergent Adverse Events by SOC and PT and Maximum Toxicity (Safety Population in the Stage 2 PK 
Phase) 
Table 14.3.1.13c Summary of Treatment Emergent Adverse Events by SOC and PT and Maximum Toxicity (Safety Population in the Extension 
Phase) 
• 
Summarize Extension Phase Data with columns for TABLET; CAPSULE; OVERALL. 
[Programming Notes] 
For all tables of adverse events by SOC and PT, sort SOCs by descending overall frequency of events reported. Within each SOC, sort 
PTs by descending overall frequency of events reported. Within each PT, sort by presented maximum toxicity grade. 


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Table 14.3.1.13d 
Summary of Treatment Emergent Adverse Events by SOC and PT and CTCAE Toxicity Grade (Safety Population in the Stage 3 PK Phase) 
 
System Organ Class 
Preferred Term 
NIRAPARIB 
TABLET FASTED [1] 
(N=xx) 
NIRAPARIB 
TABLET FED [2] 
(N=xx) 
FU/Ext  
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Grade 1 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  ... 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  Grade 5 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Grade 1 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  ... 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  Grade 5 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 
 
 
 
 
 PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Grade 1 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  ... 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  Grade 5 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  ... 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase. 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Table 14.3.1.14a 
Summary of Treatment Emergent Adverse Events by PT (Safety Population in the Stage 1 PK Phase) 
 
Preferred Term 
TABLET [1] 
(N=xx) 
CAPSULE [2] 
(N=xx) 
FU/Ext Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   PT 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib capsules. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase. 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.3.1.14b Summary of Treatment Emergent Adverse Events by PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.14c Summary of Treatment Emergent Adverse Events by PT (Safety Population in the Extension Phase) 
• 
Summarize Extension Phase Data with columns for TABLET; CAPSULE; OVERALL. 
• 
[1], [2], [3] and [4] are not applicable. 
 
[Programming Notes] 
Sort PTs by descending overall frequency of events reported.  
 
 


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Table 14.3.1.14d 
Summary of Treatment Emergent Adverse Events by PT (Safety Population in the Stage 3 PK Phase) 
 
Preferred Term 
NIRAPARIB  
TABLET FASTED [1] 
(N=xx) 
NIRAPARIB  
TABLET FED [2] 
(N=xx) 
FU/Ext  
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   PT 3 
 
 
 
 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Table 14.3.1.15a 
Listing of Serious TEAEs During PK Phase (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
 
Patient 
Number 
Dosing Period/ 
Niraparib 
Treatment 
Adverse Event 
[P]MedDRA Preferred Term 
[S]System Organ Class 
Start 
Date 
Time/ 
(Rel 
Day 
[1])  
Stop 
Date 
Time 
(Rel 
Day 
[1]) TEAE? 
SAE/ 
Reason 
[2] 
Severity 
Action Taken 
on Study 
Treatment[3] 
Other 
Action 
Taken 
Relationship 
[3] 
Outcome 
 
Period 1/ 
Capsule 
XXXXXXXXXXXXXXXX 
[P]XXXXXXXXXXXXXXXXXXX 
[S]XXXXXXXXXXXXXXXXXXX 
yyyy-
mm-dd 
hh:mm 
[x] 
yyyy-
mm-dd 
[x] 
Y 
N 
Grade 1 T: NA 
C: Dose Not 
Changed 
 
T: NA 
C: Related 
Recovered/ 
Resolved 
 
Period 2/ 
Tablet 
XXXXXXXXXXXXXXXX 
[P]XXXXXXXXXXXXXXXXXXX 
[S]XXXXXXXXXXXXXXXXXXX 
yyyy-
mm-dd 
hh:mm 
[x] 
yyyy-
mm-dd 
[x] 
Y 
N 
Grade 1 T: Dose Not 
Changed 
C: NA 
 
T: Related 
C: NA 
Recovered/ 
Resolved 
 
PK Safety FU  
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in PK Phase. 
[2] Reason for SAE: 1 = Result in death; 2 = Life threatening; 3 = Result in persistent or significant disability/incapacity; 
4 = Requires or prolongs hospitalization; 5 = Congenital abnormality/birth defect; 6 = Other medically important event. 
[3] T=Tablet; C=Capsule. 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming notes] 
Please add time to Start Date column for PK Phase Stage 2 and Extension Phase. 
 
Repeat for: 
Table 14.3.1.15b Listing of Serious TEAEs During the PK Phase (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.15c Listing of Serious TEAEs During the Extension Phase (Safety Population in the Extension Phase) 
Table 14.3.1.15d Listing of Serious TEAEs During the PK Phase (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.16a Listing of Deaths During the PK Phase (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.16b Listing of Deaths During the PK Phase (Safety Population in the Stage 2 PK Phase) 


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Table 14.3.1.16c Listing of Deaths During the Extension Phase (Safety Population in the Extension Phase) 
Table 14.3.1.16d Listing of Deaths During the PK Phase (Safety Population in the Stage 3 PK Phase) 
• 
Footnote: ‘NOTE: Deaths due to progressive disease were not collected as adverse events.’ 
Table 14.3.1.17c Listing of TEAE Leading to Dose Interruption During the Extension Phase (Safety Population in the Extension Phase) 
Table 14.3.1.17d Listing of TEAE Leading to Dose Interruption During the PK Phase (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.18a Listing of TEAE Leading to Dose Reduction During the PK Phase (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.18b Listing of TEAE Leading to Dose Reduction During the PK Phase (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.18c Listing of TEAE Leading to Dose Reduction During the Extension Phase (Safety Population in the Extension Phase) 
Table 14.3.1.18d Listing of TEAE Leading to Dose Reduction During the PK Phase (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.19a Listing of TEAE Leading to Treatment Discontinuation During the PK Phase (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.19b Listing of TEAE Leading to Treatment Discontinuation During the PK Phase (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.19c Listing of TEAE Leading to Treatment Discontinuation During the Extension Phase (Safety Population in the Extension 
Phase) 
Table 14.3.1.19d Listing of TEAE Leading to Treatment Discontinuation During the PK Phase (Safety Population in the Stage 3 PK Phase) 
[Programming Notes] 
• 
Stage 3: Treatment Sequence will be NIRAPARIB TABLET FASTED/FED and NIRAPARIB TABLET FED/FASTED. 
• 
Stage 3: Column 2: Dosing Period/Treatment – Treatment should be NIRAPARIB FASTED or NIRAPARIB FED. 
• 
Stage 3: Treatment discontinuation during PK Phase – add column to record if discontinuation was due to COVID-19 [“COVID-19 Reason” 
with Options “COVID-19 infection” or “Issues rel. to COVID-19 pandemic”]. 
• 
Extension Phase: Replace column for Dosing Period/Treatment with Treatment (TABLET, CAPSULE) and Starting Dose. 
• 
Extension Phase: Do not need time with start/stop dates. 
• 
Extension Phase: Footnote: [1] Relative to first dose during the Extension Phase. 
 
 


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Table 14.3.1.16.1c 
All-Cause Mortality (Safety Population in the Extension Phase) 
 
TABLET 
(N=xx) 
CAPSULE 
(N=xx) 
OVERALL 
(N=xx) 
Death due to any cause 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
NOTE: Deaths occurring outside 30-day window following end of Extension Phase treatment are included in the counts. 
 
Source: Listing 16.2.1c.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
This table is for final disclosure reporting purposes ONLY. All deaths reported/recorded in the database should be included.


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Table 14.3.1.20d 
Summary of Incidence of COVID-19 Related Adverse Events Over Time (Safety Population in the Stage 3 PK Phase) 
 
 
Period during COVID-19 
Pandemic [1] 
NIRAPARIB 
TABLET FASTED 
(N=xx) 
NIRAPARIB 
TABLET FED 
(N=xx) 
n/Patients at Risk (%) 
n/Patients at Risk (%) 
 
 
 
 
Any COVID-19 Related AE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related SAE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related Grade ≥3 AE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
 
[1] TABLET PK Phase Stage 3 opened to recruitment on DDMMMYYYY, with first patient consented on DDMMMYYYY, placing the start of the 
recruitment during the COVID-19 pandemic. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Table 14.3.1.20c 
Summary of Incidence of COVID-19 Related Adverse Events Over Time 
(Safety Population in the Extension Phase) 
 
 
TABLET 
(N=xx) 
CAPSULE 
(N=xx) 
OVERALL 
(N=xx) 
n/Patients at Risk (%) 
n/Patients at Risk (%) 
n/Patients at Risk (%) 
 
 
 
 
Any COVID-19 Related AE 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related SAE 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related Grade ≥3 AE 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
 
Note: Extension Phase for all Stages of TABLET study overlapped with COVID-19 pandemic, with all Stage 3 patients commencing treatment 
for the Extension Phase on or after 02JUN2021 placing the AE onset during the pandemic, while last patient commenced treatment for 
Stages 1 and 2 on 14MAY2018 and 05DEC2019, respectively, placing their first Extension Phase treatment dose administration prior to 
the start of the pandemic, as defined by WHO as of 20MAR2020, with patients across all Stages ongoing until DDMMMYYYY. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
[Programming Notes] 
N accounts for all patients in Safety Population of the Extension Phase. 
n – number of patients with an event related to COVID-19. 
Patients at Risk (%) – number of patients who were ongoing on Extension Phase treatment on or after 20MAR2020. 
 


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Table 14.3.1.21d 
Summary of Incidence of COVID-19 Related Adverse Events Over Time by Gender (Safety Population in the Stage 3 PK Phase) 
Report on separate page for each: <Gender: Male, Female>  
 
 
Period during COVID-19 
Pandemic [1] 
NIRAPARIB 
TABLET FASTED 
(N=xx) 
NIRAPARIB 
TABLET FED 
(N=xx) 
n/Patients at Risk (%) 
n/Patients at Risk (%) 
 
 
 
 
Any COVID-19 Related AE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related SAE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related Grade ≥3 AE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
 
[1] TABLET PK Phase Stage 3 opened to recruitment on DDMMMYYYY, with first patient consented on DDMMMYYYY, placing the start of the 
recruitment during the COVID-19 pandemic. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.3.1.22d Summary of Incidence of Adverse Events Over Time by Age Group (Safety Population in the Stage 3 PK Phase) 
• 
Use the FDAAA age groups <=18, 18-64, >=65. 
 


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Table 14.3.1.21c 
Summary of Incidence of COVID-19 Related Adverse Events Over Time by Gender  
(Safety Population in the Extension Phase) 
Report on separate page for each: <Gender: Male, Female>  
 
 
TABLET 
(N=xx) 
CAPSULE 
(N=xx) 
OVERALL 
(N=xx) 
n/Patients at Risk (%) 
n/Patients at Risk (%) 
n/Patients at Risk (%) 
 
 
 
 
Any COVID-19 Related AE 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related SAE 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related Grade ≥3 AE 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
 
Note: Extension Phase for all Stages of TABLET study overlapped with COVID-19 pandemic, with all Stage 3 patients commencing treatment 
for the Extension Phase on or after 02JUN2021 placing the AE onset during the pandemic, while last patient commenced treatment for 
Stages 1 and 2 on 14MAY2018 and 05DEC2019, respectively, placing their first Extension Phase treatment dose administration prior to 
the start of the pandemic, as defined by WHO as of 20MAR2020, with patients across all Stages ongoing until DDMMMYYYY. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
Repeat for: 
Table 14.3.1.22c Summary of Incidence of Adverse Events Over Time by Age Group (Safety Population in the Extension Phase) 
• 
Use the FDAAA age groups <=18, 18-64, >=65. 
 
 


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Table 14.3.4.1a 
Summary of Study Treatment Exposure During the PK Phase (Safety Population in the Stage 1 PK Phase) 
 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
# of 100 mg Capsules Received 
 
 
 
 
3 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
# of 300 mg Tablets Received 
 
 
 
 
1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.3.4.1b Summary of Study Treatment Exposure During the PK Phase (Safety Population in the Stage 2 PK Phase) 
 
 


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Table 14.3.4.1c 
Summary of Study Treatment Exposure During the Extension Phase (Safety Population in the Extension Phase) 
Parameters 
Statistic 
TABLET 
(N=xx) 
CAPSULE 
(N=xx) 
OVERALL 
(N=xx) 
Maximum Number of Cycles 
1 
2 
... 
≥ 6 
 
n (%) 
n (%) 
... 
n (%) 
 
xx (xx.x) 
xx (xx.x) 
... 
xx (xx.x) 
 
xx (xx.x) 
xx (xx.x) 
... 
xx (xx.x) 
 
xx (xx.x) 
xx (xx.x) 
... 
xx (xx.x) 
Median number of cycles started 
n 
xx  
xx  
xx  
Duration of Treatment (months) 
n 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
Duration on Study (months) 
n 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
Exposure duration (Months)  
<1 Month 
1 - <2 Months 
2 - <3 Months 
>= 3 Months 
>= 6 Months 
>= 12 Months 
n 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
xx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Total Number of Patients with at least 1 dose interruption 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Total Number of Patients with at least 1 dose reduction 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Total Number of Patients with at least 1 dose re-escalation 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Dose intensity (mg/day) [1] 
n 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
[1] Dose intensity was calculated as sum of daily doses consumed divided by overall treatment exposure, in days. 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 86 of 135 
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Page 1 of x 
Protocol: XXXXX 
Table 14.3.4.1d 
Summary of Study Treatment Exposure During the PK Phase (Safety Population in the Stage 3 PK Phase) 
 
Statistic 
NIRAPARIB 
FASTED 
(N=XX) 
NIRAPARIB 
FED 
(N=XX) 
 
OVERALL 
(N=xx) 
# of 300 mg Tablets Received 
 
 
 
 
1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 87 of 135 
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Protocol: XXXXX 
Table 14.3.4.2c 
Summary of Niraparib Dose by Cycle (Safety Population in the Extension Phase) 
Cycle 
Starting 
Niraparib 
Dose (mg) 
Statistic 
TABLET 
 
CAPSULE 
 
OVERALL 
 
1 
 
300 
200 
100 
N 
n (%) 
n (%) 
n (%) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
2 
 
300 
200 
100 
N 
n (%) 
n (%) 
n (%) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
3 
 
300 
200 
100 
N 
n (%) 
n (%) 
n (%) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
…. 
 
 
 
 
 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 88 of 135 
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Protocol: XXXXX 
Table 14.3.4.3.1c 
Summary and Change from Baseline of Select Hematology Parameters by Visit During the Extension Phase 
(Safety Population in the Extension Phase) 
Parameter Visit 
Statistic 
TABLET (N=xx) 
CAPSULE (N=xx) 
OVERALL (N=xx) 
Actual 
Change 
Actual 
Change 
Actual 
Change 
Parameter 
1 
Baseline n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
 
Cycle 1 
– Day 8 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
Cycle 1 
– Day 15 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
Cycle 1 
– Day 22 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
Cycle 2 
– Day 1 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
……. 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
EOT 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 


Niraparib 
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Figure 14.3.4.3.1c 
Change from Baseline (± SE) of Select Hematology Parameters Over Time 
(Safety Population in the Extension Phase) 
Parameter (unit) 
SE=Standard Error, calculated as standard deviation (SD) divided by square root of sample size (N). 
 
Source: Table 14.3.4.3.1c.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
Programming Notes: 
• 
Report hemoglobin, neutrophils and platelets only.


Niraparib 
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Table 14.3.4.3.2c 
Shift Summary of Select Hematology Parameters During the Extension Phase (Safety Population in the Extension Phase) 
Treatment Group 
 
 
Post-Baseline Maximum CTCAE Grade 
TABLET 
Laboratory 
Test 
Baseline 
CTCAE Grade 
Statistic 
Grade 0 
Grade 1 
Grade 2 
Grade 3 
Grade 4  
Missing 
 
xxxxx 
Grade 0 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
Grade 1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
Grade 2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
Grade 3 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
Grade 4 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
Missing 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
Include TABLET, CAPSULE and OVERALL. 
Repeat for: 
Table 14.3.4.4.1c Summary and Change from Baseline of Select Chemistry Parameters by Visit During the Extension Phase (Safety 
Population in the Extension Phase) 
Table 14.3.4.4.2c Shift Summary of Select Chemistry Parameters in Maximum Toxicity Grade During the Extension Phase (Safety Population 
in the Extension Phase) 
 


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Protocol: XXXXX 
Table 14.3.4.4.1d 
Summary of COVID-19 Assessments for Patients with Suspected, Probable or Confirmed COVID-19 Case Diagnosis  
(Safety Population in the Stage 3 PK Phase) 
Assessment 
NIRAPARIB TABLET  
FASTED 
(N=XX) 
NIRAPARIB TABLET 
FED  
(N=XX) 
 
 
 
COVID-19 Case Diagnosis [1] 
xx (xx.x%) 
xx (xx.x%) 
  Confirmed 
xx (xx.x%) 
xx (xx.x%) 
  Probable 
xx (xx.x%) 
xx (xx.x%) 
  Suspected 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
COVID-19 Test Performed [2] 
 
 
  n 
xx 
xx 
  No 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
  Yes 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
 
 
 
Result from the COVID-19 Test 
 
 
  n 
xx 
xx 
  Negative 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
  Positive 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
  Indeterminate 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
 
 
 
 
[1] COVID-19 Case Diagnosis is based on WHO Definition as of DDMMMYYYY. 
[2] COVID-19 Test Performed is only captured for patients with a COVID-19 Case Diagnosis. 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For COVID-19 Test Performed, the small n is based on the number of subjects with a COVID-19 Case Diagnosis. For Result of the COVID-19 
Test, the small n is based on the COVID-19 Test Performed=Yes. 
IDSL standard shell PAN1. 
 


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Table 14.3.4.5.1c 
Summary of COVID-19 Assessments for Patients with Suspected, Probable or Confirmed COVID-19 Case Diagnosis  
(Safety Population in the Extension Phase) 
 
Assessment 
TABLET 
(N=XX) 
CAPSULE 
(N=XX) 
OVERALL 
(N=XX) 
 
 
 
 
COVID-19 Case Diagnosis [1] 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  Confirmed 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  Probable 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
  Suspected 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
COVID-19 Test Performed [2] 
 
 
 
  n 
xx 
xx 
xx 
  No 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
  Yes 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
 
 
 
 
Result from the COVID-19 Test 
 
 
 
  n 
xx 
xx 
xx 
  Negative 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
  Positive 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
  Indeterminate 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
 
 
 
 
 
[1] COVID-19 Case Diagnosis is based on WHO Definition as of 20MAR2020. 
[2] COVID-19 Test Performed is only captured for patients with a COVID-19 Case Diagnosis. 
Note: Extension Phase for all Stages of TABLET study overlapped with COVID-19 pandemic, with all Stage 3 patients commencing treatment 
for the Extension Phase on or after 02JUN2021 placing the AE onset during the pandemic, while last patient commenced treatment for 
Stages 1 and 2 on 14MAY2018 and 05DEC2019, respectively, placing their first Extension Phase treatment dose administration prior to 
the start of the pandemic, as defined by WHO as of 20MAR2020, with patients across all Stages ongoing until DDMMMYYYY. 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
 


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Table 14.4.1c 
Summary of Important Protocol Deviations (Safety Population in the Extension Phase) 
Category/Coded Term 
TABLET 
(N=XX) 
CAPSULE 
(N=XX) 
TOTAL 
(N=XX) 
 
 
 
 
Any important protocol deviations 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
 
 
 
 
CATEGORY 1 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
   SUBCATEGORY 1 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
   SUBCATEGORY 2 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
…. 
 
 
 
 
 
 
 
CATEGORY 2 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
   SUBCATEGORY 1 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
   SUBCATEGORY 2 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
… 
 
 
 
 
 
 
 
 
Source: Listing XXXXXXXXX.  Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes]: 
• 
Include only IMPORTANT protocol deviations. 
• 
<Category 1...> represents ADDV.DVCAT. <Subcategory 1...> represents ADDV.DVDECOD. 
• 
Sort Categories in descending order according to overall counts, if ties are present, present alphabetically. 
 
 
 


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Protocol: XXXXX 
Table 14.4.1d 
Summary of Important Protocol Deviations for the PK Phase Occurring Through End of Treatment 
(Safety Population in the Stage 3 PK Phase) 
Category/Coded Term 
NIRAPARIB TABLET  
FASTED [1] 
(N=XX) 
NIRAPARIB TABLET 
FED [2] 
(N=XX) 
TOTAL [3] 
(N=XX) 
 
 
 
 
Any important protocol deviations 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
 
 
 
 
CATEGORY 1 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
   SUBCATEGORY 1 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
   SUBCATEGORY 2 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
…. 
 
 
 
 
 
 
 
CATEGORY 2 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
   SUBCATEGORY 1 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
   SUBCATEGORY 2 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Includes protocol deviations with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes protocol deviations with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] Includes protocol deviations occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes]: 
• 
Include only IMPORTANT protocol deviations. 
• 
<Category 1...> represents ADDV.DVCAT. <Subcategory 1...> represents ADDV.DVDECOD. 
• 
Sort Categories in descending order according to overall counts, if ties are present, present alphabetically. 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 95 of 135 
LISTINGS 
General guidelines: 
Listings are separated for the PK Phase (Stage 1, Stage 2 and Stage 3 separately) and the Open-Label Extension Phase. 
For the PK Phase:  
• Treatment=Sequence (for Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET; for Stage 3: NIRAPARIB TABLET 
FASTED/FED or NIRAPARIB TABLET FED/FASTED). 
• Population=Safety Population in the PK Phase (i.e., those who receive at least 1 dose), unless otherwise specified. 
• Include all data assessments relative to the PK Phase. 
o 
For patients who do not continue to the Extension Phase, include all EOT/Safety FU data. Also include Extension Phase 
Screening for those patients who DO not proceed to the Extension Phase. 
• Relative day: With respect to first date of dosing in PK period. 
For the Extension Phase: 
• Treatment=TABLET; CAPSULE. 
• Population=Safety Population in the Open-Label Extension Phase (i.e., those who receive at least 1 dose), unless otherwise specified. 
• Include all assessments relative to the Extension Phase. 
o 
Any assessment specific to Extension Phase, including Screening Data. 
• Relative day: With respect to first date of dosing in Extension Phase. 
o 
“-” event taking place prior to first dose in Extension Phase. 
o 
“*” event taking place after EOT in Extension Phase. 
 
 


Niraparib 
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Listing 16.2.1a 
Disposition for PK Phase (All Patients Enrolled in the Stage 1 PK Phase) 
 
Treatment: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or CAPSULE>, 
as applicable 
 
Patient 
Number 
Date of Last 
Niraparib Dose 
During PK Phase 
(Rel Day) 
Date of 
Discontinuation 
From PK Phase 
(Rel Day) 
Reason for 
Discontinuation 
from PK Phase 
Date of 
Discontinuation 
from Study (Rel 
Day)  
Reason for 
Discontinuation 
from Study 
Date of 
Death 
(Rel 
Day) 
Date of 
Progression 
(Rel Day) 
Protocol 
Version 
 
 
 
Other: specify 
 
 
 
 
 
 
 
 
Completion 
 
 
 
 
 
 
Relative Day calculated relative to first dose in PK Phase. 
 
Only study discontinuations, disease progressions and deaths that occur during PK Phase (i.e., before 1st dose of extension or prior 
to discontinuing the study for patients not entering the Extension Phase) are listed. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes – PK Phase] 
• 
Include only data that falls before first-dose Open-Label Extension Phase, i.e., for those patients who DC study and do not continue 
in the Open-Label Extension Phase. 
 
Repeat for: 
Listing 16.2.1b Disposition for PK Phase (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.1c Disposition for Open-Label Extension Phase (All Patients Enrolled for the Extension Phase) 
Listing 16.2.1d Disposition for PK Phase (Safety Population in the Stage 3 PK Phase) 
[Programming Notes – Extension Phase] 
• 
Change ‘PK Phase’ to ‘Extension’ Phase in respective columns. 
• 
Treatment: Niraparib Tablet or Niraparib Capsule. 
• 
Footnote: Relative Day calculated relative to first dose in Extension Phase. ‘-’ Rel day before first Dose during Extension Phase, 
‘*’ Rel day post 30-day safety window from EOT . 
 
 


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Protocol: XXXXX 
Listing 16.2.1.2a 
Reasons for Screen Failure (Patients who Failed Screening in the Stage 1 PK Phase) 
 
Treatment Sequence: <SCREEN FAILURE> 
Patient 
Number 
Protocol Version 
Inclusion/Exclusion Criteria Not Met 
 
xxxxxx-xxxx 
Version 1.0 (original) INPXX: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
xxxxxx-xxxx 
Version 1.0 (original) EXPXX: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.1.2b Reasons for Screen Failure (Patients who Failed Screening in the Stage 2 PK Phase) 
Listing 16.2.1.2d Reasons for Screen Failure (Patients who Failed Screening in the Stage 3 PK Phase) 
 
 


Niraparib 
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Listing 16.2.2a 
Protocol Deviations for the PK Phase (Safety Population in the Stage 1 PK Phase) 
 
Treatment: < Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET>  
Patient 
Number 
 
Visit 
Protocol Deviation Category 
Protocol Deviation Severity 
Description of Protocol Deviation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
 
 
[Programming Notes] 
• 
Include only data that falls before first-dose Open-Label Extension Phase (i.e., for those patients who DC study and do not 
continue in the Open-Label Extension Phase) 
 
Repeat for: 
Listing 16.2.2b Protocol Deviation for the PK Phase (Safety Population in the Stage 2 PK Phase) 
 
 


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Listing 16.2.2c 
Important Protocol Deviations for the Open-Label Extension Phase (Safety Population in the Extension Phase) 
Treatment: <TABLET, CAPSULE>  
Patient 
Number 
 
Visit 
Protocol Deviation 
Category 
 
Description of Protocol 
Deviation 
TESARO Classification [1] 
GSK  
Classification [2] 
 
 
 
 
<<SIGNIFICANT/ IMPORTANT>> 
<<IMPORTANT/NON-
IMPORTANT>> 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] For Stages 1 & 2, protocol deviation classification is done based on TESARO Protocol Deviation Management System only. GSK 
Classification will remain blank. 
[2] For Stage 3, protocol deviation classification is done based on GSK Protocol Deviation Management System only. TESARO Classification 
will remain blank. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming notes] 
For Stage 3 Extension Phase, patients will receive NIRAPARIB TABLET formulation only. 
 
For Stages 1 and 2 reporting, only TESARO Classifications will be populated, for Stage 3 – only GSK Classification will be 
populated. 
 
Only include protocol deviation classified as Important. 
 


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Listing 16.2.2.1d 
Important Protocol Deviations for the PK Phase Occurring Through End of Treatment (Safety Population for Stage 3 PK Phase) 
Treatment: <NIRAPARIB FASTED or NIRAPARIB FED>  
Patient 
Number 
 
Visit 
Protocol Deviation Category 
Protocol Deviation Severity 
Description of Protocol Deviation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming notes]: 
• 
Only include protocol deviation classed as Important. 


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Listing 16.2.2.2d 
GSK Protocol Deviations related to COVID-19 (Safety Population for Stage 3 PK Phase) 
Treatment: <NIRAPARIB FASTED or NIRAPARIB FED>  
Patient 
Number 
Deviation Category 
Description of Deviation 
GSK Classification 
Date 
 
 
 
<IMPORTANT/NOT-IMPORTANT> 
 
 
 
 
 
 
 
 
 
 
 
 
Note: * Patients with probable, suspected or confirmed COVID-19. 
Note: This listing only includes COVID-19 related protocol deviations. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 


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Listing 16.2.2.2c 
GSK Protocol Deviations related to COVID-19 (Safety Population in the Extension Phase) 
Treatment: <TABLET, CAPSULE>  
Patient 
Number 
Deviation Category 
Description of Deviation 
GSK Classification 
Date 
 
 
 
<IMPORTANT/NOT-IMPORTANT> 
 
 
 
 
 
 
 
 
 
 
 
 
Note: * Patients with probable, suspected or confirmed COVID-19. 
Note: This listing only includes COVID-19 related protocol deviations. 
Note: Extension Phase for all Stages of TABLET study overlapped with COVID-19 pandemic, with all Stage 3 patients commencing 
treatment for the Extension Phase on or after 02JUN2021 placing the AE onset during the pandemic, while last patient commenced 
treatment for Stages 1 and 2 on 14MAY2018 and 05DEC2019, respectively, placing their first Extension Phase treatment dose 
administration prior to the start of the pandemic, as defined by WHO as of 20MAR2020, with patients across all Stages ongoing until 
DDMMMYYYY. 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 


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Listing 16.2.3a 
Study Populations for the PK Phase (All Patients Enrolled in the Stage 1 PK Phase) 
 
Treatment: <TABLET/CAPSULE or CAPSULE/TABLET or SCREEN FAILURE> 
 
Patient 
Number 
PK Phase Safety  
(SAF) Population 
Informed Consent Date 
Randomization Date 
 
Y 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.3b Study Populations for the PK Phase (All Patients Screened in the Stage 2 PK Phase) 
• 
For Stage 2 PK, add column for BE Evaluable Population (Y/N). 
 
 


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Listing 16.2.3c 
Study Populations for the Open-Label Extension Phase (All Patients Enrolled in the Extension Phase) 
Treatment: <TABLET or CAPSULE> 
 
Patient 
Number 
Extension Phase 
Safety (SAF) 
Population 
 
 
 
 
 
 
 
 
 
Y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Listing 16.2.3d 
Study Populations for the PK Phase (All Patients Enrolled in the Stage 3 PK Phase) 
Treatment: <FASTED/FED or FED/FASTED or SCREEN FAILURE> 
Patient 
Number 
PK Phase 
Safety (SAF) Population 
FE Population 
Informed Consent Date 
Randomization Date 
 
Y 
Y 
 
 
 
 
N 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
 


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Listing 16.2.4.1a 
Demographics (Safety Population in the Stage 1 PK Phase) 
Study Treatment: <Stage 1 & 2: NOT DOSED or TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: NOT DOSED or FASTED/FED or FED/FASTED> or 
<Extension: TABLET or CAPSULE>, as applicable  
Patient 
Number 
Age 
(yrs) 
Sex 
Child-Bearing 
Potential 
Ethnicity 
Race 
Height 
(cm) 
Weight 
(kg) 
BMI 
(kg/m2) 
ECOG Performance 
Status 
 
 
 
 
 
Other: specify 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECOG = Eastern Cooperative Oncology Group:  
0=Fully active, able to carry on all pre-disease performance without restriction 
1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature  
2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 
3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours  
4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.4.1b Demographics (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.4.1c Demographics (Safety Population in the Extension Phase) 
Add footnote for Extension Phase and relevant reference in the listing:  
[1] Only weight and ECOG Performance Status were repeated at Extension Phase entry.  
 
Listing 16.2.4.1d Demographics (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.4.2a 
Medical History (Safety Population in the Stage 1 PK Phase) 
PK Phase Treatment: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
 
Patient 
Number 
System Organ Class 
   Preferred Term 
      Medical Condition or Event 
Start 
Date 
Ongoing at  
Study Start? 
Stop Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Includes only patients with major medical conditions. 
 
Note: MedDRA version XX.X. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.4.2b Medical History (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.4.2c Medical History (Safety Population in the Extension Phase) 
Listing 16.2.4.2d Medical History (Safety Population in the Stage 3 PK Phase) 
[Programming notes] 
• 
For Stage 3, the latest available MedDRA version is to be used. 
 
 


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Listing 16.2.4.3a 
Prior Anti-Cancer Treatment (Safety Population in the Stage 1 PK Phase) 
Treatment: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or CAPSULE>, 
as applicable 
 
Patient 
Number 
Regimen 
Number 
-Verbatim Term 
 --Preferred Term 
Reason for Administration 
Best Response 
 
 
 
Other: specify 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.4.3b Prior Anti-Cancer Treatment (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.4.3c Prior Anti-Cancer Treatment (Safety Population in the Extension Phase) 
Listing 16.2.4.3d Prior Anti-Cancer Treatment (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.4.4a 
Primary Cancer History (Safety Population in the Stage 1 PK Phase) 
Treatment: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or CAPSULE>, 
as applicable 
 
Patient 
Number 
Tumor Type 
Date of First 
Diagnosis 
Cancer Stage (Most Recent) 
Number of Prior Lines 
of Therapy 
 
<Other: specify> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.4.4b Primary Cancer History (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.4.4c Primary Cancer History (Safety Population in the Extension Phase) 
Listing 16.2.4.4d Primary Cancer History (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.4.5a 
Prior/Concomitant Radiotherapy (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable  
Patient 
Number 
Site or Region 
Date Started 
Date Stopped 
Total Grays 
Prior/ 
Concomitant Flag 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Includes patients with prior or concomitant radiotherapy with respect to the PK Phase.  
P=Prior (radiotherapy with start date earlier than the first dose date of study treatment). 
C=Concomitant (radiotherapy occurring on or after the initial study treatment dosing date through either the first dose of the Extension 
Phase or through 30 days after the last dose, for those not continuing into the Extension Phase).  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.4.5b Prior/Concomitant Radiotherapy (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.4.5c Prior/Concomitant Radiotherapy (Safety Population in the Extension Phase) 
[Programming Notes for Extension Phase] 
Note: Includes patients with prior or concomitant radiotherapy with respect to the Extension Phase. 
P=Prior (radiotherapy with start date earlier than the first dose date of Extension Phase treatment). 
C=Concomitant (radiotherapy occurring on or after the initial Extension Phase treatment dosing date through EOT in Extension Phase). 
 
Listing 16.2.4.5d Prior/Concomitant Radiotherapy (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.5.1a 
Prior and Concomitant Medications (Safety Population in the Stage 1 PK Phase) 
 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
Patient Number = xxxxxx-xxxx 
 
ATC/ 
Preferred 
Term/ 
Verbatim 
Term 
Dose per 
Administration 
Dose 
Unit 
Frequenc
y 
Indica
tion 
Route of 
Administr
ation 
Start/ 
Stop Date 
Ongoing  
Prior/ 
Concomitant 
Flag 
PK Dose 1 
PK Dose 2 
 
 
 
 
 
 
 
 
 
YYYY-MM-DD 
YYYY-MM-DD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Includes patients with prior or concomitant medications taken during the PK Phase.  
P=Prior medication only; C=Concomitant medication only; B=Both prior and concomitant medications. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
• 
For the Prior/Concomitant Flag, list all that apply. 
• 
If ATC3 not available, use a footnote [1] ATC level 3 term is not available through WHO Drug Dictionary. 
 
Repeat for: 
Listing 16.2.5.1b Prior and Concomitant Medications (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.5.1c Prior and Concomitant Medications (Safety Population in the Extension Phase) 
[Programming Notes for Extension Phase] 
Note: Includes patients with prior or concomitant medications during the Extension Phase. 
P=Prior (any medication taken earlier than the first dose date of Extension Phase treatment). 
C=Concomitant (any medication on or after the initial Extension Phase treatment dosing date through EOT in Extension Phase). 
Prior and concomitant medications taken during PK Phase only are classified as Prior medications during Extension Phase. 
Concomitant medications taken during PK Phase and ongoing during Extension Phase are classified as Both prior and concomitant 
medications during Extension Phase. 
• 
Drop ‘PK Dose 1’ column and replace ‘PK Dose 2’ with ‘Extension Phase’. 
 
Listing 16.2.5.1d Prior and Concomitant Medications (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.5.1.1c 
Treatment Exposure and Duration (Safety Population in the Extension Phase) 
Study Stage/Formulation: <Stage 1: TABLET/CAPSULE/EXT, CAPSULE/TABLET/EXT> <Stage 2: TABLET/CAPSULE/EXT, CAPSULE/TABLET/EXT > <Stage 
3: TABLET>, as applicable 
 
Patient 
Number 
Randomization 
Date 
Stage 
Treatment Sequence 
PK Dose 1/ Rel 
Day [1] 
PK Dose 2/ Rel 
Day [1] 
Extension 
Phase  
Dose 1 
Time between PK 
and Extension 
Phase doses [2] 
xxxxxx-xxxx 
YYYY-MM-DD 
<Stage 1/2> <TABLET/CAPSULE/EXT, 
CAPSULE/TABLET/EXT> 
YYYY-MM-DD/ -xx 
YYYY-MM-DD/ -xx 
YYYY-MM-DD 
xx 
 
 
 
 
 
 
 
 
xxxxxx-xxxx 
YYYY-MM-DD 
Stage 3 
<TABLET/EXT> 
YYYY-MM-DD/ -xx 
YYYY-MM-DD/ -xx 
YYYY-MM-DD 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Randomized patients who did not start PK Phase treatment and proceeded to Extension Phase treatment directly will have time 
between PK and Extension Phase dosing set to missing. 
[1] Relative to first dose during the Extension Phase. ‘-’ Rel day before first Dose during Extension Phase. 
[2] The time between last non-missing PK dose and first Extension Phase dose (in days). 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For treatment sequence use actual sequence labels, as displayed in ADaMs. 
Randomized patients who did not start PK Phase treatment and proceeded to Extension Phase treatment directly will have time between PK 
and Extension Phase dosing set to ‘.’. 
Treatment sequence displays actual treatment formulation received during Stages 1 and 2 (T/C, C/T), and for Stage 3 displays TABLET 
formulation irrespective of fasting (FED/FASTED) status.  
 


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Listing 16.2.5.2a 
Prior/Concomitant Procedures During PK Phase (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
 
Patient 
Number 
Procedure 
Date 
Rel Day 
[1]  
Procedure 
Results/Findings 
AE/SAE? Indication 
Prior/Concomitant 
Flag 
xxxxxx-xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the PK Phase. 
Note: Includes patients with prior or concomitant procedures during the PK Phase. 
P=Prior (any procedure earlier than the first dose date of study treatment). 
C=Concomitant (any procedure on or after the initial study treatment dosing date through either the first dose of the Extension Phase 
or through 30 days after the last dose, for those not continuing into the Extension Phase). 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for 
Listing 16.2.5.2b Prior/Concomitant Procedures During the PK Phase (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.5.2c Prior/Concomitant Procedures During the Extension Phase (Safety Population in the Extension Phase) 
[Programming Notes for Extension Phase] 
• 
Footnote: [1] Relative to first dose during the Extension Phase. ‘-’ Rel day before first Dose during Extension Phase, ‘*’ Rel 
day post 30-day safety window from EOT. 
Note: Includes patients with prior or concomitant procedures during the Extension Phase. 
P=Prior (any procedure undertaken earlier than the first dose date of Extension Phase treatment). 
C=Concomitant (any procedure undertaken on or after the initial Extension Phase treatment dosing date through EOT in Extension 
Phase). 
Prior and concomitant procedure undertaken during PK Phase only are classified as Prior procedure during Extension Phase. 
Concomitant procedures performed during PK Phase and ongoing during Extension Phase are classified as Both prior and concomitant 
procedure during Extension Phase. 
 
Listing 16.2.5.2d Prior/Concomitant Procedures During the PK Phase (Safety Population in the Stage 3 PK Phase) 
 


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Listing 16.2.5.3a 
Prior and Concomitant Transfusions (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable  
 
Patient 
Number 
Received Transfusion 
within 14 days of first 
dose or during study? 
Type of 
Administration 
Units 
Transfusion Date 
Rel Day [1] 
Prior/ 
Concomitant Flag 
 
 
Other: specify 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the PK Phase. 
Note: Includes patients with prior or concomitant transfusions during the PK Phase. 
P=Prior (any transfusion earlier than the first dose date of study treatment). 
C=Concomitant (any transfusion on or after the initial study treatment dosing date through either the first dose of the Extension 
Phase or through 30 days after the last dose, for those not continuing into the Extension Phase). 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
• 
For the Prior/Concomitant Flag, list all that apply. 
 
Repeat for: 
Listing 16.2.5.3b Prior and Concomitant Transfusions (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.5.3c Prior and Concomitant Transfusions (Safety Population in the Extension Phase) 
[Programming Notes for Extension Phase] 
Footnote: [1] Relative to first dose during the Extension Phase. ‘-’ Rel day before first Dose during Extension Phase, ‘*’ Rel 
day post 30-day safety window from EOT. 
Note: Includes patients with prior or concomitant transfusions during the Extension Phase. 
P=Prior (any transfusion started earlier than the first dose date of Extension Phase treatment). 
C=Concomitant (any transfusion started on or after the initial Extension Phase treatment dosing date through EOT in Extension 
Phase). 
Prior and concomitant transfusion completed during PK Phase only are classified as Prior transfusion during Extension Phase. 
Concomitant transfusion started during PK Phase and ongoing during Extension Phase are classified as Both prior and concomitant 
transfusion during Extension Phase. 
 
Listing 16.2.5.3d Prior and Concomitant Transfusions (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.5.4a 
Prior and Concomitant Growth Factors (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
 
Patient 
Number 
Received growth factor within 14 
days of first dose or during study? 
Type of 
Administration 
Dose 
Unit 
Administration 
Date 
Prior/ 
Concomitant Flag 
 
 
Other: specify 
 
Other: specify 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Includes patients with prior or concomitant growth factors during the PK Phase. 
P=Prior (any growth factor earlier than the first dose date of study treatment). 
C=Concomitant (any growth factor given on or after the initial study treatment dosing date through either the first dose of the 
Extension Phase or through 30 days after the last dose, for those not continuing into the Extension Phase). 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
• 
For the Prior/Concomitant Flag, list all that apply. 
 
Repeat for: 
Listing 16.2.5.4b Prior and Concomitant Growth Factors (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.5.4c Prior and Concomitant Growth Factors (Safety Population in the Extension Phase) 
[Programming Notes] 
Note: Includes patients with prior or concomitant growth factors during the Extension Phase. 
P=Prior (any growth factors administered earlier than the first dose date of Extension Phase treatment). 
C=Concomitant (any growth factors administered on or after the initial Extension Phase treatment dosing date through EOT in Extension 
Phase). 
Prior and concomitant growth factors administered during PK Phase only are classified as Prior growth factors during Extension Phase. 
Concomitant growth factors administered during PK Phase and ongoing during Extension Phase are classified as Both prior and concomitant 
growth factors during Extension Phase. 
 
Listing 16.2.5.4d Prior and Concomitant Growth Factors (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.5.5a 
Study Treatment (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET>  
Patient 
Number 
Visit 
Formulation 
Date:Time of 
Administration 
(Rel Day [1]) 
Full 
Dose 
Taken? 
If No, how 
much 
consumed? 
Reason  
for Change 
Bottle 
Number 
Fast 8 hrs 
prior to 
administration? 
Vomit 
within 8 
hours of 
dose? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the PK Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.5.5b Study Treatment (Safety Population in the Stage 2 PK Phase) 
[For Stage 2 PK Phase] 
• 
Modify label for Vomiting Question, ‘Vomit within specified time of dose’. 
• 
Add column for Nausea Question, ‘Nausea within specified time of dose’. 
 
 


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Listing 16.2.5.5c 
Study Treatment (Safety Population in the Extension Phase) 
TREATMENT:  < TABLET or CAPSULE> 
Patient 
Number 
Visit 
Dose 
Prescribed 
(mg) 
Start Date (Rel Day [1])/ 
Stop Date (Rel Day [1]) 
 
Action Taken 
Reason for 
Modification 
Bottle 
number 
Dispensed 
Bottle Number 
Returned 
 
 
 
 
 
 
Other <specify 
reason> 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the Extension Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Listing 16.2.5.5d 
Study Treatment (Safety Population in the Stage 3 PK Phase) 
Treatment Sequence: <FASTED/FED or <FED/FASTED> 
 
Patient 
Number 
Visit 
Fasted or 
Fed State 
Date:Time of 
Administration 
(Rel Day [1]) 
Bottle Number 
Fast 10 hrs 
prior to 
administration? 
Vomit within 
protocol 
specified hours 
from dose? 
Fast for 
minimum of 4 
hours post 
dose? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the PK Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Listing 16.2.5.6b 
Subsequent Anti-Cancer Therapy (Safety Population in the Stage 2 PK Phase) 
Treatment Sequence:  TABLET/CAPSULE or CAPSULE/TABLET 
Patient 
Number 
Date of Subsequent Anti-Cancer 
Administration  
Relative Day [1] 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the PK Phase. 
Note: Includes only patients with subsequent anti-cancer therapy recorded for patients who do not continue to Extension Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 


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Listing 16.2.5.6c 
Subsequent Anti-Cancer Therapy (Safety Population in the Extension Phase) 
Treatment:  < TABLET or CAPSULE> 
Patient 
Number 
Date of Subsequent Anti-Cancer 
Administration 
Relative Day [1] 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the Extension Phase. ‘*’ Rel day post 30-day safety window from EOT. 
Note: Includes only patients with subsequent anti-cancer therapy recorded as initiated after last dose of the Extension Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 


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Listing 16.2.5.6d 
Meal Status (Safety Population in the Stage 3 PK Phase) 
Treatment Sequence:  <FASTED/FED or <FED/FASTED> 
Patient 
Number 
Visit 
Meal Start Date 
Meal Start Time 
Meal End Time 
% of Meal Consumed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Listing 16.2.6.1c 
Investigator Assessment of Response (Safety Population in the Extension Phase) 
TREATMENT:  < TABLET or CAPSULE> 
Patient 
Number 
Tumor Type 
Date 
Rel Day [1] 
Overall Response 
 
 
 
 
NE:  <Reason> 
 
 
 
 
 
Abbreviations: CP=Complete Response, PD=Progressive Disease, PR=Partial Response, SD=Stable Disease, NE=Not Evaluable. 
[1] Relative to first dose during the Extension Phase. ‘-’ Rel day before first Dose during Extension Phase, ‘*’ Rel day post 30-day 
safety window from EOT. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Listing 16.2.7.1a 
Adverse Events (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
 
Patient 
Number 
Dosing Period/ 
Niraparib 
Treatment 
Adverse Event 
MedDRA Preferred Term 
System Organ Class 
Start Date:Time 
(Rel Day [1]) 
End Date (Rel 
Day [1])  
TEAE? 
SAE/ 
Reason 
[2] 
Severity 
Action 
Taken on 
Study 
Treatment 
Other 
Action 
Taken 
Relation-
ship 
Outcome 
 
Period 1/ 
Capsule 
XXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXX 
yyyy-mm-dd [x] 
yyyy-mm-dd [x] 
Y 
N 
Grade 1  
 
 
Recovered/ 
Resolved 
 
Period 2/ 
Tablet 
XXXXXXXXXXXXXXXX 
[P]XXXXXXXXXXXXXXXXXXX 
[S]XXXXXXXXXXXXXXXXXXX 
yyyy-mm-dd [x] 
yyyy-mm-dd [x] 
Y 
N 
Grade 1  
 
 
Recovered/ 
Resolved 
 
PK Safety FU 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in PK Phase. 
[2] Reason for SAE: 1 = Result in death; 2 = Life threatening; 3 = Result in persistent or significant disability/incapacity;  
4 = Requires or prolongs hospitalization; 5 = Congenital abnormality/birth defect; 6 = Other medically important event. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.7.1b Adverse Events (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.7.1d Adverse Events (Safety Population in the Stage 3 PK Phase) 
[Programming Notes] 
• 
Stage 3: Treatment Sequence will be Fasted/Fed and Fed/Fasted. 
• 
Stage 3: Column 2: Dosing Period/Treatment – Treatment should be Niraparib FASTED or Niraparib FED. 


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Listing 16.2.7.1c 
Adverse Events (Safety Population in the Extension Phase) 
Treatment: <TABLET or CAPSULE>, as applicable 
Patient ID = XXXXXX-XXXX 
Adverse Event 
MedDRA Preferred Term 
System Organ Class 
Start Date (Rel Day [1]) 
End Date (Rel Day [1])  
TEAE? 
 
SAE/ 
Reason 
[2] 
Severity 
Action Taken on 
Study Treatment 
Other 
Action 
Taken Relationship 
Outcome 
XXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXX 
yyyy-mm-dd [x] 
yyyy-mm-dd [x] 
Y 
N 
Grade 1  
 
 
Recovered/ 
Resolved 
XXXXXXXXXXXXXXXX 
[P]XXXXXXXXXXXXXXXXXXX 
[S]XXXXXXXXXXXXXXXXXXX 
yyyy-mm-dd [x] 
yyyy-mm-dd [x] 
Y 
N 
Grade 1  
 
 
Recovered/ 
Resolved 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose during the Extension Phase. ‘*’ Rel day post 30-day safety window from EOT. 
[2] Reason for SAE: 1 = Result in death; 2 = Life threatening; 3 = Result in persistent or significant disability/incapacity;  
4 = Requires or prolongs hospitalization; 5 = Congenital abnormality/birth defect; 6 = Other medically important event. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Listings 16.2.7.1c and 16.2.7.2c should be mutually exclusive. Any AEs with onset during PK Phase or after, but prior to first dose of 
Extension Phase should be in Listing 16.2.7.2c. If the AE is ongoing from before 1st dose of Extension Phase, and the Grade is increased, 
it is still an ongoing AE. 
There should be no records with relative days prior to first dose of Extension Phase. If an AE has onset after EOT, indicate this 
with ‘*’. 
 


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Listing 16.2.7.2c 
Adverse Events Ongoing from PK Phase (Safety Population in the Extension Phase) 
Treatment: <TABLET or CAPSULE>, as applicable 
Patient ID = XXXXXX-XXXX 
Adverse Event 
MedDRA Preferred Term 
System Organ Class 
Start Date (Rel Day 
[1]) 
End Date (Rel Day [1])  
TEAE? 
 
SAE/ 
Reason 
[2] 
Severity 
Action Taken on 
Study Treatment 
Other 
Action 
Taken Relationship 
Outcome 
XXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXX 
yyyy-mm-dd [x] 
yyyy-mm-dd [x] 
Y 
N 
Grade 1  
 
 
Recovered/ 
Resolved 
XXXXXXXXXXXXXXXX 
[P]XXXXXXXXXXXXXXXXXXX 
[S]XXXXXXXXXXXXXXXXXXX 
yyyy-mm-dd [x] 
yyyy-mm-dd [x] 
Y 
N 
Grade 1  
 
 
Recovered/ 
Resolved 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose during the Extension Phase. ‘-’ Rel day before first Dose during Extension Phase, ‘*’ Rel 
day post 30-day safety window from EOT. 
[2] Reason for SAE: 1 = Result in death; 2 = Life threatening; 3 = Result in persistent or significant disability/incapacity;  
4 = Requires or prolongs hospitalization; 5 = Congenital abnormality/birth defect; 6 = Other medically important event. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Only include AEs with date of onset during PK Phase/prior (including Extension Phase Screening/EOT for PK Phase/Safety follow-up) to 
first dose of Extension Phase and ongoing/resolved during Extension Phase. 
Rel Day [1] should always be either zero or negative (with onset during PK Phase, Extension Screening etc.).


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Listing 16.2.8.1.1a 
Hematology Results in the PK Phase (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
Patient 
Number 
Parameter 
(unit) 
Visit 
Rel Day 
[1] 
Sample 
date/time 
Result 
Change from 
baseline 
Normal range 
Out of 
range flag 
Clinically 
significant flag 
 
 
 
 
 
xx.x 
xx.x 
xx.x – xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. 
Scheduled and unscheduled visits through the extension screening phase or through study discontinuation for those not continuing in 
the Extension Phase, are included. Visits related to the extension screening phase are not included. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes]: 
• 
If required for readability, move ‘Patient Number’ into Header row after ‘Treatment Sequence’. 
Repeat for: 
Listing 16.2.8.1.1b Hematology Results (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.1.1c Hematology Results (Safety Population in the Extension Phase) 
Listing 16.2.8.1.1d Hematology Results Through the PK End of Treatment Visit (Safety Population in the Stage 3 PK Phase) 
Listing 16.2.8.1.2a Chemistry Results (Safety Population in the Stage 1 PK Phase) 
Listing 16.2.8.1.2b Chemistry Results (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.1.2c Chemistry Results (Safety Population in the Extension Phase) 
Listing 16.2.8.1.2d Chemistry Results Through the PK End of Treatment Visit (Safety Population in the Stage 3 PK Phase) 
Listing 16.2.8.1.3a Urinalysis Results (Safety Population in the Stage 1 PK Phase) 
Listing 16.2.8.1.3b Urinalysis Results (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.1.3c Urinalysis Results (Safety Population in the Extension Phase) 
Listing 16.2.8.1.3d Urinalysis Results Through the PK End of Treatment Visit (Safety Population in the Stage 3 PK Phase)  
[Programming Notes For Extension Phase]: 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 127 of 135 
• 
Footnote: [1] Relative to first dose during the Extension Phase. ‘-’ Rel day before first Dose during Extension Phase, ‘*’ Rel 
day post 30-day safety window from EOT.  
 


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Listing 16.2.8.1.4c 
Liver Function Tests – Potential Hy’s Law Cases (Safety Population in the Extension Phase) 
TREATMENT: < TABLET or CAPSULE> 
Patient  
Number 
Visit 
Sample 
Collection Date 
Day [1] 
Laboratory Analyte 
(result/xULN) 
ALT (U/L) 
AST (U/L) 
Total Bilirubin 
(umol/L) 
ALP (U/L) 
 
 
DDMMMYYYY  
 
150/3.3 
100/2.7 
40/2.3 
100/0.7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ALP=alkaline phosphatase. ALT=alanine aminotransferase. AST=aspartate aminotransferase. ULN=upper limit of normal. 
 
[1] Relative to first dose during the Extension Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Include all visits for any Patients with ALT or AST >3×ULN with bilirubin >2×ULN and ALP <2×ULN at any time in Extension Phase. 
 
 


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Listing 16.2.8.2a 
Vital Signs (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
 
Patient 
Number 
Visit 
Assessment 
Date 
Rel 
Day 
[1]  
Height 
(cm) 
Weight 
(kg) 
Temperature 
(°C) 
Pulse 
(beats/min) 
Systolic Blood 
Pressure (mmHg) 
Diastolic Blood 
Pressure (mmHg) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. 
Data is listed only when the vital sign assessment was performed. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.8.2b Vital Signs (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.2c Vital Signs (Safety Population in the Extension Phase) 
 
[Programming Notes For Extension Phase]: 
• 
Footnote: [1] Relative to first dose during the Extension Phase. ‘-’ Rel day before first Dose during Extension Phase, ‘*’ Rel 
day post 30-day safety window from EOT. 
• 
Drop Height column. 
 
Listing 16.2.8.2d Vital Signs Through the PK End of Treatment Visit (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.8.3a 
ECG Results (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
 
Patient 
Number 
Visit Date 
Rel Day [1] 
ECG Interpretation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. 
NCS = Not Clinically Significant, CS = Clinically Significant. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.8.3b ECG Results (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.3c ECG Results (Safety Population in the Extension Phase) 
Listing 16.2.8.3d ECG Results (Safety Population in the Stage 3 PK Phase) 
 
[Programming Notes For Extension Phase]: 
• 
Footnote: [1] Relative to first dose during the Extension Phase. ‘-’ Rel day before first Dose during Extension Phase, ‘*’ Rel 
day post 30-day safety window from EOT. 
 
 


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Listing 16.2.8.4a 
ECOG Performance Status (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
 
Patient 
Number 
Visit 
Assessment Date  
Rel Day [1] 
Performance Status 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. Data is listed only when the ECOG Performance Status assessment was performed.  
ECOG = Eastern Cooperative Oncology Group:  
0=Fully active, able to carry on all pre-disease performance without restriction  
1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature  
2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 
3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours  
4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.8.4b ECOG Performance Status (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.4c ECOG Performance Status (Safety Population in the Extension Phase) 
[Programming Notes For Extension Phase]: 
• 
Footnote: [1] Relative to first dose during the Extension Phase. ‘-’ Rel day before first Dose during Extension Phase, ‘*’ Rel 
day post 30-day safety window from EOT. 
Listing 16.2.8.4d ECOG Performance Status Through the PK End of Treatment Visit (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.8.5a 
Baseline Physical Examination Findings (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
 
Patient 
Number 
Visit 
Date Performed 
Rel  
Day [1]  
Body System 
Status 
Abnormality Description 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
Repeat for: 
Listing 16.2.8.5b Baseline Physical Examination Findings (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.5c Baseline Physical Examination Findings (Safety Population in the Extension Phase) 
 
[Programming Notes For Extension Phase]: 
Footnote: [1] Relative to first dose during the Extension Phase. 
 
Listing 16.2.8.5d Baseline Physical Examination Findings (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.8.6a 
Pregnancy Test (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: TABLET or 
CAPSULE>, as applicable 
 
Patient 
Number 
Visit 
Was 
Pregnancy Test Performed? 
Date of Test 
Rel Day [1] 
Type 
Result 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. 
Scheduled and unscheduled visits through the Extension Screening Phase or through study discontinuation for those not continuing in 
the Extension Phase, are included. Visits related to the Extension Screening Phase are not included. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.8.6b Pregnancy Test (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.6c Pregnancy Test (Safety Population in the Extension Phase) 
 
[Programming Notes For Extension Phase]: 
Footnote: [1] Relative to first dose during the Extension Phase. ‘-’ Rel day before first Dose during Extension Phase, ‘*’ Rel 
day post 30-day safety window from EOT. 
 
Listing 16.2.8.6d Pregnancy Test (Safety Population in the Stage 3 PK Phase) 
 


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Listing 16.2.9.2d 
Listing of COVID-19 Assessments and Symptom Assessments for Patients with COVID-19 Adverse Events 
(Safety Population in the Stage 3 PK Phase) 
Treatment Sequence: <Stage 3: Period 1: FASTED or FED; Period 2: FASTED or FED> 
 
Patient 
Number 
Treatment 
Period (State) 
Adverse 
Event 
AE  
Start Date 
COVID-19 Case 
Diagnosis [1] 
COVID-19 Test 
Performed/ Test 
Date/ Results 
Assessments and  
Symptom Assessments 
Result 
 
 
 
 
 
 
 
 
xxxx 
1 (FASTED) 
Coronavirus 
infection 
2020-04-16 
Suspected 
Yes/ 
2020-04-17/ 
Indeterminate 
Travel to Location with Community 
Transmission [2] 
No 
 
 
 
 
 
 
Visited Health Care Facility [2] 
No 
 
 
 
 
 
 
Contact with COVID-19 
Confirmed/Probable Case [2] 
Unknown 
 
 
 
 
 
 
Medication Taken to Treat COVID-19 
Yes 
 
 
 
 
 
 
Fever 
Yes 
 
 
 
 
 
 
Cough 
Yes 
 
 
 
 
 
 
Shortness of Breath 
Yes 
 
 
 
 
 
 
Sore Throat 
No 
 
 
 
 
 
 
Loss of Appetite 
No 
 
 
 
 
 
 
Nausea 
No 
 
 
 
 
 
 
Vomiting 
No 
 
 
 
 
 
 
Diarrhea 
No 
 
 
 
 
 
 
Abdominal Pain 
No 
 
 
 
 
 
 
Fatigue 
No 
 
 
 
 
 
 
Loss of Smell 
No 
 
 
 
 
 
 
Loss of Taste 
No 
 
 
 
 
 
 
Asymptomatic 
No 
 
 
 
 
 
 
Home Quarantined/Isolated 
Unknown 
 
 
 
 
 
 
 
 
 
2 (FED) 
 
 
 
 
... 
 
 
 
 
 
 
 
 
 
 
AE=Adverse event. 
[1] COVID-19 Case Diagnosis is based on WHO Definition as of DDMMMYYYY. 
[2] Within 14 days prior to symptom onset. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
The COVID-19 AE terms include: Asymptomatic COVID-19, Coronavirus infection, COVID-19, COVID-19 pneumonia, Suspected COVID-19.  
Note that the number of COVID-19 AE terms may change.


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Listing 16.2.9.2c 
Listing of COVID-19 Assessments and Symptom Assessments for Patients with COVID-19 Adverse Events 
(Safety Population in the Extension Phase) 
Treatment: <CAPSULE or TABLET> 
 
Patient 
Number 
Formulation  
Adverse 
Event 
AE Start 
Date 
COVID-19 Case 
Diagnosis [1] 
COVID-19 Test 
Performed/ Test 
Date/ Results 
Assessments and  
Symptom Assessments 
Result 
 
 
 
 
 
 
 
 
xxxx 
TABLET 
Coronavirus 
infection 
2020-04-
16 
Suspected 
Yes/ 
2020-04-17/ 
Indeterminate 
Travel to Location with 
Community Transmission [2] 
No 
 
 
 
 
 
 
Visited Health Care 
Facility [2] 
No 
 
 
 
 
 
 
Contact with COVID-19 
Confirmed/Probable Case [2] 
Unknown 
 
 
 
 
 
 
Medication Taken to Treat 
COVID-19 
Yes 
 
 
 
 
 
 
Fever 
Yes 
 
 
 
 
 
 
Cough 
Yes 
 
 
 
 
 
 
Shortness of Breath 
Yes 
 
 
 
 
 
 
Sore Throat 
No 
 
 
 
 
 
 
Loss of Appetite 
No 
 
 
 
 
 
 
Nausea 
No 
 
 
 
 
 
 
Vomiting 
No 
 
 
 
 
 
 
Diarrhea 
No 
 
 
 
 
 
 
Abdominal Pain 
No 
 
 
 
 
 
 
Fatigue 
No 
 
 
 
 
 
 
Loss of Smell 
No 
 
 
 
 
 
 
Loss of Taste 
No 
 
 
 
 
 
 
Asymptomatic 
No 
 
 
 
 
 
 
Home Quarantined/Isolated 
Unknown 
 
 
 
 
 
 
 
 
 
CAPSULE 
 
 
 
 
... 
 
 
 
 
 
 
 
 
 
 
AE=Adverse event. 
[1] COVID-19 Case Diagnosis is based on WHO Definition as of DDMMMYYYY. 
[2] Within 14 days prior to symptom onset. 
Note: Extension Phase for all Stages of TABLET study overlapped with COVID-19 pandemic, with all Stage 3 patients commencing treatment 
for the Extension Phase on or after 02JUN2021 placing the AE onset during the pandemic, while last patient commenced treatment for 
Stages 1 and 2 on 14MAY2018 and 05DEC2019, respectively, placing their first Extension Phase treatment dose administration prior to 
the start of the pandemic, as defined by WHO as of 20MAR2020, with patients across all Stages ongoing until DDMMMYYYY. 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 


Signature Page for  213362 TMF-16339705 v1.0
Signature Page for TMF-16339705 v1.0
Reason for signing: Approved
Name: 
Role: Author
Date of signature: 12-Jul-2023 13:42:14 GMT+0000
Reason for signing: Approved
Name: 
Role: Approver
Date of signature: 12-Jul-2023 15:14:33 GMT+0000
PPD
PPD


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 1 of 119 
 
Statistical Analysis Plan 
AN OPEN-LABEL, RANDOMIZED-SEQUENCE, MULTICENTER, SINGLE-CROSSOVER 
STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY AND BIOEQUIVALENCE OF 
NIRAPARIB TABLET FORMULATION COMPARED TO NIRAPARIB CAPSULE 
FORMULATION IN PATIENTS WITH ADVANCED SOLID TUMORS 
 
GSK/TESARO Protocol 
Number: 
213362/3000-01-004 
Protocol Version: 
6.0 (Amendment 5) 
Compound Number: 
GSK 3985771, MK-4827 
Study Drug Name:  
Niraparib 
Phase:  
Phase 1 
Methodology:  
Open-Label, Cross-Over 
Sponsor:  
TESARO, a Glaxo Smith Kline Company 
Analysis Plan Date: 
21 December 2021 
Analysis Plan Version:  
Version 6.0 
 
 
Confidentiality Statement 
All information contained in this document is privileged and confidential to TESARO, a wholly 
owned subsidiary of Glaxo Smith Kline (GSK). Any distribution, copying, or disclosure is strictly 
prohibited without prior written approval by TESARO. 


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Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 3 of 119 
TABLE OF CONTENTS 
SPONSOR SIGNATURE PAGE.................................................................................................................. 2 
TABLE OF CONTENTS .............................................................................................................................. 3 
TABLES INCLUDED IN THE TEXT ......................................................................................................... 5 
FIGURES INCLUDED IN THE TEXT ....................................................................................................... 5 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ............................................................... 6 
1 
INFORMATION FROM THE STUDY PROTOCOL ......................................................................... 8 
1.1 
Introduction and Objectives .......................................................................................................... 8 
1.1.1 
Introduction ........................................................................................................................... 8 
1.1.2 
Study Objectives ................................................................................................................... 8 
1.1.3 
Scope and Revision History .................................................................................................. 9 
1.2 
Study Design ............................................................................................................................... 12 
1.2.1 
Synopsis of Study Design ................................................................................................... 12 
1.2.2 
Randomization Methodology .............................................................................................. 15 
1.2.3 
Unblinding .......................................................................................................................... 16 
1.2.4 
Study Procedures................................................................................................................. 16 
1.2.5 
Efficacy, Safety, and Pharmacokinetic parameters ............................................................. 16 
2 
Patient Population ............................................................................................................................... 16 
2.1 
Population Definitions ................................................................................................................ 16 
2.2 
Protocol Deviations ..................................................................................................................... 17 
3 
GENERAL STATISTICAL METHODS ........................................................................................... 17 
3.1 
Sample Size Justification ............................................................................................................ 17 
3.2 
General Methods ......................................................................................................................... 18 
3.3 
Baseline Definitions .................................................................................................................... 19 
3.4 
Methods of Pooling Data ............................................................................................................ 20 
3.5 
Adjustments for Covariates ......................................................................................................... 20 
3.6 
Multiplicity Adjustment .............................................................................................................. 20 
3.7 
Subpopulations ............................................................................................................................ 20 
3.8 
Withdrawals, Drop-outs, Loss to Follow-up ............................................................................... 20 
3.9 
Missing Data ............................................................................................................................... 20 
3.10 
Visit Windows ............................................................................................................................ 21 
3.11 
Interim Analysis .......................................................................................................................... 21 
3.12 
COVID-19 ................................................................................................................................... 21 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 4 of 119 
4 
STUDY ANALYSES ......................................................................................................................... 21 
4.1 
Patient Disposition ...................................................................................................................... 21 
4.2 
Demographics, Baseline Characteristics and Medical History ................................................... 22 
4.3 
Investigator Assessment of Response ......................................................................................... 23 
4.4 
Safety Evaluation ........................................................................................................................ 23 
4.4.1 
Treatment Exposure and Compliance ................................................................................. 23 
4.4.2 
Adverse Events ................................................................................................................... 23 
4.4.3 
Laboratory Data .................................................................................................................. 26 
4.4.4 
Vital Signs and Physical Examination ................................................................................ 27 
4.4.5 
Electrocardiogram ............................................................................................................... 27 
4.4.6 
Prior and Concomitant Mediations ..................................................................................... 27 
4.4.7 
Prior and Concomitant Transfusions and Growth Factors .................................................. 28 
4.4.8 
COVID-19 ........................................................................................................................... 28 
5 
CHANGES TO PLANNED ANALYSES .......................................................................................... 29 
5.1 
Changes in v5.0 of the SAP ........................................................................................................ 29 
5.2 
Changes in v6.0 of the SAP ........................................................................................................ 29 
6 
APPENDIX ......................................................................................................................................... 30 
6.1 
Planned Statistical Tables, Listings, and Figures ........................................................................ 30 
 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 5 of 119 
TABLES INCLUDED IN THE TEXT 
TABLE 1 REVISION HISTORY ....................................................................................................................... 11 
TABLE 2 NCI COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS V4.03 (CTCAE) ..................... 27 
FIGURES INCLUDED IN THE TEXT 
FIGURE 1 STUDY DESIGN: SINGLE-CROSSOVER STUDY ............................................................................. 15 
 
 


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Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 7 of 119 
Abbreviation 
Definition 
Q1 
first quartile 
Q3 
third quartile 
QD 
one time per day 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
standard deviation 
SOC 
system organ class 
t1/2 
termination elimination half-life  
TEAE 
treatment-emergent adverse event 
tmax 
Time to reach Cmax 
US 
United States 
ULN 
upper limit of normal 
Vz/F 
apparent terminal volume of distribution  
WHO 
World Health Organization 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 8 of 119 
1 INFORMATION FROM THE STUDY PROTOCOL 
1.1 Introduction and Objectives 
1.1.1 Introduction 
The approved niraparib drug product is an immediate release hard gelatin capsule dosage form that 
contains 100 mg of niraparib per capsule. The labelled starting dose for niraparib is 300 mg. Facilitating 
this dose requires the administration of three 100 mg capsules.  
It is Sponsor’s intent to introduce a tablet dosage form that provides the 100 mg, 200 mg and 300 mg dose 
in single dose strength tablets to reduce the pill burden on the patients. 
To this end, the Sponsor has developed a tablet dosage form with the specific intent to provide 
comparable performance to the approved capsule dosage form. The formulation and manufacturing 
process of the tablet were selected to produce a tablet with comparable in-vitro performance to the 
capsule.  
This study is an open-label Phase 1 study to evaluate the relative bioavailability (BA) and bioequivalence 
(BE) of niraparib administered as a tablet formulation compared to the reference capsule formulation 
manufactured by the same process as currently marketed in the United States. Specifically, a 300 mg 
niraparib tablet will be compared to three (3) niraparib capsules (3 × 100 mg). In addition, this study will 
evaluate the effect of a high-fat meal on the pharmacokinetics (PK) of the niraparib 300 mg tablet 
formulation (Stage 3). The Extension Phase of this study is to enable patients enrolled in the study to 
continue to receive treatment with niraparib if they are tolerating it and, in the Investigator’s opinion, may 
receive benefit. 
1.1.2 Study Objectives 
The primary objectives of this study are as follows: 
• 
Stage 1: To obtain preliminary assessment of the relative bioavailability of 300 mg niraparib 
administered as a tablet versus capsule formulation and to estimate the intra-subject variability of 
niraparib PK 
• 
Stage 2: To evaluate if the tablet formulation (1 × 300 mg) of niraparib is bioequivalent to the 
capsule formulation (3 × 100 mg) 
• 
Stage 3: To assess the effect of a high-fat meal on niraparib PK following a single 300 mg dose of 
the tablet formulation. 
The secondary objectives of this study are as follows: 
• 
Stage 1, Stage 2, and Stage 3: To evaluate the safety of single dose niraparib when administered as 
a tablet or capsule formulation in patients with advanced solid tumors 
• 
Extension Phase: To evaluate the safety of continuously dosed niraparib in patients with 
advanced solid tumors. 
 
 


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Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 10 of 119 
Table titles updated to  
• 
Table 14.3.1.20D Summary of 
Incidence of COVID-19 Related 
Adverse Events Over Time (Safety 
Population in the Stage 3 PK Phase)  
• 
Table 14.3.1.21D Summary of 
Incidence of COVID-19 Related 
Adverse Events Over Time by Gender 
(Safety Population in the Stage 3 
PK Phase) 
• 
Table 14.3.1.22D Summary of 
Incidence of COVID-19 Related 
Adverse Events Over Time by Age 
Group (Safety Population in the 
Stage 3 PK Phase) 
Clarification of titles to reflect the 
reporting effort of COVID-19 related 
AE incidence rates. 
Table 14.4.1C 
Summary table of Important Protocol 
Deviations for Open-Label Extension Phase 
added. 
Added upon request from study team 
for CSR reporting purposes. 
Table 14.4.1D 
Summary table of Important Protocol 
Deviations for the PK Phase Occurring Through 
End of Treatment (Safety Population in the 
Stage 3 PK Phase). 
Footnotes and corresponding references added 
to the table. 
Added upon request from study team 
for CSR reporting purposes. 
 
 
Added upon request for clarification. 
Listing 16.2.5.1D 
Added “PK Dose 1” and “PK Dose 2” date 
columns to the listing. 
 
Moved “Patient Number” into header row. 
Added columns to the shells to align 
Stage 3 reported outputs with those 
reported in Stages 1 and 2. 
For readability purposes. 
Listing 16.2.5.3D 
Added “Rel Day [1]” column and [1] footnote: 
“[1] Relative to first dose during the PK Phase.” 
Added to the shells to align Stage 3 
reported outputs with those reported in 
Stages 1 and 2. 
Listing 16.2.5.5D 
Columns “Full Dose Taken?”, “If N, how much 
consumed?”, “Reason for Change”, “Nausea 
within specified time of dose?” removed from 
the listing.  
Columns removed from Stage 3 listing 
as not applicable, as per study design. 
Listing 16.2.8.1.1D 
and associated 
repeat listings 
Programming note added regarding location of 
“Patient Number” in the outputs. 
Depending on spacing/information 
displayed, “Patient Number” may be 
displayed in the header row after 
“Treatment Sequence” in order to aid 
readability of the listing. 
Listing 16.2.8.2D 
Removed “Heart Rate” column. 
Data collected under “Pulse” in 
Stage 3, added “Heart Rate” to the 
shells in error. 
Listing 16.2.8.5D 
Added text to footnote: “in the PK Phase” 
Previously missing in error. 
Listing 16.2.2C 
Listing updated to include only “Important” 
protocol deviations, title updated to reflect 
change. 
Updated upon request from study team 
for CSR reporting purposes. 
Listing 16.2.2.1D 
Listing updated to include only “Important” 
protocol deviations, title updated to reflect 
change. 
Updated upon request from study team 
for CSR reporting purposes. 
Section 1.2 
Definition of data cut has been amended. 
Definition changed to reflect study 
reporting requirements upon request 
from study team. 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 11 of 119 
Table 1 Revision History 
SAP  
version 
Protocol 
version 
eCRF  
version 
Changes from previous version 
1.0 
2.0 
5.0 
(26FEB2018) 
First Draft 
2.0 
4.0 
8.0 
(12FEB2019) 
Major changes to this draft of the SAP include the following: 
• 
Incorporate changes based on amended protocol. 
• 
Modify Stage 2 analysis of AEs to accommodate the increase in 
washout time between period 1 and period 2 for Stage 2. 
• 
For the Extension Phase, specify that analysis will be performed 
by formulation and overall to accommodate allowance of both 
tablet and capsule formulation in the Extension Phase. 
• 
Define the BA/BE evaluable population and add demographic 
and baseline characteristic summaries for this population. 
• 
Clarify definition of concomitant medications and add additional 
table for Stage 2 to analyze only medications taken during the 
PK collection period. 
• 
Clarifications to mock table and listing shells (e.g., numbering, 
footnotes). 
3.0 
5.0 
10.0 
(31JUL2019) 
Major changes to this draft of the SAP include the following: 
• 
Incorporate changes based on amended protocol, including: 
o 
Updated numbers of patients enrolled to account for 
non-evaluability. 
o 
Specification of reasons for non-evaluability for the 
analysis of bioequivalence. 
• 
Focus Extension Phase laboratory summaries on select 
laboratory assessments hemoglobin, neutrophils, platelets, 
bilirubin, creatinine, AST, and ALT). 
4.0 
6.0 
11.0 
(23MAR2021) 
Major changes to this draft of the SAP include the following: 
• 
Incorporate changes based on amended protocol, to address the 
objectives for Stage 3 of the study. 
• 
Addition of sections relating to COVID-19 reporting. 
5.0 
6.0 
11.0 
(23MAR2021) 
Primary changes to this draft associated with addition of Important 
Protocol Deviation table and updates to the associated listing to reporting 
effort.  
Minor updates to align Stage 1, 2 and 3 TLFs with shells, and associated 
update to Protocol Deviation reporting, as per the SAP. 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 12 of 119 
SAP  
version 
Protocol 
version 
eCRF  
version 
Changes from previous version 
6.0 
6.0 
11.0 
(23MAR2021) 
Primary change to this draft of the SAP is change of the data cut for 
reporting of final Stage 3 analysis. 
Minor update to footnotes of Important Protocol Deviation summary 
table. 
Minor update to Section 5 formatting. 
1.2 Study Design 
1.2.1 Synopsis of Study Design 
This is a multicenter, open-label study in patients with advanced solid tumors. This is a 3-stage, 
randomized-sequence, single-crossover study to assess the relative BA and BE of niraparib tablet 
formulation relative to the capsule formulation. In addition, Stage 3 of the protocol is a single cohort, 
randomized-sequence, 2 period, single dose, crossover study to assess effect of food on the PK of the 
niraparib tablet formulation. 
Pharmacokinetics (PK) Phase: In Stages 1 and 2, patients will be randomized 1:1 to receive tablet 
formulation followed by capsule formulation or capsule formulation followed by tablet formulation. In 
Stage 3, patients will be randomized 1:1 to receive tablet formulation in a fasted state followed by tablet 
taken with a high-fat meal, or by tablet taken with a high-fat meal followed by tablet formulation taken in 
a fasted state. 
Stage 1: Following an 8-hour fast on Day 1, patients will receive a single dose of the formulation (tablet 
[1 × 300 mg] or capsule [3 × 100 mg]) followed by a 7-day (+1 day) Washout/PK period, followed by a 
dose of the alternate formulation also in a fasted state, followed by a 7-day (+1 day) Washout/PK period 
for Stage 1 of the study followed by a dose of the alternate formulation also in a fasted state, followed by 
a 7-day Washout/PK period. Patients receiving the tablet in the first treatment period will receive the 
capsules in the second treatment period and vice versa (Figure 1). Extensive PK sampling will be carried 
out after niraparib dosing. 
Stage 2: Following an 8-hour fast on Day 1, patients will receive a single dose of the formulation (tablet 
[1 × 300 mg] or capsule [3 × 100 mg]) followed by a 14-day (+/- 4 days) Washout/PK period followed by 
a dose of the alternate formulation also in a fasted state, followed by a 7-day Washout/PK period. Patients 
receiving the tablet in the first treatment period will receive the capsules in the second treatment period 
and vice versa (Figure 1). Extensive PK sampling will be carried out after niraparib dosing. 
Stage 3: In period 1, patients will receive a single 300 mg niraparib tablet either following a 10-hour fast 
or directly following consumption of a high-fat meal, followed by a 14-day (+4 days) PK sampling and 
Washout period. In period 2, patients will be crossed over to receive a single 300 mg niraparib tablet in a 
fasted state or with a high-fat meal, followed by a 7-day PK sampling period. All patients will fast for a 
minimum of 4 hours post-dose in both periods. Patients receiving the tablet in the fasted state in the first 
treatment period will receive the tablet with a high-fat meal in the second treatment period and vice versa. 


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Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 14 of 119 
will take one 200 mg strength tablet or 2 × 100 mg tablet/capsules at each dose administration (QD). For 
patients whose initial starting dose is 200 mg QD, escalation to 300 mg QD is permitted after 2 cycles of 
therapy if no treatment interruption or discontinuation was required during the first 2 cycles of Extension 
Phase therapy and after approval from the Sponsor. Additional dose modifications will not be based upon 
changes in the patient’s actual body weight during study participation. If laboratory values at the 
beginning of Extension Phase are outside of the range specified in the inclusion criteria, the patient may 
continue to participate in the study only upon Sponsor approval with consideration for an appropriately 
reduced dose. Should a patient start the Extension Phase at 100 mg, consideration may be given to 
escalate to 200 mg after 2 cycles, therapy if no treatment interruption or discontinuation was required 
during the first 2 cycles of Extension Phase therapy and after approval from the Sponsor.  
Patients have up to 28 days (21 days for Stage 3 only; up to 28 days may be acceptable following 
discussion between the Sponsor and Investigator) after completion of the PK Phase to complete the 
screening assessments and the Extension Phase Screening Visit. 
A tumor assessment is to be performed prior to the first dose of the Extension Phase (pre-Extension 
Phase). The pre-Extension Phase tumor assessment need not be completed if the baseline tumor 
assessment was performed ≤ 56 days before the first dose of the Extension Phase. 
The Cycle 1/Day 1 Visit can occur on the same day as the Extension Phase Screening Visit, dependent 
upon availability of radiographic results obtained ≤ 56 days of the first planned dose in the Extension 
Phase. If the Extension Phase Screening Visit and the Cycle 1/Day 1 Visit occur on the same day, the 
clinical laboratory results will be reviewed by the study personnel prior to study drug administration to 
ensure eligibility. At the Cycle 1/Day 1 Visit, patients will undergo safety assessments and will receive 
study drug supply for the duration of 1 cycle (300 mg or 200 mg tablets of niraparib for QD dosing or 
3 × 100 mg or 2 × 100 mg tablet/capsules of niraparib for QD dosing, depending on availability). It is 
preferred that patients remain on the same formulation (tablet versus capsule) throughout the Extension 
Phase. Patients will return on the first day of every treatment cycle (28 ± 7 days) to receive study drug 
and for safety assessments. Visits will continue approximately every 4 weeks until treatment 
discontinuation. In line with the niraparib United States Package Insert (US PI), dose interruption (no 
longer than 28 days) will be allowed based on adverse events (AEs). In addition, dose reductions to 
200 mg QD and subsequently to 100 mg QD will be allowed based on AEs (please refer to US PI). Any 
dose reductions differing from this must be discussed with the medical monitor. Patients can continue in 
the Extension Phase until the patient meets 1 of the withdrawal criteria. 
End-of-treatment (EOT) and Safety Follow-up Visits: The EOT visit will occur within 7 days of the 
decision to discontinue study drug, for any reason, or completion of the PK Phase for patients who 
participate in the Extension Phase (Stage 3 only), whichever occurs first. Should the first dose of a new 
anti-cancer therapy occur within 14 days of the decision to discontinue study drug, all assessments 
required for the Safety Follow-up visit should occur at the EOT visit and this visit will be considered the 
Safety Follow-up visit. If the first dose of the new anti-cancer therapy occurs >14 days of the decision to 
discontinue study, the Safety Follow-up visit will occur 30 +7 days after the last dose of the study drug, or 
at the start of any new anti-cancer therapy, whichever occur first. 
For Stage 3 of the PK Phase only, the data cut will occur when all patients have completed the PK Phase. 
Data collected up to and including PK EOT visit prior to the data cut will be presented in the FE Stage 3 


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Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 16 of 119 
1.2.3 Unblinding 
Unblinding is not applicable as this is an open-label study. 
1.2.4 Study Procedures 
Refer to the latest protocol for the schedule of assessments. 
1.2.5 Efficacy, Safety, and Pharmacokinetic parameters 
1.2.5.1 
Efficacy parameters 
Investigator assessment of response will occur every 3-cycles while on study or per the Institution’s 
standard practice. 
1.2.5.2 
Safety parameters 
Safety parameters to be assessed include: 
• 
Treatment emergent adverse events (TEAE) 
• 
Discontinuations due to AEs 
• 
Physical examination (PE) findings 
• 
Vital signs 
• 
Clinical laboratory results (hematology, chemistry, urinalysis) 
• 
Electrocardiograms (ECG) 
• 
Use of concomitant medications. 
1.2.5.3 
PK parameters 
PK parameters and analysis methodology will be addressed in the PK analysis plan. 
2 Patient Population 
2.1 Population Definitions 
The following patient populations will be evaluated for analyses specified in this SAP. Additional 
populations, relevant to the PK analysis will be defined in the PK analysis plan. 
• 
Safety Population in the Stage 1 PK Phase: All patients who receive any amount of niraparib 
during the Stage 1 PK Phase of the study. 
• 
Safety Population in the Stage 2 PK Phase: All patients who receive any amount of niraparib 
during the Stage 2 PK Phase of the study. 
• 
Safety Population in the Stage 3 PK Phase: All patients who receive any amount of niraparib 
during the Stage 3 PK Phase of the study. 
• 
Safety Population in the Extension Phase: All patients who receive any amount of niraparib in the 
Open-Label Extension Phase of the study. 
• 
BA/BE Evaluable Population: All patients who complete both PK periods and have sufficient PK 
sample collection to accurately estimate PK parameters, without significant niraparib carryover 
(baseline concentration > 5% of Cmax), in both PK Periods. Patients who have significant 
niraparib carryover from period 1 in period 2 will be completely excluded from the BA/BE 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 17 of 119 
Evaluable Population. The terminology BA Evaluable Population will be used for Stage 1 and BE 
Evaluable Population will be used for Stage 2. 
• 
Food effect (FE) Evaluable Population: All patients who complete both PK periods and have 
sufficient PK sample collection to accurately estimate PK parameters in both periods. Patients 
meeting non-evaluability criteria or having significant niraparib carryover (baseline 
concentration >5% of Cmax) will be completely excluded from the FE Population. 
2.2 Protocol Deviations 
Protocol deviations will be assessed and classified as important and/or significant per Sponsor’s SOP. The 
Medical Data Review Plan (MDRP) prospectively identifies classification criteria for important 
deviations. All protocol deviations will be identified, classified and finalized prior to database lock. 
A listing of protocol deviations will be provided for the Stage 1 PK Phase, Stage 2 PK Phase; for Stage 3 
PK Phase and the Open-Label Extension Phase a listing of only “Important” protocol deviations will be 
provided. 
For Stage 3 PK Phase and Open-Label Extension Phase, tables summarizing “Important” protocol 
deviations will be provided. 
3 GENERAL STATISTICAL METHODS 
3.1 Sample Size Justification 
Stage 1 
No formal sample size calculation was performed for Stage 1. Approximately 24 patients will be enrolled 
in Stage 1. This sample size is considered adequate for preliminary assessment of the relative 
bioavailability of the tablet compared to the capsules and for estimating the intra-subject coefficient of 
variation, after accounting for patient drop-outs and potential carryover.  
Stage 2 
Based on estimates from Stage 1, 100 BA/BE evaluable patients are required in Stage 2. With 100 
evaluable patients, assuming the intra-subject coefficient of variation (CV) is 25% and the true ratio of 
means is 0.89 (89%), there is at least 90% power to demonstrate the bioequivalence (bioequivalence 
range: 0.80 to 1.250 [80% – 125%], alpha=0.05). Power calculations were also performed under 
alternative assumptions for the CV and mean ratio. Assuming the CV is 30% and the true ratio of means 
is 0.89 (89%), with 100 evaluable patients, there is at least 82% power to demonstrate bioequivalence. 
Assuming the true ratio is 0.90 (90%), the power is 96% and 88% assuming CVs of 25% and 30%, 
respectively.  
The final analysis of bioequivalence will be based on Stage 2 BA/BE evaluable patients only, with a 
target sample size of 100 evaluable patients. Patients may be identified as non-evaluable due to issues 
arising during the study conduct, such as: 
• 
Emesis within 9 hours of dosing,  


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 18 of 119 
• 
Dosing errors,  
• 
Patient did not fast prior to dosing,  
• 
Missing critical PK sample on Day 8,  
• 
Failure to complete both PK periods, and 
• 
Significant changes to the patient medical status that would potentially affect the PK profile as 
determined by the Sponsor in consultation with the Investigator prior to PK data analysis.  
In this patient population, approximately 170 total patients are targeted for enrollment, assuming a 35% 
non-evaluability rate during the study conduct, and an additional 10% non-evaluability rate during PK 
analysis. The non-evaluability rate arising during the study conduct will be continuously monitored by the 
Sponsor and the total number of enrolled patients may be adjusted accordingly with the aim to target the 
resulting sample size of 100 BA/BE evaluable patients.  
Stage 3 
Assuming the true ratio of means is 1 and the intra-subject CV is 20% for AUC0-t and AUC0-∞, with 16 
evaluable patients, there is approximately 83% probability that the 90% CI of the ratio of geometric 
means will be within 0.800 and 1.250 (80% - 125%). Based on the results of a FE study conducted using 
the capsule formulation, an effect of a high-fat meal on Cmax is possible. The sample size of 16 patients is 
deemed adequate to characterize this effect. AUC0-t and AUC0-∞ will be the primary parameters for 
analysis.  
The primary analysis will be based on the FE Evaluable Population as it is the most conservative 
approach, which maximizes the benefits of the crossover design, where each patient serves as their own 
control. Results for the PK Evaluable Population will also be summarized and reported for this study. 
To account for non-evaluable patients, approximately 20 total patients are targeted for enrollment. The 
final analysis will be based on Stage 3 FE evaluable patients only. Patients may be identified as 
non-evaluable due to issues arising during the study conduct, such as: 
• 
Emesis within 10 hours of dosing, 
• 
Dosing errors, 
• 
Patient did not follow dietary requirements prior to dose and post-dose, 
• 
Failure to complete both PK periods, and 
• 
Significant changes to the patient medical status that would potentially affect the PK profile as 
determined by the Sponsor in consultation with the Investigator prior to PK data analysis.  
Patients who miss critical PK samples or miss sufficient samples to render calculation of AUC unreliable 
will be discontinued from the PK Phase; those that meet other criteria for continued niraparib therapy will 
be eligible to be screened for the Extension Phase. The non-evaluability rate arising during the study 
conduct will be continuously monitored by the Sponsor and the total number of enrolled patients may be 
adjusted accordingly with the aim to target the resulting sample size of 16 evaluable patients. 
3.2 General Methods 
All statistical analyses will be performed using SAS statistical software v9.4 or later, unless otherwise 
noted. All output will be incorporated into Microsoft Word or Excel files, or Adobe Acrobat PDF files, 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 19 of 119 
sorted and labeled according to the International Conference on Harmonisation (ICH) recommendations, 
and formatted to the appropriate page size(s). 
For categorical variables, summary tabulations of the number and percentage of patients within each 
category of the parameter will be presented. Percentages will be based on the patients with a non-missing 
parameter unless missing category is presented. Percentages will be reported to one decimal place. 
Percentages will not be presented for zero counts. 
For continuous variables, the number of patients, mean, standard deviation (SD), median, first quartile 
(Q1), third quartile (Q3), minimum, and maximum values will be presented. Mean, median, Q1, and Q3 
will be reported to 1 more decimal place than the raw data, while the SD will be reported to 2 more 
decimal places than the raw data. 
All data listings that contain an evaluation date will also contain a relative study day. A unique relative 
study day will be calculated for the PK Phase and Extension Phase based on the first date of dosing within 
the study phase. Pre-treatment and on-treatment study days are numbered relative to the day of the first 
dose of study drug which is designated as Day 1. The preceding day is Day -1, the day before that is 
Day -2, etc. Post-treatment study days are numbered relative to the first dose and are designated as 
Day +1, Day +2, etc. 
In addition: 
• 
Medical history and AEs will be coded using the most up-to-date version of Medical Dictionary 
for Regulatory Activities (MedDRA).  
• 
Laboratory parameter changes during the Extension Phase for selected laboratory tests will be 
described using shift tables, relative to the National Cancer Institute (NCI) Common Terminology 
Criteria for Adverse Events (CTCAE) v4.03.  
• 
Concomitant medications will be coded using the latest version of the World Health 
Organization’s (WHO) Anatomical Therapeutic Chemical (ATC) classification. 
• 
CIs will be presented to one more decimal place than the raw data. 
Summaries in the Extension Phase will be performed by formulation and overall, regardless of starting 
dose, unless otherwise specified. The niraparib formulation and dose at onset will be included in the 
listing for the Extension Phase. 
All tables, figures, and listings will include footers at the bottom of the page reflecting the programs used 
to generate the tables, figures, and listings, and date and time of the generation of the output. 
Some minor modifications may be necessary to the planned design of tables, figures, and listings to 
accommodate data collected during the actual study conduct. 
3.3 Baseline Definitions 
For all analyses unless otherwise noted, baseline is defined as the most recent measurement prior to the 
first administration of study drug, for each phase of the study. Baseline can be the same date as first dose, 
given the measurement is expected prior to first dose when only date information is available.  


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 20 of 119 
3.4 Methods of Pooling Data 
Data will be pooled across study sites.  
3.5 Adjustments for Covariates 
No formal statistical analyses that adjust for possible covariate effects are planned for the safety endpoints. 
3.6 Multiplicity Adjustment 
Multiplicity is not adjusted in this study. 
3.7 Subpopulations 
Not applicable. 
3.8 Withdrawals, Drop-outs, Loss to Follow-up 
Patients will not be replaced during Stage 1. During Stage 2 and Stage 3, patients who do not complete 
period 1 or period 2, or who are missing PK samples which render the determination of the primary PK 
parameters not possible, will be replaced. After evaluation, patients receiving concomitant medications 
which may affect the final analysis may be replaced. 
3.9 Missing Data 
In general, there will be no imputations made to accommodate missing data points. All data recorded on 
the eCRF will be included in data listings for the CSR. 
When tabulating AE data, partial dates will be handled as follows: 
• 
If the day of the month is missing, the onset day will be set to the first day of the month unless it 
is the same month and year as first study treatment. In this case, in order to conservatively report 
the event as treatment-emergent, the onset date will be assumed to be the date of first study 
treatment. 
• 
If the onset day and month are both missing, the day and month will be assumed to be January 1, 
unless the event occurred in the same year as the first study treatment. In this case, the event onset 
will be coded to the day of first study treatment in order to conservatively report the event as 
treatment-emergent. 
• 
A missing onset date will be coded as the first day of study treatment. If the resulting onset date is 
after a reported date of resolution, the onset date will be set equal to the date of resolution, after 
considering any required imputation. 
Imputation of partial dates is used only to determine whether an event is treatment-emergent; data listings 
will present the partial date as recorded in the eCRF. 
Partial start dates for prior/concomitant medication, growth factor and transfusion data will be handled in 
the same way as described above for adverse events. Stop dates will be imputed as follows: 
• 
If only day of the month is missing, the end day will be set to the last day of the month.  
• 
If end day and end month are missing, and the year is not missing, then the day and month will be 
set to December 31 (or date of study discontinuation/completion if earlier than December 31).  


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 21 of 119 
• 
If the stop date is completely missing, it will be set to the date of study 
discontinuation/completion. 
• 
If the imputed stop date is greater than the date of study discontinuation/completion then the date 
will be set to the date of study discontinuation/completion. 
3.10 Visit Windows 
By-visit summaries and analyses will be performed by nominal visit. All data will be tabulated per the 
evaluation visit as recorded on the eCRF even if the assessment is outside of the visit window for 
analysis. 
3.11 Interim Analysis 
There will be no interim analysis for this study. 
3.12 COVID-19 
COVID-19 pandemic may impact the conduct of clinical studies. Challenges may arise from quarantines, 
site closures, travel limitations interruptions to the supply chain for the investigational product or other 
considerations if site personnel or patients become infected with COVID-19. These challenges may lead 
to difficulties in meeting protocol specified procedures, including administering or using the 
investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. 
This study was initiated by TESARO, which was subsequently acquired by GSK. Prior to the acquisition, 
protocol deviations were classified using TESARO definitions. The TESARO protocol deviation system 
was decommissioned in May 2020, and thereafter, protocol deviations were classified using GSK 
definitions. 
All protocol deviations collected during the study will be reviewed by the TESARO (for Stage 1 and 
Stage 2) or GSK (for Stage 3 only) study team, as appropriate, in order to identify TESARO 
“Significant”/“Important” protocol deviations and GSK “Important” protocol deviations, respectively. 
Consistent with ICH E3 guidance, only protocol deviations identified as “Important” (GSK) are evaluated 
in the CSR for impact on the Stage 3 primary endpoint. 
4 STUDY ANALYSES 
4.1 Patient Disposition 
A by-patient data listing of patient disposition information will be presented for each phase. 
For the PK Phase (Stage 1, Stage 2 and Stage 3 separately), patient disposition will be tabulated and will 
include the number of patients in each of the following categories: 
• 
Patients screened 
• 
Patients randomized 
• 
Patients treated with each formulation (Stage 1 and 2) 
• 
Patients treated in fed and fasted state (Stage 3) 
• 
Patients in the safety population 


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• 
Patients completing the PK Phase 
• 
Primary reason for discontinuation from the PK Phase 
• 
Primary reason for discontinuation from the study, for patients who do not continue to the 
Extension Phase. 
For the Open-Label Extension Phase, patient disposition will be tabulated and will include the number of 
patients in each of the following categories: 
• 
Patients treated with at least one dose 
• 
Patients who discontinue treatment and the reason(s) for withdrawal 
• 
Patients who discontinue the study and the reason(s) for withdrawal. 
4.2 Demographics, Baseline Characteristics and Medical History 
Demographics, baseline characteristics, primary cancer history, and medical history information will be 
summarized for the PK safety population by sequence and overall (Stage 1, Stage 2 and Stage 3 
separately) and for the Open-Label Extension Phase, using descriptive statistics for the safety population. 
No formal statistical comparisons will be performed. Demographics and baseline characteristics will also 
be summarized for the BA for Stage 1, BE Evaluable Population for Stage 2 and FE Evaluable population 
for Stage 3. 
The demographic and baseline characteristics tables will include the following variables: 
• 
Age at time of screening (years) 
• 
Age categories (18 to <65, 65 to <75, ≥75; and ≥65) 
• 
Sex 
• 
Race (White, Black, Asian, American Indian/Alaska Native, Native Hawaiian or other Pacific 
Islander, Other and Not Reported) 
• 
Ethnicity (Hispanic or Latino, not-Hispanic or Latino, Not Reported and Unknown) 
• 
Baseline weight (in kilograms) 
• 
Baseline height (in centimeters) 
• 
Baseline body mass index (BMI) (kg/m2), calculated using the patient’s height and weight at 
screening [BMI (kg/m2) = weight (kg) / height (m)2] 
• 
Eastern Cooperative Oncology Group (ECOG) performance status at baseline. 
Primary cancer history will be summarized for the safety population and will include the following 
variables: 
• 
Tumor type 
• 
Time from first diagnosis to informed consent (years) 
• 
Cancer stage (most recent) (Locally advanced, Metastatic) 
• 
Number of prior lines of therapy 
• 
Any prior radiotherapy. 
Prior anti-cancer treatments will be coded using the most current version of the WHO Drug Dictionary. 
The number and percentage of patients reporting the use of at least one preferred term will be reported for 


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the safety population in the PK Phase (Stage 1, Stage 2 and Stage 3 separately) and the safety population 
in the Extension Phase. 
Medical history will be coded using the most current version of MedDRA, and the number and 
percentage of patients experiencing at least one such diagnosis by MedDRA System Organ Class (SOC) 
and preferred term (PT) will be reported for the safety population in the PK Phase (Stage 1, Stage 2 and 
Stage 3 separately) and the safety population in the Extension Phase. 
Demographics, baseline characteristics, primary cancer history, and medical history information for each 
patient will be provided in data listings. 
4.3 Investigator Assessment of Response 
Investigator assessment of response will be provided in data listings for the Extension Phase. Additional 
descriptive summaries of response may be performed by tumor type. 
4.4 Safety Evaluation 
4.4.1 Treatment Exposure and Compliance 
PK Phase 
The number and percentage of patients receiving capsules and tablets during the PK Phase (Stage 1 and 
Stage 2, separately) will be summarized. For Stage 3, the number of tablets received will be summarized 
by fed/fasted state. 
A by-patient listing of the niraparib treatment data will be produced for the PK safety population. 
Extension Phase 
Study treatment exposure and compliance will be summarized by formulation and overall, including: 
• 
Number and percentage of patients who initiated 1, 2, 3, 4, 5, ≥6 treated cycles. 
• 
Duration of treatment (months), defined as: 
[last dose date - first dose date in the Extension Phase + 1] / 30.4375. 
• 
Duration on study (months), defined as: 
[last contact date - first dose date in the Extension Phase + 1] / 30.4375, where last 
contact date is the last visit date or date of death. 
• 
Number of patients with at least one dose interruption. 
• 
Number of patients with at least one dose reduction. 
In addition, the starting niraparib dose for each cycle will be summarized. 
A by-patient listing of the niraparib treatment data will be produced for the Open-Label Extension Phase 
safety population. 
4.4.2 Adverse Events 
All AEs will be classified by SOC and PT using the most up-to-date version of MedDRA. 


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Per protocol, all SAEs will be collected from the signing of the ICF for this study through 90 days after 
the last dose of study drug (or until the start of alternate anticancer therapy, whichever occurs first, and 
recorded in the eCRF. 
All AEs, regardless of the source of identification (e.g., physical examination, laboratory assessment, 
ECG, or reported by patient), will be collected and recorded in the eCRF for each patient from the time of 
randomization and/or treatment assignment until 30 days after the last dose of study drug. 
All AEs experienced by a patient, regardless of the suspected causality, will be monitored until the AE or 
SAE has resolved, until AE(s) or SAE(s) have returned to baseline or normal levels, until stabilized with a 
satisfactory explanation for the changes observed, until the patient is lost to follow-up, or until the patient 
has died, starts alternate anti-cancer therapy, or until the patient withdraws consent. 
For analysis, TEAEs will be defined as any AEs collected with a start date on or after the first dose of 
study drug. Any AEs recorded in the database that occur from the time of ICF to first dose will be listed 
only and not included in safety analyses. Pre-existing conditions will be recorded in the eCRF on the 
Medical History or appropriate page. 
The severity of the toxicities will be graded according to the NCI CTCAE v4.03. Within the same 
MedDRA PT, only the most severe AE for each patient will be counted in tabulations by severity. Within 
a MedDRA SOC, patients with more than 1 MedDRA PT will be counted only once for the most severe 
AE reported. 
The Investigator must provide a causality assessment (related or not related) regarding the relationship of 
the event with the study drug and/or study procedure for all AEs. In Stage 1, for analysis of the PK Phase, 
AEs considered related to either tablet or capsule will be considered to be related to study drug. Any AEs 
for which the relationship is missing (for either tablet or capsule during the Stage 1 PK Phase) will be 
considered as related to study treatment. During the PK Phase 2, PK Phase 3 and Extension Phase, 
relationship relative to niraparib will be considered. Within the same MedDRA PT, only the AE with the 
highest ranked relationship to treatment for each patient will be counted in tabulations by relationship to 
treatment. Within a MedDRA SOC, patients with more than 1 MedDRA PT will be counted only once for 
the AE that is most related to treatment. The imputation for a missing relationship will take place prior to 
determining the most related AE within a SOC or PT for a given patient. 
If the start date is missing for an AE and the actual start date cannot be determined from a partial date, the 
AE will be considered treatment-emergent. 
Adverse Events of Special Interest (AESI) for niraparib are the following:  
• 
Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) 
• 
Secondary cancers (new malignancies [other than MDS or AML]) 
• 
Pneumonitis (for Stage 1 and Stage 2 only) 
• 
Embryo-fetal toxicity (for Stage 1 and Stage 2 only). 
AEs will be classified into the following time periods for analysis. 
• 
PK Phase (for Stage 1, Stage 2 and Stage 3 separately): 


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o Period 1: Any AE that begins on or after Dose 1 but prior to Dose 2. 
▪ 
For Stage 1, Period 1 will be defined as 7-days post Dose 1 for patients who do 
not receive Dose 2. 
▪ 
For Stage 2, Period 1 will be defined as 14-days post Dose 1 for patients who do 
not receive Dose 2. 
o Period 2: Any AEs that begins on or after Dose 2 but prior to the end of the PK Phase as 
defined by 7-days post Dose 2. 
o Safety Follow-Up/Extension Screening Period: 
▪ 
For patients not participating in the Extension Phase, AEs that begin after the end 
of the PK Phase. 
▪ 
For patients participating in the Extension Phase, AEs that begin after the end of 
the PK Phase until the date of first dose in the Extension Phase. 
• 
Open-Label Extension Phase: 
o Any AEs that start on or after the first dose in the Extension Phase. 
The analyses indicated below will be performed for each of the above-mentioned phases. 
A high-level overview of TEAEs will be presented in a summary table. This table will include the number 
and percentage of patients for the following categories:  
• 
Any TEAE 
• 
Any related TEAEs 
• 
Any serious TEAEs 
• 
Any related serious TEAEs 
• 
Any TEAEs with CTCAE toxicity grade 3 or above 
• 
Any related TEAEs with CTCAE toxicity grade 3 or above 
• 
Any TEAEs leading to treatment discontinuation 
• 
Any related TEAEs leading to treatment discontinuation 
• 
Any TEAEs leading to dose interruption 
• 
Any TEAEs leading to dose reduction 
• 
Any TEAEs leading to death. 
The number and percentage of patients reporting a TEAE will be summarized in the following additional 
AE tables. AE tabulations will be ordered in terms of decreasing frequency for SOC (alphabetically for 
SOCs with the same number of AEs reported), and decreasing frequency for PT within SOC 
(alphabetically for PTs with the same number of AEs reported within a SOC) considering the overall rate. 
• 
TEAE by SOC and PT 
• 
Related TEAE by SOC and PT 
• 
Treatment emergent SAEs by SOC and PT 
• 
Related treatment emergent SAEs by SOC and PT 
• 
TEAE with toxicity grade 3 or above by SOC and PT 
• 
Related TEAE with toxicity grade 3 or above by SOC and PT 
• 
TEAEs leading to treatment discontinuation by SOC and PT 
• 
TEAEs leading to dose interruption by SOC and PT (Extension Phase Only) 


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• 
TEAEs leading to dose reduction by SOC and PT  
• 
TEAEs leading to death by SOC and PT 
• 
TEAE by PT (sorted by frequency) 
• 
TEAE by SOC, PT, and maximum toxicity grade 
• 
Treatment emergent AESI. 
For Stage 1 and Stage 2 PK Phase, primary tabulations for the PK Phase data will be provided by 
formulation (regardless of period), those occurring during the follow-up/extension screening and overall. 
In addition, the high-level overview of TEAEs and summary of TEAEs by SOC and PT will be 
summarized by sequence and formulation. For Stage 3 PK Phase, primary tabulations for the PK Phase 
data will be provided by fed/fasted state (regardless of period), and overall. In addition, the high-level 
overview of TEAEs and summary of TEAEs by SOC and PT will be summarized by sequence and 
fed/fasted state. For the Open-Label Extension Phase, data will be summarized by formulation and for all 
patients overall. 
The following by-patient listings will be produced for the PK Phase (Stage 1, Stage 2 and Stage 3 
separately) and the Open-Label Extension Phase: 
• 
All TEAEs 
• 
Treatment emergent SAEs 
• 
All Deaths 
• 
TEAEs leading to dose interruption (Extension Phase Only) 
• 
TEAEs leading to dose reduction 
• 
TEAEs leading to treatment discontinuation. 
4.4.3 Laboratory Data 
Laboratory assessments for safety oversight are performed locally at each center’s laboratory by means of 
their established methods. All laboratory values will be converted to SI units and classified as normal, 
low, or high based on normal ranges supplied by the local laboratories and upon employing 
standardization. 
A by-patient listing of all laboratory data will be provided, with laboratory reference ranges and abnormal 
values highlighted, and including center, patient identifier, and visit for the PK Phase and the Extension 
Phase of the study. 
For the Extension Phase, select hematology (hemoglobin, neutrophils and platelets) and chemistry 
(bilirubin, creatinine, aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) will be 
analyzed using change from baseline by visit. 
For the Extension Phase, select hematology (hemoglobin, neutrophils and platelets) and chemistry tests 
(bilirubin, creatinine, ALT, and AST), baseline and post-baseline results will be categorized by NCI 
CTCAE v4.03 grade (Table 2). Shift tables will be produced by maximum post-baseline grade. Results 
that are considered ‘normal’ will be assigned a grade 0. 


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• 
Concomitant medications during the PK Phase: any medications being taken on or after the initial 
study treatment dosing date through either the first dose of the Extension Phase or through 30 
days after the last dose, for those not continuing into the Extension Phase. 
o For PK Stage 2, concomitant medications will be further identified as those taken during 
the PK collection period, defined by dates of the first PK-draw to last PK-draw. 
• 
Prior medications during the Extension Phase: any medications which started prior to the first 
dose date of study treatment during the Extension Phase. 
• 
Concomitant medications during the Extension Phase: any medications on or after the first 
treatment dosing date in the Extension Phase through 30 days after the last dose of treatment. 
Note: medications can be classified as both prior and concomitant. 
Both prior medications and concomitant medications will be summarized by ATC classification drug 
class and WHO preferred name using the number and percentage of patients for each cohort. A patient 
reporting the same medication more than once will be counted only once when calculating the number 
and percentage of patients who received that medication in a given time category (prior or concomitant). 
The summary of concomitant medications will be ordered alphabetically by drug class and then by 
descending frequency of preferred name in total within the drug class. For drugs with the same frequency, 
sorting will be done alphabetically. Summaries will be based on the safety population. 
For PK Stage 2, an additional summary of concomitant medications used during the PK collection period 
will be provided for the BE Evaluable Population. 
For each phase of the study, all prior and concomitant medications will be provided in a by-patient listing 
sorted by patient ID number and administration date in chronological order. 
4.4.7 Prior and Concomitant Transfusions and Growth Factors 
The number and percentage of patients receiving prior and concomitant growth factors during the PK 
Phase and Extension Phase will be summarized. The data will be classified as prior or concomitant using 
similar logic as provided in Section 4.4.6. 
For each phase of the study, all prior and concomitant transfusions and growth factor use will be provided 
in a by-patient listing sorted by patient ID number and administration date in chronological order. 
4.4.8 COVID-19 
The Pharmacokinetics Phase Stage 3 of the trial takes place during COVID-19 pandemic, as a result of 
which some of the trial procedures could be impacted in terms of missing visits and/or assessments. 
Missing protocol required data/visits due to COVID-19 must be noted in participant notes and recorded as 
a COVID-19-related protocol deviations. 
A summary of the following COVID-19 assessments will be produced: case diagnosis, COVID-19 test 
performed, and results of the COVID-19 test. 
The incidence of COVID-19 related AEs and SAEs will be summarized as part of the safety reporting 
summaries along with COVID-19-related as reasons for treatment discontinuation. 


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A listing of all patients with COVID-19 assessments and symptom assessments will be produced and will 
include the following: 
• 
Treatment sequence 
• 
Patient number 
• 
COVID-19 case diagnosis 
• 
COVID-19 test performed 
• 
Result of the COVID-19 test 
• 
Assessments and symptom assessments performed 
• 
Results of the assessments and symptom assessments. 
For PK Phase Stage 3, a separate listing defining “Important” GSK protocol deviations related to 
COVID-19 will be presented. 
For protocol deviation reporting during the Extension Phase, a listing will be produced to present 
TESARO Classification of protocol deviations for patients continuing from Stage 1 and Stage 2, and GSK 
Classification of protocol deviations for patients continuing from Stage 3. 
5 CHANGES TO PLANNED ANALYSES 
There is no change between the protocol-defined statistical analyses and those planned in this SAP. 
5.1 Changes in v5.0 of the SAP 
Section 2.2 has been updated to include a summary tables of Important protocol deviations for Stage 3 PK 
Phase and Open-Label Extension Phases, as well as clarification of associated deviation listings 
presenting only protocol deviations classified as “Important”. 
5.2 Changes in v6.0 of the SAP 
Section 1.2 has been updated to reflect the change in PK data cut requirements for final Stage 3 analysis. 
 
 


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6 APPENDIX 
6.1 Planned Statistical Tables, Listings, and Figures 
 
TABLE 14.1.1A SUBJECT DISPOSITION IN THE PK PHASE (ALL PATIENTS IN THE STAGE 1 PK PHASE) ........................ 39 
TABLE 14.1.1B SUBJECT DISPOSITION IN THE PK PHASE (ALL PATIENTS IN THE STAGE 2 PK PHASE) ........................ 40 
TABLE 14.1.1C SUBJECT DISPOSITION IN THE EXTENSION PHASE (ALL PATIENTS IN THE EXTENSION PHASE) ............ 41 
TABLE 14.1.1D SUBJECT DISPOSITION IN THE PK PHASE (ALL PATIENTS IN THE STAGE 3 PK PHASE) ........................ 42 
TABLE 14.1.2A DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................................... 43 
TABLE 14.1.2.1A DEMOGRAPHICS (BA EVALUABLE POPULATION IN THE STAGE 1 PK PHASE) .................................. 43 
TABLE 14.1.2.1B DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................................................ 43 
TABLE 14.1.2.2B DEMOGRAPHICS (BE EVALUABLE POPULATION IN THE STAGE 2 PK PHASE) ................................... 44 
TABLE 14.1.2C DEMOGRAPHICS (SAFETY POPULATION IN THE EXTENSION PHASE) .................................................... 44 
TABLE 14.1.2.1D DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ................................................ 44 
TABLE 14.1.2.2D DEMOGRAPHICS (FE EVALUABLE POPULATION IN THE STAGE 3 PK PHASE) ................................... 44 
TABLE 14.1.3A BASELINE CHARACTERISTICS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .............................. 45 
TABLE 14.1.3.1A BASELINE CHARACTERISTICS (BA EVALUABLE POPULATION IN THE STAGE 1 PK PHASE) .............. 45 
TABLE 14.1.3.1B BASELINE CHARACTERISTICS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ........................... 46 
TABLE 14.1.3.2B BASELINE CHARACTERISTICS (BE EVALUABLE POPULATION IN THE STAGE 2 PK PHASE) .............. 46 
TABLE 14.1.3C BASELINE CHARACTERISTICS (SAFETY POPULATION IN THE EXTENSION PHASE) ............................... 46 
TABLE 14.1.3.1D BASELINE CHARACTERISTICS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ........................... 46 
TABLE 14.1.3.2D BASELINE CHARACTERISTICS (FE EVALUABLE POPULATION IN THE STAGE 3 PK PHASE) ............... 46 
TABLE 14.1.4A PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................ 47 
TABLE 14.1.4B PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................................ 47 
TABLE 14.1.4C PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE EXTENSION PHASE) ................................. 47 
TABLE 14.1.4D PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ................................ 47 
TABLE 14.1.5A PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ...................... 49 
TABLE 14.1.5B PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ....................... 49 
TABLE 14.1.5C PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE EXTENSION PHASE) ........................ 49 
TABLE 14.1.5D PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ...................... 49 
TABLE 14.1.6A MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .............................................. 50 
TABLE 14.1.6B MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) .............................................. 50 
TABLE 14.1.6C MEDICAL HISTORY (SAFETY POPULATION IN THE EXTENSION PHASE) ............................................... 50 
TABLE 14.1.6D MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .............................................. 50 
TABLE 14.1.7A PRIOR MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................ 51 
TABLE 14.1.7B PRIOR MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................ 51 
TABLE 14.1.7C PRIOR MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE EXTENSION PHASE) ................. 51 
TABLE 14.1.7D PRIOR MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ................ 51 
TABLE 14.1.8A CONCOMITANT MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .. 53 
TABLE 14.1.8.1B CONCOMITANT MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 2 PK PHASE)
 ............................................................................................................................................................................ 53 
TABLE 14.1.8.2B CONCOMITANT MEDICATIONS DURING THE PK COLLECTION PERIOD BY ATC AND PT (BE 
EVALUABLE POPULATION IN THE STAGE 2 PK PHASE) ........................................................................................ 53 
TABLE 14.1.8C CONCOMITANT MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE EXTENSION PHASE) ... 53 
TABLE 14.1.8D CONCOMITANT MEDICATIONS BY ATC AND PT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .. 54 
TABLE 14.1.9A CONCOMITANT TRANSFUSIONS AND GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 1 PK 
PHASE) ................................................................................................................................................................ 55 


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TABLE 14.1.9B CONCOMITANT TRANSFUSIONS AND GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 2 PK 
PHASE) ................................................................................................................................................................ 55 
TABLE 14.1.9C CONCOMITANT TRANSFUSIONS AND GROWTH FACTORS (SAFETY POPULATION IN THE EXTENSION 
PHASE) ................................................................................................................................................................ 55 
TABLE 14.1.9D CONCOMITANT TRANSFUSIONS AND GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 3 PK 
PHASE) ................................................................................................................................................................ 55 
TABLE 14.3.1.1.1A OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS (SAFETY POPULATION IN THE 
STAGE 1 PK PHASE) ............................................................................................................................................ 56 
TABLE 14.3.1.1.1B OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS (SAFETY POPULATION IN THE 
STAGE 2 PK PHASE) ............................................................................................................................................ 56 
TABLE 14.3.1.1.1C OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 56 
TABLE 14.3.1.1.1D OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) ............................................................................................................................................ 57 
TABLE 14.3.1.1.2A OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SEQUENCE AND PERIOD 
(SAFETY POPULATION IN THE STAGE 1 PK PHASE) ............................................................................................. 58 
TABLE 14.3.1.1.2B OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SEQUENCE AND PERIOD 
(SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................................................................................. 58 
TABLE 14.3.1.1.2D OVERALL SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SEQUENCE AND PERIOD 
(SAFETY POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................. 59 
TABLE 14.3.1.2.1A SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 1 PK PHASE) ................................................................................................................................. 60 
TABLE 14.3.1.2.1B SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 2 PK PHASE) ................................................................................................................................. 60 
TABLE 14.3.1.2.1C SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE OPEN-LABEL EXTENSION PHASE)............................................................................................................. 61 
TABLE 14.3.1.2.1D SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 3 PK PHASE) ................................................................................................................................. 62 
TABLE 14.3.1.2.1.1D SUMMARY OF COVID-19 RELATED ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 3 PK PHASE) ................................................................................................................................. 63 
TABLE 14.3.1.2.2A SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 1 PK PHASE) ................................................................................................................................. 64 
TABLE 14.3.1.2.2B SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 2 PK PHASE) ................................................................................................................................. 64 
TABLE 14.3.1.2.2D SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT (SAFETY POPULATION 
IN THE STAGE 3 PK PHASE) ................................................................................................................................. 65 
TABLE 14.3.1.3A SUMMARY OF RELATED TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 1 PK PHASE)
 ............................................................................................................................................................................ 66 
TABLE 14.3.1.3B SUMMARY OF RELATED TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 2 PK PHASE)
 ............................................................................................................................................................................ 66 
TABLE 14.3.1.3C SUMMARY OF RELATED TEAE BY SOC AND PT (SAFETY POPULATION IN THE EXTENSION PHASE)66 
TABLE 14.3.1.3D SUMMARY OF RELATED TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 3 PK PHASE)
 ............................................................................................................................................................................ 66 
TABLE 14.3.1.4A SUMMARY OF SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) 66 
TABLE 14.3.1.4B SUMMARY OF SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) 66 
TABLE 14.3.1.4C SUMMARY OF SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE EXTENSION PHASE) . 66 
TABLE 14.3.1.4D SUMMARY OF SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) 66 
TABLE 14.3.1.5A SUMMARY OF RELATED SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 1 PK 
PHASE) ................................................................................................................................................................ 66 


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TABLE 14.3.1.5B SUMMARY OF RELATED SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 2 PK 
PHASE) ................................................................................................................................................................ 66 
TABLE 14.3.1.5C SUMMARY OF RELATED SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE EXTENSION 
PHASE) ................................................................................................................................................................ 66 
TABLE 14.3.1.5D SUMMARY OF RELATED SERIOUS TEAE BY SOC AND PT (SAFETY POPULATION IN THE STAGE 3 PK 
PHASE) ................................................................................................................................................................ 66 
TABLE 14.3.1.6A SUMMARY OF TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY POPULATION IN 
THE STAGE 1 PK PHASE) ..................................................................................................................................... 66 
TABLE 14.3.1.6B SUMMARY OF TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY POPULATION IN 
THE STAGE 2 PK PHASE) ..................................................................................................................................... 66 
TABLE 14.3.1.6C SUMMARY OF TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY POPULATION IN 
THE EXTENSION PHASE) ...................................................................................................................................... 66 
TABLE 14.3.1.6D SUMMARY OF TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY POPULATION IN 
THE STAGE 3 PK PHASE) ..................................................................................................................................... 66 
TABLE 14.3.1.7A SUMMARY OF RELATED TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 1 PK PHASE) ............................................................................................................ 66 
TABLE 14.3.1.7B SUMMARY OF RELATED TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 2 PK PHASE) ............................................................................................................ 66 
TABLE 14.3.1.7C SUMMARY OF RELATED TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 66 
TABLE 14.3.1.7D SUMMARY OF RELATED TEAE WITH CTCAE TOXICITY GRADE ≥3 BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 66 
TABLE 14.3.1.8A SUMMARY OF TEAE LEADING TO TREATMENT DISCONTINUATION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 1 PK PHASE) ............................................................................................................ 66 
TABLE 14.3.1.8B SUMMARY OF TEAE LEADING TO TREATMENT DISCONTINUATION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 2 PK PHASE) ............................................................................................................ 66 
TABLE 14.3.1.8C SUMMARY OF TEAE LEADING TO TREATMENT DISCONTINUATION BY SOC AND PT (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 67 
TABLE 14.3.1.8D SUMMARY OF TEAE LEADING TO TREATMENT DISCONTINUATION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 67 
TABLE 14.3.1.9C SUMMARY OF TEAE LEADING TO TREATMENT DOSE INTERRUPTION BY SOC AND PT (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 67 
TABLE 14.3.1.10A SUMMARY OF TEAE LEADING TO TREATMENT DOSE REDUCTION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 1 PK PHASE) ............................................................................................................ 67 
TABLE 14.3.1.10B SUMMARY OF TEAE LEADING TO TREATMENT DOSE REDUCTION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 2 PK PHASE) ............................................................................................................ 67 
TABLE 14.3.1.10C SUMMARY OF TEAE LEADING TO TREATMENT DOSE REDUCTION BY SOC AND PT (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 67 
TABLE 14.3.1.10D SUMMARY OF TEAE LEADING TO TREATMENT DOSE REDUCTION BY SOC AND PT (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 67 
TABLE 14.3.1.11A SUMMARY OF TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN THE STAGE 1 
PK PHASE) ........................................................................................................................................................... 67 
TABLE 14.3.1.11B SUMMARY OF TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN THE STAGE 2 
PK PHASE) ........................................................................................................................................................... 67 
TABLE 14.3.1.11C SUMMARY OF TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 67 
TABLE 14.3.1.11D SUMMARY OF TEAE LEADING TO DEATH BY SOC AND PT (SAFETY POPULATION IN THE STAGE 3 
PK PHASE) ........................................................................................................................................................... 67 


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TABLE 14.3.1.12A SUMMARY OF TREATMENT EMERGENT AESI BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 1 PK PHASE) ............................................................................................................................................ 67 
TABLE 14.3.1.12B SUMMARY OF TREATMENT EMERGENT AESI BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 2 PK PHASE) ............................................................................................................................................ 67 
TABLE 14.3.1.12C SUMMARY OF TREATMENT EMERGENT AESI BY SOC AND PT (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 67 
TABLE 14.3.1.12D SUMMARY OF TREATMENT EMERGENT AESI BY SOC AND PT (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) ............................................................................................................................................ 67 
TABLE 14.3.1.13A SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT AND CTCAE TOXICITY 
GRADE (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................................................................. 68 
TABLE 14.3.1.13B SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT AND MAXIMUM 
TOXICITY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................................................................. 68 
TABLE 14.3.1.13C SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT AND MAXIMUM 
TOXICITY (SAFETY POPULATION IN THE EXTENSION PHASE) .............................................................................. 68 
TABLE 14.3.1.13D SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY SOC AND PT AND CTCAE TOXICITY 
GRADE (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ................................................................................. 69 
TABLE 14.3.1.14A SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY PT (SAFETY POPULATION IN THE 
STAGE 1 PK PHASE) ............................................................................................................................................ 70 
TABLE 14.3.1.14B SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY PT (SAFETY POPULATION IN THE 
STAGE 2 PK PHASE) ............................................................................................................................................ 70 
TABLE 14.3.1.14C SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY PT (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 70 
TABLE 14.3.1.14D SUMMARY OF TREATMENT EMERGENT ADVERSE EVENTS BY PT (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) ............................................................................................................................................ 71 
TABLE 14.3.1.15A LISTING OF SERIOUS TEAES DURING PK PHASE (SAFETY POPULATION IN THE STAGE 1 PK PHASE)
 ............................................................................................................................................................................ 72 
TABLE 14.3.1.15B LISTING OF SERIOUS TEAES DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 2 PK 
PHASE) ................................................................................................................................................................ 72 
TABLE 14.3.1.15C LISTING OF SERIOUS TEAES DURING THE EXTENSION PHASE (SAFETY POPULATION IN THE 
EXTENSION PHASE) ............................................................................................................................................. 72 
TABLE 14.3.1.15D LISTING OF SERIOUS TEAES DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 3 PK 
PHASE) ................................................................................................................................................................ 72 
TABLE 14.3.1.16A LISTING OF DEATHS DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .. 72 
TABLE 14.3.1.16B LISTING OF DEATHS DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 2 PK PHASE) .. 72 
TABLE 14.3.1.16C LISTING OF DEATHS DURING THE EXTENSION PHASE (SAFETY POPULATION IN THE EXTENSION 
PHASE) ................................................................................................................................................................ 73 
TABLE 14.3.1.16D LISTING OF DEATHS DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .. 73 
TABLE 14.3.1.17C LISTING OF TEAE LEADING TO DOSE INTERRUPTION DURING THE EXTENSION PHASE (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 73 
TABLE 14.3.1.17D LISTING OF TEAE LEADING TO DOSE INTERRUPTION DURING THE PK PHASE (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 73 
TABLE 14.3.1.18A LISTING OF TEAE LEADING TO DOSE REDUCTION DURING THE PK PHASE (SAFETY POPULATION 
IN THE STAGE 1 PK PHASE) ................................................................................................................................. 73 
TABLE 14.3.1.18B LISTING OF TEAE LEADING TO DOSE REDUCTION DURING THE PK PHASE (SAFETY POPULATION 
IN THE STAGE 2 PK PHASE) ................................................................................................................................. 73 
TABLE 14.3.1.18C LISTING OF TEAE LEADING TO DOSE REDUCTION DURING THE EXTENSION PHASE (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 73 
TABLE 14.3.1.18D LISTING OF TEAE LEADING TO DOSE REDUCTION DURING THE PK PHASE (SAFETY POPULATION 
IN THE STAGE 3 PK PHASE) ................................................................................................................................. 73 


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TABLE 14.3.1.19A LISTING OF TEAE LEADING TO TREATMENT DISCONTINUATION DURING THE PK PHASE (SAFETY 
POPULATION IN THE STAGE 1 PK PHASE) ............................................................................................................ 73 
TABLE 14.3.1.19B LISTING OF TEAE LEADING TO TREATMENT DISCONTINUATION DURING THE PK PHASE (SAFETY 
POPULATION IN THE STAGE 2 PK PHASE) ............................................................................................................ 73 
TABLE 14.3.1.19C LISTING OF TEAE LEADING TO TREATMENT DISCONTINUATION DURING THE EXTENSION PHASE 
(SAFETY POPULATION IN THE EXTENSION PHASE)............................................................................................... 73 
TABLE 14.3.1.19D LISTING OF TEAE LEADING TO TREATMENT DISCONTINUATION DURING THE PK PHASE (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 73 
TABLE 14.3.1.20D SUMMARY OF INCIDENCE OF COVID-19 RELATED ADVERSE EVENTS OVER TIME (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................................ 74 
TABLE 14.3.1.21D SUMMARY OF INCIDENCE OF COVID-19 RELATED ADVERSE EVENTS OVER TIME BY GENDER 
(SAFETY POPULATION IN THE STAGE 3 PK PHASE) ............................................................................................. 75 
TABLE 14.3.1.22D SUMMARY OF INCIDENCE OF ADVERSE EVENTS OVER TIME BY AGE GROUP (SAFETY POPULATION 
IN THE STAGE 3 PK PHASE) ................................................................................................................................. 75 
TABLE 14.3.4.1A SUMMARY OF STUDY TREATMENT EXPOSURE DURING THE PK PHASE (SAFETY POPULATION IN THE 
STAGE 1 PK PHASE) ............................................................................................................................................ 76 
TABLE 14.3.4.1B SUMMARY OF STUDY TREATMENT EXPOSURE DURING THE PK PHASE (SAFETY POPULATION IN THE 
STAGE 2 PK PHASE) ............................................................................................................................................ 76 
TABLE 14.3.4.1C SUMMARY OF STUDY TREATMENT EXPOSURE DURING THE EXTENSION PHASE (SAFETY 
POPULATION IN THE EXTENSION PHASE) ............................................................................................................. 77 
TABLE 14.3.4.1D SUMMARY OF STUDY TREATMENT EXPOSURE DURING THE PK PHASE (SAFETY POPULATION IN THE 
STAGE 3 PK PHASE) ............................................................................................................................................ 78 
TABLE 14.3.4.2C SUMMARY OF NIRAPARIB DOSE BY CYCLE (SAFETY POPULATION IN THE EXTENSION PHASE) ........ 79 
TABLE 14.3.4.3.1C SUMMARY AND CHANGE FROM BASELINE OF SELECT HEMATOLOGY PARAMETERS BY VISIT 
DURING THE EXTENSION PHASE (SAFETY POPULATION IN THE EXTENSION PHASE) ........................................... 80 
TABLE 14.3.4.3.2C SHIFT SUMMARY OF SELECT HEMATOLOGY PARAMETERS DURING THE EXTENSION PHASE 
(SAFETY POPULATION IN THE EXTENSION PHASE)............................................................................................... 81 
TABLE 14.3.4.4.1C SUMMARY AND CHANGE FROM BASELINE OF SELECT CHEMISTRY PARAMETERS BY VISIT DURING 
THE EXTENSION PHASE (SAFETY POPULATION IN THE EXTENSION PHASE) ......................................................... 81 
TABLE 14.3.4.4.2C SHIFT SUMMARY OF SELECT CHEMISTRY PARAMETERS IN MAXIMUM TOXICITY GRADE DURING 
THE EXTENSION PHASE (SAFETY POPULATION IN THE EXTENSION PHASE) ......................................................... 81 
TABLE 14.4.1C SUMMARY OF IMPORTANT PROTOCOL DEVIATIONS (SAFETY POPULATION IN THE EXTENSION PHASE)
 ............................................................................................................................................................................ 83 
TABLE 14.4.1D SUMMARY OF IMPORTANT PROTOCOL DEVIATIONS FOR THE PK PHASE OCCURRING THROUGH END OF 
TREATMENT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ......................................................................... 84 
LISTING 16.2.1A DISPOSITION FOR PK PHASE (ALL PATIENTS ENROLLED IN THE STAGE 1 PK PHASE)....................... 86 
LISTING 16.2.1B DISPOSITION FOR PK PHASE (SAFETY POPULATION IN THE STAGE 2 PK PHASE) .............................. 86 
LISTING 16.2.1C DISPOSITION FOR OPEN-LABEL EXTENSION PHASE (ALL PATIENTS ENROLLED FOR THE EXTENSION 
PHASE) ................................................................................................................................................................ 86 
LISTING 16.2.1D DISPOSITION FOR PK PHASE (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .............................. 86 
LISTING 16.2.1.2A REASONS FOR SCREEN FAILURE (PATIENTS WHO FAILED SCREENING IN THE STAGE 1 PK PHASE) 87 
LISTING 16.2.1.2B REASONS FOR SCREEN FAILURE (PATIENTS WHO FAILED SCREENING IN THE STAGE 2 PK PHASE) 87 
LISTING 16.2.1.2D REASONS FOR SCREEN FAILURE (PATIENTS WHO FAILED SCREENING IN THE STAGE 3 PK PHASE) 87 
LISTING 16.2.2A PROTOCOL DEVIATIONS FOR THE PK PHASE (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ..... 88 
LISTING 16.2.2B PROTOCOL DEVIATION FOR THE PK PHASE (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ....... 88 
LISTING 16.2.2C IMPORTANT PROTOCOL DEVIATIONS FOR THE OPEN-LABEL EXTENSION PHASE (SAFETY 
POPULATION FOR OPEN-LABEL EXTENSION PHASE) ........................................................................................... 89 
LISTING 16.2.2.1D IMPORTANT PROTOCOL DEVIATIONS FOR THE PK PHASE OCCURRING THROUGH END OF 
TREATMENT (SAFETY POPULATION FOR STAGE 3 PK PHASE) ............................................................................. 90 


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LISTING 16.2.2.2D GSK PROTOCOL DEVIATIONS RELATED TO COVID-19 (SAFETY POPULATION FOR STAGE 3 PK 
PHASE) ................................................................................................................................................................ 91 
LISTING 16.2.3A STUDY POPULATIONS FOR THE PK PHASE (ALL PATIENTS ENROLLED IN THE STAGE 1 PK PHASE) .. 92 
LISTING 16.2.3B STUDY POPULATIONS FOR THE PK PHASE (ALL PATIENTS SCREENED IN THE STAGE 2 PK PHASE) .. 92 
LISTING 16.2.3C STUDY POPULATIONS FOR THE OPEN-LABEL EXTENSION PHASE (ALL PATIENTS ENROLLED IN THE 
EXTENSION PHASE) ............................................................................................................................................. 93 
LISTING 16.2.3D STUDY POPULATIONS FOR THE PK PHASE (ALL PATIENTS ENROLLED IN THE STAGE 3 PK PHASE) .. 94 
LISTING 16.2.4.1A DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .............................................. 95 
LISTING 16.2.4.1B DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) .............................................. 95 
LISTING 16.2.4.1C DEMOGRAPHICS (SAFETY POPULATION IN THE EXTENSION PHASE) ............................................... 95 
LISTING 16.2.4.1D DEMOGRAPHICS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .............................................. 95 
LISTING 16.2.4.2A MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ......................................... 96 
LISTING 16.2.4.2B MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ......................................... 96 
LISTING 16.2.4.2C MEDICAL HISTORY (SAFETY POPULATION IN THE EXTENSION PHASE) .......................................... 96 
LISTING 16.2.4.2D MEDICAL HISTORY (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ......................................... 96 
LISTING 16.2.4.3A PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................. 97 
LISTING 16.2.4.3B PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................. 97 
LISTING 16.2.4.3C PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE EXTENSION PHASE)................... 97 
LISTING 16.2.4.3D PRIOR ANTI-CANCER TREATMENT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ................. 97 
LISTING 16.2.4.4A PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ........................... 98 
LISTING 16.2.4.4B PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ........................... 98 
LISTING 16.2.4.4C PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE EXTENSION PHASE) ............................ 98 
LISTING 16.2.4.4D PRIMARY CANCER HISTORY (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ........................... 98 
LISTING 16.2.4.5A PRIOR/CONCOMITANT RADIOTHERAPY (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .......... 99 
LISTING 16.2.4.5B PRIOR/CONCOMITANT RADIOTHERAPY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ........... 99 
LISTING 16.2.4.5C PRIOR/CONCOMITANT RADIOTHERAPY (SAFETY POPULATION IN THE EXTENSION PHASE) ............ 99 
LISTING 16.2.4.5D PRIOR/CONCOMITANT RADIOTHERAPY (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .......... 99 
LISTING 16.2.5.1B PRIOR AND CONCOMITANT MEDICATIONS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) .... 100 
LISTING 16.2.5.1C PRIOR AND CONCOMITANT MEDICATIONS (SAFETY POPULATION IN THE EXTENSION PHASE) ..... 100 
LISTING 16.2.5.1D PRIOR AND CONCOMITANT MEDICATIONS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .... 100 
LISTING 16.2.5.2A PRIOR/CONCOMITANT PROCEDURES DURING PK PHASE (SAFETY POPULATION IN THE STAGE 1 PK 
PHASE) .............................................................................................................................................................. 101 
LISTING 16.2.5.2B PRIOR/CONCOMITANT PROCEDURES DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 2 
PK PHASE) ......................................................................................................................................................... 101 
LISTING 16.2.5.2C PRIOR/CONCOMITANT PROCEDURES DURING THE EXTENSION PHASE (SAFETY POPULATION IN THE 
EXTENSION PHASE) ........................................................................................................................................... 101 
LISTING 16.2.5.2D PRIOR/CONCOMITANT PROCEDURES DURING THE PK PHASE (SAFETY POPULATION IN THE STAGE 
3 PK PHASE) ...................................................................................................................................................... 101 
LISTING 16.2.5.3A PRIOR AND CONCOMITANT TRANSFUSIONS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .. 102 
LISTING 16.2.5.3B PRIOR AND CONCOMITANT TRANSFUSIONS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) .. 102 
LISTING 16.2.5.3C PRIOR AND CONCOMITANT TRANSFUSIONS (SAFETY POPULATION IN THE EXTENSION PHASE) ... 102 
LISTING 16.2.5.3D PRIOR AND CONCOMITANT TRANSFUSIONS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .. 102 
LISTING 16.2.5.4A PRIOR AND CONCOMITANT GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 1 PK PHASE)
 .......................................................................................................................................................................... 103 
LISTING 16.2.5.4B PRIOR AND CONCOMITANT GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 2 PK PHASE)
 .......................................................................................................................................................................... 103 
LISTING 16.2.5.4C PRIOR AND CONCOMITANT GROWTH FACTORS (SAFETY POPULATION IN THE EXTENSION PHASE)
 .......................................................................................................................................................................... 103 


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LISTING 16.2.5.4D PRIOR AND CONCOMITANT GROWTH FACTORS (SAFETY POPULATION IN THE STAGE 3 PK PHASE)
 .......................................................................................................................................................................... 103 
LISTING 16.2.5.5A STUDY TREATMENT (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ...................................... 104 
LISTING 16.2.5.5B STUDY TREATMENT (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ...................................... 104 
LISTING 16.2.5.5C STUDY TREATMENT (SAFETY POPULATION IN THE EXTENSION PHASE) ....................................... 105 
LISTING 16.2.5.5D STUDY TREATMENT (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ...................................... 106 
LISTING 16.2.5.6B SUBSEQUENT ANTI-CANCER THERAPY (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ......... 107 
LISTING 16.2.5.6C SUBSEQUENT ANTI-CANCER THERAPY (SAFETY POPULATION IN THE EXTENSION PHASE) .......... 108 
LISTING 16.2.5.6D MEAL STATUS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .............................................. 109 
LISTING 16.2.6.1C INVESTIGATOR ASSESSMENT OF RESPONSE (SAFETY POPULATION IN THE EXTENSION PHASE) ... 110 
LISTING 16.2.7.1A ADVERSE EVENTS (SAFETY POPULATION IN THE STAGE 1 PK PHASE)......................................... 111 
LISTING 16.2.7.1B ADVERSE EVENTS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ......................................... 111 
LISTING 16.2.7.1C ADVERSE EVENTS (SAFETY POPULATION IN THE EXTENSION PHASE) .......................................... 111 
LISTING 16.2.7.1D ADVERSE EVENTS (SAFETY POPULATION IN THE STAGE 3 PK PHASE)......................................... 111 
LISTING 16.2.8.1.1A HEMATOLOGY RESULTS IN THE PK PHASE (SAFETY POPULATION IN THE STAGE 1 PK PHASE) 112 
LISTING 16.2.8.1.1B HEMATOLOGY RESULTS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ............................ 112 
LISTING 16.2.8.1.1C HEMATOLOGY RESULTS (SAFETY POPULATION IN THE EXTENSION PHASE) ............................. 112 
LISTING 16.2.8.1.1D HEMATOLOGY RESULTS THROUGH THE PK END OF TREATMENT VISIT (SAFETY POPULATION IN 
THE STAGE 3 PK PHASE) ................................................................................................................................... 112 
LISTING 16.2.8.1.2A CHEMISTRY RESULTS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................ 112 
LISTING 16.2.8.1.2B CHEMISTRY RESULTS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................................. 112 
LISTING 16.2.8.1.2C CHEMISTRY RESULTS (SAFETY POPULATION IN THE EXTENSION PHASE) .................................. 112 
LISTING 16.2.8.1.2D CHEMISTRY RESULTS THROUGH THE PK END OF TREATMENT VISIT (SAFETY POPULATION IN 
THE STAGE 3 PK PHASE) ................................................................................................................................... 112 
LISTING 16.2.8.1.3A URINALYSIS RESULTS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................ 112 
LISTING 16.2.8.1.3B URINALYSIS RESULTS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................................ 112 
LISTING 16.2.8.1.3C URINALYSIS RESULTS (SAFETY POPULATION IN THE EXTENSION PHASE) ................................. 112 
LISTING 16.2.8.1.3D URINALYSIS RESULTS THROUGH THE PK END OF TREATMENT VISIT (SAFETY POPULATION IN 
THE STAGE 3 PK PHASE) ................................................................................................................................... 112 
LISTING 16.2.8.1.4C LIVER FUNCTION TESTS – POTENTIAL HY’S LAW CASES (SAFETY POPULATION IN THE 
EXTENSION PHASE) ........................................................................................................................................... 113 
LISTING 16.2.8.2A VITAL SIGNS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) ................................................. 114 
LISTING 16.2.8.2B VITAL SIGNS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ................................................. 114 
LISTING 16.2.8.2C VITAL SIGNS (SAFETY POPULATION IN THE EXTENSION PHASE) .................................................. 114 
LISTING 16.2.8.2D VITAL SIGNS THROUGH THE PK END OF TREATMENT VISIT (SAFETY POPULATION IN THE STAGE 3 
PK PHASE) ......................................................................................................................................................... 114 
LISTING 16.2.8.3A ECG RESULTS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .............................................. 115 
LISTING 16.2.8.3B ECG RESULTS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) .............................................. 115 
LISTING 16.2.8.3C ECG RESULTS (SAFETY POPULATION IN THE EXTENSION PHASE) ............................................... 115 
LISTING 16.2.8.3D ECG RESULTS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) .............................................. 115 
LISTING 16.2.8.4A ECOG PERFORMANCE STATUS (SAFETY POPULATION IN THE STAGE 1 PK PHASE) .................... 116 
LISTING 16.2.8.4B ECOG PERFORMANCE STATUS (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ..................... 116 
LISTING 16.2.8.4C ECOG PERFORMANCE STATUS (SAFETY POPULATION IN THE EXTENSION PHASE) ...................... 116 
LISTING 16.2.8.4D ECOG PERFORMANCE STATUS THROUGH THE PK END OF TREATMENT VISIT (SAFETY 
POPULATION IN THE STAGE 3 PK PHASE) .......................................................................................................... 116 
LISTING 16.2.8.5A BASELINE PHYSICAL EXAMINATION FINDINGS (SAFETY POPULATION IN THE STAGE 1 PK PHASE)
 .......................................................................................................................................................................... 117 
LISTING 16.2.8.5B BASELINE PHYSICAL EXAMINATION FINDINGS (SAFETY POPULATION IN THE STAGE 2 PK PHASE)
 .......................................................................................................................................................................... 117 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 37 of 119 
LISTING 16.2.8.5C BASELINE PHYSICAL EXAMINATION FINDINGS (SAFETY POPULATION IN THE EXTENSION PHASE)
 .......................................................................................................................................................................... 117 
LISTING 16.2.8.5D BASELINE PHYSICAL EXAMINATION FINDINGS (SAFETY POPULATION IN THE STAGE 3 PK PHASE)
 .......................................................................................................................................................................... 117 
LISTING 16.2.8.6A PREGNANCY TEST (SAFETY POPULATION IN THE STAGE 1 PK PHASE)......................................... 118 
LISTING 16.2.8.6B PREGNANCY TEST (SAFETY POPULATION IN THE STAGE 2 PK PHASE) ......................................... 118 
LISTING 16.2.8.6C PREGNANCY TEST (SAFETY POPULATION IN THE EXTENSION PHASE) .......................................... 118 
LISTING 16.2.8.6D PREGNANCY TEST (SAFETY POPULATION IN THE STAGE 3 PK PHASE)......................................... 118 
LISTING 16.2.9.2D LISTING OF COVID-19 ASSESSMENTS AND SYMPTOM ASSESSMENTS FOR PATIENTS WITH COVID-
19 ADVERSE EVENTS (SAFETY POPULATION IN THE STAGE 3 PK PHASE) ......................................................... 119 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 38 of 119 
TABLES 
General guidelines: 
Tables will be provided for the Stage 1 PK Phase, Stage 2 PK Phase, Stage 3 PK Phase and the Open-Label Extension Phase. 
For the PK Phase (Stage 1, Stage 2 and Stage 3): 
• 
Treatment=Sequence and Overall, in general. For PK and AE data, please see mock tables. 
• 
Population=Safety Population in Stage 1 PK (Stage 2 PK or Stage 3 PK) Phase, unless otherwise specified. 
• 
PK Phase Data: 
o For patients who do not continue to Extension Phase, PK Phase is any data collected. 
o For patients who do continue to Extension Phase, 
▪ 
AEs – prior to first dose in Extension Phase 
▪ 
Prior meds/procedures/etc. – prior to first dose in PK Phase 
▪ 
Concomitant meds – meds prior to first dose in Extension Phase. 
• 
Assessments (Labs, ECGs, Vitals, ECOG, PE, etc.) – use visit to identify data. 
For the Extension Phase: 
• 
Treatment=Niraparib Tablet or Capsule (regardless of starting dose); Summarize by Tablet; Capsule; Overall, unless otherwise specified. 
• 
Population=Safety Population in the Open-Label Extension Phase (i.e., those who receive at least 1 dose), unless otherwise specified. 
• 
Extension Phase Data: 
o For patients who do not continue to Extension Phase, there is no Extension Phase data. 
o For patients who do continue to Extension Phase, 
▪ 
AEs – on or after first dose in Extension Phase 
▪ 
Prior meds/procedures/etc. – prior to first dose in Extension Phase 
▪ 
Concomitant meds – meds on or after the first dose in Extension Phase 
▪ 
Assessments (Labs, ECGs, Vitals, ECOG, PE, etc.) – use visit to identify data. 
Sort order: All AE tabulations, unless otherwise specified, will be ordered in terms of decreasing frequency for SOC (alphabetically for SOCs with 
the same number of AEs reported), and decreasing frequency for PT within SOC (alphabetically for PTs with the same number of AEs reported 
within a SOC) considering the overall rate. 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Table 14.1.1A 
Subject Disposition in the PK Phase (All Patients in the Stage 1 PK Phase) 
Parameter 
Statistic Sequence 
TABLET/CAPSULE 
Sequence 
CAPSULE/TABLET 
 
Overall 
Number of Patients  
 
 
 
 
Screened 
n  
-- 
-- 
xx 
Randomized 
n  
x  
x  
x  
Received Tablet 
n  
x  
x  
x  
Received Capsule 
n  
x  
x  
x  
Received Both Tablet and Capsule 
n  
x  
x  
x  
PK Phase Safety Population 
n 
x  
x  
x  
 
 
 
 
 
Completed PK Phase 
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from PK Phase 
n 
x  
x  
x  
   Reason1 
n 
x  
x  
x  
   Reason2 
n 
x  
x 
x  
 
 
 
 
 
Participate in Extension Phase  
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from Study Prior to Entering the Extension 
Phase 
 
 
 
 
   Reason1 
n 
xx  
xx  
xx  
   Reason2 
n 
xx  
xx  
xx  
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Only include DC from study for those patients who do not enter the Extension Phase. 
 
 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Protocol No: XXXXX 
Table 14.1.1B 
Subject Disposition in the PK Phase (All Patients in the Stage 2 PK Phase) 
Parameter 
Statistic 
Sequence 
TABLET/CAPSULE 
Sequence 
CAPSULE/TABLET 
 
Overall 
Number of Patients 
 
 
 
 
Screened 
n  
-- 
-- 
xx 
Randomized 
n  
x  
x  
x  
  Not Treated 
n  
x  
x  
x  
  Received Tablet 
n  
x  
x  
x  
  Received Capsule 
n  
x  
x  
x  
  Received Both Tablet and Capsule 
n  
x  
x  
x  
PK Phase Safety Population 
n 
x  
x  
x  
 
 
 
 
 
Completed PK Phase 
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from PK Phase [1] 
n 
x  
x  
x  
    Reason 1 
n 
x  
x  
x  
    Reason 2 
n 
x  
x  
x  
 
 
 
 
 
Participate in Extension Phase 
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from Study Prior to Entering the Extension Phase 
 
 
 
 
   Reason 1 
n 
xx  
xx  
xx  
   Reason 2 
n 
xx  
xx  
xx  
 
 
 
 
 
 
[1] Includes patients in the Safety Population (i.e., treated patients) only. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Only include DC from study for those patients who do not enter the Extension Phase. 
 
 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Protocol No: XXXXX 
Table 14.1.1C 
Subject Disposition in the Extension Phase (All Patients in the Extension Phase) 
Parameter 
Statistic Niraparib 
Tablet 
Niraparib 
Capsule 
Niraparib 
Overall 
Number of Patients  
 
 
 
 
Dosed 
n  
xx 
xx 
xx 
 
 
 
 
 
Discontinued Treatment After Receiving at Least 1 Dose 
n  
xx 
xx 
xx 
   Reason 1 
n  
xx 
xx 
xx 
   Reason 2 
n  
xx 
xx 
xx 
 
 
 
 
 
Discontinued Study 
n  
xx 
xx 
xx 
   Reason 1 
n  
xx 
xx 
xx 
   Reason 2 
n  
xx 
xx 
xx 
 
 
 
 
 
 
Source: Listing XXXXXXXXX, Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Statistical Analysis Plan 
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Protocol No: XXXXX 
Table 14.1.1D 
Subject Disposition in the PK Phase (All Patients in the Stage 3 PK Phase) 
Parameter 
Statistic 
Sequence 
NIRAPARIB TABLET 
FASTED/FED 
Sequence 
NIRAPARIB TABLET 
FED/FASTED 
 
 
OVERALL 
Number of Patients 
 
 
 
 
Screened [1] 
n  
-- 
-- 
xx 
Randomized 
n  
x  
x  
x  
  Not Treated 
n  
x  
x  
x  
  Received Tablet in Fasted State 
n  
x  
x  
x  
  Received Tablet in Fed State 
n  
x  
x  
x  
  Received Tablet in Both Fasted and Fed State 
n  
x  
x  
x  
PK Phase Safety Population 
n 
x  
x  
x  
 
 
 
 
 
Completed PK Phase 
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from PK Phase [2] 
n 
x  
x  
x  
    Reason 1 
n 
x  
x  
x  
    Reason 2 
n 
x  
x  
x  
 
 
 
 
 
Participate in Extension Phase 
n 
x 
x 
x 
 
 
 
 
 
Discontinuation from Study Prior to Entering the Extension Phase 
 
 
 
 
   Reason 1 
n 
xx  
xx  
xx  
   Reason 2 
n 
xx  
xx  
xx  
 
 
 
 
 
 
[1] Patient xxxxxx-xxxx (Screen Failure ID: XXi) and xxxxxx-xxxx (Screen Failure ID: YYi) re-screened and reconsented after screen 
failure are counted twice in Screening. 
[2] Includes patients in the Safety Population (i.e., treated patients) only. 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
[Programming Note] 
 
XXi/YYi is ID that was SF. 
Programming, please note footnote references changed order in the shell and footer. 
 
 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Protocol No: XXXXX 
Table 14.1.2A 
Demographics (Safety Population in the Stage 1 PK Phase) 
Parameter 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Age (yrs) 
n  
xx  
xx  
xx  
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
Age Group 
 
 
 
 
18 -< 65 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
65 -< 75 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
≥ 75 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Missing 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Sex 
 
 
 
 
Male 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Female 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Race 
 
 
 
 
White 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
African American 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Asian 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
American Indian or Alaska Native 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Native Hawaiian or other Pacific Islander 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Other 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Not Reported 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Ethnicity 
 
 
 
 
Hispanic or Latino 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Not Hispanic or Latino 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Unknown 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Not Reported 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for:  
Table 14.1.2.1A Demographics (BA Evaluable Population in the Stage 1 PK Phase) 
Table 14.1.2.1B Demographics (Safety Population in the Stage 2 PK Phase) 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 44 of 119 
Table 14.1.2.2B Demographics (BE Evaluable Population in the Stage 2 PK Phase) 
Table 14.1.2C Demographics (Safety Population in the Extension Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall 
Table 14.1.2.1D Demographics (Safety Population in the Stage 3 PK Phase) 
Table 14.1.2.2D Demographics (FE Evaluable Population in the Stage 3 PK Phase) 
• Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL. 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 45 of 119 
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Protocol No: XXXXX 
Table 14.1.3A 
Baseline Characteristics (Safety Population in the Stage 1 PK Phase) 
Parameter 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Weight (kg) 
n  
xx  
xx  
xx  
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
Height (cm) 
n  
xx  
xx  
xx  
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
BMI (kg/m2) 
n  
xx  
xx  
xx  
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
ECOG Performance Status 
 
 
 
 
0 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
3 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
4 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Missing 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
ECOG = Eastern Cooperative Oncology Group: 
0=Fully active, able to carry on all pre-disease performance without restriction 
1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 
2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 
3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 
4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.1.3.1A Baseline Characteristics (BA Evaluable Population in the Stage 1 PK Phase) 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 46 of 119 
Table 14.1.3.1B Baseline Characteristics (Safety Population in the Stage 2 PK Phase) 
Table 14.1.3.2B Baseline Characteristics (BE Evaluable Population in the Stage 2 PK Phase) 
Table 14.1.3C Baseline Characteristics (Safety Population in the Extension Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall 
Table 14.1.3.1D Baseline Characteristics (Safety Population in the Stage 3 PK Phase) 
• Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
Table 14.1.3.2D Baseline Characteristics (FE Evaluable Population in the Stage 3 PK Phase) 
• Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 47 of 119 
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Protocol No: XXXXX 
Table 14.1.4A 
Primary Cancer History (Safety Population in the Stage 1 PK Phase) 
Parameter 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Tumor Type 
 
 
 
 
  Xxxxxxxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Xxxxxxxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Xxxxxxxx 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Time from first diagnosis to informed consent (years) 
n 
xx  
xx  
xx  
 
Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
Median 
xx.x 
xx.x 
xx.x 
 
Q1, Q3 
xx.x, xx.x 
xx.x, xx.x 
xx.x, xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
Cancer Stage (most recent) 
 
 
 
 
  Locally advanced 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Metastatic 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Missing 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Number of prior lines of therapy 
 
 
 
 
  0 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  3 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  4 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  5 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  >=6 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Missing 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Any prior radiotherapy 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.1.4B Primary Cancer History (Safety Population in the Stage 2 PK Phase) 
Table 14.1.4C Primary Cancer History (Safety Population in the Extension Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall 
Table 14.1.4D Primary Cancer History (Safety Population in the Stage 3 PK Phase) 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 48 of 119 
• Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 49 of 119 
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Confidential 
Page 1 of x 
Protocol No: XXXXX 
Table 14.1.5A 
Prior Anti-Cancer Treatment (Safety Population in the Stage 1 PK Phase) 
Preferred Term 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
 
 
 
 
 
Agent 1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Agent 2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Agent 3 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Sort by decreasing frequency in the OVERALL column. 
Repeat for: 
Table 14.1.5B Prior Anti-Cancer Treatment (Safety Population in the Stage 2 PK Phase) 
Table 14.1.5C Prior Anti-Cancer Treatment (Safety Population in the Extension Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall 
Table 14.1.5D Prior Anti-Cancer Treatment (Safety Population in the Stage 3 PK Phase) 
• Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED AND OVERALL. 
 
 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Protocol No: XXXXX 
Table 14.1.6A 
Medical History (Safety Population in the Stage 1 PK Phase) 
System Organ Class 
Preferred Term 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Any condition 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . .  
 
 
 
 
 
 
 
 
 
SOC2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . . 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Sort alphabetically by SOC/PT. 
Repeat for:  
Table 14.1.6B Medical History (Safety Population in the Stage 2 PK Phase) 
Table 14.1.6C Medical History (Safety Population in the Extension Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall. 
Table 14.1.6D Medical History (Safety Population in the Stage 3 PK Phase) 
• Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
 
 


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Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Protocol No: XXXXX 
Table 14.1.7A 
Prior Medications by ATC and PT (Safety Population in the Stage 1 PK Phase) 
ATC (Level 3) 
Preferred Term 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Any prior medication 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
ATC1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . .  
 
 
 
 
 
 
 
 
 
ATC2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . . 
 
 
 
 
 
 
 
 
 
 
Note: Prior medications are any medications with a start date earlier than the first dose date of study treatment and are coded using 
WHO Drug Dictionary version YYYYMM. Study treatment, prior anti-cancer treatments for primary cancer, transfusions and growth factors 
are not included. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Sort alphabetically by ATC3 and Preferred Term. If there are uncoded terms due to no ATC level 3 term not being available, add footnote 
for uncoded term: [1] ATC level 3 term is not available through WHO Drug Dictionary. 
 
Repeat for:  
Table 14.1.7B Prior Medications by ATC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.1.7C Prior Medications by ATC and PT (Safety Population in the Extension Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall 
 
[Programming Notes]  
• Footnote – Extension Phase:  Prior medications are any medications, other than study treatments and pre-medications for study 
treatment, with a start date earlier than the first dose date of study treatment during the Extension Phase and are coded using 
WHO Drug Dictionary version YYYYMM. 
• Prior anti-cancer treatments for primary cancer are not included. 
 
Table 14.1.7D Prior Medications by ATC and PT (Safety Population in the Stage 3 PK Phase) 


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Statistical Analysis Plan 
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Page 52 of 119 
• Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
 
 


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Table 14.1.8A 
Concomitant Medications by ATC and PT (Safety Population in the Stage 1 PK Phase) 
ATC (Level 3) 
Preferred Term 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Any concomitant medication 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
ATC1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . .  
 
 
 
 
 
 
 
 
 
ATC2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
. . . 
 
 
 
 
 
 
 
 
 
 
Note: Concomitant medications are any medications being taken on or after the initial study treatment dosing date through either the 
first dose of the Extension Phase or through 30 days after the last dose, for those not continuing into the Extension Phase. They are 
coded using WHO Drug Dictionary version YYYYMM. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Sort alphabetically by ATC3 and Preferred Term. If there are uncoded terms due to no ATC level 3 term not being available, add footnote 
for uncoded term: [1] ATC level 3 term is not available through WHO Drug Dictionary. 
Repeat for:  
Table 14.1.8.1B Concomitant Medications by ATC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.1.8.2B Concomitant Medications During the PK Collection Period by ATC and PT (BE Evaluable Population in the Stage 2 PK 
Phase) 
• Footnote: Concomitant medications during the PK collection period are any concomitant medications taken between the first PK-draw 
until the last PK-draw. They are coded using WHO Drug Dictionary version YYYYMM. 
 
Table 14.1.8C Concomitant Medications by ATC and PT (Safety Population in the Extension Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 54 of 119 
[Programming Notes] 
• Footnote – Extension Phase: Concomitant medications are any medications being taken on or after the initial study treatment dosing 
date during the Extension Phase through 30 days after the last dose. They are coded using WHO Drug Dictionary version YYYYMM. 
Table 14.1.8D Concomitant Medications by ATC and PT (Safety Population in the Stage 3 PK Phase) 
• Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
• Footnote – Stage 3: Concomitant medications are any medications being taken on or after the initial study treatment dosing date 
through either the first dose of the Extension Phase or through 30 days after the last dose, for those not continuing into the 
Extension Phase. They are coded using WHO Drug Dictionary version YYYYMM. 
 
 


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Table 14.1.9A 
Concomitant Transfusions and Growth Factors (Safety Population in the Stage 1 PK Phase) 
Parameter 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
Any Concomitant Transfusions  
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Red Blood Cells 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Platelet 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Other 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
Any Concomitant Growth Factors 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
G-CSF 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
GM-CSF 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Recombinant Erythropoietin 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Other 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Note: Concomitant transfusions or growth factors are any transfusion or growth factor given on or after the initial study treatment 
dosing date through either the first dose of the Extension Phase or through 30 days after the last dose for those not continuing into 
the Extension Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for:  
Table 14.1.9B Concomitant Transfusions and Growth Factors (Safety Population in the Stage 2 PK Phase) 
Table 14.1.9C Concomitant Transfusions and Growth Factors (Safety Population in the Extension Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall 
[Programming Notes] 
• Footnote – Extension Phase: Concomitant transfusions or growth factors are any transfusion or growth factor given on or after the 
initial study treatment dosing date during the Extension Phase through 30 days after the last dose. 
Table 14.1.9D Concomitant Transfusions and Growth Factors (Safety Population in the Stage 3 PK Phase) 
• Summarize Stage 3 data by Sequence with columns for NIRAPARIB TABLET FASTED/FED, NIRAPARIB TABLET FED/FASTED and OVERALL 
• Footnote – Stage 3: Concomitant transfusions or growth factors are any transfusion or growth factor given on or after the initial 
study treatment dosing date through either the first dose of the Extension Phase or through 30 days after the last dose for those 
not continuing into the Extension Phase. 
 


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Table 14.3.1.1.1A 
Overall Summary of Treatment Emergent Adverse Events (Safety Population in the Stage 1 PK Phase) 
 
TABLET [1] 
(N=xx) 
CAPSULE [2] 
(N=xx) 
FU/Ext Screening 
[3] (N=xx) 
Total [4] 
(N=xx) 
Any Treatment Emergent Adverse Event (TEAE) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Reduction 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Interruption 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib capsules. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for:  
Table 14.3.1.1.1B Overall Summary of Treatment Emergent Adverse Events (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.1.1C Overall Summary of Treatment Emergent Adverse Events (Safety Population in the Extension Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall 
[Programming Notes]  
• Sort order: All AE tabulations, unless otherwise specified, will be ordered in terms of decreasing frequency for SOC 
(alphabetically for SOCs with the same number of AEs reported), and decreasing frequency for PT within SOC (alphabetically for 
PTs with the same number of AEs reported within a SOC) considering the overall rate. 


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Table 14.3.1.1.1D 
Overall Summary of Treatment Emergent Adverse Events (Safety Population in the Stage 3 PK Phase) 
 
NIRAPARIB 
TABLET FASTED [1] 
(N=xx) 
NIRAPARIB 
TABLET FED [2] 
(N=xx) 
FU/Ext 
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any Treatment Emergent Adverse Event (TEAE) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Reduction 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Interruption 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any COVID-19 related TEAE Leading to Treatment 
Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
 


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Table 14.3.1.1.2A 
Overall Summary of Treatment Emergent Adverse Events by Sequence and Period (Safety Population in the Stage 1 PK Phase) 
 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
TABLET 
Period 1 
(N=xx) 
CAPSULE 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
CAPSULE 
Period 1 
(N=xx) 
TABLET 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
Any Treatment Emergent Adverse Event (TEAE) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Reduction 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Interruption 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE Leading to Treatment 
Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.3.1.1.2B Overall Summary of Treatment Emergent Adverse Events by Sequence and Period (Safety Population in the Stage 2 PK 
Phase) 
 
 


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Table 14.3.1.1.2D 
Overall Summary of Treatment Emergent Adverse Events by Sequence and Period (Safety Population in the Stage 3 PK Phase) 
 
Sequence 
NIRAPARIB TABLET FASTED/FED 
(N=xx) 
Sequence 
NIRAPARIB TABLET FED/FASTED 
(N=xx) 
NIRAPARIB 
TABLET 
FASTED 
Period 1 
(N=xx) 
NIRAPARIB 
TABLET  
FED  
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
NIRAPARIB 
TABLET  
FED 
Period 1 
(N=xx) 
NIRAPARIB 
TABLET FASTED 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
Any Treatment Emergent Adverse Event (TEAE) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related Serious TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE with CTCAE Toxicity Grade ≥ 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE with CTCAE Toxicity Grade ≥ 
3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Reduction 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE leading to Dose Interruption 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Related TEAE Leading to Treatment 
Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any TEAE Leading to Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any Serious COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Any COVID-19 related TEAE Leading to 
Treatment Discontinuation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
 


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Table 14.3.1.2.1A 
Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 1 PK Phase) 
 
System Organ Class 
Preferred Term 
TABLET [1] 
(N=xx) 
CAPSULE [2] 
(N=xx) 
FU/Ext Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib capsules. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For all tables of adverse events by SOC and PT, sort SOCs by descending overall frequency of events reported. Within each SOC, sort PTs 
by descending overall frequency of events reported. 
Table 14.3.1.2.1B Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 2 PK Phase) 
 
 


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Table 14.3.1.2.1C 
Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Open-Label Extension Phase) 
 
System Organ Class 
Preferred Term 
Niraparib 
TABLET 
(N=xx) 
Niraparib 
CAPSULE 
(N=xx) 
Niraparib 
OVERALL 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Source: Listing XXXXXXXXX, Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For all tables of adverse events by SOC and PT, sort SOCs by descending overall frequency of events reported. Within each SOC, sort PTs 
by descending overall frequency of events reported. 
 
 


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Table 14.3.1.2.1D 
Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 3 PK Phase) 
 
System Organ Class 
Preferred Term 
NIRAPARIB 
TABLET FASTED [1] 
(N=xx) 
NIRAPARIB 
TABLET FED [2] 
(N=xx) 
FU/Ext  
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For all tables of adverse events by SOC and PT, sort SOCs by descending overall frequency of events reported. Within each SOC, sort PTs 
by descending overall frequency of events reported. 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 63 of 119 
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Protocol No: XXXXX 
Table 14.3.1.2.1.1D 
Summary of COVID-19 related Adverse Events by SOC and PT (Safety Population in the Stage 3 PK Phase) 
 
System Organ Class 
Preferred Term 
NIRAPARIB 
TABLET FASTED [1] 
(N=xx) 
NIRAPARIB 
TABLET FED [2] 
(N=xx) 
FU/Ext  
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any COVID-19 related TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Note: COVID-19 Case Diagnosis is based on WHO Definition as of DDMMMYYYY. 
[1] Includes COVID-19 related TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes COVID-19 related TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes COVID-19 related TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For all tables of adverse events by SOC and PT, sort SOCs by descending overall frequency of events reported. Within each SOC, sort PTs 
by descending overall frequency of events reported. 
Select only COVID-19 related TEAEs. 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 64 of 119 
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Confidential 
Page 1 of x 
Protocol No: XXXXX 
Table 14.3.1.2.2A 
Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 1 PK Phase) 
 
System Organ Class 
Preferred Term 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
TABLET 
Period 1 
(N=xx) 
CAPSULE 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
CAPSULE 
Period 1 
(N=xx) 
TABLET  
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For tables of adverse events by SOC and PT by sequence and period, sort alphabetically by SOCs and PTs. 
Table 14.3.1.2.2B Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 2 PK Phase) 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 65 of 119 
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Page 1 of x 
Protocol No: XXXXX 
Table 14.3.1.2.2D 
Summary of Treatment Emergent Adverse Events by SOC and PT (Safety Population in the Stage 3 PK Phase) 
 
Sequence 
NIRAPARIB TABLET FASTED/FED 
(N=xx) 
Sequence 
NIRAPARIB TABLET FED/FASTED 
(N=xx) 
 
System Organ Class 
Preferred Term 
NIRAPARIB 
TABLET FASTED 
Period 1 
(N=xx) 
NIRAPARIB 
TABLET FED 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
NIRAPARIB 
TABLET FASTED 
Period 1 
(N=xx) 
NIRAPARIB 
TABLET FED 
Period 2 
(N=xx) 
FU/Ext 
Screening 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
SOC2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
For tables of adverse events by SOC and PT by sequence and period, sort alphabetically by SOCs and PTs. 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 66 of 119 
Using Mock Shell (Table 14.3.1.2.1A, Table 14.3.1.2.1B, Table 14.3.1.2.1C, Table 14.3.1.2.1D)  
Repeat for: 
Table 14.3.1.3A Summary of Related TEAE by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.3B Summary of Related TEAE by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.3C Summary of Related TEAE by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.3D Summary of Related TEAE by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.4A Summary of Serious TEAE by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.4B Summary of Serious TEAE by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.4C Summary of Serious TEAE by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.4D Summary of Serious TEAE by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.5A Summary of Related Serious TEAE by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.5B Summary of Related Serious TEAE by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.5C Summary of Related Serious TEAE by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.5D Summary of Related Serious TEAE by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.6A Summary of TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.6B Summary of TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.6C Summary of TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.6D Summary of TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.7A Summary of Related TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.7B Summary of Related TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.7C Summary of Related TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.7D Summary of Related TEAE with CTCAE Toxicity Grade ≥3 by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.8A Summary of TEAE Leading to Treatment Discontinuation by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.8B Summary of TEAE Leading to Treatment Discontinuation by SOC and PT (Safety Population in the Stage 2 PK Phase) 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 67 of 119 
Table 14.3.1.8C Summary of TEAE Leading to Treatment Discontinuation by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.8D Summary of TEAE Leading to Treatment Discontinuation by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.9C Summary of TEAE Leading to Treatment Dose Interruption by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.10A Summary of TEAE Leading to Treatment Dose Reduction by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.10B Summary of TEAE Leading to Treatment Dose Reduction by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.10C Summary of TEAE Leading to Treatment Dose Reduction by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.10D Summary of TEAE Leading to Treatment Dose Reduction by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.11A Summary of TEAE Leading to Death by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.11B Summary of TEAE Leading to Death by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.11C Summary of TEAE Leading to Death by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.11D Summary of TEAE Leading to Death by SOC and PT (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.12A Summary of Treatment Emergent AESI by SOC and PT (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.12B Summary of Treatment Emergent AESI by SOC and PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.12C Summary of Treatment Emergent AESI by SOC and PT (Safety Population in the Extension Phase) 
Table 14.3.1.12D Summary of Treatment Emergent AESI by SOC and PT (Safety Population in the Stage 3 PK Phase) 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 68 of 119 
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Page 1 of x 
Protocol No: XXXX 
Table 14.3.1.13A 
Summary of Treatment Emergent Adverse Events by SOC and PT and CTCAE Toxicity Grade (Safety Population in the Stage 1 PK Phase) 
 
System Organ Class 
Preferred Term 
TABLET [1] 
(N=xx) 
CAPSULE [2] 
(N=xx) 
FU/Ext  
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  Grade 1 
 
 
 
 
  …….. 
 
 
 
 
  Grade 5 
 
 
 
 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  Grade 1 
 
 
 
 
  …….. 
 
 
 
 
  Grade 5 
 
 
 
 
 
 
 
 
 
 PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  Grade 1 
 
 
 
 
  …….. 
 
 
 
 
  Grade 5 
 
 
 
 
…… 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib capsules. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.3.1.13B Summary of Treatment Emergent Adverse Events by SOC and PT and Maximum Toxicity (Safety Population in the Stage 2 PK 
Phase) 
Table 14.3.1.13C Summary of Treatment Emergent Adverse Events by SOC and PT and Maximum Toxicity (Safety Population in the Extension 
Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall 
[Programming Notes] 
For all tables of adverse events by SOC and PT, sort SOCs by descending overall frequency of events reported. Within each SOC, sort 
PTs by descending overall frequency of events reported. Within each PT, sort by presented maximum toxicity grade. 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 1 of x 
Protocol No: XXXX 
Table 14.3.1.13D 
Summary of Treatment Emergent Adverse Events by SOC and PT and CTCAE Toxicity Grade (Safety Population in the Stage 3 PK Phase) 
 
System Organ Class 
Preferred Term 
NIRAPARIB 
TABLET FASTED [1] 
(N=xx) 
NIRAPARIB 
TABLET FED [2] 
(N=xx) 
FU/Ext  
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Grade 1 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  …….. 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  Grade 5 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 
 
 
 
 
SOC1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Grade 1 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  …….. 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  Grade 5 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 
 
 
 
 
 PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Grade 1 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  …….. 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
  Grade 5 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
 x (xx.x) 
…… 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 70 of 119 
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Protocol No: XXXXX 
Table 14.3.1.14A 
Summary of Treatment Emergent Adverse Events by PT (Safety Population in the Stage 1 PK Phase) 
 
Preferred Term 
TABLET [1] 
(N=xx) 
CAPSULE [2] 
(N=xx) 
FU/Ext Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   PT 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib capsules. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.3.1.14B Summary of Treatment Emergent Adverse Events by PT (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.14C Summary of Treatment Emergent Adverse Events by PT (Safety Population in the Extension Phase) 
• Summarize Extension Phase Data with columns for Tablet; Capsule; Overall 
 
[Programming Notes] 
Sort PTs by descending overall frequency of events reported.  
 
 


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Protocol No: 3000-01-004 
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Protocol No: XXXXX 
Table 14.3.1.14D 
Summary of Treatment Emergent Adverse Events by PT (Safety Population in the Stage 3 PK Phase) 
 
Preferred Term 
NIRAPARIB  
TABLET FASTED [1] 
(N=xx) 
NIRAPARIB  
TABLET FED [2] 
(N=xx) 
FU/Ext  
Screening [3] 
(N=xx) 
Total [4] 
(N=xx) 
Any TEAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
PT 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
PT 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   PT 3 
 
 
 
 
 
 
 
 
 
 
[1] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes TEAEs with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] For patients not participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase through the End of 
Study. For patients participating in the Extension Phase, includes TEAEs that began after the end of the PK Phase until the date of 
first dose in the Extension Phase. 
[4] Includes TEAEs occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 72 of 119 
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Page 1 of x  
Protocol No: XXXXX 
Table 14.3.1.15A 
Listing of Serious TEAEs During PK Phase (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Dosing Period/ 
Niraparib 
Treatment 
Adverse Event 
[P]MedDRA Preferred Term 
[S]System Organ Class 
Start 
Date 
Time/ 
(Rel 
Day 
[1])  
Stop 
Date 
Time 
(Rel 
Day 
[1]) TEAE? 
SAE/ 
Reason 
[2] 
Severity 
Action Taken 
on Study 
Treatment[3] 
Other 
Action 
Taken 
Relationship 
[3] 
Outcome 
 
Period 1/ 
Capsule 
XXXXXXXXXXXXXXXX 
[P]XXXXXXXXXXXXXXXXXXX 
[S]XXXXXXXXXXXXXXXXXXX 
yyyy-
mm-dd 
hh:mm 
[x] 
yyyy-
mm-dd 
[x] 
Y 
N 
Grade 1 T: NA 
C: Dose Not 
Changed 
 
T: NA 
C: Related 
Recovered/ 
Resolved 
 
Period 2/ 
Tablet 
XXXXXXXXXXXXXXXX 
[P]XXXXXXXXXXXXXXXXXXX 
[S]XXXXXXXXXXXXXXXXXXX 
yyyy-
mm-dd 
hh:mm 
[x] 
yyyy-
mm-dd 
[x] 
Y 
N 
Grade 1 T: Dose Not 
Changed 
C: NA 
 
T: Related 
C: NA 
Recovered/ 
Resolved 
 
PK Safety FU  
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in PK Phase. 
[2] Reason for SAE: 1 = Result in death; 2 = Life threatening; 3 = Result in persistent or significant disability/incapacity; 
4 = Requires or prolongs hospitalization; 5 = Congenital abnormality/birth defect; 6 = Other medically important event. 
[3] T=Tablet; C=Capsule. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming notes] 
Please add time to Start Date column for PK Phase Stage 2 and Extension Phase. 
 
Repeat for: 
Table 14.3.1.15B Listing of Serious TEAEs During the PK Phase (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.15C Listing of Serious TEAEs During the Extension Phase (Safety Population in the Extension Phase) 
Table 14.3.1.15D Listing of Serious TEAEs During the PK Phase (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.16A Listing of Deaths During the PK Phase (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.16B Listing of Deaths During the PK Phase (Safety Population in the Stage 2 PK Phase) 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
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Page 73 of 119 
Table 14.3.1.16C Listing of Deaths During the Extension Phase (Safety Population in the Extension Phase) 
Table 14.3.1.16D Listing of Deaths During the PK Phase (Safety Population in the Stage 3 PK Phase) 
• Footnote: ‘NOTE: Deaths due to progressive disease were not collected as adverse events.’ 
Table 14.3.1.17C Listing of TEAE Leading to Dose Interruption During the Extension Phase (Safety Population in the Extension Phase) 
Table 14.3.1.17D Listing of TEAE Leading to Dose Interruption During the PK Phase (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.18A Listing of TEAE Leading to Dose Reduction During the PK Phase (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.18B Listing of TEAE Leading to Dose Reduction During the PK Phase (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.18C Listing of TEAE Leading to Dose Reduction During the Extension Phase (Safety Population in the Extension Phase) 
Table 14.3.1.18D Listing of TEAE Leading to Dose Reduction During the PK Phase (Safety Population in the Stage 3 PK Phase) 
Table 14.3.1.19A Listing of TEAE Leading to Treatment Discontinuation During the PK Phase (Safety Population in the Stage 1 PK Phase) 
Table 14.3.1.19B Listing of TEAE Leading to Treatment Discontinuation During the PK Phase (Safety Population in the Stage 2 PK Phase) 
Table 14.3.1.19C Listing of TEAE Leading to Treatment Discontinuation During the Extension Phase (Safety Population in the Extension 
Phase) 
Table 14.3.1.19D Listing of TEAE Leading to Treatment Discontinuation During the PK Phase (Safety Population in the Stage 3 PK Phase) 
[Programming Notes] 
• Stage 3: Treatment Sequence will be NIRAPARIB TABLET FASTED/FED and NIRAPARIB TABLET FED/FASTED. 
• Stage 3: Column 2: Dosing Period/Treatment – Treatment should be NIRAPARIB FASTED or NIRAPARIB FED. 
• Stage 3: Treatment discontinuation during PK phase – add column to record if discontinuation was due to COVID-19 [“COVID-19 
Reason” with Options “COVID-19 infection” or “Issues rel. to COVID-19 pandemic”]. 
• Extension Phase: Replace column for Dosing Period/Treatment with Treatment and Starting Dose. 
• Extension Phase: Do not need time with start/stop dates. 
• Extension Phase: Footnote: [1] Relative to first dose during the Extension Phase. 
• Extension Phase: Add column for Dose at Onset of AE. 
 
 


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Table 14.3.1.20D 
Summary of Incidence of COVID-19 Related Adverse Events Over Time (Safety Population in the Stage 3 PK Phase) 
 
 
Period during COVID-19 
Pandemic [1] 
NIRAPARIB 
TABLET FASTED 
(N=xx) 
NIRAPARIB 
TABLET FED 
(N=xx) 
n/Patients at Risk (%) 
n/Patients at Risk (%) 
 
 
 
 
Any COVID-19 Related AE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related SAE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related Grade ≥3 AE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
 
[1] TABLET PK Phase Stage 3 opened to recruitment on DDMMMYYYY, with first patient consented on DDMMMYYYY, placing the start of the 
recruitment during the COVID-19 pandemic. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 


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Protocol No: XXXXX 
Table 14.3.1.21D 
Summary of Incidence of COVID-19 Related Adverse Events Over Time by Gender (Safety Population in the Stage 3 PK Phase) 
Report on separate page for each: <Gender: Male, Female>  
 
 
Period during COVID-19 
Pandemic [1] 
NIRAPARIB 
TABLET FASTED 
(N=xx) 
NIRAPARIB 
TABLET FED 
(N=xx) 
n/Patients at Risk (%) 
n/Patients at Risk (%) 
 
 
 
 
Any COVID-19 Related AE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related SAE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
Any COVID-19 Related Grade ≥3 AE 
Period 1 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
Period 2 
xx/xxx (xx.x%) 
xx/xxx (xx.x%) 
 
 
 
 
 
[1] TABLET PK Phase Stage 3 opened to recruitment on DDMMMYYYY, with first patient consented on DDMMMYYYY, placing the start of the 
recruitment during the COVID-19 pandemic. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.3.1.22D Summary of Incidence of Adverse Events Over Time by Age Group (Safety Population in the Stage 3 PK Phase) 
• Use the FDAAA age groups <=18, 18-64, >=65 


Niraparib 
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Protocol No: XXXXX 
Table 14.3.4.1A 
Summary of Study Treatment Exposure During the PK Phase (Safety Population in the Stage 1 PK Phase) 
 
Statistic 
Sequence 
TABLET/CAPSULE 
(N=xx) 
Sequence 
CAPSULE/TABLET 
(N=xx) 
 
OVERALL 
(N=xx) 
# of 100 mg Capsules Received 
 
 
 
 
3 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
# of 300 mg Tablets Received 
 
 
 
 
1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Table 14.3.4.1B Summary of Study Treatment Exposure During the PK Phase (Safety Population in the Stage 2 PK Phase) 
 
 


Niraparib 
Statistical Analysis Plan 
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Table 14.3.4.1C 
Summary of Study Treatment Exposure During the Extension Phase (Safety Population in the Extension Phase) 
Parameters 
Statistic 
Niraparib  
TABLET 
(N=xx) 
Niraparib  
CAPSULE 
(N=xx) 
Niraparib  
OVERALL 
(N=xx) 
Number of Cycles 
 
1 
 
2 
 
... 
 
≥ 6 
 
n (%) 
n (%) 
... 
n (%) 
 
xx (xx.x) 
xx (xx.x) 
... 
xx (xx.x) 
 
xx (xx.x) 
xx (xx.x) 
... 
xx (xx.x) 
 
xx (xx.x) 
xx (xx.x) 
... 
xx (xx.x) 
Duration of Treatment (months) 
n 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
Duration on Study (months) 
n 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
Total Number of Patients with dose interruption 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Total Number of Patients with dose reduction 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Total Number of Patients with dose re-escalation 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
Source: Listing XXXXXXXXX, Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Protocol No: XXXXX 
Table 14.3.4.1D 
Summary of Study Treatment Exposure During the PK Phase (Safety Population in the Stage 3 PK Phase) 
 
Statistic 
NIRAPARIB 
FASTED 
(N=XX) 
NIRAPARIB 
FED 
(N=XX) 
 
OVERALL 
(N=xx) 
# of 300 mg Tablets Received 
 
 
 
 
1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


Niraparib 
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Table 14.3.4.2C 
Summary of Niraparib Dose by Cycle (Safety Population in the Extension Phase) 
Cycle 
Starting 
Niraparib 
Dose (mg) 
Statistic 
Niraparib 
TABLET 
 
Niraparib  
CAPSULE 
 
Niraparib 
OVERALL 
 
1 
 
300 
200 
100 
N 
n (%) 
n (%) 
n (%) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
2 
 
300 
200 
100 
N 
n (%) 
n (%) 
n (%) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
3 
 
300 
200 
100 
N 
n (%) 
n (%) 
n (%) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xxx 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
…. 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


Niraparib 
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Table 14.3.4.3.1C 
Summary and Change from Baseline of Select Hematology Parameters by Visit During the Extension Phase 
(Safety Population in the Extension Phase) 
Parameter Visit 
Statistic 
NIRAPARIB TABLET (N=xx) 
NIRAPARIB CAPSULE (N=xx) 
NIRAPARIB OVERALL (N=xx) 
Actual 
Change 
Actual 
Change 
Actual 
Change 
Parameter 
1 
Baseline n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
 
Cycle 1 
– Day 8 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
Cycle 1 
– Day 15 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
Cycle 1 
– Day 22 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
Cycle 2 
– Day 1 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
……. 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
 
EOT 
n (missing) 
Mean (SD) 
Median 
Q1, Q3 
Min, Max 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
xx (xx) 
xx.x (xx.xx) 
xx.x 
xx.x, xx.x 
xx, xx 
Source: Listing XXXXXXXXX, Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 


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Protocol No: XXXXX 
Table 14.3.4.3.2C 
Shift Summary of Select Hematology Parameters During the Extension Phase (Safety Population in the Extension Phase) 
Treatment Group 
 
 
Post-Baseline Maximum CTCAE Grade 
Niraparib 
Tablet 
Laboratory 
Test 
Baseline 
CTCAE Grade 
Statistic 
Grade 0 
Grade 1 
Grade 2 
Grade 3 
Grade 4  
Missing 
 
xxxxx 
Grade 0 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
Grade 1 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
Grade 2 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
Grade 3 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
Grade 4 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
Missing 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Listing XXXXXXXXX, Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
Include Tablet, Capsule and Overall 
Repeat for: 
Table 14.3.4.4.1C Summary and Change from Baseline of Select Chemistry Parameters by Visit During the Extension Phase (Safety 
Population in the Extension Phase) 
Table 14.3.4.4.2C Shift Summary of Select Chemistry Parameters in Maximum Toxicity Grade During the Extension Phase (Safety Population 
in the Extension Phase) 
 


Niraparib 
Statistical Analysis Plan 
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Protocol No: XXXXX 
Table 14.3.4.4.1D 
Summary of COVID-19 Assessments for Patients with Suspected, Probable or Confirmed COVID-19 Case Diagnosis  
(Safety Population in the Stage 3 PK Phase) 
Assessment 
NIRAPARIB TABLET  
FASTED 
(N=XX) 
NIRAPARIB TABLET 
FED  
(N=XX) 
 
 
 
COVID-19 Case Diagnosis [1] 
xx (xx.x%) 
xx (xx.x%) 
  Confirmed 
xx (xx.x%) 
xx (xx.x%) 
  Probable 
xx (xx.x%) 
xx (xx.x%) 
  Suspected 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
COVID-19 Test Performed [2] 
 
 
  n 
xx 
xx 
  No 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
  Yes 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
 
 
 
Result from the COVID-19 Test 
 
 
  n 
xx 
xx 
  Negative 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
  Positive 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
  Indeterminate 
xx/xx (xx.x%) 
xx/xx (xx.x%) 
 
 
 
 
[1] COVID-19 Case Diagnosis is based on WHO Definition as of DDMMMYYYY. 
[2] COVID-19 Test Performed is only captured for patients with a COVID-19 Case Diagnosis. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
 


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Protocol No: XXXXX 
Table 14.4.1C 
Summary of Important Protocol Deviations (Safety Population in the Extension Phase) 
Category/Coded Term 
NIRAPARIB 
TABLET 
(N=XX) 
NIRAPARIB 
CAPSULE 
(N=XX) 
TOTAL 
(N=XX) 
 
 
 
 
Any important protocol deviations 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
 
 
 
 
CATEGORY 1 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
   SUBCATEGORY 1 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
   SUBCATEGORY 2 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
…. 
 
 
 
 
 
 
 
CATEGORY 2 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
   SUBCATEGORY 1 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
   SUBCATEGORY 2 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
… 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes]: 
• Include only IMPORTANT protocol deviations. 
• <Category 1...> represents ADDV.DVCAT. <Subcategory 1...> represents ADDV.DVDECOD. 
• Sort Categories in descending order according to overall counts, if ties are present, present alphabetically. 
 
 
 


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Protocol No: XXXXX 
Table 14.4.1D 
Summary of Important Protocol Deviations for the PK Phase Occurring Through End of Treatment 
(Safety Population in the Stage 3 PK Phase) 
Category/Coded Term 
NIRAPARIB TABLET  
FASTED [1] 
(N=XX) 
NIRAPARIB TABLET 
FED [2] 
(N=XX) 
TOTAL [3] 
(N=XX) 
 
 
 
 
Any important protocol deviations 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
 
 
 
 
CATEGORY 1 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
   SUBCATEGORY 1 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
   SUBCATEGORY 2 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
…. 
 
 
 
 
 
 
 
CATEGORY 2 
xxx (xx%) 
xxx (xx%) 
xxx (xx%) 
   SUBCATEGORY 1 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
   SUBCATEGORY 2 
 xx (xx%) 
 xx (xx%) 
 xx (xx%) 
… 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Includes protocol deviations with onset date in Period 1 or Period 2 where patient received niraparib tablet in fasted state. 
[2] Includes protocol deviations with onset date in Period 1 or Period 2 where patient received niraparib tablet in fed state. 
[3] Includes protocol deviations occurring at any time during the PK Phase.  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes]: 
• Include only IMPORTANT protocol deviations. 
• <Category 1...> represents ADDV.DVCAT. <Subcategory 1...> represents ADDV.DVDECOD. 
• Sort Categories in descending order according to overall counts, if ties are present, present alphabetically. 
 


Niraparib 
Statistical Analysis Plan 
Protocol No: 3000-01-004 
Confidential 
Page 85 of 119 
LISTINGS 
General guidelines: 
Listings are separated for the PK Phase (Stage 1, Stage 2 and Stage 3 separately) and the Open)-Label Extension Phase. 
For the PK Phase:  
• 
Treatment=Sequence (for Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET; for Stage 3: NIRAPARIB 
TABLET FASTED/FED or NIRAPARIB TABLET FED/FASTED). 
• 
Population=Safety Population in the PK Phase (i.e., those who receive at least 1 dose), unless otherwise specified. 
• 
Include all data assessments relative to the PK Phase. 
o For patients who do not continue to the Extension Phase, include all EOT/Safety FU data. Also include 
Extension Phase Screening for those patients who DO not proceed to the Extension Phase. 
• 
Relative day: With respect to first date of dosing in PK period. 
For the Extension Phase: 
• 
Treatment=Niraparib Tablet; Niraparib Capsule. 
• 
Population=Safety Population in the Open-Label Extension Phase (i.e., those who receive at least 1 dose), unless otherwise specified. 
• 
Include all assessments relative to the Extension Phase. 
o Any assessment specific to Extension Phase, including Screening Data. 
• 
Relative day: With respect to first date of dosing in Extension Phase. 
 
 


Niraparib 
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Protocol No: XXXXX 
Listing 16.2.1A 
Disposition for PK Phase (All Patients Enrolled in the Stage 1 PK Phase) 
 
Treatment: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB TABLET or 
NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Date of Last 
Niraparib Dose 
During PK Phase 
(Rel Day) 
Date of 
Discontinuation 
From PK Phase 
(Rel Day) 
Reason for 
Discontinuation 
from PK Phase 
Date of 
Discontinuation 
from Study (Rel 
Day)  
Reason for 
Discontinuation 
from Study 
Date of 
Death 
(Rel 
Day) 
Date of 
Progression 
(Rel Day) 
Protocol 
Version 
 
 
 
Other: specify 
 
 
 
 
 
 
 
 
Completion 
 
 
 
 
 
 
Relative Day calculated relative to first dose in PK Phase. 
 
Only study discontinuations, disease progressions and deaths that occur during PK phase (i.e., before 1st dose of extension or prior 
to discontinuing the study for patients not entering the Extension Phase) are listed. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes – PK Phase] 
• Include only data that falls before first-dose Open-Label Extension Phase, i.e., for those patients who DC study and do not continue 
in the Open-Label Extension Phase. 
 
Repeat for: 
Listing 16.2.1B Disposition for PK Phase (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.1C Disposition for Open-Label Extension Phase (All Patients Enrolled for the Extension Phase) 
Listing 16.2.1D Disposition for PK Phase (Safety Population in the Stage 3 PK Phase) 
[Programming Notes – Extension Phase] 
• Change ‘PK Phase’ to ‘Open-Label Extension’ Phase in respective columns. 
• Treatment: Niraparib Tablet or Niraparib Capsule. 
• Footnote: Relative Day calculated relative to first dose in Extension Phase. 
 
 


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Listing 16.2.1.2A 
Reasons for Screen Failure (Patients who Failed Screening in the Stage 1 PK Phase) 
 
Treatment Sequence: <SCREEN FAILURE> 
Patient 
Number 
Protocol Version 
Inclusion/Exclusion Criteria Not Met 
 
xxxxxx-xxxx 
Version 1.0 (original) INPXX: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
xxxxxx-xxxx 
Version 1.0 (original) EXPXX: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.1.2B Reasons for Screen Failure (Patients who Failed Screening in the Stage 2 PK Phase) 
Listing 16.2.1.2D Reasons for Screen Failure (Patients who Failed Screening in the Stage 3 PK Phase) 
 
 


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Listing 16.2.2A 
Protocol Deviations for the PK Phase (Safety Population in the Stage 1 PK Phase) 
 
Treatment: < Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET>  
Patient 
Number 
 
Visit 
Protocol Deviation Category 
Protocol Deviation Severity 
Description of Protocol Deviation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
 
 
[Programming Notes] 
• Include only data that falls before first-dose Open-Label Extension Phase (i.e., for those patients who DC study and do not 
continue in the Open-Label Extension Phase) 
 
Repeat for: 
Listing 16.2.2B Protocol Deviation for the PK Phase (Safety Population in the Stage 2 PK Phase) 
 
 


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Listing 16.2.2C 
Important Protocol Deviations for the Open-Label Extension Phase (Safety Population for Open-Label Extension Phase) 
Treatment: <Extension (Stages 1 & 2): NIRAPARIB TABLET or NIRAPARIB CAPSULE; Extension (Stage 3): NIRAPARIB TABLET>  
Patient 
Number 
 
Visit 
Protocol Deviation 
Category 
Protocol Deviation 
Severity 
Description of 
Protocol Deviation 
TESARO 
Classification [1] 
GSK  
Classification [2] 
 
 
 
 
 
<<SIGNIFICANT/ 
IMPORTANT>> 
<<IMPORTANT/NON-
IMPORTANT>> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] For Stages 1 & 2, protocol deviation classification is done based on TESARO Protocol Deviation Management System only. GSK 
Classification will remain blank. 
[2] For Stage 3, protocol deviation classification is done based on GSK Protocol Deviation Management System only. TESARO Classification 
will remain blank. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming notes] 
For Stage 3 Extension Phase, patients will receive NIRAPARIB TABLET formulation only. 
 
For Stages 1 and 2 reporting, only TESARO Classifications will be populated, for Stage 3 – only GSK Classification will be 
populated. 
 
Only include protocol deviation classed as Important. 
 


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Listing 16.2.2.1D 
Important Protocol Deviations for the PK Phase Occurring Through End of Treatment (Safety Population for Stage 3 PK Phase) 
Treatment: <NIRAPARIB FASTED or NIRAPARIB FED>  
Patient 
Number 
 
Visit 
Protocol Deviation Category 
Protocol Deviation Severity 
Description of Protocol Deviation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming notes]: 
 
• 
Only include protocol deviation classed as Important. 


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Listing 16.2.2.2D 
GSK Protocol Deviations related to COVID-19 (Safety Population for Stage 3 PK Phase) 
Treatment: <NIRAPARIB FASTED or NIRAPARIB FED>  
Patient 
Number 
Deviation Category 
Description of Deviation 
GSK Classification 
Date 
 
 
 
<IMPORTANT/NOT-IMPORTANT> 
 
 
 
 
 
 
 
 
 
 
 
 
Note: * Patients with probable, suspected or confirmed COVID-19. 
Note: This listing only includes COVID-19 related protocol deviations. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 


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Listing 16.2.3A 
Study Populations for the PK Phase (All Patients Enrolled in the Stage 1 PK Phase) 
 
Treatment: <TABLET/CAPSULE or CAPSULE/TABLET or SCREEN FAILURE> 
 
Patient 
Number 
PK Phase Safety  
(SAF) Population 
Informed Consent Date 
Randomization Date 
 
Y 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.3B Study Populations for the PK Phase (All Patients Screened in the Stage 2 PK Phase) 
• For Stage 2 PK, add column for BE Evaluable Population (Y/N). 
 
 


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Listing 16.2.3C 
Study Populations for the Open-Label Extension Phase (All Patients Enrolled in the Extension Phase) 
Treatment: <NIRAPARIB TABLET or NIRAPARIB CAPSULE> 
 
Patient 
Number 
Extension Phase 
Safety (SAF) 
Population 
 
 
 
 
 
 
 
 
 
Y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Listing 16.2.3D 
Study Populations for the PK Phase (All Patients Enrolled in the Stage 3 PK Phase) 
Treatment: <FASTED/FED or FED/FASTED or SCREEN FAILURE> 
Patient 
Number 
PK Phase 
Safety (SAF) Population 
FE Population 
Informed Consent Date 
Randomization Date 
 
Y 
Y 
 
 
 
 
N 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 
 


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Listing 16.2.4.1A 
Demographics (Safety Population in the Stage 1 PK Phase) 
Study Treatment: <Stage 1 & 2: NOT DOSED or TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: NOT DOSED or FASTED/FED or FED/FASTED> or 
<Extension: NIRAPARIB TABLET or NIRAPARIB CAPSULE>, as applicable  
Patient 
Number 
Age 
(yrs) 
Sex 
Child-Bearing 
Potential 
Ethnicity 
Race 
Height 
(cm) 
Weight 
(kg) 
BMI 
(kg/m2) 
ECOG Performance 
Status 
 
 
 
 
 
Other: specify 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECOG = Eastern Cooperative Oncology Group: 0=Fully active, able to carry on all pre-disease performance without restriction 
1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature  
2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 
3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours  
4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.4.1B Demographics (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.4.1C Demographics (Safety Population in the Extension Phase) 
Listing 16.2.4.1D Demographics (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.4.2A 
Medical History (Safety Population in the Stage 1 PK Phase) 
PK Phase Treatment: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
System Organ Class 
   Preferred Term 
      Medical Condition or Event 
Start 
Date 
Ongoing at  
Study Start? 
Stop Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Includes only patients with major medical conditions. 
 
Note: MedDRA version XX.X. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.4.2B Medical History (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.4.2C Medical History (Safety Population in the Extension Phase) 
Listing 16.2.4.2D Medical History (Safety Population in the Stage 3 PK Phase) 
[Programming notes] 
• 
For Stage 3, the latest available MedDRA version is to be used. 
 
 


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Listing 16.2.4.3A 
Prior Anti-Cancer Treatment (Safety Population in the Stage 1 PK Phase) 
Treatment: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB TABLET or 
NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Regimen 
Number 
-Verbatim Term 
 --Preferred Term 
Reason for Administration 
Best Response 
 
 
 
Other: specify 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.4.3B Prior Anti-Cancer Treatment (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.4.3C Prior Anti-Cancer Treatment (Safety Population in the Extension Phase) 
Listing 16.2.4.3D Prior Anti-Cancer Treatment (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.4.4A 
Primary Cancer History (Safety Population in the Stage 1 PK Phase) 
Treatment: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB TABLET or 
NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Tumor Type 
Date of First 
Diagnosis 
Cancer Stage (Most Recent) 
Number of Prior Lines 
of Therapy 
 
<Other: specify> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.4.4B Primary Cancer History (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.4.4C Primary Cancer History (Safety Population in the Extension Phase) 
Listing 16.2.4.4D Primary Cancer History (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.4.5A 
Prior/Concomitant Radiotherapy (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable  
Patient 
Number 
Site or Region 
Date Started 
Date Stopped 
Total Grays 
Prior/ 
Concomitant Flag 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Includes patients with prior or concomitant radiotherapy with respect to the PK Phase.  
P=Prior (radiotherapy with start date earlier than the first dose date of study treatment) 
C=Concomitant (radiotherapy occurring on or after the initial study treatment dosing date through either the first dose of the Extension 
Phase or through 30 days after the last dose, for those not continuing into the Extension Phase).  
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.4.5B Prior/Concomitant Radiotherapy (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.4.5C Prior/Concomitant Radiotherapy (Safety Population in the Extension Phase) 
Listing 16.2.4.5D Prior/Concomitant Radiotherapy (Safety Population in the Stage 3 PK Phase) 
 
 


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Protocol No: XXXXX 
Listing 16.2.5.1A 
Prior and Concomitant Medications (Safety Population in the Stage 1 PK Phase) 
 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
Patient Number = xxxxxx-xxxx 
 
ATC/ 
Preferred 
Term/ 
Verbatim 
Term 
Dose per 
Administration 
Dose 
Unit 
Frequenc
y 
Indica
tion 
Route of 
Administr
ation 
Start/ 
Stop Date 
Ongoing  
Prior/ 
Concomitant 
Flag 
PK Dose 1 
PK Dose 2 
 
 
 
 
 
 
 
 
 
YYYY-MM-DD 
YYYY-MM-DD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Includes patients with prior or concomitant medications taken during the PK Phase.  
P=Prior medication only; C=Concomitant medication only; B=Both prior and concomitant medications. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
• For the Prior/Concomitant Flag, list all that apply. 
• If ATC3 not available, use a footnote [1] ATC level 3 term is not available through WHO Drug Dictionary. 
 
Repeat for: 
Listing 16.2.5.1B Prior and Concomitant Medications (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.5.1C Prior and Concomitant Medications (Safety Population in the Extension Phase) 
Listing 16.2.5.1D Prior and Concomitant Medications (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.5.2A 
Prior/Concomitant Procedures During PK Phase (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Procedure 
Date 
Rel Day 
[1]  
Procedure 
Results/Findings 
AE/SAE? Indication 
Prior/Concomitant 
Flag 
xxxxxx-xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the PK Phase. 
Note: Includes patients with prior or concomitant procedures during the PK Phase. 
P=Prior (any procedure earlier than the first dose date of study treatment). 
C=Concomitant (any procedure on or after the initial study treatment dosing date through either the first dose of the Extension Phase 
or through 30 days after the last dose, for those not continuing into the Extension Phase). 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for 
Listing 16.2.5.2B Prior/Concomitant Procedures During the PK Phase (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.5.2C Prior/Concomitant Procedures During the Extension Phase (Safety Population in the Extension Phase) 
[Programming Notes for Extension Phase] 
• Footnote: [1] Relative to first dose during the Extension Phase. 
 
Listing 16.2.5.2D Prior/Concomitant Procedures During the PK Phase (Safety Population in the Stage 3 PK Phase) 
 


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Listing 16.2.5.3A 
Prior and Concomitant Transfusions (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable  
 
Patient 
Number 
Received Transfusion 
within 14 days of first 
dose or during study? 
Type of 
Administration 
Units 
Transfusion Date 
Rel Day [1] 
Prior/ 
Concomitant Flag 
 
 
Other: specify 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the PK Phase. 
Note: Includes patients with prior or concomitant transfusions during the PK Phase. 
P=Prior (any transfusion earlier than the first dose date of study treatment). 
C=Concomitant (any transfusion on or after the initial study treatment dosing date through either the first dose of the Extension 
Phase or through 30 days after the last dose, for those not continuing into the Extension Phase). 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
• For the Prior/Concomitant Flag, list all that apply. 
 
Repeat for: 
Listing 16.2.5.3B Prior and Concomitant Transfusions (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.5.3C Prior and Concomitant Transfusions (Safety Population in the Extension Phase) 
Listing 16.2.5.3D Prior and Concomitant Transfusions (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.5.4A 
Prior and Concomitant Growth Factors (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Received growth factor within 14 
days of first dose or during study? 
Type of 
Administration 
Dose 
Unit 
Administration 
Date 
Prior/ 
Concomitant Flag 
 
 
Other: specify 
 
Other: specify 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Includes patients with prior or concomitant growth factors during the PK Phase. 
P=Prior (any growth factor earlier than the first dose date of study treatment). 
C=Concomitant (any growth factor given on or after the initial study treatment dosing date through either the first dose of the 
Extension Phase or through 30 days after the last dose, for those not continuing into the Extension Phase). 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
• For the Prior/Concomitant Flag, list all that apply. 
 
Repeat for: 
Listing 16.2.5.4B Prior and Concomitant Growth Factors (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.5.4C Prior and Concomitant Growth Factors (Safety Population in the Extension Phase) 
Listing 16.2.5.4D Prior and Concomitant Growth Factors (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.5.5A 
Study Treatment (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET>  
Patient 
Number 
Visit 
Formulation 
Date:Time of 
Administration 
(Rel Day [1]) 
Full 
Dose 
Taken? 
If No, how 
much 
consumed? 
Reason  
for Change 
Bottle 
Number 
Fast 8 hrs 
prior to 
administration? 
Vomit 
within 8 
hours of 
dose? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the PK Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for:   
Listing 16.2.5.5B Study Treatment (Safety Population in the Stage 2 PK Phase) 
[For Stage 2 PK Phase] 
• Modify label for Vomiting Question, ‘Vomit within specified time of dose’. 
• Add column for Nausea Question, ‘Nausea within specified time of dose’. 
 
 


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Listing 16.2.5.5C 
Study Treatment (Safety Population in the Extension Phase) 
TREATMENT:  <NIRAPARIB TABLET or NIRAPARIB CAPSULE> 
Patient 
Number 
Visit 
Dose 
Prescribed 
(mg) 
Start Date 
(Rel Day [1])/ 
Stop Date (Rel 
Day [1]) 
Was Full 
Dose 
Taken? 
Action Taken 
Reason for 
Modification 
Bottle 
number 
Dispensed 
Bottle 
Number 
Returned 
Tablets 
Remaining 
 
 
 
 
No  
 
Other <specify 
reason> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the Extension Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Listing 16.2.5.5D 
Study Treatment (Safety Population in the Stage 3 PK Phase) 
Treatment Sequence: <FASTED/FED or <FED/FASTED> 
 
Patient 
Number 
Visit 
Fasted or 
Fed State 
Date:Time of 
Administration 
(Rel Day [1]) 
Bottle Number 
Fast 10 hrs 
prior to 
administration? 
Vomit within 
protocol 
specified hours 
from dose? 
Fast for 
minimum of 4 
hours post 
dose? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the PK Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Listing 16.2.5.6B 
Subsequent Anti-Cancer Therapy (Safety Population in the Stage 2 PK Phase) 
Treatment Sequence:  TABLET/CAPSULE or CAPSULE/TABLET 
Patient 
Number 
Date of Subsequent Anti-Cancer 
Administration  
Relative Day [1] 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the PK Phase. 
Note: Includes only patients with subsequent anti-cancer therapy recorded for patients who do not continue to Extension Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 


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Listing 16.2.5.6C 
Subsequent Anti-Cancer Therapy (Safety Population in the Extension Phase) 
Treatment:  <NIRAPARIB TABLET or NIRAPARIB CAPSULE> 
Patient 
Number 
Date of Subsequent Anti-Cancer 
Administration 
Relative Day [1] 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the Extension Phase. 
Note: Includes only patients with subsequent anti-cancer therapy recorded. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 


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Listing 16.2.5.6D 
Meal Status (Safety Population in the Stage 3 PK Phase) 
Treatment Sequence:  <FASTED/FED or <FED/FASTED> 
Patient 
Number 
Visit 
Meal Start Date 
Meal Start Time 
Meal End Time 
% of Meal Consumed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


Niraparib 
Statistical Analysis Plan 
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Listing 16.2.6.1C 
Investigator Assessment of Response (Safety Population in the Extension Phase) 
TREATMENT:  <NIRAPARIB TABLET or NIRAPARIB CAPSULE> 
Patient 
Number 
Visit 
Date 
Rel Day [1] 
Overall Response 
 
 
 
 
 
 
 
 
 
NE:  <Reason> 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to first dose during the Extension Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
 


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Listing 16.2.7.1A 
Adverse Events (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Dosing Period/ 
Niraparib 
Treatment 
Adverse Event 
MedDRA Preferred Term 
System Organ Class 
Start Date:Time 
(Rel Day [1]) 
End Date (Rel 
Day [1])  
TEAE? 
SAE/ 
Reason 
[2] 
Severity 
Action 
Taken on 
Study 
Treatment 
Other 
Action 
Taken 
Relation-
ship 
Outcome 
 
Period 1/ 
Capsule 
XXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXX 
XXXXXXXXXXXXXXXXXXX 
yyyy-mm-dd [x] 
yyyy-mm-dd [x] 
Y 
N 
Grade 1  
 
 
Recovered/ 
Resolved 
 
Period 2/ 
Tablet 
XXXXXXXXXXXXXXXX 
[P]XXXXXXXXXXXXXXXXXXX 
[S]XXXXXXXXXXXXXXXXXXX 
yyyy-mm-dd [x] 
yyyy-mm-dd [x] 
Y 
N 
Grade 1  
 
 
Recovered/ 
Resolved 
 
PK Safety FU 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in PK Phase. 
[2] Reason for SAE: 1 = Result in death; 2 = Life threatening; 3 = Result in persistent or significant disability/incapacity;  
4 = Requires or prolongs hospitalization; 5 = Congenital abnormality/birth defect; 6 = Other medically important event. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.7.1B Adverse Events (Safety Population in the Stage 2 PK Phase) 
[Add time for start date] 
Listing 16.2.7.1C Adverse Events (Safety Population in the Extension Phase) 
Listing 16.2.7.1D Adverse Events (Safety Population in the Stage 3 PK Phase) 
[Programming Notes] 
• Stage 3: Treatment Sequence will be Fasted/Fed and Fed/Fasted. 
• Stage 3: Column 2: Dosing Period/Treatment – Treatment should be Niraparib FASTED or Niraparib FED. 
• Extension Phase: Do not need column for Dosing Period/Treatment. 
• Extension Phase: Do not need time with start/stop dates. 
• Extension Phase: Footnote: [1] Relative to first dose during the Extension Phase. 
• Extension Phase: Add column for Dose at Onset of AE. 
 


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Listing 16.2.8.1.1A 
Hematology Results in the PK Phase (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
Patient 
Number 
Parameter 
(unit) 
Visit 
Rel Day 
[1] 
Sample 
date/time 
Result 
Change from 
baseline 
Normal range 
Out of 
range flag 
Clinically 
significant flag 
 
 
 
 
 
xx.x 
xx.x 
xx.x – xx.x 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. 
Scheduled and unscheduled visits through the extension screening phase or through study discontinuation for those not continuing in 
the Extension Phase, are included. Visits related to the extension screening phase are not included. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes]: 
• If required for readability, move ‘Patient Number’ into Header row after ‘Treatment Sequence’. 
Repeat for: 
Listing 16.2.8.1.1B Hematology Results (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.1.1C Hematology Results (Safety Population in the Extension Phase) 
Listing 16.2.8.1.1D Hematology Results Through the PK End of Treatment Visit (Safety Population in the Stage 3 PK Phase) 
Listing 16.2.8.1.2A Chemistry Results (Safety Population in the Stage 1 PK Phase) 
Listing 16.2.8.1.2B Chemistry Results (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.1.2C Chemistry Results (Safety Population in the Extension Phase) 
Listing 16.2.8.1.2D Chemistry Results Through the PK End of Treatment Visit (Safety Population in the Stage 3 PK Phase) 
Listing 16.2.8.1.3A Urinalysis Results (Safety Population in the Stage 1 PK Phase) 
Listing 16.2.8.1.3B Urinalysis Results (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.1.3C Urinalysis Results (Safety Population in the Extension Phase) 
[Programming Notes For Extension Phase Tables]: 
• Footnote: [1] Relative to first dose during the Extension Phase. 
Listing 16.2.8.1.3D Urinalysis Results Through the PK End of Treatment Visit (Safety Population in the Stage 3 PK Phase) 


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Listing 16.2.8.1.4C 
Liver Function Tests – Potential Hy’s Law Cases (Safety Population in the Extension Phase) 
TREATMENT: <NIRAPARIB TABLET or NIRAPARIB CAPSULE> 
Patient  
Number 
Visit 
Sample 
Collection Date 
Day [1] 
Laboratory Analyte 
(result/xULN) 
ALT (U/L) 
AST (U/L) 
Total Bilirubin 
(umol/L) 
ALP (U/L) 
 
 
DDMMMYYYY  
 
150/3.3 
100/2.7 
40/2.3 
100/0.7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ALP=alkaline phosphatase. ALT=alanine aminotransferase. AST=aspartate aminotransferase. ULN=upper limit of normal. 
 
[1] Relative to first dose during the Extension Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
Include all visits for any Patients with ALT or AST >3×ULN with bilirubin >2×ULN and ALP <2×ULN at any time in Extension Phase. 
 
 


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Listing 16.2.8.2A 
Vital Signs (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Visit 
Assessment 
Date 
Rel 
Day 
[1]  
Height 
(cm) 
Weight 
(kg) 
Temperature 
(°C) 
Pulse 
(beats/min) 
Systolic Blood 
Pressure (mmHg) 
Diastolic Blood 
Pressure (mmHg) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. 
Data is listed only when the vital sign assessment was performed. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.8.2B Vital Signs (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.2C Vital Signs (Safety Population in the Extension Phase) 
[Programming Notes For Extension Phase Tables]: 
• Footnote: [1] Relative to first dose during the Extension Phase 
 
Listing 16.2.8.2D Vital Signs Through the PK End of Treatment Visit (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.8.3A 
ECG Results (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Visit Date 
Rel Day [1] 
ECG Interpretation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. 
NCS = Not Clinically Significant, CS = Clinically Significant. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.8.3B ECG Results (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.3C ECG Results (Safety Population in the Extension Phase) 
Listing 16.2.8.3D ECG Results (Safety Population in the Stage 3 PK Phase) 
[Programming Notes For Extension Phase Tables]: 
• Footnote: [1] Relative to first dose during the Extension Phase 
 
 


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Listing 16.2.8.4A 
ECOG Performance Status (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Visit 
Assessment Date  
Rel Day [1] 
Performance Status 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. Data is listed only when the ECOG Performance Status assessment was performed.  
ECOG = Eastern Cooperative Oncology Group:  
0=Fully active, able to carry on all pre-disease performance without restriction  
1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature  
2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 
3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours  
4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.8.4B ECOG Performance Status (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.4C ECOG Performance Status (Safety Population in the Extension Phase) 
[Programming Notes For Extension Phase Tables]: 
• Footnote: [1] Relative to first dose during the Extension Phase 
Listing 16.2.8.4D ECOG Performance Status Through the PK End of Treatment Visit (Safety Population in the Stage 3 PK Phase) 
 
 


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Listing 16.2.8.5A 
Baseline Physical Examination Findings (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Visit 
Date Performed 
Rel  
Day [1]  
Body System 
Status 
Abnormality Description 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.8.5B Baseline Physical Examination Findings (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.5C Baseline Physical Examination Findings (Safety Population in the Extension Phase) 
Listing 16.2.8.5D Baseline Physical Examination Findings (Safety Population in the Stage 3 PK Phase) 
[Programming Notes For Extension Phase Tables]: 
• Footnote: [1] Relative to first dose during the Extension Phase. 
 
 


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Listing 16.2.8.6A 
Pregnancy Test (Safety Population in the Stage 1 PK Phase) 
Treatment Sequence: <Stage 1 & 2: TABLET/CAPSULE or CAPSULE/TABLET> or <Stage 3: FASTED/FED or FED/FASTED> or <Extension: NIRAPARIB 
TABLET or NIRAPARIB CAPSULE>, as applicable 
 
Patient 
Number 
Visit 
Was 
Pregnancy Test Performed? 
Date of Test 
Rel Day [1] 
Type 
Result 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Relative to the date of first dose in the PK Phase. 
Scheduled and unscheduled visits through the Extension Screening Phase or through study discontinuation for those not continuing in 
the Extension Phase, are included. Visits related to the Extension Screening Phase are not included. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
Repeat for: 
Listing 16.2.8.6B Pregnancy Test (Safety Population in the Stage 2 PK Phase) 
Listing 16.2.8.6C Pregnancy Test (Safety Population in the Extension Phase) 
[Programming Notes For Extension Phase Tables]: 
• Footnote: [1] Relative to first dose during the Extension Phase 
Listing 16.2.8.6D Pregnancy Test (Safety Population in the Stage 3 PK Phase)


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Listing 16.2.9.2D 
Listing of COVID-19 Assessments and Symptom Assessments for Patients with COVID-19 Adverse Events 
(Safety Population in the Stage 3 PK Phase) 
Treatment Sequence: <Stage 3: Period 1: FASTED or FED; Period 2: FASTED or FED> 
 
Patient 
Number 
Treatment 
Period (State) 
Adverse 
Event 
AE  
Start Date 
COVID-19 Case 
Diagnosis [1] 
COVID-19 Test 
Performed/ Test 
Date/ Results 
Assessments and  
Symptom Assessments 
Result 
 
 
 
 
 
 
 
 
xxxx 
1 (FASTED) 
Coronavirus 
infection 
2020-04-16 
Suspected 
Yes/ 
2020-04-17/ 
Indeterminate 
Travel to Location with Community 
Transmission [2] 
No 
 
 
 
 
 
 
Visited Health Care Facility [2] 
No 
 
 
 
 
 
 
Contact with COVID-19 
Confirmed/Probable Case [2] 
Unknown 
 
 
 
 
 
 
Medication Taken to Treat COVID-19 
Yes 
 
 
 
 
 
 
Fever 
Yes 
 
 
 
 
 
 
Cough 
Yes 
 
 
 
 
 
 
Shortness of Breath 
Yes 
 
 
 
 
 
 
Sore Throat 
No 
 
 
 
 
 
 
Loss of Appetite 
No 
 
 
 
 
 
 
Nausea 
No 
 
 
 
 
 
 
Vomiting 
No 
 
 
 
 
 
 
Diarrhea 
No 
 
 
 
 
 
 
Abdominal Pain 
No 
 
 
 
 
 
 
Fatigue 
No 
 
 
 
 
 
 
Loss of Smell 
No 
 
 
 
 
 
 
Loss of Taste 
No 
 
 
 
 
 
 
Asymptomatic 
No 
 
 
 
 
 
 
Home Quarantined/Isolated 
Unknown 
 
 
 
 
 
 
 
 
 
2 (FED) 
 
 
 
 
... 
 
 
 
 
 
 
 
 
 
 
AE=Adverse event. 
[1] COVID-19 Case Diagnosis is based on WHO Definition as of DDMMMYYYY. 
[2] Within 14 days prior to symptom onset. 
 
Source: Program:  XXXXXXXXXXXXXXXXXX.  Output: xxxxxxxxxxxx.rtf.  Generated on DDMMMYYYY:HH:MM:SS 
Data Extract Date:  DDMMMYYYY,  Data Cutoff Date:  DDMMMYYYY 
 
 
[Programming Notes] 
The COVID-19 AE terms include: Asymptomatic COVID-19, Coronavirus infection, COVID-19, COVID-19 pneumonia, Suspected COVID-19.  
Note that the number of COVID-19 AE terms may change. 

Prot_000.pdf: 
title page 
Title Pag
 
AN OPEN-LABEL, RANDOMIZED-SEQUENCE, MULTICENTER, SINGLE-
CROSSOVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY AND 
BIOEQUIVALENCE OF NIRAPARIB TABLET FORMULATION COMPARED TO 
NIRAPARIB CAPSULE FORMULATION IN PATIENTS WITH ADVANCED SOLID 
TUMORS 
Sponsor: 
TESARO, a Glaxo Smith Kline 
Company 
980 Great West Road 
Brentford 
Middlesex, TW8 9GS 
UK 
 
Medical Monitor: 
Reginald Ewesuedo, MD  
Senior Medical Director 
 
Sponsor Protocol No.: 
IND No: 
3000-01-004 
100,996 
Study Drug Names: 
Niraparib capsules, niraparib tablets 
Development Phase: 
Phase 1 
Date of Original 
Protocol: 
26 September 2017 
Date of Amendment 1: 
05 February 2018 
Date of Amendment 2: 
06 August 2018 
Date of Amendment 3: 
29 January 2019 
Date of Amendment 4: 
Date of Amendment 5: 
18 June 2019 
22 December 2020 
Version of Protocol: 
6.0 
 
The study will be conducted according to the protocol and in compliance with Good Clinical Practice 
(GCP), with the Declaration of Helsinki, and with other applicable regulatory requirements. 
Confidentiality Statement 
All information contained in this document is privileged and confidential to TESARO, a wholly 
owned subsidiary of Glaxo Smith Kline (GSK). Any distribution, copying, or disclosure is strictly 
prohibited without prior written approval by TESARO. 


Niraparib 
 
 
 
Clinical Study Protocol 3000-01-004 Version 6.0 
 
Confidential 
 
Page 2 of 103 
SPONSOR SIGNATURE PAGE 
 
Declaration of Sponsor or Responsible Medical Officer 
 
Title: An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to 
Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Formulation 
Compared to Niraparib Capsule Formulation in Patients with Advanced Solid Tumors 
 
This study protocol was subjected to critical review and has been approved by the Sponsor. The 
information it contains is consistent with the current risk/benefit evaluation of the investigational 
products as well as with the moral, ethical, and scientific principles governing clinical research 
as set out in the Declaration of Helsinki and the guidelines on Good Clinical Practice. 
 
___________________________________  
 
_____________________ 
Divya Gupta, MD, Senior Medical Director  
Date 
on behalf of: 
Reginald Ewesuedo, MD 
 
Senior Medical Director 
TESARO, a GSK company 
 


Niraparib 
 
 
Clinical Study Protocol 3000-01-004 Version 6.0 
 
Confidential 
 
Page 3 of 103 
INVESTIGATOR’S AGREEMENT 
 
Declaration of the Principal Investigator 
 
Title: An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to 
Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Formulation 
Compared to Niraparib Capsule Formulation in Patients with Advanced Solid Tumors 
 
I have read this study protocol, including all appendices. By signing this protocol, I agree to 
conduct the clinical study, following approval by an Independent Ethics Committee/Institutional 
Review Board, in accordance with the study protocol, the current International Council for 
Harmonisation Guideline for Good Clinical Practice, and applicable regulatory requirements. I 
will ensure that all personnel involved in the study under my direction will be informed about the 
contents of this study protocol and will receive all necessary instructions for performing the 
study according to the study protocol. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Institution 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Investigator 
 
 
 
 
 
 
 
 
Date 
 


Niraparib 
 
 
 
Clinical Study Protocol 3000-01-004 Version 6.0 
 
Confidential 
 
Page 4 of 103 
Table 1: 
Summary of Changes for Amendment 5 (Version 6.0) 
Header, cover page, and 
Table 1: Summary of 
Changes for Amendment 5 
(Version 6.0) 
Header updated with new version 
number, cover page updated with 
new amendment number, version 
number, and date of approval. 
Table 1 created to include rationale 
for this version. 
Updated document per best 
documentation practices 
Entire document 
Added  Stage 3 FE Study. 
Editorial changes were made 
throughout the document and to 
align with the Sponsor’s standards 
and processes. 
To assess the effect of a high-fat 
meal or a fasted state on 
niraparib PK following a single 
oral dose of niraparib 300 mg 
tablet formulation. 
Editorial changes were made for 
conformity, clarity, flow, and 
typographical error correction 
Section 1. Synopsis – Studied 
period (years) 
Added date last patient completed 
in the Stage 3 FE Study PK Phase 
To provide an estimated date for 
last patient completion in 
Stage 3 FE Study PK phase 
Section 1. Synopsis – 
Primary Objectives  
Section 5.1. Primary 
Objectives 
New Stage 3 FE Study primary 
objective defined: to assess the 
effect of a high-fat meal on 
niraparib tablet PK 
New primary objective for 
Stage 3 FE Study 
Section 1. Synopsis – 
Secondary Objectives  
Section 5.2. Secondary 
Objectives 
Included Stage 3 FE Study into the 
original secondary objective  
New secondary objective for 
Stage 3 FE Study 
Section 1. Synopsis – 
Rationale for Study 
Section 4.2. Rationale for 
Study 
Detailed rationale for Stage 3 FE 
Study 
New rationale for Stage 3 FE 
Study 
Section 1. Synopsis –  
Methodology: Overall Study 
Design 
Section 6.1. Overall Study 
Design 
Added a brief description of Stage 
3 FE Study 
New brief description of Stage 3 
FE Study 
Section 1. Synopsis – 
Methodology: 
Pharmacokinetics (PK) Phase 
Section 6.1. Overall Study 
Design – PK Phase 
Section 9.5. Administration 
Described cohort-specific dietary 
instructions, requirements, PK 
parameters, and sampling intervals 
for Stage 3 FE Study PK Phase  
New information pertinent to 
Stage 3 FE Study only 


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Table 1: 
Summary of Changes for Amendment 5 (Version 6.0) (Continued) 
Section 1. Synopsis – 
Methodology: Extension 
Phase 
Section 6.1 Overall Study 
Design – Extension Phase 
Reduced window for Stage 3 FE 
Study Extension Phase enrollment. 
Addition of tablet formulation. 
To reduce administrative 
burden. 
Patients may receive tablet 
formulation in the Stage 3 FE 
Study Extension Phase. 
Section 1. Synopsis – Figure 
1: Study Design: 
Single-Crossover Study  
Section 6.1. Overall Study 
Design – Figure 2: Study 
Design: Single Crossover 
Study 
Added Stage 3 FE Study 
Details the study design for 
Stage 3 FE Study 
Section 1. Synopsis – 
Number of patients (planned) 
Section 6.2. Number of 
Patients 
Added Stage 3 FE Study 
Provides estimate of patient 
numbers required for Stage 3 FE 
Study 
Section 1. Synopsis – 
Inclusion and Exclusion 
Criteria for Stage 3 PK Phase 
and Extension Phase 
Section 7.1.2. Patient 
Inclusion Criteria (Stage 3 
only) 
Section 7.2.2. Patient 
Exclusion Criteria (Stage 3 
only) 
Section 7.3.1. Extension 
Study Patient Inclusion 
Criteria (Stage 3 only) 
Added inclusion and exclusion 
criteria specific to Stage 3 FE 
Study PK and Extension Phase  
Details the inclusion and 
exclusion criteria required for 
patient eligibility to enroll in 
Stage 3 FE Study PK and 
Extension Phase 
Section 1. Synopsis – 
Duration of treatment 
Added treatment duration for Stage 
3 FE Study 
New information pertinent to 
Stage 3 FE Study only 
Section 1. Synopsis – Criteria 
for evaluation: 
Pharmacokinetics  
Section 10. Pharmacokinetic 
Assessments 
Added PK parameter tlag for 
Stage 3 FE Study 
 
Per FDA guidance for industry: 
Food-Effect Bioavailability and 
Fed Bioequivalence Studies 
Section 1. Synopsis – Criteria 
for evaluation: Blood Sample 
Collection  
Section 10.1. Blood Sample 
Collection 
Provided blood sample collection 
parameters for Stage 3 FE Study 
New information pertinent to 
Stage 3 FE Study only 


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Table 1: 
Summary of Changes for Amendment 5 (Version 6.0) (Continued) 
Section 1. Synopsis – 
Analysis Populations 
Section 12.1. Analysis 
Populations 
Added new analysis population for 
Stage 3 FE Study 
New patient population to 
evaluate the PK parameters for 
Stage 3 FE Study PK Phase 
Section 1. Synopsis – 
Statistical methods: Sample 
Size Consideration – Stage 3 
Section 12.2. Sample Size 
Consideration 
Added required sample size to 
characterize statistical calculations 
for Stage 3 FE Study PK Phase 
Provides rationale for sample 
size and statistical calculations 
criteria for Stage 3 FE Study 
Section 1. Synopsis – 
Statistical methods: Safety 
Analyses 
Section 12.3. Safety Analyses 
Described safety analyses 
provisions for patients enrolled in 
Stage 3 FE Study PK and 
Extension Phases 
Safety analyses expanded to  
include patients enrolled in 
Stage 3 FE Study PK and 
Extension Phases 
Section 1. Synopsis – 
Statistical methods: Safety 
Analyses 
Section 11.2.1.4. Adverse 
Events of Special Interest 
(AESI) 
Removed monitoring requirement 
for AESIs of pneumonitis and 
embryo-fetal toxicity 
Pneumonitis and embryo-fetal 
toxicity will be monitored as an 
ADR and pregnancy outcome, 
respectively. 
Section 1. Synopsis – 
Statistical methods: 
Pharmacokinetic Analyses 
Added specific requirements 
related to Stage 3 FE Study 
New information pertinent to 
Stage 3 FE Study only 
Section 4.2. Rationale for 
Study 
Included key results from Stage 2 
CSR 
New information available since 
last amendment (Amendment 4) 
Section 6.1. Overall Study 
Design 
Briefly described of the Stage 3 FE 
Study cohort design 
New information pertinent to 
Stage 3 FE Study only 
Section 6.1. Overall Study 
Design – Extension Phase 
Described patient eligibility criteria 
for inclusion in Stage 3 FE Study 
Extension Phase (this study or an 
alternative study) 
New information pertinent to 
Stage 3 FE Study only  
Section 6.1.1. Fasting and 
Study Drug Administration 
for the PK Phase 
Described specific instructions for 
patients enrolled in Stage 3 FE 
Study PK Phase 
Section 6.1.2. General Study 
Conduct 
Section 9.5. Administration 
Section 6.3.2. Randomization 
Scheme 
Briefly described the Stage 3 FE 
Study randomization scheme 
New information pertinent to 
Stage 3 FE Study only 


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Table 1: 
Summary of Changes for Amendment 5 (Version 6.0) (Continued) 
Section 6.6.1 Schedule of 
Events – Table 7: Schedule of 
Events: Study Drug and PK 
Phase – Stage 3, Table 8: 
Schedule of Events: 
Extension Phase (vital signs 
and weight row and 
corresponding footnote 10) 
New table added for Stage 3 FE 
Study PK Phase  
New information pertinent to 
Stage 3 FE Study only. 
Increased vital signs monitoring 
from 1 week to 4 weeks to 
ensure they are appropriately 
monitored to address new PRES 
and hypertension guidelines. 
Section 7.4.1. 
Discontinuation from 
Pharmacokinetic Phase 
Added that patient must fast for 
14 (10+4) hours for both fed and 
fasted conditions. 
Further detail on options for 
continuing to receive niraparib 
provided. 
Clarity. 
 
 
New criteria pertinent to Stage 3 
FE Study only. 
Section 7.5. Restrictions 
During Study – #6and #10 
Added that patients must be able to 
fast for 14 (10+4)  hours for both 
PK dosing periods 
Added restriction #10. 
Clarity 
 
Prohibits patients enrolled in 
Stage 3 from taking lipase 
inhibitors or cholesterol 
absorption inhibitors. 
Section 7.5.1. Lifestyle 
Considerations 
Updated to detail potential 
photosensitivity associated with  
niraparib  
New Sponsor guidelines due to 
updated niraparib safety 
information 
Section 8.1. Description of 
Study Drug – Table 9: 
Investigational Product  
Added Stage 3 FE Study 
New information pertinent to 
Stage 3 FE Study only 
Section 11.1.6. Vital Signs 
Included heart rate monitoring 
requirement 
New Sponsor guidelines due to 
updated niraparib safety 
information 
Section 11.2.8. Hypertension, 
Including Hypertensive Crisis 
New safety monitoring 
requirements for hypertension, and 
hypertensive crisis added 
Section 6.4.2. Safety Criteria 
for Adjustment or Stopping 
Doses During Extension 
Phase – Table 3: Niraparib 
Dose Reductions for 
Non-Hematologic Toxicities 
Section 11.2.9 – Posterior 
Reversible Encephalopathy 
Syndrome 
New safety monitoring 
requirements for PRES added 


Niraparib 
 
 
Clinical Study Protocol 3000-01-004 Version 6.0 
 
Confidential 
 
Page 8 of 103 
Table 1: 
Summary of Changes for Amendment 5 (Version 6.0) (Continued) 
Section 11.2.10. Allergic 
Reaction 
New allergic reaction data added 
 
Section 11.1.10.6. Pregnancy 
Screen 
Revised language to indicate test 
should occur prior to PK period 1 
only 
Clarity 
Section 12.4. 
Pharmacokinetic Analysis 
Details specific PK analyses to be 
conducted for Stage 3 FE Study 
PK Phase 
Clarifies additional requirement 
for Stage 3 FE Study PK Phase 
Appendix E – Guidance on 
Composition of High-Fat 
Meal 
New appendix added to provide 
guidance on composition of a 
high-fat meal 
Provides supportive instruction 
for Stage 3 FE Study 
Abbreviations:  ADR=adverse drug reaction; AESI=adverse events of special interest; CSR=clinical study report; 
FDA=Food and Drug Administration; FE=food effect; PK=pharmacokinetic(s); PRES=Posterior Reversible 
Encephalopathy Syndrome; tlag=time from administration of the dose to the first quantifiable concentration 


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Niraparib 
 
 
Clinical Study Protocol 3000-01-004 Version 6.0 
 
Confidential 
 
Page 10 of 103 
compared to 3 niraparib capsules (3×100 mg). In addition, this study will evaluate the effect of a 
high-fat meal on the PK of the niraparib 300 mg tablet formulation. The Extension Phase will enable 
patients enrolled in the study to continue to receive treatment with niraparib if they are tolerating it 
and, in the Investigator’s opinion, may receive benefit. 
Methodology:  
Overall Study Design 
This is a multicenter, open-label study in patients with advanced solid tumors. This is a 3-stage, single 
cohort, randomized-sequence, single-crossover study to assess the relative BA and BE of niraparib 
tablet formulation relative to the capsule formulation. In addition, Stage 3 of the protocol is a single 
cohort, randomized-sequence, 2-period, single dose, crossover study to assess effect of food on the PK 
of the niraparib tablet formulation. 
Pharmacokinetics (PK) Phase: In Stages 1 and 2, patients will be randomized 1:1 to receive tablet 
formulation followed by capsule formulation or capsule formulation followed by tablet formulation. In 
Stage 3, patients will be randomized 1:1 to receive tablet formulation in a fasted state followed by 
tablet formulation taken with a high-fat meal or tablet formulation taken with a high-fat meal followed 
by tablet formulation taken in a fasted state. 
Stage 1:  Following an 8-hour fast on Day 1 (see Section 6.1.1), patients will receive a single dose of 
the formulation (tablet [1×300 mg] or capsule [3×100 mg]) followed by a 7-day (+1 day) Washout/PK 
period followed by a dose of the alternate formulation also in a fasted state, followed by a 7-day 
Washout/PK period. Patients receiving the tablet in the first treatment period will receive the capsules 
in the second treatment period and vice versa (see Section 6.1.1). Extensive PK sampling will be 
carried out after niraparib dosing (see Section 10.1).  
Stage 2:  Following an 8-hour fast on Day 1 (see Section 6.1.1), patients will receive a single dose of 
the formulation (tablet [1×300 mg] or capsule [3×100 mg]) followed by a 14-day (+/- 4 days) 
Washout/PK period, followed by a dose of the alternate formulation also in a fasted state, followed by 
a 7-day Washout/PK period. Patients receiving the tablet in the first treatment period will receive the 
capsules in the second treatment period and vice versa (see Section 6.1.1). Extensive PK sampling will 
be carried out after niraparib dosing (see Section 10.1 ).  
Stage 3: In period 1, patients will receive a single 300 mg niraparib tablet either following a 10-hour 
fast (see Section 6.1.1) or directly following consumption of a high-fat meal (see Section 6.1.1), 
followed by a 14-day (+4 days) PK sampling and washout period. In period 2, patients will be crossed 
over to receive a single 300 mg niraparib tablet in a fasted state or with a high-fat meal, followed by a 
7-day PK sampling period. All patients will fast for a minimum of 4 hours postdose in both periods. 
Patients receiving the tablet in a fasted state in the first treatment period will receive the tablet with a 
high-fat meal in the second treatment period and vice versa.  
In the rare instance where a delay of the entire PK period 2 is needed for any reason beyond the 4-day 
window specified above, the site must contact the Sponsor's Medical Monitor to discuss the patient 
circumstances. The Sponsor will then decide if the patient can continue with PK period 2 with a delay.  
Similarly, should the laboratory results on D15 (the day of niraparib administration in PK Period 2) 
show changes in organ function such that the original inclusion criteria for laboratory values are no 
longer met, or in the event of a significant change of patient’s clinical status as judged by the 
Investigator, the site must consult with the Sponsor to discuss the patient's continued participation in 
PK period 2. Note that sites need not wait for the pre-dose laboratory results to begin PK period 2, but 


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CCI


Niraparib 
 
 
Clinical Study Protocol 3000-01-004 Version 6.0 
 
Confidential 
 
Page 12 of 103 
if no treatment interruption or discontinuation was required during the first 2 cycles of Extension Phase 
therapy and after approval from the Sponsor. 
Patients have up to 28 days (21 days for Stage 3 only; up to 28 days may be acceptable following 
discussion between the Sponsor and Investigator) after completion of the PK Phase to complete the 
screening assessments and the Extension Phase Screening Visit. A tumor assessment is to be 
performed prior to the first dose of the Extension Phase (pre-Extension Phase). The pre-Extension 
Phase tumor assessment need not be completed if the baseline tumor assessment was performed 
≤56 days before the first dose of the Extension Phase. 
The Cycle 1/Day 1 Visit can occur on the same day as the Extension Phase Screening Visit, dependent 
upon availability of radiographic results obtained ≤56 days of the first planned dose in the Extension 
Phase. If the Extension Phase Screening Visit and the Cycle 1/Day 1 Visit occur on the same day, the 
clinical laboratory results will be reviewed by the study personnel prior to study drug administration to 
ensure eligibility. At the Cycle 1/Day 1 Visit, patients will undergo safety assessments and will receive 
study drug supply for the duration of 1 cycle (300 mg or 200 mg tablets of niraparib for QD dosing or 
3×100 mg or 2×100 mg tablets/capsules of niraparib for QD dosing, depending on availability). It is 
preferred that patients remain on the same formulation (tablet versus capsule) throughout the Extension 
Phase. Patients will return on the first day of every treatment cycle (28±7 days) to receive study drug 
and for safety assessments. Visits will continue approximately every 4 weeks until treatment 
discontinuation. In line with the niraparib United States Package Insert (US PI), dose interruption (no 
longer than 28 days) will be allowed based on adverse events (AEs). In addition, dose reductions to 
200 mg QD and subsequently to 100 mg QD will be allowed based on AEs (please refer to US PI). 
Any dose reductions differing from this must be discussed with the medical monitor. Patients can 
continue in the Extension Phase until the patient meets 1 of the withdrawal criteria (Section 7.4). 
End of Treatment (EOT) and Safety Follow-up Visits: The EOT visit will occur within 7 days of 
the decision to discontinue study drug for any reason. Patients who do not participate in the Extension 
Phase will also have an EOT visit within 7 days of the decision to discontinue study. Should the first 
dose of a new anti-cancer therapy occur within 14 days of the decision to discontinue study drug, all 
assessments required for the Safety Follow-up visit should occur at the EOT visit and this visit will be 
considered the Safety Follow-up visit. If the first dose of the new anti-cancer therapy occurs >14 days 
of the decision to discontinue study, the Safety Follow-up visit will occur 30+7 days after the last dose 
of the study drug, or at the start of any new anti-cancer therapy, whichever occur first.   


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14-day washout 
period, including 7-
day PK sample 
collection
7-day PK sample 
collection
300 mg dose
1:1 Randomization
Niraparib
Dose 1: 
Tablet
Niraparib
Dose 1:
Capsule
14-day washout 
period, including 7-
day PK sample 
collection
Niraparib
Dose 2: 
Tablet
Niraparib
Dose 2:
Capsule
Option to qualify 
for treatment in 
Extension Phase 
Option to qualify 
for treatment in 
Extension Phase 
300 mg dose 
N=16 evaluable
1:1 Randomization
Niraparib
Dose 1: 
Fasted
Niraparib
Dose 1:
Fed
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period, including 7-
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collection
Niraparib
Dose 2: 
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Niraparib
Dose 2:
Fed
Option to qualify 
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Extension Phase 
Option to qualify 
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Extension Phase 
14-day washout 
period, including 7-
day PK sample 
collection
7-day PK sample 
collection
7-day PK sample 
collection


Niraparib 
 
 
Clinical Study Protocol 3000-01-004 Version 6.0 
 
Confidential 
 
Page 14 of 103 
standard therapy, or for which no standard therapy exists, and who may benefit from treatment 
with a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor as assessed by the 
Investigator. Patients with lymphoma are eligible. Patients with primary central nervous 
system (CNS) malignancy are eligible provided they do not have new or progressive signs or 
symptoms, and are not requiring steroid dose exceeding the equivalent of 10 mg of prednisone 
daily. 
3. Patient is at least 18 years of age. 
4. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 
5. Patient has adequate organ function as defined below (Note: complete blood count [CBC] 
should be obtained without transfusion or receipt of colony stimulating factors [CSFs],  
erythropoietin stimulating agents or platelet-stimulating agents within 2 weeks before first 
dose): 
a. Absolute neutrophil count ≥1,500/µL 
b. Platelets ≥100,000/µL 
c. Hemoglobin ≥9 g/dL (5.6 mM) 
d. Serum creatinine ≤1.5× the upper limit of normal (ULN) or a calculated creatinine 
clearance ≥60 mL/min using the Cockcroft-Gault equation. 
e. Total bilirubin ≤1.5× ULN except in patients with Gilbert’s syndrome. Patients with 
Gilbert’s syndrome may enroll if direct bilirubin ≤1.5× ULN of the direct bilirubin. 
f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN unless 
liver metastases are present, in which case, they must be ≤5× ULN 
6. Patient has recovered to baseline or Grade 1 toxicity from prior cancer therapy (a patient with 
Grade 2 neuropathy or Grade 2 alopecia or Grade 2 hypothyroidism on a stable dose of thyroid 
replacement are an exception to this criterion and may qualify for this study). For patients with 
hematologic, renal or hepatic toxicity from prior therapy inclusion criterion #5 should be 
applied to determined eligibility. 
7. Patient is able to take oral medications. 
8. Female patient meets the following criteria: 
a. Patient (of childbearing potential) is not breastfeeding, has a negative serum pregnancy test 
within 72 hours prior to taking study drug and agrees to abstain from activities that could 
result in pregnancy from Screening through 180 days after the last dose of study drug, or is 
of non-childbearing potential. Note: A urine pregnancy test may be performed if the serum 
pregnancy test is not available before dosing. 
b. Female patient of non-childbearing potential (other than medical reasons) is defined by the 
following: 
i. 
≥45 years of age and has not had menses for >1 year. 
ii. 
Amenorrheic for <2 years without a hysterectomy and oophorectomy and a 
follicle-stimulating hormone value in the postmenopausal range upon Screening 
evaluation. 
iii. 
Had undergone a hysterectomy, bilateral oophorectomy, or tubal ligation. 
Documented hysterectomy, oophorectomy or tubal ligation must be confirmed in 
the medical records, otherwise the patient must be willing to use highly effective 
contraception (see Appendix C) throughout the study, starting with the Screening 


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Visit through 180 days after the last dose of study drug. Information must be 
captured appropriately within the site’s source documents. 
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
9. Male patient agrees to use an adequate method of contraception and not donate sperm starting 
with the first dose of study drug through 90 days after the last dose of study drug.  
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient.  
Main Criteria for Inclusion (Stage 3 only): 
PK Phase:  
To be considered eligible to participate in this study, all of the following requirements must be met:  
1. Patient is capable of understanding the written informed consent, provides signed and 
witnessed written informed consent, and agrees to comply with protocol requirements. 
2. Patient has histologically or cytologically confirmed diagnosis of metastatic or locally 
advanced solid tumors that have failed to respond to standard therapy, has progressed despite 
standard therapy, or for which no standard therapy exists, and who may benefit from treatment 
with a PARP inhibitor as assessed by the Investigator. Patients with lymphoma are eligible. 
Patients with CNS malignancy are eligible provided they do not have new or progressive signs 
or symptoms and are not requiring steroid dose exceeding the equivalent of 10 mg of 
prednisone daily. 
3. Patient is at least 18 years of age. 
4. Patient has an ECOG performance status of 0 to 2. 
5. Patient has adequate organ function as defined below (Note: CBC should be obtained without 
transfusion or receipt of CSFs in the 1 week before obtaining sample.): 
a. Absolute neutrophil count ≥1,000/µL 
b. Platelets ≥100,000/µL 
c. Hemoglobin ≥9 g/dL (5.6 mM) 
d. Serum creatinine ≤1.5× ULN or a calculated creatinine clearance ≥60 mL/min using the 
Cockcroft-Gault equation. 
e. Total bilirubin ≤1.5× ULN except in patients with Gilbert’s syndrome. Patients with 
Gilbert’s syndrome may enroll if direct bilirubin ≤1.5× ULN of the direct bilirubin. 
f. AST and ALT ≤2.5× ULN unless liver metastases are present, in which case, they must be 
≤5× ULN 
6. Patient has recovered to baseline or Grade 1 toxicity from prior cancer therapy (a patient with 
Grade 2 neuropathy or Grade 2 alopecia or Grade 2 hypothyroidism on a stable dose of thyroid 
replacement are an exception to this criterion and may qualify for this study). For patients with 
hematologic, renal, or hepatic toxicity resulting from prior cancer therapy should meet 
inclusion criterion #5 for eligibility. 
7. Patient is able to swallow and retain oral medication. 
8. Female patient meets the following criteria: 


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a. Female patient (of childbearing potential) is not breastfeeding, has a negative serum 
pregnancy test within 72 hours prior to taking study drug, and agrees to abstain from 
activities that could result in pregnancy from Screening through 180 days after the last 
dose of study drug, or is of nonchildbearing potential. Note: A urine pregnancy test may be 
performed if the serum pregnancy test is not available before dosing. 
b. Female patient of nonchildbearing potential (other than medical reasons) is defined by the 
following: 
i. 
≥45 years of age and has not had menses for >1 year. 
ii. 
Amenorrheic for <2 years without a hysterectomy and oophorectomy and a 
follicle-stimulating hormone value in the postmenopausal range upon Screening 
evaluation. 
iii. 
Had undergone a hysterectomy, bilateral oophorectomy, or tubal ligation. 
Documented hysterectomy, oophorectomy or tubal ligation must be confirmed in 
the medical records, otherwise the patient must be willing to use highly effective 
contraception (see Appendix C) throughout the study, starting with the Screening 
Visit through 180 days after the last dose of study drug. Information must be 
captured appropriately within the site’s source documents. 
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
9. Male patient agrees to use an adequate method of contraception and not donate sperm starting 
with the first dose of study drug through 90 days after the last dose of study drug.  
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
10. CNS inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must 
have one of the following: 
a. No evidence of brain metastases 
b. Untreated brain metastases not needing immediate local therapy 
c. Previously treated brain metastases not needing immediate local therapy 
d. Brain metastases previously treated with local therapy may either be stable since treatment 
or may have progressed since prior local CNS therapy 
e. Patients treated with CNS local therapy for newly identified lesions found on contrast 
brain MRI performed during screening for this study may be eligible to enroll if the 
following criteria are met: 
i. 
Time since whole brain radiation therapy (WBRT) is ≥21 days prior to first 
dose of study drug, time since stereotactic radiosurgery (SRS) is ≥7 days prior 
to first dose of study drug, or time since surgical resection is ≥28 days. 
ii. 
Other sites of disease assessable by Response Evaluation Criteria in Solid 
Tumors version 1.1 (RECIST v1.1) are present  
f. Relevant records of any CNS treatment must be available to allow for classification of 
target and non-target lesions 
11. Patient is able to eat a high-fat meal. See Section 6.1.1.  
12. Patient is able to fast for a minimum of 10 hours before start of visit and for an additional 4 
hours after study visit. See Section 6.1.1. 
 


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Main Criteria for Exclusion (Stage 1 and 2 only):  
PK Phase: 
Patients will not be eligible for study entry if any of the following criteria are met:  
1. Patient has a known hypersensitivity to the components of niraparib or excipients (see 
Appendix B).  
2. Patient has a known diagnosis of immunodeficiency (Note: Patients with splenectomy are 
allowed)  
3. Patient has symptomatic uncontrolled brain or leptomeningeal metastases. To be considered 
“controlled,” the patient must have undergone treatment (eg, radiation or chemotherapy) at 
least 1 month prior to study entry. The patient must not have any new or progressive signs or 
symptoms related to the central nervous system disease and must be taking ≤10 mg of 
prednisone or equivalent per day or no steroids. 
4. Patient underwent major surgery within 3 weeks of starting the study or patient has not 
recovered from any effects of any major surgery. 
5. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder; 
nonmalignant systemic disease; or active, uncontrolled infection. Examples include, but are not 
limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, 
uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava 
syndrome, uncontrolled hypertension, active uncontrolled coagulopathy, bleeding disorder, or 
any psychiatric disorder that prohibits obtaining informed consent. 
6. Female patient is pregnant or is expecting to conceive children while receiving study drug or 
for up to 180 days after the last dose of study drug. Male patient is expecting to donate sperm 
or father children while receiving study drug or for up to 90 days after the last dose of study 
drug. 
a. Female patient is breastfeeding or is expecting to breastfeed within 30 days of receiving 
final dose of study drug (females should not breastfeed or store breastmilk for use, during 
treatment and for 30 days after receiving the final dose of study drug). 
7. Patient has a known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia 
(AML). 
8. <THIS EXCLUSION HAS BEEN INTENTIONALLY LEFT BLANK.> 
9. Patient is unable to refrain from any intake of grapefruit or grapefruit juice within 7 days of the 
first administration of niraparib until 2 days postdose (Does not apply for Extension Phase). 
10. Patient is currently taking any of the following P-glycoprotein inhibitors: amiodarone, 
azithromycin, captopril, carvedilol, clarithromycin, conivaptan, cyclosporine, diltiazem, 
dronedarone, erythromycin, felodipine, itraconazole, ketoconazole, lopinavir and ritonavir, 
quercetin, quinidine, ranolazine, ticagrelor, and verapamil, unless the dose and regimen has 
been stable for at least 14 days prior to first dose and will not change during PK periods 1 and 
2 (Does not apply for Extension Phase). 


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11. Patient taking proton pump inhibitors, antacids, or histamine 2 blockers unless the dose and 
regimen is stable for at least 14 days prior to first dose and will not change during PK periods 
1 and 2.  Patients must hold these therapies starting within 8 hours prior to study drug 
administration until 9 hours after study drug administration (Does not apply for Extension 
Phase). 
12. Patient has gastric, gastro-esophageal, or esophageal cancer; patient is unable to swallow orally 
administered medication; patient has gastrointestinal disorders or significant gastrointestinal 
resection likely to interfere with the absorption of niraparib. 
13. Patient has known active hepatic disease (known hepatic cirrhosis, hepatitis B surface 
antigen-positive status, or suspected active hepatitis C infection). 
14. Patient has a past or current history of chronic alcohol use (3 or more drinks per day for the 
30 days prior to the Screening Visit) or dependence or is unable to abstain from alcohol for the 
duration of the study. 
15. Patient has had a prior cytotoxic therapy or anticancer monoclonal antibodies (mAbs) within 
14 days prior to start of PK Phase. There is no required washout for palliative radiation. For 
targeted small anti-cancer molecules (eg, tyrosine kinase inhibitors), the required washout is 5 
half-lives of the start of PK Phase. Certain hormonal agents are allowed and are listed in 
Appendix D. For hormonal agents not listed Appendix D, the Site must consult with the 
Sponsor regarding allowing patient on study. For patient taking hormonal agents, dose and 
regimen of hormonal agents should have been stable for at least 14 days prior to first dose and 
is not expected to change during PK periods 1 and 2.  
16. Patient has significant pleural effusion or ascites that is expected to require drainage during the 
PK Phase (Does not apply for Extension Phase). 
Main Criteria for Exclusion (Stage 3 only):  
PK Phase: 
Patients will not be eligible for study entry if any of the following criteria are met:  
1. Patient has a known hypersensitivity to the components of niraparib or excipients (see 
Appendix B).  
2. Patient has a known diagnosis of immunodeficiency (Note: Patients with splenectomy are 
allowed)  
3. <THIS EXCLUSION HAS BEEN INTENTIONALLY LEFT BLANK.> 
4. Patient underwent major surgery within 3 weeks of starting the study or patient has not 
recovered from any effects of any major surgery. 
5. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder; 
nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not 
limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, 
uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava 
syndrome, uncontrolled hypertension, active uncontrolled coagulopathy, bleeding disorder, or 
any psychiatric disorder that prohibits obtaining informed consent. 


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6. Female patient is pregnant or is expecting to conceive children while receiving study drug or 
for up to 180 days after the last dose of study drug. Male patient is expecting to donate sperm 
or father children while receiving study drug or for up to 90 days after the last dose of study 
drug. 
a. Female patient is breastfeeding or is expecting to breastfeed within 30 days of receiving 
final dose of study drug (females should not breastfeed or store breastmilk for use, during 
treatment and for 30 days after receiving the final dose of study drug). 
7. Patient has a known history of MDS or AML. 
8. <THIS EXCLUSION HAS BEEN INTENTIONALLY LEFT BLANK.> 
9. Patient is unable to refrain from any intake of grapefruit or grapefruit juice within 7 days of the 
first administration of niraparib until 2 days postdose (Does not apply for participation in 
Extension Phase of this study). 
10. Patient is currently taking any of the following P-glycoprotein inhibitors: amiodarone, 
azithromycin, captopril, carvedilol, clarithromycin, conivaptan, cyclosporine, diltiazem, 
dronedarone, erythromycin, felodipine, itraconazole, ketoconazole, lopinavir and ritonavir, 
quercetin, quinidine, ranolazine, ticagrelor, and verapamil, unless the dose and regimen has 
been stable for at least 14 days prior to first dose and will not change during PK periods 1 and 
2 (Does not apply for for participation in Extension Phase of this study). 
11. Patient is taking a proton pump inhibitor, antacids, or H2 blocker within 48 of dose (Does not 
apply for participation in Extension Phase of this study). 
12. Patient has gastric, gastroesophageal or esophageal cancer; patient is unable to swallow orally 
administered medication; patient has gastrointestinal disorders or significant gastrointestinal 
resection likely to interfere with the absorption of niraparib. 
13. Patient has known active hepatic disease (known hepatic cirrhosis, hepatitis B surface antigen 
positive status, or suspected active hepatitis C infection). 
14. Patient has a past or current history of chronic alcohol use (3 or more drinks per day for the 
30 days prior to the Screening Visit) or dependence or is unable to abstain from alcohol for the 
duration of the study. 
15. <THIS EXCLUSION HAS BEEN INTENTIONALLY LEFT BLANK.> 
16. Patient has significant pleural effusion or ascites that is expected to require drainage during the 
PK Phase (Does not apply for participation in Extension Phase of this study). 
17. Patient is currently taking a lipase inhibitor or cholesterol absorption inhibitor, such as orlistat 
or ezetimibe, respectively.  (Does not apply for participation in Extension Phase of this study). 
Main Criteria for Inclusion (Stage 1 and 2 only):  
Extension Phase: 
To be considered eligible to participate in the Extension Phase, all of the following requirements must 
be met: 
1. Patient has an ECOG performance status of 0 to 2. 
2. Patient has adequate organ function as defined below; these criteria must be confirmed within 
72 hours of dose 1 in Extension Phase (Note: CBC should be obtained without transfusion or 


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Page 20 of 103 
receipt of CSFs, erythropoietin stimulating agents or platelet stimulating factors within 
2 weeks before first dose): 
a. Absolute neutrophil count ≥1,500/µL 
b. Platelets ≥100,000/µL 
c. Hemoglobin ≥9 g/dL (5.6 mM) 
d. Serum creatinine ≤1.5× the ULN or a calculated creatinine clearance ≥60 mL/min using 
the Cockcroft-Gault equation or 24-hour urine creatinine clearance 
e. Total bilirubin ≤1.5× ULN except in patients with Gilbert’s syndrome. Patients with 
Gilbert’s syndrome may enroll if direct bilirubin ≤1.5× ULN of the direct bilirubin. 
f. AST and ALT ≤2.5× ULN unless liver metastases are present, in which case, they must be 
≤5× ULN 
Note:  If laboratory values at the beginning of Extension Phase are outside of the range 
specified above, the patient may continue to participate in the study only upon Sponsor 
approval and with consideration for an appropriately reduced dose.  
3. Female patient meets the following criteria: 
a. Patient (of childbearing potential) is not breastfeeding, has a negative serum pregnancy test 
within 72 hours prior to taking study drug and agrees to abstain from activities that could 
result in pregnancy from Screening through 180 days after the last dose of study drug, or is 
of non-childbearing potential. Note: A urine pregnancy test may be performed if the serum 
pregnancy test is not available before dosing. 
b. Female patient of non-childbearing potential (other than medical reasons) is defined by the 
following: 
i. 
≥45 years of age and has not had menses for >1 year). 
ii. 
Amenorrheic for <2 years without a hysterectomy and oophorectomy and a 
follicle-stimulating hormone value in the postmenopausal range upon Screening 
evaluation. 
iii. 
Had a hysterectomy, bilateral oophorectomy, or tubal ligation. Documented 
hysterectomy, oophorectomy or tubal ligation must be confirmed in the medical 
records, otherwise the patient must be willing to use highly effective contraception 
(see Appendix D) throughout the study, starting with the Screening Visit through 
180 days after the last dose of study drug. Information must be captured 
appropriately within the site’s source documents. 
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
4. Male patient agrees to use an adequate method of contraception and not donate sperm starting 
with the first dose of study drug through 90 days after the last dose of study drug.  
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
Main Criteria for Inclusion (Stage 3 only):  
Extension Phase: 
To be considered eligible to participate in the Extension Phase, all of the following requirements must 
be met: 
1. Patient has an ECOG performance status of 0 to 2. 


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Page 21 of 103 
2. Patient has adequate organ function as defined below; these criteria must be confirmed within 
72 hours of dose 1 in the Extension Phase (should be obtained without transfusion or receipt of 
colony-stimulating factors in the 1 week before obtaining sample): 
a. Absolute neutrophil count ≥1,000/µL 
b. Platelets ≥100,000/µL 
c. Hemoglobin ≥9 g/dL (5.6 mM) 
d. Serum creatinine ≤1.5× ULN or a calculated creatinine clearance of ≥30 mL/min using the 
Cockcroft-Gault equation. 
e. Total bilirubin ≤1.5× ULN except in patients with Gilbert’s syndrome. Patients with 
Gilbert’s syndrome may enroll if direct bilirubin ≤1.5× ULN of the direct bilirubin. 
f. AST and ALT ≤2.5× ULN unless liver metastases are present, in which case, they must be 
≤5× ULN 
Note:  If laboratory values at the beginning of Extension Phase are outside of the range 
specified above, the patient may continue to participate in the study only upon Sponsor 
approval and with consideration for an appropriately reduced dose.  
3. Female patient meets the following criteria: 
a. Patient (of childbearing potential) is not breastfeeding, has a negative serum pregnancy test 
within 72 hours prior to taking study drug, and agrees to abstain from activities that could 
result in pregnancy from Screening through 180 days after the last dose of study drug, or is 
of nonchildbearing potential. Note: A urine pregnancy test may be performed if the serum 
pregnancy test is not available before dosing. 
b. Female patient of nonchildbearing potential (other than medical reasons) is defined by the 
following: 
i. 
≥45 years of age and has not had menses for >1 year). 
ii. 
Amenorrheic for <2 years without a hysterectomy and oophorectomy and a 
follicle-stimulating hormone value in the postmenopausal range upon Screening 
evaluation. 
iii. 
Had a hysterectomy, bilateral oophorectomy, or tubal ligation. Documented 
hysterectomy, oophorectomy or tubal ligation must be confirmed in the medical 
records, otherwise the patient must be willing to use highly effective contraception 
(see Appendix C) throughout the study, starting with the Screening Visit through 
180 days after the last dose of study drug. Information must be captured 
appropriately within the site’s source documents. 
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
4. Male patient agrees to use an adequate method of contraception and not donate sperm starting 
with the first dose of study drug through 90 days after the last dose of study drug. 
Note: Abstinence is acceptable if this is the established and preferred contraception method 
for the patient. 
Investigational product, dosage and mode of administration:  
Niraparib 300 mg QD (1×300 mg tablet) orally  
Niraparib 200 mg QD (1×200 mg tablet) orally (Stage 1 and 2 only) 
Niraparib 100 mg QD (1×100 mg tablet) orally  
Reference product, dosage and mode of administration (Stage 1 and 2 only):  


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Statistical methods: 
Sample Size Consideration 
Stage 1 
No formal sample size calculation was performed for Stage 1. Approximately 24 patients will be 
enrolled in Stage 1. This sample size is considered adequate for preliminary assessment of the relative 
bioavailability of the tablet compared to the capsules and for estimating the intra-subject coefficient of 
variation, after accounting for patient drop-outs and potential carryover. 
Stage 2 
Based on estimates from Stage 1, 100 BA/BE evaluable patients are required in Stage 2.  With 100 
evaluable patients, assuming the intra-subject coefficient of variation (CV) is 25% and the true ratio of 
means is 0.89, there is at least 90% power to demonstrate the bioequivalence (bioequivalence range: 
0.800 to 1.250; alpha=0.05).  Power calculations were also performed under alternative assumptions 
for the CV and mean ratio.  Assuming the CV is 30% and the true ratio of means is 0.89, with 100 
evaluable patients, there is 82% power to demonstrate bioequivalence. Assuming the true ratio is 0.90, 
the power is 96% and 88% assuming CVs of 25% and 30%, respectively. 
The final analysis of bioequivalence will be based on Stage 2 BA/BE evaluable patients only, with a 
target sample size of 100 evaluable patients. Patients may be identified as non-evaluable due to issues 
arising during the study conduct, such as: 
• 
emesis within 9 hours of dosing,  
• 
dosing errors,  
• 
patient did not fast prior to dosing,  
• 
missing critical PK sample on Day 8,  
• 
failure to complete both PK periods, and 
• 
significant changes to the patient’s medical status that would potentially affect the PK profile 
as determined by the Sponsor in consultation with the Investigator prior to PK data analysis.  
In this patient population, approximately 170 total patients are targeted for enrollment, assuming a 35% 
non-evaluability rate during the study conduct, and an additional 10% non-evaluability rate during PK 
analysis. The non-evaluability rate arising during the study conduct will be continuously monitored by 
the Sponsor and the total number of enrolled patients may be adjusted accordingly with the aim to 
target the resulting sample size of 100 BA/BE evaluable patients.  
Stage 3 
Assuming the true ratio of means is 1 and the intra-subject CV is 20% for AUC0-t and AUC0-∞, with 16 
evaluable patients, there is approximately 83% probability the 90% CI of the ratio of geometric means 
will be within 0.800 and 1.250. Based on the results of a FE study conducted using the capsule 
formulation, an effect of a high-fat meal on Cmax is possible. The sample size of 16 patients is deemed 
adequate to characterize this effect. AUC0-t and AUC0-∞ will be the primary parameters for analysis.  
The primary analysis will be based on the FE Evaluable Population as it is the most conservative 
approach, which maximizes the benefits of the crossover design, where each patient serves as their 
own control. Results for the PK Evaluable Population will also be summarized and reported for this 
study. 


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Patients may be identified as non-evaluable due to issues arising during the study conduct, such as: 
• 
dosing errors,  
• 
patient did not follow dietary requirements prior to dose and postdose,  
• 
failure to complete both PK periods, and 
• 
significant changes to the patient’s medical status that would potentially affect the PK profile 
as determined by the Sponsor in consultation with the Investigator prior to PK data analysis.  
Patients who experience emesis within 10 hours of dosing or miss sufficient samples to render 
calculation of AUC unreliable will be discontinued from the PK phase. To account for non-evaluable 
patients, approximately 20 total patients are targeted for enrollment. The non-evaluability rate arising 
during the study conduct will be continuously monitored by the Sponsor and the total number of 
enrolled patients may be adjusted accordingly with the aim to target the resulting sample size of 16 
evaluable patients.  
Safety Analyses 
Data from the Stage 1 PK Phase, Stage 2 PK Phase, Stage 3 PK Phase and Extension Phase will be 
summarized separately. Summaries will be performed by formulation, fed/fasted state, and dosing 
period as applicable.  
Demographic characteristics will be summarized descriptively and will include age, sex, race, height, 
and weight. 
Protocol deviations will be listed by patient. 
All analysis for safety endpoints will be performed in a descriptive manner. Continuous variables will 
be summarized using descriptive statistics (number of patients, mean, standard deviation [SD], 
minimum, median, and maximum). Categorical variables will be summarized using counts of patients 
and percentages. 
All AEs will be listed. The number and percent of patients who experience a TEAE will be 
summarized by timing/treatment for each system organ class and preferred term. AEs will also be 
tabulated accordingly by intensity and causality.  
Serious treatment emergent adverse events (TEAEs) and TEAEs resulting in study discontinuation will 
be listed separately. 
All AEs will be coded using the current version of the Medical Dictionary for Regulatory Activities. 
Safety will be assessed through adverse event assessment, physical examination, vital sign 
measurements, clinical laboratory tests, and monitoring of concomitant medications. 
AEs are required to be captured through 30 days after cessation of study drug; serious adverse events 
(SAEs) are required to be captured through 90 days after cessation of study drug (or to a minimum of 
30 days post-treatment if the patient starts alternative anticancer therapy); and any pregnancies that 
occur within 180 days post-treatment are to be captured. Study drug-related SAEs and adverse events 
of special interest (AESIs) (Section 11.2.1.4 )  will continue to be monitored until study closeout 
(unless death or loss to follow-up occurs first). All AEs and SAEs experienced by a patient, regardless 
of the suspected causality, will be monitored until the AE or SAE has resolved, until any abnormal 
laboratory values have returned to baseline or normalized, until there is a satisfactory explanation for 


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the change(s) observed, until the patient is lost to follow-up or withdraws consent, or until the patient 
has died. 
The AESIs for this study are MDS, AML, and secondary cancer (new malignancies other than 
MDS/AML). AESIs must be reported to the Sponsor as soon as the Investigator becomes aware of 
them or within 24 hours. 
Individual data listings of laboratory test results will be presented. Flags will be attached to values 
outside of the laboratory's reference limits along with the Investigator's assessment. Clinically 
significant laboratory test abnormalities that were considered AEs by the Investigator will be presented 
in the AE listing. 
In addition, for the Extension Phase, clinical laboratory tests (observed values and changes from 
baseline) will be summarized descriptively in tabular format. Shift tables will be presented for select 
laboratory parameters (chemistry and hematology). 
Individual data listings of vital signs (observed and change from Baseline) will be presented for each 
patient. Individual clinically significant vital sign findings that were considered AEs by the 
Investigator will be presented in the AE listing. 
All clinically relevant abnormal physical examination findings will be listed. 
Pharmacokinetic Analysis 
Individual patient PK parameter values will be derived by non-compartmental methods using Phoenix 
WinNonlin, version 5.1 or higher. Actual time will be used for parameter calculation. The analysis of 
Stage 1, Stage 2, and Stage 3 will be conducted separately.  
During the pharmacokinetic analysis, the following rules will apply: 
• Predose sample >5% of Cmax: profile will be excluded from PK concentration and PK parameters 
summary and inferential statistics 
• Rsq,adj <0.800: AUC0-∞, λz, CL/F, Vz/F, and t1/2 will be excluded from descriptive and  
inferential statistics 
• AUC0-t /AUC0-∞, <0.800: AUC0-∞ and parameters derived from it will be excluded from 
descriptive and inferential statistics  
Planned sampling times will be used to generate the mean concentration-time profiles. Individual and 
mean plasma concentrations over time will be plotted by formulation in Stage 1 and 2 and by 
fed/fasted state in Stage 3. Plasma concentrations and PK parameters will be summarized in terms of 
the number of patients, arithmetic mean, median, SD, coefficient of variation (CV), geometric mean, 
geometric CV, minimum and maximum by formulation in Stage 1 and 2 and by fed/fasted state in 
Stage 3, as appropriate. In Stage 3, differences in tmax between the fed and fasted state will be assessed 
and summarized based on the FE Evaluable Population. Details will be provided in the 
Pharmacokinetic Analysis Plan. 
The pharmacokinetic profiles and parameters will be summarized across the PK, PK Evaluable, 
BA/BE Evaluable, and FE Evaluable populations, as appropriate. Details will be provided in the 
Pharmacokinetic Analysis Plan. 


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To assess relative bioavailability/bioequivalence, an analysis of variance model (ANOVA) will be used 
on logarithmically transformed AUC0-t, AUC0-∞, and Cmax accounting for the following sources of 
variation: sequence, subjects nested in sequences, period and treatment. The point estimate and 90% CI 
for the ratios of the geometric means of the test treatment (tablet) compared to the reference treatment 
(capsule) will be obtained. Bioequivalence will be claimed if the 90% CI for the ratio of geometric 
means is between 0.800 and 1.250 for AUC0-∞, AUC0-t and Cmax. To assess the effect of food in Stage 
3, the ratio of geometric means for AUC0-t, AUC0-∞, and Cmax of the test treatment (high-fat meal) 
compared to the reference treatment (fasted state) and corresponding 90% CI will be obtained for 
AUC0-t,, AUC0-∞, and Cmax. 
A population PK analysis may be performed on the PK data from the PK Phase of the study and will be 
reported separately from the study. 


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2. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES  
SPONSOR SIGNATURE PAGE ....................................................................................................2 
INVESTIGATOR’S AGREEMENT ...............................................................................................3 
1. 
SYNOPSIS ...................................................................................................................9 
2. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES ...............28 
LIST OF TABLES .........................................................................................................................33 
LIST OF FIGURES .......................................................................................................................33 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS.............................34 
4. 
INTRODUCTION ......................................................................................................37 
4.1. 
Background .................................................................................................................37 
4.1.1. 
Niraparib Nonclinical Studies .....................................................................................37 
4.1.2. 
Niraparib Clinical Studies ...........................................................................................37 
4.1.3. 
Baseline Platelet Count and Weight as Predictors of Thrombocytopenia in 
Patients Treated with Niraparib ..................................................................................38 
4.2. 
Rationale for Study .....................................................................................................39 
5. 
STUDY OBJECTIVES AND PURPOSE ..................................................................40 
5.1. 
Primary Objective .......................................................................................................40 
5.2. 
Secondary Objectives .................................................................................................40 
5.3. 
Exploratory Objectives ...............................................................................................40 
6. 
INVESTIGATIONAL PLAN .....................................................................................41 
6.1. 
Overall Study Design ..................................................................................................41 
6.1.1. 
Fasting and Study Drug Administration for the PK Phase .........................................44 
6.1.2. 
General Study Conduct ...............................................................................................45 
6.2. 
Number of Patients .....................................................................................................46 
6.3. 
Treatment Assignment ................................................................................................46 
6.3.1. 
Patient Identification ...................................................................................................46 
6.3.2. 
Randomization Scheme ..............................................................................................46 
6.4. 
Dose Adjustment Criteria ...........................................................................................47 
6.4.1. 
Safety Criteria for Stopping Doses During PK Phase ................................................47 
6.4.2. 
Safety Criteria for Adjustment or Stopping Doses During Extension Phase .............47 
6.5. 
Criteria for Study Termination ...................................................................................49 
6.6. 
Study Conduct ............................................................................................................49 


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6.6.1. 
Schedule of Events .....................................................................................................49 
7. 
SELECTION AND WITHDRAWAL OF PATIENTS ..............................................59 
7.1. 
Patient Inclusion Criteria ............................................................................................59 
7.1.1. 
Patient Inclusion Criteria (Stages 1 and 2) .................................................................59 
7.1.2. 
Patient Inclusion Criteria (Stage 3 only) ....................................................................60 
7.2. 
Patient Exclusion Criteria ...........................................................................................62 
7.2.1. 
Patient Exclusion Criteria (Stages 1 and 2) ................................................................62 
7.2.2. 
Patient Exclusion Criteria (Stage 3 only) ...................................................................64 
7.3. 
Extension Study Patient Inclusion Criteria (Stage 1 and 2) .......................................65 
7.3.1. 
Extension Study Patient Inclusion Criteria (Stage 3 only) .........................................66 
7.4. 
Patient Withdrawal Criteria ........................................................................................67 
7.4.1. 
Discontinuation from Pharmacokinetic Phase ............................................................67 
7.4.2. 
Discontinuation from Treatment During Extension Phase .........................................68 
7.4.3. 
Discontinuation from the Study ..................................................................................69 
7.4.4. 
Replacement of Patients .............................................................................................69 
7.5. 
Restrictions During Study...........................................................................................69 
7.5.1. 
Lifestyle Considerations .............................................................................................70 
8. 
TREATMENT OF PATIENTS ..................................................................................71 
8.1. 
Description of Study Drug ..........................................................................................71 
8.2. 
Concomitant Medications ...........................................................................................71 
8.2.1. 
Permitted Concomitant Medications ..........................................................................71 
8.2.2. 
Concomitant Medications Taken with Caution ..........................................................72 
8.3. 
Contraception ..............................................................................................................72 
8.4. 
Treatment Compliance ................................................................................................72 
9. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................73 
9.1. 
Study Drug ..................................................................................................................73 
9.2. 
Study Drug Packaging and Labeling ..........................................................................73 
9.3. 
Study Drug Storage .....................................................................................................73 
9.4. 
Study Drug Administration.........................................................................................73 
9.5. 
Administration ............................................................................................................73 
9.6. 
Study Drug Accountability .........................................................................................74 
9.7. 
Study Drug Handling and Disposal ............................................................................74 


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10. 
PHARMACOKINETIC ASSESSMENTS .................................................................75 
10.1. 
Blood Sample Collection ............................................................................................75 
10.2. 
Sample Analysis .........................................................................................................76 
11. 
ASSESSMENT OF SAFETY .....................................................................................77 
11.1. 
Safety Parameters .......................................................................................................77 
11.1.1. 
Demographics and Baseline Characteristics ...............................................................77 
11.1.2. 
Patient Eligibility ........................................................................................................77 
11.1.3. 
Patient Demography ...................................................................................................77 
11.1.4. 
Disease History ...........................................................................................................77 
11.1.5. 
Medical and Surgical History .....................................................................................77 
11.1.6. 
Vital Signs ..................................................................................................................77 
11.1.7. 
Physical Examination .................................................................................................78 
11.1.8. 
Concomitant Medications and Procedures .................................................................78 
11.1.9. 
Electrocardiogram .......................................................................................................78 
11.1.10. 
Laboratory Assessments .............................................................................................78 
11.1.10.1. Hematology .................................................................................................................78 
11.1.10.2. Chemistry ....................................................................................................................78 
11.1.10.3. Urinalysis ....................................................................................................................79 
11.1.10.4. Virus Serology ............................................................................................................79 
11.1.10.5. Drug Screen ................................................................................................................79 
11.1.10.6. Pregnancy Screen ........................................................................................................79 
11.1.10.7. Eastern Cooperative Oncology Group Performance Status ........................................79 
11.2. 
Adverse Events and Special Situations .......................................................................80 
11.2.1. 
Definitions ..................................................................................................................80 
11.2.1.1. 
Adverse Event (AE) ....................................................................................................80 
11.2.1.2. 
Serious Adverse Event (SAE) ....................................................................................80 
11.2.1.3. 
Treatment-Emergent Adverse Event (TEAE) ............................................................81 
11.2.1.4. 
Adverse Events of Special Interest (AESI) ................................................................81 
11.2.1.5. 
Special Situation: Abuse, Misuse, Medication Errors, Overdose, and 
Accidental or Occupational Exposure ........................................................................81 
11.2.2. 
Assessment of Adverse Events ...................................................................................82 
11.2.2.1. 
Severity Assessment ...................................................................................................82 
11.2.2.2. 
Relationship to Study Intervention .............................................................................82 


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11.2.2.3. 
Expectedness ...............................................................................................................82 
11.2.3. 
Collection and Recording of Adverse Events .............................................................82 
11.2.4. 
Follow-Up of Adverse Events ....................................................................................83 
11.2.5. 
Reporting ....................................................................................................................83 
11.2.6. 
Submission and Distribution of Serious Adverse Event Reports ...............................84 
11.2.7. 
Adverse Events of Special Interest .............................................................................84 
11.2.8. 
Hypertension, Including Hypertensive Crisis .............................................................85 
11.2.9. 
Posterior Reversible Encephalopathy Syndrome ........................................................85 
11.2.10. 
Allergic Reaction ........................................................................................................85 
11.2.11. 
Pregnancy ...................................................................................................................85 
11.2.12. 
Special Situations ........................................................................................................86 
12. 
STATISTICS ..............................................................................................................87 
12.1. 
Analysis Populations ..................................................................................................87 
12.2. 
Sample Size Consideration .........................................................................................87 
12.3. 
Safety Analyses ..........................................................................................................89 
12.4. 
Pharmacokinetic Analysis ..........................................................................................90 
13. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS.........................................92 
13.1. 
Study Monitoring ........................................................................................................92 
13.2. 
Audits and Inspections ................................................................................................92 
13.3. 
Institutional Review Board .........................................................................................93 
14. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................94 
15. 
ETHICS ......................................................................................................................95 
15.1. 
Ethics Review .............................................................................................................95 
15.2. 
Ethical Conduct of the Study ......................................................................................95 
15.3. 
Written Informed Consent ..........................................................................................95 
16. 
DATA HANDLING AND RECORDKEEPING .......................................................96 
16.1. 
Inspection of Records .................................................................................................96 
16.2. 
Retention of Records ..................................................................................................96 
17. 
PUBLICATION POLICY ..........................................................................................97 
18. 
LIST OF REFERENCES ............................................................................................98 
APPENDIX A. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE STATUS .......................................................................................99 


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APPENDIX B. COMPONENTS AND EXCIPIENTS OF NIRAPARIB CAPSULES 
AND TABLETS .......................................................................................................100 
APPENDIX C. CONTRACEPTION GUIDELINES ...............................................................101 
APPENDIX D. PERMITTED HORMONAL THERAPIES ....................................................102 
APPENDIX E. GUIDANCE ON COMPOSITION OF HIGH-AT MEAL ..............................103 
 


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LIST OF TABLES 
Table 1: 
Summary of Changes for Amendment 5 (Version 6.0) ................................................4 
Table 2: 
Abbreviations and Specialist Terms ...........................................................................34 
Table 3: 
Niraparib Dose Reductions for Non-Hematologic Toxicities .....................................47 
Table 4: 
Management of Hematologic Toxicities ....................................................................48 
Table 5: 
Schedule of Events: Study Drug and PK Phase – Stage 1 (COMPLETED) ..............50 
Table 6: 
Schedule of Events: Study Drug and PK Phase – Stage 2  (COMPLETED) .............52 
Table 7: 
Schedule of Events: Study Drug and PK Phase – Stage 3 ..........................................54 
Table 8: 
Schedule of Events: Extension Phase .........................................................................57 
Table 9: 
Investigational Product ...............................................................................................71 
Table 10: Timing of Contraception and Sperm Donation ..........................................................72 
 
LIST OF FIGURES 
Figure 1: 
Study Design: Single-Crossover Study ......................................................................13 
Figure 2: 
Study Design: Single-Crossover Study ......................................................................44 
 


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3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Table 2: 
Abbreviations and Specialist Terms  
Abbreviation or Specialist Term 
Explanation 
ADP 
Adenosine diphosphate 
AE 
Adverse event 
AESI 
Adverse Event of Special Interest 
ALT 
Alanine aminotransferase 
AML 
Acute myeloid leukemia 
ANOVA 
Analysis of covariance 
AST 
Aspartate aminotransferase 
AUC 
Area under the plasma concentration-time curve 
AUC0-∞ 
Area under the plasma concentration-time curve from time 0 
extrapolated to infinity 
AUC0-t 
Area under the plasma concentration-time curve from time 0 
to the time of the last quantifiable concentration 
BA 
Bioavailability 
BE 
Bioequivalence 
BP 
Blood pressure 
BRCA 
Breast cancer 
CBC 
Complete blood count 
CI 
Confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CL/F 
Apparent total body clearance 
Cmax 
Maximum observed plasma concentration 
CNS 
Central nervous system 
CRF 
Case report form 
CSF 
Colony stimulating factor 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV 
Coefficient of variation 
CYP 
Cytochrome P450 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic case report form  
EOT 
End of Treatment 


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Table 2: 
Abbreviations and Specialist Terms  (Continued) 
Abbreviation or Specialist Term 
Explanation 
SD 
Standard deviation 
SUSAR 
Serious Unexpected Serious Adverse Reaction 
t1/2 
Terminal elimination half-life 
TEAE 
Treatment-emergent adverse event 
tmax 
Time to reach Cmax 
tlag 
Time from administration of the dose to the first quantifiable 
concentration 
ULN 
Upper limit of normal 
US PI 
United States Package Insert 
Vz/F 
Apparent terminal volume of distribution 


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4. 
INTRODUCTION 
4.1. 
Background 
Niraparib is an orally available, potent, highly selective poly (adenosine diphosphate 
[ADP])-ribose polymerase (PARP)-1 and -2 inhibitor. Niraparib cocrystallized with the human 
PARP-1 catalytic domain and was shown to inhibit PARP-1 and PARP-2 activity in vitro with a 
median inhibitory concentration (IC50) of 3.8 and 2.1 nM, respectively. 
Niraparib was approved by the Food and Drug Administration in March 2017 and is indicated 
for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, 
or primary peritoneal cancer who are in a complete or partial response to platinum-based 
chemotherapy. 
4.1.1. 
Niraparib Nonclinical Studies 
The niraparib nonclinical studies are described in detail in the Investigator’s Brochure (IB). 
4.1.2. 
Niraparib Clinical Studies 
In 2008, a Phase 1 study was initiated in an all solid tumors population to investigate the safety 
and tolerability of niraparib. Eight (40% [95% CI 19-64]) of 20 BRCA1 or BRCA2 mutation 
carriers with ovarian cancer had Response Evaluation Criteria in Solid Tumors (RECIST) partial 
responses, as did two (50% [7-93]) of four mutation carriers with breast cancer. Antitumor 
activity was also reported in sporadic high-grade serous ovarian cancer, non-small-cell lung 
cancer, and prostate cancer (Sandhu, 2013).   
Clinical studies have shown that PARP inhibitors are active in recurrent ovarian cancer, breast 
cancer, and prostate cancer (Sandhu, 2013; Fong, 2009; Audeh, 2010; Gelmon, 2011; Kummar, 
2012; Ledermann, 2012; Ledermann, 2014). PARP inhibition appears to be most active in 
patients with gBRCA mutations and in patients who are sensitive to platinum-containing therapy. 
However, clinical benefit has also been observed in gBRCA wild-type patients (Sandhu, 2013; 
Gelmon, 2011; Kummar, 2012; Ledermann, 2012; Ledermann, 2014).  In the registrational 
ENGOT-OV16/NOVA trial, maintenance treatment of patients with recurrent high-grade serous 
ovarian cancer showed that the PARP-1/2 inhibitor niraparib significantly improved 
progression-free survival (PFS) in gBRCAmut patients (21 months for niraparib vs. 5.5 months 
for control). Furthermore, in the non-BRCAmut population, significant improvement in PFS was 
also observed (9.3 months for niraparib vs. 3.9 months for placebo, hazard ratio [HR]=0.45, 
p < 0.0001). (Sandhu, 2013; Mirza, 2016) Niraparib has been recently approved in the US for the 
maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary 
peritoneal cancer (Guan, 2017). The niraparib clinical studies are described in detail in the IB. 
The safety, tolerability, and PK of niraparib has been evaluated in a series of clinical studies 
including single-and multiple-dose PK, absorption, metabolism and elimination, and a Phase 3 
study (ENGOT-OV16/NOVA), (Mirza, 2016) comprising the QT/QTc and food effect substudy, 
using the capsule formulation. No clinically significant food effect was observed with the 
capsule formulation, with no change in niraparib AUC0-t and AUC0-∞ following a high-fat meal, 
and a 20% reduction in Cmax when compared to fasted state administration.  


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Orally-administered niraparib was absorbed with a median time to reach maximum observed 
plasma concentration (tmax) of approximately 2 to 4 hours, highly tissue-distributed, and slowly 
metabolized and eliminated. The oral BA of niraparib with the capsule formulation is high 
(absolute BA of the capsule formulation of approximately 73%). Details of the clinical 
pharmacology of niraparib are described in the niraparib label and IB. 
4.1.3. 
Baseline Platelet Count and Weight as Predictors of Thrombocytopenia in 
Patients Treated with Niraparib 
An analysis was conducted using the data collected in ENGOT-OV16/NOVA and the initial 
Phase 1 study, PN001. This analysis determined that only baseline platelets had an impact on 
platelet nadir; lower baseline platelets (<180,000 /μL) were associated with an increased 
frequency of thrombocytopenia Grade ≥1 (76%) or Grade ≥ 3 (45%) compared to patients with 
higher baseline platelet counts. Further, an exploratory analysis of clinical data versus baseline 
body weight from ENGOT-OV16/NOVA was conducted. For this analysis, the weight categories 
were based on quartiles with the lowest quartile (patients with a body weight less than 58 kg at 
baseline) compared to the highest quartile (patients with a body weight greater than or equal to 
77 kg at baseline). While TEAEs occurred in most patients regardless of body weight, Grade ≥3 
TEAEs, SAEs, and TEAEs leading to dose modification or treatment discontinuation occurred 
more commonly in the weight <58 kg cohort than in the ≥77 kg cohort. In the cohort of patients 
with a body weight <58 kg, approximately 80% of patients had a dose reduction compared to 
59% of patients with a weight greater than or equal to 77 kg. Treatment discontinuations were 
increased in the subjects with lower body weight (24%) compared to patients in the highest 
quartile (10%). 
The potential relationship between body weight and TEAEs was further explored in an analysis 
to evaluate the correlation of Grade 3 or 4 thrombocytopenia and baseline body weight. The 
lowest platelet count in the first 30 days was plotted versus baseline body weight to determine if 
low body weight identified a subgroup of patients with higher levels of thrombocytopenia during 
Cycle 1. In the first 30 days of treatment, a baseline body weight >77 kg is associated with a 
lower incidence of Grade 3 or 4 thrombocytopenia (14%) relative to the group with body 
weight<58 kg (43%). 
Finally, a classification tree approach was used to refine the best cut-off points for predicting the 
likelihood of a patient developing Grade ≥3 thrombocytopenia within 30 days after the first dose 
of niraparib. The results of the model show that the subgroup of patients with a baseline body 
weight <77 kg or baseline platelet count <150,000/μL had a Grade 3/4 thrombocytopenia rate in 
the first 30 days of 35.4% compared to 11.5% in the group of patients with a body weight >77 kg 
and a platelet count >150,000/μL. Further, the average daily dose was 258 mg through the first 
two cycles for patients with a body weight >77 kg and platelet count >150,000/μL, and was only 
206 mg for patients with body weight < 77 kg or platelet count <150,000/μL. Thus, the actual 
delivered dose approximated a starting dose of 200 mg despite the intended delivery of a starting 
dose of 300 mg. Therefore, in the present study in the Extension Phase, patients whose baseline 
weight is <77 kg or baseline platelet count is <150,000/μL will be treated at the 200 mg starting 
dose of niraparib. 


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4.2. 
Rationale for Study 
The approved niraparib drug product is an immediate release hard gelatin capsule dosage form 
that contains 100 mg of niraparib per capsule. The labelled starting dose for niraparib is 300 mg. 
Facilitating this dose requires the administration of three 100 mg capsules.  
It is the Sponsor’s intent to introduce a tablet dosage form that provides the 100 mg, 200 mg and 
300 mg dose in single dose strength tablets to reduce the pill burden on the patients. 
To this end, the Sponsor has developed a tablet dosage form with the specific intent to provide 
comparable performance to the approved capsule dosage form. The formulation and 
manufacturing process of the tablet were selected to produce a tablet with comparable in-vitro 
performance to the capsule.  
This study is an open label Phase 1 study to evaluate the relative BA and BE of niraparib 
administered as a tablet formulation compared to the reference capsule formulation 
manufactured by the same process as currently marketed in the United States. Specifically, a 300 
mg niraparib tablet will be compared to 3 niraparib capsules (3×100 mg).  
Following the PK analysis from the Stage 1 (relative BA), the tablet and capsule formulation  
were found to have similar bioavailability with the 90% confidence interval (CI) for the least 
squares geometric mean ratios of the tablet/capsule Cmax, AUC0-t , and AUC0-∞ falling entirely 
within 0.800 to 1.250. The inter-subject variability of the tablet formulations’ PK parameter 
estimates appears to be lower than the capsule formulation. 
Niraparib PK in Stage 2 of this study was found to be consistent with the values reported in 
Stage 1 and other studies where niraparib PK was assessed. BE was established between the 
niraparib tablet (1×300 mg) and capsule (3×100 mg) formulations. The 90% CIs of the least 
squares geometric mean ratios for tablet compared to capsules fell within the limits of 0.800 and 
1.250 for all 3 primary niraparib PK parameters (Cmax, AUC0-t, and AUC0-∞). Intrasubject 
variability was low, ranging from 18.1% to 23.7% for the key PK parameters. 
In addition, this study will evaluate the effect of a high-fat meal on the PK of the niraparib 300 
mg tablet formulation (Stage 3). The Extension Phase of this study will enable patients to 
continue to receive treatment with niraparib if they are tolerating it and, in the Investigator’s 
opinion, may receive clinical benefit. 


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6. 
INVESTIGATIONAL PLAN 
6.1. 
Overall Study Design 
This is a multicenter, open label study in patients with advanced solid tumors. This is a 3-stage, 
randomized-sequence, single-crossover study to assess the relative BA and BE of niraparib tablet 
formulation relative to the capsule formulation. In addition, Stage 3 of the protocol is a single 
cohort, randomized-sequence, 2 period, single dose, crossover study to assess effect of food on 
the PK of the niraparib tablet formulation. 
Pharmacokinetics (PK) Phase: In Stages 1 and 2 patients will be randomized 1:1 to receive 
tablet formulation followed by capsule formulation or capsule formulation followed by tablet 
formulation. In Stage 3, patients will be randomized 1:1 to receive tablet formulation in a fasted 
state followed by tablet formulation taken with a high-fat meal, or tablet formulation taken with a 
high-fat meal followed by tablet formulation taken in a fasted state. 
Stage 1: Following an 8-hour fast on Day 1 (see Section 6.1.1), patients will receive a single dose 
of the formulation (tablet [1×300 mg] or capsule [3×100 mg]) followed by a 7-day (+1 day) 
Washout/PK period followed by a dose of the alternate formulation also in a fasted state, 
followed by a 7-day Washout/PK period. Patients receiving the tablet in the first treatment period 
will receive the capsules in the second treatment period and vice versa (Figure 2). Extensive PK 
sampling will be carried out after niraparib dosing (see Section 10.1).  
Stage 2: Following an 8-hour fast on Day 1 (see Section 6.1.1), patients will receive a single dose 
of the formulation (tablet [1×300 mg] or capsule [3× 100 mg]) followed by a 14-day (+/- 4 days) 
Washout/PK period followed by a dose of the alternate formulation also in a fasted state, 
followed by a 7-day Washout/PK period. Patients receiving the tablet in the first treatment period 
will receive the capsules in the second treatment period and vice versa (Figure 2). Extensive PK 
sampling will be carried out after niraparib dosing (see Section 10.1).  
Stage 3: In period 1, patients will receive a single 300 mg niraparib tablet either following a 
10-hour fast (see Section 6.1.1) or directly following consumption of a high-fat meal (see 
Section 6.1.1), followed by a 14-day (+4 days) PK sampling and washout period. In period 2, 
patients will be crossed over to receive a single 300 mg niraparib tablet in a fasted state or with a 
high-fat meal, followed by a 7-day PK sampling period. All patients will fast for a minimum of 4 
hours postdose in both periods. Patients receiving the tablet in a fasted state in the first treatment 
period will receive the tablet with a high-fat meal in the second treatment period and vice versa.  
In the rare instance where a delay of the entire PK period 2 is needed for any reason beyond the 
4-day window specified above the site must contact the sponsor's medical monitor to discuss the 
patient circumstances, the Sponsor will decide if the patient can continue with PK period 2 with 
a delay. Similarly, should the laboratory results on D15 in Stage 2 (the day of niraparib 
administration in PK Period 2) show changes in organ function such that the original inclusion 
criteria for laboratory values are no longer met, or in the event of a significant change of 
patient’s clinical status as judged by the Investigator, the site must consult with the Sponsor to 
discuss the patient's continued participation in PK period 2. Note that sites need not wait for the 
pre-dose laboratory results to begin PK period 2, but rather consult the Sponsor once the results 
are available as needed.  


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In Stage 1 and 2, patients who experience emesis within 9 hours of dosing or who miss a critical 
PK sample (such as the last PK sample on Day 8 in each Period [Stage 3]) will be discontinued 
from the PK phase and will be allowed to be screened for the Extension Phase (see Section 6.1).  
In Stage 3, patients who experience emesis within 10 hours of dosing or miss sufficient samples 
to render calculation of AUC unreliable will be discontinued from the PK phase. Patients may 
also be identified and discontinued from the PK phase as non-evaluable due to issues arising 
during the study conduct (Section 7.4.1). Patients who are discontinued from the PK phase and 
meet other criteria for continued niraparib therapy will be eligible to be screened for the 
Extension Phase (see Section 6.1). 
The PK parameters that will be estimated include area under the plasma concentration-time 
curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-t), area under 
the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞), apparent total 
body clearance (CL/F), Cmax, tmax, terminal elimination half-life (t1/2), apparent terminal volume 
of distribution (Vz/F), and bioavailability/bioequivalence of the tablet formulation relative to the 
capsule formulation. 
For Stage 2, the same PK parameters as above will be estimated. To conclude bioequivalence, 
the 90% CI of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) 
product should be within 0.800 - 1.250 for AUC0-∞ AUC0-t and Cmax. 
For Stage 3, the same PK parameters as above will be estimated. In addition, tlag, the time from 
administration of the dose to the first quantifiable concentration, will be determined, and tmax will 
be compared between the fed and fasted states. The relative bioavailability of the 300 mg 
niraparib tablet administered with a high-fat meal relative to fasted dosing will be based on the 
ratio of geometric least-squares means of AUC0-t, AUC0-∞, and Cmax.  
Additional PK parameters may be estimated (e.g., residual area) if deemed appropriate.  
Extension Phase: When patients complete the PK Phase of the study (at least 7 days from 
niraparib, dose 2), the Sponsor will work with the Investigator to determine if the patient would 
benefit from continued access to niraparib therapy. Eligibility to participate in the Extension 
Phase will be at the discretion of the Investigator and Sponsor and will follow review of the 
study’s Extension Phase’s respective inclusion criteria and completion of the required screening 
assessments. Continued treatment in the study will be based on documented evidence of clinical 
benefit determined by local standard of care disease assessment frequency.  
The starting dose of niraparib in the Extension Phase will be based on the patient’s baseline 
actual body weight or platelet count. Patients with a baseline actual body weight of ≥77 kg and 
screening platelet count of ≥150,000/µL (obtained after completion of the PK phase, as part of 
Extension Phase screening) will take one 300 mg strength tablet or 3 x 100 mg tablets/capsules at 
each dose administration (QD). Patients with a baseline actual body weight of <77 kg or 
screening platelet count of <150,000/µL will take one 200 mg strength tablet or 2 x 100 mg 
tablets/capsules at each dose administration (QD). For patients whose initial starting dose is 200 
mg QD, escalation to 300 mg QD is permitted after 2 cycles of therapy if no treatment 
interruption or discontinuation was required during the first 2 cycles of Extension Phase therapy 
and after approval from the Sponsor. Additional dose modifications will not be based upon 
changes in the patient’s actual body weight during study participation. If laboratory values at the 


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beginning of Extension Phase are outside of the range specified in the inclusion criteria, the 
patient may continue to participate in the study only upon Sponsor approval and with 
consideration for an appropriately reduced dose. Should a patient start Extension Phase at 100 
mg, consideration may be given to escalate to 200 mg after 2 cycles of therapy if no treatment 
interruption or discontinuation was required during the first 2 cycles of Extension Phase therapy 
and after approval from the Sponsor. 
Patients have up to 28 days (21 days for Stage 3 only; up to 28 days may be acceptable following 
discussion between the Sponsor and Investigator) after completion of the PK Phase to complete 
the screening assessments and the Screening Visit.  
A tumor assessment is to be performed prior to the first dose of the Extension (pre-Extension 
Phase). The pre-Extension Phase tumor assessment need not be completed if the baseline tumor 
assessment was performed ≤56 days before the first dose of the Extension Phase. 
The Cycle 1/Day 1 Visit can occur on the same day as the Extension Phase Screening Visit, 
dependent upon availability of radiographic results obtained ≤ 56 days of the first planned dose 
in the Extension Phase. If the Extension Phase Screening Visit and the Cycle 1/Day 1 Visit occur 
on the same day, the clinical laboratory results will be reviewed by the study personnel prior to 
study drug administration to ensure eligibility. At the Cycle 1/Day 1 Visit, patients will undergo 
safety assessments and will receive study drug supply for the duration of 1 cycle (300 mg or 200 
mg tablets of niraparib for QD dosing or 3 x 100 mg or 2 x 100 mg tablets/capsules of niraparib 
for QD dosing, depending upon availability). It is preferred that patients remain on the same 
formulation (tablet versus capsule) throughout the Extension Phase. Patients will return on the 
first day of every treatment cycle (28 ± 7 days) to receive study drug and for safety assessments. 
Visits will continue approximately every 4 weeks until treatment discontinuation. In line with the 
niraparib US PI, dose interruption (no longer than 28 days) will be allowed based on adverse 
events (AEs). In addition, dose reductions to 200 mg QD and subsequently to 100 mg QD will be 
allowed based on AEs (please refer to US PI). Any dose reductions differing from this must be 
discussed with the medical monitor. Patients can continue in the Extension Phase until the 
patient meets 1 of the withdrawal criteria. 
EOT and Safety Follow-up Visits:  
The EOT visit will occur within 7 days of the decision to discontinue study treatment for any 
reason. Patients who do not participate in the Extension Phase will also have an EOT visit within 
7 days of the decision to discontinue study. Should the first dose of a new anti-cancer therapy 
occur within 14 days of the decision to discontinue study treatment, all assessments required for 
the Safety Follow-up visit should occur at the EOT visit and this visit will be considered the 
Safety Follow-up visit. If the first dose of the new anti-cancer therapy occurs >14 days of the 
decision to discontinue study, the Safety Follow-up visit will occur 30+7 days after the last dose 
of the study drug, or at the start of any new anti-cancer therapy, whichever occur first.   


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7-day PK sample 
collection
7-day PK sample 
collection
14-day washout 
period, including 
7-day PK sample 
collection
300 mg dose
1:1 Randomization
Niraparib
Dose 1: 
Tablet
Niraparib
Dose 1:
Capsule
14-day washout 
period, including 
7-day PK sample 
collection
Niraparib
Dose 2: 
Tablet
Niraparib
Dose 2:
Capsule
Option to qualify 
for treatment in 
Extension Phase 
Option to qualify 
for treatment in 
Extension Phase 
300 mg dose 
N=16 evaluable
1:1 Randomization
Niraparib
Dose 1: 
Fasted
Niraparib
Dose 1:
Fed
14-day washout 
period, including 7-
day PK sample 
collection
Niraparib
Dose 2: 
Fasted
Niraparib
Dose 2:
Fed
Option to qualify 
for treatment in 
Extension Phase 
Option to qualify 
for treatment in 
Extension Phase 
14-day washout 
period, including 
7-day PK sample 
collection
7-day PK sample 
collection
7-day PK sample 
collection


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Patients will receive a single dose of the study drug with approximately 250 ml of water on 
Day 1 of the Study Drug and Washout/PK period and subsequent Study Drug and PK period. 
Patients may take sips of water after the single dose and resume their regular diet 4 hours 
thereafter. 
In Stage 3, all patients should arrive at the clinic following an overnight fast for a minimum of 
10 hours. For patients taking niraparib with a high-fat meal, the  meal (see Appendix E) should 
start 30 minutes before administration of niraparib. Patients should eat this meal in 30 minutes or 
less, and every effort should be made for the patient to complete the entire meal.. The dose of 
niraparib should be taken within 5 minutes of finishing the meal, with 240 mL (8 fluid ounces) of 
water. Patients taking the drug product in a fasted state should also take it with 240 mL of water. 
Additional water is allowed except for 1 hour before and 1 hour after drug administration. No 
food is allowed for at least 4 hours postdose in both treatment periods. 
6.1.2. 
General Study Conduct 
This study will consist of a Screening Period (Day -21 to Day -1), a PK Phase (Study Drug and 
Washout/PK period 1 and Study Drug and PK period 2), an EOT visit, and a Safety Follow-up 
Visit. When patients complete the PK Phase of the study (at least 7 days from the beginning of 
PK period 2), they may be eligible to participate in the Extension Phase prior to EOT and Safety 
Follow-up Visits, following review of the Extension Phase inclusion criteria and completion of 
the required screening assessments. See Section 6.1. 
Following informed consent, all patients will undergo screening procedures within 21 days prior 
to the first dose of study drug to determine eligibility for study entry. Screening procedures 
include medical, surgical, cancer, and medication history; complete physical examination, 
including vital signs, height, and weight; Eastern Cooperative Oncology Group (ECOG) 
performance status; clinical laboratory assessments (complete blood count [CBC], chemistry, 
and urinalysis); pregnancy test for women of childbearing potential; baseline tumor assessment 
and electrocardiogram (ECG). 
Once randomized to either capsule to tablet crossover or tablet to capsule crossover, patients will 
receive a single dose of the formulation (tablet or capsule) in a fasted state (Stage 1 and Stage 2). 
Stage 1:  Following an 8-hour fast on Day 1 (see Section 6.1.1), patients will receive a single 
dose of the formulation (tablet [1× 300 mg] or capsule [3× 100 mg]) followed by a 7-day (+ 1 
day) Washout/PK period followed by a dose of the alternate formulation also in a fasted state, 
followed by a 7-day Washout/PK period. Patients receiving the tablet in the first treatment period 
will receive the capsules in the second treatment period and vice versa (Figure 2). Extensive PK 
sampling will be carried out after niraparib dosing (see Section 10.1). Blood will be collected 
during the study for PK assessments at the following time points relative to niraparib dosing: 
predose (30 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 
168 hours postdose.   
Stage 2: Following an 8-hour fast on Day 1 (see Section 6.1.1), patients will receive a single dose 
of the formulation (tablet [1× 300 mg] or capsule [3× 100 mg]) followed by a 14-day (+/- 4 days) 
Washout/PK period followed by a dose of the alternate formulation also in a fasted state, 
followed by a 7-day Washout/PK period. Patients receiving the tablet in the first treatment period 
will receive the capsules in the second treatment period and vice versa (Figure 2). Extensive PK 


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sampling will be carried out after niraparib dosing (see Section 10.1). Blood will be collected 
during the study for PK assessments at the following time points relative to niraparib dosing: 
predose (30 minutes prior to dosing) and at 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96,120, and 
168 hours postdose. 
Stage 3: In period 1, patients will receive a single 300 mg niraparib tablet either following a 10-
hour fast or directly following consumption of a high-fat meal followed by a 14-day (+4 days) 
PK sampling and washout period. In period 2, patients will be crossed over to receive a single 
300 mg niraparib tablet in a fasted state or with a high-fat meal, followed by a 7-day PK 
sampling period. All patients will fast for a minimum of 4 hours postdose in both periods. 
Patients receiving the tablet in a fasted state in the first treatment period will receive the tablet 
with a high-fat meal in the second treatment period and vice versa. Extensive PK sampling will 
be carried out after niraparib dosing (see Section 10.1). Blood will be collected during the study 
for PK assessments at the following time points relative to niraparib dosing: predose (30 minutes 
prior to dosing) and at 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120, and 168 hours postdose. 
Safety assessments conducted throughout the study include symptom-directed physical 
examination, vital signs, ECOG performance status, clinical laboratory assessments (CBC, 
chemistry, and urinalysis) (Section 6.6.1). Laboratory results from D8 (start of PK Period 2) 
should be reviewed by the site personnel, and significant changes in renal or hepatic function 
compared to baseline should be discussed with the sponsor. 
6.2. 
Number of Patients 
Approximately 24 patients will be enrolled in Stage 1, and approximately 170 will be enrolled in 
Stage 2 to ensure 100 evaluable patients for BE analysis. Approximately 20 patients will be 
enrolled in Stage 3 to ensure 16 evaluable patients for the FE analysis. 
6.3. 
Treatment Assignment 
6.3.1. 
Patient Identification 
All patients who enter into the screening period of the study (defined as the point at which the 
patient signs the Informed Consent Form [ICF]) will receive a unique patient identification 
number. This number will be used to identify the patient throughout the study and must be used 
on all study documentation related to that patient. A patient will be considered enrolled when the 
patient has been consented, screened, and all eligibility criteria have been confirmed in the 
electronic case report form (eCRF). The patient identification number must remain constant 
throughout the entire study, and it must not be changed at the time of enrollment. 
6.3.2. 
Randomization Scheme 
Randomization will occur centrally using an interactive voice response system/integrated web 
response system. In Stage 1 and Stage 2, subjects will be assigned randomly in a 1:1 ratio to a 
dosing sequence: capsule formulation followed by tablet formulation, or vice versa. In Stage 3, 
subjects will be assigned randomly in a 1:1 ratio to a dosing sequence: dosing after receiving a 
high-fat meal (fed) followed by dosing after fasting, or vice versa. The period between 
randomization and Cycle 1/Day 1 should be no longer than 5 calendar days. 


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6.4. 
Dose Adjustment Criteria 
6.4.1. 
Safety Criteria for Stopping Doses During PK Phase 
During the PK Phase, patients must be discontinued for any treatment-related nonhematologic 
National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 
(NCI-CTCAE v.4.03) Grade 3 or 4 AE or serious adverse event (SAE) that the Investigator 
considers to be related to the administration of niraparib and, in case this resulted in incomplete 
PK collection. Patients may be permitted to enter the Extension Phase at an appropriately 
reduced dose. 
6.4.2. 
Safety Criteria for Adjustment or Stopping Doses During Extension Phase 
During the Extension Phase, dose interruption and/or reduction may be implemented at any time 
for any grade toxicity considered intolerable by the patient and per the US label. In addition, 
protocol-defined criteria for dose modification are discussed below. 
Treatment must be interrupted for any treatment-related nonhematologic NCI-CTCAE v.4.03 
Grade 3 or 4 AE or SAE that the Investigator considers to be related to niraparib administration. 
If the toxicity is resolved to baseline or ≤Grade 1 within 28 days, the patient may restart 
treatment with niraparib but with an appropriate dose reduction unless prophylaxis is considered 
feasible (Table 3). If the event recurs at a similar or worse grade, treatment should be interrupted 
again, and upon resolution, a further dose reduction must be made. If upon rechallenging with 
niraparib at the lowest allowable dose, any NCI-CTCAE Grade 3 or 4 AEs, which the 
Investigator considers to be related to niraparib recur, the patient must be discontinued. At the 
Investigator’s discretion, following dose interruption (no longer than 28 days), patients may be 
considered for dose reductions, provided that they have not already undergone the maximum 
number of 2 dose reductions allowed (no more than 2 dose reductions will be permitted). Any 
dose reductions deviating from this guidance must be discussed with the medical monitor. 
Table 3: 
Niraparib Dose Reductions for Non-Hematologic Toxicities 
Event 
Dose1 
Initial dose 
300 mg QD 
First dose reduction for treatment-related NCI-CTCAE 
v.4.03 Grade 3 or 4 AE or SAE where prophylaxis is not 
considered feasible 
200 mg QD 
Second dose reduction for NCI-CTCAE v.4.03 Grade 3 or 4 
AE or SAE where prophylaxis is not considered feasible 
100 mg QD 
Continued treatment-related CTCAE Grade 3 or 4 AE or 
SAE ≥28 days 
Discontinue study medication 
Posterior Reversible Encephalopathy Syndrome (PRES) 
(see Section 11.2.9) 
Discontinue niraparib and treat specific 
symptoms including hypertension. 
Abbreviations: AE=adverse event; CTCAE=Common Terminology Criteria for Adverse Events; 
NCI-CTCAE=National Cancer Institute CTCAE; QD=once daily; PRES=Posterior Reversible Encephalopathy 
Syndrome; SAE=serious adverse event. 
1 Dose not to be decreased below 100 mg daily. 


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Management of hematologic toxicities (Guan, 2017) is described in Table 4. For Grade 3 or 4 
neutropenia, thrombocytopenia, or anemia, treatment with niraparib must be interrupted with 
weekly blood counts monitored until recovery to ≤Grade 1. Niraparib should be resumed with a 
dose level reduction at that time. Cytokines (granulocyte colony stimulating factor [CSF]) may 
be administered as clinically indicated to manage febrile neutropenia according to local standard 
of care.  
For major surgery, up to 28 days of drug interruption is allowed. 
Thrombocytopenia is an expected event associated with the use of niraparib and is described in 
the IB. Thrombocytopenia associated with the use of niraparib resolved upon treatment 
interruption and/or dose reduction. The occurrence of thrombocytopenia during Cycle 1 requires 
additional patient monitoring in order to identify hematologic changes early and prevent higher 
grade thrombocytopenic events. A weekly monitoring of CBC during the first month is 
mandatory. 
If a patient completes the first cycle with no incidence of hematologic toxicity requiring dose 
interruption or modification, then CBC monitoring will proceed according to protocol every 
4 weeks, thereafter. If dose interruption or modification is required at any point on study, weekly 
CBC will be required for another 4 weeks after the AE has been resolved, to ensure safety of the 
new dose, after which monitoring every 4 weeks may resume. 
It is strongly recommended to refer the patient to the hematologist for further evaluation if (1) 
transfusions are required on more than 2 occasions in the absence of non-treatment related causes 
or (2) the treatment-related hematologic toxicities have not recovered to allow retreatment with 
niraparib after 4 weeks. If a diagnosis of myelodysplastic syndromes (MDS)/acute myeloid 
leukemia (AML) is confirmed by a hematologist, the patient must permanently discontinue study 
drug. 
Table 4: 
Management of Hematologic Toxicities 
Platelet count < 100,000/μL 
First occurrence: 
• 
Withhold study medication for a maximum of 28 days and 
monitor blood counts weekly until platelet counts return to 
≥100,000/μL. 
• 
Resume study medication at same or reduced dose per Table 3. 
• 
If platelet count is <75,000/μL, resume at a reduced dose. 
Second occurrence: 
• 
Withhold study medication for a maximum of 28 days and 
monitor blood counts weekly until platelet counts return to 
≥100,000/μL. 
• 
Resume study medication at a reduced dose per Table 3. 
• 
Discontinue study medication if platelet count has not returned 
to acceptable levels within 28 days of the dose interruption 
period, or if the patient has already undergone dose reduction 
to 100 mg once daily. 


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Table 4: 
Management of Hematologic Toxicities (Continued) 
Neutrophil < 1,000/µL or 
hemoglobin < 8 g/dL 
• 
Withhold study medication for a maximum of 28 days and 
monitor blood counts weekly until neutrophil counts return to 
≥1,500/μL or hemoglobin returns to ≥9 g/dL. 
• 
Resume study medication at a reduced dose per Table 3. 
• 
Discontinue study medication if neutrophils and/or hemoglobin 
have not returned to acceptable levels within 28 days of the 
dose interruption period, or if the patient has already undergone 
dose reduction to 100 mg once daily.a 
Hematologic adverse 
reaction requiring 
transfusion 
• 
For patients with platelet count ≤10,000/μL, platelet transfusion 
should be considered. If there are other risk factors such as 
co-administration of anticoagulation or antiplatelet drugs, 
consider interrupting these drugs and/or transfusion at a higher 
platelet count. 
• 
RBC transfusion is at the discretion of the Investigator 
• 
Resume study medication at a reduced dose. 
Confirmed MDS/AML 
• 
Permanently discontinue treatment. 
Abbreviations: AML=acute myeloid leukemia; CBC=complete blood count; Hb=hemoglobin; 
MDS=myelodysplastic syndrome; RBC=red blood cell.  
a If MDS/AML is confirmed, niraparib will be discontinued. 
6.5. 
Criteria for Study Termination 
The Sponsor may terminate this study at any time. The Sponsor will notify the Investigators 
when the study is to be placed on hold, completed, or terminated. 
6.6. 
Study Conduct 
6.6.1. 
Schedule of Events 
The schedule of events for the study is provided in Table 5: for Stage 1, Table 6 for Stage 2, 
Table 7: 
for Stage 3, and Table 8 for the Extension Phase.  


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Table 5: 
Schedule of Events: Study Drug and PK Phase – Stage 1 (COMPLETED) 
Cycle/Visit 
Screening 
Study Drug and Washout/PK 
Period 1 
Study Drug and Washout/PK 
Period 2    
EOT 
Safety Follow-up 
Day of Procedure 
-21 to -1 
1 
2 
3 
4 
5 
6 
81 
9 
10 
11 
12 
13 
15 
+7 days of 
the decision 
to 
discontinue 
treatment for 
any reason2 
30 + 7 days post- 
treatment2 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/ exclusion criteria review 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
X3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical, surgical, cancer, and 
medication history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Laboratory assessments: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC4 
X 
X5 
 
 
 
 
 
X5 
 
 
 
 
 
 
X 
X 
Chemistry6 
X 
X5 
 
 
 
 
 
X5 
 
 
 
 
 
 
X 
X 
Pregnancy test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Urinalysis 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Complete physical examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Symptom-directed physical examination 
 
X5 
 
 
 
 
 
X5 
 
 
 
 
 
 
 
 
Vital signs and weight 
X 
X5 
 
 
 
 
 
X5 
 
 
 
 
 
 
 
X 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECOG performance status 
X 
X5 
 
 
 
 
 
X5 
 
 
 
 
 
 
X 
X 
Tumor assessment 
X7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Niraparib study drug 
administration 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 


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Cycle/Visit 
Screening 
Study Drug and Washout/PK 
Period 1 
Study Drug and Washout/PK 
Period 2    
EOT 
Safety Follow-up 
Day of Procedure 
-21 to -1 
1 
2 
3 
4 
5 
6 
81 
9 
10 
11 
12 
13 
15 
+7 days of 
the decision 
to 
discontinue 
treatment for 
any reason2 
30 + 7 days post- 
treatment2 
 
Pharmacokinetic sample collection 
 
X 
X 
X 
X 
X 
X 
X8 
X 
X 
X 
X 
X 
X 
 
 
Concomitant medications and 
procedures 
X 
 
Recorded from informed consent through EOT 
Adverse event monitoring9 
X 
 
Recorded from informed consent through 30 days post-treatment 
Abbreviations: AE=adverse event; AESI=adverse events of special interest; CBC=complete blood count; CT=computed tomography; ECG=electrocardiogram; 
ECOG=Eastern Cooperative Oncology Group; EOT=end of treatment; MRI=magnetic resonance imaging; PK=pharmacokinetics; SAE=serious adverse event. 
1 Study Drug and PK Period may be delayed up to 1 day if necessary for scheduling purposes. 
2 Patients who do not participate in the Extension Phase of the study will proceed to the EOT visit followed by the Safety Follow-up Visit. Patients participating 
in the Extension Phase will proceed into screening for the Extension Phase directly after completing the Study drug and PK period.  
3 Patients to be randomized within 5 calendar days of first dose. 
4 CBC to include: Hemoglobin, Platelet count, Mean corpuscular volume, White blood cell count, Differential white blood cell count 
5 Need not be repeated at screening or during the Washout/PK period if done within 72 hours of dosing 1 and 2, respectively. 
6 Chemistry to include: Sodium, Potassium, Magnesium, Chloride, Albumin, Calcium, Amylase, Phosphate, Glucose, Creatinine, Urea or blood urea nitrogen, 
Total protein, Lactate dehydrogenase, Total bilirubin, Alkaline phosphatase, Aspartate aminotransferase, and Alanine aminotransferase  
7 Tumor assessments may be performed within 28 days of first dose of study drug. Tumor assessments performed outside of the 28 day window but ≤ 56 days of 
the planned start of the Extension Phase are acceptable. Tumor assessment via a CT or MRI scan of clinically indicated areas should be performed. 
8 PK sample collection for the 168 hour postdose timepoint from the first Study Drug and Washout/PK Period and the predose for the second Study Drug and 
Washout/PK Period can occur at the same time.  
9 AEs will be collected and recorded for each patient from the time of randomization and/or treatment assignment until 30 days after the last dose of study drug. 
SAEs are required to be captured through 90 days after the last dose of study drug (or until the start of alternate anticancer therapy, whichever occurs first). All 
SAEs assessed by the Investigator as related to the study drug and AESIs will be collected and reported until study closeout (unless death or loss to follow-up 
occurs first). Any pregnancies that occur within 180 days post-treatment will be reported. All AEs and SAEs experienced by a patient, irrespective of the 
suspected causality, will be monitored until the AE or SAE has resolved, until abnormal laboratory values have returned to baseline or normalized, until there is 
a satisfactory explanation for the changes observed, until the patient is lost to follow-up, or until the patient has died. 


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Table 6: 
Schedule of Events: Study Drug and PK Phase – Stage 2  (COMPLETED) 
Cycle/Visit 
Screening 
Study Drug and Washout/PK 
Period 1 
 
Study Drug and Washout/PK Period 
2  
EOT 
Safety Follow-up 
Day of Procedure 
-21 to -1 
1 
2 
3 
4 
5 
6 
8 
15 
(±4) 
16 
17 
18 
19 
20 
22 
+7 days of 
the decision 
to 
discontinue 
treatment for 
any reason1 
30 + 7 days post- 
treatment1 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/ exclusion criteria review 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
X2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical, surgical, cancer, and 
medication history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Laboratory assessments: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC3 
X 
X4 
 
 
 
 
 
 
X4 
 
 
 
 
 
 
X 
X 
Chemistry5 
X 
X4 
 
 
 
 
 
 
X4 
 
 
 
 
 
 
X 
X 
Pregnancy test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Urinalysis 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Complete physical examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Symptom-directed physical examination 
 
X4 
 
 
 
 
 
 
X4 
 
 
 
 
 
 
 
 
Vital signs and weight 
X 
X4 
 
 
 
 
 
 
X4 
 
 
 
 
 
 
 
X 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECOG performance status 
X 
X4 
 
 
 
 
 
 
X4 
 
 
 
 
 
 
X 
X 
Tumor assessment 
X6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Cycle/Visit 
Screening 
Study Drug and Washout/PK 
Period 1 
 
Study Drug and Washout/PK Period 
2  
EOT 
Safety Follow-up 
Day of Procedure 
-21 to -1 
1 
2 
3 
4 
5 
6 
8 
15 
(±4) 
16 
17 
18 
19 
20 
22 
+7 days of 
the decision 
to 
discontinue 
treatment for 
any reason1 
30 + 7 days post- 
treatment1 
 
Niraparib study drug 
administration 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Pharmacokinetic sample collection 
 
X 
X 
X 
X 
X 
X 
X  
X 
X 
X 
X 
X 
X 
X 
 
 
Concomitant medications and 
procedures 
X 
Recorded from informed consent through EOT 
Adverse event monitoring7 
X 
Recorded from informed consent through 30 days post-treatment 
Abbreviations: AE=adverse event; AESI=adverse events of special interest; CBC=complete blood count; CT=computed tomography; ECG=electrocardiogram; 
ECOG=Eastern Cooperative Oncology Group; EOT=end of treatment; MRI=magnetic resonance imaging; PK=pharmacokinetics; SAE=serious adverse event. 
1 Patients who do not participate in the Extension Phase of the study will proceed to the EOT visit followed by the Safety Follow-up Visit. Patients participating 
in the Extension Phase will proceed into screening for the Extension Phase directly after completing the Study drug and PK period. The EOT visit will occur 
within 7 days of the decision to discontinue study treatment for any reason. Should the first dose of a new anti-cancer therapy occur within 14 days of the 
decision to discontinue study treatment, all assessments required for the Safety Follow-up visit should occur at the EOT visit and this visit will be considered the 
Safety Follow-up visit. If the first dose of the new anti-cancer therapy occurs >14 days of the decision to discontinue study, the Safety Follow-up visit will occur 
30+7 days after the last dose of the study drug, or at the start of any new anti-cancer therapy, whichever occur first.   
2 Patients to be randomized within 5 calendar days of first dose. 
3 CBC to include: Hemoglobin, Platelet count, Mean corpuscular volume, White blood cell count, Differential white blood cell count 
4 Need not be repeated at screening or during the Washout/PK period if done within 72 hours of dosing 1 and 2, respectively. 
5 Chemistry to include: Sodium, Potassium, Magnesium, Chloride, Albumin, Calcium, Amylase, Phosphate, Glucose, Creatinine, Urea or blood urea nitrogen, 
Total protein, Lactate dehydrogenase, Total bilirubin, Alkaline phosphatase, Aspartate aminotransferase, and Alanine aminotransferase  
6 Tumor assessments may be performed within 28 days of first dose of study drug. Tumor assessments performed outside of the 28 day window but ≤56 days of 
the planned start of the Extension Phase are acceptable. Tumor assessment via a CT or MRI scan of clinically indicated areas should be performed. 
7 AEs will be collected and recorded for each patient from the time of randomization and/or treatment assignment until 30 days after the last dose of study drug. 
SAEs are required to be captured through 90 days after the last dose of study drug (or until the start of alternate anticancer therapy, whichever occurs first). All 
SAEs assessed by the Investigator as related to the study drug and AESIs will be collected and reported until study closeout (unless death or loss to follow-up 
occurs first). Any pregnancies that occur within 180 days post-treatment will be reported. All AEs and SAEs experienced by a patient, irrespective of the 
suspected causality, will be monitored until the AE or SAE has resolved, until abnormal laboratory values have returned to baseline or normalized, until there is 
a satisfactory explanation for the changes observed, until the patient is lost to follow-up, or until the patient has died. 


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Table 7: 
Schedule of Events: Study Drug and PK Phase – Stage 3 
Cycle/Visit 
Screening 
Study Drug and Washout/ 
PK Period 1 
 
Study Drug and Washout/ 
PK Period 2  
EOT 
Safety Follow-up 
Day of Procedure 
-21 to -1 
1 
2 
3 
4 
5 
6 
8 
15 
(+4) 
16 
17 
18 
19 
20 
22 
+7 days of 
the decision 
to 
discontinue 
treatment for 
any reason1 
30+7 days post- 
treatment1 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria review 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
X2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical, surgical, cancer, and 
medication history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Laboratory assessments: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC3   
X 
X4 
 
 
 
 
 
 
X4 
 
 
 
 
 
 
X 
X 
Chemistry5 
X 
X4 
 
 
 
 
 
 
X4 
 
 
 
 
 
 
X 
X 
Pregnancy test10 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Urinalysis 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Complete physical examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Symptom-directed physical examination 
 
X4 
 
 
 
 
 
 
X4 
 
 
 
 
 
 
 
 
Vital signs and weight11 
X 
X4 
 
 
 
 
 
 
X4 
 
 
 
 
 
 
X 
X 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECOG performance status 
X 
X4 
 
 
 
 
 
 
X4 
 
 
 
 
 
 
X 
X 


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Table 7: 
Schedule of Events: Study Drug and PK Phase – Stage 3 (continued) 
Tumor assessment 
X6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Confirmation of fasting state8 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Consumption of high-fat meal, as 
applicable9 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Niraparib study drug administration 
 
X 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Pharmacokinetic sample collection 
 
X 
X 
X 
X 
X 
X 
X  
X 
X 
X 
X 
X 
X 
X 
 
 
Concomitant medications and 
procedures 
X 
Recorded from informed consent through EOT 
Adverse event monitoring7 
X 
Recorded from informed consent through 30 days post-treatment 
Abbreviations: AE=adverse event; AESI=adverse events of special interest; BP=blood pressure; CBC=complete blood count; CT=computed tomography; 
eCRF=electronic case report form; ECG=electrocardiogram; ECOG=Eastern Cooperative Oncology Group; EOT=end of treatment; MRI=magnetic resonance 
imaging; PK=pharmacokinetics; SAE=serious adverse event. 
1  Patients who do not participate in the Extension Phase of the study will proceed to the EOT visit followed by the Safety Follow-up Visit. Patients participating 
in the Extension Phase will proceed into Screening for the Extension Phase directly after completing the Study Drug and PK Period. The EOT visit will occur 
within 7 days of the decision to discontinue study drug for any reason. Should the first dose of a new anti-cancer therapy occur within 14 days of the decision 
to discontinue study drug, all assessments required for the Safety Follow-up visit should occur at the EOT visit and this visit will be considered the Safety 
Follow-up visit. If the first dose of the new anti-cancer therapy occurs >14 days of the decision to discontinue study, the Safety Follow-up visit will occur 30+7 
days after the last dose of the study drug, or at the start of any new anti-cancer therapy, whichever occur first.   
2  Patients may be randomized within 5 calendar days of first dose. 
3  CBC to include: hemoglobin, platelet count, mean corpuscular volume, white blood cell count, differential white blood cell count.  
4  Need not be repeated at Screening or during the Washout/PK Period if done within 72 hours of dosing 1 and 2, respectively. 
5  Chemistry to include: sodium, potassium, magnesium, chloride, albumin, calcium, amylase, phosphate, glucose, creatinine, urea or blood urea nitrogen, total 
protein, lactate dehydrogenase, total bilirubin, alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase  
6 Tumor assessments may be performed within 28 days of first dose of study drug. Tumor assessments performed outside of the 28 day window but ≤56 days 
before the planned start of the Extension Phase are acceptable. Tumor assessment via a CT or MRI scan of clinically indicated areas should be performed. 
7 AEs will be collected and recorded for each patient from the time of randomization and/or treatment assignment until 30 days after the last dose of study drug. 
SAEs are required to be captured through 90 days after the last dose of study drug (or until the start of alternate anticancer therapy, whichever occurs first). All 
SAEs assessed by the Investigator as related to the study drug and AESIs will be collected and reported until study closeout (unless death or loss to follow-up 
occurs first). Any pregnancies that occur within 180 days post-treatment will be reported. All AEs and SAEs experienced by a patient, irrespective of the 
suspected causality, will be monitored until the AE or SAE has resolved, until abnormal laboratory values have returned to baseline or normalized, until there 
is a satisfactory explanation for the changes observed, until the patient is lost to follow-up, or until the patient has died. 
8  Patient must fast for a minimum of 10 hours prior to start of visit. No food is allowed for at least 4 hours postdose in both treatment periods. Patients should 
start the high-fat meal (if assigned) 30 minutes before administration of niraparib and eat the meal in 30 minutes or less. The dose of niraparib should be taken 


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within 5 minutes of finishing the meal, with 240 mL (8 fluid ounces) of water. Patients taking the drug product in fasted state should also take it with 240 mL 
of water. Additional water is allowed except for 1 hour before and 1 hour after drug administration. 
9 Consumption of high-fat meal in either period 1 or period 2 is determined by patient randomization allocation. 
10 A negative serum or urine pregnancy test is required within 72 hours for females of childbearing potential prior to first dose of study drug for PK period 1 and 
Extension Phase.  
11 Vital signs include BP, pulse, heart rate, and temperature.  


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Table 8: 
Schedule of Events: Extension Phase 
Cycle/Visit 
Extension Phase 
Screening 
Extension Phase  
Extension Phase 
EOT 
Safety Follow-up 
 
Day of Procedure 
1-28 days1 
Cycle 1  
(28 ± 7 days)2  
Cycle 2 and on  
(28 ± 7 days)2  
+7 days of the decision 
to discontinue 
treatment for any 
reason3  
30 + 7 days post- 
treatment3 
 
Inclusion/exclusion criteria review 
X2 
 
 
 
 
Laboratory assessments: 
 
 
 
 
 
CBC4 
X 
Weekly6 
Monthly 
X 
X 
Chemistry5 
X 
Every other week6 
Monthly 
X 
X 
Pregnancy test 
X 
 
 
 
X 
Urinalysis 
 
 
 
 
X 
ECG 
 
 
 
 
X 
Complete physical examination 
 
 
 
 
X 
Symptom-directed physical 
examination including vital signs 
X 
X6 (Day 1) 
X6 (Day 1) 
 
 
Vital signs and weight10 
X 
Weekly 
X6 (Day 1) 
X 
X 
ECOG performance status 
X 
X6 (Day 1) 
X6 (Day 1) 
X 
X 
Tumor assessment 
X7 
 
X (every 3 cycles)8  
 
 
Niraparib study drug dispensed 
 
X 
X 
 
 
Concomitant medications and 
procedures 
Recorded from informed consent through EOT 
 
Adverse event monitoring9 
Recorded from informed consent through 30 days post-treatment 
X 
Abbreviations: AE=adverse event; AESI=adverse events of special interest; BP=blood pressure; CBC=complete blood count; CT=computed tomography; 
ECG=electrocardiogram; ECOG=Eastern Cooperative Oncology Group; EOT=end of treatment; MRI=magnetic resonance imaging; SAE=serious adverse event. 


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1 When patients complete the PK Phase of the study (at least 7 days from the beginning of PK period 2), they will be eligible to participate in the Extension 
Phase following re-review of selected entry criteria and completion of the screening assessments. If laboratory values are outside of the range specified in the 
inclusion criteria, the patient may continue to participate in the study at the discretion of the Sponsor and Investigator with consideration for a reduced dose.  
   Patients have 28 days to complete the screening assessments. The Screening Visit and Cycle 1/Day 1 Visit can occur on the same day dependent upon 
availability of radiographic results obtained ≤ 56 days of the first planned dose in the Extension Phase. 
2 The intent of the 7-day Day 1 window is to allow flexibility in scheduling; please note study drug is dispensed in 31-day increments. 
3  The EOT visit will occur within 7 days of the decision to discontinue study treatment for any reason. Patients who do not participate in the Extension Phase 
will also have an EOT visit within 7 days of the decision to discontinue study. Should the first dose of a new anti-cancer therapy occur within 14 days of the 
decision to discontinue study treatment, all assessments required for the Safety Follow-up visit should occur at the EOT visit and this visit will be considered 
the Safety Follow-up visit. If the first dose of the new anti-cancer therapy occurs >14 days of the decision to discontinue study, the Safety Follow-up visit will 
occur 30+7 days after the last dose of the study drug, or at the start of any new anti-cancer therapy, whichever occur first.   
4 CBC to include: Hemoglobin, Platelet count, Mean corpuscular volume, White blood cell count, Differential white blood cell count. CBC needs to obtained 
within 72 hrs prior to starting C1D1 of the Extension Phase and monthly for the next 10 months of niraparib treatment. CBC will be obtained periodically after 
this time to monitor for clinically significant changes in any hematological parameter during niraparib treatment. 
5 Chemistry to include: Sodium, Potassium, Magnesium, Chloride, Albumin, Calcium, Amylase, Phosphate, Glucose, Creatinine, Urea or blood urea nitrogen, 
Total protein, Lactate dehydrogenase, Total bilirubin, Alkaline phosphatase, Aspartate aminotransferase,  and Alanine aminotransferase. Chemistry needs to 
obtained within 72 hrs prior to starting C1D1 of the Extension Phase 
6 Need not be repeated if done within 72 hours of dosing Day 1. 
7 Tumor assessment to be performed prior to the first dose of the Extension Phase (pre-Extension Phase). The pre-Extension Phase tumor assessment need not be 
performed if the baseline tumor assessment was performed  ≤56 days before the first dose of the Extension Phase 
8 Tumor assessment via a CT or MRI scan of clinically indicated areas and evaluation of clinical signs and symptoms should be performed during the Extension 
Phase every three cycles (+/- 7 days) or per the Institution’s standard practice. The Investigator will evaluate the patient scans and clinical symptoms to 
evaluate disease status and progression, discontinue niraparib and initiate subsequent anticancer treatment as necessary. 
9 AEs will be collected and recorded for each patient from the time of randomization and/or treatment assignment until 30 days after the last dose of study drug. 
SAEs are required to be captured through 90 days after the last dose of study drug (or until the start of alternate anticancer therapy, whichever occurs first). All 
SAEs assessed by the Investigator as related to the study drug and AESIs will be collected and reported until study closeout (unless death or loss to follow-up 
occurs first). Any pregnancies that occur within 180 days post-treatment will be reported. All AEs and SAEs experienced by a patient, irrespective of the 
suspected causality, will be monitored until the AE or SAE has resolved, until abnormal laboratory values have returned to baseline or normalized, until there is 
a satisfactory explanation for the changes observed, until the patient is lost to follow-up, or until the patient has died. 
10 Vital signs include BP, pulse, heart rate, and temperature. BP and heart rate will be monitored weekly for the first 4 weeks of the Extension Phase and monthly 
thereafter. 
 


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7. 
SELECTION AND WITHDRAWAL OF PATIENTS 
7.1. 
Patient Inclusion Criteria 
7.1.1. 
Patient Inclusion Criteria (Stages 1 and 2) 
PK Phase: 
To be considered eligible to participate in this study, all of the following requirements must be 
met:  
1. Patient is capable of understanding the written informed consent, provides signed and 
witnessed written informed consent, and agrees to comply with protocol requirements. 
2. Patient has histologically or cytologically confirmed diagnosis of metastatic or locally 
advanced solid tumors that have failed to respond to standard therapy, has progressed 
despite standard therapy, or for which no standard therapy exists, and who may benefit 
from treatment with a PARP inhibitor as assessed by the Investigator. Patients with 
lymphoma are eligible. Patients with primary CNS malignancy are eligible provided they 
do not have new or progressive signs or symptoms, and are not requiring steroid dose 
exceeding the equivalent of 10 mg of prednisone daily. 
3. Patient is at least 18 years of age. 
4. Patient has an ECOG performance status of 0 to 2. 
5. Patient has adequate organ function as defined below (Note: CBC should be obtained 
without transfusion or receipt of CSFs, erythropoietin stimulating agents or platelet-
stimulating agents within 2 weeks before first dose): 
a. Absolute neutrophil count ≥1,500/µL 
b. Platelets ≥100,000/µL 
c. Hemoglobin ≥ 9 g/dL (5.6 mM) 
d. Serum creatinine ≤1.5× the upper limit of normal (ULN) or a calculated creatinine 
clearance ≥ 60 mL/min using the Cockcroft-Gault equation or 24-hour urine 
creatinine clearance. 
e. Total bilirubin ≤1.5× ULN except in patients with Gilbert’s syndrome. Patients with 
Gilbert’s syndrome may enroll if direct bilirubin ≤1.5× ULN of the direct bilirubin. 
f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN 
unless liver metastases are present, in which case, they must be ≤5× ULN 
6. Patient has recovered to baseline or Grade 1 toxicity from prior cancer therapy (a patient 
with Grade 2 neuropathy or Grade 2 alopecia or Grade 2 hypothyroidism on a stable dose 
of thyroid replacement are an exception to this criterion and may qualify for this study).  
For patients with hematologic, renal or hepatic toxicity from prior therapy, inclusion 
criterion #5 should be applied to determined eligibility. 
7. Patient is able to take oral medications. 
8. Female patient meets the following criteria: 


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a. Patient (of childbearing potential) is not breastfeeding, has a negative serum 
pregnancy test within 72 hours prior to taking study drug and agrees to abstain from 
activities that could result in pregnancy from Screening through 180 days after the 
last dose of study drug, or is of non-childbearing potential. Note: A urine pregnancy 
test may be performed if the serum pregnancy test is not available before dosing. 
b. Female patient is of non-childbearing potential (other than medical reasons) as 
defined by the following: 
i. 
≥45 years of age and has not had menses for >1 year). 
ii. 
Amenorrheic for <2 years without a hysterectomy and oophorectomy and a 
follicle-stimulating hormone value in the postmenopausal range upon 
Screening evaluation. 
iii. 
Had undergone a hysterectomy, bilateral oophorectomy, or tubal ligation. 
Documented hysterectomy, oophorectomy, or tubal ligation must be 
confirmed in the medical records; otherwise the patient must be willing to use 
highly effective contraception (see Appendix C) throughout the study starting 
from the Screening visit through 180 days after the last dose of study drug. 
Information must be captured appropriately within the site’s source 
documents. 
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
9. Male patient agrees to use an adequate method of contraception and not donate sperm 
starting with the first dose of study drug through 90 days after the last dose of study drug. 
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
7.1.2. 
Patient Inclusion Criteria (Stage 3 only) 
PK Phase:  
To be considered eligible to participate in this study, all of the following requirements must be 
met:  
1. Patient is capable of understanding the written informed consent, provides signed and 
witnessed written informed consent, and agrees to comply with protocol requirements. 
2. Patient has histologically or cytologically confirmed diagnosis of metastatic or locally 
advanced solid tumors that have failed to respond to standard therapy, has progressed 
despite standard therapy, or for which no standard therapy exists, and who may benefit 
from treatment with a PARP inhibitor as assessed by the Investigator. Patients with 
lymphoma are eligible. Patients with CNS malignancy are eligible provided they do not 
have new or progressive signs or symptoms and are not requiring steroid dose exceeding 
the equivalent of 10 mg of prednisone daily. 
3. Patient is at least 18 years of age. 
4. Patient has an ECOG performance status of 0 to 2. 
5. Patient has adequate organ function as defined below (Note: CBC should be obtained 
without transfusion or receipt of CSFs in the 1 week before obtaining sample.): 
a. Absolute neutrophil count ≥1,000/µL 


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b. Platelets ≥100,000/µL 
c. Hemoglobin ≥9 g/dL (5.6 mM) 
d. Serum creatinine ≤1.5× ULN or a calculated creatinine clearance ≥60 mL/min using 
the Cockcroft-Gault equation. 
e. Total bilirubin ≤1.5× ULN except in patients with Gilbert’s syndrome. Patients with 
Gilbert’s syndrome may enroll if direct bilirubin ≤1.5× ULN of the direct bilirubin. 
f. AST and ALT ≤2.5× ULN unless liver metastases are present, in which case, they 
must be ≤5× ULN 
6. Patient has recovered to baseline or Grade 1 toxicity from prior cancer therapy (a patient 
with Grade 2 neuropathy or Grade 2 alopecia or Grade 2 hypothyroidism on a stable dose 
of thyroid replacement are an exception to this criterion and may qualify for this study). 
For patients with hematologic, renal, or hepatic toxicity resulting from prior cancer 
therapy should meet inclusion criterion #5 for eligibility. 
7. Patient is able to swallow and retain  oral medication. 
8. Female patient meets the following criteria: 
a. Female patient (of childbearing potential) is not breastfeeding, has a negative serum 
pregnancy test within 72 hours prior to taking study drug, and agrees to abstain from 
activities that could result in pregnancy from Screening through 180 days after the 
last dose of study drug, or is of nonchildbearing potential. Note: A urine pregnancy 
test may be performed if the serum pregnancy test is not available before dosing. 
b. Female patient of nonchildbearing potential (other than medical reasons) is defined 
by the following: 
i. 
≥45 years of age and has not had menses for >1 year. 
ii. 
Amenorrheic for <2 years without a hysterectomy and oophorectomy and a 
follicle-stimulating hormone value in the postmenopausal range upon 
Screening evaluation. 
iii. 
Had undergone a hysterectomy, bilateral oophorectomy, or tubal ligation. 
Documented hysterectomy, oophorectomy or tubal ligation must be confirmed 
in the medical records, otherwise the patient must be willing to use highly 
effective contraception (see Appendix C) throughout the study, starting with 
the Screening Visit through 180 days after the last dose of study drug. 
Information must be captured appropriately within the site’s source 
documents. 
 
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
9. Male patient agrees to use an adequate method of contraception and not donate sperm 
starting with the first dose of study drug through 90 days after the last dose of study drug. 
Note: Abstinence is acceptable if this is the established and preferred contraception method 
for the patient. 
10. CNS inclusion - Based on screening brain magnetic resonance imaging (MRI), patients 
must have one of the following: 


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a. No evidence of brain metastases 
b. Untreated brain metastases not needing immediate local therapy 
c. Previously treated brain metastases not needing immediate local therapy 
d. Brain metastases previously treated with local therapy may either be stable since 
treatment or may have progressed since prior local CNS therapy 
e. Patients treated with CNS local therapy for newly identified lesions found on contrast 
brain MRI performed during screening for this study may be eligible to enroll if the 
following criteria are met: 
i. 
Time since whole brain radiation therapy (WBRT) is ≥21 days prior to first 
dose of study drug, time since stereotactic radiosurgery (SRS) is ≥7 days prior 
to first dose of study drug, or time since surgical resection is ≥28 days. 
ii. 
Other sites of disease assessable by Response Evaluation Criteria in Solid 
Tumors version 1.1 (RECIST v1.1) are present  
f. Relevant records of any CNS treatment must be available to allow for classification 
of target and non-target lesions 
11. Patient is able to eat a high-fat meal See Section 6.1.1. 
12. Patient is able to fast for a minimum of 10 hours before start of visit and for an additional 
4 hours after study visit. See Section 6.1.1. 
7.2. 
Patient Exclusion Criteria 
7.2.1. 
Patient Exclusion Criteria (Stages 1 and 2) 
PK Phase: 
Patients will not be eligible for study entry if any of the following criteria are met:  
1. Patient has a known hypersensitivity to the components of niraparib or excipients (please 
see Appendix B).  
2. Patient has a known diagnosis of immunodeficiency (Note: Patients with splenectomy are 
allowed).  
3. Patient has symptomatic uncontrolled brain or leptomeningeal metastases. To be 
considered “controlled,” the patient must have undergone treatment (e.g., radiation or 
chemotherapy) at least 1 month prior to study entry. The patient must not have any new 
or progressive signs or symptoms related to the central nervous system disease and must 
be taking ≤10 mg of prednisone or equivalent per day or no steroids.  
4. Patient underwent major surgery within 3 weeks of starting the study or patient has not 
recovered from any effects of any major surgery. 
5. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder; 
nonmalignant systemic disease; or active, uncontrolled infection. Examples include, but 
are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) 
myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord 
compression, superior vena cava syndrome, uncontrolled hypertension, active 
uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits 
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6. Female patient is pregnant or is expecting to conceive children while receiving study 
drug or for up to 180 days after the last dose of study drug. Male patient is expecting to 
donate sperm or father children while receiving study drug or for up to 90 days after the 
last dose of study drug. 
a. Female patient is breastfeeding or is expecting to breastfeed within 30 days of 
receiving final dose of study drug (women should not breastfeed or store breastmilk 
for use, during treatment and for 30 days after receiving the final dose of study 
treatment) 
7. Patient has a known history of myelodysplastic syndrome (MDS) or acute myeloid 
leukemia (AML). 
8. <THIS EXCLUSION HAS BEEN INTENTIONALLY LEFT BLANK.> 
9. Patient is unable to refrain from any intake of grapefruit or grapefruit juice within 7 days 
of the first administration of niraparib until 2 days post-dose (Does not apply for 
Extension Phase). 
10. Patient is currently taking any of the following P-glycoprotein (P-gp) inhibitors: 
amiodarone, azithromycin, captopril, carvedilol, clarithromycin, conivaptan, 
cyclosporine, diltiazem, dronedarone, erythromycin, felodipine, itraconazole, 
ketoconazole, lopinavir and ritonavir, quercetin, quinidine, ranolazine, ticagrelor, and 
verapamil, unless the dose and regimen has been stable for at least 14 days prior to first 
dose and will not change during PK periods 1 and 2 (Does not apply for Extension 
Phase). 
11. Patient taking proton pump inhibitors, antacids, or histamine 2 blockers unless the dose 
and regimen is stable for at least 14 days prior to first dose and will not change during PK 
periods 1 and 2.  Patients must hold these therapies starting within 8 hours prior to study 
drug administration until 9 hours after study drug administration (Does not apply for 
Extension Phase). 
12. Patient has gastric, gastro-esophageal or esophageal cancer; patient is unable to swallow 
orally administered medication; or patient has gastrointestinal disorders or significant 
gastrointestinal resection likely to interfere with the absorption of niraparib. 
13. Patient has known active hepatic disease (known hepatic cirrhosis, hepatitis B surface 
antigen-positive status, or suspected active hepatitis C infection). 
14. Patient has a past or current history of chronic alcohol use (3 or more drinks per day for 
the 30 days prior to the Screening Visit) or dependence or is unable to abstain from 
alcohol for the duration of the study. 
15. Patient has had a prior cytotoxic therapy or anticancer monoclonal antibodies (mAbs) 
within 14 days prior to start of PK Phase. There is no required washout for palliative 
radiation.  For targeted small anti-cancer molecules (e.g., tyrosine kinase inhibitors), the 
required washout is 5 half-lives of the start of PK Phase. Certain hormonal agents are 
allowed and are listed in Appendix D. For hormonal agents not listed in Appendix D, the 
Site must consult with the Sponsor regarding allowing patient on study. For patient taking 


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hormonal agents, dose and regimen of hormonal agents should have been stable for at 
least 14 days prior to first dose and is not expected to change during PK periods 1 and 2.  
16. Patient has significant pleural effusion or ascites that is expected to require drainage 
during the PK Phase (Does not apply for Extension Phase). 
7.2.2. 
Patient Exclusion Criteria (Stage 3 only) 
PK Phase:  
Patients will not be eligible for study entry if any of the following criteria are met:  
1. Patient has a known hypersensitivity to the components of niraparib or excipients (see 
Appendix B).  
2. Patient has a known diagnosis of immunodeficiency (Note: Patients with splenectomy are 
allowed)  
3. <THIS EXCLUSION HAS BEEN INTENTIONALLY LEFT BLANK.> 
4. Patient underwent major surgery within 3 weeks of starting the study or patient has not 
recovered from any effects of any major surgery. 
5. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder; 
nonmalignant systemic disease; or active, uncontrolled infection. Examples include, but 
are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) 
myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord 
compression, superior vena cava syndrome, uncontrolled hypertension, active 
uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits 
obtaining informed consent. 
6. Female patient is pregnant or is expecting to conceive children while receiving study 
drug or for up to 180 days after the last dose of study drug. Male patient is expecting to 
donate sperm or father children while receiving study drug or for up to 90 days after the 
last dose of study drug. 
a. Female patient is breastfeeding or is expecting to breastfeed within 30 days of 
receiving final dose of study drug (females should not breastfeed or store breastmilk 
for use, during treatment and for 30 days after receiving the final dose of study drug). 
7. Patient has a known history of MDS or AML. 
8. <THIS EXCLUSION HAS BEEN INTENTIONALLY LEFT BLANK.> 
9. Patient is unable to refrain from any intake of grapefruit or grapefruit juice within 7 days 
of the first administration of niraparib until 2 days postdose (Does not apply for 
participation in Extension Phase of this study). 
10. Patient is currently taking any of the following P-glycoprotein inhibitors: amiodarone, 
azithromycin, captopril, carvedilol, clarithromycin, conivaptan, cyclosporine, diltiazem, 
dronedarone, erythromycin, felodipine, itraconazole, ketoconazole, lopinavir and 
ritonavir, quercetin, quinidine, ranolazine, ticagrelor, and verapamil, unless the dose and 
regimen has been stable for at least 14 days prior to first dose and will not change during 
PK periods 1 and 2 (Does not apply for participation in Extension Phase of this study). 


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11. Patient is taking a proton pump inhibitor, antacids, or H2 blocker within 48 hours of dose 
(Does not apply for participation in Extension Phase of this study). 
12. Patient has gastric, gastroesophageal or esophageal cancer; patient is unable to swallow 
orally administered medication; patient has gastrointestinal disorders or significant 
gastrointestinal resection likely to interfere with the absorption of niraparib. 
13. Patient has known active hepatic disease (known hepatic cirrhosis, hepatitis B surface 
antigen positive status, or suspected active hepatitis C infection). 
14. Patient has a past or current history of chronic alcohol use (3 or more drinks per day for 
the 30 days prior to the Screening Visit) or dependence or is unable to abstain from 
alcohol for the duration of the study. 
15. <THIS EXCLUSION HAS BEEN INTENTIONALLY LEFT BLANK.> 
16. Patient has significant pleural effusion or ascites that is expected to require drainage 
during the PK Phase (Does not apply for participation in Extension Phase of this study). 
17. Patient is currently taking a lipase inhibitor or cholesterol absorption inhibitor, such as 
orlistat or ezetimibe, respectively.  (Does not apply for participation in Extension Phase 
of this study). 
7.3. 
Extension Study Patient Inclusion Criteria (Stage 1 and 2) 
 
To be considered eligible to participate in the Extension study, all of the following requirements 
must be met: 
1. Patient has an ECOG performance status of 0 to 2. 
2. Patient has adequate organ function as defined below; these criteria must be confirmed 
within 72 hours of dose 1 in Extension (Note: CBC should be obtained without 
transfusion or receipt of CSFs, erythropoietin stimulating agents or platelet stimulating 
factors within 2 weeks before first dose): 
a. Absolute neutrophil count ≥ 1,500/µL 
b. Platelets ≥ 100,000/µL 
c. Hemoglobin ≥ 9 g/dL (5.6 mM) 
d. Serum creatinine ≤1.5× the ULN or a calculated creatinine clearance ≥ 60 mL/min 
using the Cockcroft-Gault equation or 24-hour urine creatinine clearance 
e. Total bilirubin ≤1.5× ULN except in patients with Gilbert’s syndrome. Patients with 
Gilbert’s syndrome may enroll if direct bilirubin ≤1.5× ULN of the direct bilirubin. 
f. AST and ALT ≤2.5× ULN unless liver metastases are present, in which case, they 
must be ≤5× ULN 
Note:  If laboratory values at the beginning of Extension Phase are outside of the range 
specified above, the patient may continue to participate in the study only upon Sponsor 
approval and with consideration for an appropriately reduced dose.  


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3. Female patient meets the following criteria: 
a. Patient (of childbearing potential) is not breastfeeding, has a negative serum 
pregnancy test within 72 hours prior to taking study drug and agrees to abstain from 
activities that could result in pregnancy from Screening through 180 days after the 
last dose of study drug, or is of non-childbearing potential. Note: A urine pregnancy 
test may be performed if the serum pregnancy test is not available before dosing. 
b. Female patient of non-childbearing potential (other than medical reasons) is defined 
by the following: 
i. 
≥45 years of age and has not had menses for >1 year). 
ii. 
Amenorrheic for <2 years without a hysterectomy and oophorectomy and a 
follicle-stimulating hormone value in the postmenopausal range upon 
Screening evaluation. 
iii. 
Had undergone a hysterectomy, bilateral oophorectomy, or tubal ligation. 
Documented hysterectomy, oophorectomy, or tubal ligation must be 
confirmed in the medical records; otherwise the patient must be willing to use 
highly effective contraception (see Appendix C) throughout the study, starting 
from the Screening visit through 180 days after the last dose of study drug. 
Information must be captured appropriately within the site’s source 
documents. 
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
4. Male patient agrees to use an adequate method of contraception and not donate sperm 
starting with the first dose of study drug through 90 days after the last dose of study drug. 
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
7.3.1. 
Extension Study Patient Inclusion Criteria (Stage 3 only) 
 
To be considered eligible to participate in the Extension Phase, all of the following requirements 
must be met: 
1. Patient has an ECOG performance status of 0 to 2. 
2. Patient has adequate organ function as defined below; these criteria must be confirmed 
within 72 hours of dose 1 in the Extension Phase (should be obtained without transfusion 
or receipt of colony-stimulating factors in the 1 week before obtaining sample): 
a. Absolute neutrophil count ≥1,000/µL 
b. Platelets ≥100,000/µL 
c. Hemoglobin ≥9 g/dL (5.6 mM) 
d. Serum creatinine ≤1.5× ULN or a calculated creatinine clearance of ≥30 mL/min 
using the Cockcroft-Gault equation. 
e. Total bilirubin ≤1.5× ULN except in patients with Gilbert’s syndrome. Patients with 
Gilbert’s syndrome may enroll if direct bilirubin ≤1.5× ULN of the direct bilirubin. 
f. AST and ALT ≤2.5× ULN unless liver metastases are present, in which case, they 
must be ≤5× ULN 


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Note:  If laboratory values at the beginning of Extension Phase are outside of the range 
specified above, the patient may continue to participate in the study only upon Sponsor 
approval and with consideration for an appropriately reduced dose.  
3. Female patient meets the following criteria: 
a. Patient (of childbearing potential) is not breastfeeding, has a negative serum 
pregnancy test within 72 hours prior to taking study drug, and agrees to abstain from 
activities that could result in pregnancy from Screening through 180 days after the 
last dose of study drug, or is of nonchildbearing potential. Note: A urine pregnancy 
test may be performed if the serum pregnancy test is not available before dosing. 
b. Female patient of nonchildbearing potential (other than medical reasons) is defined 
by the following: 
i. 
≥45 years of age and has not had menses for >1 year). 
ii. 
Amenorrheic for <2 years without a hysterectomy and oophorectomy and 
a follicle-stimulating hormone value in the postmenopausal range upon 
Screening evaluation. 
iii. 
Had a hysterectomy, bilateral oophorectomy, or tubal ligation. 
Documented hysterectomy, oophorectomy or tubal ligation must be 
confirmed in the medical records, otherwise the patient must be willing to 
use highly effective contraception (see Appendix C) throughout the study, 
starting with the Screening Visit through 180 days after the last dose of 
study drug. Information must be captured appropriately within the site’s 
source documents. 
 
Note: Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
4. Male patient agrees to use an adequate method of contraception and not donate sperm 
starting with the first dose of study drug through 90 days after the last dose of study drug. 
Note: Abstinence is acceptable if this is the established and preferred contraception method 
for the patient. 
7.4. 
Patient Withdrawal Criteria 
7.4.1. 
Discontinuation from Pharmacokinetic Phase 
Patients may be discontinued from the PK Phase of the study at any time. Specific reasons for 
discontinuing include the following: 
• Unacceptable toxicity  
• Vomiting within 10 hours of dose administration 
• Loss to follow up 
• Disease progression per Investigator’s discretion  
• It is in the best interest of the patient as judged by the Investigator and/or Sponsor 


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• Severe noncompliance with the protocol as judged by the Investigator and/or Sponsor  
or other reasons that would make the collected PK data non-evaluable, to include but 
not limited to: 
− Dosing errors  
− Patient did not fast for a minimum of 10 hours before and for 4 hours after either 
dosing period  
− Significant changes to the patient’s medical status that would potentially affect 
the PK profile as determined by the Sponsor in consultation with the Investigator 
prior to data analysis. 
• Withdrawal of consent 
− Note: All reasonable efforts should be made to encourage patients to remain on 
study even if they withdraw from treatment. 
• Patient becomes pregnant 
• Sponsor decision to terminate study 
• Death 
Those patients deemed to derive clinical benefit from niraparib treatment at the time of final 
analysis will have the option to continue treatment with niraparib through an alternative study, if 
available, and at the discretion of the Investigator and Sponsor. 
Patients who discontinued from the PK Phase of the study and discontinue niraparib treatment 
prior to the Extension Phase will continue to receive safety follow-up assessments 
(Section 6.6.1) as part of the study unless they are discontinued from the study. 
7.4.2. 
Discontinuation from Treatment During Extension Phase 
Patients may be discontinued from the study drug at any time. Specific reasons for discontinuing 
include the following: 
• Unacceptable toxicity that cannot be managed by dose modifications 
• Loss to follow up 
• Disease progression per Investigator’s discretion  
• It is in the best interest of the patient as judged by the Investigator and/or Sponsor 
• Severe noncompliance with the protocol as judged by the Investigator and/or Sponsor  
• Withdrawal of consent 
− Note: All reasonable efforts should be made to encourage patients to remain on 
study even if they withdraw from treatment. 
• Patient becomes pregnant 
• Sponsor decision to terminate study 
• Death 


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Details of any required niraparib dose modifications, including interruptions, dose reductions, 
and permanent discontinuations, related to toxicity, are provided in Section 6.4. 
Patients who discontinue from treatment will continue to receive follow-up assessments 
(Section 6.6.1) as part of the study unless they are discontinued from the study. 
7.4.3. 
Discontinuation from the Study 
Patients may be discontinued from the study for any of the following reasons: 
• Completion of the required safety follow up 
• Withdrawal of consent by the patient, who is at any time free to discontinue their 
participation in the study 
• Death 
• Loss to follow-up 
• Sponsor decision to terminate study 
If a patient is lost to follow-up, attempts should be made to contact the patient to determine the 
reason for discontinuation. For patients who are lost to follow-up, at least 3 documented 
attempts, including one via certified mail, should be made to contact the patient before 
considering the patient lost to follow-up. 
7.4.4. 
Replacement of Patients 
Patients will not be replaced during Stage 1. During Stages 2 and 3, the non-evaluability rate 
arising during the study conduct will be continuously monitored by the Sponsor and the total 
number of enrolled patients may be adjusted accordingly.  
7.5. 
Restrictions During Study 
Restrictions during the study include the following: 
1. No other anticancer therapy is permitted during the course of study drug for any patient. 
If the patient discontinues study drug, this restriction no longer applies. Palliative 
radiotherapy is allowed for preexisting small areas of painful metastases that cannot be 
managed with local or systemic analgesics as long as no evidence of disease progression 
is present. Hormonal therapy is allowed provided an agent listed in Appendix D is used.  
For hormonal agents not listed in Appendix D, the Site must consult with the Sponsor 
regarding allowing patient on study. For patient taking hormonal agents, dose and 
regimen of hormonal agents should have been stable for at least 14 days prior to first dose 
and is not expected to change during PK periods 1 and 2.   
2. An increased risk of infection with the administration of live virus and bacterial vaccines 
has been observed with conventional chemotherapy drugs. Effects with niraparib are 
unknown, so live virus and bacterial vaccines should not be administered to patients in 
the study. 
3. P-glycoprotein inhibitors: amiodarone, azithromycin, captopril, carvedilol, 
clarithromycin, conivaptan, cyclosporine, diltiazem, dronedarone, erythromycin, 


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felodipine, itraconazole, ketoconazole, lopinavir and ritonavir, quercetin, quinidine, 
ranolazine, ticagrelor, and verapamil are not permitted per protocol unless the dose and 
regimen has been stable for at least 14 days prior to first dose and will not change during 
PK periods 1 and 2 (does not apply for Extension Phase). 
4. Patient taking proton pump inhibitors, antacids, or H2 blocker within 48 of dose (Does 
not apply for Extension Phase). 
5. Patients who are blood donors should not donate blood during the study and for 90 days 
after the last dose of study drug. 
6. Patients must be able to fast for 10 hours before and 4 hours after dosing in the 2 PK 
dosing periods. 
7. Patients must avoid alcohol intake during the PK portion of the study.  
8. Grapefruit and grapefruit juice is not allowed 7 days before or 2 days after dosing in the 
PK portion of the study (does not apply for Extension Phase). 
9. Administration of blood or platelet transfusion should be avoided during the PK 
Phase. Should administration of blood products or other colloid solutions become 
necessary during the PK Phase the site must contact the Sponsor to discuss timing of 
blood (or other product) administration in relation to the timing of PK sampling. 
10. Patient is currently taking a lipase inhibitor or cholesterol absorption inhibitor, such as 
orlistat or ezetimibe, respectively.  (Does not apply for participation in Extension Phase 
of this study). 
7.5.1. 
Lifestyle Considerations  
Cases of photosensitivity have been reported for patients on niraparib treatment. Participants 
must be informed on measures to decrease exposure to ultraviolet light, such as minimizing time 
in direct sunlight unless wearing hats and long-sleeves and application of sun protection creams. 


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8. 
TREATMENT OF PATIENTS 
8.1. 
Description of Study Drug 
Table 9: 
Investigational Product 
 
Investigational Product 
 
Stage 1 and Stage 2 
Stage 3 
Product Name: 
Niraparib 
Niraparib 
Niraparib 
Dosage Form: 
Capsule 
Tablet 
Tablet 
Unit Dose 
100 mg per capsule 
300 mg per tablet  
200 mg per tablet  
100 mg per tablet 
[200 mg and 100 mg 
tablets for use in 
Extension Phase] 
300 mg per tablet for 
both PK periods 
100 mg per tablet  for 
Extension Phase 
 
Route of 
Administration 
Oral 
Oral 
Oral 
Physical  
Description 
Capsules may be 
packaged in high-density 
polyethylene bottles with 
child-resistant closures or 
in blister cards 
Tablets will be packaged 
in high-density 
polyethylene bottles 
Tablets will be 
packaged in high 
density polyethylene 
bottles with child 
resistant closures 
8.2. 
Concomitant Medications 
Any medication the patient takes during the study other than the study drugs, including herbal 
and other nontraditional remedies, is considered a concomitant medication. All concomitant 
medications must be recorded in the eCRF. The following information must be recorded in the 
eCRF for each concomitant medication: generic name, route of administration, start date, stop 
date, dosage, and indication. Any changes in the dosage or regimen of a concomitant medication 
must be also recorded in the eCRF. 
At Screening Visit, patients will be asked what medications they have taken during the last 
30 days. At each subsequent study visit, patients will be asked what concomitant medications 
they are currently taking or have taken since the previous visit. 
8.2.1. 
Permitted Concomitant Medications 
Denosumab and bisphosphonates are allowed while on study. 
Prophylactic antiemetics are allowed while on study. Should they be used, the same antiemetic 
prophylaxis MUST be administered in conjunction with Days 1 and 15 niraparib dosing in the 
PK Phase and within the same time interval from niraparib administration.  


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8.2.2. 
Concomitant Medications Taken with Caution 
Niraparib weakly induces cytochrome P450 (CYP)1A2 in vitro and is an insensitive substrate for 
P-glycoprotein (P-gp); therefore, investigators should be advised to use caution with drugs that 
are the sensitive substrates for CYP1A2 with a narrow therapeutic range, i.e. theophylline and 
tizanidine. 
8.3. 
Contraception 
Niraparib is known to have properties that require the female patient of childbearing potential to 
use a highly effective form of contraception. For details on contraceptive guidelines, please refer 
to Appendix C. 
Male patients must use an adequate method of contraception and not donate sperm starting with 
the first dose of study drug through 90 days after the last dose of study drug (Table 10). For a 
non-pregnant woman of childbearing potential partner, contraception recommendations should 
also be considered. Abstinence is acceptable if this is the established and preferred contraception 
method for the patient. 
Patients should be informed that taking the study drug may involve unknown risks to the fetus if 
pregnancy were to occur during the study. In order to participate in the study, both male and 
female patients must adhere to the contraception requirement (described above) for the duration 
of the study and through 90 and 180 days, respectively, after the last study drug. This applies to 
female study patients and partners of male study patients. If there is any question that a patient 
will not reliably comply with the requirements for contraception, that patient should not be 
entered into the study. 
Table 10: Timing of Contraception and Sperm Donation 
Parameter 
Timeframe 
Contraception use, female patients 
Starting with the Screening Visit through 180 days 
after the last dose of study drug 
Contraception use, male patients 
Starting with the first dose of study drug through 
90 days after the last dose of study drug 
Sperm donation 
Starting with the first dose of study drug through 
90 days after the last dose of study drug 
8.4. 
Treatment Compliance 
Compliance with inclusion and exclusion criteria will be assessed as outlined in Section 7.1 
and Section 7.2, respectively. 
Niraparib will be administered by site personnel at study sites as detailed in Section 9.5. 
Study drug accountability will be monitored as detailed in Section 9.6.  


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9. 
STUDY DRUG MATERIALS AND MANAGEMENT 
9.1. 
Study Drug 
Niraparib is a PO available, potent, highly selective PARP1 and PARP2 inhibitor. The excipients 
for niraparib are lactose monohydrate and magnesium stearate. Niraparib will be supplied as 
100 mg capsules and 300, 200, and 100 mg tablets.  
9.2. 
Study Drug Packaging and Labeling 
Niraparib 100 mg capsules may be packed in high-density polyethylene bottles with 
child-resistant closures or in blister cards.  
Niraparib 100 mg, 200 mg and 300 mg tablets will be provided in high-density polyethylene 
bottles. Additional information on packaging can be found in the Pharmacy Manual.  
The label text of the study drug will comply with Good Manufacturing Practice and the national 
legislation to meet the requirements of the United States. The study drug will be open-label and 
nonpatient-specific. 
9.3. 
Study Drug Storage 
All study drug supplies must be stored in accordance with the Pharmacy Manual instructions and 
package labeling. Until dispensed or administered to the patients, the study drug will be stored in 
a securely locked area, accessible to authorized personnel only. 
The pharmacist will dispense study drug for each patient according to the protocol and Pharmacy 
Manual, if applicable. 
9.4. 
Study Drug Administration 
The Pharmacy Manual contains descriptions of the packaging of study drug and instructions for 
administration of study drug.  
9.5. 
Administration 
Niraparib as 100 mg capsules and 300, 200, and 100 mg tablets will be supplied (Table 9). In the 
Stage 1 and 2 PK Phases, patients will receive a single dose (300 mg) of the study drug 
(tablet [1× 300 mg] or capsule [3× 100 mg]) in a fasted state (see Section 6.1.1) followed by a 7-
day (+1 day) for Stage 1 of the study and a 14-day (+/- 4 days) Washout/PK period for Stage 2 of 
the study, followed by a dose of the alternate formulation (patients receiving tablets in the first 
treatment period will receive the capsule in the second treatment period and vice versa).  
For Stage 3 during period 1, patients will receive a single 300 mg niraparib tablet either 
following a 10 hour fast or directly following consumption of a high-fat meal followed by a 14-
day (+4 days) PK sampling and washout period. In period 2, patients will be crossed over to 
receive a single 300 mg niraparib tablet in a fasted state or with a high-fat meal (see 
Section 6.1.1), followed by a 7-day PK sampling period. Patients receiving the tablet in a fasted 
state in the first treatment period will receive the tablet with a high-fat meal in the second 
treatment period and vice versa.  


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In the Extension Phase, the starting dose of niraparib will be based on the patient’s baseline 
actual body weight or platelet count. Patients with a baseline actual body weight of ≥77 kg and 
screening platelet count of ≥150,000/µL will take one 300 mg strength tablet or 3 x 100 mg 
tablets/capsules at each dose administration. Patients with a baseline actual body weight of <77 
kg or screening platelet count of <150,000/µL will take one 200 mg strength tablet or 2 x 100 mg 
tablets/capsules at each dose administration. For patients whose initial starting dose is 200 mg 
QD, escalation to 300 mg once daily is permitted if no treatment interruption or discontinuation 
was required during the first 2 cycles of Extension Phase therapy and with Sponsor’s approval. 
Additional dose modifications will not be based upon changes in the patient’s actual body weight 
during study participation. If laboratory values at the beginning of Extension Phase are outside of 
the range specified in the inclusion criteria, the patient may continue to participate in the study 
only upon Sponsor approval and with consideration for an appropriately reduced dose. Should a 
patient start the Extension Phase at 100 mg, consideration may be given to escalate to 200 mg 
after 2 cycles of therapy if no treatment interruption or discontinuation was required during the 
first 2 cycles of Extension Phase therapy and after approval from the Sponsor.   
9.6. 
Study Drug Accountability 
Accountability of the investigational study drugs is under the responsibility of the Investigator 
and can be delegated to an appropriately qualified person. 
Study drug accountability should be maintained by each site based on investigational study drug 
dispensed versus returned to the clinic at each visit and the number days since last visit. 
Details of maintaining drug accountability, including information on the accountability log, will 
be provided in the Pharmacy Manual. 
All dispensation and accountability records will be available for Sponsor review. The study 
monitor will assume the responsibility to reconcile the study drug accountability log. The 
pharmacist will dispense study drug for each patient according to the protocol and Pharmacy 
Manual, if applicable. 
9.7. 
Study Drug Handling and Disposal 
At the end of study, when all patients have stopped protocol treatment, complete drug 
reconciliation per batch should be available at the site for verification in order to allow drug 
destruction or return procedure. After receiving Sponsor approval in writing, the investigational 
site is responsible for destruction of study drug according to local regulations. If a site does not 
have the capability for onsite destruction, the Sponsor will provide a return for destruction 
service to a third party. Both the unused and expired study drug must be destroyed, upon 
authorization of the Sponsor, according to local regulations and procedures, and a copy of the 
destruction form must be filed in the study binder. 
The medication provided for this study is to be used only as indicated in this protocol and only 
for the patients entered in this study. 


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11. 
ASSESSMENT OF SAFETY 
11.1. 
Safety Parameters 
Safety parameters evaluated during the conduct of the study will include treatment-emergent 
adverse events (TEAEs), discontinuations due to AEs, physical examinations, vital signs, clinical 
laboratory results, and use of concomitant medications. All AEs will be coded using the current 
version of the Medical Dictionary for Regulatory Activities (MedDRA) coding system. 
11.1.1. 
Demographics and Baseline Characteristics 
Demographics and baseline characteristics consist of those variables that are assessed at 
screening/baseline. 
11.1.2. 
Patient Eligibility 
Compliance with inclusion and exclusion criteria will be assessed as outlined in Section 7.1 and 
Section 7.2. 
11.1.3. 
Patient Demography 
Patient demography consists of age at screening, race, ethnicity, and sex. 
11.1.4. 
Disease History 
The following will be documented for disease history, if available: 
• Primary Cancer diagnosis 
• Date of first diagnosis 
• Stage of disease at enrollment (local versus metastatic) 
• Information on prior neoadjuvant/adjuvant treatment, if applicable: 
− Agents used in treatment 
• Information on previous anticancer treatments: 
− Agents in all subsequent treatments 
• Best response for each line of therapy  
11.1.5. 
Medical and Surgical History 
Major medical and surgical history (including medication history), including history of 
thrombocytopenia, neutropenia, leukopenia, or anemia will be collected, if available. Details of 
any prior malignancy will be collected if available. Medical and surgical history will be obtained 
by interviewing the patient or by reviewing the patient’s medical records. 
11.1.6. 
Vital Signs 
Vital signs (blood pressure [BP], pulse, heart rate, and temperature) will be assessed according to 
the schedule of events (Section 6.6.1).  


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Body weight and height will be assessed during screening according to the schedule of events 
(Section 6.6.1). 
11.1.7. 
Physical Examination 
A complete physical examination and symptom-directed physical examination will be performed 
in accordance with the schedule of events. 
11.1.8. 
Concomitant Medications and Procedures 
Refer to Section 8.2 for a description of prior and concomitant medications. For prior 
medications, patients will be asked during the Screening Visit for the PK Phase and the 
Extension Phase what medications they have taken during the last 30 days. All concomitant 
medications will be recorded from the time the patient signs the ICF through completion of the 
study. Medications will be coded according to the most current version of the World Health 
Organization Drug Dictionary. 
11.1.9. 
Electrocardiogram 
All patients will undergo 12-lead ECGs in accordance with the schedule of events 
(Section 6.6.1). ECGs should be performed prior to blood draws. Patients will be rested for 
approximately 2 minutes before ECGs are recorded. 
11.1.10. 
Laboratory Assessments 
The hematology, chemistry, urinalysis, and pregnancy screening will occur in accordance with 
the schedule of events (Section 6.6.1 ). These tests will be performed by the local laboratory at 
the clinical site. 
11.1.10.1. Hematology 
Hematology will be measured in accordance with the Schedule of Events (Section 6.6.1). The 
following values will be obtained/analyzed: 
• CBC: 
− Hemoglobin 
− Platelet count 
− Mean corpuscular volume 
− White blood cell count 
− Differential white blood cell count 
11.1.10.2. Chemistry 
Chemistry will be assessed in accordance with the Schedule of Events (Section 6.6.1 ). The 
following values will be obtained/analyzed: 


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• Sodium 
• Total bilirubin 
• Potassium 
• Alkaline phosphatase 
• Chloride 
• Aspartate aminotransferase 
• Creatinine 
• Alanine aminotransferase 
• Urea or blood urea nitrogen 
• Glucose  
• Total protein  
• Albumin 
• Calcium  
• Amylase 
• Phosphate 
• Magnesium 
• Lactate dehydrogenase  
11.1.10.3. Urinalysis 
Urinalysis will be assessed in accordance with the Schedule of Events (Section 6.6.1). The 
following values will be obtained/analyzed: 
• Specific gravity 
• Protein 
• Leukocyte esterase 
• Glucose 
• Nitrite 
• Ketones 
• Blood 
• Bilirubin 
11.1.10.4. Virus Serology 
Not applicable. 
11.1.10.5. Drug Screen 
Not applicable. 
11.1.10.6. Pregnancy Screen 
A negative serum or urine pregnancy test is required within 72 hours prior to first dose of study 
drug for PK period 1 and first dose of Extension Phase for females of childbearing potential. 
Urine pregnancy testing will be performed in accordance with the schedule of events 
(Section 6.6.1).  
11.1.10.7. Eastern Cooperative Oncology Group Performance Status 
Performance status will be assessed using the ECOG scale (see Appendix A) in accordance with 
the schedule of events (Section 6.6.1). The same observer should assess performance status each 
time. 


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11.2. 
Adverse Events and Special Situations 
11.2.1. 
Definitions  
11.2.1.1. Adverse Event (AE) 
Any untoward medical occurrence in a patient or clinical investigation subject administered a 
medicinal product and which does not necessarily have to have a causal relationship with this 
treatment. An AE can therefore be any unfavorable and unintended sign (including a clinically 
significant abnormal laboratory finding, for example), symptom, or disease temporally 
associated with the use of study treatment, whether or not considered related to the product.  
AEs may include the onset of new illness and the exacerbation of pre-existing medical 
conditions. An AE can include an undesirable medical condition occurring at any time after the 
time of randomization and/or treatment assignment, including baseline or washout periods, even 
if no study treatment has been administered (see Section 11.2.3 for information about AE 
collecting and reporting.) 
11.2.1.2.  Serious Adverse Event (SAE) 
Any untoward medical occurrence that, at any dose; 
• Results in death;  
• Is life threatening (i.e., an event in which the patient was at risk of death at the time of 
the event; it does not refer to an event that hypothetically might have caused death if 
it were more severe);  
• Requires inpatient hospitalization* or prolongation of existing hospitalization;  
• Results in persistent or significant disability/incapacity;  
• Is a congenital anomaly/birth defect; or 
• Is an important medical event** 
*Exception: Preplanned (at time of informed consent) hospitalization for elective procedures, for 
protocol compliance or social reasons, or for observation will not be considered criteria for an 
SAE. The reason for the planned hospitalization should be captured in medical history section in 
the eCRF. Complications experienced during these hospitalizations must be reported as AEs (or 
SAEs, if hospitalization is prolonged due to the AE).  
**Medical and scientific judgment should be exercised in determining whether situations or 
events should be considered serious adverse events: an important medical event may not be 
immediately life-threatening or result in death or require hospitalization but may jeopardize the 
patient or require intervention to prevent one of the above outcomes. Examples of such events 
are allergic bronchospasm, blood dyscrasias, or convulsions that may require intensive treatment 
in an emergency room or at home but do not result in hospitalization, development of drug 
dependency or drug abuse, and transmission of disease associated with the administration of the 
study drug. (See Section 11.2.5 for information about SAE reporting.)  


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11.2.1.3. Treatment-Emergent Adverse Event (TEAE) 
Any event that was not present prior to the initiation of study treatment or any event already 
present that worsens in either intensity or frequency following exposure to study treatment. 
11.2.1.4. Adverse Events of Special Interest (AESI) 
Any AE (serious or non-serious) that is of scientific and medical concern specific to the study 
treatment, for which ongoing monitoring and rapid communication by the Investigator to the 
Sponsor is appropriate.  
11.2.1.5. Special Situation: Abuse, Misuse, Medication Errors, Overdose, and Accidental 
or Occupational Exposure 
• Abuse: is the persistent or sporadic, intentional excessive use of the study treatment 
which is accompanied by harmful physical or psychological effects.  
• Misuse: medicinal product is intentionally and inappropriately used not in accordance 
with the authorized/approved product information. 
• Medication error: is any preventable incident that may cause or lead to inappropriate 
study treatment use or patient harm while the study treatment is in the control of the 
health care professionals or patients. Such incident may be due to health care 
professional practice, product labeling, packaging and preparation, procedures for 
administration, and systems, including the following: prescribing, order 
communication, nomenclature, compounding, dispensing, distribution, 
administration, education, monitoring, and use. 
• Overdose: is a deliberate or accidental administration of study treatment to a study 
patient, at a dose greater than that which was assigned to that patient per the study 
protocol and under the direction of the Investigator. If an overdose occurs, the 
Investigator and the Sponsor should be notified immediately, and the patient should 
be observed closely for AEs. Associated AEs should be treated and monitored by the 
Investigator. The dosage of study drug administered, any associated AEs, and/or 
treatment provided to the patient because of the overdose, should be documented on 
the applicable sections within the eCRF. An overdose (including an AE or SAE 
resulting from the overdose, if any) will be reported as described in Section 11.2.5. 
• Accidental /Occupational exposure: is the unintentional exposure to a study 
treatment as a result of one’s professional or non-professional occupation, or 
accidental exposure to a non-professional to whom exposure was not intended (i.e., 
study product given to wrong patient). 
Reporting Special Situations: All occurrences of abuse, misuse, medication error, overdose, and 
accidental or occupational exposure with any study treatment must be reported on an SAE 
Report Form [or designated Special Form] to the Sponsor regardless of whether or not an AE or 
SAE has occurred. If the abuse, misuse, medication error, overdose, or accidental / occupational 
exposure is associated with an SAE, an SAE report form must be submitted to the Sponsor 
within 24 hours of awareness. If there is no AE or SAE, the occurrence must be submitted on the 
designated Special Form (indicate ‘no AE has occurred’) as soon as possible. 


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11.2.2. 
Assessment of Adverse Events 
11.2.2.1. Severity Assessment 
All AEs will be assessed by the Investigator for severity according to Common Terminology 
Criteria for Adverse Events (CTCAE) v4.03: 14 June 2010; National Institutes of Health (NIH), 
National Cancer Institute (NCI). The CTCAE severity grades 1 through 5 provide unique clinical 
descriptions of severity of each adverse event. The CTCAE v4.03 is available on the NCI/NIH 
website. 
Please note that there is a distinction between serious and severe AEs. Severity is a measure of 
intensity whereas seriousness is defined by the criteria in Section 11.2.1.2. For example, a mild 
degree of gastrointestinal bleeding requiring an overnight hospitalization for monitoring 
purposes may be considered an SAE but is not necessarily severe. 
11.2.2.2. Relationship to Study Intervention 
The Investigator must provide a causality assessment regarding the relationship of the event with 
the study drug and/or study procedure for all AEs. One of the following categories should be 
selected based on medical judgment, considering all contributing factors: 
• Related: A causal relationship between the medicinal product (and/or study 
procedures) and AE is a reasonable possibility. For example, the occurrence of the 
AE cannot be explained by other causative factors. The AE, however, can be 
explained by pharmacological effect of the medicinal product such as a similar event 
having been reported previously, alteration of the dose effect, or the timing or 
seriousness of the AE, etc. Positive rechallenge/dechallenge is supportive.  
• Not Related: A causal relationship between the medicinal product (and/or study 
procedures) and AE is not a reasonable possibility: there is no temporal relationship 
between the medicinal product and event, or an alternative etiology is more 
reasonable.  
11.2.2.3. Expectedness 
The Sponsor will be responsible for determining whether an adverse event is ‘expected’ or 
‘unexpected’. An AE will be considered unexpected if the nature, severity, or frequency of the 
event is not consistent with the risk information provided in the Reference Safety Information of 
the effective niraparib Investigator Brochure (IB). 
11.2.3. 
Collection and Recording of Adverse Events 
AEs may be volunteered spontaneously by the study patient, or discovered by the study staff 
during physical examinations or by asking an open, nonleading question such as, “How have you 
been feeling since your last study visit?” The Investigator will document the nature of AE, date 
of onset of the AE (and time, if known), date of outcome of the AE (and time, if known), 
severity of the AE, action taken with study drug as a result of the AE, assessment of the 
seriousness of the AE, and assessment of the causal relationship of the AE to study drug and/or 
study procedure. 


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AEs, including laboratory abnormalities that are assessed as clinically significant or require 
intervention, should be described using a diagnosis whenever possible, rather than individual 
underlying signs and symptoms. When a clear diagnosis cannot be identified, each sign or 
symptom should be recorded as a separate AE. 
All SAEs will be collected from the signing of the ICF for this study through 90 days after the 
last dose of study drug (or until the start of alternate anticancer therapy, whichever occurs first), 
and recorded in the eCRF. SAEs will also be reported on an SAE form as described in 
Section 11.2.5 of this protocol. SAEs considered by the Investigator to be related to study 
medication are reported until study closeout.  
All AEs, regardless of the source of identification (e.g., physical examination, laboratory 
assessment, ECG, or reported by patient), will be collected and recorded in the eCRF for each 
patient from the time of randomization and/or treatment assignment until 30 days after the last 
dose of study drug. 
Concomitant illnesses that existed before entry into the study will not be considered AEs unless 
the illness worsens during the Treatment Period. Pre-existing conditions will be recorded as 
Medical History in the eCRF and on the SAE Report Form. 
Disease progression is an efficacy criterion and is therefore not considered an AE or SAE (even 
if fatal). Disease progression should be reported within the appropriate eCRF. If AEs/SAEs 
occur in relation to disease progression that are not consistent with the natural progression of the 
patient’s disease, these AEs/SAEs must be reported per AE/SAE reporting requirements 
described in Section 11.2.5. 
11.2.4. 
Follow-Up of Adverse Events 
All AEs experienced by a patient, regardless of the suspected causality, will be monitored until 
the AE or SAE has resolved, until AE(s) or SAE(s) have returned to baseline or normal levels, 
until stabilized with a satisfactory explanation for the changes observed, until the patient is lost 
to follow-up, or until the patient has died, starts alternate anti-cancer therapy, or until the patient 
withdraws consent.  
If an Investigator becomes aware of an SAE after the specified follow-up period and considers 
the SAE related to the study drug, the Investigator should report the SAE to the Sponsor 
according to timelines for reporting SAEs described in Section 11.2.5. 
11.2.5. 
Reporting  
The Investigator must report all SAEs, and all follow up information to the Sponsor on an SAE 
Report Form within 24 hours of becoming aware of the initial event or follow-up information. 
The Investigator must provide a causality assessment and must sign and date all SAE Report 
Forms. 
It is the responsibility of the Investigator to review source documentation and describe pertinent 
information on the SAE Report Form. If supporting documentation is requested (e.g., hospital 
reports, consultant reports, death certificates, autopsy reports, etc.), the Investigator should 
highlight all relevant and pertinent information within such documents, ensure that any patient’s 
personal identifiers (including Medical Record number) are removed, and submit the documents 


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with the SAE Form to the Sponsor. The Sponsor (or designee) will return a confirmation of 
receipt for all email reports (if received from other than a “no reply” domain) within 1 business 
day.  
The minimum information required for an initial SAE report is: 
• Name of person sending the report (ie, name, address of Investigator) 
• Patient identification (screening/randomization number, initials [if permitted by local 
data privacy regulations], NOT patient name) 
− Protocol number 
• Description of SAE with diagnosis if possible 
− Causality assessment 
− Seriousness assessment 
The Sponsor (or designee) will confirm receipt of all email reports (as long as the email is not 
coming from “no reply” domain) within 1 business day. 
SAE REPORTING CONTACT INFORMATION  
 Email: OAX37649@gsk.com 
 Fax: +44(0) 208754 7822 
After receipt of the initial report, the Sponsor (or designee) will review the information and, if 
necessary, contact the Investigator to obtain further information. The Investigator must promptly 
respond to queries from the Sponsor. 
11.2.6. 
Submission and Distribution of Serious Adverse Event Reports 
Per regulatory requirements, if an event is assessed by the Sponsor as a Serious Unexpected 
Adverse Reaction (SUSAR), it is the responsibility of the Sponsor to submit the SUSAR to 
Regulatory Authorities according to applicable regulations. 
In addition, the SUSAR will be distributed to the Investigators/sites, utilizing a Council for 
International Organizations of Medical Sciences (CIOMS) report form, or the MedWatch 3500A 
form). The Investigator/site will submit a copy of the report to their respective Institutional 
Review Board (IRB) or Independent Ethics Committee (IEC) per the governing institutional 
requirements and in compliance with local laws and guidelines. 
11.2.7. 
Adverse Events of Special Interest 
Adverse Events of Special Interest (AESI) for niraparib are the following:  
• Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) 
• Secondary cancers (new malignancies [other than MDS or AML]) 
AESI should be collected and reported as follows: 
• MDS and AML along with other secondary cancers should be reported to the Sponsor 
until study closeout (unless death or loss to follow-up occurs first). 
•  


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11.2.8. 
Hypertension, Including Hypertensive Crisis 
Hypertension, including hypertensive crisis, has been reported with the use of niraparib. 
Preexisting hypertension should be adequately controlled before starting niraparib treatment. 
While receiving treatment, hypertension should be medically managed with antihypertensive 
medicinal products with or without niraparib dose adjustment.  
BP and heart rate should be monitored at least weekly for the first 2 months of niraparib 
treatment in the maintenance setting, then monthly for the first year and periodically thereafter 
during treatment with niraparib. Niraparib should be discontinued in case of hypertensive crisis 
or if medically significant hypertension cannot be adequately controlled with antihypertensive 
therapy. 
11.2.9. 
Posterior Reversible Encephalopathy Syndrome 
There have been rare reports of niraparib-treated patients developing signs and symptoms that 
are consistent with posterior reversible encephalopathy syndrome (PRES). PRES is a rare 
neurologic disorder that can present with the following signs and symptoms including seizures, 
headache, altered mental status, visual disturbance, or cortical blindness, with or without 
associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, 
preferably MRI. In patients developing PRES, treatment of specific symptoms including control 
of hypertension is recommended, along with discontinuation of niraparib. The safety of 
reinitiating niraparib therapy in patients previously experiencing PRES is not known. 
11.2.10. 
Allergic Reaction 
Niraparib capsules contain tartrazine, which may cause allergic-type reactions. 
11.2.11. 
Pregnancy 
The Investigator must report all pregnancies and the outcomes to the Sponsor. The Sponsor has 
the responsibility to monitor the outcome of all pregnancies reported during the clinical study. 
Each pregnancy must be reported by the Investigator to the Sponsor on an Initial Pregnancy 
Report Form within 24 hours of becoming aware of the pregnancy. Pregnancy is not an AE, and 
therefore does not need to be reported as an AE in the eCRF unless there is a suspicion that the 
study drug may have interfered with the effectiveness of a contraceptive medication. The 
Investigator must follow-up all pregnancies, document the course and the outcome, and report 
this information to the Sponsor on a Pregnancy Outcome Report Form within 24 hours of 
becoming aware; even if the patient was withdrawn from the study or the study has finished. 
An elective abortion without complications should not be regarded as an AE, however, it should 
be reported as the outcome to the pregnancy on the Pregnancy Outcome Report Form. 
Therapeutic abortions should be reported as a treatment procedure; the reason for the therapeutic 
abortion should be reported on the Pregnancy Outcome Report Form and as an AE in the eCRF. 
Hospitalization for normal delivery of a healthy newborn should not be considered an SAE. 
Any SAE that occurs during pregnancy must be recorded on the Pregnancy Outcome Report 
Form, reported as an SAE on the SAE Report Form (e.g., maternal serious complications, 
therapeutic abortion, ectopic pregnancy, stillbirth, neonatal death, congenital anomaly, birth 


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defect) and reported to the Sponsor within 24 hours. Hospitalization for normal delivery of a 
healthy newborn should not be considered an SAE.  
11.2.12. 
Special Situations 
All occurrences of abuse, misuse, medication error, overdose, and accidental or occupational 
exposure with any study treatment must be reported on a Special Situations Report Form to the 
Sponsor within 5 calendar days of becoming aware of the occurrence, regardless of whether it is 
categorized as an AE. If the occurrence is associated with an SAE, an SAE Report Form, along 
with the Special Situations Report Form, must be submitted to the Sponsor within 24 hours of 
awareness. 


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The final analysis of bioequivalence will be based on Stage 2 BA/BE evaluable patients only, 
with a target sample size of 100 evaluable patients. Patients may be identified as non-evaluable 
due to issues arising during the study conduct, such as: 
• emesis within 9 hours of dosing,  
• dosing errors,  
• patient did not fast prior to dosing,  
• missing critical PK sample on Day 8,  
• failure to complete both PK periods, and 
• significant changes to the patient medical status that would potentially affect the PK 
profile as determined by the Sponsor in consultation with the Investigator prior to PK data 
analysis.  
In this patient population, approximately 170 total patients are targeted for enrollment, assuming 
a 35% non-evaluability rate during the study conduct, and an additional 10% non-evaluability 
rate during PK analysis. The non-evaluability rate arising during the study conduct will be 
continuously monitored by the Sponsor and the total number of enrolled patients may be adjusted 
accordingly with the aim to target the resulting sample size of 100 BA/BE evaluable patients.  
Stage 3 
Assuming the true ratio of means is 1 and the intra-subject CV is 20% for AUC0-t and AUC0-∞, 
with 16 evaluable patients, there is approximately 83% probability the 90% CI of the ratio of 
geometric means will be within 0.800 and 1.250. Based on the results of a FE study conducted 
using the capsule formulation, an effect of a high-fat meal on Cmax is possible. The sample size of 
16 patients is deemed adequate to characterize this effect. AUC0-t and AUC0-∞ will be the 
primary parameters for analysis.  
The primary analysis will be based on the FE Evaluable Population as it is the most conservative 
approach, which maximizes the benefits of the crossover design, where each patient serves as 
their own control. Results for the PK Evaluable Population will also be summarized and reported 
for this study. 
To account for non-evaluable patients, approximately 20 total patients are targeted for 
enrollment. The final analysis will be based on Stage 3 FE evaluable patients only. Patients may 
be identified as non-evaluable due to issues arising during the study conduct, such as: 
• dosing errors,  
• patient did not follow dietary requirements prior to dose and postdose,  
• failure to complete both PK periods, and 
• significant changes to the patient medical status that would potentially affect the PK 
profile as determined by the Sponsor in consultation with the Investigator prior to PK 
data analysis.  
Patients who vomit within 10 hours of dosing or miss sufficient samples to render calculation of 
AUC unreliable will be discontinued from the PK phase; those that meet other criteria for 


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continued niraparib therapy will be eligible to be screened for the Extension Phase (see 
Section 6.1). The non-evaluability rate arising during the study conduct will be continuously 
monitored by the Sponsor and the total number of enrolled patients may be adjusted accordingly 
with the aim to target the resulting sample size of 16 evaluable patients.  
12.3. 
Safety Analyses 
Data from the Stage 1 PK Phase, Stage 2 PK Phase, Stage 3 PK Phase and Extension Phase will 
be summarized separately. Summaries will be performed by formulation, fed/fasted state and 
dosing period as applicable. The safety population will consist of all patients who receive drug. 
Demographic characteristics will be summarized descriptively and will include age, sex, race, 
height, and weight. 
Protocol deviations will be listed by patient. 
All analysis for safety endpoints will be done in a descriptive manner. Continuous variables will 
be summarized using descriptive statistics (number of patients, mean, standard deviation [SD], 
minimum, median, and maximum). Categorical variables will be summarized using counts of 
patients and percentages. All AEs will be coded using the most up-to-date version of MedDRA. 
NCI-CTCAE v.4.03 will be used to grade the severity of AEs and laboratory abnormalities.  
All AEs will be listed. The number and percent of patients who experience a TEAE will be 
summarized by formulation, fed/fasted state and dosing period as applicable for each system 
organ class and preferred term. TEAEs will also be tabulated accordingly by intensity and 
causality. 
An analysis of AEs will include the following categories: 
• TEAEs 
• Drug-related TEAEs 
• Grade 3, 4, and 5 TEAEs (presented by grade and overall) 
• Grade 3, 4, and 5 drug-related TEAEs (presented by grade and overall) 
• TEAEs resulting in study drug discontinuation 
• Most commonly reported TEAEs 
• Treatment-emergent SAEs 
• AESIs 
Individual data listings of laboratory test results will be presented. Flags will be attached to 
values outside of the laboratory's reference limits along with the Investigator's assessment. 
Clinically significant laboratory test abnormalities that were considered AEs by the Investigator 
will be presented in the AE listing. 
In addition, for the Extension Phase, clinical laboratory tests (observed values and changes from 
baseline) will be summarized descriptively in tabular format. Shift tables will be presented for 
select laboratory parameters (chemistry and hematology). 


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Individual data listings of vital signs (observed and change from Baseline) will be presented for 
each patient. Individual clinically significant vital sign findings that were considered AEs by the 
Investigator will be presented in the AE listing. 
All clinically relevant physical examination findings will be listed. 
12.4. 
Pharmacokinetic Analysis 
Individual and mean plasma concentrations over time will be plotted by formulation for the 300-
mg dose group in Stage 1 and 2 and by fed/fasted state in Stage 3. Planned sampling times will 
be used to generate the mean concentration-time profiles. 
Individual patient PK parameter values will be derived by non-compartmental methods using 
WinNonlin, version 5.1 or higher. Actual time will be used in parameter estimation. The analysis 
of Stage 1, Stage 2, and Stage 3 will be conducted separately.  
During the pharmacokinetic analysis, the following rules will apply: 
• 
Predose sample >5% of Cmax: profile will be excluded from PK concentration and PK 
parameters summary and inferential statistics 
• 
Rsq,adj <0.800: AUC0-∞, λz, CL/F, Vz/F, and t1/2 will be excluded from descriptive and  
inferential statistics 
• 
AUC0-t /AUC0-∞, <0.800: AUC0-∞ and parameters derived from it will be excluded from 
descriptive and inferential statistics  
Individual and mean plasma concentrations over time will be plotted by formulation in Stage 1 
and 2 and by fed/fasted state in Stage 3. The individual plasma concentration versus actual time 
profiles for each subject, as well as the mean plasma concentration versus scheduled time 
profiles for each treatment, will be presented graphically on a linear-linear and log-linear scale. 
Combined individual concentration versus time graphs per treatment will also be presented, 
together with  mean values. Plasma concentrations and PK parameters will be summarized in 
terms of the number of patients, arithmetic mean, median, SD, coefficient of variation (CV), 
geometric mean, geometric CV, minimum and maximum by formulation in Stage 1 and 2 and by 
fed/fasted state in Stage 3, across the PK, PK Evaluable, BA/BE Evaluable and FE Evaluable 
populations, as appropriate. In Stage 3, differences in tmax between the fed and fasted state will be 
assessed and summarized based on the FE Evaluable Population. Details will be provided in the 
Pharmacokinetic Analysis Plan. 
To assess relative bioavailability/bioequivalence, an analysis of variance model (ANOVA) will 
be used on logarithmically transformed AUC0-t, AUC0-∞, and Cmax accounting for the following 
sources of variation: sequence, subjects nested in sequences, period and treatment. The point 
estimate and 90% CIs for the ratios of the geometric means of the test treatment (tablet) 
compared to the reference treatment (capsule) will be obtained. Bioequivalence will be claimed 
if the 90% CI for the ratio of geometric means is between 0.800 and 1.250 for AUC0-t, AUC0-∞, 
and Cmax. To assess the effect of food for Stage 3, the ratio of geometric means of the test 
treatment (high-fat meal) and corresponding 90% CI compared to the reference treatment (fasted 
state) will be obtained for AUC0-t, AUC0-∞, and Cmax. 


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A population PK analysis may be performed on the PK data from the PK Phase of the study and 
will be reported separately from the study. 


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13. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
13.1. 
Study Monitoring 
Before an investigational site can enter a patient into the study, a representative of the Sponsor 
will visit the investigational study site to: 
• Determine the adequacy of the facilities 
• Discuss with the investigator(s) and other personnel their responsibilities with regard to 
protocol adherence, and the responsibilities of the Sponsor or its representatives. This 
will be documented in a Clinical Study Agreement between the Sponsor and the 
investigator. 
During the study, a monitor from the Sponsor or representative will have regular contacts with 
the investigational site, for the following: 
• Provide information and support to the investigator(s) 
• Confirm that facilities remain acceptable 
• Confirm that the investigational team is adhering to the protocol, that data are being 
accurately recorded in the case report forms (CRFs), and that investigational product 
accountability checks are being performed 
• Perform source data verification. This includes a comparison of the data in the CRFs with 
the patient’s medical records at the hospital or practice, and other records relevant to the 
study. This will require direct access to all original records for each patient (eg, clinic 
charts). 
• Record and report any protocol deviations not previously sent to the Sponsor. 
• Confirm AEs and SAEs have been properly documented on CRFs and confirm any SAEs 
have been forwarded to the Sponsor and those SAEs that met criteria for reporting have 
been forwarded to the IRB. 
The monitor will be available between visits if the investigator(s) or other staff needs 
information or advice. 
13.2. 
Audits and Inspections 
Authorized representatives of the Sponsor, a regulatory authority, an IEC or an IRB may visit the 
site to perform audits or inspections, including source data verification. The purpose of a the 
Sponsor audit or inspection is to systematically and independently examine all study-related 
activities and documents to determine whether these activities were conducted, and data were 
recorded, analyzed, and accurately reported according to the protocol, Good Clinical Practice 
(GCP) guidelines of the International Council for Harmonization (ICH), and any applicable 
regulatory requirements. The investigator should contact the Sponsor immediately if contacted 
by a regulatory agency about an inspection. 


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13.3. 
Institutional Review Board 
The Principal Investigator must obtain IRB approval for the investigation. Initial IRB approval, 
and all materials approved by the IRB for this study including the patient consent form and 
recruitment materials must be maintained by the Investigator and made available for inspection. 


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14. 
QUALITY CONTROL AND QUALITY ASSURANCE 
To ensure compliance with GCPs and all applicable regulatory requirements, the Sponsor may 
conduct a quality assurance audit. Please see Section 13.2 for more details regarding the audit 
process. 


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15. 
ETHICS 
15.1. 
Ethics Review 
The final study protocol, including the final version of the ICF, must be approved or given a 
favorable opinion in writing by an IRB or IEC as appropriate. The investigator must submit 
written approval to the Sponsor before he or she can enroll any patient/subject into the study. 
The Principal Investigator is responsible for informing the IRB or IEC of any amendment to the 
protocol in accordance with local requirements. In addition, the IRB or IEC must approve all 
advertising used to recruit patients for the study. The protocol must be re-approved by the IRB or 
IEC upon receipt of amendments and annually, as local regulations require. 
The Principal Investigator is also responsible for providing the IRB with reports of any 
reportable serious adverse drug reactions from any other study conducted with the investigational 
product. the Sponsor will provide this information to the Principal Investigator. 
Progress reports and notifications of serious adverse drug reactions will be provided to the IRB 
or IEC according to local regulations and guidelines. 
15.2. 
Ethical Conduct of the Study 
The study will be performed in accordance with ethical principles that have their origin in the 
Declaration of Helsinki and are consistent with ICH/GCP, applicable regulatory requirements 
and TESARO’s policy on Bioethics. 
15.3. 
Written Informed Consent 
The Principal Investigator(s) at each center will ensure that the patient is given full and adequate 
oral and written information about the nature, purpose, possible risk and benefit of the study. 
Patients must also be notified that they are free to discontinue from the study at any time. The 
patient should be given the opportunity to ask questions and allowed time to consider the 
information provided. 
The patient’s signed and dated informed consent must be obtained before conducting any study 
procedures. 
The Principal Investigator(s) must maintain the original, signed ICF. A copy of the signed ICF 
must be given to the patient. 


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16. 
DATA HANDLING AND RECORDKEEPING 
16.1. 
Inspection of Records 
The Sponsor will be allowed to conduct site visits to the investigation facilities for the purpose of 
monitoring any aspect of the study. The Investigator agrees to allow the monitor to inspect the 
drug storage area, study drug stocks, drug accountability records, subject charts and study source 
documents, and other records relative to study conduct. 
16.2. 
Retention of Records 
The Principal Investigator must maintain all documentation relating to the study for a period of 
2 years after the last marketing application approval, or if not approved 2 years following the 
discontinuance of the test article for investigation. If it becomes necessary for the Sponsor or the 
Regulatory Authority to review any documentation relating to the study, the Investigator must 
permit access to such records. 


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17. 
PUBLICATION POLICY 
Information regarding publication of study results is contained in the Clinical Trial Agreement 
for this study. 


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18. 
LIST OF REFERENCES  
1. 
Sandhu SK, Schelman WR, Wilding G, et al. The poly(ADP-ribose) polymerase inhibitor 
niraparib (MK4827) in BRCA mutation carriers and patients with sporadic cancer: a 
phase 1 dose-escalation trial. Lancet Oncol. 2013;14(9):882-892. 
2. 
Fong PC, Boss DS, Yap TA, et al. Inhibition of poly(ADP-ribose) polymerase in tumors 
from BRCA mutation carriers. N Engl J Med. 2009;361(2):123-134. 
3. 
Audeh MW, Carmichael J, Penson RT, et al. Oral poly(ADP-ribose) polymerase inhibitor 
olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a 
proof-of-concept trial. Lancet. 2010;376(9737):245-251. 
4. 
Gelmon KA, Tischkowitz M, Mackay H, et al. Olaparib in patients with recurrent high-
grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a 
phase 2, multicentre, open-label, non-randomised study. Lancet Oncol. 2011;12(9):852-
861. 
5. 
Kummar S, Ji J, Morgan R, et al. A phase I study of veliparib in combination with 
metronomic cyclophosphamide in adults with refractory solid tumors and lymphomas. 
Clin Cancer Res. 2012;18(6):1726-1734. 
6. 
Ledermann J, Harter P, Gourley C, et al. Olaparib maintenance therapy in platinum-
sensitive relapsed ovarian cancer. N Engl J Med. 2012;366(15):1382-1392. 
7. 
Ledermann J, Harter P, Gourley C, et al. Olaparib maintenance therapy in patients with 
platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of 
outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014;15(8):852-
861. 
8. 
Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib Maintenance Therapy in Platinum-
Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016;375(22):2154-2164. 
9. 
Guan J, Lim KS, Mekhail T, Chang CC. Programmed Death Ligand-1 (PD-L1) 
Expression in the Programmed Death Receptor-1 (PD-1)/PD-L1 Blockade: A Key Player 
Against Various Cancers. Archives of pathology & laboratory medicine. 
2017;141(6):851-861. 
10. 
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern 
Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655. 
11. 
FDA. US Food and Drug Administration Center for Drug Evaluation and Research. 
Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies. 
2002. Accessed 08 Dec 2020. Available at: https://www.fda.gov/media/70945/download. 


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APPENDIX C. CONTRACEPTION GUIDELINES 
Patients of childbearing potential who are sexually active and their partners must agree to the use 
of 2 highly effective form of contraception throughout their participation during the study 
treatment and for 180 days after last dose of study treatment(s). Acceptable birth control methods 
include: 
• Combined (estrogen and progestogen containing) hormonal contraception associated 
with inhibition of ovulation: 
− oral route 
− intravaginal route 
− transdermal route 
• Progestogen-only hormonal contraception associated with inhibition of ovulation  
− oral 
− injectable 
− implantable  
• Intrauterine device 
• Intrauterine hormone-releasing system 
• Bilateral tubal occlusion 
• Vasectomized partner 
• Sexual abstinence, if the preferred and usual lifestyle of the subject  


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APPENDIX D. PERMITTED HORMONAL THERAPIES 
• Anastrozole 
• Letrozole  
• Exemestane 
• Fulvestrant 
• Abiraterone acetate 
• Enzalutamide  
• Goserelin 
• Bicalutamide 
• Leuprolide 
 


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APPENDIX E. GUIDANCE ON COMPOSITION OF HIGH-AT MEAL 
During Stage 3 PK periods, patients will receive their niraparib dose in a fasted state or directly 
after having had a high-fat meal. Below is an example of a high-fat meal, where ≥50% of 
calories are derived from fat. Substitutions can be made to this meal if the caloric content, 
volume, and viscosity are maintained. 
Example of a high-fat meal: 
Total Calories 
800-1000 
Calories from Protein 
150 
Calories from Carbohydrates 
250 
Calories from Fat 
500-600 
An Example of a High-Fat Breakfast 
• Two eggs fried in butter 
• Two strips of bacon 
• Two slices of toast with butter 
• Four ounces of hash brown potatoes 
• Eight ounces of whole milk 
Source: FDA, 2002