Clinical trial NCT02354586
Conditions: Ovarian Neoplasms Ovarian Cancer
Keywords: gBRCAmut BRCA PARP inhibitor HRD Ovarian cancer Serous Epithelial Fallopian Tube Primary Peritoneal
Sponsor: Tesaro, Inc.
Start date: 2015-03-23; Completion date: 2021-08-23
Enrollment: 463 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Niraparib
Intervention descriptions: intervention 1: None

Protocol documents:
SAP_002.pdf: 
 
 
 
 
Statistical Analysis Plan 
 
 
Study ID:  213360 (PR-30-5020-C) 
 
Official Title of Study: A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety 
and Efficacy of Niraparib in Patients with Advanced, Relapsed, High-Grade Serous 
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received 
Three or Four Previous Chemotherapy Regimens 
 
Date of Document: 21-JUL-2021 
 


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STATISTICAL ANALYSIS PLAN 
A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and 
Efficacy of Niraparib in Patients with Advanced, Relapsed, High-Grade 
Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer 
Who Have Received Three or Four Previous Chemotherapy Regimens 
Protocol PR-30-5020-C 
 
Protocol Number: 
PR-30-5020-C 
Protocol Version and Date: 
Version 8.0: 21 December 2017 (Amendment 5) 
Version 7.0: 07 April 2017 (Amendment 4) 
Version 6.0: 14 September 2016 (Amendment 3.2) 
Version 5.0: 07 September 2016 (Amendment 3.1) 
Version 4.0: 29 July 2016 (Amendment 3) 
Version 3.0: 24 May 2016 (Amendment 2) 
Version 2.0: 30 October 2015 (Amendment 1) 
Version 1.0: 17 December 2014 (Original) 
Name of Test Drug: 
Niraparib ([3S]-3-[4-{7-(aminocarbonyl)-2H-indazol-2-yl} 
phenyl] piperidine [tosylate monohydrate salt]) 
Phase: 
Phase 2 
Methodology: 
Open-Label, Single-Arm 
Sponsor: 
TESARO, Inc. 
1000 Winter Street 
Waltham MA  02451 
Tel: 
 
Sponsor Representative: 
Romnee Clark, MD 
Senior Medical Director 
Analysis Plan Date: 
21 July 2021 
Analysis Plan Version: 
Version 4.0 
 
Confidentiality Statement 
The information contained herein is confidential and the proprietary property of 
TESARO, Inc., and any unauthorized use or disclosure of such information  
without the prior written authorization of TESARO, Inc., is expressly prohibited. 
PPD


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APPROVAL SIGNATURE PAGE 
Protocol Title: 
A Phase 2, Open-Label, Single-Arm Study to Evaluate the 
Safety and Efficacy of Niraparib in Patients with Advanced, 
Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian 
Tube, or Primary Peritoneal Cancer Who Have Received Three 
or Four Previous Chemotherapy Regimens 
Protocol Number: 
PR-30-5020-C 
Sponsor: 
TESARO, Inc. 
1000 Winter Street 
Waltham MA 02451 
Author: 
Veristat, LLC 
118 Turnpike Road 
Southborough, MA 01772 
 
 
Author Signatory: 
 
Principal Biostatistician 
 
Signature:______________________________________ 
 
Date:__________________________________________ 
Sponsor Approval: 
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 guidances and guidelines. 
I have discussed any questions I have regarding the contents of this document with the 
biostatistical author. 
I also understand that any subsequent changes to the planned statistical analyses, as 
described herein, may have a regulatory impact and/or result in timeline adjustments. All 
changes to the planned analyses will be described in the clinical study report. 
Sponsor Signatory: 
Romnee Clark, MD 
Senior Medical Director 
 
Signature:______________________________________ 
 
Date:__________________________________________ 
 
 
Yong Li, PhD 
Director, Biostatistics 
Signature:______________________________________ 
 
Date:__________________________________________ 
PPD


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TABLE OF CONTENTS 
1. 
INFORMATION FROM THE STUDY PROTOCOL .............................. 10 
1.1. 
Introduction and Objectives ........................................................... 10 
1.1.1. 
Introduction ..................................................................... 10 
1.1.2. 
Study Objectives ............................................................. 10 
1.2. 
Study Design .................................................................................. 12 
1.2.1. 
Synopsis of Study Design ............................................... 12 
1.2.2. 
Randomization Methodology .......................................... 13 
1.2.3. 
Stopping Rules and Unblinding ...................................... 13 
1.2.4. 
Study Procedures ............................................................ 13 
1.2.5. 
Efficacy, Pharmacokinetic, and Safety Parameters ........ 17 
1.2.5.1. Efficacy Parameters ......................................... 17 
1.2.5.2. Pharmacokinetic Parameters ............................ 17 
1.2.5.3. Safety Parameters ............................................. 17 
2. 
PATIENT POPULATION ......................................................................... 19 
2.1. 
Population Definitions ................................................................... 19 
2.2. 
Protocol Deviations ........................................................................ 19 
3. 
GENERAL STATISTICAL METHODS .................................................. 20 
3.1. 
Sample Size Justification ............................................................... 20 
3.2. 
General Methods ............................................................................ 20 
3.3. 
Computing Environment ................................................................ 22 
3.4. 
Baseline Definitions ....................................................................... 22 
3.5. 
Methods of Pooling Data ............................................................... 22 
3.6. 
Adjustments for Covariates ............................................................ 22 
3.7. 
Multiple Comparisons/Multiplicity ................................................ 22 
3.8. 
Subpopulations ............................................................................... 22 
3.8.1. 
Prior Lines of Chemotherapy .......................................... 22 
3.8.2. 
Response to the Last Platinum-Based Therapy............... 23 
3.8.3. 
Prior PARP Treatment .................................................... 23 
3.8.4. 
Biomarker Subpopulations .............................................. 23 
3.8.4.1. Biomarker Definitions ...................................... 23 
3.8.4.2. Study-Specific Biomarker Populations ............ 24 


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3.9. 
Withdrawals, Dropouts, Loss to Follow-up ................................... 25 
3.10. Missing Data .................................................................................. 25 
3.11. Visit Windows ................................................................................ 26 
3.12. Administrative Interim Analyses ................................................... 26 
4. 
STUDY ANALYSES ................................................................................ 27 
4.1. 
Patient Disposition ......................................................................... 27 
4.2. 
Demographics, Baseline Characteristics, and Medical History ..... 27 
4.3. 
Efficacy Evaluation ........................................................................ 28 
4.3.1. 
Efficacy Variables for Primary and Key Secondary 
Analyses .......................................................................... 28 
4.3.2. 
Secondary Efficacy Variables ......................................... 32 
4.3.2.1. Duration of Response ....................................... 32 
4.3.2.2. Disease Control Rate ........................................ 33 
4.3.2.3. Progression-Free Survival ................................ 33 
4.3.2.4. Time to First Subsequent Therapy ................... 34 
4.3.2.5. Overall Survival ............................................... 34 
4.3.2.6. Pharmacokinetic Evaluations ........................... 34 
4.4. 
Safety Analyses .............................................................................. 34 
4.4.1. 
Study Treatment Exposure .............................................. 34 
4.4.2. 
Study Treatment Compliance.......................................... 35 
4.4.3. 
Adverse Events ............................................................... 36 
4.4.3.1. Overview .......................................................... 36 
4.4.3.2. Adverse Events of Special Interest .................. 38 
4.4.3.3. Other Adverse Events of Interest ..................... 39 
4.4.3.4. Examination of Adverse Events Controlling for 
Duration of Drug Exposure .............................. 40 
4.4.3.5. Examination of Duration of Adverse Events ... 41 
4.4.4. 
Laboratory Data .............................................................. 41 
4.4.5. 
Vital Signs and Physical Examination ............................ 42 
4.4.6. 
Electrocardiogram ........................................................... 42 
4.4.7. 
Concomitant Medications ............................................... 43 
5. 
CHANGES TO PLANNED ANALYSES ................................................. 45 
6. 
REFERENCES ........................................................................................... 46 


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7. 
APPENDIX ................................................................................................ 47 
7.1. 
MedDRA Preferred Terms for Adverse Events of Special Groups
 ........................................................................................................ 47 
7.2. 
SMQ Terms for Malignant Tumors ............................................... 51 
7.3. 
SMQ Terms for Pregnancy and Neonatal Topics ........................ 136 
7.4. 
SMQ Terms for Hypertension ...................................................... 207 
7.5. 
List of Per-Protocol Chemotherapy Regimens in Preferred Term
 ...................................................................................................... 213 
8. 
STATISTICAL OUTPUT SHELLS ........................................................ 216 
9. 
REVISION HISTORY ............................................................................. 217 
 


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TABLES INCLUDED IN THE TEXT 
Table 1-1 
Schedule of Assessments ................................................................................................. 14 
Table 3-1 
Evaluation Intervals ......................................................................................................... 26 
Table 4-1 
Overall Response for Patients with Measureable Disease at Study Entry....................... 29 
Table 4-2: 
Best Overall Response when Confirmation of CR and PR Required .............................. 30 
Table 4-3: 
Censoring Rules used in Duration of Response Analysis ............................................... 32 
Table 4-4: 
Censoring Rules used in Progression-Free Survival Analysis ........................................ 33 
Table 4-5: 
Adverse Events of Special Interest and Other Grouped Events ...................................... 40 
 
 


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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Abbreviation 
Definition 
AE 
Adverse event 
AESI 
Adverse event(s) of special interest 
ALT 
Alanine aminotransferase 
AML 
Acute myeloid leukemia 
AST 
Aspartate aminotransferase 
ATC 
Anatomical Therapeutic Chemical 
BER 
Base excision repair 
BMI 
Body mass index 
BRCA 
Breast cancer gene 
CA-125 
Cancer antigen 125 
CBC 
Complete blood count 
CI 
Confidence interval 
CR 
Complete response 
CSR 
Clinical study report 
CT 
Computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DCR 
Disease control rate 
DNA 
Deoxyribonucleic acid 
DOR 
Duration of response 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic case report form 
EOT 
End of treatment 
FDA 
(United States) Food and Drug Administration 
FIGO 
International Federation of Gynecology and Obstetrics 
FISH 
Fluorescence in situ hybridization 
gBRCAmut 
Germline breast cancer gene mutation 
GCIG 
Gynecologic Cancer Intergroup 
GCP 
Good Clinical Practice 
GGT 
Gamma glutamyl transferase 
H0 
Null hypothesis 
H1 
Alternative hypothesis 
HEENT 
Head, Eyes, Ears, Neck, and Throat 
HRD 
Homologous recombination deficiency 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 


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Abbreviation 
Definition 
IRB 
Institutional Review Board 
ITT 
Intent-to-treat 
KM 
Kaplan-Meier 
LLN 
Lower limit of normal 
MDS 
Myelodysplastic syndrome 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
Magnetic resonance imaging 
NCI 
National Cancer Institute 
ORR 
Objective response rate 
OS 
Overall survival 
PARP 
Poly(ADP-ribose) polymerase 
PD 
Progressive disease (in the context of disease evaluation) or protocol 
deviation 
PEY 
Patient-exposure year 
PFI 
Platinum-free interval 
PFS 
Progression-free survival 
PK 
Pharmacokinetic 
PP 
Per-protocol 
PR 
Partial response 
PT 
Preferred Term (MedDRA) 
Q1 
First quartile 
Q3 
Third quartile 
QD 
Once daily 
QTc 
QT interval corrected for heart rate 
QTcB 
QT interval corrected for heart rate using Bazett’s formula 
QTcF 
QT interval corrected for heart rate using Fridericia’s formula 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
Serious adverse event 
SAF 
Safety 
SAP 
Statistical analysis plan 
sBRCAmut 
Somatic breast cancer gene mutation 
SD 
Stable disease (in the context of disease evaluation) or standard 
deviation (in the context of statistics) 
SOC 
System Organ Class (MedDRA) 
tBRCAmut 
Tumor breast cancer gene mutation 
tBRCAwt 
Tumor breast cancer gene wild-type 
TEAE 
Treatment-emergent adverse event 
TFST 
Time to first subsequent therapy 
ULN 
Upper limit of normal 


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Abbreviation 
Definition 
WHO 
World Health Organization 
WHODD 
World Health Organization Drug Dictionary 


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1. 
INFORMATION FROM THE STUDY PROTOCOL 
1.1. 
Introduction and Objectives 
1.1.1. 
Introduction 
Niraparib is a potent, orally active poly(ADP-ribose) polymerases (PARP)-1 and -2 inhibitor 
being developed as an agent for tumors with defects in the homologous recombination 
deoxyribonucleic acid (DNA) repair pathway or that are driven by PARP-mediated transcription 
factors. 
PARP-1 and -2 are zinc-finger DNA-binding enzymes that play a crucial role in DNA repair. 
Upon formation of DNA breaks, PARP binds at the end of broken DNA strands, a process that 
activates its enzymatic activity. Activated PARP catalyzes addition of long polymers of 
ADP-ribose onto PARP and several other proteins associated with chromatin, including histones 
and various DNA repair proteins. This results in chromatin relaxation, fast recruitment of DNA 
repair proteins, and efficient repair of DNA breaks. In this manner, PARP plays a key role in 
sensing DNA damage and converting it into intracellular signals that activate the base excision 
repair (BER) and single-strand break repair pathways. 
Clinical studies have shown that PARP inhibitors are active for recurrent ovarian 
cancer.[1, 2, 3, 4, 5, 6, 7] Clinical anti-cancer activity has been observed in patients with and 
without germline breast cancer gene (BRCA) mutation (gBRCAmut) and in patients who are 
platinum-sensitive and platinum-resistant. PARP inhibition appears to be most active in patients 
with gBRCAmut platinum-sensitive disease.[1, 3, 5] Additionally, maintenance therapy in 
patients with relapsed, platinum-sensitive ovarian cancer appears promising.[6] Of patients with 
a BRCA mutation, median progression-free survival (PFS) was significantly longer in the PARP 
inhibitor group than in the placebo group (11.2 months vs 4.3 months; hazard ratio: 0.18; 
p < 0.0001). Similar findings were noted for patients with wild-type BRCA, although the 
difference between groups was smaller (7.4 months vs 5.5 months; hazard ratio: 0.54; 
p = 0.007). Patient-reported outcomes, including Functional Assessment of Cancer Therapy – 
Ovarian Symptom Index, did not show a significant difference between the placebo and 
treatment groups, suggesting that maintenance treatment did not decrease functioning or quality 
of life in these patients. Patient-reported outcome data beyond progression was not captured, 
and therefore quality of life effects related to subsequent chemotherapy treatments (likely to 
occur sooner in the placebo group) could not be used to assess the benefit of extending PFS on 
patient-reported outcomes for patients treated with a PARP inhibitor vs placebo. 
1.1.2. 
Study Objectives 
In this document, “ovarian cancer” refers to high-grade serous epithelial cancers of the ovary, 
fallopian tube, or primary peritoneal cancer. As detailed in Section 3.8, “sensitivity to platinum-
based therapy” is defined by platinum-free interval (PFI) following the first platinum-based 
therapy (required for eligibility) or the last platinum-based therapy (defines patient population 
for primary and key secondary objectives). Homologous recombination deficiency (HRD) status 
is based upon the Myriad MyChoice HRD test and/or a centralized gBRCA test. 
The primary objective of the study is to evaluate the Objective Response Rate (ORR) of 
niraparib in HRD-positive patients with advanced, relapsed, high-grade serous epithelial 
ovarian, fallopian tube, or primary peritoneal cancer, who have received 3 or 4 prior lines of 


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anti-cancer therapy and are platinum-sensitive to the last platinum-based therapy (excluding 
patients with prior PARP treatment). 
The key secondary objectives of the study are as follows: 
• To evaluate the ORR of niraparib in all patients with advanced, relapsed, high-grade 
serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 
3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-
based therapy (excluding patients with prior PARP treatment). 
• To evaluate the ORR of niraparib in all patients with advanced, relapsed, high-grade 
serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 
3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive or platinum-resistant 
to the last platinum-based therapy (excluding patients with prior PARP treatment). 
• To evaluate the ORR of niraparib in all patients with advanced, relapsed, high-grade 
serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. 
Other secondary objectives of the study are as follows: 
• To evaluate the efficacy (duration of response [DOR], disease control rate [DCR], PFS, 
time to first subsequent therapy [TFST] and overall survival [OS]) of niraparib in 
patients who have received 3 or 4 prior lines of anti-cancer therapy. 
• To evaluate the efficacy (DOR, DCR, PFS, TFST and OS) of niraparib in all patients 
regardless of prior lines of anti-cancer therapy. 
• To evaluate the safety and tolerability of niraparib. 
The exploratory objectives of the study are as follows: 
• To evaluate the efficacy and safety of niraparib in all patients who are platinum-
refractory to the last platinum-based therapy. 
• To evaluate the efficacy and safety of niraparib in all patients with prior PARP 
treatment. 
• To evaluate QT interval corrected for heart rate (QTc) in a subset of niraparib-treated 
ovarian cancer patients. 
• To assess population pharmacokinetics (PK) and estimate PK parameters for niraparib 
and its major metabolite. 
• To explore potential biomarkers related to ovarian cancer and poly(ADP-ribose) 
polymerase (PARP) inhibition (eg, DNA repair pathways). 
This statistical analysis plan (SAP) is designed to outline the methods to be used in the analyses 
of study data in order to answer the study objectives. 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. 
This SAP will also outline any differences in the currently planned analytical objectives relative 
to those planned in the study protocol. 
The SAP is based upon the following study documents: 


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• Study Protocol v8.0 dated 21 December 2017 
• Electronic Case Report Form (eCRF) v.1.184 dated 23 October 2017 
• Analyses of PK data are described in a separate SAP, but all data will be displayed in the 
listings associated with this SAP. 
1.2. 
Study Design 
1.2.1. 
Synopsis of Study Design 
This study is a multicenter, open-label, single-arm, Phase 2 study evaluating the safety and 
efficacy of niraparib in patients with recurrent ovarian cancer who experienced a response 
lasting at least 6 months to first-line platinum-based therapy and who previously treated with 
3 or 4 lines of anti-cancer therapy (including, but not limited to, gemcitabine, doxorubicin, 
topotecan, carboplatin, oxaliplatin, cisplatin, bevacizumab, or PARP inhibitors as single agents 
or in combination per standard of care). Study objectives are discussed in Section 1.1.2. 
In order to determine eligibility, a tumor sample will be sent to a centralized laboratory for 
immediate HRD testing. Archival or fresh tissue is required in order to enroll in the study. The 
sample may be sent in advance of the protocol-defined screening period in order to facilitate the 
screening and enrollment process. Patients must wait for the results from the on-study 
centralized HRD testing prior to enrollment, unless they have previously detected gBRCA 
mutation. Blood samples also will be collected for all patients during screening for 
determination of gBRCAmut status. If HRD status is known, then it is not necessary to wait for 
HRD testing results for enrollment into the study, however confirmatory HRD testing still needs 
to be performed. 
In order to evaluate tumor markers, an optional fresh biopsy may be done at screening and at the 
end of treatment (EOT) visit. 
Niraparib 300 mg will be administered orally QD continuously beginning on Day 1 and every 
cycle (28 days) thereafter until the patient discontinues study treatment. Three capsules of 
100 mg strength will be taken at each dose administration. Dose interruption (no longer than 
28 days) and dose reductions to 2 capsules daily (200 mg), and subsequently to 1 capsule daily 
(100 mg), will be allowed (no further dose reductions will be allowed). Dose interruption and/or 
reduction may be implemented at any time for any grade toxicity considered intolerable by the 
patient. The timing of efficacy or safety evaluations should not be affected by dose interruptions 
or reductions. Patients will continue on study medication until disease progression as long as in 
the Investigator’s opinion they are benefiting from treatment and do not meet any other 
discontinuation criteria. 
Blood samples for measurements of plasma levels of niraparib and its major metabolite will be 
obtained on Cycle 1/Day 1 predose and 2 hours postdose, Cycle 2/Day 1 predose and 2 hours 
postdose, Cycle 4/ Day 1 predose, and Cycle 8/ Day 1 predose. At selected sites, a subset of 
approximately 12 patients will undergo intensive, triplicate ECG monitoring to coincide with 
PK evaluation on Cycle1/Day 1. Triplicate ECGs should be performed between 2 and 5 minutes 
apart and should be performed prior to blood draws for PK. These patients will have triplicate 
ECGs and PK samples taken predose and at 1, 2, 4, 6, and 8 hours postdose. Patients will be 
supine and rested for approximately 2 minutes before ECGs are recorded. The average of the 
triplicate measures will be used for analysis. This subset of patients will undergo all other 


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assessments in the study. As of 09 February 2016, the PK QTc sub-study had reached the 
enrollment target of 12 patients and is now closed to enrollment. 
Blood samples will be collected for all patients at screening for the exploratory evaluation of 
circulating biomarkers. 
Clinic visits will be weekly during Cycle 1 and then every 4 weeks (±3 days) for subsequent 
cycles. Response Evaluation Criteria in Solid Tumors (RECIST; v.1.1) tumor assessment via CT 
or MRI of the abdomen/pelvis and clinically indicated areas is required every 8 weeks (±7 days) 
from Cycle 1/Day 1 for 6 months and then every 12 weeks until progression. Copies of scans 
will be collected for future central evaluation if needed. Cycle timing will not be delayed for 
treatment interruptions, and tumor assessment should occur according to this schedule 
regardless of whether study treatment is interrupted. All AEs and serious adverse events (SAEs) 
will be collected and recorded for each patient from the day of signing the screening informed 
consent form (ICF) until the EOT visit. New SAEs (including deaths) will be collected for 
30 days after the last dose of study treatment. All AEs and SAEs experienced by a patient, 
irrespective of the suspected causality, will be monitored until the AE or SAE has resolved, any 
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. The Adverse Events of Special Interest (AESIs) for this study are myelodysplastic 
syndrome (MDS), acute myeloid leukemia (AML), and secondary cancers (new malignancies 
other than MDS/AML, pneumonitis, and embryo-fetal toxicity. AESIs must be reported to the 
Sponsor as soon as the Investigator becomes aware of them (per Section 6.2.5.3 of the protocol). 
Approximately 500 patients will be enrolled in the study at approximately 60 sites. The study 
will be conducted in conformance with Good Clinical Practice (GCP). 
1.2.2. 
Randomization Methodology 
Not applicable as this is a single-arm study. 
1.2.3. 
Stopping Rules and Unblinding 
There are no pre-specified stopping rules for the study. Unblinding is not applicable as this is a 
single-arm, open-label study. 
1.2.4. 
Study Procedures 
The schedule of assessments, as outlined in the study protocol, is provided in Table 1-1. 
 


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Table 1-1 
Schedule of Assessments 
Cyclea 
Screeningb 
1 
Subsequent 
Cyclesa 
EOT (within 
7 days of last 
dose) 
Post-
Treatment 
Assessments 
Day 
-28 to -1 
1 
8 
15 
22 
Cycle n, Day 1 
Informed consentb, c 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Medical, surgical, cancer, and 
medication history 
X 
 
 
 
 
 
 
 
Sample collection (tumor) for 
centralized tBRCAmut/HRD testingc 
Xc 
 
 
 
 
 
 
 
Sample collection (whole blood) for 
gBRCAmut testing 
X 
 
 
 
 
 
 
 
Tumor sample (optional) d 
X 
 
 
 
 
 
X 
 
Blood sample for exploratory 
biomarker analysise 
X 
 
 
 
 
 
 
 
Blood sample for PKf 
 
X 
 
 
 
X 
 
 
Tumor assessment (RECIST)g 
X 
 
 
 
 
Xg 
X 
Xg 
Chest CT/MRIh 
X 
 
 
 
 
 
 
 
Pregnancy testi 
X 
 
 
 
 
X 
 
 
Serum chemistry 
X 
Xj 
 
X 
 
X 
X 
 
CBCk 
X 
Xj 
Xl 
X 
Xl 
X 
X 
 
Serum CA-125j 
X 
Xg 
 
 
 
Xg 
X 
X 
ECGm 
Xm 
 
 
 
 
 
 
 
Physical examination 
X 
 
 
 
 
 
 
 
Symptom-directed physical 
examination 
 
X 
 
X 
 
Xn 
X 
 
Vital signs, height, weighto 
X 
X 
 
X 
 
X 
X 
 


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Cyclea 
Screeningb 
1 
Subsequent 
Cyclesa 
EOT (within 
7 days of last 
dose) 
Post-
Treatment 
Assessments 
Day 
-28 to -1 
1 
8 
15 
22 
Cycle n, Day 1 
ECOG performance status 
X 
 
 
 
 
Xn 
X 
 
Bone marrow aspirate and biopsyp 
 
Xp 
Concomitant medication 
X 
X 
 
X 
 
X 
X 
 
Adverse event monitoring 
X 
X 
 
X 
 
X 
Xq 
X 
Study treatment dispensed/collected 
 
X 
 
 
 
X 
X 
 
Survival assessmentr 
 
 
 
 
 
 
 
X 
Abbreviations: AE = adverse event; AML = acute myloid leukemia; BP = blood pressure; CA-125 = cancer antigen 125; CBC = complete blood count; CT = computed 
tomography; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EOT = end of treatment; gBRCAmut = germline breast cancer gene mutation; 
HRD = homologous recombination deficiency; ICF = informed consnt form; MDS = myelodysplastic syndrome; MRI = magnetic resonance imaging; PK = pharmacokinetics; 
RECIST = Response Evaluation Criteria in Solid Tumors; SAE = serious adverse event; tBRCAmut = tumor breast cancer gene mutation. 
a Treatment cycles are 28 days long, with visits on Day 1 of each cycle unless otherwise specified. Visits (other than Cycle 1) continue every 28 days until study treatment 
discontinuation. All visits have a window of ±3 days (calculated in reference to Cycle 1/Day 1). 
b Screening tests that could be considered standard of care (ie, CT/MRI, physical examination, vital signs, height, weight, and assessment of serum chemistry, CBC, pregnancy 
testing, and serum CA-125) that were performed within the protocol-required timelines (ie, within the 28-day screening window; within 72 hours prior to first dose [ie, 
Cycle 1/Day 1] where required) but prior to informed consent being obtained may be used as part of the patient’s screening assessment. 
c For patients who do not have archival tissue, tissue from a fresh biopsy must be obtained prior to study treatment initiation. Centralized HRD testing of tumor sample must be 
completed with results reported prior to enrollment. The sample may be sent in advance of the protocol-defined screening period in order to facilitate the screening and 
enrollment process. A separate ICF may be signed prior to the screening period for HRD testing in order to facilitate early testing. Depending on local site requirements, patients 
may sign a screening study ICF prior to the screening period to facilitate early HRD testing only. All other study tests and procedures must be done in the screening window 
(Day -28 to Day -1). For patients who do not have archival tissue, tissue from a fresh biopsy must be obtained. 
d Formalin-fixed, paraffin-embedded tumor sample consisting of a total of 100-micron thickness of sections (≥80-micron minimum) or unsectioned paraffin block. 
e Blood samples will be collected for all patients during screening for the exploratory evaluation of circulating markers of efficacy. The sponsor may discontinue the blood 
collection when samples have been collected from an adequate number of patients. 
f Blood samples for PK may be collected on Cycle 1/Day 1 predose (within 30 minutes) and 2 hours (± 15 minutes) postdose, on Cycle 2/ Day 1 predose (within 30 minutes) and 
2 hours (± 15 minutes) postdose, on Cycle 4/Day 1 predose (within 30 minutes), and on Cycle 8/Day 1 predose (within 30 minutes). At selected sites, a subset of patients 
(approximately 12) will undergo triplicate ECG monitoring to coincide with PK evaluation on Cycle 1/Day 1 predose and at 1, 2, 4, 6, and 8 hours postdose. Note: The exact 
time of the PK blood draw will be recorded, and ECG monitoring is to be completed prior to the PK blood draw or other laboratory evaluations. 


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g RECIST tumor assessment via CT or MRI of abdomen/pelvis and clinically indicated areas required at screening, every 8 weeks (±7 days) from Cycle 1/Day 1 (ie, Cycle 3, 
Cycle 5, Cycle 7) for 6 months, and then every 12 weeks (ie, Cycle 10, Cycle 13, Cycle 16, etc) until progression. Positron emission tomography/CT may be used according to 
RECIST guidelines. Cycle timing will not be delayed for treatment interruptions, and tumor assessment should occur according to this schedule regardless of whether study 
treatment is interrupted. If a patient discontinues treatment for a reason other than disease progression as defined in the protocol or death, withdrawal of consent, or loss to 
follow-up, then scans and CA-125 testing should continue at the specified intervals (until the start of subsequent anticancer treatment). If a patient had a CT/MRI of the 
abdomen/pelvis and clinically indicated areas within the 28-day screening window before Cycle 1/Day 1 but prior to signing the main ICF, the patient is not required to 
complete an additional CT/MRI scan for study screening. CT/MRI scans completed during screening prior to signing the main ICF must have been performed and be able to be 
submitted per the image acquisition guidelines. 
h Chest CT/MRI if not done as part of RECIST tumor assessment at screening. If the chest CT/MRI is clear at screening, repeat chest imaging is not required in the absence of 
lesions to be followed or in the absence of clinical indication requiring follow‐up. 
I Negative serum pregnancy test required within 72 hours from first dose of study treatment (ie, Cycle 1/Day 1) for females of childbearing potential; repeated every 3 months for 
duration of study (ie, Cycle 4, Cycle 7, etc). 
j If screening laboratory testing (serum chemistry, CBC, CA-125) performed within 72 hours of Day 1, repeat testing is not required. 
k If dose interruption or modification is required at any point on study because of hematologic toxicity, weekly blood draws for CBC will be monitored until the AE resolves, and 
to ensure safety of the new dose, weekly blood draws for CBC will be also required for an additional 4 weeks after the AE has been resolved to the specified levels, after which 
monitoring every 4 weeks may resume. 
l Collection of blood for the Cycle 1/Day 8 and Day 22 CBC may be done at the study center’s local laboratory or at a laboratory local to the patient, if approved by the Principal 
Investigator as an adequate laboratory. The laboratory must have the capability to provide results to the Principal Investigator electronically or by fax within 24 hours of blood 
collection. 
m Patients will undergo a single ECG monitoring assessment at screening, prior to laboratory evaluations. At selected sites, a subset of patients (approximately 12) will undergo 
triplicate ECG monitoring to coincide with PK evaluation on Cycle 1/Day 1 predose and at 1, 2, 4, 6, and 8 hours postdose. Triplicate ECGs should be performed between 2 and 
5 minutes apart and should be performed prior to blood draws for PK or other laboratory evaluations. 
n Symptom-directed physical examination is to be conducted at every visit and ECOG assessed every 12 weeks (±7 days) until EOT. 
o Vital signs include BP, pulse, and temperature. Height obtained at screening only. 
p For any suspected MDS/AML case reported while a patient is receiving treatment or being followed for post-treatment assessments, bone marrow aspirate and biopsy testing 
must be completed by a local hematologist. A whole blood sample will also be collected for cytogenetic analysis (mutations of select myeloid-associated genes). Testing 
completed as part of standard of care is sufficient as long as the methods are acceptable to the Sponsor's Medical Monitor. The study site must receive a copy of the 
hematologist’s report of aspirate/biopsy findings (which must include a classification according to World Health Organization criteria) and other sample testing results related to 
MDS/AML. 
q New SAEs recorded up to 30 days after last dose of study treatment administration. 
r Every 90 (±7) days after treatment discontinuation. In addition to survival, this assessment also includes outcomes for subsequent anticancer therapies including any new 
malignancy information. 
 


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1.2.5. 
Efficacy, Pharmacokinetic, and Safety Parameters 
1.2.5.1. 
Efficacy Parameters 
Protocol-specified efficacy parameters include: 
• ORR, which is defined as the proportion of patients achieving confirmed complete 
response (CR) or partial response (PR) as assessed by the Investigator per RECIST 
(v1.1). 
• DOR, which is defined as the time from first documentation of CR or PR until the earlier 
date of first documentation of progressive disease (PD) or death by any cause in the 
absence of progression as assessed by the Investigator per RECIST (v1.1). 
• DCR, which is defined as the proportion of patients achieving best overall response of 
CR, PR, or stable disease (SD) as assessed by the Investigator per RECIST (v1.1). 
• PFS, which is defined as the time from the date of first dose of study treatment to the 
earlier date of assessment of progression or death by any cause in the absence of 
progression as assessed by the Investigator per RECIST (v1.1). 
• OS, which is defined as the time from the date of first dose to the date of death for any 
cause. 
• TFST, which is defined as the time from the date of first dose of study treatment to the 
date of first dose of first subsequent therapy or death, whichever occurs first. 
1.2.5.2. 
Pharmacokinetic Parameters 
A separate analysis plan will describe PK parameters and analyses; considering that the PK 
analyses 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 
protoctol 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. In addition, a separate listing defining “Important” GSK protocol deviations related to 
COVID-19 will be presented. 
 
1.2.5.3. 
Safety Parameters 
Safety parameters evaluated during the conduct of the study include: treatment-emergent AEs 
(TEAEs), clinical laboratory (hematology, chemistry, coagulation, and urinalysis), vital signs, 
ECG, physical examination, Eastern Cooperative Oncology Group (ECOG) performance status, 
and use of concomitant medications. The safety endpoints are: 
• TEAEs 
• Clinical laboratory: 
o Complete blood count (CBC): hemoglobin, platelets, mean platelet volume 
(optional), mean corpuscular volume, white blood cell count, differential white 
cell count (absolute lymphocyte count, percent lymphocytes, absolute neutrophil 
count, and percent neutrophils) 


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o Serum chemistry assessments for safety include: sodium, potassium, calcium, 
magnesium, chloride, glucose, creatinine, total bilirubin, gamma 
glutamyltransferase (GGT), alkaline phosphatase, aspartate aminotransferase 
(AST), alanine aminotransferase (ALT), urea or blood urea nitrogen, total 
protein, albumin, lactate dehydrogenase, amylase 
o Serum CA-125 
o Serum pregnancy testing 
• Physical examination, which includes assessments of the following body systems: 
o General Appearance 
o Dermatologic 
o Head, Eyes, Ears, Nose, and Throat (HEENT) 
o Thyroid 
o Lymph Nodes 
o Respiratory 
o Cardiovascular 
o Gastrointestinal 
o Extremities 
o Musculoskeletal 
o Psychiatric 
• Vital signs: 
o Height (at screening only) 
o Weight 
o Blood pressure 
o Pulse 
o Temperature 
• ECOG performance status 
• ECG (all patients at screening, PK QTc sub-study patients at all time points)  
• Concomitant medications 
Additional safety parameters include study treatment exposure and compliance. 
 


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2. 
PATIENT POPULATION 
2.1. 
Population Definitions 
The following patient populations will be evaluated and used for presentation and analysis of 
the data: 
• Safety (SAF) population is defined as all patients who receive at least 1 dose of study 
drug. 
• Intent-to-Treat (ITT) population is defined as all dosed patients with measurable disease 
at baseline. Measurable disease at baseline is determined by the existence of at least 1 
target lesion at baseline tumor scan. 
• Response-Evaluable (RE) population is defined as all ITT patients with at least 1 
evaluable post-baseline tumor scan. 
Given the single arm study design, the SAF population will be used to summarize the patient 
disposition and baseline characteristics in this study. The ITT population is the primary 
population for the analysis of efficacy endpoints. The SAF population is the primary population 
for the analysis of safety endpoints. The RE population will be used in supportive analyses 
when applicable. 
2.2. 
Protocol Deviations 
Protocol Deviations (PD) will be assessed as important or significant per Sponsor’s SOP. 
• A PD is classified as important if there is the potential to impact the completeness, 
accuracy, and/or reliability of the study data, or affect a patient’s rights, safety, or well-
being. 
• An important PD is classified as significant if it is confrrmed to adversely impact the 
completeness, accuracy, and/or reliability of the study data, or affect a patient’s rights, 
safety, or well-being. 
All PDs will be identified and finalized prior to database lock. 
The following protocol deviation summaries will be provided: 
• Number and percentage of patients with a signficant protocol deviation by type of 
deviation. 
• Number and percentage of patients with an important protocol deviation by type of 
deviation. 
• A listing of all protocol deviations. 
Per-protocol analysis that excludes patients with significant protocol deviations will not be 
performed. 


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3. 
GENERAL STATISTICAL METHODS 
3.1. 
Sample Size Justification 
The study protocol initially allowed enrollment of all patients with at least 3 prior lines of anti-
cancer therapy. In the subsequent protocol amendments, the study enrollment was adjusted to 
allow only HRD-positive patients with 3 or 4 prior lines of anti-cancer therapy. This adjustment 
was made in consideration of the evolving role of PARP inhibitors in ovarian cancer treatment 
based on external data. Overall, approximately 500 patients are expected in the study. The study 
enrollment is also expected to include a minimum number of tBRCAmut patients (≥50) and 
HRD-positive patients (≥150). 
For the primary efficacy endpoint of ORR in HRD-positive patients who have received 3 or 4 
prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based therapy, 
an alternative hypothesis of ORR ≥30% is considered against a null hypothesis of ORR ≤10%. 
For the key secondary efficacy endpoints of ORR tested in broader subgroups to include 
platinum-resistant patients and/or HRD-negative/unknown patients, an alternative hypothesis of 
ORR ≥25% is considered against a null hypothesis of ORR ≤10%. 
It is estimated that 45 patients would provide 90% power for testing the primary efficacy 
analyses. Statistical power for various sample sizes are presented below to provide guidance for 
the key secondary hypotheses when tested individually (regardless of sequential testing) using 
1-sided alpha 0.025. The power is calculated by assuming the exact binomial distribution using 
East® software Version 6.4. 
n 
Statistical Power* 
45 
72% 
60 
85% 
75 
92% 
90 
96% 
* Ho: ORR ≤10% vs Ha: ORR ≥25% 
As of August 2017, approximately 450 patients were dosed in the study. Approximately 320 
patients had 3 or 4 prior lines of anti-cancer therapy (~150 HRD positive). Based on a 
preliminary calculation of the platinum-sensitivity to the last platinum-based therapy, the 
number of enrolled patients for the primary endpoint and the key secondary efficacy endpoints 
are considered adequate to ensure sufficient power for the planned analysis. 
3.2. 
General Methods 
All safety data listings that contain an evaluation date will also contain a relative study day. 
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. The last day of study drug is designated with an “L” (eg, Day 14L). Post-treatment 
study days are numbered relative to the last dose and are designated as Day +1, Day +2, etc. In 
addition to relative day, cycle and day of treatment within cycle will be calculated and 
presented. 


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All output will be incorporated into Microsoft Word or Excel files or Adobe Acrobat PDF files, 
sorted and labeled according to the International Conference on Harmonisation (ICH) 
recommendations[8], and formatted to the appropriate page size(s). 
Tabulations will be produced for appropriate demographic, baseline, efficacy, and safety 
parameters. Unless otherwise stated, all tabulations will be summarized for patients with 3 or 4 
previous chemotherapy regimens, ≥5 previous chemotherapy regimens, and overall (all lines of 
prevous chemotherapy regimens including ≤ 2 lines). 
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. Percentages will be reported to 1 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. 
Time-to-event data will be summarized using Kaplan-Meier (KM) methodology using 25th, 50th 
(median), and 75th percentiles with associated 2-sided 95% confidence intervals (CIs), as well as 
percentage of censored observations. 
Formal statistical hypothesis testing will be performed on the primary efficacy endpoint as 
described in the sections below. 
In addition: 
• P-values greater than or equal to 0.001, in general, will be presented to 3 decimal places; 
p-values less than 0.001 will be presented as “<0.001” 
• CIs will be presented to 1 more decimal place than the raw data 
• Weeks will be calculated as Number of days divided by 7 
• Months will be calculated as Number of days divided by 30.4375 
• Years will be calculated as Number of days divided by 365.25 
• Day 1 will be considered as the first day of treatment 
• End of Study is defined as the last available study assessment 
• All tables, figures, and listings will include footers at the bottom of the page reflecting 
the path and date of the datasets, datasets used to generate the tables, figures, and 
listings, and date and time of the generation of the output 
 
Note regarding 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. 
 


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3.3. 
Computing Environment 
All statistical analyses will be performed using SAS statistical software v9.4 or later, unless 
otherwise noted. Medical history and AEs will be coded using the Medical Dictionary for 
Regulatory Activities (MedDRA) v20.0 or later. Laboratory parameter changes 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. 
3.4. 
Baseline Definitions 
For all analyses except ECG, baseline is defined as the most recent measurement prior to the 
first administration of study drug. For ECG analyses, baseline will be defined as the average of 
the closest triplicate (if triplicates were collected) readings prior to dosing on the first day that 
study drug is administered. 
3.5. 
Methods of Pooling Data 
Data will be pooled across study sites. 
3.6. 
Adjustments for Covariates 
No formal statistical analyses that adjust for possible covariate effects are planned for the 
efficacy or safety endpoints. Formal analyses adjusting for possible covariate effects for the PK 
endpoints are contained in a separate SAP. 
3.7. 
Multiple Comparisons/Multiplicity 
Multiplicity is controlled by conducting a hierarchical testing of the primary endpoint and the 
key secondary endpoints. 
3.8. 
Subpopulations 
3.8.1. 
Prior Lines of Chemotherapy 
The reported cancer therapy regmens from eCRF page (Ovarian Cancer Treatment) will be 
checked with the per-protocol list of chemotherapy regimens to determine patients with 3 or 4 
previous chemotherapy regimens consistent with the protocol inclusion criteria #5: 
• Patients must have completed 3 or 4 previous chemotherapy regimens (eg, gemcitabine, 
doxorubicin, topotecan, carboplatin, oxaliplatin, cisplatin, bevacizumab, or PARP 
inhibitors as single agents or in combination per standard of care). 
A list of the per-protocol chemotherapy regimens is provided in the Appendix (Section 7.5). 
Patients will be classified by ≤2, 3-4, and ≥5 previous chemotherapy regimens based on the per-
protocol chemotherapy regimens, and summarized by: 
• Number and percentage by the number of prior chemotherapy regimens 
• Duration (in months) between the end date of the last chemotherapy regimen and the 
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3.8.2. 
Response to the Last Platinum-Based Therapy 
Platinum-free interval (PFI) to the last platinum-based therapy will be determined between the 
reported stop date of the last platinum-based therapy and the reported date of disease 
progression following the last platinum-based therapy. 
• Platinum-sensitive: PFI ≥6 months (180 days) after the end date of last platinum-based 
therapy 
• Platinum-resistant: PFI >4 weeks (28 days) and <6 months (180 days) after the end date 
of last platinum-based therapy 
• Platinum-refractory: PFI ≤4 weeks (28 days) after the end date of last platinum-based 
therapy 
• Response-unknown: PFI is missing. PFI is missing if both dates are completely missing. 
Partial dates will be handled according to Section 3.10 
The per-protocol platinum-based therapies are determined using the list in the Appendix 
(Section 7.5). 
Patients will be summarized by: 
• Number and percentage by the number of prior platinum-based therapies 
• Duration (in months) between the end date of the last platinum-based therapy and the 
date of first dose of study treatment 
3.8.3. 
Prior PARP Treatment 
Patients with any PARP treatment prior to the first dose of study treatment will be identified and 
analyzed for exploratory purpose. 
The list of prior PARP treatment includes: nirapariab, olaparib, rucaparib, and veliparib. 
3.8.4. 
Biomarker Subpopulations 
3.8.4.1. 
Biomarker Definitions 
BRCA mutation (BRCA-mut): A deleterious or suspected deleterious BRCA1 or BRCA2 
mutation found in a tumor and/or in blood. In this document, BRCA-mut refers to patients with 
either germline or somatic mutation. 
• Germline BRCA mutation (gBRCA-mut): A germline BRCA mutation is an inherited 
deleterious or suspected deleterious mutation in either a BRCA1 or BRCA2 tumor 
suppressor gene found in blood. 
• Somatic BRCA mutation (sBRCA-mut): A somatic BRCA mutation is a deleterious or 
suspected deleterious alteration in the BRCA1 or BRCA2 genes that is acquired after 
conception (not hereditary). sBRCA-mut can be determined by the presence of tumor 
BRCA mutation (tBRCA-mut) but the absence of gBRCA-mut in blood. 
BRCA wild type (BRCA-wt): A tumor and/or blood does not possess either a deleterious or 
suspected deleterious germline or a somatic BRCA mutation. In this document, BRCA-wt refers 
to patients without gBRCA-mut and sBRCA-mut. 


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Homologous recombination deficiency (HRD) – Dysregulation in the homologous 
recombination pathway (due to genetic mutations or alterations) leading to cellular genomic 
instability and an inability to efficiently repair damaged DNA. 
HRD positive (HRD-pos): HRD positive status may be determined by the myChoice HRD test. 
Any tumor that scores ≥42 or has a deleterious or suspected deleterious BRCA mutation would 
be considered HRD positive. 
HRD negative (HRD-neg): HRD negative status may be determined by the myChoice HRD test. 
Any tumor that scores <42 and does not possess a deleterious or suspected deleterious BRCA 
mutation would be considered HRD negative. 
3.8.4.2. 
Study-Specific Biomarker Populations 
In this study, tumor BRCA and HRD status are determined by tumor samples at screening via 
the myChoice HRD test. The gBRCA status is determined by a central test of blood samples at 
screening and recorded in the eCRF BRCA form. 
All patients will be classified by BRCA mutation status as follows: 
• BRCA-mut: 
o gBRCA-mut: patients with any variant or large rearrangement found in 
BRCA1/2 that is either positive for a deleterious mutation or genetic variant for 
suspected deleterious 
o sBRCA-mut: patients with tBRCA-mut but without gBRCA-mut 
• BRCA-wt: patients without gBRCA-mut and sBRCA-mut 
• BRCA unknown (BRCA-unk): None of tBRCA and gBRCA test results available (eg, 
test canceled, incomplete/inconclusive, or data missing for a patient). 
All patients will be summarized by HRD status in the following subgroups: 
• HRD-pos: 
o BRCA-mut 
o (BRCA-wt or BRCA-unk) and HRD test score ≥42 
• HRD-neg: (BRCA-wt or BRCA-unk) and HRD test score <42 
• HRD unknown (HRD-unk): HRD test result not available (eg, test canceled, 
incomplete/inconclusive, or data missing for a patient) 
In addition, the tBRCA-mut patients will also be summarized based on the reported BRCA 
variants found in tumor: 
• BRCA1 variant 
• BRCA2 variant 
The gBRCAmut patients will also be summarized based on the reported BRCA variants found 
in blood and recorded in the eCRF BRCA form:  
• BRCA1 variant 
• BRCA2 variant 


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• Large rearrangement in BRCA1/2 
If applicable, other exploratory biomarker subpopulations may be further defined and analyzed. 
3.9. 
Withdrawals, Dropouts, Loss to Follow-up 
Patients who are withdrawn or discontinue from the study will not be replaced. 
3.10. 
Missing Data 
In general, there will be no substitutions made to accommodate missing data points. All data 
recorded on the eCRF will be included in data listings that will accompany the CSR. 
When calculating PFI to the last platinum-based therapy, partial dates of the last platinum-based 
therapy and the disease progression following the last platinum-based therapy will be handled as 
follows. If the day of the month is missing, the day will be set to the first day of the month. If 
the day and month are both missing, the day and month will be assumed to be January 1. If the 
imputed date of the disease proression following the last platinum-based therapy is earlier than 
the end date of the last platinum-based therapy, the imputed date of the disease progression will 
be set equal to the end date of the last platinum-based therapy. Imputation of partial dates is 
used only to estimate PFI; data listings will present the partial date as recorded in the eCRF. 
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 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 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 study treatment. In this case, the event onset will be coded to the day of 
treatment in order to conservatively report the event as treatment-emergent. A missing onset 
date will be coded as the day of 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. 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. 


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3.11. 
Visit Windows 
Table 3-1 
Evaluation Intervals 
Evaluation 
Protocol-Specified Interval 
Interval for Analysis 
Screening 
Day -28 to Day -1 
Day -28 to Day -1 
Cycle 1, Day 1 
Day 1 
Day 1 
Cycle 1, Day 8 
Day 5 to Day 11 
Day 5 to Day 11 
Cycle 1, Day 15 
Day 12 to Day 18 
Day 12 to Day 18 
Cycle 1, Day 22 
Day 19 to Day 25 
Day 19 to Day 25 
Cycle n, Day 1 
Day 28(n-1) - 3 to Day 28(n-1) + 3* 
Day 28(n-1) - 3 to Day 28(n-1) + 3* 
End of Treatment 
Within 7 days of last dose, except for AEs 
which will be collected for up to 30 days 
after the date of the last dose 
Within 7 days of last dose, except for 
AEs which will be collected for up to 
30 days after the date of the last dose 
Abbreviations: AE = adverse event; ECOG = Eastern Cooperative Oncology Group; RECIST = Response Evaluation Criteria in 
Solid Tumors. 
* Symptom-directed physical examination and ECOG performance status are required every 12 weeks (±7 days), 
serum pregnancy tests are required at 3-month intervals from screening (Cycles 4, 7, etc), and RECIST (v1.1) 
tumor assessments (as clinically indicated) are required every 8 weeks (±7 days) for 6 months and then every 
12 weeks (±7 days) until progression. Therefore, the symptom-directed physical examinations and ECOG 
performance status are required at Cycle 4, Cycle 7, etc, with a protocol-specified interval and an interval for 
analysis of Day 28(n-1) – 7 to Day 28(n-1) + 7 (where n is the cycle number). RECIST tumor assessments are 
required at Cycles 3, 5, 7, 10, 13, etc, with a protocol-specified interval and an interval for analysis of 
Day 28(n-1) – 7 to Day 28(n-1) + 7 (where n is the cycle number). 
Note: Day 25 is contained within both the Cycle 1 Day 22 and the Cycle 2 Day 1 visit windows. 
Visits occurring on Day 25 will be classified based on the purpose of the visit. 
It is expected that all visits should occur according to the protocol schedule. By-visit summaries 
and analyses will be 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). In data 
listings, the relative day of all dates will be presented. 
3.12. 
Administrative Interim Analyses 
Safety data from this study collected through 20 May 2016 was analyzed to write an interim 
CSR and for inclusion as part of the integrated summaries of safety in the niraparib submission 
in the second half of 2016. Efficacy data from this study were not analyzed. 


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4. 
STUDY ANALYSES 
4.1. 
Patient Disposition 
Patient disposition will be tabulated and include the numbers of screened patients (who have 
signed informed consent) and the numbers of patients in each patient population for analysis, the 
numbers who discontinued treatment and discontinued study and reason(s) for withdrawal, and 
the number of patients who died. 
Tables will be summarized by 3-4 prior lines, ≥5 prior lines, and Overall. A by-patient data 
listing of study completion information including the reasons for treatment discontinuation 
and/or study discontinuation will be presented. 
4.2. 
Demographics, Baseline Characteristics, and Medical History 
Demographics, baseline characteristics, and medical history information will be summarized 
using descriptive statistics. Tables will be summarized by 3-4 prior lines, ≥5 prior lines, and 
Overall. No formal statistical comparisons will be performed. 
Demographic and baseline data for each patient will be provided in data listings. 
The demographic and baseline characteristics tables will include the following variables: 
• Region (US, Canada) 
• Age at time of screening (years) calculated as date of screening minus date of birth / 
365.25, unless local regulations prevent the collection of date of birth, in which case age, 
as reported on the eCRF, will be used 
• Age categories (18 to <65, 65 to <75, ≥75; and ≥65) 
• Reproductive status (childbearing/non-childbearing potential) 
• Race (White, Black, Asian, American Indian/Alaska native, native Hawaiian or other 
Pacific Islander, other, unknown, and not reported) 
• Ethnicity (Hispanic, non-Hispanic, unknown, and not reported) 
• Time from first diagnosis to first dose (years) 
• Primary tumor site (ovarian, primary peritoneal, or fallopian tube) 
• International Federation of Gynecology and Obstetrics (FIGO) stage at time of initial 
diagnosis 
• Baseline weight (in kilograms, last value prior to first dose; if weight is reported in 
pounds, convert to kilograms by dividing by 2.2) 
• Baseline height (in centimeters, last value prior to first dose; if height is reported in 
inches, convert to centimeters by multiplying by 2.54) 
• Baseline body mass index (BMI) (kg/m2), calculated using the patient’s height and 
weight at Baseline [BMI (kg/m2) = weight (kg) / height (m)2] 
• ECOG performance status at baseline 
• History of myelosuppression (thrombocytopenia, leukopenia, anemia, or neutropenia) 
within the past year 


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• History of blood transfusion 
• History of thrombocytopenia with grade 3 or 4 (repeated for leukopenia, anemia, and 
neutropenia) 
• Prior ovarian cancer treatment, including number of prior lines of chemotherapy, number 
of prior platinum courses, any surgeries/procedures related to the study indication, 
number of surgeries, any radiotherapy prior to enrollment, response to last platinum-
based therapy, PFI (months) after the last platinum-based therapy 
• Histology and grade of disease at diagnosis and most recent biopsy, if additional biopsy 
performed 
• BRCA and HRD status including: 
o gBRCA-mut variant [BRCA1, BRCA2, Large rearrangement in BRCA1/2] 
o tBRCA-mut variant [BRCA1, BRCA2] 
o BRCA status [BRCA-mut, gBRCA-mut and sBRCA-mut status within BRCA-
mut; BRCA-wt; BRCA-unk] 
o HRD status [HRD-pos, BRCA-mut and (BRCA-wt/BRCA-unk and HRD ≥42) 
within HRD-pos; HRD-neg; HRD-unk] 
• Prior PARP treatment (yes, no) 
Medical history will be coded using MedDRA v20.0 or later, and the number and percentage of 
patients experiencing at least 1 such diagnosis by MedDRA System Organ Class (SOC) and 
preferred term (PT) will be reported. 
In addition, the following baseline subgroups will be presented for all patients, patients without 
prior PARP treatment and with prior PARP, respectively. 
• BRCA status [BRCA-mut, BRCA-wt, BRCA-unk] by the response to the last platinum-
based therapy 
• HRD status [HRD-pos, HRD-neg, HRD-unk] by the response to the last platinum-based 
therapy 
4.3. 
Efficacy Evaluation 
4.3.1. 
Efficacy Variables for Primary and Key Secondary Analyses 
The primary and key secondary efficacy analyses will be based on the investigator-assessed 
confirmed ORR per RECIST v1.1. 
At each evaluation, the criteria in Table 4-1 were used to define each patient’s overall response 
at that evaluation. 


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Table 4-1 
Overall Response for Patients with Measureable Disease at Study Entry 
Target Lesions 
Non-Target Lesions 
New Lesions 
Overall Response 
CR 
CR 
No 
CR 
CR 
Non-CR/Non-PD 
No 
PR 
CR 
Not evaluated 
No 
PR 
PR 
Non-CR/Non-PD/Not evaluated 
No 
PR 
SD 
Non-CR/Non-PD/Not evaluated 
No 
SD 
PD 
Any 
Yes or No 
PD 
Any 
PD 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
Abbreviations: CR = complete response; PD = progressive disease; PR = partial response; SD = stable disease. 
As confirmed CR/PR is required, the best overall response (BOR) will be determined as shown 
in Table 4-2. 
Given protocol scheduled tumor assessment interval is every 8 weeks (±7 days) from 
Cycle 1/Day 1 for 6 months and then every 12 weeks (±7 days) until progression. The minimum 
criteria for SD duration are at least 7 weeks from the date of first dose of study treatment. 


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Table 4-2: 
Best Overall Response when Confirmation of CR and PR Required 
Overall 
Response First 
Time Point 
Overall Response Subsequent 
Time Point (at least 4 weeks) 
Best Overall Response 
CR 
CR 
CR 
CR 
PR 
SD provided minimum criteria for SD duration met, 
otherwise, PD 
CR 
SD 
SD provided minimum criteria for SD duration met, 
otherwise, PD 
CR 
PD 
SD provided minimum criteria for SD duration met, 
otherwise, PD 
CR 
NE 
SD provided minimum criteria for SD duration met, 
otherwise, NE 
PR 
CR 
PR 
PR 
PR 
PR 
PR 
SD 
SD provided minimum criteria for SD duration met, 
otherwise, NE 
PR 
PD 
SD provided minimum criteria for SD duration met, 
otherwise, PD 
PR 
NE 
SD provided minimum criteria for SD duration met, 
otherwise, NE 
SD 
SD 
SD provided minimum criteria for SD duration met, 
otherwise, NE 
SD 
PD 
SD provided minimum criteria for SD duration met, 
otherwise, PD 
SD 
NE 
SD provided minimum criteria for SD duration met, 
otherwise, NE 
NE 
NE 
NE 
Abbreviations: CR = complete response; NE = not evaluable; PD = progressive disease; PR = partial response; SD = stable 
disease. 
For each patient, BOR will be determined based on the overall responses at all time points 
between the date of first dose and the date of first documented radiological disease progression, 
or the date of subsequent anti-cancer therapy, or the date of study discontinuation, whichever 
occurs first. Specifically: 
• Day 1 can be determined from the “dose administration date” field on the “first dose” 
form. 
• The date of radiological disease progression can be determined by selecting the earliest 
date from the “date of the radiological scan or assessment on which the response 
evaluation was based” field on the “evaluation of response (RECIST)” form where 
“overall response” = PD. 
• Subsequent anti-cancer therapy can be determined by checking for any entries made on 
the “follow up anti-cancer therapy” form. 


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• The date of premature study discontinuation can be determined by using the “date of 
premature study discontinuation” field on the “premature study discontinuation” form. 
This date should be compared to the date on the “discontinuation of treatment” form 
where the primary reason for discontinuation is listed as “lost to follow up,” “death,” 
“sponsor decision to terminate study,” or “patient withdrew consent.” If these dates 
differ, select the earlier date. 
• For each patient, select all “evaluation of response (RECIST)” forms meeting the 
following criteria: 
o The “date of the radiological scan or assessment on which the response 
evaluation was based” is after Day 1. 
o The “date of the radiological scan or assessment on which the response 
evaluation was based” is on or before the date of radiological disease 
progression, date that anti-cancer therapy first began, and the date of study 
discontinuation. If the patient did not experience radiological disease 
progression, begin anti-cancer therapy, or discontinue the study prematurely, 
select all forms after Day 1. 
Patients with a BOR of either confirmed CR or PR are considered to have responded to 
treatment (“responders”) for the primary efficacy variable (ORR). All other patients are 
considered to have not responded to treatment (“non-responders”) for the primary efficacy 
variable. 
The primary efficacy analysis will be testing the alternative hypothesis of ORR ≥30% will be 
tested against a null hypothesis of ORR ≤10% in the HRD-positive patients who have received 
3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based 
therapy. Patients with prior PARP inhibitor treatment are excluded. 
The key secondary efficacy analyses will be sequentially testing the alternative hypothesis of 
ORR ≥25% against a null hypothesis of ORR ≤10% in: 
• All patients who have received 3 or 4 prior lines of anti-cancer therapy and are platinum-
sensitive to the last platinum-based therapy, regardless of HRD status (excluding 
patients with prior PARP treatment) 
• All patients who have received 3 or 4 prior lines of anti-cancer therapy and are platinum-
sensitive or platinum-resistant to the last platinum-based therapy, regardless of HRD 
status (excluding patients with prior PARP treatment) 
• All patients treated in the study 
The ORR and 2-sided 95% confidence interval along with a 1-sided p-value for testing the null 
hypothesis (one-sided alpha 0.025) based on the binomial distribution will be provided. The 
exact (Clopper-Pearson) method will be used to calculate 2-sided 95% CI. This can be 
programmed in SAS by appending the “/ BINOMIAL(EXACT)” option to the end of the 
appropriate “TABLE” statement. 


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The following subgroup analyses on ORR will be performed for the largest patient population 
achieving statistical significance among the sequential testing of primary and key secondary 
endpoints, and for all treated patients unless already available: 
• Age categories [<65, ≥65] 
• Primary tumor site [ovarian, primary peritoneal, fallopian tube] 
• Response to last platinum-based therapy [platinum-sensitive, platinum-resistant, 
platinum-refractory, response-unknown] 
• BRCA status [BRCA-mut, BRCA-wt, BRCA-unk] 
• HRD status [HRD-pos, HRD-neg, HRD-unk] 
• HRD-pos [BRCA-mut, (BRCA-wt/BRCA-unk and HRD score ≥42)] 
• BRCA-mut [gBRCA-mut, sBRCA-mut] 
• tBRCA-mut variant [BRCA1, BRCA2] 
• gBRCA-mut variant [BRCA1, BRCA2, large rearrangement in BRCA1/2] 
• Prior PARP treatment [yes, no] 
4.3.2. 
Secondary Efficacy Variables 
4.3.2.1. 
Duration of Response 
For patients who responded to treatment, DOR (in months) is defined as the earliest date of 
initial response date of confirmed CR or PR to the earliest date of radiological PD or death, 
calculated as: 
[Earliest date of radiological PD or death –  
Earliest of (Date of confirmed CR or PR) + 1] / 30.4375 
Table 4-3 provides a summary of the censoring rules used in DOR analysis. 
Table 4-3: 
Censoring Rules used in Duration of Response Analysis 
Situation 
Date of Event or Censoring 
Outcome 
Start of subsequent anti-cancer therapy 
prior to a documented radiological 
progression or death 
Date of last radiological tumor assessment 
prior to or on the date of initiation of the 
subsequent anti-cancer therapy 
Censored 
Free of radiological progression and no 
subsequent anti-cancer therapy started and 
no death 
Date of last radiological tumor assessment 
Censored 
Documented radiological progression or 
death after 2 or more consecutive missing 
radiological assessments 
Date of last radiological tumor assessment 
prior to the missed radiological assessment 
Censored 
Documented radiological progression or 
death 
Earliest date of documented radiological 
progression or death 
Event 
Details about defining CR, PR, PD, and end of study can be found in Section 4.3.1. 


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For each of the patient populations in the primary and key secondary endpoints, a time-to-event 
analysis of DOR will be performed respectively using KM methods including quartile estimates 
and 2-sided 95% CIs. A figure will be produced. 
The same subgroup analyses performed for ORR will be peformed for DOR. 
4.3.2.2. 
Disease Control Rate 
Patients who achieved a best overall response rate of CR, PR, or SD (SD must have met the 
7-week criteria described in Section 4.3.1) will be considered “responders” for this endpoint. All 
other patients will be considered “non-responders” for this endpoint. Details about defining best 
overall response rate can be found in Section 4.3.1. 
For each of the patient populations in the primary and key secondary endpoints, the DCR and 
2-sided 95% CI will be provided respectively. The exact (Clopper-Pearson) method will be used 
to calculate 95% CI. This can be programmed in SAS by appending the 
“/ BINOMIAL(EXACT)” option to the end of the appropriate “TABLE” statement. 
4.3.2.3. 
Progression-Free Survival 
Progressive disease (PD) will be determined based on RECIST criteria as defined in 
Section 4.3.1. 
PFS (in months) is defined as the time from the date of first dose to the earlier date of 
radiological PD or death from any cause, calculated as: 
[Earlier of (Date of radiological PD or death) – First dose date + 1] / 30.4375 
Table 4-4 provides a summary of the censoring rules used in PFS analysis. 
Table 4-4: 
Censoring Rules used in Progression-Free Survival Analysis 
Situation 
Date of Event or Censoring 
Outcome 
No baseline tumor assessments 
First dose date 
Censored 
No post-baseline tumor assessments and no 
death 
First dose date 
Censored 
Start of subsequent anti-cancer therapy 
without a prior documented radiological 
progression or death 
Date of last post-baseline radiological tumor 
assessment prior to or on the date of 
initiation of the subsequent anti-cancer 
therapy 
Censored 
Free of radiological progression and no 
subsequent anti-cancer therapy started and 
no death 
Date of last post-baseline radiological tumor 
assessment 
Censored 
Documented radiological progression or 
death after 2 or more consecutive missing 
radiological assessments 
Date of last post-baseline radiological tumor 
assessment prior to the missed radiological 
assessment 
Censored 
Documented radiological progression or 
death 
Earliest date of radiological PD or death 
Event 
For each of the patient populations in the primary and key secondary endpoints, a time-to-event 
analysis of PFS will be performed respectively using KM methods including quartile estimates 
and 2-sided 95% CIs. A figure will be produced. 


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4.3.2.4. 
Time to First Subsequent Therapy 
TFST (in months) is defined as the date of first dose of study treatment in the current study to 
the earlier date of first dose of first subsequent therapy or death, calculated as: 
[Earlier of (First dose of first subsequent therapy or death) – First dose date + 1] / 30.4375 
Patients who are alive without a subsequent therapy will be censored on the last contact date. 
For each of the patient populations in the primary and key secondary endpoints, a time-to-event 
analysis of TFST will be performed respectively using KM methods including quartile estimates 
and 2-sided 95% CIs. A figure will be produced. 
4.3.2.5. 
Overall Survival 
Overall survival (in months) is defined as the time from the date of the first dose to the date of 
death for any cause, calculated as: 
[Date of Death – First dose date + 1] / 30.4375 
Patients who are known to be alive will be censored at the last contact date. 
For each of the patient populations in the primary and key secondary endpoints, a time-to-event 
analysis of OS will be performed respectively using KM methods including quartile estimates 
and 2-sided 95% CIs. A figure will be produced. 
4.3.2.6. 
Pharmacokinetic Evaluations 
Details of the population PK and intensive PK analyses, including combined analyses of the 
ECG variables and PK parameters, will be contained in a separate analysis plan. 
4.4. 
Safety Analyses 
Safety analyses will be conducted using the Safety population. 
4.4.1. 
Study Treatment Exposure 
Extent of treatment will be summarized as follows: 
• Number and percent of patients beginning 1, 2, 3, ..., 12, and >12 cycles. 
• Number of cycles started summarized as a continuous variable. 
• Overall treatment exposure (months), defined as the [last dose date - first dose date + 1] / 
30.4375, will be summarized and graphed both as a continuous and time-to-event 
variable. 
• Time on study (months), defined as the [last visit date or date of death - first dose date + 
1] / 30.4375, will be summarized and graphed both as a continuous and time-to-event 
variable. 
Intensity of study treatment: 
• The total number of capsules consumed is the sum of the number of capsules dispensed 
less the sum of the number of capsules returned by the patient during the study. The sum 
of the daily doses consumed (mg) is the total number of capsules consumed multiplying 
by 100 mg. Unused capsules not returned will be assumed to have been consumed. 


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• Dose intensity (mg/day), defined as sum of the daily doses actually consumed divided by 
overall treatment exposure (converted to days), will be summarized as a continuous 
variable. 
• Relative dose intensity (%), defined as dose intensity (mg/day) divided by intended dose 
intensity (mg/day), where intended dose intensity is 300 mg/day, will be summarized as 
a continuous variable. 
Dose reductions and dose interruptions by cycle: 
• Number and percentage of patients with a dose reduction, defined as the dose consumed 
is less than the dose prescribed, for any reason and due to an AE. 
• Number and percentage of patients with a dose interruption, defined as the dose 
consumed is 0 mg, for any reason and due to an AE. 
Dosing information for each patient will be presented in a data listing. 
4.4.2. 
Study Treatment Compliance 
Patient compliance with the study drug will be assessed via pill counts during the study. 
For each cycle, study drug compliance (%) will be defined on the patient level by the dosing 
compliance ratio: the number of capsules consumed (the number of capsules dispensed less the 
number of capsules returned by the patient) divided by the number of capsules prescribed per 
protocol for a patieint in a cycle. 
• Number of capsules dispensed per cycle is 93 capsules in a bottle throughout the trial. If 
the prescribed dose level at a cycle is unknown, assume both number of capsules 
prescribed and number of capsules dispensed at this cycle is 0. Otherwise: 
o Number of capsules prescribed for 300 mg/day per cycle is calculated by 
3 capsules per day multiplied by the actual treatment duration (day) in the cycle 
o Number of capsules prescribed for 200 mg/day per cycle is calculated by 
2 capsules per day multiplied by the actual treatment duration (day) in the cycle 
o Number of capsules prescribed for 100 mg/day per cycle is calculated by 
1 capsule per day multiplied by the actual treatment duration (day) in the cycle 
o The calculated number of capsules prescribed for a cycle will be capped at the 
maximum number of 93 capsules 
• The treatment duration in a cycle n is calculated by the start date of dose prescribed at 
next cycle n+1 minus the start date of dose prescribed at cycle n. If a patient 
discontinued study treatment during the cycle n, the treatment duration is calculated by 
the date of the last study dose minus the start date of dose prescribed at cycle n. The 
relevant data are in the eCRF pages: First Dose, Study Medication, and Discontinuation 
of Treatment. 
o If the treatment duration for a cycle can not be derived due to missing date, 
assume 28 days 
o If the number of returned capsules is missing in a cycle, assume the number of 
capsules consumed to be the prescribed number of capsules/day (eg, 3/2/1 
capsules per day) multiplied by the treatmdnt duration in that cycle 


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• Any dose reduction in the middle of a cycle will not impact the compliance calculation 
in the current cycle. It will be taken into account for the compliance calculation at the 
next cycle as the reduced dose level will become the prescribed dose for that patient at 
the start of the next cycle. 
• For any patients still ongoing with treatment at the time of analysis, compliance will be 
calculated up to and including the most recently completed cycle. 
The overall study drug compliance (%) on the patient level is the total number of capsules 
consumed by a patient in all cycles divided by the total number of capsules prescribed per 
protocol for a patient in all cycles during the study. 
A patient is evaluated as compliant if the patient has taken 80% to 120% of the prescribed 
capsules during the study. Study drug compliance rate (%) and the proportions of patients 
(<80%, 80%-120%, >120%) will be summarized. 
4.4.3. 
Adverse Events 
4.4.3.1. 
Overview 
All AEs will be classified using MedDRA v20.0 or later. The severity of the toxicities will be 
graded according to the NCI CTCAE v4.03. Any AEs leading to death or discontinuation of 
study treatment, events classified as NCI CTCAE v4.03 Grade 3 or higher, study treatment-
related events, and SAEs will be presented. 
Any TEAEs will be defined as: 
• Any new AE (one that was not seen prior to the start of treatment) that occurs for the 
first time after at least 1 dose of study treatment has been administered; or, 
• A preexisting condition (one that was seen prior to the start of treatment) that worsens in 
severity (according to the CTCAE grade) after at least 1 dose of study treatment has 
been administered. 
• Note: 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. 
All AEs will be collected from the time of signing the main ICF through the EOT visit. New 
SAEs (including deaths) will be collected for 30 days after the EOT visit. Any AEs recorded in 
the database that occur from the time of informed consent 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. 
Related TEAEs are defined as TEAEs considered likely related or related to treatment as judged 
by the Investigator. Any AEs for which the relationship to study drug is missing will be 
considered as related to study treatment. 
The number and percentage of patients reporting a TEAE will be summarized by SOC, PT, 
toxicity grade, and relationship to study drug. 
The toxicity grade of AEs as assessed by the investigator will be graded using 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. 


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The relationship of each AE to the study drug will be summarized as assessed by the 
Investigator. All AEs for which the relationship to study drug is missing will be considered as 
related. 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. 
A high-level overview of AEs 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 TEAE, 
any grade ≥3 TEAE, any treatment-related grade ≥3 TEAE, any treatment-emergent serious 
adverse events (SAEs), any treatment-related serious TEAE, any AE leading to study drug 
interruption, any AE leading to study drug reduction, any AE leading to study drug withdrawal, 
any TEAE leading to death, and any pregnancies. 
All AE tables will be summarized on the SAF population by 3-4 prior lines, ≥5 prior lines, and 
Overall. Subgroup analyses of TEAEs will be conducted in the following subgroups on the SAF 
respectively by 3-4 prior lines, ≥5 prior lines, and Overall: 
• Age (<65 vs ≥65 years) 
• Primary tumor site (ovarian, peritoneal, fallopian tube) 
• Response to last platinum-based therapy (platinum-sensitive, platinum-resistant, 
platinum-refractory, response-unknown) 
• Patients with prior PARP treatment 
The following lists the AE tables to be displayed; those designated with an ‘*’ will be produced 
for the subgroups described above. 
• Overview of AEs* 
• TEAE by SOC and PT* 
• TEAE by PT (sorted by frequency)* 
• Related TEAE by SOC and PT 
• Treatment-emergent SAEs by SOC and PT* 
• Related treatment-emergent SAEs by SOC and PT 
• TEAE by SOC, PT, and maximum grade 
• Related TEAE by SOC, PT, and maximum grade 
• Grade ≥3 TEAEs by SOC and PT* 
• Grade ≥3 TEAEs by PT (sorted by frequency)* 
• Related Grade ≥3 TEAEs by SOC and PT 
• TEAEs resulting in death by SOC and PT 
• TEAEs resulting in study drug dose interruption by SOC and PT 
• TEAEs resulting in study drug dose reduction by SOC and PT 
• TEAEs resulting in study drug withdrawal by SOC and PT* 


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• TEAEs of special interest (AESI) and other grouped events in Section 4.4.3.2, by the 
grouped event and PT within each group 
o All TEAEs* 
o Grade ≥3 TEAE* 
o SAEs 
o TEAE resulting in dose interruption 
o TEAE resulting in dose reduction 
o TEAE resulting in study drug withdrawal 
o Grade ≥3 TEAE resulting in study drug withdrawal 
• Non-serious TEAEs ≥5% by SOC and PT (required by ClinicalTrials.gov) 
Tables structured as listings will be provided for the following: 
• Deaths 
• SAEs 
• TEAEs resulting in study drug interruption 
• TEAEs resulting in study drug dose reduction 
• TEAEs resulting in study drug withdrawn 
• AESI and other grouped events 
• Mapping of AE reported term to PT 
• Patients developing MDS/AML; this listing will include the following: 
o Age and weight of patients with documented MDS/AML 
o Number of previous chemotherapy regimens 
o Types of previous chemotherapies 
o Time from last platinum therapy to start of study drug 
o Prior history of myelosuppression 
o Myelosuppression AESIs on study 
o Fluorescence in situ hybridization (FISH) result if available 
Adverse event summaries 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). 
4.4.3.2. 
Adverse Events of Special Interest 
In the latest protocol amendment v8.0, the Adverse Events of Special Interest (AESIs) for this 
study are MDS, AML, secondary cancers (new malignancies other than MDS/AML), 
pneumonitis, and embryo-fetal toxicity. 


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4.4.3.3. 
Other Adverse Events of Interest 
In addition to AESIs, other AEs such as myelosuppression and hyptertension are also grouped 
for analysis. Table 4-5 outlines all the grouped events including AESIs with the criteria of 
mapping MedDRA PTs for each group using Standardized MedDRA Queries (SMQs), High 
Level Terms (HLTs), and/or PTs. A complete list of grouped events is provided in the Appendix 
(Section 7.1). 
For TEAEs of special interest and other grouped events, the following analyses will be 
performed: 
• Tabulations of all TEAEs, Grade ≥3 TEAEs, SAEs, TEAEs leading to dose interruption, 
dose reduction and withdrawal of study drug will be presented. 
• A summary of all myelosuppression events and myelosuppression events ≥Grade 3 in 
severity will be produced to display the incidence of these events amongst patients with 
and without a prior history of myelosuppression. 
• Tabulations of the thrombocytopenia event will be summarized by baseline platelet 
cutoffs. 
• Tabulations of the anemia event will be summarized by baseline hemoglobin level. 
• Tabulations of the thrombocytopenia, anemia, leukopenia, and neutropenia event will be 
summarized based on prior history of thrombocytopenia, anemia, leukopenia, and 
neutropenia event, respectively. 
• Tabulations of all the AESI and other grouped events and ≥Grade 3 events for the 
subgroups described in the analysis of all TEAEs. 
• A summary tabulation for patients who experienced thrombocytopenia event and who 
did and did not receive platelet transfusion (World Health Organization [WHO] drug 
preferred terms of platelets or platelets concentrated). 
• A summary tabulation for patients who experienced anemia event and who did and did 
not receive red blood cell transfusion (WHO drug preferred terms of blood cells, packed 
human; red blood cells; red blood cells concentration; blood transfusion, auxiliary 
products) or who did and did not receive erythropoietin. 
• A summary tabulation for patients who experienced neutropenia event and who did and 
did not receive colony stimulating factors (WHO drug preferred terms of filgrastim or 
granulocyte colony stimulating factor). 
• A summary tabulation and a figure of time to first onset for each grouped event. 
• 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:  
o Treatment sequence  
o Patient number  
o COVID-19 case diagnosis  


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o COVID-19 test performed  
o Result of the COVID-19 test  
o Assessments and symptom assessments performed  
o Results of the assessments and symptom assessments.  
 
Table 4-5: 
Adverse Events of Special Interest and Other Grouped Events 
Group Term 
MedDRA V18.1 Criteria for Selection of Preferred Terms1 
Thrombocytopenia events 
Haematopoietic thrombocytopenia SMQ (Broad) 
Anemia events 
Haematopoietic erythropenia SMQ (Broad) 
Leukopenia events 
Haematopoietic leukopenia SMQ (Broad) 
Neutropenia events 
Selected PTs related to neutropenia in the Haematopoietic leukopenia SMQ 
(Broad) 
Pancytopenia events 
Haematopoietic cytopenias SMQ (Broad) 
AESI (MDS/AML events) 
MedDRA PTs associated with MDS/AML 
AESI (new malignancies other 
than MDS/AML) 
Malignant tumor SMQ (other than MDS/AML) 
AESI (pneumonitis) 
Lower respiratory tract inflammatory and immunologic conditions (HLT) 
AESI (embryo-fetal toxicity) 
Pregnancy and neonatal topics SMQ 
Hypertension events 
Hypertension SMQ 
Abbreviations: AESI = adverse event of special interest; AML = acute myelogenous leukemia; HLT = high-level term; 
MDS = myelodysplastic syndrome; MedDRA = medical dictionary for regulatory activities; PT = preferred term; 
SMQ = Standardized MedDRA Query. 
1 The list of preferred terms for each group is provided in the Appendix (Section 7.1). 
4.4.3.4. 
Examination of Adverse Events Controlling for Duration of Drug Exposure 
Since patients’ duration of exposure to study drug will vary, AEs will also be presented as rates 
normalized for cumulative exposure. Total duration of exposure will be calculated as the last 
treatment date – first treatment date + 1. 
In these tables, incidence rates per patient-exposure year (PEY) will be calculated as the number 
of patients experiencing an event in the numerator, and the total exposure time in PEY in the 
denominator. PEY is defined as follows: for each patient with the AE, the exposure-years will 
be the time of exposure to the drug in years at the time of first occurrence of the AE; for patients 
without the AE, the exposure-years will be defined as their total exposure in years on the study. 
For recurring events, the first occurrence of an AE (by MedDRA preferred term) will be 
reported. 
The US Food and Drug Administration (FDA) guidance recommends examining AE incidence 
by cumulative exposure time (as discussed above), but notes that it is necessary to assume a 
constant risk of AEs across time for such analyses. If there is not a constant risk for a given AE, 
the incidence per PEY analysis would be biased. Therefore, a second method will be used to 
summarize AEs occurring by duration of exposure to study treatment within specific reporting 
intervals as defined by cycles of therapy. The number of patients on study—that is patients who 


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have not withdrawn from the study, at the start of the reporting interval (number at risk)—will 
be used as the denominator for incidence and prevalence calculations. 
Reporting of Incidence by Cycle: For incidence rates by cycle, the specific AE will be assigned 
to the relevant time period if the start date of the AE occurs within the period. For recurrent 
events during a reporting interval, the first event occurrence is reported. For events that recur in 
more than 1 reporting interval (event start date is in different reporting intervals), the event will 
be reported in the first applicable reporting interval. In addition, incidence adjusted for exposure 
on a per-interval basis will be performed. This analysis will calculate the cumulative exposure in 
patient-months up to the beginning of each interval, and divide the total number of patients with 
first incidence of the specific event in the interval by this cumulative exposure. Incidence of 
AESIs and the potentially bothersome gastrointestinal events of nausea and vomiting will be 
analyzed using these methods, for any severity event as well as for ≥Grade 3 events. 
Reporting of Prevalence by Cycle: For prevalence rates by cycle, the specific AE will be 
assigned to the relevant time period if the AE occurs within the period, regardless of the interval 
in which the event started. For events that recur in more than 1 reporting interval (event occurs 
in different reporting intervals), the event will be reported in each applicable reporting interval. 
In addition, prevalence adjusted for exposure on a per-interval basis will be performed. This 
analysis will calculate the cumulative exposure in patient-months up to the beginning of each 
interval, and divide the total number of patients with any occurrence of the specific event in the 
interval by this cumulative exposure. Prevalence of AESIs and the gastrointestinal events of 
nausea and vomiting will be analyzed using these methods, for any severity event as well as for 
≥Grade 3 events. 
4.4.3.5. 
Examination of Duration of Adverse Events 
The duration of AESIs by category and the gastrointestinal events of nausea and vomiting will 
be calculated on a per-patient basis as the sum of the durations of each discrete episode of 
occurrence. The duration in days of overlapping occurrences will be calculated as the first start 
date to the last stop date + 1. The average duration over patients for these events of any severity 
and of ≥Grade 3 severity will be summarized with descriptive statistics. Ongoing events will be 
censored at the time of the analysis cut-off date. 
As individual events of long duration may be clinically relevant, the incidence of anemia events 
of ≥28 days in duration for events of any severity and for events of ≥Grade 3 severity will be 
tabulated. In addition, events of ≥Grade 2 hematologic toxicities (defined as thrombocytopenia, 
leukopenia, neutropenia, or pancytopenia events) ≥28 days with any grade anemia ≥28 days will 
be summarized. Note that these durations are for specific instances of the event, and not based 
on cumulative time with the event. Incidence categories of 0, 1, 2, 3, and 4 or more will be 
summarized. 
4.4.4. 
Laboratory Data 
Laboratory assessments will be 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. Laboratory 
assessments will be assigned to cycles based on the start date of the cycle based on exposure 
data. 
Hematologic and chemistry laboratory results will be graded according to the cut points defined 
in the NCI CTCAE v4.03 severity grade. Laboratory results will be summarized by maximum 


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CTCAE grade as available. For platelet count decrease, an additional category for CTCAE 
v4.03 will be included for values that are <10,000/µL. Continuous results will be analyzed using 
change from baseline and shift values. 
Change from baseline will be summarized and analyzed according to the largest increase, 
decrease, and at EOT, irrespective of scheduled or unscheduled visit. Graphical line mean 
changes over time may be provided, but due to the varying visits, no repeated measures analysis 
will be performed. 
Shift from baseline to the smallest, largest, and EOT will be reported using number and 
percentage of patients. Baseline and post-baseline results will be categorized as low, normal, or 
high relative to the normal range, or by CTCAE grade as applicable. 
A listing of potential Hy’s Law cases (patients with AST or ALT >3×upper limit of normal 
[ULN] in combination with bilirubin >2 ×ULN and ALP within normal range or ≤1.5 ×ULN) 
will be also presented. Additionally, a Hy’s Law (DILI) plot will be produced which plots peak 
ALT and peak total bilirubin in 1 panel and peak AST and peak total bilirubin in a second panel. 
A distribution boxplot of liver function test (albumin, ALT, AST, alkaline phosphatase, total 
bilirubin, direct bilirubin and GGT) and selected hematology and other chemistry laboratory test 
values over time will be presented. A side panel will be added to the plot to show the 
distribution of maximum values. 
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. 
4.4.5. 
Vital Signs and Physical Examination 
Summaries of vital signs parameters (systolic and diastolic blood pressures, pulse rate, and 
temperature) and weight will be presented by visit. Summary statistics will be produced for both 
observed and change from baseline values, for each parameter. 
Change from baseline will be summarized and analyzed according to the largest increase, 
decrease, and at the end of treatment, irrespective of scheduled or unscheduled visit. Graphical 
line mean changes over time may be provided, but due to the varying visits no repeated 
measures analysis will be performed. 
Vital sign measurements will be presented for each patient in a data listing. 
The number and percentage of patients experiencing at least 1 abnormal result at the baseline 
physical examination will be summarized by body system. Subsequent symptom-targeted 
physical examination findings will be presented for each patient in a data listing. 
All physical examination findings will be presented in a data listing. 
4.4.6. 
Electrocardiogram 
All patients will undergo a single ECG assessment at the screening visit. A subset of 
approximately 12 patients will undergo intensive, triplicate ECG monitoring to coincide with 
PK evaluation on Cycle 1/Day 1 and all other assessments in the study. The average of each of 
the triplicate measures will be used for analysis. 
Any ECG findings that were assessed as clinically significant and were reported as an AE or 
SAE will be summarized in the tables and listings. 


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Electrocardiogram results will be summarized descriptively. Baseline will be defined as the 
average of the closest triplicate (if triplicates were collected) readings prior to dosing on the first 
day that study drug is administered. 
Electrocardiogram measurements including PR interval, QT interval, RR interval, and QRS 
complex will be collected. 
QTc will be used for the data analysis and interpretation. Commonly used techniques including 
Bazett’s (QTcB) and Fridericia’s (QTcF) methods are applied. QTcF will be used for the 
primary QT evaluation. A summary of the number and percentage of patients with QTc interval 
exceeding some predefined upper limit (eg, >450 ms, >480 ms, >500 ms) will be provided. A 
summary of the number and percentage of patients with change from baseline in QTc interval 
exceeding some predefined upper limit (eg, >30 ms, >60 ms) will be provided. A separate 
summary will be provided which summarizes the change from baseline to the most extreme 
high or low value at any time during treatment. Change from baseline will be summarized and 
analyzed according to the largest increase, decrease, and at EOT, irrespective of scheduled or 
unscheduled visit. Graphical line mean changes over time may be provided. 
No values will be imputed for missing data except for averaging of triplicate measurements. If 
1 or 2 of the triplicate measurements for an ECG parameter are missing, the average of the 
remaining 2 measurements or the single measurement will be used in analyses. If all triplicate 
measurements are missing at a time point for an ECG parameter, no values will be imputed for 
this time point and no analyses related to this time point will be performed. If the triplicate is not 
good because of an artifact, then if the triplicate is repeated within about 15 minutes, it can be 
used at that nominal time. Patients who have data on other days or unscheduled ECGs but not at 
the scheduled time points will be included in the categorical tables but not the statistical 
analyses. 
All ECG data for each patient will be provided in a data listing. 
4.4.7. 
Concomitant Medications 
All medications will be coded using the September 2017 or later version of the WHO Drug 
Dictionary (WHODD). Medication start and stop dates will be compared to the date of first dose 
of study drug to allow medications to be classified as either Prior only, both Prior and 
Concomitant, or Concomitant only. Medications starting after the treatment withdrawal date will 
be listed but will not be classified or summarized. 
Medications that start and stop prior to the date of first dose of study drug will be classified as 
Prior only. If a medication starts before the date of first dose of study drug and stops on or after 
the date of first dose of study drug, then the medication will be classified as both Prior and 
Concomitant. Medications will be classified as Concomitant only if they have a start date on or 
after the date of first dose of study drug. Concomitant medication will be summarized by ATC 
level 3 and PT in frequency tables by treatment. Patients with more than 1 medication in a given 
ATC level and PT will be counted only once in that category. 
If medication start and/or stop dates are missing or partial, the dates will be compared as far as 
possible with the date of first dose of study drug. Medications will be assumed to be 
Concomitant only, unless there is clear evidence (through comparison of partial dates) to 
suggest that the medication started prior to the first dose of study drug. If there is clear evidence 
to suggest that the medication started prior to the first dose of study drug, the medication will be 
assumed to be both Prior and Concomitant, unless there is clear evidence to suggest that the 


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medication stopped prior to the first dose of study drug. If there is clear evidence to suggest that 
the medication stopped prior to the first dose of study drug, the medication will be assumed to 
be Prior only. The following lists the concomitant medication tables to be displayed: 
• Number and percentage with at least 1 prior medication by ATC level 3 and PT 
• Number and percentage with at least 1 concomitant medication by ATC level 3 and PT 
• Number and percentage with at least 1 prior and concomitant medication by ATC level 3 
and PT 
The use of concomitant medications will be included in a by-patient data listing. 


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5. 
CHANGES TO PLANNED ANALYSES 
As of this date, there have been no changes between the protocol-defined statistical analyses and 
those presented in this SAP. 
If any modifications in the experimental design, dosages, parameters, patient selection, or any 
other sections of the protocol are indicated or required, the Investigator will consult with the 
Sponsor before such changes are instituted. Modifications will be accomplished through formal 
amendments to this protocol by the Sponsor and approval from the appropriate Institutional 
Review Board (IRB) or Independent Ethics Committee (IEC). 
 


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6. 
REFERENCES 
 
1  
Fong, P.C., et al., Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA 
mutation carriers. N Engl J Med, 2009. 361(2): p. 123-34. 
2  
Audeh, M.W., 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): p. 245-51. 
3  
Gelmon, K.A., 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): p. 852-61. 
4  
Kummar, S., 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): p. 1726-34. 
5  
Ledermann, J., et al., Olaparib maintenance therapy in platinum-sensitive relapsed 
ovarian cancer. N Engl J Med, 2012. 366(15): p. 1382-92. 
6  
Ledermann, J., 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): p. 852-61. 
7  
Sandhu, S.K., 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): p. 882-92. 
8  
US Federal Register. International Conference on Harmonization; Guidance on 
Statistical Principles for Clinical Trials. Department of Health and Human Services: 
Food and Drug Administration [Docket No. 97D 0174]. Federal Register Volume 63, 
Number, pages 49583 49598. September 16, 1998. 


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7. 
APPENDIX 
7.1. 
MedDRA Preferred Terms for Adverse Events of Special Groups 
AE Category 
  MedDRA Level 
Preferred Terms 
SMQ 
Scope 
Thrombocytopenia Event 
 
 
Haematopoietic cytopenias affecting more than 1 
type of blood cell (SMQ) [20000028] 
Megakaryocytes decreased 
Narrow 
Platelet count decreased 
Narrow 
Platelet maturation arrest 
Narrow 
 
Platelet production decreased 
Narrow 
 
Platelet toxicity 
Narrow 
 
Thrombocytopenia 
Narrow 
 
Megakaryocytes abnormal 
Broad 
 
Platelet count abnormal 
Broad 
 
Platelet disorder 
Broad 
 
Plateletcrit abnormal 
Broad 
 
Plateletcrit decreased 
Broad 
 
Thrombocytopenia neonatal 
Broad 
Anemia Event: 
Haematopoietic erythropenia (SMQ) [20000029] 
Anaemia macrocytic 
Narrow 
 
Aplasia pure red cell 
Narrow 
 
Aplastic anaemia 
Narrow 
 
Erythroblast count decreased 
Narrow 
 
Erythroid maturation arrest 
Narrow 
 
Erythropenia 
Narrow 
 
Hypoplastic anaemia 
Narrow 
 
Microcytic anaemia 
Narrow 
 
Proerythroblast count decreased 
Narrow 
 
Red blood cell count decreased 
Narrow 
 
Reticulocyte count decreased 
Narrow 
 
Reticulocytopenia 
Narrow 
 
Anaemia 
Broad 
 
Anaemia neonatal 
Broad 
 
Erythroblast count abnormal 
Broad 
 
Erythropoiesis abnormal 
Broad 
 
Haematocrit abnormal 
Broad 
 
Haematocrit decreased 
Broad 
 
Haemoglobin abnormal 
Broad 
 
Haemoglobin decreased 
Broad 
 
Leukoerythroblastic anaemia 
Broad 
 
Normochromic normocytic anaemia 
Broad 
 
Proerythroblast count abnormal 
Broad 
 
Red blood cell count abnormal 
Broad 
 
Reticulocyte count abnormal 
Broad 
 
Reticulocyte percentage decreased 
Broad 


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AE Category 
  MedDRA Level 
Preferred Terms 
SMQ 
Scope 
Leukopenia Event 
Haematopoietic leukopenia (SMQ) [20000030] 
Agranulocytosis 
Narrow 
 
Band neutrophil count decreased* 
Narrow 
 
Band neutrophil percentage decreased* 
Narrow 
 
Basophil count decreased 
Narrow 
 
Basophilopenia 
Narrow 
 
B-lymphocyte count decreased 
Narrow 
 
Cyclic neutropenia* 
Narrow 
 
Eosinopenia 
Narrow 
 
Eosinophil count decreased 
Narrow 
 
Febrile neutropenia* 
Narrow 
 
Granulocyte count decreased* 
Narrow 
 
Granulocytes maturation arrest* 
Narrow 
 
Granulocytopenia* 
Narrow 
 
Idiopathic neutropenia* 
Narrow 
 
Leukopenia 
Narrow 
 
Lymphocyte count decreased 
Narrow 
 
Lymphopenia 
Narrow 
 
Metamyelocyte count decreased 
Narrow 
 
Monoblast count decreased 
Narrow 
 
Monocyte count decreased 
Narrow 
 
Monocytopenia 
Narrow 
 
Myeloblast count decreased 
Narrow 
 
Myelocyte count decreased 
Narrow 
 
Neutropenia* 
Narrow 
 
Neutropenic infection* 
Narrow 
 
Neutropenic sepsis* 
Narrow 
 
Neutrophil count decreased* 
Narrow 
 
Promyelocyte count decreased 
Narrow 
 
Pure white cell aplasia 
Narrow 
 
Radiation leukopenia 
Narrow 
 
T-lymphocyte count decreased 
Narrow 
 
White blood cell count decreased 
Narrow 
 
Basophil count abnormal 
Broad 
 
Basophil percentage decreased 
Broad 
 
B-lymphocyte abnormalities 
Broad 
 
Differential white blood cell count 
abnormal* 
Broad 
 
Eosinophil count abnormal 
Broad 
 
Eosinophil percentage decreased 
Broad 
 
Full blood count abnormal 
Broad 
 
Granulocytes abnormal* 
Broad 
 
Granulocytopenia neonatal* 
Broad 
 
Leukopenia neonatal 
Broad 


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AE Category 
  MedDRA Level 
Preferred Terms 
SMQ 
Scope 
 
Lymphocyte count abnormal 
Broad 
 
Lymphocyte percentage abnormal 
Broad 
 
Lymphocyte percentage decreased 
Broad 
 
Lymphocytopenia neonatal 
Broad 
 
Monocyte count abnormal 
Broad 
 
Monocyte percentage decreased 
Broad 
 
Myeloblast percentage decreased 
Broad 
 
Myelocyte percentage decreased 
Broad 
 
Myeloid maturation arrest 
Broad 
 
Neutropenia neonatal* 
Broad 
 
Neutrophil count abnormal* 
Broad 
 
Neutrophil percentage decreased* 
Broad 
 
Plasma cell disorder 
Broad 
 
Plasma cells absent 
Broad 
 
T-lymphocyte count abnormal 
Broad 
 
White blood cell analysis abnormal 
Broad 
 
White blood cell count abnormal 
Broad 
 
White blood cell disorder 
Broad 
Pancytopenia Event: 
Haematopoietic cytopenias affecting more than 1 
type of blood cell (SMQ) [20000028] 
 
 
Aplastic anaemia 
Narrow 
Autoimmune aplastic anaemia 
Narrow 
 
Bicytopenia 
Narrow 
 
Bone marrow failure 
Narrow 
 
Cytopenia 
Narrow 
 
Febrile bone marrow aplasia 
Narrow 
 
Full blood count decreased 
Narrow 
 
Pancytopenia 
Narrow 
 
Panmyelopathy 
Narrow 
 
Aspiration bone marrow abnormal 
Broad 
 
Biopsy bone marrow abnormal 
Broad 
 
Blood count abnormal 
Broad 
 
Blood disorder 
Broad 
 
Bone marrow disorder 
Broad 
 
Bone marrow infiltration 
Broad 
 
Bone marrow myelogram abnormal 
Broad 
 
Bone marrow necrosis 
Broad 
 
Bone marrow toxicity 
Broad 
 
Congenital aplastic anaemia 
Broad 
 
Haematotoxicity 
Broad 
 
Myelodysplastic syndrome 
Broad 
 
Myelodysplastic syndrome transformation 
Broad 
 
Myelofibrosis 
Broad 
 
Myeloid metaplasia 
Broad 
 
Plasmablast count decreased 
Broad 


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AE Category 
  MedDRA Level 
Preferred Terms 
SMQ 
Scope 
 
Primary myelofibrosis 
Broad 
 
Scan bone marrow abnormal 
Broad 
MDS/AML Event: 
MedDRA PTs as listed 
Myelodysplastic syndrome 
NA 
 
Myelodysplastic syndrome transformation 
NA 
 
Myelodysplastic syndrome unclassifiable 
NA 
 
Acute myeloid leukaemia 
NA 
 
Acute myeloid leukaemia recurrent 
NA 
 
Blast crisis in myelogenous leukaemia 
NA 
 
Myeloid leukaemia 
NA 
New malignancies other than MDS/AML 
Malignant Tumours (SMQ) [20000194] 
See Section 7.2 
 
Pneumonitis Event: 
Lower respiratory tract inflammatory and 
immunologic conditions (HLT) 
Pneumonitis 
Acute interstitial pneumonitis 
NA 
NA 
Embryo-fetal toxicity 
Pregnancy and neonatal topics (SMQ) [20000185] 
See Section 7.3 
 
Hypertension Event: 
Hypertension SMQ [20000147] 
See Section 7.4 
 
Abbreviations: AE = adverse event; AML = acute myelogenous leukemia; HLT = high-level term; MDS = myelodysplastic 
syndrome; MedDRA = medical dictionary for regulatory activities; PT = preferred term; SMQ = Standardized MedDRA Query. 
* Preferred terms are included in the Neutropenia Event. 


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7.2. 
SMQ Terms for Malignant Tumors 
SMQ Export: 20.1 - English 
1/8/2018 2:20:21 PM 
Include Inactive PT:  No 
Term Attributes:       Name, Code, Level, Scope, Category, Weight, Status, Addition Version, Last Modified Version 
Malignant tumours (SMQ) [20000194] 
Haematological malignant tumours (SMQ) [20000227] 
 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
5q minus syndrome 
1006853
2 
PT 
Narro
w 
A 
0 
Active 
11.1 
20.0 
Acute biphenotypic leukaemia 
1006739
9 
PT 
Narro
w 
A 
0 
Active 
10.1 
20.0 
Acute leukaemia 
1000083
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute leukaemia in remission 
1006093
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute lymphocytic leukaemia 
1000084
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute lymphocytic leukaemia (in remission) 
1000084
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute lymphocytic leukaemia recurrent 
1006362
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute lymphocytic leukaemia refractory 
1007686
6 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Acute megakaryocytic leukaemia 
1000086
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute megakaryocytic leukaemia (in remission) 
1005719
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute monocytic leukaemia 
1000087
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute monocytic leukaemia (in remission) 
1000087
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute myeloid leukaemia (in remission) 
1000088
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


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Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Acute myelomonocytic leukaemia 
1000089
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute promyelocytic leukaemia 
1000101
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acute undifferentiated leukaemia 
1007347
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Adult T-cell lymphoma/leukaemia 
1000141
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adult T-cell lymphoma/leukaemia recurrent 
1000141
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adult T-cell lymphoma/leukaemia refractory 
1000141
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adult T-cell lymphoma/leukaemia stage I 
1000141
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adult T-cell lymphoma/leukaemia stage II 
1000141
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adult T-cell lymphoma/leukaemia stage III 
1000142
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adult T-cell lymphoma/leukaemia stage IV 
1000142
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Aleukaemic leukaemia 
1000166
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anaplastic large cell lymphoma T- and null-cell types 
1000222
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anaplastic large cell lymphoma T- and null-cell types 
recurrent 
1000222
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anaplastic large cell lymphoma T- and null-cell types 
refractory 
1000223
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anaplastic large cell lymphoma T- and null-cell types 
stage I 
1000223
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anaplastic large cell lymphoma T- and null-cell types 
stage II 
1000223
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anaplastic large cell lymphoma T- and null-cell types 
stage III 
1000223
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


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Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Anaplastic large cell lymphoma T- and null-cell types 
stage IV 
1000223
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anaplastic large-cell lymphoma 
1007347
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Angiocentric lymphoma 
1000241
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angiocentric lymphoma recurrent 
1000241
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angiocentric lymphoma refractory 
1000241
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angiocentric lymphoma stage I 
1000241
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angiocentric lymphoma stage II 
1000241
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angiocentric lymphoma stage III 
1000241
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angiocentric lymphoma stage IV 
1000241
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angioimmunoblastic T-cell lymphoma 
1000244
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angioimmunoblastic T-cell lymphoma recurrent 
1000245
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angioimmunoblastic T-cell lymphoma refractory 
1000245
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angioimmunoblastic T-cell lymphoma stage I 
1000245
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angioimmunoblastic T-cell lymphoma stage II 
1000245
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angioimmunoblastic T-cell lymphoma stage III 
1000245
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angioimmunoblastic T-cell lymphoma stage IV 
1000245
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B precursor type acute leukaemia 
1000389
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
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19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 54 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
B-cell lymphoma 
1000389
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell lymphoma recurrent 
1000390
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell lymphoma refractory 
1000390
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell lymphoma stage I 
1000390
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell lymphoma stage II 
1000390
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell lymphoma stage III 
1000390
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell lymphoma stage IV 
1000390
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell prolymphocytic leukaemia 
1007348
0 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
B-cell small lymphocytic lymphoma 
1000390
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell small lymphocytic lymphoma recurrent 
1000391
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell small lymphocytic lymphoma refractory 
1000391
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell small lymphocytic lymphoma stage I 
1000391
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell small lymphocytic lymphoma stage II 
1000391
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell small lymphocytic lymphoma stage III 
1000391
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell small lymphocytic lymphoma stage IV 
1000391
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell type acute leukaemia 
1000391
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
B-cell unclassifiable lymphoma high grade 
1000392
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 55 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
B-cell unclassifiable lymphoma low grade 
1000392
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Blast crisis in myelogenous leukaemia 
1005028
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Blastic plasmacytoid dendritic cell neoplasia 
1007546
0 
PT 
Narro
w 
A 
0 
Active 
17.1 
20.0 
Bone marrow leukaemic cell infiltration 
1004955
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bone marrow tumour cell infiltration 
1004955
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Burkitt's leukaemia 
1006718
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Burkitt's lymphoma 
1000659
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Burkitt's lymphoma recurrent 
1000659
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Burkitt's lymphoma refractory 
1000659
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Burkitt's lymphoma stage I 
1000660
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Burkitt's lymphoma stage II 
1000660
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Burkitt's lymphoma stage III 
1000660
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Burkitt's lymphoma stage IV 
1000660
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Central nervous system leukaemia 
1006623
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Central nervous system lymphoma 
1000795
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chloroma 
1000858
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chloroma (in remission) 
1000858
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 56 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Chronic eosinophilic leukaemia 
1006585
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic leukaemia 
1000894
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic leukaemia in remission 
1006104
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic lymphocytic leukaemia 
1000895
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic lymphocytic leukaemia (in remission) 
1000895
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic lymphocytic leukaemia recurrent 
1000896
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic lymphocytic leukaemia refractory 
1000896
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic lymphocytic leukaemia stage 0 
1000896
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic lymphocytic leukaemia stage 1 
1000896
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic lymphocytic leukaemia stage 2 
1000896
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic lymphocytic leukaemia stage 3 
1000896
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic lymphocytic leukaemia stage 4 
1000896
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic lymphocytic leukaemia transformation 
1005871
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic myeloid leukaemia 
1000901
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic myeloid leukaemia (in remission) 
1000901
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic myeloid leukaemia recurrent 
1007508
1 
PT 
Narro
w 
A 
0 
Active 
17.1 
20.0 
Chronic myeloid leukaemia transformation 
1006823
2 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 57 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Chronic myelomonocytic leukaemia 
1000901
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chronic myelomonocytic leukaemia (in remission) 
1000901
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Composite lymphoma 
1007395
7 
PT 
Narro
w 
A 
0 
Active 
16.1 
20.0 
Cutaneous lymphoma 
1007994
5 
PT 
Narro
w 
A 
0 
Active 
20.1 
20.1 
Diffuse large B-cell lymphoma 
1001281
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Diffuse large B-cell lymphoma recurrent 
1001282
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Diffuse large B-cell lymphoma refractory 
1001282
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Diffuse large B-cell lymphoma stage I 
1001282
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Diffuse large B-cell lymphoma stage II 
1001282
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Diffuse large B-cell lymphoma stage III 
1001282
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Diffuse large B-cell lymphoma stage IV 
1001282
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Disseminated large cell lymphoma 
1005495
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Double hit lymphoma 
1008020
2 
PT 
Narro
w 
A 
0 
Active 
20.1 
20.1 
Enteropathy-associated T-cell lymphoma 
1007348
1 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Eosinophilic leukaemia 
1001495
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Epstein-Barr virus associated lymphoma 
1007144
1 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Erythraemic myelosis (in remission) 
1001524
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 58 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Erythroleukaemia 
1001528
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extranodal marginal zone B-cell lymphoma (MALT 
type) 
1006185
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extranodal marginal zone B-cell lymphoma (MALT 
type) recurrent 
1001582
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extranodal marginal zone B-cell lymphoma (MALT 
type) refractory 
1001582
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extranodal marginal zone B-cell lymphoma (MALT 
type) stage I 
1001582
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extranodal marginal zone B-cell lymphoma (MALT 
type) stage II 
1001582
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extranodal marginal zone B-cell lymphoma (MALT 
type) stage III 
1001582
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extranodal marginal zone B-cell lymphoma (MALT 
type) stage IV 
1001582
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma diffuse small cell lymphoma 
1006195
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma diffuse small cell lymphoma 
recurrent 
1001689
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma diffuse small cell lymphoma 
refractory 
1001689
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma diffuse small cell lymphoma 
stage I 
1001689
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma diffuse small cell lymphoma 
stage II 
1001690
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma diffuse small cell lymphoma 
stage III 
1001690
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma diffuse small cell lymphoma 
stage IV 
1001690
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma, follicular grade I, II, III 
1006117
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma, follicular grade I, II, III 
recurrent 
1001690
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 59 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Follicle centre lymphoma, follicular grade I, II, III 
refractory 
1001690
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma, follicular grade I, II, III stage 
I 
1001690
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma, follicular grade I, II, III stage 
II 
1001690
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma, follicular grade I, II, III stage 
III 
1001690
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicle centre lymphoma, follicular grade I, II, III stage 
IV 
1001691
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicular dendritic cell sarcoma 
1007533
2 
PT 
Narro
w 
A 
0 
Active 
17.1 
20.0 
Gastrointestinal lymphoma 
1001797
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.1 
Haematological malignancy 
1006647
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hairy cell leukaemia 
1001905
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hairy cell leukaemia recurrent 
1007740
3 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Hepatosplenic T-cell lymphoma 
1006695
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
High grade B-cell lymphoma Burkitt-like lymphoma 
1002006
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
High grade B-cell lymphoma Burkitt-like lymphoma 
recurrent 
1002007
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
High grade B-cell lymphoma Burkitt-like lymphoma 
refractory 
1002007
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
High grade B-cell lymphoma Burkitt-like lymphoma 
stage I 
1002007
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
High grade B-cell lymphoma Burkitt-like lymphoma 
stage II 
1002007
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
High grade B-cell lymphoma Burkitt-like lymphoma 
stage III 
1002007
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 60 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
High grade B-cell lymphoma Burkitt-like lymphoma 
stage IV 
1002007
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
High-grade B-cell lymphoma 
1008021
5 
PT 
Narro
w 
A 
0 
Active 
20.1 
20.1 
Histiocytic medullary reticulosis 
1006878
5 
PT 
Narro
w 
A 
0 
Active 
12.0 
20.0 
Histiocytic sarcoma 
1007687
6 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Hodgkin's disease 
1002020
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion stage I site 
unspecified 
1002020
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion stage I 
subdiaphragm 
1002020
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion stage I 
supradiaphragm 
1002021
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion stage II site 
unspecified 
1002021
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion stage II 
subdiaphragm 
1002021
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion stage II 
supradiaphragm 
1002021
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion type recurrent 
1002021
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion type refractory 
1002021
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion type stage III 
1002021
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion type stage IV 
1002021
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte depletion type stage 
unspecified 
1002021
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte predominance stage I site 
unspec 
1002022
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


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Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 61 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Hodgkin's disease lymphocyte predominance stage I 
subdiaphragm 
1002022
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte predominance stage I 
supradiaphragm 
1002022
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte predominance stage II 
site unspec 
1002022
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte predominance stage II 
subdiaphragm 
1002022
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte predominance stage II 
supradiaphragm 
1002022
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte predominance type 
recurrent 
1002022
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte predominance type 
refractory 
1002022
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte predominance type stage 
III 
1002022
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte predominance type stage 
IV 
1002023
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease lymphocyte predominance type stage 
unspecified 
1002023
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease mixed cellularity recurrent 
1002023
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease mixed cellularity refractory 
1002023
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease mixed cellularity stage I site 
unspecified 
1002023
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease mixed cellularity stage I 
subdiaphragmatic 
1002023
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease mixed cellularity stage I 
supradiaphragmatic 
1002023
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease mixed cellularity stage II 
subdiaphragmatic 
1002023
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease mixed cellularity stage II 
supradiaphragmatic 
1002023
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


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Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 62 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Hodgkin's disease mixed cellularity stage III 
1002024
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease mixed cellularity stage IV 
1002024
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease mixed cellularity stage unspecified 
1002024
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease nodular sclerosis 
1002024
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease nodular sclerosis recurrent 
1002024
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease nodular sclerosis refractory 
1002024
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease nodular sclerosis stage I 
1007353
5 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Hodgkin's disease nodular sclerosis stage II 
1007353
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Hodgkin's disease nodular sclerosis stage III 
1002025
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease nodular sclerosis stage IV 
1002025
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease recurrent 
1002026
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease refractory 
1002026
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease stage I 
1002026
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease stage II 
1002026
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease stage III 
1002027
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease stage IV 
1006159
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hodgkin's disease unclassifiable 
1002027
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 63 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Immunoblastic lymphoma 
1005357
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Intestinal T-cell lymphoma recurrent 
1002270
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Intestinal T-cell lymphoma refractory 
1002270
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Intestinal T-cell lymphoma stage I 
1002270
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Intestinal T-cell lymphoma stage II 
1002270
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Intestinal T-cell lymphoma stage III 
1002271
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Intestinal T-cell lymphoma stage IV 
1002271
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Juvenile chronic myelomonocytic leukaemia 
1002324
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leptomeningeal myelomatosis 
1007828
2 
PT 
Narro
w 
A 
0 
Active 
19.1 
20.0 
Leukaemia 
1002428
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemia basophilic 
1002429
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemia cutis 
1005318
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemia granulocytic 
1002429
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemia in remission 
1006122
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemia monocytic 
1002430
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemia recurrent 
1006248
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemic cardiac infiltration 
1007756
3 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 64 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Leukaemic infiltration 
1006936
0 
PT 
Narro
w 
A 
0 
Active 
12.1 
20.0 
Leukaemic infiltration extramedullary 
1006711
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemic infiltration gingiva 
1006743
1 
PT 
Narro
w 
A 
0 
Active 
10.1 
20.0 
Leukaemic infiltration hepatic 
1005867
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemic infiltration ovary 
1007585
3 
PT 
Narro
w 
A 
0 
Active 
18.0 
20.0 
Leukaemic infiltration pulmonary 
1005236
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemic infiltration renal 
1006935
9 
PT 
Narro
w 
A 
0 
Active 
12.1 
20.0 
Leukaemic lymphoma 
1002432
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leukaemic retinopathy 
1005923
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphangiosarcoma 
1002522
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphangiosis carcinomatosa 
1005313
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphocytic leukaemia 
1002527
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphocytic lymphoma 
1005217
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoid leukaemia (in remission) 
1002530
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoma 
1002531
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoma AIDS related 
1002531
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoma cutis 
1005170
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 65 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Lymphoma transformation 
1006434
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoplasmacytoid lymphoma/immunocytoma 
1002534
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoplasmacytoid lymphoma/immunocytoma 
recurrent 
1002534
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoplasmacytoid lymphoma/immunocytoma 
refractory 
1002534
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoplasmacytoid lymphoma/immunocytoma stage 
I 
1002534
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoplasmacytoid lymphoma/immunocytoma stage 
II 
1002534
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoplasmacytoid lymphoma/immunocytoma stage 
III 
1002534
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lymphoplasmacytoid lymphoma/immunocytoma stage 
IV 
1002535
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant histiocytosis 
1002558
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant lymphoid neoplasm 
1006124
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant lymphoma unclassifiable high grade 
1002563
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant lymphoma unclassifiable low grade 
1002563
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant mast cell neoplasm 
1002563
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of thymus 
1002653
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant splenic neoplasm 
1002670
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mantle cell lymphoma 
1006127
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mantle cell lymphoma recurrent 
1002680
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 66 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Mantle cell lymphoma refractory 
1002680
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mantle cell lymphoma stage I 
1002680
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mantle cell lymphoma stage II 
1002680
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mantle cell lymphoma stage III 
1002680
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mantle cell lymphoma stage IV 
1002680
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Marginal zone lymphoma 
1007659
6 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Marginal zone lymphoma recurrent 
1007753
3 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Marginal zone lymphoma refractory 
1007753
4 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Marginal zone lymphoma stage I 
1007752
9 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Marginal zone lymphoma stage II 
1007753
0 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Marginal zone lymphoma stage III 
1007753
1 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Marginal zone lymphoma stage IV 
1007753
2 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Mastocytic leukaemia 
1005645
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mature B-cell type acute leukaemia 
1002694
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to bone marrow 
1005166
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to lymph nodes 
1002745
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to spleen 
1005168
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 67 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Metastatic lymphoma 
1007154
1 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Minimal residual disease 
1007998
7 
PT 
Narro
w 
A 
0 
Active 
20.1 
20.1 
Monocytic leukaemia in remission 
1006129
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mycosis fungoides 
1002848
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mycosis fungoides recurrent 
1002850
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mycosis fungoides refractory 
1002850
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mycosis fungoides stage I 
1002850
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mycosis fungoides stage II 
1002850
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mycosis fungoides stage III 
1002850
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mycosis fungoides stage IV 
1002850
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Myeloblastoma 
1005114
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Myeloid leukaemia in remission 
1006130
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Natural killer-cell leukaemia 
1002881
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Natural killer-cell lymphoblastic lymphoma 
1005897
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Neonatal leukaemia 
1002895
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nodal marginal zone B-cell lymphoma 
1002946
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nodal marginal zone B-cell lymphoma recurrent 
1002946
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 68 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Nodal marginal zone B-cell lymphoma refractory 
1002946
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nodal marginal zone B-cell lymphoma stage I 
1002946
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nodal marginal zone B-cell lymphoma stage II 
1002946
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nodal marginal zone B-cell lymphoma stage III 
1002946
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nodal marginal zone B-cell lymphoma stage IV 
1002946
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nodular lymphocyte predominant Hodgkin lymphoma 
1008020
1 
PT 
Narro
w 
A 
0 
Active 
20.1 
20.1 
Non-Hodgkin's lymphoma 
1002954
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma metastatic 
1007153
5 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Non-Hodgkin's lymphoma recurrent 
1002960
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma refractory 
1002960
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma stage I 
1002960
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma stage II 
1002960
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma stage III 
1002960
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma stage IV 
1002960
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma transformed recurrent 
1006187
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
aggressive 
1006390
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
aggressive recurrent 
1002960
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 69 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Non-Hodgkin's lymphoma unspecified histology 
aggressive refractory 
1002961
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
aggressive stage I 
1002961
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
aggressive stage II 
1002961
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
aggressive stage III 
1002961
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
aggressive stage IV 
1002961
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
indolent 
1006585
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
indolent stage I 
1002962
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
indolent stage II 
1002962
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
indolent stage III 
1002962
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-Hodgkin's lymphoma unspecified histology 
indolent stage IV 
1002962
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ocular lymphoma 
1007532
4 
PT 
Narro
w 
A 
0 
Active 
17.1 
20.0 
Peripheral T-cell lymphoma unspecified 
1003462
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peripheral T-cell lymphoma unspecified recurrent 
1003462
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peripheral T-cell lymphoma unspecified refractory 
1003462
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peripheral T-cell lymphoma unspecified stage I 
1003462
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peripheral T-cell lymphoma unspecified stage II 
1003462
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peripheral T-cell lymphoma unspecified stage III 
1003462
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 70 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Peripheral T-cell lymphoma unspecified stage IV 
1003463
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Plasma cell leukaemia 
1003522
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Plasma cell leukaemia in remission 
1006040
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Plasma cell myeloma 
1003522
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Plasma cell myeloma in remission 
1007313
2 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Plasma cell myeloma recurrent 
1007313
3 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Plasmablastic lymphoma 
1006503
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Plasmacytoma 
1003548
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor B-lymphoblastic lymphoma 
1003652
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor B-lymphoblastic lymphoma recurrent 
1006091
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor B-lymphoblastic lymphoma refractory 
1006091
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor B-lymphoblastic lymphoma stage I 
1003653
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor B-lymphoblastic lymphoma stage II 
1003653
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor B-lymphoblastic lymphoma stage III 
1003653
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor B-lymphoblastic lymphoma stage IV 
1003653
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor T-lymphoblastic lymphoma/leukaemia 
1003654
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor T-lymphoblastic lymphoma/leukaemia 
recurrent 
1003654
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 71 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Precursor T-lymphoblastic lymphoma/leukaemia 
refractory 
1003654
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor T-lymphoblastic lymphoma/leukaemia stage I 
1003654
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor T-lymphoblastic lymphoma/leukaemia stage 
II 
1003654
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor T-lymphoblastic lymphoma/leukaemia stage 
III 
1003655
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Precursor T-lymphoblastic lymphoma/leukaemia stage 
IV 
1003655
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Primary cardiac lymphoma 
1007599
3 
PT 
Narro
w 
A 
0 
Active 
18.0 
20.0 
Primary effusion lymphoma 
1006585
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Primary gastrointestinal follicular lymphoma 
1007897
2 
PT 
Narro
w 
A 
0 
Active 
20.0 
20.0 
Primary mediastinal large B-cell lymphoma 
1003671
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Primary mediastinal large B-cell lymphoma recurrent 
1003671
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Primary mediastinal large B-cell lymphoma refractory 
1003671
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Primary mediastinal large B-cell lymphoma stage I 
1003671
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Primary mediastinal large B-cell lymphoma stage II 
1003671
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Primary mediastinal large B-cell lymphoma stage III 
1003671
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Primary mediastinal large B-cell lymphoma stage IV 
1003671
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Prolymphocytic leukaemia 
1003688
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Richter's syndrome 
1005872
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 72 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Splenic marginal zone lymphoma 
1006211
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Splenic marginal zone lymphoma recurrent 
1004165
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Splenic marginal zone lymphoma refractory 
1004165
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Splenic marginal zone lymphoma stage I 
1004165
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Splenic marginal zone lymphoma stage II 
1004165
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Splenic marginal zone lymphoma stage III 
1004165
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Splenic marginal zone lymphoma stage IV 
1004165
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell chronic lymphocytic leukaemia 
1004297
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell lymphoma 
1004297
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell lymphoma recurrent 
1004297
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell lymphoma refractory 
1004298
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell lymphoma stage I 
1004298
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell lymphoma stage II 
1004298
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell lymphoma stage III 
1004298
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell lymphoma stage IV 
1004298
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell prolymphocytic leukaemia 
1004298
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell type acute leukaemia 
1004298
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 73 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
T-cell unclassifiable lymphoma high grade 
1004298
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
T-cell unclassifiable lymphoma low grade 
1004299
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Thymic cancer metastatic 
1005510
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Thymoma malignant 
1006103
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Thymoma malignant recurrent 
1004367
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Thyroid B-cell lymphoma 
1007261
3 
PT 
Narro
w 
A 
0 
Active 
15.1 
20.0 
Transformation to acute myeloid leukaemia 
1007910
7 
PT 
Narro
w 
A 
0 
Active 
20.0 
20.0 
Triple hit lymphoma 
1008020
0 
PT 
Narro
w 
A 
0 
Active 
20.1 
20.1 
Waldenstrom's macroglobulinaemia 
1004780
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Waldenstrom's macroglobulinaemia recurrent 
1004780
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Waldenstrom's macroglobulinaemia refractory 
1004780
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Waldenstrom's macroglobulinaemia stage I 
1004780
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Waldenstrom's macroglobulinaemia stage II 
1004780
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 74 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Waldenstrom's macroglobulinaemia stage III 
1004780
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Waldenstrom's macroglobulinaemia stage IV 
1004780
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-haematological malignant tumours (SMQ) [20000228] 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Abdominal wall neoplasm malignant 
1007102
3 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Acinar cell carcinoma of pancreas 
1007336
3 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Acinic cell carcinoma of salivary gland 
1007336
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Acral lentiginous melanoma 
1000058
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acral lentiginous melanoma stage I 
1000058
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acral lentiginous melanoma stage II 
1000058
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acral lentiginous melanoma stage III 
1000058
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Acral lentiginous melanoma stage IV 
1000058
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenocarcinoma 
1000114
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenocarcinoma gastric 
1000115
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenocarcinoma of appendix 
1007335
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Adenocarcinoma of colon 
1000116
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenocarcinoma of salivary gland 
1006806
8 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 75 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Adenocarcinoma of the cervix 
1000119
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenocarcinoma pancreas 
1005274
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenoid cystic carcinoma 
1005323
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenoid cystic carcinoma of external auditory canal 
1007805
7 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Adenoid cystic carcinoma of salivary gland 
1007337
0 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Adenosquamous carcinoma of the cervix 
1000124
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenosquamous carcinoma of vagina 
1007397
8 
PT 
Narro
w 
A 
0 
Active 
16.1 
20.0 
Adenosquamous cell carcinoma 
1006887
3 
PT 
Narro
w 
A 
0 
Active 
12.0 
20.0 
Adenosquamous cell lung cancer 
1000124
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenosquamous cell lung cancer recurrent 
1000124
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenosquamous cell lung cancer stage 0 
1000124
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenosquamous cell lung cancer stage I 
1000124
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenosquamous cell lung cancer stage II 
1000125
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenosquamous cell lung cancer stage III 
1000125
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adenosquamous cell lung cancer stage IV 
1000125
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Adrenal gland cancer 
1007315
2 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Adrenal gland cancer metastatic 
1005509
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 76 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Adrenocortical carcinoma 
1000138
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Aesthesioneuroblastoma 
1000143
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Alveolar rhabdomyosarcoma 
1006586
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Alveolar soft part sarcoma 
1000188
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Alveolar soft part sarcoma metastatic 
1000188
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Alveolar soft part sarcoma recurrent 
1000188
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anal cancer 
1006142
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anal cancer metastatic 
1005509
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anal cancer recurrent 
1000213
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anal cancer stage 0 
1000213
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anal cancer stage I 
1000213
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anal cancer stage II 
1000213
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anal cancer stage III 
1000213
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anal cancer stage IV 
1000213
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anal squamous cell carcinoma 
1007335
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Anaplastic astrocytoma 
1000222
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Anaplastic meningioma 
1007312
7 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 77 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Anaplastic oligodendroglioma 
1007312
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Anaplastic thyroid cancer 
1000224
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angiocentric glioma 
1007312
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Angiosarcoma 
1000247
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angiosarcoma metastatic 
1000247
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angiosarcoma non-metastatic 
1005770
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Angiosarcoma recurrent 
1000248
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Apocrine breast carcinoma 
1006620
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Appendix cancer 
1007336
0 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Astrocytoma 
1000357
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Astrocytoma malignant 
1006097
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Atypical teratoid/rhabdoid tumour of CNS 
1006590
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Basal cell carcinoma 
1000414
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Basosquamous carcinoma 
1000417
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Basosquamous carcinoma of skin 
1000417
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bile duct adenocarcinoma 
1000458
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bile duct adenosquamous carcinoma 
1000458
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 78 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Bile duct cancer 
1000459
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bile duct cancer recurrent 
1000459
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bile duct cancer stage 0 
1005938
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bile duct cancer stage I 
1005937
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bile duct cancer stage II 
1005937
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bile duct cancer stage III 
1005937
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bile duct cancer stage IV 
1005937
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bile duct squamous cell carcinoma 
1000463
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Biliary cancer metastatic 
1005511
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Biphasic mesothelioma 
1007306
2 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Bladder adenocarcinoma recurrent 
1000498
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder adenocarcinoma stage 0 
1000498
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder adenocarcinoma stage I 
1000498
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder adenocarcinoma stage II 
1000498
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder adenocarcinoma stage III 
1000499
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder adenocarcinoma stage IV 
1000499
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder adenocarcinoma stage unspecified 
1000499
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 79 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Bladder cancer 
1000500
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder cancer recurrent 
1000500
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder cancer stage 0, with cancer in situ 
1000500
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder cancer stage 0, without cancer in situ 
1000500
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder cancer stage I, with cancer in situ 
1000500
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder cancer stage I, without cancer in situ 
1000500
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder cancer stage II 
1000501
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder cancer stage III 
1000501
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder cancer stage IV 
1000501
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder squamous cell carcinoma recurrent 
1000507
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder squamous cell carcinoma stage 0 
1000507
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder squamous cell carcinoma stage I 
1000507
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder squamous cell carcinoma stage II 
1000507
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder squamous cell carcinoma stage III 
1000507
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder squamous cell carcinoma stage IV 
1000508
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder squamous cell carcinoma stage unspecified 
1000508
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder transitional cell carcinoma 
1000508
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 80 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Bladder transitional cell carcinoma metastatic 
1007166
4 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Bladder transitional cell carcinoma recurrent 
1006675
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder transitional cell carcinoma stage 0 
1006674
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder transitional cell carcinoma stage I 
1006675
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder transitional cell carcinoma stage II 
1006675
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder transitional cell carcinoma stage III 
1006675
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bladder transitional cell carcinoma stage IV 
1006675
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bone cancer 
1000594
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bone cancer metastatic 
1005510
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bone giant cell tumour malignant 
1007310
6 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Bone sarcoma 
1000600
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bowen's disease 
1000605
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Brain cancer metastatic 
1005509
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Brain neoplasm malignant 
1000613
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Brain sarcoma 
1007385
7 
PT 
Narro
w 
A 
0 
Active 
16.1 
20.0 
Brain stem glioma 
1000614
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast angiosarcoma 
1007281
3 
PT 
Narro
w 
A 
0 
Active 
15.1 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 81 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Breast angiosarcoma metastatic 
1007281
4 
PT 
Narro
w 
A 
0 
Active 
15.1 
20.0 
Breast cancer 
1000618
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast cancer female 
1005765
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast cancer in situ 
1000618
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast cancer male 
1006102
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast cancer metastatic 
1005511
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast cancer recurrent 
1000619
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast cancer stage I 
1000619
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast cancer stage II 
1000620
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast cancer stage III 
1000620
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast cancer stage IV 
1000620
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Breast sarcoma 
1006858
2 
PT 
Narro
w 
A 
0 
Active 
11.1 
20.0 
Breast sarcoma metastatic 
1006858
3 
PT 
Narro
w 
A 
0 
Active 
11.1 
20.0 
Breast sarcoma recurrent 
1006858
4 
PT 
Narro
w 
A 
0 
Active 
11.1 
20.0 
Bronchial carcinoma 
1000641
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Bronchioloalveolar carcinoma 
1005835
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Buschke-Lowenstein's tumour 
1005942
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 82 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Cancer in remission 
1006530
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoid tumour 
1000727
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoid tumour of the appendix 
1000727
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoid tumour of the caecum 
1000727
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoid tumour of the duodenum 
1005011
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoid tumour of the gastrointestinal tract 
1000727
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoid tumour of the pancreas 
1005500
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoid tumour of the prostate 
1000728
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoid tumour of the small bowel 
1005281
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoid tumour of the stomach 
1000728
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoid tumour pulmonary 
1000728
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoma ex-pleomorphic adenoma 
1007743
5 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Carcinoma in situ 
1006145
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoma in situ of eye 
1000736
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoma in situ of penis 
1000738
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoma in situ of skin 
1000739
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Carcinoma in situ of trachea 
1000740
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 83 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Cardiac neoplasm malignant 
1006102
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Central nervous system melanoma 
1007716
0 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Central nervous system neuroblastoma 
1007313
0 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Cervix cancer metastatic 
1005509
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Cervix carcinoma 
1000834
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Cervix carcinoma recurrent 
1000834
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Cervix carcinoma stage 0 
1006180
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Cervix carcinoma stage I 
1000834
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Cervix carcinoma stage II 
1000834
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Cervix carcinoma stage III 
1000834
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Cervix carcinoma stage IV 
1000834
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Cholangiocarcinoma 
1000859
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Cholangiosarcoma 
1007786
1 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Chondrosarcoma 
1000873
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chondrosarcoma metastatic 
1000873
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chondrosarcoma recurrent 
1000873
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Chordoma 
1000874
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 84 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Choriocarcinoma 
1000875
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Choroid melanoma 
1000877
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Choroid plexus carcinoma 
1006747
8 
PT 
Narro
w 
A 
0 
Active 
10.1 
20.0 
Clear cell carcinoma of cervix 
1007490
9 
PT 
Narro
w 
A 
0 
Active 
17.1 
20.0 
Clear cell endometrial carcinoma 
1000925
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Clear cell renal cell carcinoma 
1007325
1 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Clear cell sarcoma of soft tissue 
1007314
0 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Clear cell sarcoma of the kidney 
1000925
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
CNS germinoma 
1006585
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colon cancer 
1000994
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colon cancer metastatic 
1005511
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colon cancer recurrent 
1000995
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colon cancer stage 0 
1006352
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colon cancer stage I 
1000995
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colon cancer stage II 
1000995
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colon cancer stage III 
1000995
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colon cancer stage IV 
1000995
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 85 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Colorectal adenocarcinoma 
1005236
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colorectal cancer 
1006145
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colorectal cancer metastatic 
1005235
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colorectal cancer recurrent 
1001003
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colorectal cancer stage I 
1001003
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colorectal cancer stage II 
1001003
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colorectal cancer stage III 
1001003
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colorectal cancer stage IV 
1001003
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Colorectal carcinoma stage 0 
1001003
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Congenital fibrosarcoma 
1006585
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Congenital malignant neoplasm 
1007349
2 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Congenital retinoblastoma 
1007347
0 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Conjunctival melanoma 
1006638
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Cystadenocarcinoma ovary 
1005491
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Dedifferentiated liposarcoma 
1007313
5 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Dermatofibrosarcoma protuberans 
1005707
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Dermatofibrosarcoma protuberans metastatic 
1007357
4 
PT 
Narro
w 
A 
0 
Active 
16.1 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 86 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Desmoplastic melanoma 
1007244
9 
PT 
Narro
w 
A 
0 
Active 
15.1 
20.0 
Desmoplastic mesothelioma 
1007306
3 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Desmoplastic small round cell tumour 
1006458
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ductal adenocarcinoma of pancreas 
1007336
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Ear neoplasm malignant 
1005501
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Eccrine carcinoma 
1006968
0 
PT 
Narro
w 
A 
0 
Active 
12.1 
20.0 
Embryonal rhabdomyosarcoma 
1006586
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endocrine neoplasm malignant 
1006112
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial adenocarcinoma 
1001472
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial cancer 
1001473
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial cancer metastatic 
1001473
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial cancer recurrent 
1001473
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial cancer stage 0 
1001473
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial cancer stage I 
1001473
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial cancer stage II 
1001473
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial cancer stage III 
1001474
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial cancer stage IV 
1001474
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 87 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Endometrial sarcoma 
1005764
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial sarcoma metastatic 
1006706
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial sarcoma recurrent 
1006706
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endometrial stromal sarcoma 
1004839
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Endotheliomatosis 
1007686
8 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Ependymoma malignant 
1001496
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Epididymal cancer 
1007311
5 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Epiglottic carcinoma 
1005743
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Epithelioid mesothelioma 
1007306
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Epithelioid sarcoma 
1001509
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Epithelioid sarcoma metastatic 
1001510
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Epithelioid sarcoma recurrent 
1001510
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ewing's sarcoma 
1001556
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ewing's sarcoma metastatic 
1001556
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ewing's sarcoma recurrent 
1001556
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary embryonal carcinoma 
1001578
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary germ cell tumour 
1007305
5 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 88 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Extragonadal primary germ cell tumour mixed 
1007305
6 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Extragonadal primary germ cell tumour mixed stage I 
1001580
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary germ cell tumour mixed stage II 
1001580
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary germ cell tumour mixed stage III 
1001580
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary malignant teratoma 
1006184
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary non-seminoma 
1006184
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary non-seminoma stage I 
1001580
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary non-seminoma stage II 
1001580
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary non-seminoma stage III 
1001580
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary non-seminoma stage IV 
1001581
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary seminoma (pure) 
1007305
7 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Extragonadal primary seminoma (pure) stage I 
1001581
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary seminoma (pure) stage II 
1001581
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary seminoma (pure) stage III 
1001581
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extragonadal primary seminoma (pure) stage IV 
1001581
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extramammary Paget's disease 
1006822
3 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 
Extraocular retinoblastoma 
1001583
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 89 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Extra-osseous Ewing's sarcoma 
1001575
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extra-osseous Ewing's sarcoma metastatic 
1001576
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extra-osseous Ewing's sarcoma recurrent 
1001576
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extraskeletal chondrosarcoma metastatic 
1001584
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extraskeletal chondrosarcoma recurrent 
1001584
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extraskeletal myxoid chondrosarcoma 
1007313
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Extraskeletal osteosarcoma 
1001584
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extraskeletal osteosarcoma metastatic 
1001584
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Extraskeletal osteosarcoma recurrent 
1001585
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Fallopian tube cancer 
1001618
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Fallopian tube cancer metastatic 
1001618
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Fallopian tube cancer stage I 
1001618
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Fallopian tube cancer stage II 
1001618
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Fallopian tube cancer stage III 
1001618
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Fallopian tube cancer stage IV 
1001618
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Familial medullary thyroid cancer 
1007315
3 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Female reproductive tract carcinoma in situ 
1006115
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 90 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Fibrosarcoma 
1001663
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Fibrosarcoma metastatic 
1001663
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Follicular thyroid cancer 
1001693
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gallbladder adenocarcinoma 
1005828
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gallbladder adenosquamous carcinoma 
1007306
7 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Gallbladder cancer 
1001761
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gallbladder cancer metastatic 
1006687
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gallbladder cancer recurrent 
1001761
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gallbladder cancer stage 0 
1005931
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gallbladder cancer stage I 
1005931
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gallbladder cancer stage II 
1005828
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gallbladder cancer stage III 
1005828
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gallbladder cancer stage IV 
1005828
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gallbladder squamous cell carcinoma 
1007306
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Ganglioglioma 
1001770
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ganglioneuroblastoma 
1001770
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastric cancer 
1001775
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 91 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Gastric cancer recurrent 
1001776
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastric cancer stage 0 
1001776
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastric cancer stage I 
1001776
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastric cancer stage II 
1001776
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastric cancer stage III 
1001776
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastric cancer stage IV 
1006196
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastric sarcoma 
1005500
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastrinoma malignant 
1005170
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastroenteropancreatic neuroendocrine tumour disease 
1007755
9 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Gastrointestinal cancer metastatic 
1005354
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastrointestinal carcinoma 
1001794
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastrointestinal carcinoma in situ 
1006116
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gastrointestinal melanoma 
1007716
7 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Gastrointestinal stromal cancer 
1007165
3 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Gastrooesophageal cancer 
1006287
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Genital cancer male 
1007311
6 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Genital cancer male in situ 
1007312
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 92 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Genital neoplasm malignant female 
1001816
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Genitourinary melanoma 
1007716
6 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Germ cell cancer 
1006118
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Germ cell cancer metastatic 
1006897
1 
PT 
Narro
w 
A 
0 
Active 
12.0 
20.0 
Gestational trophoblastic tumour 
1006198
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gingival cancer 
1006780
7 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 
Glioblastoma 
1001833
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Glioblastoma multiforme 
1001833
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Glioma 
1001833
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Gliomatosis cerebri 
1006625
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Glioneuronal tumour 
1006860
1 
PT 
Narro
w 
A 
0 
Active 
11.1 
20.0 
Gliosarcoma 
1001834
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Glottis carcinoma 
1001839
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Glucagonoma 
1001840
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Haemangiopericytoma 
1001882
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Haemangiopericytoma of meninges 
1001882
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Head and neck cancer 
1006782
1 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 93 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Head and neck cancer metastatic 
1007154
0 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Head and neck cancer stage I 
1007153
9 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Head and neck cancer stage II 
1007153
8 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Head and neck cancer stage III 
1007153
7 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Head and neck cancer stage IV 
1007153
6 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Hepatic angiosarcoma 
1006738
8 
PT 
Narro
w 
A 
0 
Active 
10.1 
20.0 
Hepatic cancer 
1007306
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Hepatic cancer metastatic 
1005511
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hepatic cancer recurrent 
1007307
0 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Hepatic cancer stage I 
1005931
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hepatic cancer stage II 
1005931
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hepatic cancer stage III 
1005932
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hepatic cancer stage IV 
1005932
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hepatobiliary cancer 
1007307
3 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Hepatobiliary cancer in situ 
1007307
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Hepatoblastoma 
1006200
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hepatoblastoma recurrent 
1001982
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 94 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Hepatocellular carcinoma 
1007307
1 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
HER-2 positive breast cancer 
1006543
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
HER-2 positive gastric cancer 
1006689
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hereditary leiomyomatosis renal cell carcinoma 
1006794
4 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 
Hereditary papillary renal carcinoma 
1006794
3 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 
Hidradenocarcinoma 
1007308
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Hormone refractory breast cancer 
1007693
5 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Hormone-dependent prostate cancer 
1007111
9 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Hormone-refractory prostate cancer 
1006290
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Huerthle cell carcinoma 
1006613
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hypopharyngeal cancer 
1002104
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hypopharyngeal cancer recurrent 
1002104
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hypopharyngeal cancer stage 0 
1002104
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hypopharyngeal cancer stage I 
1002104
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hypopharyngeal cancer stage II 
1002104
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hypopharyngeal cancer stage III 
1002104
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Hypopharyngeal cancer stage IV 
1002104
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 95 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Immune reconstitution inflammatory syndrome 
associated Kaposi's sarcoma 
1007279
6 
PT 
Narro
w 
A 
0 
Active 
15.1 
20.0 
Inflammatory carcinoma of breast recurrent 
1002197
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Inflammatory carcinoma of breast stage III 
1002197
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Inflammatory carcinoma of breast stage IV 
1002197
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Inflammatory carcinoma of the breast 
1002198
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Inflammatory malignant fibrous histiocytoma 
1007314
2 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Inflammatory myofibroblastic tumour 
1006791
7 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 
Intestinal adenocarcinoma 
1005192
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Intestinal metastasis 
1008031
1 
PT 
Narro
w 
A 
0 
Active 
20.1 
20.1 
Intracranial germ cell tumour 
1007375
1 
PT 
Narro
w 
A 
0 
Active 
16.1 
20.0 
Intracranial meningioma malignant 
1002277
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Intraductal papillary breast neoplasm 
1007354
0 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Intraductal papillary-mucinous carcinoma of pancreas 
1007336
5 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Intraductal proliferative breast lesion 
1007309
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Intraocular melanoma 
1006125
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Invasive breast carcinoma 
1007571
3 
PT 
Narro
w 
A 
0 
Active 
18.0 
20.0 
Invasive ductal breast carcinoma 
1007309
5 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 96 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Invasive lobular breast carcinoma 
1007309
6 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Invasive papillary breast carcinoma 
1007309
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Iris melanoma 
1007308
6 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Kaposi's sarcoma 
1002328
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Kaposi's sarcoma AIDS related 
1002328
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Kaposi's sarcoma classical type 
1002328
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Keratinising squamous cell carcinoma of nasopharynx 
1007332
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Keratoacanthoma 
1002334
7 
PT 
Narro
w 
A 
0 
Active 
13.1 
20.0 
Langerhans cell sarcoma 
1007878
2 
PT 
Narro
w 
A 
0 
Active 
20.0 
20.0 
Large cell lung cancer 
1002377
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Large cell lung cancer metastatic 
1006973
0 
PT 
Narro
w 
A 
0 
Active 
13.0 
20.0 
Large cell lung cancer recurrent 
1002377
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Large cell lung cancer stage 0 
1002377
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Large cell lung cancer stage I 
1002377
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Large cell lung cancer stage II 
1002377
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Large cell lung cancer stage III 
1002377
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Large cell lung cancer stage IV 
1002378
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 97 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Laryngeal cancer 
1002382
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Laryngeal cancer metastatic 
1007090
2 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Laryngeal cancer recurrent 
1002382
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Laryngeal cancer stage 0 
1002382
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Laryngeal cancer stage I 
1002383
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Laryngeal cancer stage II 
1002383
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Laryngeal cancer stage III 
1002383
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Laryngeal cancer stage IV 
1002383
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Laryngeal squamous cell carcinoma 
1002385
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leiomyosarcoma 
1002418
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leiomyosarcoma metastatic 
1002419
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leiomyosarcoma recurrent 
1002419
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lentigo maligna 
1002421
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lentigo maligna recurrent 
1002422
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lentigo maligna stage I 
1002422
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lentigo maligna stage II 
1002422
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lentigo maligna stage III 
1002422
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 98 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Lentigo maligna stage IV 
1002422
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Leydig cell tumour of the testis 
1002440
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Linitis plastica 
1002452
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lip and/or oral cavity cancer 
1006152
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lip and/or oral cavity cancer recurrent 
1002453
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lip and/or oral cavity cancer stage 0 
1002453
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lip and/or oral cavity cancer stage I 
1002453
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lip and/or oral cavity cancer stage II 
1002453
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lip and/or oral cavity cancer stage III 
1002453
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lip and/or oral cavity cancer stage IV 
1002454
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lip neoplasm malignant stage unspecified 
1002455
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lip squamous cell carcinoma 
1006405
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Liposarcoma 
1002462
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Liposarcoma metastatic 
1002462
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Liposarcoma recurrent 
1002463
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lobular breast carcinoma in situ 
1007309
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Lung adenocarcinoma 
1002503
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 99 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Lung adenocarcinoma recurrent 
1002503
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung adenocarcinoma stage 0 
1002503
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung adenocarcinoma stage I 
1002503
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung adenocarcinoma stage II 
1002503
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung adenocarcinoma stage III 
1002503
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung adenocarcinoma stage IV 
1002503
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung cancer metastatic 
1005001
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung carcinoma cell type unspecified recurrent 
1002506
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung carcinoma cell type unspecified stage 0 
1002506
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung carcinoma cell type unspecified stage I 
1002506
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung carcinoma cell type unspecified stage II 
1002506
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung carcinoma cell type unspecified stage III 
1002506
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung carcinoma cell type unspecified stage IV 
1002507
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung infiltration malignant 
1006204
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung neoplasm malignant 
1005846
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung squamous cell carcinoma metastatic 
1007153
3 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Lung squamous cell carcinoma recurrent 
1002512
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 100 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Lung squamous cell carcinoma stage 0 
1002512
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung squamous cell carcinoma stage I 
1002512
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung squamous cell carcinoma stage II 
1002512
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung squamous cell carcinoma stage III 
1002512
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Lung squamous cell carcinoma stage IV 
1002512
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant anorectal neoplasm 
1006123
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant blue naevus 
1007244
8 
PT 
Narro
w 
A 
0 
Active 
15.1 
20.0 
Malignant connective tissue neoplasm 
1007434
0 
PT 
Narro
w 
A 
0 
Active 
17.0 
20.0 
Malignant cranial nerve neoplasm 
1006123
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant fibrous histiocytoma 
1002555
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant fibrous histiocytoma metastatic 
1002555
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant fibrous histiocytoma of bone 
1002555
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant fibrous histiocytoma recurrent 
1002556
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant genitourinary tract neoplasm 
1007441
9 
PT 
Narro
w 
A 
0 
Active 
17.0 
20.0 
Malignant giant cell fibrous histiocytoma 
1007314
1 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Malignant glioma 
1006544
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant haemangiopericytoma 
1002556
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 101 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Malignant haemangiopericytoma metastatic 
1002556
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant haemangiopericytoma recurrent 
1002557
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant hydatidiform mole 
1002559
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant joint neoplasm 
1007814
5 
PT 
Narro
w 
A 
0 
Active 
19.1 
20.0 
Malignant mediastinal neoplasm 
1006124
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant melanoma 
1002565
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant melanoma in situ 
1002565
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant melanoma of eyelid 
1006370
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant melanoma of sites other than skin 
1002565
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant melanoma stage I 
1002566
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant melanoma stage II 
1002566
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant melanoma stage III 
1002567
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant melanoma stage IV 
1002567
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant meningioma metastatic 
1007775
8 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Malignant mesenchymoma 
1006152
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant mesenchymoma metastatic 
1002567
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant mesenchymoma recurrent 
1002567
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 102 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Malignant mesenteric neoplasm 
1006736
9 
PT 
Narro
w 
A 
0 
Active 
10.1 
20.0 
Malignant middle ear neoplasm 
1006126
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant muscle neoplasm 
1006205
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of ampulla of Vater 
1002569
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of auricular cartilage 
1005727
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of choroid 
1002583
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of conjunctiva 
1002586
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of cornea 
1002587
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of eye 
1002591
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of eyelid 
1006369
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of islets of Langerhans 
1002599
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of lacrimal duct 
1002603
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of lacrimal gland 
1002603
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of orbit 
1002618
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of paraurethral glands 
1002632
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of placenta 
1002635
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of pleura 
1002635
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 103 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Malignant neoplasm of pleura metastatic 
1007243
2 
PT 
Narro
w 
A 
0 
Active 
15.1 
20.0 
Malignant neoplasm of renal pelvis 
1002642
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of retina 
1002643
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of seminal vesicle 
1006812
4 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 
Malignant neoplasm of spermatic cord 
1002647
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of spinal cord 
1002647
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of thorax 
1002653
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm of unknown primary site 
1007305
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Malignant neoplasm of uterine adnexa 
1002661
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant neoplasm papilla of Vater 
1007730
3 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Malignant neoplasm progression 
1005139
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant nervous system neoplasm 
1006126
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant nipple neoplasm 
1006205
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant nipple neoplasm female 
1005312
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant nipple neoplasm male 
1005312
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant oligodendroglioma 
1002665
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant ovarian cyst 
1002666
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 104 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Malignant palate neoplasm 
1002666
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant pericardial neoplasm 
1005494
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant peritoneal neoplasm 
1006126
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant pituitary tumour 
1002667
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant polyp 
1007869
5 
PT 
Narro
w 
A 
0 
Active 
19.1 
20.0 
Malignant respiratory tract neoplasm 
1006127
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant sweat gland neoplasm 
1007308
7 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Malignant transformation 
1006491
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Malignant urinary tract neoplasm 
1006127
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Marjolin's ulcer 
1007624
8 
PT 
Narro
w 
A 
0 
Active 
18.0 
20.0 
Maternal cancer in pregnancy 
1007987
7 
PT 
Narro
w 
A 
0 
Active 
20.1 
20.1 
Medullary carcinoma of breast 
1002709
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Medullary thyroid cancer 
1002710
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Medulloblastoma 
1002710
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Medulloblastoma recurrent 
1006659
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Melanoma recurrent 
1006660
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Meningioma malignant 
1002719
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 105 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Mesothelioma malignant 
1002740
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mesothelioma malignant recurrent 
1002741
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metaplastic breast carcinoma 
1007310
0 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Metastases to abdominal cavity 
1002745
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to abdominal wall 
1005166
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to adrenals 
1002745
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to biliary tract 
1006219
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to bladder 
1004972
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to bone 
1002745
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to breast 
1002745
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to central nervous system 
1005928
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to chest wall 
1005166
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to diaphragm 
1005166
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to Eustachian tube 
1005166
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to eye 
1004972
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to fallopian tube 
1004972
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to gallbladder 
1005166
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 106 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Metastases to gastrointestinal tract 
1006219
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to heart 
1004971
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to kidney 
1002745
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to larynx 
1005166
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to liver 
1002745
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to lung 
1002745
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to meninges 
1005169
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to mouth 
1005166
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to muscle 
1004973
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to nasal sinuses 
1005167
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to neck 
1002746
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to nervous system 
1006128
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to oesophagus 
1005167
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to ovary 
1002746
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to pancreas 
1004972
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to pelvis 
1007091
3 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Metastases to penis 
1005167
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 107 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Metastases to perineum 
1005167
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to peripheral nervous system 
1005167
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to peripheral vascular system 
1005830
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to peritoneum 
1005167
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to pharynx 
1005167
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to pituitary gland 
1004972
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to placenta 
1004972
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to pleura 
1002746
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to prostate 
1005167
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to rectum 
1005167
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to reproductive organ 
1006128
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to retroperitoneum 
1005168
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to salivary gland 
1005168
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to skin 
1002746
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to soft tissue 
1006219
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to spinal cord 
1007826
7 
PT 
Narro
w 
A 
0 
Active 
19.1 
20.0 
Metastases to spine 
1002746
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 108 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Metastases to stomach 
1004971
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to testicle 
1005168
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to the mediastinum 
1002746
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to the respiratory system 
1006160
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to thorax 
1005168
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to thyroid 
1004972
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to tonsils 
1007747
6 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Metastases to trachea 
1005168
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to urinary tract 
1005625
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to uterus 
1004972
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastases to vagina 
1007555
5 
PT 
Narro
w 
A 
0 
Active 
18.0 
20.0 
Metastasis 
1006219
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastatic bronchial carcinoma 
1005830
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastatic carcinoid tumour 
1006811
5 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 
Metastatic carcinoma of the bladder 
1005735
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastatic choriocarcinoma 
1007153
2 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Metastatic gastric cancer 
1006391
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 109 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Metastatic glioma 
1006315
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastatic glucagonoma 
1007524
5 
PT 
Narro
w 
A 
0 
Active 
17.1 
20.0 
Metastatic malignant melanoma 
1002748
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastatic neoplasm 
1006128
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastatic nervous system neoplasm 
1007770
3 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Metastatic ocular melanoma 
1006811
7 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 
Metastatic renal cell carcinoma 
1005051
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastatic salivary gland cancer 
1006688
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastatic squamous cell carcinoma 
1006356
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Metastatic uterine cancer 
1006811
6 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 
Microsatellite instability cancer 
1007961
8 
PT 
Narro
w 
A 
0 
Active 
20.1 
20.1 
Mismatch repair cancer syndrome 
1007788
8 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Mixed adenoneuroendocrine carcinoma 
1007674
8 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Mixed hepatocellular cholangiocarcinoma 
1002776
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mixed-type liposarcoma 
1007313
6 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Mucinous adenocarcinoma of appendix 
1007336
1 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Mucinous breast carcinoma 
1007310
1 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 110 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Mucinous cystadenocarcinoma of pancreas 
1007336
6 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Mucinous cystadenocarcinoma ovary 
1005491
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mucinous endometrial carcinoma 
1002807
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mucoepidermoid carcinoma 
1005726
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Mucoepidermoid carcinoma of salivary gland 
1007337
1 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Musculoskeletal cancer 
1007767
5 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Myxofibrosarcoma 
1006694
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Myxoid liposarcoma 
1007313
7 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Naevoid melanoma 
1007905
4 
PT 
Narro
w 
A 
0 
Active 
20.0 
20.0 
Nasal cavity cancer 
1002872
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nasal sinus cancer 
1002876
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nasopharyngeal cancer 
1006130
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nasopharyngeal cancer metastatic 
1007910
4 
PT 
Narro
w 
A 
0 
Active 
20.0 
20.0 
Nasopharyngeal cancer recurrent 
1002878
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nasopharyngeal cancer stage 0 
1002878
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nasopharyngeal cancer stage I 
1002878
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nasopharyngeal cancer stage II 
1002879
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 111 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Nasopharyngeal cancer stage III 
1002879
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nasopharyngeal cancer stage IV 
1002879
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Neonatal neuroblastoma 
1004979
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Neoplasm malignant 
1002899
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nephroblastoma 
1002914
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Neuroblastoma 
1002926
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Neuroblastoma recurrent 
1006659
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Neuroendocrine breast tumour 
1007310
3 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Neuroendocrine carcinoma 
1005727
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Neuroendocrine carcinoma metastatic 
1007154
2 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Neuroendocrine carcinoma of the bladder 
1007834
1 
PT 
Narro
w 
A 
0 
Active 
19.1 
20.0 
Neuroendocrine carcinoma of the skin 
1002926
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Neuroendocrine tumour 
1005239
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Neuroendocrine tumour of the lung 
1007817
4 
PT 
Narro
w 
A 
0 
Active 
19.1 
20.0 
Neuroendocrine tumour of the lung metastatic 
1007817
5 
PT 
Narro
w 
A 
0 
Active 
19.1 
20.0 
Neurofibrosarcoma 
1006152
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Neurofibrosarcoma metastatic 
1002927
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 112 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Neurofibrosarcoma recurrent 
1002927
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nodular melanoma 
1002948
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nongerminomatous germ cell tumour of the CNS 
1006587
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Nonkeratinising carcinoma of nasopharynx 
1007332
5 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Non-renal cell carcinoma of kidney 
1006187
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-small cell lung cancer 
1006187
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-small cell lung cancer metastatic 
1005951
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-small cell lung cancer recurrent 
1002951
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-small cell lung cancer stage 0 
1002951
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-small cell lung cancer stage I 
1002951
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-small cell lung cancer stage II 
1002951
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-small cell lung cancer stage III 
1002951
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-small cell lung cancer stage IIIA 
1002952
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-small cell lung cancer stage IIIB 
1002952
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Non-small cell lung cancer stage IV 
1002952
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
NUT midline carcinoma 
1007829
5 
PT 
Narro
w 
A 
0 
Active 
19.1 
20.0 
Ocular cancer metastatic 
1005509
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 113 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Ocular haemangiopericytoma 
1005741
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal adenocarcinoma 
1003013
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal adenocarcinoma recurrent 
1003014
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal adenocarcinoma stage 0 
1003014
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal adenocarcinoma stage I 
1003014
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal adenocarcinoma stage II 
1003014
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal adenocarcinoma stage III 
1003014
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal adenocarcinoma stage IV 
1003014
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal cancer metastatic 
1005510
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal carcinoma 
1003015
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal carcinoma recurrent 
1003015
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal carcinoma stage 0 
1003016
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal squamous cell carcinoma 
1006153
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal squamous cell carcinoma metastatic 
1005852
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal squamous cell carcinoma recurrent 
1003018
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal squamous cell carcinoma stage 0 
1003018
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal squamous cell carcinoma stage I 
1003018
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 114 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Oesophageal squamous cell carcinoma stage II 
1003019
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal squamous cell carcinoma stage III 
1003019
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oesophageal squamous cell carcinoma stage IV 
1003019
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oestrogen receptor positive breast cancer 
1007057
7 
PT 
Narro
w 
A 
0 
Active 
13.1 
20.0 
Oligoastrocytoma 
1007313
1 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Oligodendroglioma 
1003028
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Optic glioma 
1007333
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Oral cavity cancer metastatic 
1005509
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oropharyngeal cancer 
1003109
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oropharyngeal cancer recurrent 
1003109
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oropharyngeal cancer stage 0 
1003109
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oropharyngeal cancer stage I 
1003110
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oropharyngeal cancer stage II 
1003110
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oropharyngeal cancer stage III 
1003110
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oropharyngeal cancer stage IV 
1006409
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oropharyngeal lymphoepithelioma 
1003110
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Oropharyngeal squamous cell carcinoma 
1003111
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 115 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Osteosarcoma 
1003129
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Osteosarcoma metastatic 
1003129
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Osteosarcoma recurrent 
1003129
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Otic cancer metastatic 
1005510
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian cancer 
1003312
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian cancer metastatic 
1005752
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian cancer recurrent 
1006669
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian cancer stage I 
1007090
5 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Ovarian cancer stage II 
1007090
6 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Ovarian cancer stage III 
1007090
7 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Ovarian cancer stage IV 
1007090
8 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Ovarian clear cell carcinoma 
1007326
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Ovarian dysgerminoma stage I 
1003314
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian dysgerminoma stage II 
1003314
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian dysgerminoma stage III 
1003315
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian dysgerminoma stage IV 
1003315
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian dysgerminoma stage unspecified 
1005275
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 116 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Ovarian embryonal carcinoma 
1005626
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian endometrioid carcinoma 
1007326
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Ovarian epithelial cancer 
1006132
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian epithelial cancer metastatic 
1003315
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian epithelial cancer recurrent 
1003316
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian epithelial cancer stage I 
1003316
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian epithelial cancer stage II 
1003316
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian epithelial cancer stage III 
1003316
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian epithelial cancer stage IV 
1003316
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell cancer 
1006189
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell cancer stage I 
1006189
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell cancer stage II 
1006189
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell cancer stage III 
1006189
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell cancer stage IV 
1006189
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell choriocarcinoma 
1007326
2 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Ovarian germ cell choriocarcinoma stage I 
1003318
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell choriocarcinoma stage II 
1003318
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 117 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Ovarian germ cell choriocarcinoma stage III 
1003319
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell choriocarcinoma stage IV 
1003319
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell embryonal carcinoma stage I 
1003319
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell embryonal carcinoma stage II 
1003320
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell embryonal carcinoma stage III 
1003320
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell embryonal carcinoma stage IV 
1003320
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell endodermal sinus tumour 
1007326
3 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Ovarian germ cell endodermal sinus tumour stage I 
1003321
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell endodermal sinus tumour stage II 
1003321
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell endodermal sinus tumour stage III 
1003322
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell endodermal sinus tumour stage IV 
1003322
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell polyembryoma 
1007326
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Ovarian germ cell polyembryoma stage I 
1003322
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell polyembryoma stage II 
1003322
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell polyembryoma stage III 
1003323
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell polyembryoma stage IV 
1003323
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell teratoma 
1007326
5 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 118 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Ovarian germ cell teratoma stage I 
1003323
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell teratoma stage II 
1003324
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell teratoma stage III 
1003324
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell teratoma stage IV 
1003324
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian germ cell tumour mixed 
1007325
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Ovarian granulosa-theca cell tumour 
1005737
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian low malignant potential tumour 
1003326
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ovarian stromal cancer 
1006585
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Paget's disease of nipple 
1003336
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Paget's disease of penis 
1003336
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Paget's disease of the vulva 
1003336
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pancoast's tumour 
1003357
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pancreatic carcinoma 
1003360
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pancreatic carcinoma metastatic 
1003361
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pancreatic carcinoma recurrent 
1003361
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pancreatic carcinoma stage 0 
1005932
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pancreatic carcinoma stage I 
1005932
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 119 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Pancreatic carcinoma stage II 
1005932
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pancreatic carcinoma stage III 
1005932
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pancreatic carcinoma stage IV 
1005932
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pancreatic neuroendocrine tumour 
1006751
7 
PT 
Narro
w 
A 
0 
Active 
10.1 
20.0 
Pancreatic neuroendocrine tumour metastatic 
1006890
9 
PT 
Narro
w 
A 
0 
Active 
12.0 
20.0 
Pancreatic sarcoma 
1005500
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pancreatoblastoma 
1007336
7 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Papillary renal cell carcinoma 
1007849
3 
PT 
Narro
w 
A 
0 
Active 
19.1 
20.0 
Papillary serous endometrial carcinoma 
1003370
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Papillary thyroid cancer 
1003370
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Paraganglion neoplasm malignant 
1003379
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Paranasal sinus and nasal cavity malignant neoplasm 
1006190
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Paranasal sinus and nasal cavity malignant neoplasm 
recurrent 
1003385
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Paranasal sinus and nasal cavity malignant neoplasm 
stage 0 
1003385
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Paranasal sinus and nasal cavity malignant neoplasm 
stage I 
1003385
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Paranasal sinus and nasal cavity malignant neoplasm 
stage II 
1003385
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Paranasal sinus and nasal cavity malignant neoplasm 
stage III 
1003385
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 120 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Paranasal sinus and nasal cavity malignant neoplasm 
stage IV 
1003386
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Parathyroid tumour malignant 
1003396
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Penile cancer 
1003429
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Penile squamous cell carcinoma 
1005963
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Penis carcinoma metastatic 
1003432
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Penis carcinoma recurrent 
1003433
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Penis carcinoma stage I 
1003433
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Penis carcinoma stage II 
1003433
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Penis carcinoma stage III 
1003433
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Penis carcinoma stage IV 
1003433
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pericardial mesothelioma malignant 
1007306
6 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Pericardial mesothelioma malignant recurrent 
1003448
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peripheral nerve sheath tumour malignant 
1003459
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peripheral neuroepithelioma of bone 
1006134
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peripheral neuroepithelioma of bone metastatic 
1003460
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peripheral neuroepithelioma of bone recurrent 
1003460
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peripheral neuroepithelioma of soft tissue 
1005764
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 121 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Peripheral primitive neuroectodermal bone tumour 
1007310
7 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Peripheral primitive neuroectodermal tumour of soft 
tissue 
1007314
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Peritoneal carcinoma metastatic 
1006897
4 
PT 
Narro
w 
A 
0 
Active 
12.0 
20.0 
Peritoneal mesothelioma malignant 
1005655
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peritoneal mesothelioma malignant recurrent 
1003467
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Peritoneal sarcoma 
1005194
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Phaeochromocytoma malignant 
1005171
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pharyngeal cancer 
1003481
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pharyngeal cancer metastatic 
1005510
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pharyngeal cancer recurrent 
1003481
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pharyngeal cancer stage 0 
1003481
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pharyngeal cancer stage I 
1003481
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pharyngeal cancer stage II 
1003481
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pharyngeal cancer stage III 
1003481
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pharyngeal cancer stage IV 
1003481
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pilomatrix carcinoma 
1007561
4 
PT 
Narro
w 
A 
0 
Active 
18.0 
20.0 
Pineal germinoma 
1003505
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 122 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Pineal parenchymal neoplasm malignant 
1006153
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pinealoblastoma 
1005048
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pituitary cancer metastatic 
1005510
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pituitary neoplasm malignant recurrent 
1005783
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pleomorphic liposarcoma 
1007313
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Pleomorphic malignant fibrous histiocytoma 
1007314
3 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Pleural mesothelioma 
1003560
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pleural mesothelioma malignant 
1005951
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pleural mesothelioma malignant recurrent 
1003560
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pleural sarcoma 
1005195
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Poorly differentiated thyroid carcinoma 
1007660
3 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Porocarcinoma 
1006360
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Postcricoid cancer 
1003633
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Primitive neuroectodermal tumour 
1005784
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Primitive neuroectodermal tumour metastatic 
1006891
0 
PT 
Narro
w 
A 
0 
Active 
12.0 
20.0 
Prostate cancer 
1006086
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Prostate cancer metastatic 
1003690
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 123 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Prostate cancer recurrent 
1003691
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Prostate cancer stage 0 
1003691
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Prostate cancer stage I 
1003691
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Prostate cancer stage II 
1003691
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Prostate cancer stage III 
1003691
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Prostate cancer stage IV 
1003692
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Pseudosarcoma 
1005180
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Queyrat erythroplasia 
1003773
2 
PT 
Narro
w 
A 
0 
Active 
17.0 
20.0 
Rectal adenocarcinoma 
1003801
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectal cancer 
1003803
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectal cancer metastatic 
1005509
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectal cancer recurrent 
1003804
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectal cancer stage 0 
1003804
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectal cancer stage I 
1003804
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectal cancer stage II 
1003804
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectal cancer stage III 
1003805
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectal cancer stage IV 
1003805
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 124 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Rectosigmoid cancer 
1003808
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectosigmoid cancer metastatic 
1006972
8 
PT 
Narro
w 
A 
0 
Active 
13.0 
20.0 
Rectosigmoid cancer recurrent 
1003809
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectosigmoid cancer stage 0 
1003809
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectosigmoid cancer stage I 
1003809
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectosigmoid cancer stage II 
1003809
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectosigmoid cancer stage III 
1003809
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rectosigmoid cancer stage IV 
1003809
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Recurrent cancer 
1003811
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Refractory cancer 
1007030
8 
PT 
Narro
w 
A 
0 
Active 
13.0 
20.0 
Renal cancer 
1003838
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Renal cancer metastatic 
1005001
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Renal cancer recurrent 
1003839
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Renal cancer stage I 
1003839
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Renal cancer stage II 
1003839
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Renal cancer stage III 
1003839
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Renal cancer stage IV 
1003839
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 125 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Renal cell carcinoma 
1006794
6 
PT 
Narro
w 
A 
0 
Active 
11.0 
20.0 
Renal cell carcinoma recurrent 
1003841
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Renal cell carcinoma stage I 
1003841
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Renal cell carcinoma stage II 
1003841
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Renal cell carcinoma stage III 
1003841
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Renal cell carcinoma stage IV 
1003841
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Respiratory tract carcinoma in situ 
1003872
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Retinal melanoma 
1003887
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Retinoblastoma 
1003891
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Retroperitoneal cancer 
1003897
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Retroperitoneal neoplasm metastatic 
1006248
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rhabdoid tumour 
1007333
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Rhabdoid tumour of the kidney 
1003901
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rhabdomyosarcoma 
1003902
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Rhabdomyosarcoma recurrent 
1003902
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Round cell liposarcoma 
1007313
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Salivary gland cancer 
1006193
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 126 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Salivary gland cancer recurrent 
1003939
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Salivary gland cancer stage 0 
1003939
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Salivary gland cancer stage I 
1003940
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Salivary gland cancer stage II 
1003940
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Salivary gland cancer stage III 
1003940
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Salivary gland cancer stage IV 
1003940
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Sarcoma 
1003949
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Sarcoma metastatic 
1006859
5 
PT 
Narro
w 
A 
0 
Active 
11.1 
20.0 
Sarcoma of skin 
1003949
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Sarcoma uterus 
1003949
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Sarcomatoid mesothelioma 
1007306
5 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Sarcomatosis 
1003950
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Scrotal cancer 
1003974
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Sebaceous carcinoma 
1006878
4 
PT 
Narro
w 
A 
0 
Active 
12.0 
20.0 
Second primary malignancy 
1003980
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Seminoma 
1003995
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Serous cystadenocarcinoma of pancreas 
1007336
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 127 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Serous cystadenocarcinoma ovary 
1005491
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Signet-ring cell carcinoma 
1005726
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Sinus cancer metastatic 
1005510
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Skin angiosarcoma 
1007289
1 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Skin cancer 
1004080
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Skin cancer metastatic 
1005511
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Skin squamous cell carcinoma metastatic 
1007731
4 
PT 
Narro
w 
A 
0 
Active 
19.0 
20.0 
Small cell carcinoma 
1004105
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small cell carcinoma of the cervix 
1004105
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small cell lung cancer 
1004106
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small cell lung cancer extensive stage 
1004106
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small cell lung cancer limited stage 
1004106
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small cell lung cancer metastatic 
1005951
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small cell lung cancer recurrent 
1004107
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small intestine adenocarcinoma 
1007337
3 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Small intestine carcinoma 
1005418
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small intestine carcinoma metastatic 
1004112
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 128 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Small intestine carcinoma recurrent 
1004112
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small intestine carcinoma stage 0 
1005936
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small intestine carcinoma stage I 
1005936
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small intestine carcinoma stage II 
1005937
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small intestine carcinoma stage III 
1005937
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small intestine carcinoma stage IV 
1005937
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Small intestine leiomyosarcoma 
1004112
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Soft tissue sarcoma 
1007533
3 
PT 
Narro
w 
A 
0 
Active 
17.1 
20.0 
Solid pseudopapillary tumour of the pancreas 
1006934
5 
PT 
Narro
w 
A 
0 
Active 
12.1 
20.0 
Spermatocytic seminoma 
1007311
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Spinal meningioma malignant 
1004158
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Spindle cell sarcoma 
1004906
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous cell breast carcinoma 
1007930
7 
PT 
Narro
w 
A 
0 
Active 
20.0 
20.0 
Squamous cell carcinoma 
1004182
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous cell carcinoma of head and neck 
1006012
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous cell carcinoma of lung 
1004182
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous cell carcinoma of pharynx 
1006647
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 129 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Squamous cell carcinoma of skin 
1004183
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous cell carcinoma of the cervix 
1004184
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous cell carcinoma of the hypopharynx 
1004184
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous cell carcinoma of the oral cavity 
1004185
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous cell carcinoma of the tongue 
1004186
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous cell carcinoma of the vagina 
1004186
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous cell carcinoma of the vulva 
1004187
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Squamous endometrial carcinoma 
1004188
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Stewart-Treves syndrome 
1005949
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Superficial spreading melanoma stage I 
1004254
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Superficial spreading melanoma stage II 
1004255
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Superficial spreading melanoma stage III 
1004255
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Superficial spreading melanoma stage IV 
1004255
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Superficial spreading melanoma stage unspecified 
1004255
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Synovial sarcoma 
1004286
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Synovial sarcoma metastatic 
1004286
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Synovial sarcoma recurrent 
1004286
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 130 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Testicular cancer metastatic 
1005510
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular choriocarcinoma 
1006212
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular choriocarcinoma recurrent 
1006981
2 
PT 
Narro
w 
A 
0 
Active 
13.0 
20.0 
Testicular choriocarcinoma stage I 
1004330
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular choriocarcinoma stage II 
1004330
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular choriocarcinoma stage III 
1004330
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular embryonal carcinoma 
1006212
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular embryonal carcinoma stage I 
1004330
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular embryonal carcinoma stage II 
1004331
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular embryonal carcinoma stage III 
1004331
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular germ cell cancer 
1006137
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular germ cell cancer metastatic 
1006869
4 
PT 
Narro
w 
A 
0 
Active 
11.1 
20.0 
Testicular germ cell tumour mixed 
1007311
9 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Testicular germ cell tumour mixed stage I 
1004333
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular germ cell tumour mixed stage II 
1004333
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular germ cell tumour mixed stage III 
1004333
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular leiomyosarcoma 
1005734
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 131 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Testicular malignant teratoma 
1007312
0 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Testicular malignant teratoma stage I 
1004333
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular malignant teratoma stage II 
1004334
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular malignant teratoma stage III 
1004334
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular seminoma (pure) 
1006212
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular seminoma (pure) stage I 
1004335
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular seminoma (pure) stage II 
1004335
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular seminoma (pure) stage III 
1004335
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular yolk sac tumour 
1007312
1 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Testicular yolk sac tumour stage I 
1004335
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular yolk sac tumour stage II 
1004335
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testicular yolk sac tumour stage III 
1004335
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testis cancer 
1005764
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Testis cancer recurrent 
1006981
3 
PT 
Narro
w 
A 
0 
Active 
13.0 
20.0 
Throat cancer 
1004351
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Thyroid cancer 
1006647
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Thyroid cancer metastatic 
1005510
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 132 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Thyroid cancer recurrent 
1007216
2 
PT 
Narro
w 
A 
0 
Active 
15.0 
20.0 
Thyroid cancer stage 0 
1007056
7 
PT 
Narro
w 
A 
0 
Active 
13.1 
20.0 
Thyroid cancer stage I 
1007102
7 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Thyroid cancer stage II 
1007102
8 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Thyroid cancer stage III 
1007102
9 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Thyroid cancer stage IV 
1007103
0 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Tongue cancer metastatic 
1005510
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Tongue cancer recurrent 
1007125
1 
PT 
Narro
w 
A 
0 
Active 
14.1 
20.0 
Tongue carcinoma stage 0 
1005842
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Tongue carcinoma stage I 
1005843
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Tongue carcinoma stage II 
1005843
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Tongue carcinoma stage III 
1005843
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Tongue carcinoma stage IV 
1005843
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Tongue neoplasm malignant stage unspecified 
1004396
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Tonsil cancer 
1004400
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Tonsil cancer metastatic 
1007279
2 
PT 
Narro
w 
A 
0 
Active 
15.1 
20.0 
Tracheal cancer 
1004428
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 133 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Transitional cell cancer of renal pelvis and ureter 
metastatic 
1004440
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Transitional cell cancer of the renal pelvis and ureter 
1004440
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Transitional cell cancer of the renal pelvis and ureter 
localised 
1004440
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Transitional cell cancer of the renal pelvis and ureter 
recurrent 
1004441
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Transitional cell cancer of the renal pelvis and ureter 
regional 
1004441
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Transitional cell carcinoma 
1004441
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Transitional cell carcinoma metastatic 
1007108
0 
PT 
Narro
w 
A 
0 
Active 
14.0 
20.0 
Transitional cell carcinoma recurrent 
1007705
1 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Transitional cell carcinoma urethra 
1004442
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Triple negative breast cancer 
1007556
6 
PT 
Narro
w 
A 
0 
Active 
18.0 
20.0 
Tubular breast carcinoma 
1007310
4 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Tumour budding 
1007696
9 
PT 
Narro
w 
A 
0 
Active 
18.1 
20.0 
Undifferentiated carcinoma of colon 
1007336
2 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Undifferentiated nasopharyngeal carcinoma 
1007332
8 
PT 
Narro
w 
A 
0 
Active 
16.0 
20.0 
Undifferentiated sarcoma 
1004551
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ureteric cancer 
1004639
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ureteric cancer local 
1004639
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 134 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Ureteric cancer metastatic 
1004639
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ureteric cancer recurrent 
1004639
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Ureteric cancer regional 
1004639
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Urethral cancer 
1004643
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Urethral cancer metastatic 
1004643
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Urethral cancer recurrent 
1004643
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Urethral melanoma metastatic 
1007279
3 
PT 
Narro
w 
A 
0 
Active 
15.1 
20.0 
Urinary bladder sarcoma 
1005169
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Urinary tract carcinoma in situ 
1006139
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Uterine cancer 
1004676
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Uterine carcinoma in situ 
1004677
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Uterine leiomyosarcoma 
1004679
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vaginal adenocarcinoma 
1006534
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vaginal cancer 
1004688
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vaginal cancer metastatic 
1004688
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vaginal cancer recurrent 
1004688
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vaginal cancer stage 0 
1004689
0 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 135 of 217 
Name 
Code 
Level 
Scope 
Categor
y 
Weigh
t 
Status 
Addition 
Version 
Last Modified 
Version 
Vaginal cancer stage I 
1004689
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vaginal cancer stage II 
1004689
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vaginal cancer stage III 
1004689
3 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vaginal cancer stage IVA 
1004689
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vaginal cancer stage IVB 
1004689
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vulval cancer 
1004774
1 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vulval cancer metastatic 
1004774
2 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vulval cancer recurrent 
1004774
4 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vulval cancer stage 0 
1004774
5 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vulval cancer stage I 
1004774
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vulval cancer stage II 
1004774
7 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vulval cancer stage III 
1004774
8 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vulval cancer stage IV 
1004774
9 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
Vulvar adenocarcinoma 
1006353
6 
PT 
Narro
w 
A 
0 
Active 
10.0 
20.0 
 
 
 


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19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 136 of 217 
7.3. 
SMQ Terms for Pregnancy and Neonatal Topics 
SMQ Export: 20.1 - English 
1/8/2018 2:22:18 PM 
Include Inactive PT:  No 
Term Attributes:       Name, Code, Level, Scope, Category, Weight, Status, Addition Version, Last 
Modified Version 
Pregnancy and neonatal topics (SMQ) [20000185] 
Congenital, familial and genetic disorders (SMQ) [20000077] 
 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
11-beta-hydroxylase deficiency 
10000002 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
17,20-desmolase deficiency 
10000013 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
17-alpha-hydroxylase deficiency 
10000014 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
18q minus syndrome 
10068533 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
20,22-desmolase deficiency 
10000020 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
21-hydroxylase deficiency 
10000021 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
2-Hydroxyglutaric aciduria 
10078971 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
3-hydroxyacetyl-coenzyme A dehydrogenase 
deficiency 
10072273 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
5-alpha-reductase deficiency 
10000029 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Aase syndrome 
10063429 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Abdominal transposition 
10000098 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Abdominal wall anomaly 
10000101 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Abnormal palmar/plantar creases 
10000162 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
ABO haemolytic disease of newborn 
10000205 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Acardia 
10075721 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Accessory auricle 
10000361 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Accessory breast 
10049786 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Accessory carpal bone 
10000362 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Accessory kidney 
10048781 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Accessory liver lobe 
10052752 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Accessory muscle 
10000364 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 137 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Accessory navicular syndrome 
10062626 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Accessory salivary gland 
10000368 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Accessory spleen 
10068059 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Acetylcholinesterase deficiency 
10071435 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Achromotrichia congenital 
10049864 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Acral peeling skin syndrome 
10078538 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Acrodermatitis enteropathica 
10000596 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Acrodysostosis 
10079856 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Acrokeratosis verruciformis 
10069445 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Activated PI3 kinase delta syndrome 
10078281 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Adactyly 
10049207 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Adams-Oliver syndrome 
10079369 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Adenine phosphoribosyl transferase deficiency 
10072609 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Adenomatous polyposis coli 
10056981 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Adrenal insufficiency neonatal 
10001368 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Adrenogenital syndrome 
10061630 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Adrenoleukodystrophy 
10051260 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Adult polyglucosan body disease 
10077946 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Aglossia 
10001501 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Aicardi's syndrome 
10054935 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Alagille syndrome 
10053870 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Albinism 
10001557 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Albright's disease 
10052032 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Alkaptonuria 
10001689 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Allan-Herndon-Dudley syndrome 
10078821 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Alpers' disease 
10062943 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Alpha-1 anti-trypsin deficiency 
10001806 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Alport's syndrome 
10001843 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Alstroem syndrome 
10068783 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Alternating hemiplegia of childhood 
10077948 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 138 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Alveolar capillary dysplasia 
10077023 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Amblyopia congenital 
10001908 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Amegakaryocytic thrombocytopenia 
10076744 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Aminoaciduria 
10001939 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Amniotic band syndrome 
10064100 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Amyotrophic lateral sclerosis gene carrier 
10052653 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anal atresia 
10002120 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Androgen insensitivity syndrome 
10056292 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anencephaly 
10002320 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Angelman's syndrome 
10049004 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Angiotensin converting enzyme inhibitor 
foetopathy 
10051098 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Aniridia 
10002532 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ankyloglossia congenital 
10049244 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Annular pancreas 
10071757 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Anodontia 
10002583 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anomalous arrangement of pancreaticobiliary 
duct 
10064902 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anomalous pulmonary venous connection 
10058079 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anomaly of external ear congenital 
10062339 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anomaly of middle ear congenital 
10060957 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anomaly of orbit, congenital 
10002633 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anophthalmos 
10002640 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anorchism 
10002641 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anorectal agenesis 
10056271 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anotia 
10002654 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anterior chamber cleavage syndrome 
10059199 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Anterior displaced anus 
10071651 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Antithrombin III deficiency 
10002832 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Aorta hypoplasia 
10049209 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 139 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Aortic valve atresia 
10066801 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Aorticopulmonary septal defect 
10063732 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Apert's syndrome 
10002943 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Aphakia congenital 
10002947 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Aplasia 
10002961 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Aplasia cutis congenita 
10002963 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Apparent mineralocorticoid excess 
10080229 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Arachnodactyly 
10063847 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Arcuate foramen 
10067850 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Arginase deficiency 
10062695 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Argininosuccinate lyase deficiency 
10058299 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Argininosuccinate synthetase deficiency 
10058298 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Arnold-Chiari malformation 
10003101 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Arrhythmogenic right ventricular dysplasia 
10058093 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Arterial tortuosity syndrome 
10080250 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Arteriovenous malformation 
10003193 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ash leaf macule 
10076367 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Aspartate-glutamate-transporter deficiency 
10079140 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Aspartylglucosaminuria 
10068220 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Asphyxiating thoracic dystrophy 
10057621 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Asplenia 
10053622 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Asymptomatic gene carrier 
10061662 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ataxia telangiectasia 
10003594 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Atrial septal defect 
10003664 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Atrioventricular node dispersion 
10077893 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Atrioventricular septal defect 
10063836 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Auditory neuropathy spectrum disorder 
10072198 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Autoimmune lymphoproliferative syndrome 
10069521 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Autosomal chromosome anomaly 
10060975 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Azygos lobe 
10069490 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 140 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Baltic myoclonic epilepsy 
10054895 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Bannayan-Riley-Ruvalcaba syndrome 
10080314 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Baraitser Rodeck Garner syndrome 
10076038 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Barakat syndrome 
10075281 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Barth syndrome 
10078537 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Bartter's syndrome 
10050839 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Basal cell naevus syndrome 
10062804 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Becker's muscular dystrophy 
10059117 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Beckwith-Wiedemann syndrome 
10050344 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Benign congenital hypotonia 
10051900 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Benign familial haematuria 
10060876 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Benign familial neonatal convulsions 
10067866 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Benign familial pemphigus 
10004265 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Berdon's syndrome 
10064596 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Beta ketothiolase deficiency 
10067728 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Bicuspid aortic valve 
10004552 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Bicuspid pulmonary valve 
10063730 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Biliary hamartoma 
10074610 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Biotinidase deficiency 
10071434 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Birth mark 
10004950 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Birt-Hogg-Dube syndrome 
10067736 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Bladder agenesis 
10056655 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Blau syndrome 
10071755 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Blepharophimosis congenital 
10049241 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Blindness congenital 
10005176 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Bloch-Sulzberger syndrome 
10077624 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Blood incompatibility haemolytic anaemia of 
newborn 
10056369 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Bloom syndrome 
10073032 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Brachycephaly 
10053682 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 141 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Brachydactyly 
10072883 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Brain malformation 
10048409 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Branchial cleft sinus 
10006162 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Branchial cyst 
10006164 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Branchiogenic syndrome 
10058169 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Branchio-oto-renal syndrome 
10071135 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Breast malformation 
10006271 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Bronchogenic cyst 
10064585 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Bruton's agammaglobulinaemia 
10060360 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Bulbospinal muscular atrophy congenital 
10068597 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Buried penis syndrome 
10067131 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Camptodactyly congenital 
10049028 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Camptomelia 
10078297 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Canavan disease 
10067608 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Cancer gene carrier 
10052648 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
CANDLE syndrome 
10073960 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Carbamoyl phosphate synthetase deficiency 
10058297 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Carbohydrate metabolism disorder 
10061023 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Carcinogenic effect in offspring 
10007268 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cardiac lymphangioma 
10055010 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cardiac malposition 
10007585 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cardiac septal defect 
10064021 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Carney complex 
10076601 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Carnitine palmitoyltransferase deficiency 
10050215 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Carnitine-acylcarnitine translocase deficiency 
10078729 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Carpus curvus 
10007700 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cartilage-hair hypoplasia 
10069596 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Cataract congenital 
10007747 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Caudal regression syndrome 
10059387 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Central core disease 
10057620 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 142 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Central nervous system dermoid tumour 
10007942 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cerebellar dysplasia 
10072942 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Cerebellar hypoplasia 
10008033 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cerebral arteriovenous malformation 
haemorrhagic 
10008086 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cerebral atrophy congenital 
10052236 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cerebral autosomal dominant arteriopathy with 
subcortical infarcts and leukoencephalopathy 
10065551 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cerebral dysgenesis 
10056467 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cerebral palsy 
10008129 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cerebrohepatorenal syndrome 
10053684 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cerebrovascular arteriovenous malformation 
10056371 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cervical auricle 
10008227 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cervical rib 
10008299 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
CHARGE syndrome 
10064063 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Chediak-Higashi syndrome 
10008415 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Chiari network 
10069393 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Chimerism 
10068051 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Choanal atresia 
10008587 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Choanal stenosis 
10074053 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Cholangiectasis congenital 
10053630 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Choledochal cyst 
10008625 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Chondrodystrophy 
10008723 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Chondroectodermal dysplasia 
10008724 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Chordee 
10008746 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Chorioretinal degeneration congenital 
10008763 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Choroidal coloboma 
10057402 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Chromosomal deletion 
10061764 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Chromosomal mutation 
10061765 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Chronic granulomatous disease 
10008906 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 143 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Chronic infantile neurological cutaneous and 
articular syndrome 
10064568 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Citrate transporter deficiency 
10077947 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Cleft lip 
10009259 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cleft lip and palate 
10009260 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cleft palate 
10009269 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cleft uvula 
10053507 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cleidocranial dysostosis 
10075994 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Clinodactyly 
10058668 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cloacal exstrophy 
10067424 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Coagulation factor mutation 
10065442 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Coarctation of the aorta 
10009807 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cobb syndrome 
10068841 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Cockayne's syndrome 
10009835 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cohen syndrome 
10049066 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Collodion baby 
10009926 
PT 
Narrow 
A 
0 
Active 
10.0 
16.1 
Coloboma 
10009934 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Colour blindness 
10010050 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Combined immunodeficiency 
10010099 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Complement deficiency disease 
10075551 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Congenital abdominal hernia 
10067183 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital absence of bile ducts 
10010317 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital absence of cranial vault 
10010318 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital absence of vertebra 
10010320 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital acrochordon 
10050730 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital adrenal gland hypoplasia 
10049057 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital amputation 
10079701 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Congenital anaemia 
10010329 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital androgen deficiency 
10063469 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital anomalies of ear ossicles 
10010341 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 144 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Congenital anomaly 
10010356 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital anomaly in offspring 
10063726 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital anomaly of adrenal gland 
10062341 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital anomaly of inner ear 
10062340 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital anosmia 
10079876 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Congenital aortic anomaly 
10061052 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital aortic atresia 
10010368 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital aortic dilatation 
10058150 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital aortic stenosis 
10010369 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital aortic valve incompetence 
10010370 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital aortic valve stenosis 
10010371 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital aplastic anaemia 
10053138 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital aqueductal stenosis 
10066084 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital arterial malformation 
10062325 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital arteriovenous fistula 
10010374 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital astigmatism 
10074992 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Congenital aural fistula 
10054215 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital benign neoplasm 
10073493 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Congenital bladder anomaly 
10061053 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital bladder diverticulum 
10010381 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital bladder neck obstruction 
10010382 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital bowing of long bones 
10054064 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital brain damage 
10010390 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital bronchiectasis 
10010391 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital bronchomalacia 
10010392 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital calyceal diverticulum 
10057510 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cardiovascular anomaly 
10061054 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital carnitine deficiency 
10062698 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital central diabetes insipidus 
10073008 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Congenital central hypoventilation syndrome 
10066131 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 145 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Congenital central nervous system anomaly 
10010411 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cerebellar agenesis 
10048784 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cerebral cyst 
10054954 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cerebral haemangioma 
10048924 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cerebrovascular anomaly 
10062327 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital choroid plexus cyst 
10048785 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital choroidal anomaly 
10057886 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital chylothorax 
10078770 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Congenital clavicular agenesis 
10010416 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital claw toe 
10010417 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital coagulopathy 
10063563 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital condyloma 
10066944 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital corneal anomaly 
10061059 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital coronary artery malformation 
10061060 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cranial nerve paralysis 
10069774 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Congenital cutis laxa 
10057042 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cyst 
10062328 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cystic disease of liver 
10010427 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cystic kidney disease 
10010428 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cystic lung 
10010429 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital cytomegalovirus infection 
10010430 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital deformity of clavicle 
10010434 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital dermal sinus 
10048728 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital diaphragmatic anomaly 
10061061 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital diaphragmatic eventration 
10010438 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital diaphragmatic hernia 
10010439 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital disorder of glycosylation 
10075892 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Congenital dysfibrinogenaemia 
10051123 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital dyskeratosis 
10062759 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital ectodermal dysplasia 
10010452 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 146 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Congenital ectopic bladder 
10010453 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital ectopic pancreas 
10056987 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital elevation of scapula 
10010455 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital emphysema 
10010456 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital endocrine anomaly 
10062329 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital epiblepharon 
10056531 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital epiglottal anomaly 
10062330 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital Eustachian tube anomaly 
10062331 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital eye disorder 
10059159 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital eye naevus 
10051050 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital eyelid malformation 
10061146 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital facial nerve hypoplasia 
10049449 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital fallopian tube anomaly 
10061062 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital fibrosarcoma 
10065859 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital flaccid paralysis 
10010474 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital flat feet 
10010475 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital floppy infant 
10053153 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital foot malformation 
10062332 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital gastric anomaly 
10061063 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital gastrointestinal vessel anomaly 
10062342 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital generalised lipodystrophy 
10053547 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital genital malformation 
10062333 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital genital malformation female 
10010481 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital genital malformation male 
10059492 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital genitourinary abnormality 
10062334 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital great vessel anomaly 
10061080 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital haematological disorder 
10072107 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Congenital hair disorder 
10061064 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hand malformation 
10062335 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hearing disorder 
10010493 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 147 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Congenital heart valve disorder 
10064086 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital heart valve incompetence 
10077594 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Congenital hemiparesis 
10071359 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Congenital hepatic fibrosis 
10056533 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hepatitis B infection 
10010496 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hepatobiliary anomaly 
10061065 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hepatomegaly 
10051130 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital herpes simplex infection 
10019949 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hiatus hernia 
10010501 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital high airway obstruction syndrome 
10074187 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Congenital HIV infection 
10010504 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital Horner's syndrome 
10074554 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Congenital hydrocele renalis 
10051147 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hydrocephalus 
10010506 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hydronephrosis 
10050975 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hypercoagulation 
10070954 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Congenital hyperextension of knee 
10048954 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hyperextension of spine 
10048953 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hyperthyroidism 
10062264 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hypertrichosis 
10010507 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hypogammaglobulinaemia 
10060747 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hypoparathyroidism 
10051315 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital hypothyroidism 
10010510 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital infection 
10062343 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital inguinal hernia 
10068321 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Congenital intestinal malformation 
10061067 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital intestinal obstruction 
10073207 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Congenital intrinsic factor deficiency 
10070440 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Congenital iris anomaly 
10057411 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital jaw malformation 
10062336 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 148 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Congenital joint malformation 
10062337 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital knee deformity 
10061068 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital knee dislocation 
10010520 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital kyphoscoliosis 
10048890 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital labia pudendi adhesions 
10050268 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital lacrimal gland anomaly 
10010523 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital lacrimal passage anomaly 
10062338 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital large intestinal atresia 
10010526 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital laryngeal stridor 
10010527 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital lenticonus 
10064660 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital limb hyperextension 
10049011 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital lip fistula 
10010532 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital lymphoedema 
10010535 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital malaria 
10010538 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital malignant neoplasm 
10073492 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Congenital megacolon 
10010539 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital megaureter 
10010540 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital melanocytic naevus 
10072036 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Congenital melanosis 
10010541 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital methaemoglobinaemia 
10010543 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital midline defect 
10079687 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Congenital mitochondrial cytopathy 
10057954 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital mitral valve incompetence 
10010547 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital mitral valve stenosis 
10010548 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital monorchidism 
10069505 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Congenital multiplex arthrogryposis 
10051643 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital muscle absence 
10010550 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital musculoskeletal anomaly 
10062344 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital myopathy 
10062547 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital myopia 
10069153 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 149 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Congenital naevus 
10067248 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital nail disorder 
10010557 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital neoplasm 
10078557 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Congenital nephrogenic diabetes insipidus 
10068304 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Congenital nephrotic syndrome 
10060737 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital neurological degeneration 
10010558 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital neurological disorder 
10062345 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital neuropathy 
10062346 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital night blindness 
10010559 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital nose malformation 
10062347 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital nystagmus 
10010562 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital oculomotor apraxia 
10053877 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital oesophageal anomaly 
10061069 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital oesophageal stenosis 
10010564 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital oesophageal web 
10010565 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital optic nerve anomaly 
10061528 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital oral malformation 
10061070 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital osteodystrophy 
10010582 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital ovarian anomaly 
10061071 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital oxalosis 
10068593 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Congenital pancreatic anomaly 
10061072 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital perforated nasal septum 
10010588 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital pharyngeal anomaly 
10061073 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital pigmentation disorder 
10010593 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital pneumonia 
10010594 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital poikiloderma 
10052465 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital pseudarthrosis 
10061573 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital pulmonary artery anomaly 
10061074 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital pulmonary hypertension 
10050701 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital pulmonary valve atresia 
10052644 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 150 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Congenital pulmonary valve disorder 
10061075 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital pyelocaliectasis 
10049938 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital renal cyst 
10010607 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital renal disorder 
10066875 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital retinoblastoma 
10073470 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Congenital rubella infection 
10010619 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital salivary gland anomaly 
10010620 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital scleral disorder 
10061530 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital scoliosis 
10050694 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital scrotal hypertrophy 
10048800 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital skin dimples 
10072978 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Congenital skin disorder 
10067769 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Congenital small intestinal atresia 
10010626 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital spinal cord anomaly 
10061076 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital spinal fusion 
10010629 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital spinal stenosis 
10077379 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Congenital spondylolisthesis 
10010633 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital spondylolysis 
10010634 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital syphilis 
10010641 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital syphilitic encephalitis 
10010643 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital syphilitic meningitis 
10010644 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital syphilitic osteochondritis 
10054002 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital teratoma 
10052012 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital thrombocyte disorder 
10058896 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital thrombocytopenia 
10077833 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Congenital thymus absence 
10048801 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital thyroid disorder 
10076602 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Congenital tongue anomaly 
10061077 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital torticollis 
10010650 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital toxoplasmosis 
10010652 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 151 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Congenital tracheomalacia 
10010654 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital trichomegaly 
10073654 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Congenital tricuspid valve atresia 
10049767 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital tricuspid valve incompetence 
10067887 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Congenital tricuspid valve stenosis 
10010656 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital tuberculosis 
10010657 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital umbilical hernia 
10010658 
PT 
Narrow 
A 
0 
Active 
10.0 
15.1 
Congenital ureteric anomaly 
10061078 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital ureterocele 
10056434 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital ureterovesical junction anomaly 
10068133 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Congenital urethral anomaly 
10062349 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital urinary tract obstruction 
10010663 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital uterine anomaly 
10061079 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital vaginal cyst 
10063457 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital varicella infection 
10010668 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital varicocele 
10074459 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Congenital vas deferens absence 
10010670 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital vesicoureteric reflux 
10010672 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital visual acuity reduced 
10059157 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital vitreous anomaly 
10061085 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Congenital white blood cell disorder 
10061086 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Conjoined twins 
10010688 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Conjunctivitis gonococcal neonatal 
10010749 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Constricted ear deformity 
10071233 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Cor biloculare 
10010967 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cor triatriatum 
10010972 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Corneal dystrophy 
10011005 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Corneal opacity congenital 
10011037 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cornelia de Lange syndrome 
10077707 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Corrected transposition of great vessels 
10011120 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 152 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Cortical dysplasia 
10070666 
PT 
Narrow 
A 
0 
Active 
13.1 
14.0 
Costello syndrome 
10067380 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Cowden's disease 
10051906 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Craniofacial deformity 
10074180 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Craniofacial dysostosis 
10066946 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Craniolacunia 
10072116 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Craniorachischisis 
10011321 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Craniosynostosis 
10049889 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Craniotabes 
10065419 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cri du Chat syndrome 
10011385 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Crigler-Najjar syndrome 
10011386 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cryopyrin associated periodic syndrome 
10068850 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Cryptophthalmos 
10011497 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cryptorchism 
10011498 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Currarino syndrome 
10079857 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Cutaneovisceral angiomatosis with 
thrombocytopenia 
10069098 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Cyclopia 
10057648 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cystathionine beta-synthase deficiency 
10071093 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cystic angiomatosis 
10079371 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Cystic eyeball, congenital 
10011761 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cystic fibrosis 
10011762 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cystic fibrosis carrier 
10052656 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cystic fibrosis gastrointestinal disease 
10079428 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Cystic fibrosis hepatic disease 
10068289 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Cystic fibrosis lung 
10011763 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cystic fibrosis pancreatic 
10011766 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cystic fibrosis related diabetes 
10068271 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Cystic lymphangioma 
10058949 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cystinosis 
10011777 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 153 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Cystinuria 
10011778 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Cytogenetic abnormality 
10067477 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Dacryostenosis congenital 
10011850 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dandy-Walker syndrome 
10048411 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Deaf mutism 
10011875 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Deafness congenital 
10011882 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Deficiency of the interleukin-1 receptor antagonist 
10072224 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Deficiency of the interleukin-36 receptor 
antagonist 
10079451 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Delayed foetal renal development 
10079753 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Delta-beta thalassaemia 
10012236 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dentatorubral-pallidoluysian atrophy 
10075298 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Dentinogenesis imperfecta 
10054013 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dentofacial anomaly 
10012331 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dent's disease 
10069199 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Denys-Drash syndrome 
10070179 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Dermatofibrosis lenticularis disseminata 
10056878 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dermatoglyphic anomaly 
10061455 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dermoid cyst 
10012522 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Developmental glaucoma 
10012565 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Developmental hip dysplasia 
10073767 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Dextrocardia 
10012592 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Diabetic foetopathy 
10059116 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Diaphragmatic aplasia 
10012711 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Diastematomyelia 
10012750 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Diencephalic syndrome of infancy 
10012774 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Diethylstilboestrol syndrome 
10012780 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
DiGeorge's syndrome 
10012979 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dihydropyrimidine dehydrogenase deficiency 
10052622 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dilatation intrahepatic duct congenital 
10013003 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 154 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Disorder of sex development 
10070597 
PT 
Narrow 
A 
0 
Active 
13.1 
14.0 
Distichiasis 
10066128 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Diverticulitis Meckel's 
10013542 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Diverticulum of pharynx, congenital 
10013568 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
DNA mismatch repair protein gene mutation 
10078672 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Dolichocolon 
10063917 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dopa-responsive dystonia 
10080034 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Double cortex syndrome 
10073490 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Double heterozygous sickling disorders 
10013609 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Double outlet left ventricle 
10080133 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Double outlet right ventricle 
10013611 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Double ureter 
10013613 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dowling-Degos disease 
10068651 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Duane's syndrome 
10013799 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dubin-Johnson syndrome 
10013800 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dubowitz syndrome 
10059589 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Duchenne muscular dystrophy 
10013801 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Duchenne muscular dystrophy gene carrier 
10052655 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ductus arteriosus premature closure 
10049996 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ductus arteriosus stenosis foetal 
10013808 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ductus venosus agenesis 
10068665 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Duodenal atresia 
10013812 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Duplex appendix 
10078212 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Dyke-Davidoff-Masson syndrome 
10080312 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Dyschondrosteosis 
10071437 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Dysgnathia 
10074336 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Dysmorphism 
10066054 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Dysmyelination 
10067601 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Dysplastic naevus syndrome 
10013960 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Eagle Barrett syndrome 
10051025 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 155 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Ear malformation 
10014016 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Early onset familial Alzheimer's disease 
10078036 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Early onset primary dystonia 
10076668 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Ebstein's anomaly 
10014075 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ectopia cordis 
10014144 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ectopic kidney 
10063044 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ectopic ovary 
10074217 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Ectopic posterior pituitary gland 
10077557 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Ectopic thyroid 
10069503 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Ectopic ureter 
10014172 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ectrodactyly 
10079827 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Ehlers-Danlos syndrome 
10014316 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Elliptocytosis hereditary 
10014490 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ellis-van Creveld syndrome 
10076418 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Emanuel syndrome 
10079203 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Encephalocele 
10014617 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Encephalocutaneous angiomatosis 
10057653 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Endocardial fibroelastosis 
10014663 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Enteric duplication 
10076653 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Entropion congenital 
10014923 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Epidermal naevus 
10014985 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Epidermal naevus syndrome 
10077952 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Epidermolysis 
10053177 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Epidermolysis bullosa 
10014989 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Epilepsy congenital 
10015039 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Epispadias 
10015088 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Erythroblastosis foetalis 
10015251 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Erythrokeratodermia variabilis 
10049048 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Essential fructosuria 
10015487 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Exomphalos 
10015677 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 156 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Exophthalmos congenital 
10050696 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
External auditory canal atresia 
10054875 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Extrarenal pelvis 
10072727 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Eye anterior chamber congenital anomaly 
10061051 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Eyelid ptosis congenital 
10015996 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fabry's disease 
10016016 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Faciodigitogenital dysplasia 
10067141 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Facioscapulohumeral muscular dystrophy 
10064087 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor I deficiency 
10016075 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor II deficiency 
10016076 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor II mutation 
10065003 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor III deficiency 
10052473 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor IX deficiency 
10016077 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor V deficiency 
10048930 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor V Leiden carrier 
10075652 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Factor V Leiden mutation 
10058279 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor VII deficiency 
10016079 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor VIII deficiency 
10016080 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor X deficiency 
10052474 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor XI deficiency 
10016082 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor XII deficiency 
10051806 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Factor XIII deficiency 
10016083 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fallot's pentalogy 
10059205 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fallot's tetralogy 
10016193 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fallot's trilogy 
10064011 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Familial amyloidosis 
10016202 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Familial amyotrophic lateral sclerosis 
10077024 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Familial cold autoinflammatory syndrome 
10064570 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Familial haemophagocytic lymphohistiocytosis 
10070904 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Familial hemiplegic migraine 
10067039 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 157 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Familial high density lipoprotein deficiency 
10079119 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Familial hypertriglyceridaemia 
10059183 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Familial hypocalciuric hypercalcaemia 
10068698 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Familial infantile bilateral striatal necrosis 
10077450 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Familial mediterranean fever 
10016207 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Familial medullary thyroid cancer 
10073153 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Familial periodic paralysis 
10016208 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Familial polycythaemia 
10016209 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Familial renal glycosuria 
10073689 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Familial scaphocephaly syndrome 
10072229 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Familial tremor 
10016212 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fanconi syndrome 
10016219 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fatal familial insomnia 
10072077 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Fatty acid oxidation disorder 
10077951 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Femoral anteversion 
10064516 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Femoral retroversion 
10064514 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Femur-fibula-ulna complex 
10068448 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Fibrodysplasia ossificans progressiva 
10068715 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Fibrous dysplasia of bone 
10016664 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fibrous dysplasia of jaw 
10070535 
PT 
Narrow 
A 
0 
Active 
13.1 
14.0 
Fibula agenesis 
10054882 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fissure of tongue, congenital 
10016715 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Floating-Harbor syndrome 
10079943 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Foetal alcohol syndrome 
10016845 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Foetal anticonvulsant syndrome 
10066485 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Foetal chromosome abnormality 
10064041 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Foetal cystic hygroma 
10052011 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Foetal malformation 
10060919 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Foetal megacystis 
10073660 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Foetal methotrexate syndrome 
10071183 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


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Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 158 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Foetal retinoid syndrome 
10073720 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Foetal warfarin syndrome 
10051445 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Foramen magnum stenosis 
10064157 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fragile X carrier 
10052657 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fragile X syndrome 
10017324 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fraser syndrome 
10080219 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Frasier syndrome 
10080313 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Freeman-Sheldon syndrome 
10073655 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Frenulum breve 
10072007 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Friedreich's ataxia 
10017374 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Fryns syndrome 
10075223 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Galactosaemia 
10017604 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gallbladder agenesis 
10079018 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Gallbladder anomaly congenital 
10061163 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gastrointestinal arteriovenous malformation 
10017932 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gastrointestinal disorder congenital 
10061973 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gastrointestinal malformation 
10061596 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gastroschisis 
10018046 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gaucher's disease 
10018048 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gaucher's disease type I 
10075697 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Gaucher's disease type II 
10075698 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Gaucher's disease type III 
10075699 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Gene mutation 
10064571 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Generalised resistance to thyroid hormone 
10018096 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Genitalia external ambiguous 
10018183 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gilbert's syndrome 
10018267 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gitelman's syndrome 
10062906 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Glucose transporter type 1 deficiency syndrome 
10078727 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Glucose-6-phosphate dehydrogenase deficiency 
10018444 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Glucose-galactose malabsorption 
10066388 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 159 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Glutathione synthetase deficiency 
10079364 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Glycogen storage disease type I 
10018464 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Glycogen storage disease type II 
10053185 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Glycogen storage disease type III 
10053250 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Glycogen storage disease type IV 
10053249 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Glycogen storage disease type V 
10018462 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Glycogen storage disease type VI 
10053240 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Glycogen storage disease type VII 
10053241 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Glycogen storage disease type VIII 
10053242 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Glycogen storage disorder 
10061990 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gnathoschisis 
10068845 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
GNE myopathy 
10077945 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Goitre congenital 
10018499 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gollop-Wolfgang complex 
10079731 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Gonadal dysgenesis 
10018504 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Gorham's disease 
10071283 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Greig's syndrome 
10053878 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemangioma congenital 
10018818 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemangioma of retina 
10018822 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemochromatosis trait 
10073217 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Haemoglobin C disease 
10018883 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemoglobin C trait 
10055021 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemoglobin D disease 
10055019 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemoglobin D trait 
10055020 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemoglobin E disease 
10053215 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemoglobin E trait 
10063740 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemoglobin E-thalassaemia disease 
10062917 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemoglobinopathy 
10060892 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemophilia 
10061992 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemophilia A with anti factor VIII 
10056492 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 160 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Haemophilia A without inhibitors 
10056493 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemophilia B with anti factor IX 
10056494 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemophilia B without inhibitors 
10056495 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemophilia carrier 
10051658 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Haemorrhagic arteriovenous malformation 
10064595 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hamartoma 
10061193 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hamartoma vascular 
10019106 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hand-foot-genital syndrome 
10072361 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Harlequin foetus 
10019163 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hartnup disease 
10019165 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Heart block congenital 
10019263 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Heart disease congenital 
10019273 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hemihypertrophy 
10019463 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hemimegalencephaly 
10078100 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Hemivertebra 
10019477 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hepatic arteriovenous malformation 
10019633 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hepatic hamartoma 
10079685 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Hepato-lenticular degeneration 
10019819 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary angioedema 
10019860 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary areflexic dystasia 
10063449 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary cerebral degeneration 
10061204 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary choroidal dystrophy 
10019864 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary disorder 
10061205 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary fructose intolerance 
10019878 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary haemochromatosis 
10057873 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary haemolytic anaemia 
10060893 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary haemorrhagic telangiectasia 
10019883 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary hypophosphataemic rickets 
10077943 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Hereditary leiomyomatosis renal cell carcinoma 
10067944 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Hereditary motor and sensory neuropathy 
10077306 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 161 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Hereditary motor neurone disease 
10071328 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Hereditary multiple osteochondromas 
10079019 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Hereditary neuropathic amyloidosis 
10019889 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary neuropathy with liability to pressure 
palsies 
10069382 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Hereditary non-polyposis colorectal cancer 
syndrome 
10051922 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary optic atrophy 
10019895 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary palmoplantar keratoderma 
10072537 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Hereditary pancreatitis 
10056976 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary papillary renal carcinoma 
10067943 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Hereditary retinal dystrophy 
10019899 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary sideroblastic anaemia 
10019902 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary spastic paraplegia 
10019903 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary spherocytosis 
10019904 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hereditary stomatocytosis 
10053589 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hermansky-Pudlak syndrome 
10071775 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Hermaphroditism 
10019906 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hernia congenital 
10019912 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Heterochromia iridis 
10066799 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Heterotaxia 
10067265 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hexokinase deficiency anaemia 
10020022 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
High arched palate 
10020046 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hollow visceral myopathy 
10060811 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Holoprosencephaly 
10056304 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Holt-Oram syndrome 
10050469 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Homocystinaemia 
10048707 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Homocystinuria 
10020365 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hooded prepuce 
10072135 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Huntington's disease 
10070668 
PT 
Narrow 
A 
0 
Active 
13.1 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 162 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Hydranencephaly 
10073472 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Hydrocele 
10020488 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hydroxyprolinaemia 
10053148 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hyper IgD syndrome 
10072010 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Hyper IgE syndrome 
10051040 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hyper IgM syndrome 
10066130 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hyperexplexia 
10058271 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hyperinsulinism syndrome 
10077858 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Hypermethioninaemia 
10051245 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypermethioniuria 
10051231 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hyperprolinaemia 
10058509 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypersplenism congenital 
10049282 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypertelorism of orbit 
10020771 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypertrophic cardiomyopathy 
10020871 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Hypocalvaria 
10073670 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Hypochondroplasia 
10020967 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypodontia 
10055001 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypomelanosis of Ito 
10075301 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Hypophosphatasia 
10049933 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypopituitarism foetal 
10021068 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypoplastic left heart syndrome 
10021076 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypoplastic nasal cartilage 
10074970 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Hypoplastic right heart syndrome 
10064962 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypospadias 
10021093 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypotelorism of orbit 
10057855 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Hypothalamic hamartoma 
10078217 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Hypoxanthine-guanine phosphoribosyl transferase 
deficiency 
10075774 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Ichthyosis 
10021198 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ileal atresia 
10021298 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 163 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Immunodeficiency congenital 
10021450 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Imperforate hymen 
10021529 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Imperforate oesophagus 
10021530 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Inborn error in primary bile acid synthesis 
10070882 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Inborn error of bilirubin metabolism 
10062017 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Inborn error of lipid metabolism 
10072272 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Inborn error of metabolism 
10062018 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Infantile cortical hyperostosis 
10073206 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Infantile genetic agranulocytosis 
10052210 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Infantile septic granulomatosis 
10048708 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Inherited cardiac conduction disorder 
10070294 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Iniencephaly 
10022034 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Interferon gamma receptor deficiency 
10057605 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Interruption of aortic arch 
10022599 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Intestinal atresia 
10062022 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Intestinal malrotation 
10064024 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Intestinal neuronal dysplasia 
10073659 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Intestinal transposition 
10022712 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Intracranial arterial fenestration 
10077285 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Intracranial lipoma 
10072288 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Iris coloboma 
10052642 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Johanson-Blizzard syndrome 
10074947 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Joubert syndrome 
10078574 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Juvenile Paget's disease 
10078977 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Kabuki make-up syndrome 
10063935 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Kaufman-McKusick syndrome 
10052312 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Kearns-Sayre syndrome 
10048804 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Kenny-Caffey syndrome 
10073228 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Keratitis-ichthyosis-deafness syndrome 
10048786 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Keratolysis exfoliativa congenital 
10052290 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 164 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Keratosis follicular 
10023369 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Kidney duplex 
10023416 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Kidney malformation 
10023430 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Kidney malrotation 
10067877 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Kimmerle's anomaly 
10076416 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Kinematic imbalances due to suboccipital strain 
10062992 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Kleefstra syndrome 
10079365 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Klinefelter's syndrome 
10023463 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Klippel-Feil syndrome 
10023464 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Klippel-Trenaunay syndrome 
10051452 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Krabbe's disease 
10023492 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Kyphosis congenital 
10048576 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Labial tie 
10076772 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Lacrimal punctum agenesis 
10023636 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Laevocardia 
10071015 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Lafora's myoclonic epilepsy 
10054030 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lamin A/C gene mutation 
10075979 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Langer-Giedion syndrome 
10050638 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Laron syndrome 
10075492 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Larsen syndrome 
10073856 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Laryngeal cleft 
10069115 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Laryngeal web 
10023871 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Laryngocele 
10023885 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Laryngomalacia 
10060786 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Laryngo-onycho-cutaneous syndrome 
10062987 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Laurence-Moon-Bardet-Biedl syndrome 
10056715 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
LDLR mutation 
10075640 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Leber's congenital amaurosis 
10070667 
PT 
Narrow 
A 
0 
Active 
13.1 
14.0 
Lecithin-cholesterol acyltransferase deficiency 
10077917 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Left ventricle outflow tract obstruction 
10065930 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 165 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Left-to-right cardiac shunt 
10077834 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Lens abnormality, congenital 
10024202 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Leukodystrophy 
10024381 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lichen spinulosus 
10024436 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Liddle's syndrome 
10052313 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Li-Fraumeni syndrome 
10066795 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Limb hypoplasia congenital 
10048575 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Limb malformation 
10024500 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Limb reduction defect 
10024503 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lipid proteinosis 
10051661 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lipidosis 
10024585 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lipodermoid tumour 
10073484 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Lipomeningocele 
10050084 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lissencephaly 
10048911 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Long QT syndrome congenital 
10057926 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Long-chain acyl-coenzyme A dehydrogenase 
deficiency 
10072653 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Low set ears 
10024929 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lown-Ganong-Levine syndrome 
10024984 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lowry-Wood syndrome 
10062600 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lumbarisation 
10063410 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lymphangiectasia intestinal congenital 
10054722 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lysinuric protein intolerance 
10058300 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Lysosomal acid lipase deficiency 
10077267 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Macrocephaly 
10050183 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Macrocheilia 
10025378 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Macrocornea 
10059253 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Macrodactyly 
10025386 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Macrogenia 
10025387 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Macroglossia 
10025391 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 166 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Macrognathia 
10052658 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Macrostomia 
10025395 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Macrotia 
10025396 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Macular dystrophy congenital 
10025412 
PT 
Narrow 
A 
0 
Active 
10.0 
16.1 
Majeed's syndrome 
10072223 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Malformation biliary 
10025523 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Malformation venous 
10025532 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mandibulofacial dysostosis 
10051456 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Maple syrup disease 
10026817 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Marcus Gunn syndrome 
10064583 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Marfan's syndrome 
10026829 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Maxillonasal dysplasia 
10075843 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Mayer-Rokitansky-Kuster-Hauser syndrome 
10065148 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Medium-chain acyl-coenzyme A dehydrogenase 
deficiency 
10072654 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Meier-Gorlin syndrome 
10070612 
PT 
Narrow 
A 
0 
Active 
13.1 
14.0 
MELAS syndrome 
10053872 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Melkersson-Rosenthal syndrome 
10027166 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Membranous lipodystrophy 
10065127 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Meningocele 
10027266 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Meningomyelocele 
10027287 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Menkes' syndrome 
10027294 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mesoblastic nephroma 
10070665 
PT 
Narrow 
A 
0 
Active 
13.1 
14.0 
Mesonephric duct cyst 
10027405 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Metabolic myopathy 
10068836 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Metachromatic leukodystrophy 
10067609 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Metaphyseal dysplasia 
10066147 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Metatarsus primus varus 
10027489 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Methylenetetrahydrofolate reductase deficiency 
10070309 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 167 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Methylenetetrahydrofolate reductase gene 
mutation 
10074753 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Methylmalonic aciduria 
10059521 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mevalonate kinase deficiency 
10072221 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Mevalonic aciduria 
10072219 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Microcephaly 
10027534 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Microcheilia 
10027535 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Microcolon 
10073456 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Microcornea 
10057414 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Microencephaly 
10068320 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Microgenia 
10027541 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Microglossia 
10027542 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Micrognathia 
10027543 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Micropenis 
10071706 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Microphthalmos 
10027548 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Microstomia 
10027553 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Microtia 
10027555 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Microvillous inclusion disease 
10068494 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Mismatch repair cancer syndrome 
10077888 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Mitochondrial DNA deletion 
10051403 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mitochondrial DNA depletion 
10059396 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mitochondrial DNA duplication 
10052640 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mitochondrial DNA mutation 
10052641 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mitochondrial encephalomyopathy 
10058799 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mitochondrial enzyme deficiency 
10067729 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Mitochondrial hepatopathy 
10062938 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mitochondrial myopathy 
10027710 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mitochondrial neurogastrointestinal 
encephalopathy 
10065271 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mitral valve atresia 
10066800 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 168 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Mitral valve hypoplasia 
10049211 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mittendorf dot 
10076031 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
MLASA syndrome 
10078801 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Mobile caecum syndrome 
10074307 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Moebius II syndrome 
10027802 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Molybdenum cofactor deficiency 
10069687 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Monopodia 
10049214 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Morning glory syndrome 
10027974 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Morton's syndrome 
10079320 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Mosaicism 
10068052 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Mount-Reback syndrome 
10065658 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Muckle-Wells syndrome 
10064569 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mucolipidosis 
10072939 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Mucolipidosis type I 
10072927 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Mucolipidosis type II 
10072928 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Mucolipidosis type III 
10072929 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Mucolipidosis type IV 
10072930 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Mucopolysaccharidosis 
10028093 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mucopolysaccharidosis I 
10056886 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mucopolysaccharidosis II 
10056889 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mucopolysaccharidosis III 
10056890 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mucopolysaccharidosis IV 
10028095 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mucopolysaccharidosis V 
10056891 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mucopolysaccharidosis VI 
10056892 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mucopolysaccharidosis VII 
10056893 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Muir-Torre syndrome 
10063042 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Multiple carboxylase deficiency 
10028176 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Multiple cardiac defects 
10028178 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Multiple congenital abnormalities 
10028182 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Multiple cutaneous and uterine leiomyomatosis 
10077859 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 169 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Multiple endocrine neoplasia 
10051747 
PT 
Narrow 
A 
0 
Active 
10.0 
16.0 
Multiple endocrine neoplasia Type 1 
10073150 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Multiple endocrine neoplasia Type 2 
10073149 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Multiple endocrine neoplasia Type 2A 
10073148 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Multiple endocrine neoplasia Type 2B 
10073151 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Multiple epiphyseal dysplasia 
10028197 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Multiple gastrointestinal atresias 
10028210 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Multiple lentigines syndrome 
10062901 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Muscular dystrophy 
10028356 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Mutagenic effect 
10028400 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Myeloperoxidase deficiency 
10074767 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
MYH9-related disease 
10079437 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Myocardial bridging 
10052289 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Myoclonic epilepsy and ragged-red fibres 
10069825 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Myotonia congenita 
10028655 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Myotonic dystrophy 
10068871 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
N-acetylglutamate synthase deficiency 
10071092 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Naevus anaemicus 
10069365 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Naevus flammeus 
10067193 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Naevus spider congenital 
10050896 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Nail aplasia 
10079732 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Nail-patella syndrome 
10063431 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Nasopharyngeal atresia 
10069701 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Neonatal alloimmune thrombocytopenia 
10075149 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Neonatal haemochromatosis 
10078355 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Neonatal leukaemia 
10028958 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Neonatal lupus erythematosus 
10057887 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Netherton's syndrome 
10062909 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Neural tube defect 
10052046 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Neurofibromatosis 
10029268 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 170 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Neuronal ceroid lipofuscinosis 
10074607 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Neuronal migration disorder 
10076677 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Neuropathy, ataxia, retinitis pigmentosa syndrome 
10062940 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Niemann-Pick disease 
10029403 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Nijmegen breakage syndrome 
10067857 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Non-compaction cardiomyopathy 
10079253 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Nonketotic hyperglycinaemia 
10070639 
PT 
Narrow 
A 
0 
Active 
13.1 
14.0 
Noonan syndrome 
10029748 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Norrie's disease 
10069760 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Ocular albinism 
10065276 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Oculoauriculovertebral dysplasia 
10051934 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Oculocerebrorenal syndrome 
10051707 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Oculodentodigital dysplasia 
10063691 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Oculopharyngeal dystrophy 
10052181 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Odontogenic cyst 
10063413 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Oesophageal atresia 
10030146 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Oesophageal cyst 
10079063 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Olfacto genital dysplasia 
10053142 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Olfactory nerve agenesis 
10072941 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Olmsted syndrome 
10068842 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Omenn syndrome 
10069097 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Opitz-G/BBB syndrome 
10079435 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Optic disc pit 
10079967 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Optic nerve hypoplasia 
10062942 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Oral-facial-digital syndrome type II 
10078419 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Ornithine transcarbamoylase deficiency 
10052450 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Oroticaciduria congenital 
10052773 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Os trigonum 
10069805 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Osteogenesis imperfecta 
10031243 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Osteopathia striata 
10073776 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 171 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Osteopetrosis 
10031280 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Osteopoikilosis 
10031281 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Osteoporosis-pseudoglioma syndrome 
10052452 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ota's naevus 
10051713 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Otocephaly 
10058118 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ovarian agenesis 
10033120 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ovarian hypoplasia 
10079495 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Pachydermoperiostosis 
10051686 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pachygyria 
10048910 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pachyonychia congenita 
10080088 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Pallister-Killian syndrome 
10080297 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Pancreas divisum 
10069419 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Parachute mitral valve 
10064192 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Paranasal sinus aplasia 
10074401 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Parkes-Weber syndrome 
10075554 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Patent ductus arteriosus 
10034130 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pearson's syndrome 
10062941 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pectus carinatum 
10034203 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pectus excavatum 
10034204 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pelizaeus-Merzbacher disease 
10067610 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Pelvic kidney 
10034259 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Penile torsion 
10070235 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Penoscrotal fusion 
10064951 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Penoscrotal transposition 
10067287 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Periodontal congenital anomaly 
10057476 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Periventricular nodular heterotopia 
10066854 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Perry syndrome 
10079207 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Persistent cloaca 
10069442 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Persistent foetal circulation 
10034708 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Persistent left superior vena cava 
10064193 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


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Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 172 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Persistent pupillary membrane 
10070872 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Persistent urogenital sinus 
10059800 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Peutz-Jeghers syndrome 
10034764 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
PHACES syndrome 
10068032 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Phakomatosis 
10048734 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Phalangeal agenesis 
10054879 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Phalangeal hypoplasia 
10049212 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Phenylketonuria 
10034872 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Phimosis 
10034878 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Phytosterolaemia 
10063985 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pierre Robin syndrome 
10035009 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pilonidal cyst congenital 
10054019 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Plagiocephaly 
10048586 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Platelet glycoprotein gene mutation 
10071024 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Platonychia 
10072590 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Platybasia 
10057115 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Platyspondylia 
10068629 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
Poland's syndrome 
10036007 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Polycystic liver disease 
10048834 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Polydactyly 
10036063 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Polymicrogyria 
10073489 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Popliteal pterygium syndrome 
10079892 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Porencephaly 
10036172 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Porokeratosis 
10036175 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Porphyria 
10036181 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Porphyria acute 
10036182 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Porphyria non-acute 
10036186 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Porphyrin metabolism disorder 
10061356 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Porphyrinuria 
10036193 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Portal venous system anomaly 
10076609 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 173 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Postauricular fistula 
10036329 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Posterior segment of eye anomaly congenital 
10053202 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Potter's syndrome 
10036462 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Prader-Willi syndrome 
10036476 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Preauricular cyst 
10036509 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Preduodenal portal vein 
10059798 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Preternatural anus 
10064917 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Primary cerebellar degeneration 
10036686 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Primary ciliary dyskinesia 
10069713 
PT 
Narrow 
A 
0 
Active 
13.0 
14.0 
Primary familial brain calcification 
10078822 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Primary familial hypomagnesaemia 
10076626 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Primary hypercholesterolaemia 
10077965 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Primary immunodeficiency syndrome 
10064859 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Primary insulin like growth factor-1 deficiency 
10071079 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Progeria 
10036794 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Progressive cerebellar degeneration 
10036801 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Progressive external ophthalmoplegia 
10036802 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Progressive familial intrahepatic cholestasis 
10076033 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Prominent epicanthal folds 
10065273 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Protein C deficiency 
10051298 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Protein S deficiency 
10051292 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Proteus syndrome 
10074067 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Protuberant ear 
10071232 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Proximal focal femoral deficiency 
10078473 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Pseudocholinesterase deficiency 
10062674 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pseudohermaphroditism 
10037122 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pseudohermaphroditism female 
10037123 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pseudohermaphroditism male 
10037124 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pseudohypoparathyroidism 
10037126 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pseudotruncus arteriosus 
10050053 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 174 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Pseudoxanthoma elasticum 
10037150 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pterygium colli 
10051972 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pulmonary aplasia 
10037322 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pulmonary arteriovenous fistula 
10037332 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pulmonary artery atresia 
10037337 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pulmonary artery stenosis congenital 
10037339 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pulmonary hypoplasia 
10037407 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pulmonary lymphangiectasia 
10073661 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Pulmonary malformation 
10037419 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pulmonary sequestration 
10059160 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pulmonary valve stenosis congenital 
10037451 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pyloric stenosis 
10037621 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Pyogenic sterile arthritis pyoderma gangrenosum 
and acne syndrome 
10072222 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Pyruvate carboxylase deficiency 
10077944 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Pyruvate kinase deficiency anaemia 
10037682 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Radioulnar synostosis 
10037798 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Rathke's cleft cyst 
10058969 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Rectal atresia 
10038031 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Red blood cell enzymes abnormal 
10049191 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Refsum's disease 
10038275 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Renal aplasia 
10064655 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Renal arteriovenous malformation 
10038368 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Renal dysplasia 
10038433 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Renal fusion anomaly 
10068033 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Renal hypoplasia 
10049102 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Renal malposition 
10072019 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Renal vessel congenital anomaly 
10038552 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Reproductive tract hypoplasia, male 
10057858 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Respiratory tract malformation 
10038733 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 175 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Retinal anomaly congenital 
10038821 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Retinal arteriovenous malformation 
10038824 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Retinal coloboma 
10052643 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Retinitis pigmentosa 
10038914 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Retinopathy congenital 
10050706 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Retinoschisis congenital 
10038938 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Rett syndrome 
10077709 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Rhesus haemolytic disease of newborn 
10039037 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Rib hypoplasia 
10048893 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Rib synostosis 
10076624 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Right aortic arch 
10067407 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Right ventricle outflow tract obstruction 
10064195 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Right ventricular false tendon 
10080132 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Right-to-left cardiac shunt 
10076605 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Riley-Day syndrome 
10039179 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Rippling muscle disease 
10069417 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Rotor's syndrome 
10039234 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Rubinstein-Taybi syndrome 
10039281 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Sacral hypoplasia 
10056659 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Sacralisation 
10064932 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Sarcosinaemia 
10059299 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Scaphocephaly 
10049426 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Schimke immunoosseous dysplasia 
10048699 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Schinzel-Giedion syndrome 
10063540 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Schizencephaly 
10073487 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Scimitar syndrome 
10051951 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Sclerotylosis 
10070504 
PT 
Narrow 
A 
0 
Active 
13.1 
14.0 
Sebaceous naevus 
10039785 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Sensory neuropathy hereditary 
10040037 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Septate hymen 
10068484 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 176 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Septo-optic dysplasia 
10067159 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Septum pellucidum agenesis 
10062267 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Sertoli-cell-only syndrome 
10066833 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Severe myoclonic epilepsy of infancy 
10073677 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Sex chromosome abnormality 
10061513 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Shone complex 
10066802 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Short-chain acyl-coenzyme A dehydrogenase 
deficiency 
10072655 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Shwachman-Diamond syndrome 
10067940 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Sickle cell anaemia 
10040641 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Sickle cell trait 
10040650 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Silver-Russell syndrome 
10062282 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Single umbilical artery 
10049807 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Sirenomelia 
10072457 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Sjogren-Larsson syndrome 
10048676 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Skeletal dysplasia 
10072610 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Skin hypoplasia 
10040869 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Skin malformation 
10040888 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Skull malformation 
10062348 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Smith-Lemli-Opitz syndrome 
10078573 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Sotos' syndrome 
10064387 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Special senses congenital anomaly 
10041420 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Spherophakia 
10041513 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Spina bifida 
10041524 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Spina bifida cystica 
10071011 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Spina bifida occulta 
10041525 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Spinal muscular atrophy 
10041582 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Spinal vessel congenital anomaly 
10041603 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Spine malformation 
10041611 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Spinocerebellar ataxia 
10057660 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 177 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Spleen malformation 
10062350 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Splenic hamartoma 
10076586 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Spondyloepiphyseal dysplasia 
10062920 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Stargardt's disease 
10062766 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Steatocystoma multiplex 
10048905 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Stickler's syndrome 
10063402 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Sticky platelet syndrome 
10068788 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Strabismus congenital 
10042161 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Sturge-Weber syndrome 
10042265 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Subependymal nodular heterotopia 
10071150 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Sucrase-isomaltase deficiency 
10066387 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Supernumerary nipple 
10042571 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Supernumerary vertebra 
10077919 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Syndactyly 
10042778 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Synostosis 
10042856 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Syringomyelia 
10042928 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Talipes 
10043101 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tangier disease 
10051875 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tay-Sachs disease 
10043147 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Telangiectasia congenital 
10061575 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Teratogenicity 
10043275 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Testicular dysplasia 
10059271 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Testotoxicosis 
10063654 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tetrahydrobiopterin deficiency 
10069116 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Thalassaemia 
10043388 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Thalassaemia alpha 
10043390 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Thalassaemia beta 
10043391 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Thalassaemia sickle cell 
10043395 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Thalidomide embryopathy 
10071249 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Thanatophoric dwarfism 
10049808 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 178 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Thrombocytopenia-absent radius syndrome 
10071719 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Thymus hypoplasia 
10052645 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Thyroglossal cyst 
10051320 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Thyroglossal fistula 
10062601 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Thyroid hemiagenesis 
10077609 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Thyroid malformation 
10062125 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tibial agenesis 
10079730 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Tibial torsion 
10064515 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tilted disc syndrome 
10079368 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Timothy syndrome 
10079205 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Tooth discolouration congenital 
10044033 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tooth hypoplasia 
10044041 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tooth malformation hereditary 
10044047 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tornwaldt cyst 
10078492 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Tourette's disorder 
10044126 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tracheal atresia 
10054955 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tracheal web 
10077940 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Tracheo-oesophageal fistula 
10044310 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Transitional vertebrae 
10074306 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Transposition of the great vessels 
10044443 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Trichorhinophalangeal syndrome 
10051956 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Trifunctional protein deficiency 
10077949 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Trimethylaminuria 
10068233 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Triple A syndrome 
10073592 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Trisomy 11 
10044685 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Trisomy 12 
10063092 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Trisomy 13 
10044686 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Trisomy 14 
10071762 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Trisomy 15 
10062757 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Trisomy 17 
10053925 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 179 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Trisomy 18 
10053884 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Trisomy 21 
10044688 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Trisomy 22 
10044689 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Trisomy 4p 
10080079 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Trisomy 8 
10053871 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Trisomy 9 
10071547 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Truncus arteriosus persistent 
10044703 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tuberous sclerosis 
10045138 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tumour necrosis factor receptor-associated 
periodic syndrome 
10067774 
PT 
Narrow 
A 
0 
Active 
11.0 
14.0 
Turner's syndrome 
10045181 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Twin reversed arterial perfusion sequence 
malformation 
10073455 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Type I hyperlipidaemia 
10060749 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Type II hyperlipidaemia 
10045254 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Type IIa hyperlipidaemia 
10045261 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Type IIb hyperlipidaemia 
10045263 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Type III hyperlipidaemia 
10060751 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Type IV hyperlipidaemia 
10060753 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Type V hyperlipidaemia 
10060755 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Tyrosinaemia 
10063443 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Uhl's anomaly 
10048951 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Umbilical artery hypoplasia 
10045445 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Umbilical malformation 
10045469 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Univentricular heart 
10045545 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Urachal abnormality 
10066125 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Urea cycle disorder 
10080020 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Ureteric atresia 
10078351 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Urethral atresia 
10064895 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Urethral valves 
10046479 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 180 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Urinary tract malformation 
10046580 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Usher's syndrome 
10063396 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Uterine aplasia 
10067704 
PT 
Narrow 
A 
0 
Active 
10.1 
14.0 
Uterine cervix hypoplasia 
10063120 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Uterine hypoplasia 
10063146 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Uvula aplasia 
10053506 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
VACTERL syndrome 
10066022 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Vaginal atresia 
10046879 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Vaginal hypoplasia 
10053843 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Vaginal septum 
10064513 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Vascular malformation 
10074979 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Vein of Galen aneurysmal malformation 
10077889 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Velo-cardio-facial syndrome 
10066430 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Venolymphatic malformation 
10079880 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Venous angioma of brain 
10053485 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ventricular hypoplasia 
10047296 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Ventricular septal defect 
10047298 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Vertebral artery hypoplasia 
10066907 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Vertical talus 
10066242 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Very long-chain acyl-coenzyme A dehydrogenase 
deficiency 
10072656 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Virilism foetal 
10047487 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Vitello-intestinal duct remnant 
10066969 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Von Hippel-Lindau disease 
10047716 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Von Willebrand's disease 
10047715 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Waardenburg syndrome 
10069203 
PT 
Narrow 
A 
0 
Active 
12.0 
14.0 
Wagner's disease 
10063383 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Weill-Marchesani syndrome 
10064963 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Welander distal myopathy 
10078052 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Werner's syndrome 
10049429 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 181 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Wildervanck syndrome 
10069402 
PT 
Narrow 
A 
0 
Active 
12.1 
14.0 
Williams syndrome 
10049644 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Winchester syndrome 
10078901 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Wiskott-Aldrich syndrome 
10047992 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Wolff-Parkinson-White syndrome congenital 
10049291 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Wolf-Hirschhorn syndrome 
10050361 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Wolfram syndrome 
10078338 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Wyburn Mason's syndrome 
10048661 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Xeroderma pigmentosum 
10048220 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
X-linked chromosomal disorder 
10056554 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
X-linked lymphoproliferative syndrome 
10068348 
PT 
Narrow 
A 
0 
Active 
11.1 
14.0 
XXX syndrome 
10076910 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
XXXY syndrome 
10048228 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
XXYY syndrome 
10048230 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
XYY syndrome 
10056894 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Y-linked chromosomal disorder 
10056555 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Young's syndrome 
10063689 
PT 
Narrow 
A 
0 
Active 
10.0 
14.0 
Foetal disorders (SMQ) [20000190] 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Alpha 1 foetoprotein amniotic fluid abnormal 
10001776 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Alpha 1 foetoprotein amniotic fluid decreased 
10060746 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Alpha 1 foetoprotein amniotic fluid increased 
10001778 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniocentesis abnormal 
10001959 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniorrhexis 
10051641 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniorrhoea 
10066470 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amnioscopy abnormal 
10001965 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic cavity disorder 
10060936 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic cavity infection 
10060937 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 182 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Amniotic fluid erythropoietin level increased 
10064845 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic fluid index abnormal 
10067079 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic fluid volume decreased 
10063356 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic fluid volume increased 
10063357 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic infection syndrome of Blane 
10051407 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Anaesthetic complication foetal 
10052850 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Angiotensin converting enzyme inhibitor 
foetopathy 
10051098 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Baseline foetal heart rate variability disorder 
10074638 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Biopsy chorionic villous abnormal 
10048537 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Biopsy foetal abnormal 
10058370 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Bradycardia foetal 
10006094 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cerebral haemorrhage foetal 
10050157 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cerebral infarction foetal 
10008119 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Chronic villitis of unknown etiology 
10072271 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Cordocentesis 
10066447 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Diabetic foetopathy 
10059116 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Diethylstilboestrol syndrome 
10012780 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Discordant twin 
10069150 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Ductus arteriosus stenosis foetal 
10013808 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Erythroblastosis foetalis 
10015251 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal acidosis 
10050347 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal alcohol syndrome 
10016845 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal anaemia 
10077577 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Foetal anticonvulsant syndrome 
10066485 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal arrhythmia 
10016847 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal biophysical profile score abnormal 
10078124 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Foetal biophysical profile score equivocal 
10078123 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Foetal cardiac disorder 
10052088 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal cerebrovascular disorder 
10053601 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 183 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Foetal chromosome abnormality 
10064041 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal compartment fluid collection 
10077628 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Foetal cystic hygroma 
10052011 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal damage 
10016852 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal disorder 
10061157 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal distress syndrome 
10016855 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal gastrointestinal tract imaging abnormal 
10077579 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Foetal growth abnormality 
10077582 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Foetal growth restriction 
10070531 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal heart rate abnormal 
10051139 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal heart rate acceleration abnormality 
10074642 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Foetal heart rate deceleration abnormality 
10074636 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Foetal heart rate decreased 
10051136 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal heart rate disorder 
10061158 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal heart rate increased 
10051138 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal heart rate indeterminate 
10079882 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Foetal hypokinesia 
10068461 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal macrosomia 
10053700 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal malformation 
10060919 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal malnutrition 
10016862 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal megacystis 
10073660 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Foetal methotrexate syndrome 
10071183 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal monitoring abnormal 
10071507 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Foetal movement disorder 
10077576 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Foetal musculoskeletal imaging abnormal 
10077580 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Foetal non-stress test abnormal 
10071516 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Foetal placental thrombosis 
10072240 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Foetal renal imaging abnormal 
10077581 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Foetal renal impairment 
10078987 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Foetal retinoid syndrome 
10073720 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 184 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Foetal tachyarrhythmia 
10077575 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Foetal therapeutic procedure 
10057294 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal warfarin syndrome 
10051445 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal-maternal haemorrhage 
10016871 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Gestational age test abnormal 
10072479 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Haemorrhage foetal 
10061191 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hydrops foetalis 
10020529 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hypocalvaria 
10073670 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Hypopituitarism foetal 
10021068 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Intrauterine infection 
10056254 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Maternal condition affecting foetus 
10057673 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Maternal death affecting foetus 
10026912 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Maternal drugs affecting foetus 
10026923 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Maternal hypertension affecting foetus 
10026924 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meconium in amniotic fluid 
10051133 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meconium increased 
10027059 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meconium peritonitis 
10058113 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meconium stain 
10057028 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Mirror syndrome 
10068875 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Nonreassuring foetal heart rate pattern 
10074641 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Oligohydramnios 
10030289 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Omphalorrhexis 
10064270 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Paternal drugs affecting foetus 
10050425 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Polyhydramnios 
10036079 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Prenatal screening test abnormal 
10069151 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Radiation injury affecting foetus 
10053602 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Sinusoidal foetal heart rate pattern 
10074643 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Tachycardia foetal 
10043074 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Thalidomide embryopathy 
10071249 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 185 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Twin reversed arterial perfusion sequence 
malformation 
10073455 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Ultrasound antenatal screen abnormal 
10045400 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Ultrasound foetal abnormal 
10077578 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Umbilical cord abnormality 
10048596 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord around neck 
10045447 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord compression 
10045451 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord cyst 
10079122 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Umbilical cord haemorrhage 
10064534 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord occlusion 
10076714 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Umbilical cord prolapse 
10045452 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord short 
10045453 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord thrombosis 
10071652 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Umbilical cord vascular disorder 
10045454 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Vesicoamniotic shunt 
10068236 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Virilism foetal 
10047487 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Alpha 1 foetoprotein abnormal 
10001773 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Alpha 1 foetoprotein decreased 
10001780 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Alpha 1 foetoprotein increased 
10001781 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Lactation related topics (incl neonatal exposure through breast milk) (SMQ) [20000187] 
Functional lactation disorders (SMQ) [20000188] 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Breast milk discolouration 
10058665 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Galactocele 
10017590 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Galactostasis 
10060710 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Lactation disorder 
10061261 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Lactation inhibition therapy 
10069058 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Lactation puerperal increased 
10023671 
PT 
Narrow 
A 
0 
Active 
14.0 
 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 186 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Lactation stimulation therapy 
10079806 
PT 
Narrow 
A 
0 
Active 
20.1 
 
Mastitis 
10026883 
PT 
Narrow 
A 
0 
Active 
17.0 
 
Mastitis bacterial 
10065212 
PT 
Narrow 
A 
0 
Active 
17.0 
 
Mastitis fungal 
10065211 
PT 
Narrow 
A 
0 
Active 
17.0 
 
Mastitis postpartum 
10026889 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Neonatal insufficient breast milk syndrome 
10072188 
PT 
Narrow 
A 
0 
Active 
15.0 
 
Nipple infection 
10029419 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Nipple inflammation 
10064043 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Retracted nipple 
10038944 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Suppressed lactation 
10042576 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Viral mastitis 
10074560 
PT 
Narrow 
A 
0 
Active 
17.0 
 
Neonatal exposures via breast milk (SMQ) [20000189] 
 
 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Exposure during breast feeding 
10071402 
PT 
Narrow 
A 
0 
Active 
14.1 
 
Intoxication by breast feeding 
10049999 
PT 
Narrow 
A 
0 
Active 
14.0 
 
Neonatal disorders (SMQ) [20000191] 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Acne infantile 
10000507 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Adrenocortical insufficiency neonatal 
10001391 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Agitation neonatal 
10001500 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Alveolar capillary dysplasia 
10077023 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Anaemia neonatal 
10002068 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Anaesthetic complication neonatal 
10052851 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Aorticopulmonary window repair 
10066834 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Apgar score abnormal 
10056850 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Apgar score low 
10002944 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 187 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Arrhythmia neonatal 
10003124 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Arterial switch operation 
10066129 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Atelectasis neonatal 
10003599 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Atrial septal defect repair 
10003667 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Atrial switch operation 
10068964 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Balloon atrial septostomy 
10064200 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Birth trauma 
10004954 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Blood loss anaemia neonatal 
10005644 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Bradycardia neonatal 
10056471 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Breast engorgement in newborn 
10006241 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Bronchopulmonary dysplasia 
10006475 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Caput succedaneum 
10056311 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cardiac arrest neonatal 
10007516 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cardiomyopathy neonatal 
10050111 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cardio-respiratory arrest neonatal 
10007618 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cephalhaematoma 
10008014 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cerebral haemorrhage neonatal 
10008112 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Circulatory failure neonatal 
10009196 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cleft lip repair 
10056999 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cleft palate repair 
10009272 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Coagulation disorder neonatal 
10009732 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Collodion baby 
10009926 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Coma neonatal 
10059497 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Convulsion neonatal 
10010911 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Coxsackie viral disease of the newborn 
10011260 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cranial nerve injury secondary to birth trauma 
10011308 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cranial sutures widening 
10058604 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cyanosis neonatal 
10011705 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Death neonatal 
10011912 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Delayed closure of cranial sutures 
10054008 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 188 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Delayed fontanelle closure 
10054034 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Developmental hip dysplasia 
10073767 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Diarrhoea infectious neonatal 
10012744 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Diarrhoea neonatal 
10012743 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Discordant twin 
10069150 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Disseminated intravascular coagulation in 
newborn 
10013443 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Disturbance of thermoregulation of newborn 
10074158 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Drug withdrawal syndrome neonatal 
10013756 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Dry lung syndrome 
10074163 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Dyskinesia neonatal 
10013922 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Early infantile epileptic encephalopathy with 
burst-suppression 
10071545 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Eczema infantile 
10014198 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Encephalopathy neonatal 
10014633 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Endocardial cushion defect repair 
10014657 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Epileptic encephalopathy 
10077380 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Erythema toxicum neonatorum 
10056274 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Facial nerve injury due to birth trauma 
10016056 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Familial infantile bilateral striatal necrosis 
10077450 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Feeding intolerance 
10076042 
PT 
Narrow 
A 
0 
Active 
18.0 
18.1 
Fever neonatal 
10016562 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Fixed bowel loop 
10074216 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Floppy infant 
10051004 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Fontanelle bulging 
10016945 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Fontanelle depressed 
10053214 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Fracture of clavicle due to birth trauma 
10017107 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Fryns syndrome 
10075223 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Funisitis 
10064502 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Gangrene neonatal 
10017717 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 189 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Gasping syndrome 
10069162 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Granulocytopenia neonatal 
10018688 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Grey syndrome neonatal 
10018723 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Group B streptococcus neonatal sepsis 
10053588 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Haemolysis neonatal 
10050190 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Haemorrhage neonatal 
10061993 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Haemorrhagic disease of newborn 
10019008 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Head circumference abnormal 
10060043 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hepatitis neonatal 
10019785 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hepatocellular damage neonatal 
10019834 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hepatosplenomegaly neonatal 
10019848 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Herpes simplex virus conjunctivitis neonatal 
10049458 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hygroma colli 
10050249 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hyperbilirubinaemia neonatal 
10020580 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hyperkinesia neonatal 
10020652 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hypertension neonatal 
10049781 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hypertonia neonatal 
10048615 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hypoglycaemia neonatal 
10020994 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hypokinesia neonatal 
10021022 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hypoplastic nasal cartilage 
10074970 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Hypothermia neonatal 
10050080 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hypotonia neonatal 
10021119 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hypoventilation neonatal 
10021134 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Immature larynx 
10048855 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Immature respiratory system 
10021412 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Inclusion conjunctivitis neonatal 
10053991 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Incubator therapy 
10056613 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Infantile apnoea 
10077321 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Infantile asthma 
10049585 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Infantile back arching 
10077276 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 190 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Infantile colic 
10021746 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Infantile haemangioma 
10075378 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Infantile scurvy 
10021749 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Infantile spasms 
10021750 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Infantile spitting up 
10063338 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Infantile vomiting 
10075315 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Injury to brachial plexus due to birth trauma 
10022158 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Injury to spinal cord secondary to birth trauma 
10022343 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Intoxication by breast feeding 
10049999 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Intraventricular haemorrhage neonatal 
10022841 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Isoimmune haemolytic disease 
10023052 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Jaundice neonatal 
10023138 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Johanson-Blizzard syndrome 
10074947 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Junctional ectopic tachycardia 
10074640 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Kernicterus 
10023376 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Large for dates baby 
10023789 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Late metabolic acidosis of newborn 
10024004 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Lenticulostriatal vasculopathy 
10073774 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Leukopenia neonatal 
10050504 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Low birth weight baby 
10067508 
PT 
Narrow 
A 
0 
Active 
14.0 
14.1 
Lymphocytopenia neonatal 
10025279 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meconium abnormal 
10051132 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meconium aspiration syndrome 
10076496 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Meconium cyst 
10074182 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Meconium ileus 
10027058 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meconium increased 
10027059 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meconium peritonitis 
10058113 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meconium plug syndrome 
10057075 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meconium stain 
10057028 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Melaena neonatal 
10049777 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 191 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Meningitis neonatal 
10058780 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Meningoencephalitis herpes simplex neonatal 
10053586 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Myasthenia gravis neonatal 
10028419 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Necrotising enterocolitis neonatal 
10055667 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal alloimmune thrombocytopenia 
10075149 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Neonatal alveolar aeration excessive 
10028918 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal anoxia 
10028921 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal anuria 
10049778 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal asphyxia 
10028923 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal aspiration 
10059033 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal behavioural syndrome 
10072605 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Neonatal candida infection 
10028924 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal cardiac failure 
10049780 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal cholestasis 
10056528 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal complications of substance abuse 
10061862 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal diabetes mellitus 
10028933 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal disorder 
10028934 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal exchange blood transfusion 
10028937 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal gastrointestinal disorder 
10076388 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Neonatal gastrointestinal haemorrhage 
10074159 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Neonatal haemochromatosis 
10078355 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Neonatal hepatomegaly 
10049995 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal hypocalcaemia 
10079306 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Neonatal hyponatraemia 
10049222 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal hypoparathyroidism 
10056974 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal hypotension 
10049223 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal hypoxia 
10050081 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal infection 
10061308 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal infective mastitis 
10028950 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal intestinal dilatation 
10058934 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 192 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Neonatal intestinal obstruction 
10028951 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal intestinal perforation 
10074160 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Neonatal mucocutaneous herpes simplex 
10053587 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal multi-organ failure 
10050401 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal neuroblastoma 
10049793 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal oversedation 
10050395 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal pneumonia 
10053584 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal respiratory acidosis 
10028966 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal respiratory alkalosis 
10028967 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal respiratory arrest 
10028968 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal respiratory depression 
10028970 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal respiratory distress syndrome 
10028974 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal respiratory distress syndrome 
prophylaxis 
10054933 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal respiratory failure 
10028975 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal tachycardia 
10049775 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal tachypnoea 
10057183 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal testicular torsion 
10075380 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Neonatal tetany 
10057037 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal thyrotoxicosis 
10028976 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neonatal toxicity 
10078986 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Neonatal warming therapy 
10056585 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Neuroendocrine cell hyperplasia of infancy 
10072968 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Neutropenia neonatal 
10029358 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Norwood procedure 
10068098 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Oedema neonatal 
10061317 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Omphalitis 
10030306 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Ophthalmia neonatorum 
10030861 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Overfeeding of infant 
10059260 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Parenteral nutrition associated liver disease 
10074151 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 193 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Patent ductus arteriosus repair 
10034131 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Perinatal brain damage 
10056392 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Perinatal HBV infection 
10075233 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Perinatal HIV infection 
10071049 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Perinatal stroke 
10073945 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Peripheral oedema neonatal 
10049779 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Periventricular haemorrhage neonatal 
10076706 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Periventricular leukomalacia 
10052594 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Polycythaemia neonatorum 
10060476 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Poor feeding infant 
10075316 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Poor sucking reflex 
10058605 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Poor weight gain neonatal 
10050086 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Posthaemorrhagic hydrocephalus 
10079859 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Postmature baby 
10036392 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Premature baby 
10036590 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Premature closure of cranial sutures 
10048907 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Primary familial hypomagnesaemia 
10076626 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Pulmonary air leakage 
10067826 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pulmonary dysmaturity syndrome 
10053766 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pulmonary lymphangiectasia 
10073661 
PT 
Narrow 
A 
0 
Active 
16.1 
16.1 
Pulmonary oedema neonatal 
10050459 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Purpura neonatal 
10037557 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pyloromyotomy 
10037626 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Rash neonatal 
10037871 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Renal failure neonatal 
10038447 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Renal impairment neonatal 
10049776 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Repair of imperforate rectum 
10038570 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Respiratory disorder neonatal 
10061484 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Respiratory tract haemorrhage neonatal 
10038728 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Retinopathy of prematurity 
10038933 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 194 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Rhesus incompatibility 
10063676 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Sepsis neonatal 
10040049 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Small for dates baby 
10041092 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Somnolence neonatal 
10041350 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Sporadic infantile bilateral striatal necrosis 
10077451 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 
Subarachnoid haemorrhage neonatal 
10042317 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Subdural haemorrhage neonatal 
10042365 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Subgaleal haematoma 
10069510 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Sudden infant death syndrome 
10042440 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Systemic-pulmonary artery shunt 
10052717 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Tetanus neonatorum 
10043378 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Tetralogy of Fallot repair 
10067017 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Thrombocytopenia neonatal 
10043557 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Thrombophlebitis neonatal 
10043586 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Transient hypogammaglobulinaemia of infancy 
10044388 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Transient hypothyroxinaemia of prematurity 
10075901 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Transient neonatal pustular melanosis 
10072688 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Transient tachypnoea of the newborn 
10044403 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Tremor neonatal 
10044575 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical discharge 
10072595 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Umbilical granuloma 
10067731 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical sepsis 
10045470 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Urinary tract infection neonatal 
10046573 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Venous thrombosis neonatal 
10064602 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Ventricular septal defect repair 
10047301 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Vision abnormal neonatal 
10047511 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Weight decrease neonatal 
10047894 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
ABO incompatibility 
10000206 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Alloimmunisation 
10060935 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Apparent life threatening event 
10065044 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 195 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Breast milk substitute intolerance 
10072187 
PT 
Broad 
A 
0 
Active 
15.0 
15.0 
Extraocular retinoblastoma 
10015831 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Failure to thrive 
10016165 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Growth failure 
10071095 
PT 
Broad 
A 
0 
Active 
14.0 
20.0 
Maternal exposure during delivery 
10071407 
PT 
Broad 
A 
0 
Active 
15.0 
15.0 
Neuroblastoma 
10029260 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Thymus enlargement 
10065588 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Normal pregnancy conditions and outcomes (SMQ) [20000193] 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Alpha 1 foetoprotein amniotic fluid normal 
10001779 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniocentesis normal 
10001963 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amnioscopy normal 
10001966 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Biopsy foetal normal 
10058398 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Birth weight normal 
10078661 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Caesarean delivery on maternal request 
10076983 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Cervical dilatation 
10079273 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Chloasma 
10008570 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Delivery 
10067647 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
False negative pregnancy test 
10063476 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
First trimester pregnancy 
10052395 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal heart rate normal 
10051140 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Human chorionic gonadotropin increased 
10071332 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Human chorionic gonadotropin positive 
10071335 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Labour pain 
10059204 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Live birth 
10049550 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Multigravida 
10028160 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Multiparous 
10028163 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Newborn head moulding 
10077984 
PT 
Narrow 
A 
0 
Active 
19.0 
19.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 196 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Normal foetus 
10049081 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Normal labour 
10029767 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Normal newborn 
10029769 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Nulliparous 
10029827 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Parity 
10033997 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Planning to become pregnant 
10076056 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Postpartum state 
10048738 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy 
10036556 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy after post coital contraception 
10063671 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy of partner 
10050192 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy on contraceptive 
10067667 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy on oral contraceptive 
10036567 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy test positive 
10036575 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy test urine positive 
10036578 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy with contraceptive device 
10063130 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy with contraceptive patch 
10067082 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy with implant contraceptive 
10063122 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy with injectable contraceptive 
10053394 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Prenatal care 
10052859 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Primigravida 
10036757 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Primiparous 
10036758 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Second trimester pregnancy 
10052396 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Term birth 
10072953 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Third trimester pregnancy 
10052397 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Ultrasound antenatal screen normal 
10045401 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Unintended pregnancy 
10045542 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Unwanted pregnancy 
10046267 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine contractions during pregnancy 
10049975 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 197 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Alpha 1 foetoprotein normal 
10001782 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Breast engorgement 
10006240 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (SMQ) [20000186] 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Abnormal labour 
10000153 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abnormal labour affecting foetus 
10000154 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Acute fatty liver of pregnancy 
10000746 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Afterbirth pain 
10049589 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniocentesis abnormal 
10001959 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniorrhexis 
10051641 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniorrhoea 
10066470 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amnioscopy abnormal 
10001965 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic cavity disorder 
10060936 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic cavity infection 
10060937 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic fluid erythropoietin level increased 
10064845 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic fluid index abnormal 
10067079 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic fluid index decreased 
10075866 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Amniotic fluid index increased 
10075867 
PT 
Narrow 
A 
0 
Active 
18.0 
18.0 
Amniotic fluid volume decreased 
10063356 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic fluid volume increased 
10063357 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic infection syndrome of Blane 
10051407 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Amniotic membrane rupture test positive 
10078834 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Anaemia of pregnancy 
10066468 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Anaphylactoid syndrome of pregnancy 
10067010 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Angiotensin II receptor type 1 antibody positive 
10079737 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Arrested labour 
10003118 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Artificial rupture of membranes 
10003440 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Assisted delivery 
10061661 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 198 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Bacteriuria in pregnancy 
10004058 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Benign hydatidiform mole 
10004272 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Biopsy chorionic villous abnormal 
10048537 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Blood type incompatibility 
10078985 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Breech delivery 
10006346 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Breech presentation 
10006356 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Brief psychotic disorder, with postpartum onset 
10006362 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Brow presentation 
10052848 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Caesarean section 
10006924 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cephalo-pelvic disproportion 
10008020 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cervical incompetence 
10008267 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cervix cerclage procedure 
10054992 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cervix dystocia 
10054939 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Chloasma 
10008570 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Cholestasis of pregnancy 
10049055 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Chronic villitis of unknown etiology 
10072271 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Complication of delivery 
10061781 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Complication of pregnancy 
10061452 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Decidual cast 
10068735 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Delayed delivery 
10012186 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Delivery outside health facility 
10072446 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Diabetes complicating pregnancy 
10012596 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Discordant twin 
10069150 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Drug dependence, antepartum 
10013675 
PT 
Narrow 
A 
0 
Active 
14.0 
20.1 
Drug dependence, postpartum 
10013676 
PT 
Narrow 
A 
0 
Active 
14.0 
20.1 
Drug use disorder, antepartum 
10079382 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Drug use disorder, postpartum 
10079383 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Eclampsia 
10014129 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Ectopic pregnancy 
10014166 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Ectopic pregnancy termination 
10014168 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 199 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Ectopic pregnancy with contraceptive device 
10074497 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Elderly primigravida 
10014349 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Endometritis bacterial 
10074861 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Endometritis decidual 
10014792 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Exposure during pregnancy 
10073513 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Exposure via father 
10071403 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
External cephalic version 
10070636 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Face presentation 
10016035 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Failed induction of labour 
10016123 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Failed trial of labour 
10016142 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
False labour 
10016194 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal arm prolapse 
10016846 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal exposure during delivery 
10071409 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Foetal exposure during pregnancy 
10071404 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Foetal exposure timing unspecified 
10071405 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Foetal malposition 
10016863 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal malpresentation 
10058013 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal monitoring abnormal 
10071507 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Foetal placental thrombosis 
10072240 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Gestational diabetes 
10018209 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Gestational hypertension 
10070538 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Gestational oedema 
10063412 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Gestational trophoblastic detachment 
10049469 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Glucose tolerance impaired in pregnancy 
10018430 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Glycosuria during pregnancy 
10018475 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Haemorrhage in pregnancy 
10018981 
PT 
Narrow 
A 
0 
Active 
14.0 
15.0 
HELLP syndrome 
10049058 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Herpes gestationis 
10019939 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Heterotopic pregnancy 
10064228 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
High foetal head 
10020065 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 200 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
High risk pregnancy 
10052744 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hyperemesis gravidarum 
10020614 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Hyperreactio luteinalis 
10074866 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Impetigo herpetiformis 
10021534 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Incoordinate uterine action 
10021648 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Induced labour 
10021718 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Inferior vena cava syndrome 
10070911 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Intrapartum haemorrhage 
10067703 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Intrauterine infection 
10056254 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Kleihauer-Betke test positive 
10072577 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Labour augmentation 
10079807 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Labour complication 
10061050 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Labour induction 
10052856 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Labour stimulation 
10052855 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Large for dates baby 
10023789 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Lochial infection 
10066103 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Locked twins 
10024787 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Lymphocytic hypophysitis 
10063685 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Malignant hydatidiform mole 
10025598 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Malignant neoplasm of placenta 
10026350 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Mastitis postpartum 
10026889 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Maternal alcohol use 
10065158 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Maternal cancer in pregnancy 
10079877 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Maternal death during childbirth 
10066376 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Maternal distress during labour 
10056391 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Maternal exposure before pregnancy 
10071406 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Maternal exposure during pregnancy 
10071408 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Maternal exposure timing unspecified 
10071415 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Maternal therapy to enhance foetal lung maturity 
10058340 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Metastases to placenta 
10049725 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 201 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Mirror syndrome 
10068875 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Missed labour 
10059107 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Multiple pregnancy 
10028243 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Oblique presentation 
10052849 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Obstetric infection 
10053636 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Obstetric procedure complication 
10061315 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Obstetrical pulmonary embolism 
10029925 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Obstructed labour 
10029934 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Oligohydramnios 
10030289 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Omphalorrhexis 
10064270 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Paternal exposure before pregnancy 
10080093 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Paternal exposure during pregnancy 
10080091 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Paternal exposure timing unspecified 
10080092 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Pelvic haematoma obstetric 
10034248 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Perineal repair breakdown 
10034528 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Peripartum cardiomyopathy 
10049430 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Peripartum haemorrhage 
10072693 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Placenta accreta 
10062936 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placenta praevia 
10035119 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placenta praevia haemorrhage 
10035121 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placental chorioangioma 
10056718 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placental disorder 
10035132 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placental dysplasia 
10054810 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placental hypertrophy 
10068326 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placental infarction 
10064620 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placental insufficiency 
10035138 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placental necrosis 
10035139 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placental neoplasm 
10061349 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placental polyp 
10035142 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Placental transfusion syndrome 
10035146 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 202 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Polyhydramnios 
10036079 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Polymorphic eruption of pregnancy 
10066100 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Postpartum disorder 
10061469 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Postpartum haemorrhage 
10036417 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Postpartum hypopituitarism 
10036297 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Postpartum neurosis 
10036419 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Postpartum sepsis 
10036422 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Postpartum stress disorder 
10056394 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Postpartum thrombosis 
10077022 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Postpartum uterine subinvolution 
10036423 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Postpartum venous thrombosis 
10036300 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Precipitate labour 
10036519 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pre-eclampsia 
10036485 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy in habitual aborter 
10036562 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy of unknown location 
10072811 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Pregnancy with advanced maternal age 
10036582 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Pregnancy with young maternal age 
10069615 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Premature delivery 
10036595 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Premature labour 
10036600 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Premature rupture of membranes 
10036603 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Premature separation of placenta 
10036608 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Prenatal screening test abnormal 
10069151 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Preterm premature rupture of membranes 
10073024 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Previous caesarean section 
10036656 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Prolonged labour 
10036872 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Prolonged pregnancy 
10036877 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Prolonged rupture of membranes 
10073027 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Prophylaxis against Rh isoimmunisation 
10066359 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Prophylaxis of abortion 
10065000 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Puerperal infection 
10072652 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 203 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Puerperal pyrexia 
10037294 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Renal disorder in pregnancy 
10056505 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Retained placenta operation 
10078243 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Retained placenta or membranes 
10038758 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Retained products of conception 
10038773 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Retroplacental haematoma 
10054798 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Rhesus incompatibility 
10063676 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Risk of future pregnancy miscarriage 
10078342 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Rubella in pregnancy 
10039264 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Ruptured ectopic pregnancy 
10048407 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Short interpregnancy interval 
10079272 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Shortened cervix 
10067726 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Shoulder dystocia 
10040613 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Silent thyroiditis 
10079012 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Small size placenta 
10072038 
PT 
Narrow 
A 
0 
Active 
15.0 
15.0 
Subchorionic haematoma 
10072596 
PT 
Narrow 
A 
0 
Active 
15.1 
15.1 
Third stage postpartum haemorrhage 
10043449 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Threatened labour 
10043508 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Thyroid dysfunction in pregnancy 
10056525 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Transverse presentation 
10044456 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Traumatic delivery 
10044520 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Tubal rupture 
10067553 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Twin pregnancy 
10045188 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Ultrasound antenatal screen abnormal 
10045400 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord abnormality 
10048596 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord around neck 
10045447 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord compression 
10045451 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord cyst 
10079122 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Umbilical cord haemorrhage 
10064534 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord prolapse 
10045452 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 204 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Umbilical cord short 
10045453 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Umbilical cord thrombosis 
10071652 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 
Umbilical cord vascular disorder 
10045454 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Unstable foetal lie 
10046255 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine adhesions 
10074333 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Uterine cervix stenosis 
10067732 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine compression sutures 
10078738 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Uterine contractions abnormal 
10061400 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine contractions during pregnancy 
10049975 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine dehiscence 
10070301 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine hyperstimulation 
10066288 
PT 
Narrow 
A 
0 
Active 
14.0 
17.1 
Uterine hypertonus 
10046790 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine hypotonus 
10046792 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine inversion 
10046796 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine irritability 
10079224 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Uterine malposition 
10046800 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine rupture 
10046820 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Uterine tachysystole 
10080022 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Vasa praevia 
10047036 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Venous thrombosis in pregnancy 
10067030 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Vomiting in pregnancy 
10047704 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Antiphospholipid syndrome 
10002817 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Induction of cervix ripening 
10073175 
PT 
Broad 
A 
0 
Active 
16.0 
16.0 
Perineal haematoma 
10034520 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Perineal injury 
10073329 
PT 
Broad 
A 
0 
Active 
16.0 
16.0 
Pituitary infarction 
10035092 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Postponement of preterm delivery 
10073177 
PT 
Broad 
A 
0 
Active 
16.0 
16.0 
Reversible cerebral vasoconstriction syndrome 
10073240 
PT 
Broad 
A 
0 
Active 
18.0 
18.0 
Uterine scar 
10074527 
PT 
Broad 
A 
0 
Active 
17.0 
17.0 
Uterine scar diverticulum 
10076608 
PT 
Broad 
A 
0 
Active 
18.1 
18.1 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 205 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Varicose veins vaginal 
10066002 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Vulvovaginal injury 
10071212 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
 
Termination of pregnancy and risk of abortion (SMQ) [20000192] 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Abnormal product of conception 
10060927 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Aborted pregnancy 
10000209 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion 
10000210 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion complete 
10061614 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion complete complicated 
10000212 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion complicated 
10061615 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion early 
10052846 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion incomplete 
10000217 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion incomplete complicated 
10000218 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion induced 
10000220 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion induced complete 
10060928 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion induced complete complicated 
10000221 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion induced complicated 
10000223 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion induced incomplete 
10053984 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion induced incomplete complicated 
10000225 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion infected 
10000228 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion late 
10052847 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion missed 
10000230 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion of ectopic pregnancy 
10066266 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion spontaneous 
10000234 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion spontaneous complete 
10061616 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion spontaneous complete complicated 
10000236 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion spontaneous complicated 
10000238 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion spontaneous incomplete 
10061617 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 206 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last 
Modified 
Version 
Abortion spontaneous incomplete complicated 
10000239 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Abortion threatened 
10000242 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Anembryonic gestation 
10079814 
PT 
Narrow 
A 
0 
Active 
20.1 
20.1 
Biochemical pregnancy 
10063639 
PT 
Narrow 
A 
0 
Active 
14.0 
17.1 
Ectopic pregnancy termination 
10014168 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Evacuation of retained products of conception 
10015550 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Foetal death 
10055690 
PT 
Narrow 
A 
0 
Active 
14.0 
15.0 
Foeticide 
10075033 
PT 
Narrow 
A 
0 
Active 
17.1 
17.1 
Habitual abortion 
10062935 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Imminent abortion 
10051459 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Induced abortion failed 
10053191 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Induced abortion haemorrhage 
10052844 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Induced abortion infection 
10052845 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Molar abortion 
10065942 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Mycoplasmal postabortal fever 
10028479 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Post abortion complication 
10036244 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Post abortion haemorrhage 
10036246 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Post abortion infection 
10061467 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Premature baby death 
10076700 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Prophylaxis of abortion 
10065000 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Retained products of conception 
10038773 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Risk of future pregnancy miscarriage 
10078342 
PT 
Narrow 
A 
0 
Active 
19.1 
19.1 
Selective abortion 
10067499 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Stillbirth 
10042062 
PT 
Narrow 
A 
0 
Active 
14.0 
14.0 
Twin reversed arterial perfusion sequence 
malformation 
10073455 
PT 
Narrow 
A 
0 
Active 
16.0 
16.0 
Vanishing twin syndrome 
10071398 
PT 
Narrow 
A 
0 
Active 
14.1 
14.1 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 207 of 217 
7.4. 
SMQ Terms for Hypertension 
SMQ Export: 20.1 - English 
1/8/2018 2:15:07 PM 
Include Inactive PT:  No 
Term Attributes:       Name, Code, Level, Scope, Category, Weight, Status, Addition Version, Last Modified Version 
Hypertension (SMQ) [20000147] 
 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last Modified 
Version 
Accelerated hypertension 
1000035
8 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Blood pressure ambulatory increased 
1000573
2 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Blood pressure diastolic increased 
1000573
9 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Blood pressure inadequately controlled 
1005112
8 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Blood pressure increased 
1000575
0 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Blood pressure management 
1006392
6 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Blood pressure orthostatic increased 
1005335
5 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Blood pressure systolic increased 
1000576
0 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Diastolic hypertension 
1001275
8 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Eclampsia 
1001412
9 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Endocrine hypertension 
1005761
5 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Essential hypertension 
1001548
8 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Gestational hypertension 
1007053
8 
PT 
Narrow 
A 
0 
Active 
13.1 
13.1 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 208 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last Modified 
Version 
HELLP syndrome 
1004905
8 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hyperaldosteronism 
1002057
1 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hypertension 
1002077
2 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hypertension neonatal 
1004978
1 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hypertensive angiopathy 
1005923
8 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hypertensive cardiomegaly 
1002080
1 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hypertensive cardiomyopathy 
1005822
2 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hypertensive cerebrovascular disease 
1007700
0 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Hypertensive crisis 
1002080
2 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hypertensive emergency 
1005817
9 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hypertensive encephalopathy 
1002080
3 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hypertensive end-organ damage 
1007949
6 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 
Hypertensive heart disease 
1002082
3 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Hypertensive nephropathy 
1005517
1 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Labile hypertension 
1004907
9 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Malignant hypertension 
1002560
0 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Malignant hypertensive heart disease 
1002560
3 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 209 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last Modified 
Version 
Malignant renal hypertension 
1002667
4 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Maternal hypertension affecting foetus 
1002692
4 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Mean arterial pressure increased 
1002698
5 
PT 
Narrow 
A 
0 
Active 
12.1 
12.1 
Metabolic syndrome 
1005206
6 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Neurogenic hypertension 
1006759
8 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Orthostatic hypertension 
1006550
8 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Page kidney 
1007670
4 
PT 
Narrow 
A 
0 
Active 
18.1 
18.1 
Pre-eclampsia 
1003648
5 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Prehypertension 
1006591
8 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Procedural hypertension 
1006288
6 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Renal hypertension 
1003846
4 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Renal sympathetic nerve ablation 
1007486
4 
PT 
Narrow 
A 
0 
Active 
17.0 
17.0 
Renovascular hypertension 
1003856
2 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Retinopathy hypertensive 
1003892
6 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Secondary aldosteronism 
1003980
8 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Secondary hypertension 
1003983
4 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Supine hypertension 
1007893
2 
PT 
Narrow 
A 
0 
Active 
20.0 
20.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 210 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last Modified 
Version 
Systolic hypertension 
1004295
7 
PT 
Narrow 
A 
0 
Active 
11.1 
11.1 
Withdrawal hypertension 
1004800
7 
PT 
Narrow 
A 
0 
Active 
11.1 
12.0 
Aldosterone urine abnormal 
1006162
5 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Aldosterone urine increased 
1000165
3 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Angiotensin converting enzyme increased 
1004953
0 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Angiotensin I increased 
1000248
8 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Angiotensin II increased 
1000249
5 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Angiotensin II receptor type 1 antibody positive 
1007973
7 
PT 
Broad 
A 
0 
Active 
20.1 
20.1 
Blood aldosterone abnormal 
1000529
4 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Blood aldosterone increased 
1000529
6 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Blood catecholamines abnormal 
1000541
2 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Blood catecholamines increased 
1000541
4 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Blood pressure abnormal 
1000572
8 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Blood pressure ambulatory abnormal 
1000573
0 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Blood pressure diastolic abnormal 
1000573
6 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Blood pressure fluctuation 
1000574
6 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Blood pressure orthostatic abnormal 
1005335
4 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 211 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last Modified 
Version 
Blood pressure systolic abnormal 
1000575
7 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Catecholamines urine abnormal 
1006174
7 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Catecholamines urine increased 
1006103
4 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Diuretic therapy 
1005307
3 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Ectopic aldosterone secretion 
1001414
8 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Ectopic renin secretion 
1001417
1 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Epinephrine abnormal 
1006184
5 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Epinephrine increased 
1001506
4 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Labile blood pressure 
1002353
3 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Metanephrine urine abnormal 
1006219
3 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Metanephrine urine increased 
1002744
5 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Non-dipping 
1006522
6 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Norepinephrine abnormal 
1006187
4 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Norepinephrine increased 
1002975
2 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Normetanephrine urine increased 
1004909
7 
PT 
Broad 
A 
0 
Active 
14.0 
14.0 
Pseudoaldosteronism 
1003711
3 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Renin abnormal 
1003855
6 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 212 of 217 
Name 
Code 
Level 
Scope 
Category 
Weight 
Status 
Addition 
Version 
Last Modified 
Version 
Renin increased 
1003855
9 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Renin-angiotensin system inhibition 
1004941
5 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
Tyramine reaction 
1006789
5 
PT 
Broad 
A 
0 
Active 
11.1 
14.0 
 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 213 of 217 
7.5. 
List of Per-Protocol Chemotherapy Regimens in Preferred Term 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 214 of 217 
Agent Name in Preferred Term 
ALTRETAMINE 
ANETUMAB RAVTANSINE 
ANTINEOPLASTIC AGENTS 
BEVACIZUMAB 
BEVACIZUMAB W/CARBOPLATIN* 
CAPECITABINE 
CARBOPLATIN* 
CARBOPLATIN W/GEMCITABINE* 
CARBOPLATIN W/GEMCITABINE HYDROCHLORIDE* 
CARBOPLATIN W/PACLITAXEL* 
CISPLATIN* 
CISPLATIN W/DOCETAXEL* 
CISPLATIN W/GEMCITABINE HYDROCHLORIDE* 
CISPLATIN W/PACLITAXEL* 
CYCLOPHOSPHAMIDE 
DECITABINE 
DOCETAXEL 
DOXORUBICIN 
DOXORUBICIN HYDROCHLORIDE 
ETOPOSIDE 
GEMCITABINE 
GEMCITABINE HYDROCHLORIDE 
IFOSFAMIDE 
INVESTIGATIONAL DRUG 
IRINOTECAN 
IXABEPILONE 
LIPOSOMAL DOXORUBICIN HYDROCHLORIDE 
LURBINECTEDIN 
MELPHALAN 
METHOTREXATE 
NINTEDANIB 
NIRAPARIB 
OLAPARIB 
OMEPRAZOLE 
OTHER ANTINEOPLASTIC AGENTS 
OXALIPLATIN* 
PACLITAXEL 
PACLITAXEL ALBUMIN 


TESARO, Inc. 
Statistical Analysis Plan, Protocol PR-30-5020-C 
19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 215 of 217 
Agent Name in Preferred Term 
PACLITAXEL POLIGLUMEX 
PACLITAXEL W/CARBOPLATIN* 
PAZOPANIB 
PEGYLATED LIPOSOMAL DOXORUBICIN 
PEGYLATED LIPOSOMAL DOXORUBICIN HYDROCHLORIDE 
PEMETREXED 
PEMETREXED DISODIUM 
PLATINUM COMPOUNDS* 
PRALATREXATE 
RUCAPARIB 
TAXANES 
TOPOTECAN 
TRABECTEDIN 
TRASTUZUMAB EMTANSINE 
VELIPARIB 
VINORELBINE 
VINORELBINE TARTRATE 
* Denotes platinum-based therapies. 
 
 


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19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 216 of 217 
8. 
STATISTICAL OUTPUT SHELLS 
The list of statistical output and corresponding table/figure/listing shells are provided in a 
separate document. 


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19 January 2018, Version 3.0 
 
CONFIDENTIAL 
 
Page 217 of 217 
9. 
REVISION HISTOR 
• The efficacy analyses were revised between versions 2.0 and 3.0 of the SAP in order to 
ensure consistency with the revised Protocol v3.2. Table, figure, and listing shells were 
modified to account for the revised analyses. 

Prot_000.pdf: 
 
 
TITLE PAGE 
 
 
A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib 
in Patients with Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian 
Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous 
Chemotherapy Regimens 
 
Sponsor: 
TESARO, Inc. 
1000 Winter Street 
Suite 3300 
Waltham, MA 02451 
 
TESARO UK, Limited 
21 Holborn Viaduct 
London 
EC1A2DY United Kingdom 
 
Medical Monitor 
 MD 
Senior Medical Director 
 
Clinical Research Organization: 
PAREXEL International, LLC 
195 West Street 
Waltham, MA 02451 
Sponsor Protocol No.: 
PR-30-5020-C 
IND No.: 
100,996 
EudraCT No.: 
2014-005478-12  
Study Drug Name: 
Niraparib capsules 
Development Phase: 
2 
Date of Original Protocol: 
17 December 2014 
Date of Amendment 1: 
Date of Amendment 2: 
Date of Amendment 3: 
Date of Amendment 3.1: 
Date of Amendment 3.2: 
Date of Amendment 4: 
Date of Amendment 5: 
30 October 2015 
24 May 2016 
29 July 2016 
7 September 2016 
14 September 2016 
7 April 2017 
21 December 2017 
Version of Protocol: 
8.0 
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. 
PPD
PPD
PPD
PPD


Niraparib 
 
Clinical Study Protocol PR-30-5020-C Amendment 5 
Confidential  
 
 
 
 
 
Page 2 of 74 
Confidentiality Statement 
All information contained in this document is privileged and confidential to TESARO. Any 
distribution, copying, or disclosure is strictly prohibited without prior written approval by 
TESARO. 


PPD
PPD


Niraparib 
 
Clinical Study Protocol PR-30-5020-C Amendment 5 
Confidential  
 
 
 
 
 
Page 4 of 74 
INVESTIGATOR SIGNATURE PAGE 
Declaration of the Principal Investigator 
 
Title: A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of 
Niraparib in Patients with Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian 
Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy 
Regimens 
 
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 
(IEC)/Institutional Review Board (IRB), in accordance with the study protocol, the current 
International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), 
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. 
 
Principal Investigator 
 
 
_____________________________________ 
_____________________ 
Name:   
Date 
Title:   
Institution:   


Niraparib 
 
Clinical Study Protocol PR-30-5020-C Amendment 5 
Confidential  
 
 
 
 
 
Page 5 of 74 
SYNOPSIS 
Name of Sponsor/Company:  TESARO, Inc. 
Name of Investigational Product:  Niraparib 
Name of Active Ingredient:  Niraparib 
Title of Study:  A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of 
Niraparib in Patients with Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian 
Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy 
Regimens 
Study Center(s):  Approximately 60 sites 
Studied Period (years):  
Estimated date first patient enrolled:  March 2015 
Estimated date last patient enrolled:   December 2017  
Phase of Development:  2 
Objectives: 
Primary Objective: 
To evaluate the Objective Response Rate (ORR) of niraparib in HRD-positive patients with advanced, 
relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have 
received 3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based 
therapy.   
Key Secondary Objectives: 
 
To evaluate the ORR of niraparib in all patients with advanced, relapsed, high-grade serous 
epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 3 or 4 
prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based 
therapy.  
  To evaluate the ORR of niraparib in all patients with advanced, relapsed, high-grade serous 
epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 3 or 4 
prior lines of anti-cancer therapy and are platinum-sensitive or platinum-resistant to the last 
platinum-based therapy. 
 
To evaluate the ORR of niraparib in all patients with advanced, relapsed, high-grade serous 
epithelial ovarian, fallopian tube, or primary peritoneal cancer. 
Other Secondary Objectives:  
 
To evaluate the efficacy (ORR, DOR, DCR, PFS, TFST and OS) of niraparib in patients 
who have received 3 or 4 prior lines of anti-cancer therapy  
 
To evaluate the efficacy (ORR, DOR, DCR, PFS, TFST and OS) of niraparib in all patients 
regardless of prior lines of anti-cancer therapy.  
 
To evaluate the safety and tolerability of niraparib 
Exploratory Objectives: 
 
To evaluate the efficacy and safety of niraparib in all patients who are platinum-refractory 
to the last platinum-based therapy. 


Niraparib 
 
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 
To evaluate the efficacy and safety of niraparib in all patients with prior PARP treatment. 
 
To evaluate QTc in a subset of niraparib-treated ovarian cancer patients 
 
To assess population pharmacokinetics (PK) and estimate PK parameters for niraparib and 
its major metabolite 
 
To explore potential biomarkers related to ovarian cancer and poly(ADP-ribose) 
polymerase (PARP) inhibition (e.g. DNA repair pathways) 
Methodology: 
This study is a multicenter (United States and Canada), open-label, single-arm, Phase 2 study 
evaluating the safety and efficacy of niraparib in patients with advanced, relapsed, HRD-positive (as 
identified with a centralized HRD test), high-grade serous epithelial ovarian, fallopian tube, or 
primary peritoneal cancer who were previously treated with chemotherapy and experienced a 
response lasting at least 6 months to first-line platinum-based therapy. Patients must have received 3 
or 4 previous chemotherapy regimens.  
In order to determine eligibility, a tumor sample will be sent to a centralized laboratory for tBRCAmut 
and HRD testing. Archival or fresh tissue is required in order to enroll in the study. The sample may 
be sent for testing in advance of the protocol-defined screening period in order to facilitate the 
screening and enrollment process. Patients must wait for the results from the on-study centralized 
HRD testing prior to receiving first dose. If gBRCAmut is previously detected, then it is not required to 
wait for tumor HRD test results prior to enrollment; however, archival tumor samples still need to be 
collected for central HRD testing and exploratory biomarker analyses. Patients may be eligible for 
enrollment if they have an HRD-positive tumor. 
Blood samples also will be collected for all patients during screening for determination of gBRCAmut 
status. If HRD status is known, then it is not necessary to wait for gBRCAmut testing results for 
enrollment into the study. However, a blood sample still needs to be collected for central gBRCAmut 
testing.  
In order to evaluate exploratory tumor biomarker changes, an optional fresh biopsy may be done at 
screening and at the end of treatment (EOT) visit.  
Niraparib 300 mg will be administered orally once daily continuously beginning on Day 1 and every 
cycle (28 days) thereafter until the patient discontinues study treatment. Three capsules of 100-mg 
strength will be taken at each dose administration. Dose interruption (no longer than 28 days) and 
dose reductions to 2 capsules daily (200 mg), and subsequently to 1 capsule daily (100 mg), will be 
allowed (no further dose reductions will be allowed). Dose interruption and/or reduction may be 
implemented at any time for any grade toxicity considered intolerable by the patient. The timing of 
efficacy or safety evaluations should not be affected by dose interruptions or reductions. Patients will 
continue on study medication until disease progression as long as in the investigator’s opinion they 
are benefiting from treatment and do not meet any other discontinuation criteria. 
As of 9 February 2016, the PK QTc sub-study had reached the enrollment target of 12 patients and is 
now closed to enrollment. 
Blood samples will be collected for all patients during screening for the exploratory evaluation of 
circulating biomarkers. 


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Clinic visits will be weekly during Cycle 1 and then every 4 weeks (±3 days) for subsequent cycles. 
Response Evaluation Criteria in Solid Tumors (RECIST; v.1.1) tumor assessment via computed 
tomography or magnetic resonance imaging of the abdomen/pelvis and clinically indicated areas is 
required every 8 weeks (±7 days) from Cycle 1/Day 1 for 6 months and then every 12 weeks (±7 
days) until progression. Copies of scans will be collected for future central evaluation if needed. 
Cycle timing will not be delayed for treatment interruptions, and tumor assessment should occur 
according to this schedule regardless of whether study treatment is interrupted. All adverse events 
(AEs) and serious adverse events (SAEs) will be collected and recorded for each patient from the day 
of signing the informed consent form until the EOT visit. New SAEs (including deaths) will be 
collected for 30 days after the last dose of study treatment. AESI and SAEs assessed as related to 
study treatment will be reported through the study and post-treatment assessments. All AEs and SAEs 
experienced by a patient, irrespective of the suspected causality, will be monitored until the AE or 
SAE has resolved, any 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.  
The Adverse Events of Special Interest (AESIs) for this study are myelodysplastic syndrome (MDS), 
acute myeloid leukemia (AML), and secondary cancers (new malignancies other than MDS/AML, 
pneumonitis, and embryo-fetal toxicity. AESIs must be reported to the Sponsor soon as the 
Investigator becomes aware of them. 
The study will be conducted in conformance with Good Clinical Practice. 
Number of Patients (Planned): Approximately 500 patients will be enrolled in the study.  
Main Criteria for Inclusion: 
To be considered eligible to participate in the study, the patient must meet the following main 
inclusion criteria and all other inclusion criteria: 
 
Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing. 
a. This test result must show that patients have an HRD-positive tumor (see 
Appendix F), defined by the presence of a deleterious or suspected deleterious breast 
cancer gene (BRCA) mutation or be positive for genomic instability. 
      Note:  The study HRD test result must be received prior to study enrollment. The tumor 
sample may be submitted for HRD testing prior to the screening period if it appears the 
patient is likely to meet other eligibility requirements. To facilitate early testing, a 
separate informed consent form (ICF) specific for HRD testing will be available to be 
signed prior to testing. 
b. If historic blood gBRCAmut is detected by a central gBRCAmut testing, then tumor 
HRD sample test results are not required prior to enrollment; however, HRD testing 
still needs to be performed.  
Note: If gBRCAmut status is known by a local test, then a fresh sample must be submitted 
for centralized gBRCAmut testing. Local gBRCAmut results are not acceptable for 
enrollment. Only patients with centralized gBRCAmut and/or HRD-positive samples can be 
enrolled in this study. 
 
Patients must have completed 3 or 4 previous chemotherapy regimens (eg, gemcitabine, 
doxorubicin, topotecan, carboplatin, oxaliplatin, cisplatin, bevacizumab, or PARP inhibitors 
as single agents or in combination per standard of care). 


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a. Patients must have completed their last chemotherapy regimen > 4 weeks prior to 
treatment initiation. 
 
Patients must have measurable disease according to RECIST (v.1.1). 
Main Criteria for Exclusion: 
To be considered eligible to participate in the study, the patient must not meet any of the following 
main exclusion criteria or any other exclusion criteria: 
 
Patients must not have any known, persistent (> 4 weeks), ≥Grade 3 hematologic toxicity 
during the last cancer therapy.  
 
Patients must not have any known, persistent (>4 weeks), ≥Grade 3 fatigue during the last 
cancer therapy. 
 
Patients must not have received pelvic radiotherapy as treatment for primary or recurrent 
disease within 1 year of the first dose of study treatment. 
 
Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases. (To be 
considered “controlled,” central nervous system [CNS] disease must have undergone 
treatment [eg, radiation or surgery at least 1 month prior to study entry]. The patient must 
have no new or progressive signs or symptoms related to the CNS disease and must be taking 
a stable dose of steroids [as long as these were started at least 4 weeks prior to enrollment] or 
no steroids.) A scan to confirm the absence of brain metastases is not required. Patients with 
spinal cord compression may be considered if they have received definitive treatment for this 
and demonstrate evidence of clinically stable disease for 28 days. 
 
Patients must not be 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, small bowel obstruction or other serious gastrointestinal disorder, or any 
psychiatric disorder that prohibits obtaining informed consent. 
 
Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of 
the first dose of study treatment. 
 
Patients must not have known history or current diagnosis of myelodysplastic syndrome 
(MDS), acute myeloid leukemia (AML), or second primary malignancy other than MDS or 
AML.  
Investigational Product, Dosage, and Mode of Administration: 
Niraparib 300 mg (3 x 100-mg niraparib capsules) will be administered orally once daily 
continuously. Patients will be instructed to take their dose at the same time of the day, preferably in 
the morning. Patients must swallow and not chew all capsules. The consumption of water and food is 
permissible. The first dose will be administered at the site. 
Duration of Treatment:  Approximately 24 weeks. Patients who are benefitting from treatment will 
have access to study treatment as long as considered acceptable by their treating physician or until 
they are discontinued from study treatment or from the study. 
Criteria for Evaluation: 
Primary Endpoint: 


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 
Investigator-assessed confirmed ORR per RECIST v1.1 in the HRD-positive patients who 
have received 3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive to the last 
platinum-based therapy. Patients with prior PARP inhibitor treatment are excluded.  
Key Secondary Endpoints: 
 
Investigator-assessed confirmed ORR per RECIST v1.1 in all patients who have received 3 or 
4 prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based 
therapy, regardless of HRD status. Patients with prior PARP treatment are excluded.  
 
Investigator-assessed confirmed ORR per RECIST v1.1 in all patients who have received 3 or 
4 prior lines of anti-cancer therapy and are platinum-sensitive or platinum-resistant to the last 
platinum-based therapy, regardless of HRD status. Patients with prior PARP treatment are 
excluded. 
 
Investigator-assessed confirmed ORR per RECIST v1.1 in all patients treated in the study.  
The primary and key secondary efficacy endpoints will be tested sequentially to control the overall 
Type I error rate at 1-sided 0.025 level. 
 Other Secondary Endpoints: 
 
DOR, DCR, PFS, TFST and OS in patient groups included in the primary and key secondary 
endpoints.  
 
ORR, DOR, DCR, PFS, TFST and OS in patients who have received 3 or 4 prior lines of anti-
cancer therapy and are platinum-resistant to the last platinum-based therapy, by HRD status. 
Patients with prior PARP treatment are excluded.  
 
ORR, DOR, DCR, PFS, TFST and OS in all patients regardless of prior lines of anti-cancer 
therapy, including HRD subgroup analysis and platinum-sensitivity (sensitive vs. resistant) 
subgroup analysis. Patients with prior PARP treatment are excluded.  
Safety: 
 
Safety of niraparib will be evaluated throughout the trial, including assessment of 
treatment-emergent AEs, clinical laboratory evaluations (hematology, chemistry), vital signs, 
physical examination, and use of concomitant medications 
A subset of approximately 12 patients will undergo intensive, triplicate ECG monitoring to coincide 
with PK evaluation on Cycle1/Day 1 
Pharmacokinetics: 
 
Evaluation of the PK of niraparib and its major metabolite; parameters of interest include area 
under the curve (AUC), minimum observed plasma concentration (Cmin), maximum observed 
plasma concentration (Cmax), time to maximum concentration (tmax), and/or AUC at steady-
state (AUCss), Cmin,ss, Cmax,ss, and, if the data allow, oral clearance (CL/F) and oral volume of 
distribution (Vz/F) 
 Exploratory Analysis: 
 
To evaluate potential biomarkers related to ovarian cancer and of poly(ADP-ribose) 
polymerase (PARP) inhibitor inhibition (e.g. DNA repair pathways) 
 
Efficacy and safety of niraparib in patients who are platinum-refractory to the last platinum 
therapy  


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 
Efficacy and safety of niraparib in patients with prior PARP treatment. 
Statistical Methods: 
General Analysis Considerations: 
Efficacy analysis will be performed on the following populations:  
 
Intent-to-Treat (ITT) Population, defined as all dosed patients with measurable disease at 
baseline  
 
Response-Evaluable Population, all ITT patients with at least one evaluable post-baseline 
tumor scan 
 
PP population, consisting of all patients in the ITT Population enrolled in the study who do 
not have protocol deviations that may significantly impact the interpretation of efficacy 
results.    
Safety analysis will be performed on the Safety Population, defined as all patients who received at 
least 1 dose of study drug.  
All analyses will include summary statistics, including number and percentage for categorical 
variables and number of patients, mean, standard deviation, median, minimum, and maximum for 
continuous variables. Time-to-event analyses will be performed using Kaplan-Meier methods. The 2-
sided 95% CIs will be provided as appropriate. Exploratory biomarkers may be evaluated with 
efficacy and safety variables. 
All AEs will be listed and tabulated. Physical examination findings, vital signs, and clinical 
laboratory results will be listed and summarized using descriptive statistics; shift tables will be 
presented as appropriate. 
The PK/PDy relationship between concentrations of niraparib and its major metabolite and efficacy 
and safety measures will be investigated. The exposure to niraparib and its major metabolite will be 
correlated with safety (selected AEs) and efficacy variables. 
Descriptive statistics and categorical analyses of ECG variables will be provided for the subset of 
patients (approximately 12) with intensive ECG collection. A population PK analysis plan will be 
written to describe the analyses of ECG variables and PK parameters. 
Sample Size: 
The study protocol initially allowed enrollment of all patients with at least 3 prior lines of anti-cancer 
therapy. In the subsequent protocol amendments, the study enrollment was adjusted to allow only 
HRD-positive patients with 3 or 4 prior lines of anti-cancer therapy. This adjustment was made in 
consideration of the evolving role of PARP inhibitors in ovarian cancer treatment based on external 
data.  Overall, approximately 500 patients are expected in the study. The study enrollment is also 
expected to include a minimum number of tBRCAmut patients (≥50) and HRD-positive patients 
(≥150).   
For the primary efficacy endpoint of ORR in HRD-positive patients who have received 3 or 4 prior 
lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based therapy, an 
alternative hypothesis of ORR ≥30% is considered against a null hypothesis of ORR ≤10%.  
For the key secondary efficacy endpoints of ORR tested in broader subgroups to include platinum-
resistant patients and/or HRD-negative/unknown patients, an alternative hypothesis of ORR ≥25% is 
considered against a null hypothesis of ORR ≤10%. 
The rationale of choosing the null and alternative hypothesis for the primary and the key secondary 
efficacy endpoints is based on data external from this study. These clinical trials of PARP inhibitors 


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(e.g. niraparib, olaparib, and rucaparib) suggest that platinum-sensitivity and/or HRD-positivity 
(including BRCA mutant) play a role in how patients with ovarian cancer respond to treatment. There 
is limited data for the overall HRD-positive population in ovarian cancer treatment. In a rucaparib 
study that included patients who are LOH-positive (another assay evaluating tumor homologous 
recombination deficiency), ORR in the non-tBRCA/LOH-positive patients with at least 2 prior lines of 
therapy was 17%.1 A recent publication of platinum-sensitive patients with at least 1 prior line of 
therapy presented an ORR of 29% in the non-tBRCA/LOH-positive group.2 Therefore, choice of the 
hypotheses of Ho: ORR ≤10% vs. Ha: ORR ≥30% for the primary efficacy and Ho: ORR ≤10% vs. 
Ha: ORR ≥25% for the key secondary analyses would be appropriate for testing the efficacy of 
niraparib treatment in the specified populations.  
It is estimated that 45 patients would provide 90% power for testing the primary efficacy analyses. 
Statistical power for various sample sizes are presented below to provide guidance for the key 
secondary hypotheses when tested individually (regardless of sequential testing). The power is 
calculated by assuming the exact binomial distribution using East® software Version 6.4.  
n 
Statistical Power* 
45 
72% 
60 
85% 
75 
92% 
90 
96% 
* Ho: ORR≤10% vs Ha: ORR≥25% 
 
As of August 2017, approximately 450 patients were dosed in the study. Approximately 320 patients 
had 3 or 4 prior lines of anti-cancer therapy (~150 HRD positive). Based on a preliminary calculation 
of the platinum-sensitivity to the last platinum-based therapy, the number of enrolled patients for the 
primary endpoint and the key secondary efficacy endpoints are considered adequate to ensure 
sufficient power for the planned analysis.  


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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
SPONSOR SIGNATURE PAGE ....................................................................................................3 
INVESTIGATOR SIGNATURE PAGE .........................................................................................4 
SYNOPSIS ......................................................................................................................................5 
TABLE OF CONTENTS ...............................................................................................................12 
TABLES IN TEXT ........................................................................................................................16 
FIGURES IN TEXT ......................................................................................................................16 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ................................................17 
1. 
INTRODUCTION ......................................................................................................19 
1.1. 
Background:  Poly(ADP-ribose) Polymerase and Homologous 
Recombination Deficiency .........................................................................................19 
1.2. 
Niraparib Background ................................................................................................21 
1.2.1. 
Nonclinical Experience ...............................................................................................21 
1.2.2. 
Clinical Experience .....................................................................................................21 
1.3. 
Rationale for Current Trial .........................................................................................23 
2. 
STUDY OBJECTIVES ..............................................................................................25 
2.1. 
Primary Objective .......................................................................................................25 
2.2. 
Secondary Objectives .................................................................................................25 
2.3. 
Exploratory Objectives ...............................................................................................25 
3. 
INVESTIGATIONAL PLAN .....................................................................................26 
3.1. 
Overall Study Design and Plan ...................................................................................26 
4. 
STUDY POPULATION .............................................................................................29 
4.1. 
Inclusion Criteria ........................................................................................................29 
4.2. 
Exclusion Criteria .......................................................................................................30 
4.3. 
Patient Withdrawal and Replacement .........................................................................31 
4.3.1. 
Discontinuation from Treatment .................................................................................32 
4.3.2. 
Discontinuation from the Study ..................................................................................32 
4.4. 
Patient Identification ...................................................................................................33 
5. 
STUDY MEDICATION .............................................................................................34 
5.1. 
Identity ........................................................................................................................34 
5.2. 
Administration ............................................................................................................34 


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5.3. 
Dose Modification ......................................................................................................34 
5.4. 
Packaging, Labeling, and Storage ..............................................................................36 
5.5. 
Study Treatment Accountability .................................................................................36 
5.6. 
Previous and Concomitant Medications .....................................................................37 
5.6.1. 
Prohibited Medications and Other Study Restrictions ................................................37 
6. 
VARIABLES AND METHODS OF ASSESSMENT ...............................................38 
6.1. 
Efficacy Variables ......................................................................................................38 
6.1.1. 
Primary Efficacy: Objective Response Rate ...............................................................38 
6.1.2. 
Secondary Efficacy .....................................................................................................38 
6.1.2.1. 
Duration of Response .................................................................................................38 
6.1.2.2. 
Disease Control Rate ..................................................................................................38 
6.1.2.3. 
Progression-Free Survival ..........................................................................................39 
6.1.2.4. 
Overall Survival ..........................................................................................................39 
6.1.2.5. 
Time to First Subsequent Therapy (TFST) .................................................................39 
6.2. 
Safety Variables ..........................................................................................................39 
6.2.1. 
Definitions ..................................................................................................................39 
6.2.2. 
Assessment of Adverse Events ...................................................................................40 
6.2.2.1. 
Intensity ......................................................................................................................40 
6.2.2.2. 
Causality .....................................................................................................................41 
6.2.3. 
Collecting and Recording Adverse Events .................................................................41 
6.2.4. 
Reporting Disease Progression ...................................................................................42 
6.2.5. 
Reporting Serious Adverse Events .............................................................................42 
6.2.5.1. 
Submission and Distribution of Adverse Events/Serious Adverse Events .................43 
6.2.5.2. 
Pregnancy ...................................................................................................................43 
6.2.5.3. 
Adverse Events of Special Interest .............................................................................44 
6.2.6. 
Clinical Laboratory Assessment .................................................................................44 
6.2.7. 
Physical Examination and Vital Signs ........................................................................45 
6.2.8. 
Eastern Cooperative Oncology Group Performance Status ........................................46 
6.2.9. 
Additional Safety Assessments...................................................................................46 
6.3. 
Demographics and Baseline Characteristics ...............................................................46 
6.3.1. 
Patient Eligibility ........................................................................................................46 
6.3.2. 
Patient Demography ...................................................................................................46 
6.3.3. 
Disease History ...........................................................................................................46 


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6.3.4. 
Medical and Surgical History .....................................................................................47 
6.3.5. 
Previous and Concomitant Medications .....................................................................47 
6.4. 
Pharmacokinetics ........................................................................................................47 
6.5. 
Blood and Tissue Samples ..........................................................................................48 
7. 
STUDY CONDUCT ...................................................................................................49 
7.1. 
Schedule of Procedures ...............................................................................................49 
7.2. 
Procedures by Visit .....................................................................................................53 
7.2.1. 
Screening (Visit 1, Day -28 to Day -1) .......................................................................53 
7.2.2. 
Cycle 1, Day 1 ............................................................................................................54 
7.2.3. 
Cycle 1, Day 8 ............................................................................................................55 
7.2.4. 
Cycle 1, Day 15 ..........................................................................................................55 
7.2.5. 
Cycle 1, Day 22 ..........................................................................................................55 
7.2.6. 
Day 1, Subsequent Cycles ..........................................................................................55 
7.2.7. 
End of Treatment (within 7 days of last dose) ............................................................56 
7.2.8. 
Post-Treatment Assessments (Study Visit Not Always Required) .............................56 
7.2.9. 
Unscheduled Assessments ..........................................................................................57 
8. 
STATISTICAL METHODS .......................................................................................58 
8.1. 
Analysis Populations ..................................................................................................58 
8.2. 
Demographics, Medical History, Baseline Characteristics, and Concomitant 
Medications .................................................................................................................58 
8.3. 
Efficacy Analyses .......................................................................................................58 
8.3.1. 
Primary Efficacy Parameter ........................................................................................58 
8.3.2. 
Secondary Efficacy Parameters ..................................................................................58 
8.4. 
Safety Analyses ..........................................................................................................59 
8.5. 
Pharmacokinetic Analyses ..........................................................................................60 
8.6. 
Biomarker Analyses ....................................................................................................60 
8.7. 
Post-Treatment Analyses ............................................................................................60 
8.8. 
Determination of Sample Size ....................................................................................60 
9. 
ETHICAL, LEGAL, AND ADMINISTRATIVE ASPECTS ....................................62 
9.1. 
Data Quality Assurance ..............................................................................................62 
9.2. 
Access to Source Data/Documents .............................................................................62 
9.3. 
Archiving Study Documents .......................................................................................62 
9.4. 
Good Clinical Practice ................................................................................................63 


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9.5. 
Informed Consent .......................................................................................................63 
9.6. 
Protocol Approval and Amendment ...........................................................................63 
9.7. 
Patient Confidentiality and Data Protection ...............................................................64 
9.8. 
Study Monitoring ........................................................................................................64 
9.9. 
Audits and Inspections ................................................................................................64 
9.10. 
Ethical Considerations ................................................................................................64 
9.11. 
Publication Policy .......................................................................................................65 
10. 
REFERENCE LIST ....................................................................................................66 
APPENDIX A. DRUGS KNOWN TO INHIBIT OR INDUCE CYP1A2 .................................68 
APPENDIX B. RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
(RECIST), V.1.1 .........................................................................................................69 
APPENDIX C. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) 
PERFORMANCE STATUS .......................................................................................71 
APPENDIX D. SELECT DRUGS ASSOCIATED WITH QT PROLONGATION 
AND TORSADES DE POINTES ..............................................................................72 
APPENDIX E. CONTRACEPTION GUIDELINES..................................................................73 
APPENDIX F. SAMPLE MYRIAD MYCHOICE® HRD CDX TEST RESULT 
FORM .........................................................................................................................74 
 


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TABLES IN TEXT 
Table 1: 
Progression-Free Survival in Ovarian Cancer Patients in NOVA ..............................23 
Table 2: 
Dose Reductions for Nonhematologic Toxicities .......................................................34 
Table 3: 
Dose Modification/Reduction for Hematologic Toxicities ........................................35 
Table 4: 
Schedule of Events .....................................................................................................50 
Table 5: 
For Patients with Measurable Disease (ie, Target Disease) .......................................70 
Table 6: 
For Patients with Non-Measurable Disease (ie, Non-Target Disease) .......................70 
FIGURES IN TEXT 
Figure 1: 
Study Design ...............................................................................................................28 
 


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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADL 
activities of daily living 
AE 
adverse event 
alt 
Alternative 
AML 
acute myeloid leukemia 
AUC 
area under the curve 
AUCss 
area under the curve at steady-state 
BER 
base excision repair 
BRCA 
breast cancer gene 
CA-125 
cancer antigen 125 
CBC 
complete blood count 
CI 
confidence interval 
CL/F 
oral clearance  
Cmax 
maximum observed plasma concentration 
Cmax,ss 
maximum observed plasma concentration at steady-state 
Cmin 
minimum observed plasma concentration 
Cmin,ss 
minimum observed plasma concentration at steady-state 
CN 
copy number 
CNS 
central nervous system 
CR 
complete response 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CYP 
cytochrome P450 
DCR 
disease control rate 
DNA 
deoxyribonucleic acid 
DOR 
duration of response 
ECG 
electrocardiogram  
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EOT 
end of treatment 
gBRCAmut 
germline BRCA mutation 
tBRCAmut 
tumor BRCA mutation 
GCP 
Good Clinical Practice 
HRD 
homologous recombination deficiency 
ICF 
informed consent form 


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ICH 
International Council on Harmonisation 
IEC 
independent ethics committee 
IRB 
institutional review board 
ITT 
intent to treat 
IUD 
intrauterine device 
IUS 
intrauterine hormone-releasing system 
LOH 
loss of heterozygosity 
LST 
large-scale state transitions 
MDS 
myelodysplastic syndrome 
MedDRA 
Medical Dictionary for Regulatory Application 
MRI 
magnetic resonance imaging 
NHEJ 
nonhomologous end-joining 
ORR 
objective response rate 
PARP 
poly(ADP-ribose) polymerase 
PD 
progressive disease 
PDy 
PFS 
pharmacodynamic 
progression-free survival 
P-gp 
P-glycoprotein 
PK 
Pharmacokinetic 
PP 
per protocol 
PR 
partial response 
QD 
once daily 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
stable disease 
TAI 
tumor telomeric allelic imbalance 
TEAE 
treatment-emergent adverse event 
TFST 
time to first subsequent treatment 
tmax  
time to maximum concentration 
ULN 
upper limit of normal 
Vz/F 
oral volume of distribution 


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1. 
INTRODUCTION 
1.1. 
Background:  Poly(ADP-ribose) Polymerase and Homologous 
Recombination Deficiency 
Poly(ADP-ribose) polymerases (PARP)-1 and -2 are zinc-finger deoxyribonucleic acid 
(DNA)-binding enzymes that play a crucial role in DNA repair. Upon formation of DNA breaks, 
PARP binds at the end of broken DNA strands, a process that activates its enzymatic activity. 
Activated PARP catalyzes addition of long polymers of ADP-ribose onto PARP and several 
other proteins associated with chromatin, including histones and various DNA repair proteins. 
This results in chromatin relaxation, fast recruitment of DNA repair proteins, and efficient repair 
of DNA breaks. In this manner, PARP plays a key role in sensing DNA damage and converting 
it into intracellular signals that activate the base excision repair (BER) and single-strand break 
repair pathways. 
Normal cells repair up to 10,000 DNA defects daily, and single-strand breaks are the most 
common form of DNA damage. Cells that are unable to repair this burden of DNA damage, such 
as those with defects in the homologous recombination or BER pathways, are at risk for 
accumulating multiple lesions that will ultimately trigger apoptosis. They enter the S (DNA 
replication) phase of the cell cycle with unrepaired single- and double-strand breaks. Pre-existing 
single-strand breaks are converted to double-strand breaks as the replication machinery passes. 
Accumulated double-strand breaks present during S phase are repaired by homologous 
recombination. Homologous recombination is the preferred repair pathway because it is 
associated with a much lower error rate than other forms of repair. Cells unable to perform DNA 
repair via homologous recombination (eg, due to inactivation of genes required for homologous 
recombination, such as breast cancer gene [BRCA] 1 or BRCA2) are at risk for accumulating 
multiple lesions that will ultimately trigger apoptosis. These cells accumulate stalled replication 
forks during S phase and are more likely to use the error-prone nonhomologous end-joining 
(NHEJ) or alternative (alt)-NHEJ pathways to repair double-strand breaks in DNA. 
Accumulation of errors in DNA by NHEJ contributes to mutations that promote the development 
of cancer. Over time, the buildup of excessive DNA errors in combination with the inability to 
complete S phase (because of stalled replication forks) contributes to cell death. 
Treatment with PARP inhibitors could represent a novel opportunity to selectively kill a subset 
of cancer cells with deficiencies in DNA repair pathways. For example, a tumor arising in a 
patient with a germline BRCA mutation (gBRCAmut) has a defective homologous recombination 
DNA repair pathway and would be increasingly dependent on NHEJ, alt-NHEJ, and BER for 
maintenance of genomic integrity. PARP inhibitors block alt-NHEJ and BER, forcing tumors 
with BRCA deficiencies to use the error-prone NHEJ to fix double-strand breaks. Non-BRCA 
deficiencies in homologous recombination DNA repair genes could also enhance tumor cell 
sensitivity to PARP inhibitors. The rationale for anticancer activity in a subset of non-gBRCAmut 
tumors is that they share distinctive DNA repair defects with gBRCAmut carriers, a phenomenon 
broadly described as “BRCAness.”3 DNA repair defects can be caused by germline or somatic 
alterations to the homologous recombination DNA repair pathway. In a recent analysis of 
approximately 500 high-grade serous ovarian adenocarcinoma tumors, approximately 50% 
contained homologous recombination defects.4 A subset of these tumors had biologically 
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Defects in the homologous recombination pathway might result in specific structural changes in 
DNA. Previously, chromosomal copy number (CN) changes have been reported to be associated 
with BRCA1 and BRCA2 mutations.5,6 Recent evidence, however, indicates that evaluation of the 
patterns of loss of heterozygosity (LOH) and homologous recombination deficiency (HRD) may 
be more robust than CN changes alone. LOH results in the irreversible loss of one of the parental 
alleles. In contrast, CN gains are not necessarily permanent. Therefore, if HRD leaves a footprint 
of genomic alterations, LOH and CN variants may provide a more stable record of those changes 
compared with CN variants alone. In a recent study, the patterns of genome-wide LOH were 
analyzed in 3 different epithelial ovarian cancer data sets extensively characterized for BRCA1 
and BRCA2 defects by evaluating HRD status.7 The HRD analysis is a DNA-based assay that is 
capable of detecting HRD independent of its etiology based on genome-wide single nucleotide 
polymorphism data. An HRD-(LOH) score was developed, which is strongly associated with 
functional defects in BRCA1 and BRCA2. This score also strongly correlated with promoter 
methylation of RAD51C, a gene implicated in the homologous recombination pathway. 
Additional DNA-based algorithms of HRD have been developed based on whole genome tumor 
telomeric allelic imbalance, HRD-(TAI),8 and large-scale state transitions, HRD-(LST).9 In a 
recent study, all 3 HRD algorithms were independently associated with BRCA1/2 deficiency and 
response to cisplatin treatment in triple-negative breast cancer.10 The arithmetic mean of the 3 
HRD algorithms was significantly associated with BRCA1/2 status in a breast all-comers cohort 
and with cisplatin response in a second independent triple-negative breast cancer cohort. The 
final clinical HRD score results from the sum of HRD-LOH, HRD-TAI, and HRD-LST scores 
and is a single value along a continuous scale from 0 to 100. Analysis of more than 1,000 breast 
and ovarian cancer tumor samples has identified 2 distinct HRD populations, HRD-negative and 
HRD-positive, with 95% of all gBRCAmut tumors with concomitant LOH at the BRCA gene in the 
sample classified as HRD-positive. 
Clinical studies have shown that PARP inhibitors are active for recurrent ovarian cancer.11-17 
Clinical anticancer activity has been observed in patients with and without gBRCAmut and in 
patients who are platinum-sensitive and platinum-resistant. PARP inhibition appears to be most 
active in patients with gBRCAmut platinum-sensitive disease.11,13,15 Additionally, maintenance 
therapy in patients with relapsed, platinum-sensitive ovarian cancer appears promising.16 Of 
patients with a BRCA mutation, median progression-free survival (PFS) was significantly longer 
in the PARP inhibitor group than in the placebo group (11.2 months vs. 4.3 months; hazard ratio: 
0.18; p < 0.0001). Similar findings were noted for patients with wild-type BRCA, although the 
difference between groups was smaller (7.4 months vs. 5.5 months; hazard ratio: 0.54; 
p = 0.007). Patient-reported outcomes, including Functional Assessment of Cancer Therapy – 
Ovarian Symptom Index, did not show a significant difference between the placebo and 
treatment groups, suggesting that maintenance treatment did not decrease functioning or quality 
of life in these patients. Patient-reported outcome data beyond progression was not captured, and 
therefore quality of life effects related to subsequent chemotherapy treatments (likely to occur 
sooner in the placebo group) could not be used to assess the benefit of extending PFS on patient-
reported outcomes for patients treated with a PARP inhibitor vs. placebo. 


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1.2. 
Niraparib Background 
Niraparib is a potent, orally active PARP-1 and -2 inhibitor being developed as an agent for 
tumors with defects in the homologous recombination DNA repair pathway or that are driven by 
PARP-mediated transcription factors. 
Nonclinical data on niraparib in ovarian cancer are discussed in detail in the Investigator’s 
Brochure and described briefly in Section 1.2.1. 
Niraparib clinical data are discussed in detail in the niraparib Investigator’s Brochure and 
described briefly in Section 1.2.2. 
1.2.1. 
Nonclinical Experience 
In preclinical models, niraparib has been observed to inhibit normal DNA repair mechanisms and 
induce synthetic lethality when administered to cells with homologous recombination defects. In 
a BRCA1-mutant xenograft study, niraparib dosed orally caused tumor regression, which was 
mirrored by >90% reduction in tumor weight compared with the control; in a BRCA2-mutant 
xenograft study, niraparib-dosed mice showed 55% to 60% growth inhibition, both by tumor 
volume and weight. 
Utilizing patient-derived ovarian xenografts (PDX), niraparib previously demonstrated response 
in both BRCA mutation and BRCA wild-type tumors.18 To better illustrate the anti-tumor effects 
of niraparib in ovarian PDX models, samples from a collection of high-grade ovarian tumors 
were subjected to HRD analysis to determine the frequency of BRCA mutation and BRCA 
hypermethylation. Single nucleotide polymorphism data were analyzed using all 3 algorithms 
(loss of heterozygosity [LOH], tumor telomeric allelic imbalance [TAI], and large-scale state 
transitions [LST]). The final HRD score was the sum of the LOH+TAI+LST scores with 
numerical outputs ranging from 0 to 100. Collectively, there was 25% BRCA deficiency in this 
primary tumor collection, consistent with previous studies in high-grade ovarian cancer.4 Using a 
threshold of 50% tumor growth inhibition as a guide, in vivo response to niraparib monotherapy 
was observed in 46% of ovarian cancer PDX modes . The response rate to niraparib in BRCA 
wild type, HRD negative models was 36%. The response rate in HRD positive models was 52%. 
The response rate to niraparib in BRCAmut models was 80%. These findings are consistent with 
the NOVA clinical study where a PFS benefit was observed in all patient subgroups.  
1.2.2. 
Clinical Experience 
Clinical safety data are available for a total of 144 patients who received niraparib as part of 
5 Phase 1 studies conducted to date. 
The common expected drug-related adverse events (AEs) for niraparib have been reported as: 
fatigue, nausea, anemia, thrombocytopenia, decreased appetite, neutropenia, vomiting, 
constipation, leukopenia, diarrhea, insomnia, dyspnea, electrocardiogram (ECG) QT prolonged, 
headache, stomatitis, hyponatremia, and alopecia. The majority of these events were effectively 
managed by dose interruption and/or reduction. AEs resulted in treatment discontinuation in 
approximately 15% of patients. 
Myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and second primary 
malignancies other than MDS/AML have been observed in patients receiving treatment with 
olaparib, rucaparib, and niraparib; given the common mechanism of action among these PARP 


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inhibitors, MDS, AML, and second primary malignancies other than MDS/AML therefore 
represent a potential risk to patients receiving niraparib. Guidance on monitoring patients for 
new events of MDS/AML, and second primary malignancies other than MDS/AML and the 
follow-up of patients with these suspected events is provided in Section 6.2.6 and Section 7. 
Currently, there are 5 ongoing Phase 3 niraparib studies. A short description of the relevant 
monotherapy studies (Study PR-30-5010-C [BRAVO] and Study PR-30-5011-C [NOVA]) is 
provided below. 
Study PR-30-5010-C (BRAVO) is a 2:1 randomized, open-label, multicenter, controlled clinical 
study in patients with previously treated human epidermal growth factor receptor 2-negative 
gBRCAmut breast cancer. In this study, patients received treatment with niraparib 300 mg once 
daily (QD) or physician’s choice single-agent chemotherapy (eribulin, vinorelbine, gemcitabine, 
or capecitabine). Evaluation of computed tomography (CT) scans and magnetic resonance 
imaging (MRI), including determination of response to treatment and date of progression based 
on Response Evaluation Criteria in Solid Tumors (RECIST; v.1.1), was conducted by a central 
blinded review committee comprised of 2 radiologists, with an arbiter as necessary. The results 
of the central blinded assessment are used in determination of the primary efficacy endpoint of 
PFS and the study investigators also assess response to treatment and date of progression based 
on RECIST (v.1.1). BRAVO was initiated (first patient consented) on 25 February 2014. 
Following a recent interim analysis of data by the independent data monitoring committee 
(IDMC), the study was closed to further enrollment. A large number of patients in the 
chemotherapy control arm (physician’s choice) did not continue in the trial long enough to 
receive their first radiological scan, resulting in an unusually high rate of censoring in the control 
arm. It is believed that this is likely associated with the desire of patients who carry germline 
BRCA mutations to be treated with a PARP inhibitor rather than chemotherapy and the increased 
availability of PARP inhibitors. No safety concerns have been noted by the IDMC with respect 
to niraparib. Following closure of enrollment, data analysis and review by the Sponsor is 
ongoing. 
Study PR-30-5011-C (NOVA) is a double-blind, 2:1 randomized, placebo-controlled study of 
maintenance with niraparib compared with placebo in patients with platinum-sensitive ovarian 
cancer who have received at least 2 platinum-based regimens, had a response to their last 
regimen, and have no measurable disease >2 cm and normal cancer antigen 125 (CA-125) (or 
>90% decrease) following their last treatment. In this study, there are 2 independent patient 
cohorts comprising patients who have deleterious gBRCAmut versus those who have a tumor with 
high-grade serous histology but without gBRCAmut (non-gBRCAmut). The study assesses the 
effect of treatment with niraparib 300 mg QD on PFS. Progression is assessed by RECIST 
(v.1.1) and clinical criteria using blinded central review by 2 independent radiologists and an 
arbiter, if necessary, as well as per blinded central clinician review. Results of the blinded central 
reviews are used in determination of the primary efficacy endpoint of PFS. NOVA was initiated 
(first patient consented) on 10 July 2013. Data from the final primary analysis of the Phase 3 
main study, as well as the QTc substudy, recently became available. The results of the PFS 
primary endpoint for each of the 3 primary efficacy populations in platinum-sensitive patients 
(ie, gBRCAmut cohort, HRDpos cohort, and overall non-gBRCAmut cohort) is shown in Table 1. 
Additionally, the median PFS in patients with HRD negative (HRDneg) tumors was 6.9 months 
(95% CI: 5.6, 9.6) in the niraparib arm compared to 3.8 months (95% CI: 3.7, 5.6) in the placebo 
arm with an HR of 0.58 (95% CI: 0.361, 0.922) (p=0.0226). The primary data to support the 


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safety of treatment with niraparib in the proposed indication are derived from the NOVA main 
study in which a total of 546 patients received study treatment.   
Table 1: 
Progression-Free Survival in Ovarian Cancer Patients in NOVA 
  
gBRCAmut Cohort 
non-gBRCAmut Cohort 
(regardless of HRD status) 
HRDpos  
(within non-gBRCAmut 
cohort) 
Niraparib 
(N=138) 
Placebo 
(N=65) 
Niraparib 
(N=234) 
Placebo 
(N=116) 
Niraparib 
(N=106) 
Placebo 
(N=56) 
PFS Median 
(95% CI)a 
21.0 
(12.9, 
NR) 
5.5 
(3.8, 7.2) 
9.3 
(7.2, 11.2) 
3.9 
(3.7, 5.5) 
12.9 
(8.1, 15.9) 
3.8 
(3.5, 5.7) 
p-value 
<0.0001 
<0.0001 
<0.0001 
Hazard 
Ratio 
(Nir:Plac) 
(95% CI) 
0.27 
(0.173, 0.410) 
0.45 
(0.338, 0.607) 
0.38 
(0.243, 0.586) 
a Progression-free survival is defined as the time in months from the date of randomization to progression or death. 
1.3. 
Rationale for Current Trial 
Treatment options are limited for patients whose ovarian cancer has progressed following 
multiple lines of prior therapy. At the time that this study was initiated, the absence of an 
approved treatment or standard of care in the recurrent setting represented an unmet need. 
National Comprehensive Cancer Network guidelines recommended treatment with single-agent 
topotecan, doxorubicin, or gemcitabine, however the optimal combination and sequence of these 
agentsis unclear and the exact population who would derive the most benefit from these 
treatments is not well defined.  
Collectively, the data from multiple published Phase 1 and 2 clinical studies of PARP inhibitors 
used as monotherapy to treat patients with recurrent ovarian cancer suggest that the agents are 
active in this population, the strongest activity being observed in the platinum-sensitive, 
gBRCAmut subgroup.  
In a Phase 2 study of maintenance therapy in 265 patients with relapsed, platinum-sensitive 
ovarian cancer, daily therapy with PARP inhibitor olaparib, compared with placebo, was 
associated with a PFS benefit (hazard ratio: 0.35) and prolongation of the median PFS from 
4.8 months to 8.4 months.15 
In a Phase 1/2 study with niraparib (PN001), 104 patients with advanced solid tumors who had 
received a median of 5 prior therapies were enrolled, of which 49 were ovarian cancer patients 
(13 platinum-sensitive, 35 platinum-resistant, and 1 platinum-refractory). Of the 49 patients, 22 
had confirmed BRCA1 or BRCA2 mutation, of whom 20 were radiologically assessable. Eight 
(40%) of these 20 patients achieved a confirmed partial response (PR) by RECIST and CA-125 
Gynecologic Cancer Intergroup criteria at doses ranging from 80 to 400 mg per day. Median 
response duration was 387 days (range: 159 to 518 days). Three (33%) of 9 patients with 
platinum-resistant BRCA-mutant ovarian cancer had PR by RECIST and CA-125 criteria. 
Additionally, a 50% response rate (5 of 10 evaluable patients) was observed at daily doses 


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ranging from 290 to 300 mg among patients with BRCA-mutant ovarian cancer who had received 
more than 3 lines of prior chemotherapy.  
Thus, niraparib has demonstrated potential for fulfilling an unmet medical need for the treatment 
of patients with relapsed ovarian cancer who have received multiple lines of prior therapy. 
The present study is designed to determine the efficacy and safety of niraparib in these patients 
with a high unmet medical need. Furthermore, the present study will assess if the HRD test can 
be utilized to identify patients with a higher probability of clinical benefit. 


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2. 
STUDY OBJECTIVES 
2.1. 
Primary Objective 
The primary objective of the study is to evaluate the Objective Response Rate (ORR) of 
niraparib in HRD-positive patients with advanced, relapsed, high-grade serous epithelial ovarian, 
fallopian tube, or primary peritoneal cancer, who have received 3 or 4 prior lines of anti-cancer 
therapy and are platinum-sensitive to the last platinum-based therapy.  
2.2. 
Secondary Objectives 
The key secondary objectives of the study are as follows: 
 To evaluate the ORR of niraparib in all patients with advanced, relapsed, high-grade 
serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have 
received 3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive to the last 
platinum-based therapy.  
 To evaluate the ORR of niraparib in all patients with advanced, relapsed, high grade 
serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have 
received 3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive or 
platinum-resistant to the last platinum-based therapy. 
 To evaluate the ORR of niraparib in all patients with advanced, relapsed, high-grade 
serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. 
The other secondary objectives of the study are as follows:  
 To evaluate the efficacy (ORR, DOR, DCR, PFS, TFST and OS) of niraparib in 
patients who have received 3 or 4 prior lines of anti-cancer therapy To evaluate the 
efficacy (ORR, DOR, DCR, PFS, TFST and OS) of niraparib in all patients regardless 
of prior lines of anti-cancer therapy.  
 To evaluate the safety and tolerability of niraparib 
2.3. 
Exploratory Objectives 
The exploratory objectives of the study are as follows: 
 To evaluate the efficacy and safety of niraparib in all patients who are platinum-
refractory to the last platinum-based therapy.  
 To evaluate the efficacy and safety of niraparib in all patients with prior PARP 
treatment.  
 To evaluate QTc in a subset of niraparib-treated ovarian cancer patients (This sub-study 
has been closed for enrollment since 9 February 2016) 
 To assess population pharmacokinetics (PK) and estimate PK parameters for niraparib 
and its major metabolite 
 To explore potential biomarkers related to ovarian cancer and poly(ADP-ribose) 
polymerase (PARP) inhibition (e.g. DNA repair pathways)  


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3. 
INVESTIGATIONAL PLAN 
3.1. 
Overall Study Design and Plan 
This study is a multicenter, open-label, single-arm, Phase 2 study evaluating the safety and 
efficacy of niraparib in patients with advanced, relapsed, homologous recombination deficiency 
(HRD)-positive, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal 
cancer with recurrent disease who were previously treated with chemotherapy and experienced a 
response lasting at least 6 months to first-line platinum-based therapy. Patients must have 
received 3 or 4 previous chemotherapy regimens (including, but not limited to, gemcitabine, 
doxorubicin, topotecan, carboplatin, oxaliplatin, cisplatin, bevacizumab, or PARP inhibitors as 
single agents or in combination per standard of care). The study will assess by ORR whether 
treatment with niraparib will benefit HRD positive patients who received 3 or 4 prior anti-cancer 
therapies and are platinum-sensitive to the last platinum-based therapy. As secondary objectives, 
niraparib efficacy (ORR, DOR, DCR, PFS, TFST, and OS) will be assessed in patients who have 
received 3 or 4 prior lines of anti-cancer therapy by platinum-sensitivity to the last platinum-
based therapy; and in all treated patients regardless of prior lines of anti-cancer therapy.  
In order to determine eligibility, a tumor sample will be sent to a centralized laboratory for 
immediate HRD testing. Archival or fresh tissue is required in order to enroll in the study. The 
sample may be sent in advance of the protocol-defined screening period in order to facilitate the 
screening and enrollment process. Patients must wait for the results from the on-study centralized 
HRD testing prior to enrollment, unless they have previously detected gBRCA mutation. Blood 
samples also will be collected for all patients during screening for determination of gBRCAmut 
status. If HRD status is known, then it is not necessary to wait for HRD testing results for 
enrollment into the study, however confirmatory HRD testing still needs to be performed. 
In order to evaluate tumor markers, an optional fresh biopsy may be done at screening and at the 
end of treatment (EOT) visit. 
Niraparib 300 mg will be administered orally QD continuously beginning on Day 1 and every 
cycle (28 days) thereafter until the patient discontinues study treatment. Three capsules of 
100-mg strength will be taken at each dose administration. Dose interruption (no longer than 
28 days) and dose reductions to 2 capsules daily (200 mg), and subsequently to 1 capsule daily 
(100 mg), will be allowed (no further dose reductions will be allowed). Dose interruption and/or 
reduction may be implemented at any time for any grade toxicity considered intolerable by the 
patient. The timing of efficacy or safety evaluations should not be affected by dose interruptions 
or reductions. Patients will continue on study medication until disease progression as long as in 
the investigator’s opinion they are benefiting from treatment and do not meet any other 
discontinuation criteria. 
Blood samples for measurements of plasma levels of niraparib and its major metabolite will be 
obtained on Cycle 1/Day 1 predose and 2 hours postdose, Cycle 2/Day 1 predose and 2 hours 
postdose, Cycle 4/ Day 1 predose, and Cycle 8/ Day 1 predose. At selected sites, a subset of 
approximately 12 patients will undergo intensive, triplicate ECG monitoring to coincide with PK 
evaluation on Cycle1/Day 1. Triplicate ECGs should be performed between 2 and 5 minutes 
apart and should be performed prior to blood draws for PK. These patients will have triplicate 
ECGs and PK samples taken predose and at 1, 2, 4, 6, and 8 hours postdose. Patients will be 


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supine and rested for approximately 2 minutes before ECGs are recorded. The average of the 
triplicate measures will be used for analysis. This subset of patients will undergo all other 
assessments in the study. As of 9 February 2016, the PK QTc sub-study had reached the 
enrollment target of 12 patients and is now closed to enrollment. 
Blood samples will be collected for all patients at screening for the exploratory evaluation of 
circulating biomarkers. 
Clinic visits will be weekly during Cycle 1 and then every 4 weeks (±3 days) for subsequent 
cycles. Response Evaluation Criteria in Solid Tumors (RECIST; v.1.1) tumor assessment via CT 
or MRI of the abdomen/pelvis and clinically indicated areas is required every 8 weeks (±7 days) 
from Cycle 1/Day 1 for 6 months and then every 12 weeks until progression. Copies of scans 
will be collected for future central evaluation if needed. Cycle timing will not be delayed for 
treatment interruptions, and tumor assessment should occur according to this schedule regardless 
of whether study treatment is interrupted. All AEs and serious adverse events (SAEs) will be 
collected and recorded for each patient from the day of signing the screening informed consent 
form (ICF) until the EOT visit. New SAEs (including deaths) will be collected for 30 days after 
the last dose of study treatment. All AEs and SAEs experienced by a patient, irrespective of the 
suspected causality, will be monitored until the AE or SAE has resolved, any 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. The 
Adverse Events of Special Interest (AESIs) for this study are MDS, AML, secondary cancers 
(new primary malignancies other than MDS/AML), pneumonitis, and embryo-fetal toxicity. 
AESIs must be reported to the Sponsor as soon as the Investigator becomes aware of them 
(Section 6.2.5.3). 
Approximately 500 patients will be enrolled in the study at approximately 60 sites. The study 
will be conducted in conformance with Good Clinical Practice (GCP). 
 
 


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Figure 1: 
Study Design 
 
 
Pre-study events 
 3 or 4 
chemotherapy 
regimens  
(eg, gemcitabine, 
doxorubicin, 
topotecan, 
carboplatin, 
oxaliplatin, 
cisplatin, 
bevacizumab, or 
PARP inhibitors) 
 HRD positive 
tumor 
 Histologically 
diagnosed high-
grade serous 
epithelial ovarian, 
fallopian tube, or 
primary peritoneal 
cancer with 
recurrent disease 
that has been 
previously treated 
with chemotherapy 
with a response of 
at least 6 months to 
first line 
platinum-based 
therapy 
 Measurable disease 
per RECIST v.1.1 
 Archival tissue 
Niraparib 
Disease progression: off study treatment 
 
ORR 
Abbreviations:  ORR = objective response rate; PARP = poly(ADP-ribose) polymerase; RECIST = Response 
Evaluation Criteria in Solid Tumors 
Time to First Subsequent Therapy 
Overall survival 
 
 


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4. 
STUDY POPULATION 
4.1. 
Inclusion Criteria 
To be considered eligible to participate in this study, all of the following requirements must be 
met: 
1. Patients must be female and at least 18 years of age. 
2. Patients must provide written informed consent. 
3. Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing. 
a. This test result must show that patients have an HRD-positive tumor, defined by the 
presence of a deleterious or suspected deleterious breast cancer gene (BRCA) 
mutation or be positive for genomic instability (Please see HRD results sample form 
in Appendix F). 
Note:  The study HRD test result must be received prior to enrollment. The tumor sample 
may be submitted for HRD testing prior to the screening period if it appears the patient is 
likely to meet other eligibility requirements. To facilitate early testing, a separate informed 
consent form (ICF) specific for HRD testing will be required to be signed prior to testing. 
b. If historic blood gBRCAmut is detected by a central gBRCAmut testing, then tumor 
HRD sample test results are not required prior to enrollment; however, HRD testing 
still needs to be performed.  
Note: If gBRCAmut status is known by a local test, then a fresh sample must be submitted for 
centralized gBRCAmut testing. Local gBRCAmut results are not acceptable for enrollment. Only 
patients with centralized gBRCAmut and/or HRD-positive samples can be enrolled in this 
study. 
4. Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial 
ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have 
been previously treated with chemotherapy and experienced a response lasting at least 
6 months to first-line platinum-based therapy. 
5. Patients must have completed 3 or 4 previous chemotherapy regimens (eg, gemcitabine, 
doxorubicin, topotecan, carboplatin, oxaliplatin, cisplatin, bevacizumab, or PARP 
inhibitors as single agents or in combination per standard of care).  
a. Patients must have completed their last chemotherapy regimen > 4 weeks prior to 
treatment initiation. 
6. Patients must have measurable disease according to RECIST (v.1.1). 
7. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 
of 0 or 1 (see Appendix C). 
8. Patients must have adequate organ function, defined as follows: 
a. Absolute neutrophil count ≥ 1,500/µL 
b. Platelets ≥ 150,000/µL 
c. Hemoglobin ≥ 10 g/dL 


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d. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine 
clearance ≥ 60 mL/min using the Cockcroft-Gault equation  
e. Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN 
f. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver 
metastases are present, in which case they must be ≤ 5 x ULN 
9. Patients must have formalin-fixed, paraffin-embedded tumor samples available from the 
primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment 
initiation. 
10. Patients must be able to take oral medications. 
11. Patients of childbearing potential must have a negative serum pregnancy test (beta human 
chorionic gonadotropin; hCG) within 72 hours prior to receiving the first dose of study 
treatment. 
12. Patients must be either postmenopausal, free from menses for > 12 months, surgically 
sterilized, or willing to use adequate contraception to prevent pregnancy or must agree to 
abstain from heterosexual activity throughout the study, starting with enrollment through 
90 days after the last dose of study treatment (see Appendix E for contraception 
guidelines). 
13. Patients must agree to blood samples during screening and at the end of treatment for 
potential cytogenetic analysis. 
4.2. 
Exclusion Criteria 
To be considered eligible to participate in this study, all of the following requirements must be 
met: 
1. Patients must not have had palliative radiotherapy encompassing > 20% of the bone 
marrow within 1 week of the first dose of study treatment. 
2. Patients must not have any known, persistent (> 4 weeks), ≥ Grade 3 hematologic toxicity 
during the last cancer therapy.  
3. Patients must not have any known, persistent (>4 weeks), ≥ Grade 3 fatigue during the 
last cancer therapy 
4. Patients must not have received pelvic radiotherapy as treatment for primary or recurrent 
disease within 1 year of the first dose of study treatment. 
5. Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases. 
(To be considered “controlled,” central nervous system [CNS] disease must have 
undergone treatment [eg, radiation or surgery at least 1 month prior to study entry]. The 
patient must have no new or progressive signs or symptoms related to the CNS disease 
and must be taking a stable dose of steroids [as long as these were started at least 4 weeks 
prior to enrollment] or no steroids.) A scan to confirm the absence of brain metastases is 
not required. Patients with spinal cord compression may be considered if they have 
received definitive treatment for this and demonstrate evidence of clinically stable 
disease for 28 days. 
6. Patients must not have known hypersensitivity to the components of niraparib. 


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7. Patients must not have had major surgery per Investigator judgment within 3 weeks of 
starting the study and patient must have recovered from any effects of any major surgery. 
8. Patients must not have had diagnosis, detection, or treatment of invasive cancer other 
than ovarian cancer ≤ 24 months prior to enrollment (except basal or squamous cell 
carcinoma of the skin that has been definitively treated). 
9. Patients must not be 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, small bowel obstruction or other 
serious gastrointestinal disorder, or any psychiatric disorder that prohibits obtaining 
informed consent. 
10. Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks 
of the first dose of study treatment. 
11. Patients must not have current evidence of any condition, therapy, or laboratory 
abnormality (including active or uncontrolled myelosuppression [ie, anemia, leukopenia, 
neutropenia, thrombocytopenia]) that might confound the results of the study or interfere 
with the patient's participation for the full duration of the study treatment or that makes it 
not in the best interest of the patient to participate. 
12. Patients must not be pregnant or breastfeeding, or expecting to conceive children, within 
the projected duration of the study treatment. 
13. Patients must not be immunocompromised (patients with splenectomy are allowed). 
14. Patients must not have known, active hepatic disease (ie, hepatitis B or C). 
15. Patients must not have a corrected QT interval (QTcF) prolongation > 470 msec at 
screening or history of drug induced ventricular tachycardia or fibrillation. 
a. Note: If a patient has a prolonged QT interval and the prolongation is deemed to be 
due to a pacemaker upon Investigator evaluation (ie, the patient otherwise has no 
cardiac abnormalities), then the patient may be eligible to participate in the study 
following discussion with the Medical Monitor. 
16. [INTENTIONALLY LEFT BLANK TO RETAIN NUMBERING OF THE 
ELIGIBILITY CRITERION FROM THE ORIGINAL PROTOCOL] 
17. Patients must not have known history or current diagnosis of myelodysplastic syndrome 
(MDS), acute myeloid leukemia (AML), or second primary malignancy other than 
MDS/AML.  
4.3. 
Patient Withdrawal and Replacement 
Patients who are benefitting from treatment will have access to study treatment as long as 
considered acceptable by their treating physician or until they are discontinued for one of the 
reasons noted below (Section 4.3.1 and Section 4.3.2). 


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4.3.1. 
Discontinuation from Treatment 
Patients may be discontinued from study treatment at any time. Specific reasons for 
discontinuing treatment are given below. 
 Any treatment-related National Cancer Institute Common Terminology Criteria for 
Adverse Events (CTCAE; v.4.03) Grade 3 or 4 events (see separate guidelines for 
platelets below) that have not reverted to CTCAE Grade 1 or better within 28 days of 
dose interruption. 
 At the Investigator’s discretion, following dose interruption (no longer than 28 
days), patients may be considered for dose reductions (to a maximum of 2 dose 
reductions [ie, a minimum dose of 100 mg once daily (QD)]). If upon rechallenge 
with study treatment at the lowest allowable dose any CTCAE Grade 3 or 4 AEs 
recur, the patient must be discontinued. 
 In the case of thrombocytopenia, following the first occurrence, resumption of therapy 
may occur at the same dose or 1 dose level lower when the platelet count has resolved 
to ≥100,000/µL. Subsequent occurrences should trigger dose reduction upon 
resumption of therapy. If the platelet count has not reverted within 28 days of 
interruption to ≥ 100,000/µL on first or subsequent occurrence, the patient should be 
discontinued. 
 Disease progression according to RECIST (v.1.1) or clinical criteria by Investigator 
 Risk to patients as judged by the Investigator and/or Sponsor 
 Severe noncompliance with the protocol as judged by the Investigator and/or Sponsor 
 Patient request 
 Patient becomes pregnant 
 Sponsor decision to terminate study 
Patients who discontinue from treatment will continue to receive post-treatment assessments as 
part of the study unless they are discontinued from the study (Section 4.3.2). 
4.3.2. 
Discontinuation from the Study 
Patients may be discontinued from the study for any of the following reasons: 
 Withdrawal of consent by the patient, who is at any time free to discontinue their 
participation in the study, without prejudice to further treatment 
 Death from any cause 
 Patient lost to follow-up 
 End of the study (when responder or discontinuation status for all patients is known) 
If a patient is lost to follow-up or withdraws from study treatment, 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. 


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4.4. 
Patient Identification 
All patients who enter into the screening period of the study (defined as the point at which the 
patient signs the main study ICF) or agree to pre-screening HRD testing (defined as the point at 
which the patient signs the screening 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. The patient identification number must remain 
constant throughout the entire study; it must not be changed at the time of enrollment. 


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5. 
STUDY MEDICATION 
5.1. 
Identity 
Niraparib ([3S]-3-[4-phenyl] piperidine [tosylate monohydrate salt]) is an orally available, 
potent, highly selective PARP-1 and -2 inhibitor. The excipients for niraparib are lactose 
monohydrate and magnesium stearate. 
5.2. 
Administration 
Niraparib 300 mg (3 x 100-mg niraparib capsules) will be administered orally QD continuously. 
Patients will be instructed to take their dose at the same time of the day, preferably in the 
morning. Patients must swallow and not chew all capsules. The consumption of water and food 
is permissible. 
Study treatment will be dispensed to patients on Cycle 1/Day 1 and on Day 1 of every cycle (28 
days) thereafter until the patient discontinues study treatment. The first dose will be administered 
at the site. 
Details on the administration of niraparib can be found in the Pharmacy Manual. 
5.3. 
Dose Modification 
Dose interruption and/or reduction may be implemented at any time for any grade toxicity 
considered intolerable by the patient. 
Treatment must be interrupted for any nonhematologic CTCAE (v.4.03) Grade 3 or 4 AE that the 
Investigator considers to be related to administration of niraparib. If toxicity is appropriately 
resolved to baseline or Grade 1 or less within 28 days of interruption, the patient may restart 
treatment with niraparib but with a dose level reduction according to Table 2 if prophylaxis is not 
considered feasible. If the event recurs at similar or worse grade, treatment should be interrupted 
again and, upon resolution, a further dose reduction must be made. No more than 2 dose 
reductions will be permitted (ie, to a minimum dose of 100 mg QD).  
If the toxicity requiring dose interruption has not resolved completely or to CTCAE Grade 1 
during the maximum 4-week (28-day) dose interruption period, and/or the patient has already 
undergone a maximum of 2 dose reductions (to a minimum dose of 100 mg QD), the patient 
must permanently discontinue treatment with niraparib. 
Table 2: 
Dose Reductions for Nonhematologic Toxicities  
Event 
Dosea 
Initial dose 
300 mg QD 
1st dose reduction for CTCAE Grade 3 or 4 treatment-related SAE/AE where prophylaxis 
is not considered feasible; or any grade toxicity considered intolerable by the patient 
200 mg QD 
2nd dose reduction for CTCAE Grade 3 or 4 treatment-related SAE/AE where prophylaxis 
is not considered feasible; or any grade toxicity considered intolerable by the patient 
100 mg QD 
Continued CTCAE Grade 3 or 4 treatment-related SAE/AE ≥ 28 days 
Discontinue study 
treatment 


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Abbreviations: AE = adverse event, CTCAE = Common Terminology Criteria for Adverse Events, QD = once daily, 
SAE = serious adverse event. 
a Dose not to be decreased below 100 mg QD. 
The dose interruption/modification criteria for hematologic parameters will be based on blood 
counts and are outlined in Table 3. 
If the hematologic toxicity has not recovered to the specified levels within 4 weeks (28 days) of 
the dose interruption period, and/or the patient has already undergone a maximum of 2 dose 
reductions (to a minimum dose of 100 mg QD), the patient must permanently discontinue 
treatment with niraparib. 
In the case of thrombocytopenia, following the first occurrence, resumption of therapy may 
occur at the same dose or 1 dose level lower when the platelet count has resolved to 
≥100,000/µL. Subsequent occurrences should trigger dose reduction upon resumption of therapy. 
If the platelet count has not reverted within 28 days of interruption to ≥ 100,000/µL on first or 
subsequent occurrence, the patient should be discontinued. 
If dose interruption or modification is required at any point on study because of hematologic 
toxicity, weekly blood draws for complete blood count (CBC) will be monitored until the AE 
resolves, and to ensure safety of the new dose, weekly blood draws for CBC will be also required 
for an additional 4 weeks after the AE has been resolved to the specified levels, after which 
monitoring every 4 weeks may resume. 
Any patient requiring transfusion of platelets or red blood cells (1 or more units) or 
hematopoietic growth factor support must undergo a dose reduction upon recovery if study 
treatment is resumed. 
It is strongly recommended that the patient be referred to a hematologist for further evaluation 
(1) if transfusions are required on more than 1 occasion or (2) if the treatment-related 
hematologic toxicities have not recovered to CTCAE Grade 1 or less after 4 weeks. If a 
diagnosis of MDS/AML is confirmed by a hematologist, the patient must permanently 
discontinue study treatment. 
Table 3: 
Dose Modification/Reduction for Hematologic Toxicities 
Platelet count 75,000-99,999/µLa 
Study treatment must be interrupted until platelet counts are 
≥ 100,000/µL, with weekly blood counts for CBC 
monitored until recovery. Study treatment may then be 
resumed at same dose or reduced dose based on clinical 
judgment. 
2nd occurrence of platelet count 75,000-99,999/µLa 
Study treatment must be interrupted until platelet counts are 
≥ 100,000/µL, with weekly blood counts for CBC 
monitored until recovery. Study treatment may then be 
resumed at a reduced dose. 
Platelet count < 75,000/µLa b 
Study treatment must be interrupted until platelet counts are 
≥ 100,000/µL, with weekly blood counts for CBC 
monitored until recovery. Study treatment may then be 
resumed at a reduced dose. 


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Table 3: 
Dose Modification/Reduction for Hematologic Toxicities (Continued) 
Neutrophil < 1,000/µL 
Study treatment must be interrupted until neutrophil counts 
are ≥ 1,500/µL, with weekly blood counts for CBC 
monitored until recovery. Study treatment may then be 
resumed at a reduced dose. 
Hemoglobin ≤ 8 g/dL 
Study treatment must be interrupted until hemoglobin is ≥ 9 
g/dL, with weekly blood counts for CBC monitored until 
recovery. Study treatment may then be resumed at a 
reduced dose. 
Abbreviations: CBC = complete blood count 
a If the platelet count has not reverted within 28 days of interruption to ≥ 100,000/µL on first or subsequent 
occurrence, the patient should be discontinued. 
b For patients with platelet count ≤ 10,000/μL, prophylactic platelet transfusion per guidelines may be 
considered17,18 For patients taking anticoagulation or antiplatelet drugs, consider the risk/benefit of interrupting 
these drugs and/or prophylactic transfusion at an alternate threshold, such as ≤ 20,000/μL. 
For major surgery while on treatment, up to 28 days of study treatment interruption is allowed.  
Once the dose of study treatment has been reduced, any re-escalation must be discussed with the 
medical monitor. 
All dose interruptions and reductions (including any missed doses), and the reasons for the 
reductions/interruptions, are to be recorded in the electronic case report form (eCRF). 
5.4. 
Packaging, Labeling, and Storage 
Niraparib will be packed in high-density polyethylene bottles with child-resistant closures. 
The label text of the study treatment will comply with Good Manufacturing Practice and national 
legislation to meet the requirements of the participating countries. The study treatment will be 
open-label and non-patient-specific. 
All study treatment supplies must be stored in accordance with the Pharmacy Manual 
instructions and package labeling. Until dispensed to the patients, the study treatment will be 
stored in a securely locked area, accessible to authorized personnel only. 
5.5. 
Study Treatment Accountability 
The Investigator or designee is responsible for maintaining accurate dispensing records of the 
study treatment throughout the clinical study. The study treatment accountability log includes 
information including the enrollment number, amount and date dispensed, and amount and date 
returned to the pharmacy, if applicable. Product returned to the pharmacy will be stored under 
the same conditions as products not yet dispensed but will be marked as 'returned' and kept 
separate from the products not yet dispensed. 
All dispensing and accountability records will be available for Sponsor review. The study 
monitor will assume the responsibility to reconcile the study treatment accountability log. The 
pharmacist will dispense study treatment for each patient according to the protocol and 
Pharmacy Manual, if applicable. 


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5.6. 
Previous and Concomitant Medications 
Any medication the patient takes other than the study treatment, 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: trade name or generic name if trade name is not available, route of 
administration, start date, stop date, frequency, dosage, and indication. Any changes in the 
dosage or regimen of a concomitant medication must be recorded in the eCRF. 
At screening, 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.  
Niraparib has been associated with QT prolongation when co-administered with medications 
known to cause QTc prolongation. Therefore, Investigator should be advised to use caution with 
drugs listed in Appendix D. Additionally, niraparib has potential to induce cytochrome P450 
(CYP)1A2 and is a substrate for P-glycoprotein (P-gp); therefore, Investigator should be advised 
to use caution with drugs metabolized by CYP1A2 (see Appendix A) or drugs that are inhibitors 
or substrates of P-gp. The niraparib safety profile includes risk for thrombocytopenia; therefore, 
Investigator should be advised to use caution with anticoagulation and antiplatelet drugs. 
5.6.1. 
Prohibited Medications and Other Study Restrictions 
An increased risk of infection by the administration of live virus and bacterial vaccines has been 
observed with conventional chemotherapy drugs. Effects with niraparib are unknown; therefore, 
live virus and bacterial vaccines should not be administered to patients 4 weeks before or during 
the study (defined by the time of first dose). 
No other anticancer therapy is permitted during the course of the study treatment for any patient. 
Temporary steroid use will be permitted for treatment of AEs or for prophylaxis. Of note, topical 
steroids are permitted without limitation. The patient can receive a stable dose of corticosteroids 
during the study as long as these were started at least 4 weeks prior to enrollment, per exclusion 
criteria above. If the patient discontinues study treatment, this restriction no longer applies, 
however the patient will remain enrolled in the study for the purpose of collecting subsequent 
outcomes. Palliative radiotherapy (excluding the pelvic region and/or palliative radiotherapy 
encompassing >20% of the bone marrow within 1 week of the first dose of study treatment) is 
allowed for pre-existing small areas of painful metastases that cannot be managed with local or 
systemic analgesics as long as no evidence of disease progression is present. 
Prophylactic cytokine (granulocyte colony-stimulating factor) should not be administered in the 
first cycle of the study but may be administered in subsequent cycles according to local 
guidelines. 
Patients who are blood donors should not donate blood during the study and for 90 days after the 
last dose of study treatment. 


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6. 
VARIABLES AND METHODS OF ASSESSMENT 
6.1. 
Efficacy Variables 
6.1.1. 
Primary Efficacy: Objective Response Rate 
The ORR is defined as the proportion of patients achieving complete response (CR) or partial 
response (PR) as assessed by the Investigator per RECIST (v.1.1) (Appendix B).  
6.1.2. 
Secondary Efficacy 
6.1.2.1. 
Duration of Response 
Duration of response is defined as the time from first documentation of CR or PR until the time 
of first documentation of disease progression (PD) as assessed by the Investigator per RECIST 
(v.1.1) or clinical criteria (Appendix B).  
Because of the pelvic location of the primary tumor and the frequent occurrence of peritoneal 
disease, imaging may not always be reliable for documentation of PD. Criteria other than 
RECIST may be applicable to define PD; thus, PD may also be determined if at least 1 of the 
following criteria is met: 
1. Additional diagnostic tests (eg, histology/cytology, ultrasound techniques, endoscopy, 
positron emission tomography) identify new lesions or determine existing lesions qualify 
for unequivocal PD AND CA-125 progression according to Gynecologic Cancer 
Intergroup criteria 
2. Definitive clinical signs and symptoms of PD unrelated to nonmalignant or iatrogenic 
causes ([a] intractable cancer-related pain; [b] malignant bowel obstruction/worsening 
dysfunction; or [c] unequivocal symptomatic worsening of ascites or pleural effusion) 
AND CA-125 progression according to Gynecologic Cancer Intergroup criteria. 
Abnormal CA-125 levels on-study do not represent disease progression; however, they may 
prompt imaging if clinically indicated. PD will not be diagnosed in case of CA-125 progression 
in the absence of at least 1 of the criteria defined above.  
The Investigator will describe why PD was diagnosed in the eCRF. 
The date of PD is defined as the earliest time point when one of the PD criteria is met. If 
CT/MRI shows existing (baseline) lesions that only equivocally suggest PD and additional 
diagnostic tests are required to determine unequivocal PD, the official date of PD will be the date 
PD was unequivocally determined. Alternatively, with new lesions (except ascites and effusions) 
that are initially equivocal that are later unequivocally determined, the date of progression will 
be the date the lesion was initially identified.  
6.1.2.2. 
Disease Control Rate 
Disease control rate is defined as the proportion of patients achieving CR, PR, or stable disease 
(SD) as assessed by the Investigator per RECIST (v.1.1) (Appendix B). 


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6.1.2.3. 
Progression-Free Survival 
Progression-free survival is defined as the time from the date of first dose to the earlier date of 
assessment of progression or death by any cause in the absence of progression as assessed by the 
Investigator per RECIST (v.1.1) or clinical criteria (Appendix B). PFS evaluation will be 
performed as described by the SAP.  
6.1.2.4. 
Overall Survival 
OS is defined as the time from the date of the first dose to the date of death by any cause. 
Following the treatment discontinuation visit, survival status will be collected for all patients 
using acceptable means including telephone contact. New malignancy information will also be 
collected as part of this assessment. 
As part of OS assessment, information will be collected on subsequent anticancer therapies 
following study treatment. Using source documentation (including clinic notes), the following 
information will be collected: 
 Name (and/or class) 
 Start date 
 Dose-limiting toxicities 
 Best response (CR, PR, SD, PD) 
 Progression date 
6.1.2.5. 
Time to First Subsequent Therapy (TFST) 
Time to first subsequent therapy (TFST) is defined as the time from the date of first dose to the 
date of first subsequent therapy or death, whichever occurs first. Using source documentation 
(including clinic notes) the same information will be collected as described in Overall Survival 
(Section 6.1.2.4).  
6.2. 
Safety Variables 
Safety parameters evaluated during the conduct of the study include: treatment-emergent AEs 
(TEAEs), clinical laboratory (hematology and chemistry), vital signs, physical examination, and 
use of concomitant medications. 
6.2.1. 
Definitions 
Adverse event:  An adverse event is any untoward medical occurrence that occurs in a patient or 
clinical investigation subject administered a pharmaceutical 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 clinically significant abnormal laboratory findings), 
symptom, or disease temporally associated with the use of an investigational product, whether or 
not considered related to the product. 
Adverse events 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, including 
baseline or washout periods, even if no study treatment has been administered.  


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A treatment-emergent adverse event will be defined as any new AE that begins, or any 
preexisting condition that worsens in severity, after at least 1 dose of study treatment has been 
administered. 
Serious adverse event:  A serious adverse event is defined as any untoward medical occurrence 
that, at any dose: 
 Results in death 
 Is life-threatening 
 Note: This means that the patient is at immediate risk of death at the time of the 
event; it does not mean that the event hypothetically might have caused death if it 
were more severe 
 Requires inpatient hospitalization or prolongation of existing hospitalization 
 Any AE that prolongs hospitalization will be considered an SAE. 
 Exception:  Planned hospitalization (eg, for observation, protocol compliance, 
elective procedures, social reasons, disease progression, etc.) will not be 
considered an SAE; however, the reason for the planned hospitalization should be 
captured in medical history. 
 Results in persistent or significant disability or incapacity 
 Is a congenital anomaly or birth defect 
 Is an important medical event(s) 
 An important medical event may not be immediately life-threatening or result in 
death or hospitalization but may jeopardize the patient or require intervention to 
prevent one of the above outcomes. Examples of such events are intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias or convulsions that do not result in hospitalization, or development of 
drug dependency or drug abuse. 
6.2.2. 
Assessment of Adverse Events 
Each AE will be assessed by the Investigator with regard to the following categories. 
6.2.2.1. 
Intensity 
Investigators should assess the severity of AEs according to CTCAE. In general, CTCAE 
(v.4.03) severity grades are: 
Grade 1:  
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated 
Grade 2: 
Moderate; minimal, local or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living (ADL). (Instrumental ADL refer 
to preparing meals, shopping for groceries or clothes, using the telephone, 
managing money, etc.) 


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Grade 3: 
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting 
self-care ADL. (Self-care ADL refer to bathing, dressing and undressing, feeding 
self, using the toilet, taking medications, and not bedridden.) 
Grade 4: 
Life-threatening consequences; urgent intervention indicated 
Grade 5: 
Death related to AE 
A distinction should be made between serious and severe AEs. Severity is a measure of intensity 
whereas seriousness is defined by the criteria above in Section 6.2.1. 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. Similarly, an AE that is severe in intensity is 
not necessarily an SAE. For example, alopecia may be assessed as severe in intensity but may 
not be considered an SAE. 
6.2.2.2. 
Causality 
The Investigator will assess the causality/relationship between the study treatment and the AE. 
One of the following categories should be selected based on medical judgment, considering the 
definitions and all contributing factors: 
 Related: A clinical event, including laboratory test abnormality, occurs in a plausible 
time relationship to treatment administration, and which concurrent disease or other 
drugs or chemicals cannot explain. The response to withdrawal of the treatment should 
be clinically plausible. 
 Likely related: A clinical event, including laboratory test abnormality, with a 
reasonable time sequence to administration of the treatment, unlikely to be attributed to 
concurrent disease or other drugs or chemicals 
 Unlikely to be related: A clinical event, including laboratory test abnormality, with a 
temporal relationship to treatment administration which makes a causal relationship 
improbable, or in which other drugs, chemicals or underlying disease provide likely 
explanations 
 Unrelated: A clinical event, including laboratory test abnormality, with little 
or no temporal relationship with treatment administration. Typically explained 
by extraneous factors (eg, concomitant disease, environmental factors, or 
other drugs or chemicals). 
6.2.3. 
Collecting and Recording Adverse Events 
All AEs, regardless of the source of identification (eg, physical examination, laboratory 
assessment, ECG, reported by patient), must be documented in the eCRF. 
All AEs and SAEs will be collected and recorded in the eCRF for each patient from the day of 
signing the screening ICF until the EOT visit (see Table 4 for schedule of events). New SAEs 
(including deaths) will be collected for an additional 30 days after the last dose of study 
treatment. All AEs and SAEs experienced by a patient, irrespective of the suspected causality, 
will be monitored until the AE or SAE has resolved, any abnormal laboratory values have 


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returned to baseline or normal levels, until there is a satisfactory explanation for the changes 
observed, until the patient is lost to follow-up, or until the patient has died. 
If an Investigator becomes aware of an SAE after the 30-day follow-up period post treatment 
discontinuation and considers the SAE related to investigational product, the Investigator should 
report the SAE to the Sponsor according to timelines for reporting SAEs described in this 
section. 
Adverse events may be volunteered spontaneously by the study patient, or discovered by the 
study staff during physical examinations or by asking an open, non-leading question such as: 
“How have you been feeling since you were last asked?”  The Investigator will document the 
nature of the 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 treatment as a result of the AE, 
assessment of the seriousness of the AE, and assessment of the causal relationship of the AE to 
study treatment and/or study procedure. 
All AEs should be recorded individually in the patient’s own words (verbatim) unless, in the 
opinion of the Investigator, the AEs constitute components of a recognized condition, disease, or 
syndrome. In the latter case, the condition, disease, or syndrome should be named rather than 
each individual symptom. 
Concomitant illnesses that existed before entry into the study will not be considered an AE 
unless the illness worsens during the treatment period. Pre-existing conditions will be recorded in 
the eCRF on the Medical History or appropriate page as well as on the SAE Report Form 
medical history section. 
6.2.4. 
Reporting Disease Progression 
The event of disease progression is an efficacy criterion and is therefore not considered an AE. If 
AEs/SAEs occur in relation to disease progression, the AEs/SAEs must be reported per AE/SAE 
reporting requirements described in Section 6.2.3 and Section 6.2.5. 
6.2.5. 
Reporting Serious Adverse Events 
The Investigator must report all SAEs within 24 hours of becoming aware of the initial SAE or 
any follow-up information regarding the SAE. 
For all SAEs, an SAE report form must be completed by the Investigator for all initial and 
follow-up SAEs. A follow-up SAE report must be completed each time an Investigator becomes 
aware of any additional information regarding the SAE. For the follow-up SAE Report Form, the 
following fields must be completed on each form:  follow-up number, site number, 
patient/subject number, protocol number, and the SAE term(s) and date of awareness. Only the 
appropriate field(s) on the SAE Report Form where the Investigator received additional or 
updated information should be completed. Previously provided information does not have to be 
entered on the follow-up SAE Report Form. 
Initial and follow-up SAE reports and any additional supporting documentation (eg, hospital 
reports, consultant reports, death certificates, autopsy reports, etc) included with the SAE report 
should be sent to the Sponsor (or designee) within 24 hours of the Investigator/site awareness or 
receipt. If supporting documentation is provided, the Investigator should highlight all relevant 
and pertinent information. Also, any additional SAE documentation must be a clear photocopy 


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with the patient’s personal identifiers removed. The Investigator must sign and date all SAE 
forms. 
The minimum information required for an initial SAE report is as follows: 
 Name of person sending the report (ie, name, address of Investigator) 
 Patient identification (screening number, initials [if permitted by local data 
privacy regulations], NOT patient name) 
 Protocol number 
 Description of SAE 
 Causality assessment 
After receipt of the initial report, the Sponsor (or designee) will review the information and, if 
necessary, contact the Investigator to obtain further information. 
SAE REPORTING CONTACT INFORMATION 
Email: 
 
Fax: 
 
6.2.5.1. 
Submission and Distribution of Adverse Events/Serious Adverse Events 
Per regulatory requirements, if an SAE is required to be submitted to a Regulatory Authority a 
copy of this report (CIOMS or MedWatch 3500A) will be distributed to the Investigators/site. 
The Investigator/site will submit a copy the report to their respective institutional review board 
(IRB) or independent ethics committee (IEC) per local requirements. 
6.2.5.2. 
Pregnancy 
Pregnancies occurring in patients/subjects enrolled in a study must be reported and followed to 
outcome. 
Pregnancy alone is not regarded as an AE unless there is a possibility that the study treatment 
may have interfered with the effectiveness of a contraceptive medication. Elective abortions 
without complications should not be considered AEs unless they were therapeutic abortions. 
Hospitalization for normal delivery of a healthy newborn should not be considered an SAE. 
Pregnancy is not considered an SAE unless there is an associated serious outcome. Spontaneous 
abortions should always be reported as SAEs. 
Any SAE that occurs during pregnancy must be recorded on the SAE Report Form (eg, maternal 
serious complications, therapeutic abortion, ectopic pregnancy, stillbirth, neonatal death, 
congenital anomaly, birth defect) and reported within 24 hours in accordance with the procedure 
for reporting SAEs. 
The Investigator should complete the Initial Pregnancy Notification report form and forward it to 
the Sponsor (or designee) within 24 hours of knowledge of the pregnancy. If there is an 
associated serious outcome, then both the Initial Pregnancy Notification report form and SAE 
report form should be completed. 
PPD
PPD


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The Investigator should follow-up with the patient/subject until delivery or termination of 
pregnancy even if the patient was withdrawn from the clinical study or if the clinical study has 
finished. At that time, the Pregnancy Outcome report form should be completed and submitted to 
the Sponsor within 24 hours after the Investigator becomes aware of the pregnancy outcome. 
In the event the pregnancy outcome occurs following the end of the study and database lock, the 
Investigator will report the pregnancy outcome to the Sponsor (or designee) within 24 hours after 
the outcome of the pregnancy is known to the Investigator in accordance with the procedure for 
reporting SAEs (see Section 6.2.5). 
6.2.5.3. 
Adverse Events of Special Interest 
MDS, AML, secondary cancers (new malignancies other than MDS/AML), pneumonitis, and 
embryo-fetal toxicity are Adverse of Special Interest (AESIs). AESIs must be reported to the 
Sponsor and recorded as such on the eCRF and on an SAE form; the SAE form must be 
submitted within 24 hours of the Investigator becoming aware as noted for SAEs in 
Section 6.2.5.  AESI monitoring must occur during the study, during long-term follow-up and 
after study discontinuation. 
6.2.6. 
Clinical Laboratory Assessment 
The following laboratory variables will be determined in accordance with Table 4 (schedule of 
events): 
 Complete blood count: 
 Hemoglobin 
 Platelets 
 Mean platelet volume (optional*) 
 Mean corpuscular volume 
 White blood cell count 
 Differential white cell count 
 Serum chemistry assessments for safety include: 
 Sodium 
 Potassium 
 Calcium 
 Magnesium 
 Chloride 
 Glucose 
 Creatinine 
 Total bilirubin 
 Gamma glutamyltransferase 


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 Alkaline phosphatase 
 Aspartate aminotransferase 
 Alanine aminotransferase 
 Urea or blood urea nitrogen 
 Total protein 
 Albumin 
 Lactate dehydrogenase 
 Amylase 
 Serum CA-125 
 Serum pregnancy testing  
These tests will be performed by the local laboratory at the clinical site. 
Any laboratory values assessed as clinically significant should be recorded as an AE or SAE. If 
SAE criteria are met, the SAE should be recorded and reported according to the SAE reporting 
process (see Section 6.2.5). 
Hematological testing may occur more frequently than is specified in Table 4 when additional 
testing is medically indicated per Investigator judgment. Additional tests may be performed at a 
laboratory facility other than the study site, but test results must be reported to the study site, the 
study site must keep a copy of test results with the patient’s study file, and the results must be 
entered into the electronic data capture system. 
For any suspected case of MDS/AML or second primary malignancies other than 
MDS/AMLreported while a patient is receiving treatment or being followed for post-treatment 
assessments, bone marrow aspirate and biopsy testing must be completed by a local 
hematologist. Testing completed as part of standard of care is sufficient as long as the methods 
are acceptable to the Sponsor's Medical Monitor. The study site must receive a copy of the 
hematologist’s report of aspirate/biopsy findings, which must include a classification according 
to World Health Organization (WHO) criteria,19 and other sample testing reports related to 
MDS/AML or secondary cancer (new malignancies other than MDS/AML). Report data will be 
entered into EDC on the appropriate eCRF pages and the site must keep a copy of all reports 
with the patient’s study file. 
* Note:  Although mean platelet volume collection is optional, it is highly encouraged, especially 
for patients with high-grade thrombocytopenia. 
6.2.7. 
Physical Examination and Vital Signs 
Physical examinations, including height (screening only), weight, and vital signs (blood pressure 
[BP], pulse, and temperature), will be performed in accordance with the schedule of events 
(Table 4). 
Any physical examination or vital sign findings assessed as clinically significant should be 
recorded as an AE or SAE. If SAE criteria are met, the SAE should be recorded and reported 
according to the SAE reporting process (see Section 6.2.5). 


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6.2.8. 
Eastern Cooperative Oncology Group Performance Status 
Performance status will be assessed using the ECOG scale (see Appendix C) in accordance with 
the schedule of events (Table 4). The same observer should assess performance status each time. 
6.2.9. 
Additional Safety Assessments 
All patients will undergo a single ECG assessment at the screening visit (Table 4). The ECG 
assessment should be performed prior to any blood draws for PK or other laboratory evaluations. 
Patients will be supine and rested for approximately 2 minutes before ECGs are recorded. ECGs 
may be archived for future central evaluation if needed. 
A subset of approximately 12 patients will undergo intensive, triplicate ECG monitoring to 
coincide with PK evaluation on Cycle1/Day 1 (see Section 6.4 for time points). This subset of 
patients will undergo all other assessments in the study. 
Any ECG findings assessed as clinically significant should be recorded as an AE or SAE. If SAE 
criteria are met, the SAE should be recorded and reported according to the SAE reporting 
process (see Section 6.2.5). 
6.3. 
Demographics and Baseline Characteristics 
Demographics and baseline characteristics consist of those variables that are assessed at 
screening/baseline. 
6.3.1. 
Patient Eligibility 
Compliance with inclusion and exclusion criteria will be assessed as outlined in Section 4.1 and 
Section 4.2. 
6.3.2. 
Patient Demography 
Patient demography consists of: 
 Age at screening 
 Race 
 Ethnicity 
 Sex 
6.3.3. 
Disease History 
For disease history, the following will be documented: 
 Date of first diagnosis 
 Tumor type 
 Stage at time of initial diagnosis 
 Histology and grade of disease at diagnosis and most recent biopsy if additional biopsy 
performed 
 Date of start of first treatment 


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 Agents in first treatment 
 Date of last dose of first treatment 
 Dates of start of all subsequent treatments 
 Agents in all subsequent treatments 
 Dates of last dose of all subsequent treatments 
 Best response and toxicities (including hematologic events) for each prior treatment 
 Date of recurrence for each treatment 
 ECOG performance status 
 Collection of hematologic events during prior therapy 
6.3.4. 
Medical and Surgical History 
Major medical and surgical history (including medication history), including history of prior 
thrombocytopenia, neutropenia, leukopenia, or anemia within 1 year prior to signing the main 
study ICF, will be collected. Details of any prior invasive malignancy will be collected. Medical 
and surgical history will be obtained by interviewing the patient or by reviewing his/her medical 
records. 
6.3.5. 
Previous and Concomitant Medications 
Previous and concomitant medication will be documented as described in Section 5.6. 
Medications will be coded using World Health Organization Anatomical Therapeutic Chemical 
classification. 
6.4. 
Pharmacokinetics 
Plasma samples for population PK assessment will be analyzed for concentrations of niraparib 
and its major metabolite. A population PK modeling approach will be used to describe plasma 
concentrations of niraparib and its major metabolite in patients. In the analysis, a number of 
covariates will be evaluated to determine if they contribute to differences in the PK estimates 
among individuals. Parameters of interest include area under the curve (AUC), minimum 
observed plasma concentration (Cmin), maximum observed plasma concentration (Cmax), and/or 
AUC at steady-state (AUCss), Cmin,ss, Cmax,ss, and, if the data allow, oral clearance (CL/F) and 
oral volume of distribution (Vz/F). 
In addition, the PK/pharmacodynamic relationship between concentrations of niraparib and its 
major metabolite and efficacy and safety measures will be investigated. The exposure to 
niraparib and its major metabolite will be correlated with safety (selected AEs) and efficacy 
variables. 
For all patients, blood samples for measurements of plasma levels of niraparib will be obtained 
on Cycle 1/Day 1 predose (within 30 minutes) and 2 hours postdose (±15 minutes), Cycle 2/Day 
1 predose (within 30 minutes) and 2 hours postdose (±15 minutes), Cycle 4/Day 1 predose 
(within 30 minutes), and Cycle 8/Day 1 predose (within 30 minutes). If niraparib is not 


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administered, collection of predose blood sample is required, however postdose sample 
collection is not required. 
At selected sites, a subset of approximately 12 patients will undergo intensive, triplicate ECG 
monitoring to coincide with PK evaluation on Cycle1/Day 1. These patients will have triplicate 
ECGs taken prior to the PK blood draw predose and at 1, 2, 4, 6, and 8 hours postdose. 
The time of last dose prior to PK blood draw should be recorded. 
Complete instructions for collection, processing, shipping, and handling of samples are detailed 
in the Laboratory Manual. 
6.5. 
Blood and Tissue Samples 
Blood samples will be collected for all patients during screening for determination of gBRCAmut 
status. 
Blood samples will be collected for all patients during screening for the exploratory evaluation of 
circulating markers. 
Tumor samples, archival and/or fresh biopsy, for all patients will be collected prior to study 
treatment initiation for the evaluation of tumor markers of niraparib sensitivity or resistance, 
such as those related to DNA repair deficiency, including centralized HRD and tBRCAmut status 
testing. Centralized HRD testing must be completed prior to enrollment. If historic blood 
gBRCAmut is detected by a central gBRCAmut testing as part of screening, then tumor HRD 
sample test results are not required prior to enrollment, however the test should be performed for 
all enrolled patients. Sites are encouraged to send tumor samples for HRD testing as soon as a 
patient is considered for enrollment in this study. 
Details on blood and tissue sample collection can be found in the Laboratory Manual. 
DNA from the blood and tumor samples will be stored and may be used at a later time for 
biomarker testing including potential to bridging to candidate companion diagnostic assays. 
The testing of markers related to tumor immunology may be conducted from tissue or blood. 


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7. 
STUDY CONDUCT 
7.1. 
Schedule of Procedures 
A schedule of events is provided in Table 4. 


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Table 4: 
Schedule of Events 
Cyclea 
Screeningb 
-28 to -1 
1 
Subsequent 
Cyclesa 
Cycle n, Day 
1 
EOT 
(within 7 
days of last 
dose) 
Post-
Treatment 
Assessments 
Day 
1 
8 
15 
22 
Informed consentb c  
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Medical, surgical, cancer, and medication history 
X 
 
 
 
 
 
 
 
Sample collection (tumor) for centralized 
tBRCAmut/HRD testingc 
Xc 
 
 
 
 
 
 
 
Sample collection (whole blood) for gBRCAmut 
testing 
X 
 
 
 
 
 
 
 
Tumor sample (optional)d  
X 
 
 
 
 
 
X 
 
Blood sample for exploratory biomarker analysese  
X 
 
 
 
 
 
 
 
Blood sample for PKf 
 
X 
 
 
 
X 
 
 
Tumor assessment (RECIST)g 
X 
 
 
 
 
Xg 
X 
Xg 
Chest CT/MRIh 
X 
 
 
 
 
 
 
 
Pregnancy testi 
X 
 
 
 
 
X 
 
 
Serum chemistry 
X 
Xj 
 
X 
 
X 
X 
 
CBCk  
X 
Xj 
Xl 
X 
Xl 
X 
X 
 
Serum CA-125j 
X 
Xg 
 
 
 
Xg 
X 
X 
ECGm 
Xm 
 
 
 
 
 
 
 
Physical examination 
X 
 
 
 
 
 
 
 
Symptom-directed physical examination 
 
X 
 
X 
 
Xn 
X 
 
Vital signs, height, weighto 
X 
X 
 
X 
 
X 
X 
 


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Cyclea 
Screeningb 
-28 to -1 
1 
Subsequent 
Cyclesa 
Cycle n, Day 
1 
EOT 
(within 7 
days of last 
dose) 
Post-
Treatment 
Assessments 
Day 
1 
8 
15 
22 
ECOG performance status 
X 
 
 
 
 
Xn 
X 
 
Bone marrow aspirate and biopsy p  
 
Xp 
Concomitant medications 
X 
X 
 
X 
 
X 
X 
 
Adverse event monitoring 
X 
X 
 
X 
 
X 
Xq 
X 
Study treatment dispensed/collected 
 
X 
 
 
 
X 
X 
 
Survival assessmentr 
 
 
 
 
 
 
 
X 
Abbreviations: CBC = complete blood count; CT = computed tomography; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EOT = 
end of treatment; gBRCAmut = germline breast cancer gene mutation; tBRCAmut = tumor breast cancer mutation; HRD = homologous recombination deficiency; 
MRI = magnetic resonance imaging; PK = pharmacokinetics; RECIST = Response Evaluation Criteria in Solid Tumors. 
a Treatment cycles are 28 days long, with visits on Day 1 of each cycle unless otherwise specified. Visits (other than Cycle 1) continue every 28 days until study 
treatment discontinuation. All visits have a window of ± 3 days (calculated in reference to Cycle 1/Day 1). 
b Screening tests that could be considered standard of care (ie, CT/MRI, physical examination, vital signs, height, weight, and assessment of serum chemistry, 
CBC, pregnancy testing, and serum CA-125) that were performed within the protocol-required timelines (ie, within the 28-day screening window; within 72 
hours prior to first dose [ie, Cycle 1/Day 1] where required) but prior to informed consent being obtained may be used as part of the patient’s screening 
assessment. 
c For patients who do not have archival tissue, tissue from a fresh biopsy must be obtained prior to study treatment initiation. Centralized HRD testing of tumor 
sample must be completed with results reported prior to enrollment. The sample may be sent in advance of the protocol-defined screening period in order to 
facilitate the screening and enrollment process. A separate ICF may be signed prior to the screening period for HRD testing in order to facilitate early testing. 
Depending on local site requirements, patients may sign a screening study ICF prior to the screening period to facilitate early HRD testing only. All other study 
tests and procedures must be done in the screening window (Day -28 to Day -1). For patients who do not have archival tissue, tissue from a fresh biopsy must 
be obtained.   
d Formalin-fixed, paraffin-embedded tumor sample consisting of a total of 100-micron thickness of sections (≥ 80-micron minimum) or unsectioned paraffin 
block. 
e Blood samples will be collected for all patients during screening for the exploratory evaluation of circulating biomarkers. The sponsor may discontinue the 
blood collection when samples have been collected from an adequate number of patients.  
f Blood samples for PK may be collected on Cycle 1/Day 1 predose (within 30 minutes) and 2 hours (± 15 minutes) postdose, on Cycle 2/ Day 1 predose (within 
30 minutes) and 2 hours (± 15 minutes) postdose, on Cycle 4/Day 1 predose (within 30 minutes), and on Cycle 8/Day 1 predose (within 30 minutes). At 
selected sites, a subset of patients (approximately 12) will undergo triplicate ECG monitoring to coincide with PK evaluation on Cycle 1/Day 1 predose and at 
1, 2, 4, 6, and 8 hours postdose. Note:  The exact time of the PK blood draw will be recorded, and ECG monitoring is to be completed prior to the PK blood 
draw or other laboratory evaluations. 


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g RECIST tumor assessment via CT or MRI of abdomen/pelvis and clinically indicated areas required at screening, every 8 weeks (± 7 days) from Cycle 1/Day 1 
(ie, Cycle 3, Cycle 5, Cycle 7) for 6 months, and then every 12 weeks (ie, Cycle 10, Cycle 13, Cycle 16, etc.) until progression.Positron emission 
tomography/CT may be used according to RECIST guidelines. Cycle timing will not be delayed for treatment interruptions, and tumor assessment should occur 
according to this schedule regardless of whether study treatment is interrupted. If a patient discontinues treatment for a reason other than disease progression as 
defined in the protocol or death, withdrawal of consent, or loss to follow-up, then scans and CA-125 testing should continue at the specified intervals (until the 
start of subsequent anticancer treatment). If a patient had a CT/MRI of the abdomen/pelvis and clinically indicated areas within the 28-day screening window 
before Cycle 1/Day 1 but prior to signing the main ICF, the patient is not required to complete an additional CT/MRI scan for study screening. CT/MRI scans 
completed during screening prior to signing the main ICF must have been performed and be able to be submitted per the image acquisition guidelines. 
h Chest CT/MRI if not done as part of RECIST tumor assessment at screening. If the chest CT/MRI is clear at screening, repeat chest imaging is not required in 
the absence of lesions to be followed or in the absence of clinical indication requiring follow‐up. 
i Negative serum pregnancy test required within 72 hours prior to first dose of study treatment (ie, Cycle 1/Day 1) for females of childbearing potential; repeated 
every 3 months for duration of study treatment (ie, Cycle 4, Cycle 7, etc). 
j If screening laboratory testing (serum chemistry, CBC, CA-125) performed within 72 hours of Day 1, repeat testing is not required. 
k If dose interruption or modification is required at any point on study because of hematologic toxicity, weekly blood draws for CBC will be monitored until the 
AE resolves, and to ensure safety of the new dose, weekly blood draws for CBC will be also required for an additional 4 weeks after the AE has been resolved 
to the specified levels, after which monitoring every 4 weeks may resume. 
l Collection of blood for the Cycle 1/Day 8 and Day 22 CBC may be done at the study center’s local laboratory or at a laboratory local to the patient, if approved 
by the Principal Investigator as an adequate laboratory. The laboratory must have the capability to provide results to the Principal Investigator electronically or 
by fax within 24 hours of blood collection. 
m Patients will undergo a single ECG monitoring assessment at screening, prior to laboratory evaluations. At selected sites, a subset of patients (approximately 
12) will undergo triplicate ECG monitoring to coincide with PK evaluation on Cycle 1/Day 1 predose and at 1, 2, 4, 6, and 8 hours postdose. Triplicate ECGs 
should be performed between 2 and 5 minutes apart and should be performed prior to blood draws for PK or other laboratory evaluations.  
n Symptom-directed physical examination is to be conducted at every visit and ECOG assessed every 12 weeks (± 7 days) until EOT. 
o Vital signs include BP, pulse, and temperature. Height obtained at screening only. 
p For any suspected case of MDS/AML or secondary cancer (new malignancies other than MDS/AML) reported while a patient is receiving treatment or being 
followed for post-treatment assessments, bone marrow aspirate and biopsy testing must be completed by a local hematologist. Testing completed as part of 
standard of care is sufficient as long as the methods are acceptable to the Sponsor's Medical Monitor. The study site must receive a copy of the hematologist's 
report of aspirate/biopsy findings (which must include a classification according to World Health Organization criteria19 and other sample testing results related 
to MDS/AML or secondary cancer (new malignancies other than MDS/AML).  
q New SAEs recorded up to 30 days after last dose of study treatment administration. 
r Every 90 (± 7) days after treatment discontinuation. In addition to survival, this assessment also includes outcomes for subsequent anticancer therapies 
including any new malignancy information. 
 


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7.2. 
Procedures by Visit 
Visits should occur within ± 3 days of the scheduled visit. All times should be recorded using the 
24-hour clock (eg, 23:20, not 11:20 PM). 
7.2.1. 
Screening (Visit 1, Day -28 to Day -1) 
At screening, the following procedures/tests will be performed: 
 Written informed consent 
 A main study ICF will be signed before any study procedures are performed. 
Patients may sign a separate HRD screening ICF prior to the screening period to 
facilitate early HRD testing only. 
 Note:  Screening tests that could be considered standard of care (ie, CT/MRI, 
physical examination, vital signs, height, weight, and assessment of serum 
pregnancy, serum chemistry, CBC, and serum CA-125) that were performed 
within the protocol-required timelines (ie, within the 28-day screening window; 
within 72 hours of first dose [ie, Cycle 1/Day 1] where required) but prior to 
informed consent being obtained may be used as part of the patient’s screening 
assessment. CT/MRI scans completed during screening prior to signing the main 
ICF must have been performed and be able to be submitted per the image 
acquisition guidelines. 
 Demographics 
 Archival or fresh tumor sample for centralized tumor BRCAmut/HRD testing 
 For patients who do not have archival tissue, tissue from a fresh biopsy must be 
obtained prior to study treatment initiation 
 Centralized HRD testing of tumor sample must be completed with results reported 
prior to enrollment. The sample may be sent after the screening ICF has been 
signed but in advance of the protocol-defined screening period in order to 
facilitate the screening and enrollment process. If historic blood gBRCAmut is 
detected by a central gBRCAmut testing as part of screening, then tumor HRD 
sample test results are not required prior to enrollment. 
 Medical/surgical/cancer/medication history, including history of prior 
thrombocytopenia, neutropenia, leukopenia, or anemia within 1 year prior to signing 
the main ICF 
 Fresh biopsy tumor sample (optional) 
 Blood sample for centralized gBRCAmut testing (whole blood) 
 Blood sample for exploratory biomarker analyses (whole blood) 
 Serum pregnancy test (within 72 hours prior to first dose [ie, Cycle 1/Day 1]) (for 
females of childbearing potential only) 
 Physical examination 


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 Vital signs (BP, pulse, and temperature) and weight 
 Height 
 ECOG performance status 
 CBC 
 Serum chemistry 
 Serum CA-125 
 Single ECG assessment (prior to any laboratory assessments) 
 RECIST (v.1.1) tumor assessment of the abdomen/pelvis and other areas (if clinically 
indicated) 
 Chest CT/MRI if not done as part of RECIST tumor assessment (if the chest CT/MRI is 
clear at screening, repeat chest imaging is not required in the absence of lesions to be 
followed or in the absence of clinical indication requiring follow‐up)  
 AE monitoring 
 Concomitant medications 
Except for HRD testing when a screening ICF has been signed by the patient, study tests and 
procedures must be done in the screening window (Day -28 to Day -1). 
7.2.2. 
Cycle 1, Day 1 
 Symptom-directed physical examination  
 Vital signs (BP, pulse, and temperature) and weight 
 CBC (repeat testing not required if Screening testing was done within 72 hours of Day 
1)  
 Serum chemistry (repeat testing not required if Screening testing was done within 72 
hours of Day 1) 
 Serum CA-125 
 Blood sample for PK determination predose (within 30 minutes) and 2 hours 
(± 15 minutes) postdose; the exact time of the blood draw is to be recorded 
 At selected sites, a subset of patients (approximately 12) will undergo triplicate ECG 
monitoring to coincide with PK evaluation predose and at 1, 2, 4, 6, and 8 hours 
postdose; triplicate ECGs should be performed between 2 and 5 minutes apart and 
should be performed prior to blood draws for PK or other laboratory evaluations 
 Study treatment capsules dispensed; first dose administered at the site 
 AE monitoring 
 Concomitant medications 


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7.2.3. 
Cycle 1, Day 8 
 CBC 
 Collection of blood for the Cycle 1/Day 8 CBC may be done at the study center’s 
local laboratory or at a laboratory local to the patient, if approved by the Principal 
Investigator as an adequate laboratory. The laboratory must have the capability to 
provide results to the Principal Investigator electronically or by fax within 24 
hours of blood collection. 
7.2.4. 
Cycle 1, Day 15 
 Symptom-directed physical examination 
 Vital signs (BP, pulse, and temperature) and weight 
 CBC 
 Serum chemistry 
 AE monitoring 
 Concomitant medications 
7.2.5. 
Cycle 1, Day 22 
 CBC 
 Collection of blood for the Cycle 1/Day 22 CBC may be done at the study 
center’s local laboratory or at a laboratory local to the patient, if approved by the 
Principal Investigator as an adequate laboratory. The laboratory must have the 
capability to provide results to the Principal Investigator electronically or by fax 
within 24 hours of blood collection. 
7.2.6. 
Day 1, Subsequent Cycles  
 Symptom-directed physical examination at every visit until EOT 
 Vital signs (BP, pulse, and temperature) and weight 
 ECOG performance status every 12 weeks (± 7 days) from Cycle 1/Day 1 (ie, Cycle 4, 
Cycle 7, Cycle 10, etc) until EOT 
 CBC 
 Serum chemistry 
 Serum CA-125 
 Serum pregnancy test at 3-month intervals from screening (Cycles 4, 7, etc) 
 Blood sample for PK determination on Cycle 2/Day 1 predose (within 30 minutes) and 
2 hours (± 15 minutes) postdose, on Cycle 4/Day 1 predose (within 30 minutes), and on 
Cycle 8/Day 1 predose (within 30 minutes). If niraparib is not administered, collection 
of predose blood sample is required, however postdose sample collection is not 
required. 


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 RECIST (v.1.1) tumor assessment of the abdomen/pelvis and other areas (if clinically 
indicated) every 8 weeks (± 7 days) from Cycle 1/Day 1 for 6 months (ie, Cycle 3, 
Cycle 5, Cycle 7), and then every 12 weeks (ie, Cycle 10, Cycle 13, Cycle 16, etc.) 
until progression 
 Study treatment capsules dispensed/collected, as appropriate 
 AEs 
 Concomitant medications 
7.2.7. 
End of Treatment (within 7 days of last dose) 
 Symptom-directed physical examination 
 Vital signs (BP, pulse, and temperature) and weight 
 ECOG performance status 
 CBC 
 Serum chemistry 
 Serum CA-125 
 If a patient discontinues treatment for a reason other than disease progression as 
defined in the protocol or death, withdrawal of consent, or loss to follow-up, then 
scans and CA-125 testing should continue at the specified intervals (every 12 
weeks until the start of subsequent anticancer treatment). 
 Fresh biopsy tumor sample (optional) 
 RECIST (v.1.1) tumor assessment of the abdomen/pelvis and other areas (if clinically 
indicated) 
 If a patient discontinues treatment for a reason other than disease progression as 
defined in the protocol or death, withdrawal of consent, or loss to follow-up, then 
scans and CA-125 testing should continue at the specified intervals (every 12 
weeks until the start of subsequent anticancer treatment). 
 Study treatment capsules collected 
 AEs (SAEs recorded up to 30 days after treatment discontinuation), SAEs assessed as 
study drug related throughout study and post-treatment assessments and AESI 
 Concomitant medications  
7.2.8. 
Post-Treatment Assessments (Study Visit Not Always Required) 
 Serum CA-125 
 If a patient discontinues treatment for a reason other than disease progression as 
defined in the protocol or death, withdrawal of consent, or loss to follow-up, then 
scans and CA-125 testing should continue at the specified intervals (every 12 
weeks until the start of subsequent anticancer treatment). 


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 RECIST (v.1.1) tumor assessment of the abdomen/pelvis and other areas (if clinically 
indicated) 
 If a patient discontinues treatment for a reason other than disease progression as 
defined in the protocol or death, withdrawal of consent, or loss to follow-up, then 
scans and CA-125 testing should continue at the specified intervals (every 12 
weeks until the start of subsequent anticancer treatment). 
 AE monitoring 
 New SAEs recorded up to 30 days after last study treatment administration 
 SAEs assessed as related to the study treatment 
 Any AEs will be monitored until it has resolved, any abnormal laboratory values 
have returned to baseline or normalized, there is a satisfactory explanation for the 
changes observed, the patient is lost to follow-up, or the patient has died 
 AESI 
 Survival assessment every 90 days including assessment of outcomes of subsequent 
anticancer therapies following study treatment 
 For patients only being followed for survival, survival assessment may be 
conducted via telephone 
 Anticancer therapies assessment 
- 
Name (and/or class) 
- 
Start date 
- 
Dose-limiting toxicities 
- 
Best response (CR, PR, SD, PD) 
- 
Progression date 
7.2.9. 
Unscheduled Assessments 
For any suspected case of MDS, AML or secondary cancer (new malignancies other than 
MDS/AML)reported while a patient is receiving treatment or being followed for post-treatment 
assessments, bone marrow aspirate and biopsy to be conducted. See Section 6.2.6 for details. 


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8. 
STATISTICAL METHODS 
Details of the statistical analyses presented below will be provided in the study’s statistical 
analysis plan (SAP). A change to the data analysis methods described in the protocol will require 
a protocol amendment only if it alters a principal feature of the protocol. The SAP will be 
finalized prior to database lock. Any changes to the methods described in the plan will be 
described and justified in the final clinical study report.  
8.1. 
Analysis Populations 
Efficacy analysis will be performed on the following populations:  
 Intent-to-Treat (ITT) Population, defined as all dosed patients with measurable disease at 
baseline.  
 Response-Evaluable Population, defined as all ITT patients with at least one evaluable 
post-baseline tumor scan.    
 Per-protocol (PP) population, consisting of all patients in the ITT Population who do not 
have protocol deviations that may significantly impact the interpretation of efficacy 
results. A detailed specification of the PP population will be provided in the SAP. 
Safety analysis will be performed on the Safety Population, defined as all patients who received 
at least 1 dose of study drug.  
8.2. 
Demographics, Medical History, Baseline Characteristics, and 
Concomitant Medications 
Patient disposition will be summarized, including the number of patients treated with niraparib, 
the number who discontinue and reason for discontinuation, and the number included for 
analysis. Patient demographics will be summarized descriptively, for the overall pool of patients 
and by subset.  
8.3. 
Efficacy Analyses 
8.3.1. 
Primary Efficacy Parameter 
The primary efficacy endpoint is the investigator-assessed confirmed ORR per RECIST v1.1 in 
the HRD-positive patients who have received 3 or 4 prior lines of anti-cancer therapy and are 
platinum-sensitive to the last platinum-based therapy. Patients with prior PARP inhibitor 
treatment are excluded. The alternative hypothesis of ORR ≥30% will be tested against a null 
hypothesis of ORR ≤10%. The rationale of the hypothesis and the power calculation are detailed 
in section 8.8. The response rate and 95% confidence interval along with a one-sided p-value for 
testing the null hypothesis based on the binomial distribution will be provided. 
8.3.2. 
Secondary Efficacy Parameters 
The following key secondary efficacy endpoints are defined: 
 Investigator-assessed confirmed ORR per RECIST v1.1 in all patients who have 
received 3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive to the last 


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platinum-based therapy, regardless of HRD status. Patients with prior PARP treatment 
are excluded. 
 Investigator-assessed confirmed ORR per RECIST v1.1 in all patients who have 
received 3 or 4 prior lines of anti-cancer therapy and are platinum-sensitive or 
platinum-resistant to the last platinum-based therapy, regardless of HRD status. Patients 
with prior PARP treatment are excluded. 
 Investigator-assessed confirmed ORR per RECIST v1.1 in all patients treated in the 
study. 
The alternative hypothesis of ORR ≥25% will be tested against a null hypothesis of ORR ≤10%. 
The response rate and 95% CI along with a one-sided p-value for testing the null hypothesis 
based on the binomial distribution will be provided for each key secondary endpoint. The 
primary and key secondary efficacy endpoints will be tested sequentially to control the overall 
Type I error rate at 1-sided 0.025 level. 
Other secondary efficacy endpoints will be analyzed descriptively including: 
 DOR, DCR, PFS, TFST and OS in patient groups included in the primary and key 
secondary endpoints. 
 ORR, DOR, DCR, PFS, TFST and OS in patients who have received 3 or 4 prior lines 
of anti-cancer therapy and are platinum-resistant to the last platinum-based therapy, by 
HRD status. Patients with prior PARP treatment are excluded.   
 ORR, DOR, DCR, PFS, TFST and OS in all patients regardless of prior lines of anti-
cancer therapy, including HRD subgroup analysis and platinum-sensitivity (sensitive 
vs. resistant) subgroup analysis. Patients with prior PARP treatment are excluded. 
Other exploratory analyses will include:  
 ORR, DOR, DCR, PFS, TFST and OS in patients with prior PARP treatment, including 
HRD subgroup analysis  
 ORR, DOR, DCR, PFS, TFST and OS in patients who are platinum-refractory to the 
last platinum-based therapy, including HRD subgroup analysis 
Response rate and 95% CI based on the binomial distribution will be provided.   
Time-to-event analysis will be performed using Kaplan-Meier method to provide median 
estimates and 95% CI.  
8.4. 
Safety Analyses 
Adverse event terms will be coded using the Medical Dictionary for Regulatory Activities and 
will be summarized for all treated patients. Incidence of AEs occurring during the study will be 
summarized by system organ class and preferred term. Adverse events will also be summarized 
by causality and grade. Serious adverse events will be listed separately. Descriptive summary 
statistics will be used to summarize changes over time in laboratory values, vital signs and 
physical examination findings Laboratory parameter changes will be described using shift tables 
according to CTCAE (v.4.03). Administrative interim safety data will be examined on an 
ongoing basis to ensure patient safety.  


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8.5. 
Pharmacokinetic Analyses 
For all patients, as appropriate, blood samples for measurements of plasma levels of niraparib 
and its major metabolite will be obtained on Cycle 1/Day 1 and on Cycle 2/ Day 1 at the 
following time points:  0 (predose, within 30 minutes) and 2 hours (±15 minutes) postdose. In 
subsequent cycles, blood samples for measurement of plasma levels of niraparib will be obtained 
on Cycle 4/Day 1 and Cycle 8/Day 1 predose (within 30 minutes) only. 
Pharmacokinetic parameters including AUC, Cmin, tmax, Cmax, AUCss, Cminss, Cmaxss, and, if the 
data allow, CL/F and Vz/F, will be determined. 
In addition, the PK/pharmacodynamic relationship between concentrations of niraparib and its 
major metabolite with efficacy and safety measures will be investigated, and exposure (AUC, 
and/or Cmax) determined for niraparib and its major metabolite will be correlated with safety 
(selected AEs) and efficacy variables. 
Descriptive statistics and categorical analyses of ECG variables will be provided for the subset of 
patients (approximately 12) with intensive ECG collection. A separate population PK analysis 
plan will be written to describe the analyses of ECG variables and PK parameters. 
8.6. 
Biomarker Analyses 
Efficacy in the biomarker subgroups, such as tBRCA and HRD or HRR gene mutations, will be 
explored and analyzed descriptively.  
8.7. 
Post-Treatment Analyses 
Descriptive summary statistics will be used to summarize post-treatment data (ie, subsequent 
anticancer therapy and any new malignancy). 
8.8. 
Determination of Sample Size 
The study protocol initially allowed enrollment of patients with at least 3 prior lines of anti-
cancer therapy. With subsequent protocol amendments, the study enrollment was adjusted to 
allow only HRD-positive patients with 3 or 4 prior lines of anti-cancer therapy. This adjustment 
was made in consideration of the evolving role of PARP inhibitors in ovarian cancer treatment 
based on external data. Overall, approximately 500 patients are expected in the study. The study 
enrollment is also expected to include a minimum number of tBRCAmut patients (≥50) and HRD-
positive patients (≥150).  
For the primary efficacy endpoint of ORR in HRD-positive patients who have received 3 or 4 
prior lines of anti-cancer therapy and are platinum-sensitive to the last platinum-based therapy, 
an alternative hypothesis of ORR ≥30% is considered against a null hypothesis of ORR ≤10%.  
For the key secondary efficacy endpoints of ORR tested in broader subgroups to include 
platinum-resistant patients and/or HRD-negative/unknown patients, an alternative hypothesis of 
ORR ≥25% is considered against a null hypothesis of ORR ≤10%. 
The rationale of choosing the null and alternative hypothesis for the primary and the key 
secondary efficacy endpoints are based on data external from this study; these clinical trials of 
PARP inhibitors (e.g. niraparib, olaparib, and rucaparib) which suggests that platinum-sensitivity 
and/or HRD positivity (including BRCA mutant) play a role in how patients with ovarian cancer 


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respond to treatment. There is limited data for the overall HRD-positive population in ovarian 
cancer treatment. In a rucaparib study that included patients who are LOH-positive (another 
assay evaluating tumor homologous recombination deficiency), ORR in the non-tBRCA/LOH-
positive patients with at least 2 prior lines of therapy was 17%.1 A recent publication of 
platinum-sensitive patients with at least 1 prior line of therapy presented an ORR of 29% in the 
non-tBRCA/LOH-positive group.2 Therefore, choice of the hypotheses of Ho: ORR ≤10% vs. 
Ha: ORR ≥30% for the primary efficacy and Ho: ORR ≤10% vs. Ha: ORR ≥25% for the key 
secondary analyses would be appropriate for testing the efficacy of niraparib treatment in the 
specified populations.  
It is estimated that 45 patients would provide 90% power for testing the primary efficacy 
analyses. Statistical power for various sample sizes are presented below to provide guidance for 
the key secondary hypotheses when tested individually (regardless of sequential testing). The 
power is calculated by assuming the exact binomial distribution using East® software Version 
6.4. 
N 
Statistical Power* 
45 
72% 
60 
85% 
75 
92% 
90 
96% 
* Ho: ORR≤10% vs Ha: ORR≥25% 
As of August 2017, approximately 450 patients were dosed in the study. Approximately 320 
patients had 3 or 4 prior lines of anti-cancer therapy (~150 HRD positive). Based on a 
preliminary calculation of the platinum-sensitivity to the last platinum-based therapy, the number 
of enrolled patients for the primary endpoint and the key secondary efficacy endpoints are 
considered adequate to ensure sufficient power for the planned analysis.   


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9. 
ETHICAL, LEGAL, AND ADMINISTRATIVE ASPECTS 
9.1. 
Data Quality Assurance 
The Sponsor (or designee) will conduct a study initiation visit to verify the qualifications of the 
Investigator, inspect the facilities, and inform the Investigator of responsibilities and procedures 
for ensuring adequate and correct documentation. 
The Investigator must prepare and maintain adequate and accurate records of all observations 
and other data pertinent to the clinical study for each study participant. Frequent communication 
between the clinical site and the Sponsor is essential to ensure that the safety of the study is 
monitored adequately. The Investigator will make all appropriate safety assessments on an 
ongoing basis. The Sponsor’s medical monitor may review safety information as it becomes 
available throughout the study. 
All aspects of the study will be carefully monitored with respect to GCP and standard operating 
procedures for compliance with applicable government regulations. The study monitor will be an 
authorized individual designated by the Sponsor. The study monitor will have access to all 
records necessary to ensure integrity of the data and will periodically review the progress of the 
study with the Principal Investigator. 
9.2. 
Access to Source Data/Documents 
An electronic data capture system to manage data collection will be utilized during this trial. The 
electronic data capture system is a software tool designed to ensure quality assurance and 
facilitate data capture during clinical trials. The system is fully compliant with Code of Federal 
Regulations 21 Part 11. 
The Investigator will ensure the accuracy, completeness, and timeliness of the data reported to 
the Sponsor. Data collection processes and procedures will be reviewed and validated to ensure 
completeness, accuracy, reliability, and consistency. A complete audit trail will be maintained of 
all data changes. The Investigator (or designee) will cooperate with the Sponsor’s 
representative(s) for the periodic review of study documents to ensure the accuracy and 
completeness of the data capture system at each scheduled monitoring visit. 
Electronic consistency checks and manual review will be used to identify any errors or 
inconsistencies in the data. This information will be provided to the respective study sites by 
means of electronic or manual queries. 
The Investigator (or designee) will prepare and maintain adequate and accurate study documents 
(medical records, ECGs, AE, and concomitant medication reporting, raw data collection forms, 
etc.) designed to record all observations and other pertinent data for each patient receiving study 
treatment. 
The Investigator will allow Sponsor representatives, contract designees, authorized regulatory 
authority inspectors, and the IRB to have direct access to all documents pertaining to the study. 
9.3. 
Archiving Study Documents  
Essential clinical documents will be maintained to demonstrate the validity of the study and the 
integrity of the data collected. Master files should be established at the beginning of the study, 


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maintained for the duration of the study, and retained according to the appropriate regulations. 
According to International Conference on Harmonisation (ICH) guidelines, essential documents 
should be retained for a minimum of 2 years after the last approval of a marketing application in 
an ICH region and until there are no pending or contemplated marketing applications in an ICH 
region or at least 2 years have elapsed since the formal discontinuation of clinical development 
of the study treatment. 
9.4. 
Good Clinical Practice 
This study will be conducted in accordance with the ICH for GCP and the Declaration of 
Helsinki (2008). The clinical study will also be carried out in accordance with national and local 
regulatory requirement(s). 
9.5. 
Informed Consent 
Before each patient is enrolled in the clinical study, written informed consent will be obtained 
from the patient according to the regulatory and legal requirements of the participating country. 
As part of this procedure, the Investigator must explain orally and in writing the nature, duration, 
and purpose of the study, and the action of the study treatment in such a manner that the patient 
is aware of the potential risks, inconveniences, or AEs that may occur. The patient should be 
informed that he/she is free to withdraw from the study at any time. The patient will receive all 
information that is required by regulatory authorities and ICH guidelines. The Investigator (or 
designee) will provide the Sponsor with a copy of the IRB/IEC-approved ICF prior to the start of 
the study. 
The ICF must be signed and dated; one copy will be given to the patient and the Investigator will 
retain a copy as part of the clinical study records. The Investigator will not undertake any 
investigation specifically required for the clinical study until written consent has been obtained. 
The terms of the consent and when it was obtained must also be documented. 
Depending on local site requirements, patients may sign a screening ICF prior to the screening 
period to facilitate early HRD testing only. This ICF should allow HRD testing procedures only. 
The informed consent process and documentation of informed consent will be the same for the 
screening ICF as for the main ICF. 
If a protocol amendment is required, then the ICF may need to be revised to reflect the changes 
to the protocol. If the ICF is revised, it must be reviewed and approved by the responsible 
IRB/IEC and signed by all patients subsequently enrolled in the clinical study as well as those 
currently enrolled in the clinical study. 
9.6. 
Protocol Approval and Amendment 
Before the start of the study, the study protocol and/or other relevant documents will be approved 
by the IEC/IRB/Competent Authorities, in accordance with local legal requirements. The 
Sponsor must ensure that all ethical and legal requirements have been met before the first patient 
is enrolled in the study. 
This protocol is to be followed exactly. To alter the protocol, amendments must be written, 
receive approval from the appropriate personnel, and receive IRB/IEC/Competent Authority 
approval prior to implementation (if appropriate). In the United States and Canada, following 


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approval, the protocol amendment(s) will be submitted to the IND under which the study is being 
conducted. Administrative changes (not affecting the patient benefit/risk ratio) may be made 
without the need for a formal amendment. All amendments will be distributed to all protocol 
recipients, with appropriate instructions. 
9.7. 
Patient Confidentiality and Data Protection 
All clinical study findings and documents will be regarded as confidential. Study documents 
(protocols, Investigator’s Brochures, and other material) will be stored appropriately to ensure 
their confidentiality. The Investigator and members of his/her research team (including the 
IRB/IEC) must not disclose such information without prior written approval from the Sponsor, 
except to the extent necessary to obtain informed consent from patients who wish to participate 
in the trial or to comply with regulatory requirements.  
The anonymity of participating patients must be maintained. Patients will be specified on study 
documents by their enrollment number or birth date, not by name. Documents that identify the 
patient (eg, the signed informed consent document) must be maintained in confidence by the 
Investigator. 
9.8. 
Study Monitoring 
Monitoring and auditing procedures approved by the Sponsor will be followed in order to 
comply with GCP guidelines. On-site checking of the eCRFs for completeness and clarity, cross-
checking with source documents, and clarification of administrative matters will be performed. 
The study will be monitored by the Sponsor (or designee). Monitoring will be done by personal 
visits from a representative of the sponsor (site monitor) who will review the eCRFs and source 
documents. The site monitor will ensure that the investigation is conducted according to protocol 
design and regulatory requirements by frequent site visits and by communications (letter, 
telephone, and fax). 
All unused study treatment and other study materials will be returned to the Sponsor after the 
clinical phase of the study has been completed. 
9.9. 
Audits and Inspections 
Regulatory authorities, the IRB/IEC, and/or the Sponsor’s clinical quality assurance group, or its 
designee, may request access to all source documents, eCRFs, and other study documentation for 
on-site audit or inspection. Direct access to these documents must be guaranteed by the 
Investigator, who must provide support at all times for these activities. 
9.10. 
Ethical Considerations 
The study will be conducted in accordance with ethical principles founded in the Declaration of 
Helsinki. The IRB/IEC will review all appropriate study documentation in order to safeguard the 
rights, safety, and well-being of the patients. The study will only be conducted at sites where 
IRB/IEC approval has been obtained. The protocol, Investigator’s Brochure, informed consent, 
advertisements (if applicable), written information given to the patients, safety updates, annual 
progress reports, and any revisions to these documents will be provided to the IRB/IEC by the 
Investigator. 


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9.11. 
Publication Policy 
Information regarding publication of study results is contained in the Steering Committee 
Charter. 


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10. 
REFERENCE LIST 
1. 
Balasubramaniam S BJ, Horton S, Fernandes LL, Tang S, Horne HN, Liu J, Liu C, 
Schrieber SJ, Yu J, Song P, Pierce W, Robertson KJ, Palmby TR, Chiu HJ, Lee EY, 
Philip R, Schuck R, Charlab R, Banerjee A, Chen XH, Wang X, Goldberg KB, Sridhara 
R, Kim G, Pazdur R. FDA Approval Summary: Rucaparib for the treatment of patients 
with deleterious BRCA mutation-associated advanced ovarian cancer. Clin Cancer Res. 
2017. 
2. 
Swisher EM LK, Oza AM, Scott CL, Giordano H, Sun J, Konecny GE, Coleman RL, 
Tinker AV, O'Malley DM, Kristeleit RS, Ma L, Bell-McGuinn KM, Brenton JD, Cragun 
JM, Oaknin A, Ray-Coquard I, Harrell MI, Mann E, Kaufmann SH, Floquet A, Leary A, 
Harding TC, Goble S, Maloney L, Isaacson J, Allen AR, Rolfe L, Yelensky R, Raponi M, 
McNeish IA. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma 
(ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol. 
2017;18(1):75-87. 
3. 
Turner N, Tutt A, Ashworth A. Hallmarks of 'BRCAness' in sporadic cancers. Nat Rev 
Cancer. 2004;4(10):814-819. 
4. 
Cancer Genome Atlas Research N. Integrated genomic analyses of ovarian carcinoma. 
Nature. 2011;474(7353):609-615. 
5. 
Stefansson OA, Jonasson JG, Johannsson OT, et al. Genomic profiling of breast tumours 
in relation to BRCA abnormalities and phenotypes. Breast Cancer Res. 2009;11(4):R47. 
6. 
Holstege H, Horlings HM, Velds A, et al. BRCA1-mutated and basal-like breast cancers 
have similar aCGH profiles and a high incidence of protein truncating TP53 mutations. 
BMC Cancer. 2010;10:654. 
7. 
Abkevich V, Timms KM, Hennessy BT, et al. Patterns of genomic loss of heterozygosity 
predict homologous recombination repair defects in epithelial ovarian cancer. Br J 
Cancer. 2012;107(10):1776-1782. 
8. 
Birkbak NJ, Wang ZC, Kim JY, et al. Telomeric allelic imbalance indicates defective 
DNA repair and sensitivity to DNA-damaging agents. Cancer Discov. 2012;2(4):366-
375. 
9. 
Popova T, Manie E, Rieunier G, et al. Ploidy and large-scale genomic instability 
consistently identify basal-like breast carcinomas with BRCA1/2 inactivation. Cancer 
Res. 2012;72(21):5454-5462. 
10. 
Timms K, Reid J, Abkevich V, Neff C, Morris B, Potter J. Association between 
BRCA1/2 status and DNA-based assays for homologous recombination deficiency. 
Cancer Res. 2013;73(24 Suppl):P6-05-10. 
11. 
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. 
12. 
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. 
13. 
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. 


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14. 
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. 
15. 
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. 
16. 
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. 
17. 
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. 
18. 
Al Hilli M, Weroha S, Becker M, Hou X, Harrington S, McKinstrey S. In vivo antitumor 
activity of the PARP inhibitor niraparib (MK-4827) in homologous recombination 
deficient and proficient ovarian cancer. Clin Cancer Res. 2013;19(19 Suppl):PR05. 
19. 
Vardiman JW, Thiele J, Arber DA, et al. The 2008 revision of the World Health 
Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale 
and important changes. Blood. 2009;114(5):937-951. 
20. 
CDER. Guidance for Industry, Drug Interaction Studies. 2012. 
21. 
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. 
22. 
Huang X, Venet F, Wang YL, et al. PD-1 expression by macrophages plays a pathologic 
role in altering microbial clearance and the innate inflammatory response to sepsis. Proc 
Natl Acad Sci U S A. 2009;106(15):6303-6308. 
23. 
Funk KA, Bostwick JR. A comparison of the risk of QT prolongation among SSRIs. Ann 
Pharmacother. 2013;47(10):1330-1341. 
 


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APPENDIX A. DRUGS KNOWN TO INHIBIT OR INDUCE CYP1A2 
Inhibitors of CYP1A2 
Strong  
≥ 5-fold increase in 
AUC or >80% 
decrease in CL 
Moderate  
≥ 2 but < 5-fold increase in AUC or 
50%-80% decrease in CL 
Weak  
≥ 1.25 but < 2-fold increase in AUC 
or 20%-50% decrease in CL 
Ciprofloxacin, 
enoxacin, 
fluvoxamine  
 
Methoxsalen, mexiletine, oral 
contraceptives, phenylpropanolamine, 
thiabendazole, vemurafenib, zileuton  
 
Acyclovir, allopurinol, 
caffeine, cimetidine, Daidzein, 
disulfiram, Echinacea, famotidine, 
norfloxacin, propafenone, 
propranolol, terbinafine, 
 ticlopidine, verapamil 
Inducers of CY1A2 
Strong 
80% decrease in 
AUC 
Moderate 
50%-80% decrease in AUC 
Weak  
20%-50% decrease in AUC 
 
Montelukast, 
phenytoin, smokers 
versus non-smokers 
Moricizine, 
omeprazole, 
phenobarbital 
Substrates of CYP1A2 
Sensitive substratesa 
Substrates with narrow 
therapeutic rangeb 
Alosetron, caffeine, duloxetine, melatonin, ramelteon, tacrine, 
tizanidine  
Theophylline, tizanidine, Warfarin 
AUC = area under the curve; CL = clearance. 
Source: CDER, 2012.20 
a Sensitive CYP substrates refers to drugs whose plasma AUC values have been shown to increase 5-fold or higher 
when coadministered with a known CYP inhibitor or AUC ratio in poor metabolizers vs. extensive metabolizers is 
greater than 5-fold. 
b CYP substrates with narrow therapeutic range refers to drugs whose exposure-response relationship indicates that 
small increases in their exposure levels by the concomitant use of CYP inhibitors may lead to serious safety 
concerns (eg, Torsades de Pointes). 


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APPENDIX B. RESPONSE EVALUATION CRITERIA IN SOLID 
TUMORS (RECIST), V.1.1 
Response Criteria by RECIST v.1.1 
Evaluation of Target Lesions 
Complete Response (CR):  Disappearance of all target lesions. Any pathological lymph nodes 
(whether target or non-target) must have reduction in short axis to <10 mm. 
Partial Response (PR):  At least a 30% decrease in the sum of the diameters of target lesions, 
taking as reference the baseline sum diameters. 
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, 
taking as reference the smallest sum on study (this includes the baseline sum if that is the 
smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an 
absolute increase of at least 5 mm. (Note:  the appearance of one or more new lesions is also 
considered progressions). 
Stable Disease (SD):  Neither sufficient shrinkage to qualify for PR nor sufficient increase to 
qualify for PD, taking as reference the smallest sum diameters while on study 
Evaluation of Non-Target Lesions 
Complete Response (CR):  Disappearance of all non-target lesions and normalization of tumor 
marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). 
Note:  If tumor markers are initially above the upper normal limit, they must normalize for a 
patient to be considered in complete clinical response. 
Non-CR/Non-PD:  Persistence of 1 or more non-target lesion(s) and/or maintenance of tumor 
marker level above the normal limits 
Progressive Disease (PD):  Appearance of one or more new lesions and/or unequivocal 
progression of existing non-target lesions. Unequivocal progression should not normally trump 
target lesion status. It must be representative of overall disease status change, not a single lesion 
increase.   
Although a clear progression of “non-target” lesions only is exceptional, the opinion of the 
treating physician should prevail in such circumstances, and the progression status should be 
confirmed at a later time by the review panel (or Principal Investigator). 
Evaluation of Best Overall Response 
The best overall response is the best response recorded from the start of the treatment until 
disease progression/recurrence (taking as reference for progressive disease the smallest 
measurements recorded since the treatment started). The patient's best response assignment will 
depend on the achievement of both measurement and confirmation criteria. 
 
 


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Table 5: 
For Patients with Measurable Disease (ie, Target Disease) 
Target 
Lesions 
Non-Target 
Lesions 
New 
Lesions 
Overall 
Response 
Best Overall Response 
When Confirmation is 
Required* 
CR 
CR 
No 
CR 
> 4 wks. 
Confirmation** 
CR 
Non-CR/Non-PD 
No 
PR 
 
> 4 wks. 
Confirmation** 
CR 
Not evaluated 
No 
PR 
PR 
Non-CR/Non-
PD/not evaluated 
No 
PR 
SD 
Non-CR/Non-
PD/not evaluated 
No 
SD 
documented at least 
once > 4 wks. from 
baseline** 
PD 
Any 
Yes or No 
PD 
 
no prior SD, PR or CR 
Any 
PD*** 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
* See RECIST 1.1 manuscript for further details on what is evidence of a new lesion. 
** Only for non-randomized trials with response as primary endpoint. 
*** In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as disease progression. 
Note: 
Patients with a global deterioration of health status requiring discontinuation of treatment without objective evidence 
of disease progression at that time should be reported as “symptomatic deterioration.”  Every effort should be made to 
document the objective progression even after discontinuation of treatment. 
 
Table 6: 
For Patients with Non-Measurable Disease (ie, Non-Target Disease) 
Non-Target Lesions 
New Lesions 
Overall Response 
CR 
No 
CR 
Non-CR/non-PD 
No 
Non-CR/non-PD* 
Not all evaluated 
No 
not evaluated 
Unequivocal PD 
Yes or No 
PD 
Any 
Yes 
PD 
* ‘Non-CR/non-PD’ is preferred over ‘stable disease’ for non-target disease since SD is increasingly used as 
an endpoint for assessment of efficacy in some trials so to assign this category when no lesions can be 
measured is not advised 
 
Duration of Response 
Duration of overall response:  The duration of overall response is measured from the time 
measurement criteria are met for CR or PR (whichever is first recorded) until the first date that 
recurrent or progressive disease is objectively documented (taking as reference for progressive 
disease the smallest measurements recorded since the treatment started). 
The duration of overall CR is measured from the time measurement criteria are first met for CR 
until the first date that progressive disease is objectively documented. 
 
Duration of stable disease:  Stable disease is measured from the start of the treatment until the 
criteria for progression are met, taking as reference the smallest measurements recorded since the 
treatment started, including the baseline measurements. 


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APPENDIX C. EASTERN COOPERATIVE ONCOLOGY GROUP 
(ECOG) PERFORMANCE STATUS 
Description 
Grade 
Fully active, able to carry on all pre-disease performance without 
restriction. 
0 
Restricted in physically strenuous activity, but ambulatory and 
able to carry out work of a light or sedentary nature, ie, light 
house work, office work. 
1 
Ambulatory and capable of all self-care but unable to carry out 
any work activities. Up and about more than 50% of waking 
hours. 
2 
Capable of only limited self-care, confined to bed or chair more 
than 50% of waking hours. 
3 
Completely disabled. Cannot carry on any self-care. Totally 
confined to bed or chair. 
4 
Source:21 


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APPENDIX D. SELECT DRUGS ASSOCIATED WITH QT 
PROLONGATION AND TORSADES DE POINTES 
Antiarrhythmics 
Antimicrobials 
Antidepressants 
Antipsychotics 
Others 
(including 
Selected 
Antiemetics) 
Amiodarone 
Sotalol 
Quinidine 
Procainamide 
Dofetilide 
Ibutilide 
Levofloxacin 
Ciprofloxacin 
Gatifloxacin 
Moxifloxacin 
Clarithromycin 
Erythromycin 
Ketoconazole* 
Itraconazole 
Amitriptyline 
Doxepin 
 
Haloperidol 
Droperidol 
Quetiapine 
Thioridazine 
Ziprasidone 
Cisapride 
Sumatriptan 
Zolmitriptan 
Arsenic 
Dolasetron 
Methadone 
*Topical use only allowed for ketoconazole 
Sources:22,23 


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APPENDIX E. CONTRACEPTION GUIDELINES 
Patients of childbearing potential and their partners who are sexually active (exception: 
abstinence for the total duration of the trial, defined as the time from the patient’s signing of the 
informed consent form through the study treatment washout period, which is at least 90 days) 
must agree to the use of a highly effective form of contraception throughout their participation 
during the study treatment and for 90 days after last dose of study treatment(s): 
 combined (estrogen and progestogen containing) hormonal contraception associated 
with inhibition of ovulation: 
 oral  
 intravaginal  
 transdermal  
 progestogen-only hormonal contraception associated with inhibition of ovulation 
 oral 
 injectable 
 implantable 
 intrauterine device (IUD) 
 intrauterine hormone-releasing system (IUS) 
 bilateral tubal occlusion 
 vasectomised partner 
 sexual abstinence, if this is the preferred and usual lifestyle of the subject 
 


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APPENDIX F. SAMPLE MYRIAD MYCHOICE® HRD CDX TEST 
RESULT FORM  
 
 
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD