Trial Outcomes & Findings for Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. (NCT NCT01844986)

NCT ID: NCT01844986

Last Updated: 2025-12-10

Results Overview

To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 450 participants
• Primary outcome timeframe: Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018
• Results posted on: 2025-12-10

Participant Flow

Global Cohort: 391 randomised. First/Last patient randomised 03Sep2013/06Mar2015. China Cohort: 64 randomised. First/Last patient randomised 09Jan2015/22Mar2016. A total of 450 patients randomised (386 global cohort only, 64 China cohort (of which 5 included in global cohort)). Global Cohort used for hypotheses testing of study.

It was planned that approximately 344 women in the Global Cohort, and 53 women in the China Cohort, with BRCA mutated ovarian cancer patients who are in clinical complete or partial response following first line platinum based chemotherapy were to receive olaparib 300 mg bd or matching placebo in a 2:1 ratio.

Participant milestones

Measure	Olaparib 300mg Tablets Taken orally twice daily	Placebo Tablets Taken orally twice daily
Overall Study (Global Cohort) STARTED	260	131
Overall Study (Global Cohort) COMPLETED	183	91
Overall Study (Global Cohort) NOT COMPLETED	77	40
Overall Study (China Cohort) STARTED	44	20
Overall Study (China Cohort) COMPLETED	33	14
Overall Study (China Cohort) NOT COMPLETED	11	6

Reasons for withdrawal

Measure	Olaparib 300mg Tablets Taken orally twice daily	Placebo Tablets Taken orally twice daily
Overall Study (Global Cohort) Severe non-compliance to protocol	1	0
Overall Study (Global Cohort) Withdrawal by Subject	21	14
Overall Study (Global Cohort) Death	55	26
Overall Study (China Cohort) Withdrawal by Subject	1	0
Overall Study (China Cohort) Death	10	6

Baseline Characteristics

Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.

Baseline characteristics by cohort

Measure	Olaparib 300mg Tablets (Global Cohort & China Cohort) n=300 Participants Taken orally twice daily	Placebo Tablets (Global Cohort & China Cohort) n=150 Participants Taken orally twice daily	Total n=450 Participants Total of all reporting groups
Age, Continuous Global Cohort	53.6 Years STANDARD_DEVIATION 9.38 • n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	53.4 Years STANDARD_DEVIATION 9.79 • n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	53.5 Years STANDARD_DEVIATION 9.51 • n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Age, Continuous China Cohort	50.7 Years STANDARD_DEVIATION 7.27 • n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	51.5 Years STANDARD_DEVIATION 7.95 • n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	51.0 Years STANDARD_DEVIATION 7.44 • n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Sex: Female, Male Global Cohort · Female	260 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	131 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	391 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Sex: Female, Male Global Cohort · Male	0 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Sex: Female, Male China Cohort · Female	44 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	20 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	64 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Sex: Female, Male China Cohort · Male	0 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) Global Cohort · American Indian or Alaska Native	0 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	1 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	1 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) Global Cohort · Asian	39 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	20 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	59 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) Global Cohort · Native Hawaiian or Other Pacific Islander	1 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	1 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	2 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) Global Cohort · Black or African American	2 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	2 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	4 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) Global Cohort · White	214 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	106 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	320 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) Global Cohort · More than one race	1 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	1 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) Global Cohort · Unknown or Not Reported	3 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	1 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	4 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) China Cohort · American Indian or Alaska Native	0 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) China Cohort · Asian	44 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	20 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	64 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) China Cohort · Native Hawaiian or Other Pacific Islander	0 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) China Cohort · Black or African American	0 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) China Cohort · White	0 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) China Cohort · More than one race	0 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Race (NIH/OMB) China Cohort · Unknown or Not Reported	0 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	0 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Response to previous platinum chemotherapy (as randomised) Global Cohort · Complete Response	213 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	107 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	320 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Response to previous platinum chemotherapy (as randomised) Global Cohort · Partial Response	47 Participants n=260 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	24 Participants n=131 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	71 Participants n=391 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Response to previous platinum chemotherapy (as randomised) China Cohort · Complete Response	37 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	18 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	55 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.
Response to previous platinum chemotherapy (as randomised) China Cohort · Partial Response	7 Participants n=44 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	2 Participants n=20 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.	9 Participants n=64 Participants • Each study is reported in a separate row. There were 4 participants who were in both the Global and China Olaparib Arm, and 1 participant in both the Global and China Placebo Arm.

PRIMARY outcome

Timeframe: Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018

Population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).

To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.

Outcome measures

Measure	Olaparib 300mg Tablets (Global Cohort) n=260 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=131 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=44 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=20 Participants Taken orally twice daily
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)	NA Months Insufficient PFS events to estimate median, lower and upper confidence limit.	13.8 Months Interval 11.1 to 18.2	NA Months Insufficient PFS events to estimate median, lower and upper confidence limit.	9.3 Months Interval 6.4 to Insufficient PFS events to estimate upper confidence limit.

SECONDARY outcome

Timeframe: Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

Population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of overall survival (OS). Reports results of a pre-specified interim analysis; results for final OS analysis (235 OS events) anticipated 2029.

Outcome measures

Measure	Olaparib 300mg Tablets (Global Cohort) n=260 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=131 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=44 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=20 Participants Taken orally twice daily
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival	NA Months Insufficient OS events to estimate median, lower and upper confidence limit.	NA Months Insufficient OS events to estimate median, lower and upper confidence limit.	NA Months Insufficient OS events to estimate median, lower and upper confidence limit.	NA Months Insufficient OS events to estimate median, lower and upper confidence limit.

SECONDARY outcome

Timeframe: CA-125 performed at baseline + every 4 weeks. Radiologic scans performed at baseline + every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. DCO:17May2018

Population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death

Outcome measures

Measure	Olaparib 300mg Tablets (Global Cohort) n=260 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=131 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=44 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=20 Participants Taken orally twice daily
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death	NA Months Insufficient events to estimate median, lower and upper confidence limit.	12.0 Months Interval 10.8 to 16.6	NA Months Insufficient events to estimate median, lower and upper confidence limit.	8.9 Months Interval 6.4 to Insufficient events to estimate upper confidence limit.

SECONDARY outcome

Timeframe: Following first progression disease then assessed per local practice every 12 weeks until second progression.

Population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second progression (PFS2)

Outcome measures

Measure	Olaparib 300mg Tablets (Global Cohort) n=260 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=131 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=44 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=20 Participants Taken orally twice daily
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression	NA Months Insufficient PFS2 events to estimate median, lower and upper confidence limit.	41.9 Months Interval 36.5 to 47.9	NA Months Insufficient PFS2 events to estimate median, lower and upper confidence limit.	NA Months Insufficient PFS2 events to estimate median, lower and upper confidence limit.

SECONDARY outcome

Timeframe: Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported

Population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) with a baseline and post baseline TOI scores available.

To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.

Outcome measures

Measure	Olaparib 300mg Tablets (Global Cohort) n=260 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=131 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) Taken orally twice daily	Placebo Tablets (China Cohort) Taken orally twice daily
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)	0.30 Scores on a scale Interval -0.717 to 1.318	3.30 Scores on a scale Interval 1.839 to 4.758	—	—

SECONDARY outcome

Timeframe: Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

Population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to first subsequent therapy or death (TFST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Outcome measures

Measure	Olaparib 300mg Tablets (Global Cohort) n=260 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=131 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=44 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=20 Participants Taken orally twice daily
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)	51.8 Months Interval 44.3 to Insufficient events to estimate upper confidence limit.	15.1 Months Interval 12.7 to 20.5	34.3 Months Interval 23.1 to Insufficient events to estimate upper confidence limit.	10.3 Months Interval 6.9 to Insufficient events to estimate upper confidence limit.

SECONDARY outcome

Timeframe: Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

Population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second subsequent therapy or death (TSST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Outcome measures

Measure	Olaparib 300mg Tablets (Global Cohort) n=260 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=131 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=44 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=20 Participants Taken orally twice daily
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)	NA Months Insufficient events to estimate median, lower and upper confidence limit.	40.7 Months Interval 32.9 to 47.7	NA Months Insufficient events to estimate median, lower and upper confidence limit.	27.4 Months Interval 19.4 to Insufficient events to estimate upper confidence limit.

SECONDARY outcome

Timeframe: Time elapsed from randomization to study treatment discontinuation or death. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

Population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to study treatment discontinuation or death (TDT). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Outcome measures

Measure	Olaparib 300mg Tablets (Global Cohort) n=260 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=131 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=44 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=20 Participants Taken orally twice daily
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)	24.6 Months Interval 24.0 to 24.8	13.8 Months Interval 11.2 to 16.4	24.8 Months Interval 14.2 to 24.9	8.6 Months Interval 5.9 to 24.8

SECONDARY outcome

Timeframe: Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months.

Population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) and confirmed as Myriad gBRCAm.

To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and potential future BRCA mutation assays (gene sequencing and large rearrangement analysis)

Outcome measures

Measure	Olaparib 300mg Tablets (Global Cohort) n=253 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=130 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) Taken orally twice daily	Placebo Tablets (China Cohort) Taken orally twice daily
Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS	NA Months Insufficient PFS events to estimate median, lower and upper confidence limit.	13.8 Months Interval 11.1 to 18.2	—	—

Adverse Events

Olaparib 300mg Tablets (Global Cohort)

Serious events: 54 serious events

Other events: 253 other events

Deaths: 55 deaths

Placebo Tablets (Global Cohort)

Serious events: 16 serious events

Other events: 117 other events

Deaths: 27 deaths

Olaparib 300mg Tablets (China Cohort)

Serious events: 13 serious events

Other events: 43 other events

Deaths: 10 deaths

Placebo Tablets (China Cohort)

Serious events: 3 serious events

Other events: 18 other events

Deaths: 6 deaths

Serious adverse events

Measure	Olaparib 300mg Tablets (Global Cohort) n=260 participants at risk Taken orally twice daily	Placebo Tablets (Global Cohort) n=130 participants at risk Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=44 participants at risk Taken orally twice daily	Placebo Tablets (China Cohort) n=20 participants at risk Taken orally twice daily
General disorders Chills	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Anaemia	6.5% 17/260 • Number of events 36 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	18.2% 8/44 • Number of events 10 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Febrile neutropenia	0.77% 2/260 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Leukopenia	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Neutropenia	0.77% 2/260 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.5% 2/44 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Abdominal pain	0.77% 2/260 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Diarrhoea	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Ileus	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Intestinal obstruction	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Small intestinal obstruction	0.77% 2/260 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Umbilical hernia	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Vomiting	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
General disorders Incarcerated hernia	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
General disorders Pyrexia	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Hepatobiliary disorders Cholecystitis acute	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Cellulitis	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Cystitis	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Gastroenteritis	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Infected lymphocele	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Infection	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Lung infection	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Medical device site cellulitis	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Pneumonia	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Urinary tract infection	1.2% 3/260 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Wound infection	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Investigations Haemoglobin decreased	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Investigations Platelet count decreased	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Metabolism and nutrition disorders Cell death	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Splenic cyst	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Cardiac disorders Myocardial infarction	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Gastritis	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Large intestine polyp	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Subileus	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Appendicitis	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Sepsis	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Upper respiratory tract infection	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Urosepsis	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Viral infection	0.77% 2/260 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Injury, poisoning and procedural complications Accidental exposure to product by child	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Injury, poisoning and procedural complications Drug administration error	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Injury, poisoning and procedural complications Stab wound	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Injury, poisoning and procedural complications Wound complication	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Investigations Alanine aminotransferase increased	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.77% 2/260 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal wall neoplasm benign	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 3/130 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer recurrent	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Nervous system disorders Ataxia	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Nervous system disorders Headache	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	1.5% 2/130 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Nervous system disorders Neuropathy peripheral	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Nervous system disorders Syncope	0.77% 2/260 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Nervous system disorders Transient ischaemic attack	0.77% 2/260 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Psychiatric disorders Depression	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/260 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.77% 2/260 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.77% 2/260 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.

Other adverse events

Measure	Olaparib 300mg Tablets (Global Cohort) n=260 participants at risk Taken orally twice daily	Placebo Tablets (Global Cohort) n=130 participants at risk Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=44 participants at risk Taken orally twice daily	Placebo Tablets (China Cohort) n=20 participants at risk Taken orally twice daily
Blood and lymphatic system disorders Anaemia	34.6% 90/260 • Number of events 156 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	9.2% 12/130 • Number of events 18 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	47.7% 21/44 • Number of events 44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.0% 3/20 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Cardiac disorders Palpitations	4.6% 12/260 • Number of events 19 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	1.5% 2/130 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.8% 3/44 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Abdominal discomfort	3.1% 8/260 • Number of events 10 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	1.5% 2/130 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	11.4% 5/44 • Number of events 8 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Abdominal distension	6.9% 18/260 • Number of events 22 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	7.7% 10/130 • Number of events 10 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.5% 2/44 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Abdominal pain	24.2% 63/260 • Number of events 86 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	19.2% 25/130 • Number of events 28 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.5% 2/44 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Abdominal pain lower	3.1% 8/260 • Number of events 8 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	3.1% 4/130 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Dyspepsia	16.5% 43/260 • Number of events 50 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	12.3% 16/130 • Number of events 18 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.5% 2/44 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Nausea	77.3% 201/260 • Number of events 412 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	37.7% 49/130 • Number of events 75 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	63.6% 28/44 • Number of events 49 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	25.0% 5/20 • Number of events 11 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Stomatitis	8.8% 23/260 • Number of events 37 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 3/130 • Number of events 5 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Toothache	3.1% 8/260 • Number of events 8 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	3.1% 4/130 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.8% 3/44 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
General disorders Fatigue	40.8% 106/260 • Number of events 138 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	30.0% 39/130 • Number of events 48 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	36.4% 16/44 • Number of events 22 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.0% 3/20 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
General disorders Influenza like illness	7.3% 19/260 • Number of events 29 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	8.5% 11/130 • Number of events 11 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
General disorders Oedema peripheral	9.2% 24/260 • Number of events 32 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.9% 9/130 • Number of events 10 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Cystitis	5.8% 15/260 • Number of events 19 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	3.8% 5/130 • Number of events 8 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Upper respiratory tract infection	10.8% 28/260 • Number of events 36 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	9.2% 12/130 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	38.6% 17/44 • Number of events 20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	30.0% 6/20 • Number of events 13 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Investigations Alanine aminotransferase increased	3.5% 9/260 • Number of events 13 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.2% 8/130 • Number of events 8 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	13.6% 6/44 • Number of events 23 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	20.0% 4/20 • Number of events 7 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Investigations Aspartate aminotransferase increased	4.2% 11/260 • Number of events 13 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.6% 6/130 • Number of events 7 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	13.6% 6/44 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.0% 3/20 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
General disorders Asthenia	24.2% 63/260 • Number of events 131 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	12.3% 16/130 • Number of events 20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.8% 3/44 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Investigations Blood creatinine increased	8.1% 21/260 • Number of events 30 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	1.5% 2/130 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.5% 2/44 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Metabolism and nutrition disorders Hypomagnesaemia	5.0% 13/260 • Number of events 17 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	7.7% 10/130 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Musculoskeletal and connective tissue disorders Arthralgia	25.4% 66/260 • Number of events 88 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	26.9% 35/130 • Number of events 47 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.5% 2/44 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.0% 3/20 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Musculoskeletal and connective tissue disorders Back pain	15.4% 40/260 • Number of events 50 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	12.3% 16/130 • Number of events 22 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.8% 3/44 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Musculoskeletal and connective tissue disorders Myalgia	10.8% 28/260 • Number of events 36 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 13/130 • Number of events 17 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.5% 2/44 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Musculoskeletal and connective tissue disorders Pain in extremity	10.8% 28/260 • Number of events 34 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	8.5% 11/130 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Bone marrow failure	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.8% 3/44 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Leukopenia	6.2% 16/260 • Number of events 33 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	3.8% 5/130 • Number of events 5 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	34.1% 15/44 • Number of events 64 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Neutropenia	15.4% 40/260 • Number of events 84 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.9% 9/130 • Number of events 11 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	38.6% 17/44 • Number of events 68 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Blood and lymphatic system disorders Thrombocytopenia	8.1% 21/260 • Number of events 52 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	1.5% 2/130 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	29.5% 13/44 • Number of events 35 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.0% 3/20 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Abdominal pain upper	17.7% 46/260 • Number of events 61 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	13.1% 17/130 • Number of events 22 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	20.5% 9/44 • Number of events 14 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Constipation	27.7% 72/260 • Number of events 97 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	19.2% 25/130 • Number of events 30 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	18.2% 8/44 • Number of events 10 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Diarrhoea	34.2% 89/260 • Number of events 205 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	24.6% 32/130 • Number of events 58 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	18.2% 8/44 • Number of events 12 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	20.0% 4/20 • Number of events 10 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Gastric dilatation	0.38% 1/260 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Mouth ulceration	1.9% 5/260 • Number of events 11 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/130 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	11.4% 5/44 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Gastrointestinal disorders Vomiting	40.0% 104/260 • Number of events 242 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	14.6% 19/130 • Number of events 26 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	40.9% 18/44 • Number of events 38 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.0% 3/20 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
General disorders Mucosal inflammation	6.5% 17/260 • Number of events 27 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
General disorders Pyrexia	11.9% 31/260 • Number of events 40 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	9.2% 12/130 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	18.2% 8/44 • Number of events 8 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Influenza	7.3% 19/260 • Number of events 24 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 3/130 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Nasopharyngitis	10.4% 27/260 • Number of events 38 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	13.1% 17/130 • Number of events 37 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	11.4% 5/44 • Number of events 16 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.0% 3/20 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Pharyngitis	3.5% 9/260 • Number of events 11 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 3/130 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	9.1% 4/44 • Number of events 5 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Sinusitis	4.2% 11/260 • Number of events 12 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.2% 8/130 • Number of events 8 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Infections and infestations Urinary tract infection	11.2% 29/260 • Number of events 52 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.2% 8/130 • Number of events 10 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	9.1% 4/44 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Investigations Neutrophil count decreased	7.7% 20/260 • Number of events 40 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.4% 7/130 • Number of events 14 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.9% 7/44 • Number of events 17 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Investigations Platelet count decreased	3.1% 8/260 • Number of events 12 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	1.5% 2/130 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	13.6% 6/44 • Number of events 19 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Investigations Weight increased	5.0% 13/260 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	9.2% 12/130 • Number of events 12 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Investigations White blood cell count decreased	6.2% 16/260 • Number of events 37 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.6% 6/130 • Number of events 9 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	22.7% 10/44 • Number of events 28 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 9 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Metabolism and nutrition disorders Decreased appetite	19.6% 51/260 • Number of events 68 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 13/130 • Number of events 19 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	38.6% 17/44 • Number of events 22 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Metabolism and nutrition disorders Hypokalaemia	5.8% 15/260 • Number of events 24 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 3/130 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.8% 3/44 • Number of events 10 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.0% 3/20 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Musculoskeletal and connective tissue disorders Muscle spasms	6.5% 17/260 • Number of events 22 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.77% 1/130 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.2% 16/260 • Number of events 17 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	8.5% 11/130 • Number of events 13 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Nervous system disorders Dizziness	19.6% 51/260 • Number of events 68 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.4% 20/130 • Number of events 23 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	18.2% 8/44 • Number of events 10 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	30.0% 6/20 • Number of events 16 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Nervous system disorders Dysgeusia	26.2% 68/260 • Number of events 92 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	3.8% 5/130 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.8% 3/44 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Nervous system disorders Headache	22.3% 58/260 • Number of events 109 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	23.1% 30/130 • Number of events 40 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.9% 7/44 • Number of events 9 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.0% 3/20 • Number of events 10 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Nervous system disorders Hypoaesthesia	1.9% 5/260 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	1.5% 2/130 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	9.1% 4/44 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Nervous system disorders Neuropathy peripheral	5.8% 15/260 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.4% 7/130 • Number of events 9 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Psychiatric disorders Anxiety	5.8% 15/260 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	8.5% 11/130 • Number of events 11 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Psychiatric disorders Depression	4.6% 12/260 • Number of events 14 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 13/130 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.5% 2/44 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Psychiatric disorders Insomnia	10.4% 27/260 • Number of events 31 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	12.3% 16/130 • Number of events 20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.8% 3/44 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	15.0% 3/20 • Number of events 5 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Respiratory, thoracic and mediastinal disorders Cough	16.2% 42/260 • Number of events 57 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	21.5% 28/130 • Number of events 37 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	11.4% 5/44 • Number of events 6 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.0% 39/260 • Number of events 53 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.4% 7/130 • Number of events 7 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/44 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.1% 21/260 • Number of events 26 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	9.2% 12/130 • Number of events 15 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	6.8% 3/44 • Number of events 3 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	10.0% 2/20 • Number of events 2 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Skin and subcutaneous tissue disorders Rash	6.2% 16/260 • Number of events 23 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	8.5% 11/130 • Number of events 11 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	4.5% 2/44 • Number of events 4 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	5.0% 1/20 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Vascular disorders Hot flush	6.5% 17/260 • Number of events 25 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	8.5% 11/130 • Number of events 12 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.
Vascular disorders Hypertension	3.5% 9/260 • Number of events 18 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	9.2% 12/130 • Number of events 17 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	2.3% 1/44 • Number of events 1 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.	0.00% 0/20 • All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm. Adverse events summaries showing subjects at risk are based on those subjects who received treatment. The summary of All cause mortality showing subjects at risk are based on those subjects who are randomised (irrespective of whether received treatment or not). Note 1 subject in Global cohort placebo arm was randomised but not treated.

Additional Information

Elizabeth Lowe

AstraZeneca

Phone: +1 302 885 1180

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60