Trial Outcomes & Findings for To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer (NCT NCT02476968)

Last Updated: 2022-09-10

Results Overview

To assess the real-world clinical effectiveness of olaparib maintenance monotherapy in patients with BRCAm and sBRCAm ovarian cancer by assessment of PFS. The PFS was defined as the time from the date of enrolment until date of objective radiological disease progression (assessed by the Investigator via Response Evaluation Criteria in Solid Tumors, version 1.1 \[RECIST 1.1\]), or death (by any cause in absence of disease progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to disease progression. Objective progression was defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) and an absolute increase of \> 5 millimeters, or an overall non-target lesion assessment of progression or a new lesion. The data cut-off (DCO) for the primary analysis of the study occurred after approximately 60% maturity of PFS in the sBRCAm and all BRCAm patient populations.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

181 participants

Primary outcome timeframe

Tumour assessments at baseline then every 12 weeks relative to date of enrolment until RECIST 1.1-defined progression. Assessed until primary analysis DCO of 17 April 2020 (up to maximum of 55 months).

Results posted on

2022-09-10

Participant Flow

This study was conducted in 8 countries in patients with platinum sensitive relapsed high grade epithelial ovarian (including fallopian tube or primary peritoneal) cancer, who were in complete or partial response to platinum-based chemotherapy.

181 patients enrolled and assigned to olaparib: 145 with breast cancer susceptibility gene mutation (BRCAm) status (87 with germline mutations \[gBRCAm\], 55 with somatic mutations \[sBRCAm\] and 3 with undetermined BRCAm status), 33 with BRCA-independent homologous recombination repair mutation (HRRm\^) status, and 3 enrolled in error (unassigned).

Participant milestones

Participant milestones
Measure	Overall BRCAm Patients received olaparib capsules orally 400 milligrams (mg) twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	HRRm^ Patients received olaparib capsules orally 400 mg twice daily. Patients in this exploratory cohort had a qualifying mutation in any of the 13 genes involved in the HRR pathway (excluding BRCA1 and BRCA2) (i.e. BRCA-independent HRRm\^).	Unassigned (Not BRCAm, Not HRRm^) Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort were not classified as being a part of either the BRCAm group or the HRRm\^ group and were enrolled in error.
Overall Study STARTED	145	33	3
Overall Study Received Treatment	143	32	2
Overall Study COMPLETED	50	15	0
Overall Study NOT COMPLETED	95	18	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall BRCAm Patients received olaparib capsules orally 400 milligrams (mg) twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	HRRm^ Patients received olaparib capsules orally 400 mg twice daily. Patients in this exploratory cohort had a qualifying mutation in any of the 13 genes involved in the HRR pathway (excluding BRCA1 and BRCA2) (i.e. BRCA-independent HRRm\^).	Unassigned (Not BRCAm, Not HRRm^) Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort were not classified as being a part of either the BRCAm group or the HRRm\^ group and were enrolled in error.
Overall Study Other	0	2	0
Overall Study Lost to Follow-up	10	0	1
Overall Study Death	48	8	1
Overall Study Eligibility criteria not fulfilled	0	0	1
Overall Study Patient decision	37	8	0

Baseline Characteristics

Mean age was calculated for patients with non-missing data (n=164). Only year of birth was reported for 17 patients in the FAS, and consequently, age at enrolment was not imputed for these patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	HRRm^ n=33 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this exploratory cohort had a qualifying mutation in any of the 13 genes involved in the HRR pathway (excluding BRCA1 and BRCA2) (i.e. BRCA-independent HRRm\^).	Unassigned (Not BRCAm, Not HRRm^) n=3 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort were not classified as being a part of either the BRCAm group or the HRRm\^ group and were enrolled in error.	Total n=181 Participants Total of all reporting groups
Age, Continuous	60.1 years STANDARD_DEVIATION 10.75 • n=130 Participants • Mean age was calculated for patients with non-missing data (n=164). Only year of birth was reported for 17 patients in the FAS, and consequently, age at enrolment was not imputed for these patients.	62.2 years STANDARD_DEVIATION 9.74 • n=31 Participants • Mean age was calculated for patients with non-missing data (n=164). Only year of birth was reported for 17 patients in the FAS, and consequently, age at enrolment was not imputed for these patients.	58.7 years STANDARD_DEVIATION 9.07 • n=3 Participants • Mean age was calculated for patients with non-missing data (n=164). Only year of birth was reported for 17 patients in the FAS, and consequently, age at enrolment was not imputed for these patients.	60.5 years STANDARD_DEVIATION 10.52 • n=164 Participants • Mean age was calculated for patients with non-missing data (n=164). Only year of birth was reported for 17 patients in the FAS, and consequently, age at enrolment was not imputed for these patients.
Age, Customized <35 years	0 Participants n=130 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	0 Participants n=31 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	0 Participants n=3 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	0 Participants n=164 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.
Age, Customized ≥35 to <50 years	27 Participants n=130 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	3 Participants n=31 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	0 Participants n=3 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	30 Participants n=164 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.
Age, Customized ≥50 to <65 years	54 Participants n=130 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	13 Participants n=31 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	2 Participants n=3 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	69 Participants n=164 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.
Age, Customized ≥65 to <80 years	48 Participants n=130 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	15 Participants n=31 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	1 Participants n=3 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	64 Participants n=164 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.
Age, Customized ≥80 years	1 Participants n=130 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	0 Participants n=31 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	0 Participants n=3 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.	1 Participants n=164 Participants • Age was summarised for patients with non-missing data (n=164). Only year of birth was reported for 17 patients inthe FAS, and consequently, age at enrolment was not imputed for these patients.
Sex: Female, Male Female	145 Participants n=145 Participants	33 Participants n=33 Participants	3 Participants n=3 Participants	181 Participants n=181 Participants
Sex: Female, Male Male	0 Participants n=145 Participants	0 Participants n=33 Participants	0 Participants n=3 Participants	0 Participants n=181 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=145 Participants	1 Participants n=33 Participants	0 Participants n=3 Participants	4 Participants n=181 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	142 Participants n=145 Participants	31 Participants n=33 Participants	3 Participants n=3 Participants	176 Participants n=181 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=145 Participants	1 Participants n=33 Participants	0 Participants n=3 Participants	1 Participants n=181 Participants
Race/Ethnicity, Customized White	142 Participants n=145 Participants	31 Participants n=33 Participants	3 Participants n=3 Participants	176 Participants n=181 Participants
Race/Ethnicity, Customized Asian	2 Participants n=145 Participants	1 Participants n=33 Participants	0 Participants n=3 Participants	3 Participants n=181 Participants
Race/Ethnicity, Customized Other	1 Participants n=145 Participants	0 Participants n=33 Participants	0 Participants n=3 Participants	1 Participants n=181 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=145 Participants	1 Participants n=33 Participants	0 Participants n=3 Participants	1 Participants n=181 Participants

PRIMARY outcome

Timeframe: Tumour assessments at baseline then every 12 weeks relative to date of enrolment until RECIST 1.1-defined progression. Assessed until primary analysis DCO of 17 April 2020 (up to maximum of 55 months).

Population: The FAS included all enrolled patients who were assigned olaparib. The primary endpoint results for PFS assessment included only BRCAm and sBRCAm patients.

Outcome measures

Outcome measures
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=55 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
Progression-Free Survival (PFS)	18.0 months Interval 14.3 to 22.1	16.6 months Interval 12.4 to 22.2

SECONDARY outcome

Timeframe: From baseline until death due to any cause. Assessed until primary analysis DCO of 17 April 2020 (up to maximum of 55 months).

Population: The FAS included all enrolled patients who were assigned olaparib. The secondary endpoint results for OS assessment included only BRCAm and sBRCAm patients.

To assess the real-world clinical effectiveness of olaparib maintenance monotherapy in patients with BRCAm and sBRCAm ovarian cancer by assessment of OS. The OS was defined as the time from the date of enrolment until death due to any cause regardless of whether the patient withdrew from therapy or received another anti-cancer therapy. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Pre-specified analysis of OS was performed at the time of primary analysis of PFS; a further analysis of OS was performed after approximately 60% maturity of OS in the sBRCAm and all BRCAm patient populations (and reported as a separate outcome measure).

Outcome measures

Outcome measures
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=55 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
Overall Survival (OS); Assessed at Primary Analysis	47.6 months Interval 36.1 to The upper limit 95% confidence interval (CI) could not be calculated as it was not reached.	NA months Interval 33.2 to The median and upper limit 95% CI could not be calculated as they were not reached.

SECONDARY outcome

Timeframe: Tumour assessments (and blood samples for CA-125, if applicable) at baseline then every 12 weeks relative to date of enrolment until second progression. Assessed until primary analysis DCO of 17 April 2020 (up to maximum of 55 months).

Population: The FAS included all enrolled patients who were assigned olaparib. The secondary endpoint results for PFS2 assessment included only BRCAm and sBRCAm patients.

To assess the real-world clinical effectiveness of olaparib maintenance monotherapy in patients with BRCAm and sBRCAm ovarian cancer by assessment of PFS2. The PFS2 was defined as the time from the date of enrolment to the earliest progression event subsequent to that used for the primary variable PFS or death (by any cause) in the absence of progression. Patients whose progression event for PFS was death had this counted as a progression event for PFS2 also. The date of second progression was recorded by the Investigator and defined according to local standard clinical practice and could involve any of the following: objective radiological, symptomatic, cancer antigen-125 (CA-125) progression or death. Pre-specified analysis of PFS2 was performed at the time of the primary analysis; a further analysis of PFS2 was performed at the final analysis (and reported as a separate outcome measure).

Outcome measures

Outcome measures
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=55 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
Time to Second Progression (PFS2) or Death; Assessed at Primary Analysis	30.9 months Interval 24.7 to 40.0	24.7 months Interval 21.8 to 36.1

SECONDARY outcome

Timeframe: From enrolment to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until primary analysis DCO of 17 April 2020 (up to maximum of 55 months).

Population: The FAS included all enrolled patients who were assigned olaparib. The secondary endpoint results for TFST assessment included only BRCAm and sBRCAm patients.

To assess the real-world clinical effectiveness of olaparib maintenance monotherapy in patients with BRCAm and sBRCAm ovarian cancer by assessment of TFST. The TFST was defined as the time from the date of enrolment to the earlier of first subsequent anti-cancer therapy start date (excluding radiotherapy), or death date. Pre-specified analysis of TFST was performed at the time of the primary analysis; a further analysis of TFST was performed at the final analysis (and reported as a separate outcome measure).

Outcome measures

Outcome measures
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=55 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
Time to First Subsequent Therapy (Treatment) or Death (TFST); Assessed at Primary Analysis	37.6 months Interval 23.5 to 47.6	31.5 months Interval 19.5 to The upper limit 95% CI could not be calculated as it was not reached.

SECONDARY outcome

Timeframe: From enrolment to second subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until primary analysis DCO of 17 April 2020 (up to maximum of 55 months).

Population: The FAS included all enrolled patients who were assigned olaparib. The secondary endpoint results for TSST assessment included only BRCAm and sBRCAm patients.

To assess the real-world clinical effectiveness of olaparib maintenance monotherapy in patients with BRCAm and sBRCAm ovarian cancer by assessment of TSST. The TSST was defined as the time from the date of enrolment to the earlier of the date of second subsequent anti-cancer therapy start date, or death date. Pre-specified analysis of TSST was performed at the time of the primary analysis; a further analysis of TSST was performed at the final analysis (and reported as a separate outcome measure).

Outcome measures

Outcome measures
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=55 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
Time to Second Subsequent Therapy (Treatment) or Death (TSST); Assessed at Primary Analysis	47.6 months Interval 29.4 to The upper limit 95% CI could not be calculated as it was not reached.	NA months Interval 24.7 to The median and upper limit 95% CI could not be calculated as they were not reached.

SECONDARY outcome

Timeframe: From enrolment to study treatment discontinuation or death (up to maximum of 6 years).

Population: The FAS included all enrolled patients who were assigned olaparib. The secondary endpoint results for TDT assessment included only BRCAm and sBRCAm patients.

To assess the real-world clinical effectiveness of olaparib maintenance monotherapy in patients with BRCAm and sBRCAm ovarian cancer by assessment of TDT. The TDT was defined as the time from the date of enrolment to the earlier of the date of study treatment discontinuation or death.

Outcome measures

Outcome measures
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=55 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
Time to Discontinuation of Treatment or Death (TDT)	19.8 months Interval 14.3 to 22.9	19.0 months Interval 13.5 to 22.8

SECONDARY outcome

Timeframe: QoL questionnaires at baseline, Day 29 (Week 4), then every 12 weeks for 24 months or DCO for primary analysis, whichever came first. QoL questionnaires also collected at discontinuation of study treatment visit and 30 days post last dose.

Population: The FAS-FACT-O-TOI population included all enrolled patients who were assigned olaparib excluding patients who did not have FACT-O TOI score at baseline and patients who did not have any FACT-O TOI score post-baseline. The secondary endpoint results for FACT-O TOI assessment included only BRCAm and sBRCAm patients.

To assess the Quality of Life (QoL) of patients with BRCAm and sBRCAm ovarian cancer by evaluation of FACT-O TOI. The TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire version 4. The FACT-O TOI score ranges from 0-100, with a higher score indicating better QoL. A change (increase or decrease) in score of at least 10 points from baseline was defined as clinically meaningful. A positive change in score from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Overall BRCAm n=131 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=50 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time Week 4	-2.2 scores on a scale Standard Deviation 9.82	-1.9 scores on a scale Standard Deviation 9.59
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time Week 28	1.2 scores on a scale Standard Deviation 9.44	3.2 scores on a scale Standard Deviation 10.25
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time Week 40	1.6 scores on a scale Standard Deviation 10.72	4.1 scores on a scale Standard Deviation 10.48
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time Week 52	3.2 scores on a scale Standard Deviation 9.03	4.9 scores on a scale Standard Deviation 7.84
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time Week 64	1.8 scores on a scale Standard Deviation 9.88	0.8 scores on a scale Standard Deviation 9.72
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time Week 76	1.4 scores on a scale Standard Deviation 9.27	0.3 scores on a scale Standard Deviation 9.83
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time Week 88	2.0 scores on a scale Standard Deviation 9.97	1.5 scores on a scale Standard Deviation 10.86
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time Week 100	-0.2 scores on a scale Standard Deviation 9.41	-3.5 scores on a scale Standard Deviation 7.54
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time Week 16	-1.3 scores on a scale Standard Deviation 10.04	-0.3 scores on a scale Standard Deviation 10.85
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time Discontinuation of olaparib visit	-4.7 scores on a scale Standard Deviation 13.00	-7.4 scores on a scale Standard Deviation 15.53
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Trial Outcome Index (TOI) Scores Over Time 30 days post discontinuation	-8.0 scores on a scale Standard Deviation 13.45	-4.3 scores on a scale Standard Deviation 13.36

SECONDARY outcome

Population: The FAS-FACIT-F population included all enrolled patients who were assigned olaparib excluding patients who did not have FACIT-F total score at baseline and patients who did not have any FACIT-F total score post-baseline. The secondary endpoint results for FACIT-F assessment included only BRCAm and sBRCAm patients.

To assess the QoL of patients with BRCAm and sBRCAm ovarian cancer by evaluation of FACIT-F. The FACIT-F is a 13-item questionnaire to assess patients' fatigue experience and its impact on their daily lives over the past 7 days. The FACIT-F total score ranges from 0-52, with a higher score indicating a lower level of fatigue (and better QoL). Changes in scores of ≥3 points were defined to be clinically meaningful. A positive change in score from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Overall BRCAm n=136 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=53 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time Week 28	-1.2 scores on a scale Standard Deviation 7.95	-0.6 scores on a scale Standard Deviation 7.25
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time Week 52	0.6 scores on a scale Standard Deviation 7.43	1.3 scores on a scale Standard Deviation 7.25
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time Week 64	0.8 scores on a scale Standard Deviation 7.26	0.5 scores on a scale Standard Deviation 8.47
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time Week 4	-2.9 scores on a scale Standard Deviation 8.21	-2.9 scores on a scale Standard Deviation 7.58
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time Week 16	-2.5 scores on a scale Standard Deviation 7.54	-2.7 scores on a scale Standard Deviation 9.26
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time Week 40	-0.3 scores on a scale Standard Deviation 7.91	0.9 scores on a scale Standard Deviation 7.02
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time Week 76	-0.3 scores on a scale Standard Deviation 8.57	-1.1 scores on a scale Standard Deviation 8.74
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time Week 88	0.3 scores on a scale Standard Deviation 8.45	-0.9 scores on a scale Standard Deviation 5.81
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time Week 100	-0.4 scores on a scale Standard Deviation 8.59	-1.3 scores on a scale Standard Deviation 8.75
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time Discontinuation of olaparib visit	-2.3 scores on a scale Standard Deviation 9.01	-2.7 scores on a scale Standard Deviation 9.32
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores Over Time 30 days post discontinuation	-5.2 scores on a scale Standard Deviation 11.16	-3.8 scores on a scale Standard Deviation 9.65

SECONDARY outcome

Timeframe: FLIE questionnaires at baseline, weekly until Day 29 (Week 4), then every 12 weeks for 24 months or DCO for primary analysis, whichever came first. FLIE questionnaires also collected at discontinuation of study treatment visit and 30 days post last dose.

Population: The FAS-FLIE population included all enrolled patients who were assigned olaparib excluding patients who did not have FLIE total score at baseline and patients who did not have any FLIE total score post-baseline. The secondary endpoint results for FLIE assessment included only BRCAm and sBRCAm patients.

The FLIE captures the impact of nausea and vomiting on patient's QoL. The FLIE consists of 18 items (9 nausea-specific and 9 vomiting-specific items), rated from 1 to 7. Two domain scores and a total score are derived; the total score ranges 18-126 and a higher score indicates a lower impact (and better QoL). A positive change in score from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Overall BRCAm n=114 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=46 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 3	-4.1 scores on a scale Standard Deviation 14.57	-3.9 scores on a scale Standard Deviation 13.23
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 4	-4.8 scores on a scale Standard Deviation 18.48	-5.4 scores on a scale Standard Deviation 19.92
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 52	0.9 scores on a scale Standard Deviation 14.41	-1.9 scores on a scale Standard Deviation 11.64
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 64	-0.2 scores on a scale Standard Deviation 15.93	-1.0 scores on a scale Standard Deviation 20.77
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 76	0.9 scores on a scale Standard Deviation 14.14	0.6 scores on a scale Standard Deviation 6.60
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 88	2.2 scores on a scale Standard Deviation 10.04	-1.3 scores on a scale Standard Deviation 9.29
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 100	0.4 scores on a scale Standard Deviation 10.37	0.1 scores on a scale Standard Deviation 13.19
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Discontinuation of olaparib visit	-0.7 scores on a scale Standard Deviation 20.17	-8.8 scores on a scale Standard Deviation 21.57
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time 30 days post discontinuation	-5.2 scores on a scale Standard Deviation 17.02	-5.6 scores on a scale Standard Deviation 15.69
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 1	-6.1 scores on a scale Standard Deviation 18.62	-1.6 scores on a scale Standard Deviation 18.28
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 2	-4.5 scores on a scale Standard Deviation 18.40	-2.6 scores on a scale Standard Deviation 15.97
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 16	-2.3 scores on a scale Standard Deviation 11.50	-6.3 scores on a scale Standard Deviation 11.00
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 28	-1.6 scores on a scale Standard Deviation 13.87	-3.0 scores on a scale Standard Deviation 7.94
Change From Baseline in Functional Living Index-Emesis (FLIE) Questionnaire Total Scores Over Time Week 40	-0.1 scores on a scale Standard Deviation 14.07	-3.2 scores on a scale Standard Deviation 14.56

SECONDARY outcome

Timeframe: From baseline until death due to any cause (up to maximum of 6 years).

Population: The FAS included all enrolled patients who were assigned olaparib. The secondary endpoint results for OS assessment included only BRCAm and sBRCAm patients.

Outcome measures

Outcome measures
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=55 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
OS; Assessed at Final Analysis	46.8 months Interval 37.9 to 54.4	43.2 months Interval 31.7 to The upper limit 95% CI could not be calculated as it was not reached.

SECONDARY outcome

Timeframe: Tumour assessments (and blood samples for CA-125, if applicable) at baseline then every 12 weeks relative to date of enrolment until second progression (up to maximum of 6 years).

Population: The FAS included all enrolled patients who were assigned olaparib. The secondary endpoint results for PFS2 assessment included only BRCAm and sBRCAm patients.

Outcome measures

Outcome measures
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=55 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
PFS2 or Death; Assessed at Final Analysis	34.0 months Interval 29.3 to 44.2	29.3 months Interval 23.7 to 44.2

SECONDARY outcome

Timeframe: From enrolment to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation (up to maximum of 6 years).

Population: The FAS included all enrolled patients who were assigned olaparib. The secondary endpoint results for TFST assessment included only BRCAm and sBRCAm patients.

Outcome measures

Outcome measures
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=55 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
TFST; Assessed at Final Analysis	32.1 months Interval 25.8 to 40.0	31.7 months Interval 18.0 to The upper limit 95% CI could not be calculated as it was not reached.

SECONDARY outcome

Timeframe: From enrolment to second subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation (up to maximum of 6 years).

Population: The FAS included all enrolled patients who were assigned olaparib. The secondary endpoint results for TSST assessment included only BRCAm and sBRCAm patients.

Outcome measures

Outcome measures
Measure	Overall BRCAm n=145 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	sBRCAm n=55 Participants Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).
TSST; Assessed at Final Analysis	38.4 months Interval 31.5 to The upper limit 95% CI could not be calculated as it was not reached.	32.1 months Interval 25.8 to 44.7

Adverse Events

gBRCAm

Serious events: 27 serious events

Other events: 79 other events

Deaths: 40 deaths

sBRCAm

Serious events: 13 serious events

Other events: 51 other events

Deaths: 28 deaths

Overall BRCAm

Serious events: 40 serious events

Other events: 131 other events

Deaths: 68 deaths

HRRm

Serious events: 7 serious events

Other events: 29 other events

Deaths: 14 deaths

Unassigned (Not BRCAm, Not HRRm^)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	gBRCAm n=87 participants at risk Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had gBRCAm disease (i.e. confirmed germline mutation).	sBRCAm n=55 participants at risk Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).	Overall BRCAm n=143 participants at risk Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	HRRm n=32 participants at risk Patients received olaparib capsules orally 400 mg twice daily. Patients in this exploratory cohort had a qualifying mutation in any of the 13 genes involved in the HRR pathway (excluding BRCA1 and BRCA2) (i.e. BRCA-independent HRRm\^).	Unassigned (Not BRCAm, Not HRRm^) n=2 participants at risk Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort were not classified as being a part of either the BRCAm group or the HRRm\^ group and were enrolled in error.
Blood and lymphatic system disorders Anaemia	8.0% 7/87 • Number of events 10 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.1% 5/55 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	8.4% 12/143 • Number of events 16 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 10 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/143 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Cardiac disorders Angina unstable	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Cardiac disorders Atrial fibrillation	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Cardiac disorders Cardiac failure	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Cardiac disorders Myocardial infarction	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/143 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Eye disorders Glaucoma	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Mesenteric vein thrombosis	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
General disorders Sudden death	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Colonic abscess	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
General disorders Pyrexia	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Hepatobiliary disorders Biliary colic	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Urinary tract infection	3.4% 3/87 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	2.1% 3/143 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Lower respiratory tract infection	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Injury, poisoning and procedural complications Procedural pain	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	2.3% 2/87 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.4% 2/143 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's lymphoma	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Nervous system disorders Dysarthria	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/143 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Nervous system disorders Transient ischaemic attack	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Vascular disorders Deep vein thrombosis	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Ear and labyrinth disorders Vertigo	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/143 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Abdominal hernia	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.0% 1/2 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Subileus	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Vomiting	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Immune system disorders Contrast media allergy	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Immune system disorders Drug hypersensitivity	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Gastroenteritis viral	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/143 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Sepsis	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Investigations Platelet count decreased	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.4% 3/87 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	2.1% 3/143 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).

Other adverse events

Other adverse events
Measure	gBRCAm n=87 participants at risk Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had gBRCAm disease (i.e. confirmed germline mutation).	sBRCAm n=55 participants at risk Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had sBRCAm disease (i.e. confirmed somatic mutation).	Overall BRCAm n=143 participants at risk Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort had BRCAm status, comprising of those with sBRCAm or gBRCAm disease, as well as any patients where the germline or somatic BRCA mutation status was not determined.	HRRm n=32 participants at risk Patients received olaparib capsules orally 400 mg twice daily. Patients in this exploratory cohort had a qualifying mutation in any of the 13 genes involved in the HRR pathway (excluding BRCA1 and BRCA2) (i.e. BRCA-independent HRRm\^).	Unassigned (Not BRCAm, Not HRRm^) n=2 participants at risk Patients received olaparib capsules orally 400 mg twice daily. Patients in this cohort were not classified as being a part of either the BRCAm group or the HRRm\^ group and were enrolled in error.
Blood and lymphatic system disorders Anaemia	43.7% 38/87 • Number of events 55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	34.5% 19/55 • Number of events 31 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	39.9% 57/143 • Number of events 86 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	34.4% 11/32 • Number of events 16 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.0% 1/2 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Blood and lymphatic system disorders Leukopenia	6.9% 6/87 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.6% 2/55 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.6% 8/143 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Blood and lymphatic system disorders Neutropenia	13.8% 12/87 • Number of events 16 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.3% 4/55 • Number of events 10 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	11.2% 16/143 • Number of events 26 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Blood and lymphatic system disorders Thrombocytopenia	5.7% 5/87 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	10.9% 6/55 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.7% 11/143 • Number of events 12 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Abdominal distension	6.9% 6/87 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.6% 2/55 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.6% 8/143 • Number of events 9 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.4% 3/32 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Abdominal pain	12.6% 11/87 • Number of events 11 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	21.8% 12/55 • Number of events 20 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	16.1% 23/143 • Number of events 31 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	25.0% 8/32 • Number of events 9 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Abdominal pain lower	3.4% 3/87 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	2.1% 3/143 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.4% 3/32 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Abdominal pain upper	10.3% 9/87 • Number of events 13 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.3% 4/55 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.1% 13/143 • Number of events 19 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Constipation	5.7% 5/87 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	14.5% 8/55 • Number of events 9 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.1% 13/143 • Number of events 15 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	15.6% 5/32 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Diarrhoea	17.2% 15/87 • Number of events 16 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	16.4% 9/55 • Number of events 11 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	16.8% 24/143 • Number of events 27 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	25.0% 8/32 • Number of events 9 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Gastrooesophageal reflux disease	3.4% 3/87 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	2.1% 3/143 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.0% 1/2 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Nausea	56.3% 49/87 • Number of events 86 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.9% 28/55 • Number of events 36 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	54.5% 78/143 • Number of events 123 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	59.4% 19/32 • Number of events 30 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Vomiting	27.6% 24/87 • Number of events 41 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	25.5% 14/55 • Number of events 27 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	26.6% 38/143 • Number of events 68 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	31.2% 10/32 • Number of events 25 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.0% 1/2 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
General disorders Asthenia	14.9% 13/87 • Number of events 19 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	20.0% 11/55 • Number of events 14 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	16.8% 24/143 • Number of events 33 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
General disorders Fatigue	43.7% 38/87 • Number of events 46 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	40.0% 22/55 • Number of events 25 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	42.0% 60/143 • Number of events 71 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	46.9% 15/32 • Number of events 18 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.0% 1/2 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
General disorders Influenza like illness	8.0% 7/87 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.6% 2/55 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.3% 9/143 • Number of events 10 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Bronchitis	5.7% 5/87 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.2% 6/143 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Influenza	8.0% 7/87 • Number of events 13 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.9% 7/143 • Number of events 13 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Nasopharyngitis	10.3% 9/87 • Number of events 12 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	8.4% 12/143 • Number of events 16 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Respiratory tract infection	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	2.1% 3/143 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Upper respiratory tract infection	2.3% 2/87 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	10.9% 6/55 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.6% 8/143 • Number of events 9 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Urinary tract infection	5.7% 5/87 • Number of events 9 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	10.9% 6/55 • Number of events 13 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.7% 11/143 • Number of events 22 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	12.5% 4/32 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/143 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.0% 1/2 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Investigations Alanine aminotransferase increased	8.0% 7/87 • Number of events 11 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.6% 8/143 • Number of events 12 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Investigations Blood creatinine increased	9.2% 8/87 • Number of events 21 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.7% 11/143 • Number of events 24 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	12.5% 4/32 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Investigations Glomerular filtration rate decreased	2.3% 2/87 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.5% 5/143 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Investigations Neutrophil count decreased	5.7% 5/87 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.6% 2/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.9% 7/143 • Number of events 11 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.0% 1/2 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Investigations Platelet count decreased	5.7% 5/87 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.2% 6/143 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Investigations White blood cell count decreased	5.7% 5/87 • Number of events 14 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.6% 2/55 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.9% 7/143 • Number of events 21 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Metabolism and nutrition disorders Decreased appetite	11.5% 10/87 • Number of events 10 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	12.7% 7/55 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	11.9% 17/143 • Number of events 18 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	15.6% 5/32 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Musculoskeletal and connective tissue disorders Back pain	8.0% 7/87 • Number of events 11 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.3% 4/55 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.7% 11/143 • Number of events 15 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.4% 3/32 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.6% 4/87 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.1% 5/55 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.3% 9/143 • Number of events 10 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Musculoskeletal and connective tissue disorders Myalgia	4.6% 4/87 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.5% 5/143 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Musculoskeletal and connective tissue disorders Pain in extremity	4.6% 4/87 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.6% 2/55 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.2% 6/143 • Number of events 9 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.4% 3/32 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Nervous system disorders Dizziness	14.9% 13/87 • Number of events 21 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.6% 2/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	10.5% 15/143 • Number of events 24 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	15.6% 5/32 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Nervous system disorders Dysgeusia	9.2% 8/87 • Number of events 10 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.7% 11/143 • Number of events 13 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	12.5% 4/32 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Nervous system disorders Headache	12.6% 11/87 • Number of events 16 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 11 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.8% 14/143 • Number of events 27 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	18.8% 6/32 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Psychiatric disorders Anxiety	4.6% 4/87 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.9% 7/143 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Psychiatric disorders Depression	4.6% 4/87 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.9% 7/143 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Psychiatric disorders Insomnia	8.0% 7/87 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.3% 4/55 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.7% 11/143 • Number of events 11 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Psychiatric disorders Irritability	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/143 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.0% 1/2 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Dyspepsia	16.1% 14/87 • Number of events 27 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	14.5% 8/55 • Number of events 10 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	16.1% 23/143 • Number of events 38 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	15.6% 5/32 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Gastrointestinal disorders Haemorrhoids	1.1% 1/87 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
General disorders Mucosal inflammation	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	2.8% 4/143 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
General disorders Oedema peripheral	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	10.9% 6/55 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.2% 6/143 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
General disorders Peripheral swelling	5.7% 5/87 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.6% 2/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.9% 7/143 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
General disorders Pyrexia	6.9% 6/87 • Number of events 9 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.6% 2/55 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.6% 8/143 • Number of events 13 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Infections and infestations Oral candidiasis	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Metabolism and nutrition disorders Hypomagnesaemia	6.9% 6/87 • Number of events 20 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.6% 2/55 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.6% 8/143 • Number of events 22 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Metabolism and nutrition disorders Vitamin d deficiency	2.3% 2/87 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.5% 5/143 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Musculoskeletal and connective tissue disorders Arthralgia	12.6% 11/87 • Number of events 15 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	10.9% 6/55 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	11.9% 17/143 • Number of events 23 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Nervous system disorders Taste disorder	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/143 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.0% 1/2 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Psychiatric disorders Personality change	0.00% 0/87 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/143 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/32 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	50.0% 1/2 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Respiratory, thoracic and mediastinal disorders Cough	10.3% 9/87 • Number of events 12 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.1% 5/55 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.8% 14/143 • Number of events 17 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	18.8% 6/32 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.3% 9/87 • Number of events 25 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.3% 4/55 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.1% 13/143 • Number of events 33 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	18.8% 6/32 • Number of events 7 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.4% 3/87 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	1.8% 1/55 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	2.8% 4/143 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Skin and subcutaneous tissue disorders Alopecia	8.0% 7/87 • Number of events 9 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.3% 4/55 • Number of events 4 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	7.7% 11/143 • Number of events 13 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Skin and subcutaneous tissue disorders Pruritus	4.6% 4/87 • Number of events 5 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.9% 7/143 • Number of events 8 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Skin and subcutaneous tissue disorders Rash	3.4% 3/87 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.2% 6/143 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	9.4% 3/32 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Vascular disorders Deep vein thrombosis	1.1% 1/87 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/55 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.70% 1/143 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	6.2% 2/32 • Number of events 2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).
Vascular disorders Hypertension	3.4% 3/87 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	5.5% 3/55 • Number of events 3 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	4.2% 6/143 • Number of events 6 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	3.1% 1/32 • Number of events 1 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).	0.00% 0/2 • From first dose of olaparib up to and including 30 days following the date of discontinuation of olaparib. Maximum timeframe of approximately 6 years. Adverse events are reported for the safety analysis set which included all patients who received at least one dose of olaparib. All- cause mortality was determined for patients in the FAS (enrolled and assigned olaparib).

Additional Information

Global Clinical Lead

AstraZeneca

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Email: [email protected]

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Principal investigator is a sponsor employee
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