Trial Outcomes & Findings for Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy (NCT NCT01874353)

Last Updated: 2025-08-03

Results Overview

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

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

327 participants

Primary outcome timeframe

Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.

Results posted on

2025-08-03

Participant Flow

Global Cohort: First patient screened: 03 Sep 2013; last patient screened on 21 Nov 2014. 602 patients screened across 119 centres in 16 countries; 295 were randomized. Results are reported for analysis of PFS (DCO: 19 Sep 2016) and OS (DCO: 03 Feb 2020). China Cohort: First patient enrolled: 07 Apr 2015; last patient enrolled: 30 Oct 2015. 127 patients screened across 16 sites; 32 were randomized. Results are reported for analysis of PFS (DCO: 16 Jan 2017) and OS (DCO: 03 Feb 2020).

It was planned that approximately 264 women from the Global Cohort and 33 women from the China Cohort, with BRCA mutated relapsed ovarian cancer who are in complete or partial response following platinum based chemotherapy, were to receive olaparib 300 mg bd or matching placebo in a 2:1 ratio.

Participant milestones

Participant milestones
Measure	Olaparib 300mg Tablets (Global Cohort) Taken orally twice daily	Placebo Tablets (Global Cohort) Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) Taken orally twice daily	Placebo Tablets (China Cohort) Taken orally twice daily
Overall Study STARTED	196	99	22	10
Overall Study COMPLETED	69	26	7	3
Overall Study NOT COMPLETED	127	73	15	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Olaparib 300mg Tablets (Global Cohort) Taken orally twice daily	Placebo Tablets (Global Cohort) Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) Taken orally twice daily	Placebo Tablets (China Cohort) Taken orally twice daily
Overall Study One patient was unblinded and one patient was randomised in error	2	0	0	0
Overall Study Lost to Follow-up	2	2	2	0
Overall Study Death	110	60	13	7
Overall Study Withdrawal by Subject	13	11	0	0

Baseline Characteristics

There are 196 Olaparib patients in the Global Cohort and 22 in the China Cohort (Total = 218). There are 99 Placebo patients in the Global Cohort and 10 in the China Cohort (Total = 109)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.

Population: Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment, excluding China \[Primary analysis\] China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.

Outcome measures

Outcome measures
Measure	Olaparib 300mg Tablets (Global Cohort) n=196 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=99 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=22 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=10 Participants Taken orally twice daily
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)	19.1 Months Interval 16.3 to 25.7	5.5 Months Interval 5.2 to 5.8	13.8 Months Interval 6.5 to 16.6	5.5 Months Interval 2.7 to Insufficient PFS events to estimate upper 95% CI

SECONDARY outcome

Timeframe: Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.

Population: Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS).

Outcome measures

Outcome measures
Measure	Olaparib 300mg Tablets (Global Cohort) n=196 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=99 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=22 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=10 Participants Taken orally twice daily
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival	51.7 Months Interval 41.5 to 59.1	38.8 Months Interval 31.4 to 48.6	41.7 Months Interval 17.6 to Insufficient OS events to estimate upper 95% CI	36.4 Months Interval 13.2 to Insufficient OS events to estimate upper 95% CI

SECONDARY outcome

Timeframe: CA-125 at baseline then every 4 wks. Radiologic scans at baseline then every ~12 wks up to 72 wks, then every ~ 24 wks until objective radiological disease progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths.

Population: Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China). China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.

Outcome measures

Outcome measures
Measure	Olaparib 300mg Tablets (Global Cohort) n=196 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=99 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=22 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=10 Participants Taken orally twice daily
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death	16.9 Months Interval 14.6 to 22.3	4.9 Months Interval 3.7 to 5.6	12.9 Months Interval 5.9 to 14.0	3.7 Months Interval 1.0 to 7.4

SECONDARY outcome

Timeframe: Scans at baseline then every 12 wks for 72 wks, then every 24 wks until first progression. Assessments then per local practice every 12 wks until second progression. Assessed until 19Sep2016 DCO (16Jan2017 DCO for China Cohort); up to a max of 36 mths

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up to second progression

Outcome measures

Outcome measures
Measure	Olaparib 300mg Tablets (Global Cohort) n=196 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=99 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=22 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=10 Participants Taken orally twice daily
Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression	NA Months Interval 24.1 to Insufficient PFS2 events to estimate upper 95% CI	18.4 Months Interval 15.4 to 22.8	NA Months Insufficient PFS2 events to estimate median and 95% CI	17.3 Months Interval 6.0 to 17.3

SECONDARY outcome

Timeframe: Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months. Assessed until 19 Sep 2016 DCO.

Population: Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) with a baseline and post baseline TOI score available \[This endpoint was not assessed in the China Cohort\]

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

Outcome measures

Outcome measures
Measure	Olaparib 300mg Tablets (Global Cohort) n=185 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=94 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) Taken orally twice daily	Placebo Tablets (China Cohort) Taken orally twice daily
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)	-2.90 Change in TOI over 12 months Interval -4.131 to -1.673	-2.87 Change in TOI over 12 months Interval -4.643 to -1.097	—	—

SECONDARY outcome

Timeframe: Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to first subsequent therapy or death (TFST).

Outcome measures

Outcome measures
Measure	Olaparib 300mg Tablets (Global Cohort) n=196 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=99 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=22 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=10 Participants Taken orally twice daily
Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST)	27.4 Months Interval 22.6 to 31.1	7.2 Months Interval 6.3 to 8.5	13.9 Months Interval 9.1 to 15.9	5.5 Months Interval 1.4 to 18.4

SECONDARY outcome

Timeframe: Time elapsed from randomization to second subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.

Outcome measures

Outcome measures
Measure	Olaparib 300mg Tablets (Global Cohort) n=196 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=99 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=22 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=10 Participants Taken orally twice daily
Efficacy of Olaparib by Time to Second Subsequent Therapy or Death (TSST)	35.8 Months Interval 29.4 to 43.9	18.9 Months Interval 15.5 to 21.5	19.0 Months Interval 10.1 to 32.8	26.4 Months Interval 6.3 to 36.0

SECONDARY outcome

Timeframe: Time elapsed from randomization to study treatment discontinuation or death. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.

Outcome measures

Outcome measures
Measure	Olaparib 300mg Tablets (Global Cohort) n=196 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=99 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) n=22 Participants Taken orally twice daily	Placebo Tablets (China Cohort) n=10 Participants Taken orally twice daily
Efficacy of Olaparib by Time From Randomization to Study Treatment Discontinuation or Death (TDT)	19.4 Months Interval 14.9 to 25.9	5.6 Months Interval 5.0 to 6.8	13.4 Months Interval 6.3 to 16.5	4.7 Months Interval 1.3 to 11.1

SECONDARY outcome

Timeframe: Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression. Assessed until 19 Sep 2016 DCO.

Population: Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) and confirmed as Myriad gBRCAm \[This endpoint was not assessed in the China Cohort\]

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

Outcome measures

Outcome measures
Measure	Olaparib 300mg Tablets (Global Cohort) n=190 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) n=96 Participants Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) Taken orally twice daily	Placebo Tablets (China Cohort) Taken orally twice daily
Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS.	19.3 Months Interval 16.5 to 27.3	5.5 Months Interval 5.0 to 5.8	—	—

SECONDARY outcome

Timeframe: Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose. Assessed until 19 Sep 2016 DCO.

Population: Pharmacokinetic (PK) Analysis Set - all patients who receive study treatment as per protocol, do not violate or deviate from the protocol in ways that would significantly affect the PK analyses and have valid PK data. The PK Analysis Set is a subset of the Global FAS; PK analysis was not performed in the China Cohort.

To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy

Outcome measures

Outcome measures
Measure	Olaparib 300mg Tablets (Global Cohort) n=93 Participants Taken orally twice daily	Placebo Tablets (Global Cohort) Taken orally twice daily	Olaparib 300mg Tablets (China Cohort) Taken orally twice daily	Placebo Tablets (China Cohort) Taken orally twice daily
To Determine the Exposure to Olaparib by Pharmacokinetic Analysis Day 1 - Pre-dose	NA mcg/mL Geometric Coefficient of Variation NA Prior to receiving olaparib so not calculated	—	—	—
To Determine the Exposure to Olaparib by Pharmacokinetic Analysis Day 1 - 1 hour	3.26 mcg/mL Geometric Coefficient of Variation 312.2	—	—	—
To Determine the Exposure to Olaparib by Pharmacokinetic Analysis Day 15 - Pre-dose	0.92 mcg/mL Geometric Coefficient of Variation 95.5	—	—	—
To Determine the Exposure to Olaparib by Pharmacokinetic Analysis Day 15 - 1 hour	5.12 mcg/mL Geometric Coefficient of Variation 61.8	—	—	—
To Determine the Exposure to Olaparib by Pharmacokinetic Analysis Day 29 - Pre-dose	0.94 mcg/mL Geometric Coefficient of Variation 179.0	—	—	—

Adverse Events

Olaparib 300 Tablets (Global Cohort)

Serious events: 50 serious events

Other events: 192 other events

Deaths: 116 deaths

Placebo Tablets (Global Cohort)

Serious events: 8 serious events

Other events: 91 other events

Deaths: 65 deaths

Olaparib 300 Tablets (China Cohort)

Serious events: 5 serious events

Other events: 21 other events

Deaths: 13 deaths

Placebo Tablets (China Cohort)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Program Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Serious adverse events
Measure	Olaparib 300 Tablets (Global Cohort) n=195 participants at risk Taken orally twice daily	Placebo Tablets (Global Cohort) n=99 participants at risk Taken orally twice daily	Olaparib 300 Tablets (China Cohort) n=22 participants at risk Taken orally twice daily	Placebo Tablets (China Cohort) n=10 participants at risk Taken orally twice daily
Blood and lymphatic system disorders Anaemia	4.1% 8/195 • Number of events 13 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	9.1% 2/22 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Blood and lymphatic system disorders Febrile neutropenia	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Blood and lymphatic system disorders Neutropenia	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.5% 1/22 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Cardiac disorders Coronary artery stenosis	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Cardiac disorders Myocardial infarction	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Cardiac disorders Pericarditis	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Abdominal hernia	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Abdominal pain	2.1% 4/195 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Ascites	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Dysphagia	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Food poisoning	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.5% 1/22 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Intestinal obstruction	2.1% 4/195 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Nausea	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	2.0% 2/99 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Subileus	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
General disorders Malaise	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
General disorders Oedema peripheral	0.51% 1/195 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
General disorders Pyrexia	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Immune system disorders Anaphylactic reaction	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Infections and infestations Gastroenteritis	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Infections and infestations Neutropenic sepsis	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Infections and infestations Pneumonia	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Infections and infestations Urinary tract infection	1.0% 2/195 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Injury, poisoning and procedural complications Incisional hernia	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations Blood creatine phosphokinase increased	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations White blood cell count decreased	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.5% 1/22 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Musculoskeletal and connective tissue disorders Muscular weakness	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	2.1% 4/195 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.51% 1/195 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Blood and lymphatic system disorders Leukopenia	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.5% 1/22 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Constipation	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	2.0% 2/99 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Enteritis	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Vomiting	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
General disorders Fatigue	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.

Other adverse events
Measure	Olaparib 300 Tablets (Global Cohort) n=195 participants at risk Taken orally twice daily	Placebo Tablets (Global Cohort) n=99 participants at risk Taken orally twice daily	Olaparib 300 Tablets (China Cohort) n=22 participants at risk Taken orally twice daily	Placebo Tablets (China Cohort) n=10 participants at risk Taken orally twice daily
Blood and lymphatic system disorders Anaemia	42.6% 83/195 • Number of events 149 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	9.1% 9/99 • Number of events 9 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	31.8% 7/22 • Number of events 14 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Blood and lymphatic system disorders Leukopenia	10.8% 21/195 • Number of events 35 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	18.2% 4/22 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Blood and lymphatic system disorders Neutropenia	13.8% 27/195 • Number of events 47 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	5.1% 5/99 • Number of events 12 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	22.7% 5/22 • Number of events 7 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Blood and lymphatic system disorders Thrombocytopenia	9.2% 18/195 • Number of events 22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	3.0% 3/99 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	13.6% 3/22 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	20.0% 2/10 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Abdominal distension	6.7% 13/195 • Number of events 13 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	7.1% 7/99 • Number of events 7 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	13.6% 3/22 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	30.0% 3/10 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Abdominal pain	27.2% 53/195 • Number of events 90 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	31.3% 31/99 • Number of events 34 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	13.6% 3/22 • Number of events 6 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Abdominal pain upper	12.3% 24/195 • Number of events 27 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	13.1% 13/99 • Number of events 14 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	13.6% 3/22 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Constipation	23.6% 46/195 • Number of events 65 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	23.2% 23/99 • Number of events 30 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.5% 1/22 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Diarrhoea	34.4% 67/195 • Number of events 128 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	20.2% 20/99 • Number of events 28 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	18.2% 4/22 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Dry mouth	6.2% 12/195 • Number of events 19 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.0% 4/99 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Flatulence	5.1% 10/195 • Number of events 11 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.7% 15/195 • Number of events 15 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.0% 4/99 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.5% 1/22 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Mouth ulceration	2.6% 5/195 • Number of events 19 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	9.1% 2/22 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Stomatitis	10.3% 20/195 • Number of events 39 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	6.1% 6/99 • Number of events 7 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.5% 1/22 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Vomiting	39.5% 77/195 • Number of events 153 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	20.2% 20/99 • Number of events 27 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	36.4% 8/22 • Number of events 17 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
General disorders Fatigue	38.5% 75/195 • Number of events 91 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	15.2% 15/99 • Number of events 22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	31.8% 7/22 • Number of events 11 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	20.0% 2/10 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
General disorders Influenza like illness	7.7% 15/195 • Number of events 18 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
General disorders Malaise	2.6% 5/195 • Number of events 5 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	2.0% 2/99 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	9.1% 2/22 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Infections and infestations Bronchitis	6.7% 13/195 • Number of events 14 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	2.0% 2/99 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Infections and infestations Herpes zoster	2.1% 4/195 • Number of events 9 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	2.0% 2/99 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Infections and infestations Nasopharyngitis	12.8% 25/195 • Number of events 48 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	11.1% 11/99 • Number of events 14 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	9.1% 2/22 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations Alanine aminotransferase increased	5.1% 10/195 • Number of events 15 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.0% 4/99 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	13.6% 3/22 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	20.0% 2/10 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations Aspartate aminotransferase increased	2.6% 5/195 • Number of events 6 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	4.0% 4/99 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	9.1% 2/22 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations Bilirubin conjugated increased	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations Blood bilirubin increased	0.51% 1/195 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations Blood bilirubin unconjugated increased	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations Blood creatinine increased	10.3% 20/195 • Number of events 29 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations Haemoglobin decreased	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/99 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations Neutrophil count decreased	9.2% 18/195 • Number of events 39 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	22.7% 5/22 • Number of events 12 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Investigations Platelet count decreased	7.7% 15/195 • Number of events 31 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	18.2% 4/22 • Number of events 13 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Metabolism and nutrition disorders Decreased appetite	22.6% 44/195 • Number of events 59 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	11.1% 11/99 • Number of events 11 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	36.4% 8/22 • Number of events 10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	20.0% 2/10 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Musculoskeletal and connective tissue disorders Pain in extremity	9.2% 18/195 • Number of events 23 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	7.1% 7/99 • Number of events 8 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/195 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	2.0% 2/99 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	9.1% 2/22 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.51% 1/195 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Nervous system disorders Dizziness	17.4% 34/195 • Number of events 43 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	6.1% 6/99 • Number of events 7 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	18.2% 4/22 • Number of events 4 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Anal fissure	1.0% 2/195 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	1.0% 1/99 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 1 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Dyspepsia	14.9% 29/195 • Number of events 43 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	9.1% 9/99 • Number of events 9 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/22 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
Gastrointestinal disorders Nausea	75.9% 148/195 • Number of events 290 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	35.4% 35/99 • Number of events 48 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	81.8% 18/22 • Number of events 33 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	10.0% 1/10 • Number of events 3 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.
General disorders Asthenia	31.8% 62/195 • Number of events 107 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	27.3% 27/99 • Number of events 29 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	9.1% 2/22 • Number of events 2 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.	0.00% 0/10 • Includes adverse events with an onset date on or after the date of first dose and up to and including 30 days following the date of last dose of olaparib/placebo.