Trial Outcomes & Findings for Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (NCT NCT02184195)

NCT ID: NCT02184195

Last Updated: 2023-09-13

Results Overview

To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 154 participants
• Primary outcome timeframe: Up to 4 years
• Results posted on: 2023-09-13

Participant Flow

This study randomised patients at a total of 59 study centres in 12 countries: United States of America (13), Germany (8), France (7), Israel (7), Spain (7), United Kingdom (6), Italy (4), Belgium (2), Republic of Korea (2), Australia (1), Canada (1) and Netherlands (1).

Screening Part 1 was only required if a patient's gBRCAm status was unknown and Screening Part 2 was for patients with known local germline BRCA (gBRCA) test. All other screening parameters were done as per the Study Schedule.

Participant milestones

Measure	Olaparib 300 mg Twice Daily (bd) Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Study STARTED	92	62
Overall Study COMPLETED	19	7
Overall Study NOT COMPLETED	73	55

Reasons for withdrawal

Measure	Olaparib 300 mg Twice Daily (bd) Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Study Patient decision	5	2
Overall Study Eligibility criteria not fulfilled	0	1
Overall Study Death	67	44
Overall Study Lost to Follow-up	1	5
Overall Study Other	0	3

Baseline Characteristics

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy

Baseline characteristics by cohort

Measure	Olaparib 300 mg Twice Daily (bd) n=92 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=62 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Total n=154 Participants Total of all reporting groups
Age, Continuous	58.2 Years STANDARD_DEVIATION 10.27 • n=93 Participants	56.4 Years STANDARD_DEVIATION 9.07 • n=4 Participants	57.5 Years STANDARD_DEVIATION 9.81 • n=27 Participants
Sex: Female, Male Female	39 Participants n=93 Participants	31 Participants n=4 Participants	70 Participants n=27 Participants
Sex: Female, Male Male	53 Participants n=93 Participants	31 Participants n=4 Participants	84 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=93 Participants	60 Participants n=4 Participants	148 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	82 Participants n=93 Participants	59 Participants n=4 Participants	141 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 4 years

Population: Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.

To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.

Outcome measures

Measure	Olaparib 300 mg Twice Daily (bd) n=92 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=62 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)	7.4 Months Interval 4.14 to 11.01	3.8 Months Interval 3.52 to 4.86

SECONDARY outcome

Timeframe: Upto 4 years

Population: Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.

To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.

Outcome measures

Measure	Olaparib 300 mg Twice Daily (bd) n=92 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=62 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Overall Survival (OS)	19.0 Months Interval 15.28 to 26.32	19.2 Months Interval 14.32 to 26.12

SECONDARY outcome

Timeframe: Up to 4 years

Population: Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.

To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.

Outcome measures

Measure	Olaparib 300 mg Twice Daily (bd) n=92 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=62 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Time From Randomisation to Second Progression (PFS2)	16.9 Months Interval 8.21 to 23.85	9.3 Months Interval 8.15 to 13.54

SECONDARY outcome

Timeframe: Up to 4 years

Population: Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.

To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.

Outcome measures

Measure	Olaparib 300 mg Twice Daily (bd) n=92 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=62 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Time From Randomisation to Second Subsequent Therapy or Death (TSST)	14.9 Months Interval 9.13 to 19.78	9.6 Months Interval 8.34 to 12.98

SECONDARY outcome

Timeframe: Up to 4 years

Population: Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.

To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.

Outcome measures

Measure	Olaparib 300 mg Twice Daily (bd) n=92 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=62 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Time From Randomisation to First Subsequent Therapy or Death (TFST)	9.0 Months Interval 6.21 to 12.85	5.4 Months Interval 3.94 to 6.21

SECONDARY outcome

Timeframe: Up to 4 years

Population: Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.

To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.

Outcome measures

Measure	Olaparib 300 mg Twice Daily (bd) n=92 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=62 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Time From Randomisation to Study Treatment Discontinuation or Death (TDT)	7.5 Months Interval 5.52 to 10.97	3.8 Months Interval 3.61 to 4.8

SECONDARY outcome

Timeframe: Up to 4 years

Population: All randomised patients with measurable disease at baseline.

To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.

Outcome measures

Measure	Olaparib 300 mg Twice Daily (bd) n=72 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=49 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1	22 Participants	11 Participants

SECONDARY outcome

Timeframe: At 16 weeks

Population: Intention to treat (ITT): All randomised patients

Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.

Outcome measures

Measure	Olaparib 300 mg Twice Daily (bd) n=92 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=62 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1 Yes	51 Participants	24 Participants
Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1 No	34 Participants	34 Participants
Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1 Not evaluable/missing	7 Participants	4 Participants

SECONDARY outcome

Timeframe: From baseline up to 6 months

Population: Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.

To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.

A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.

bd twice daily.

Outcome measures

Measure	Olaparib 300 mg Twice Daily (bd) n=84 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=55 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire	-1.03 Unit on scale Interval -3.826 to 1.759	1.18 Unit on scale Interval -2.585 to 4.939

SECONDARY outcome

Timeframe: Up to 4 years

Population: Safety Analysis Set consisted of all patients who received at least one dose of study treatment.

To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events

Outcome measures

Measure	Olaparib 300 mg Twice Daily (bd) n=90 Participants Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=61 Participants Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Number of Participants With Adverse Events (AEs) Any AE	89 Participants	56 Participants
Number of Participants With Adverse Events (AEs) Any AE of CTCAE Grade 3 or higher	44 Participants	15 Participants
Number of Participants With Adverse Events (AEs) Any AE with outcome = death	1 Participants	0 Participants
Number of Participants With Adverse Events (AEs) Any SAE (including events with outcome = death)	28 Participants	10 Participants
Number of Participants With Adverse Events (AEs) AnyAE leading to withdrawal of olaparib/placebo	8 Participants	1 Participants
Number of Participants With Adverse Events (AEs) Any AE leading to dose interruption	38 Participants	4 Participants
Number of Participants With Adverse Events (AEs) Any AE leading to dose reduction	16 Participants	3 Participants

Adverse Events

Olaparib 300 mg Twice Daily (bd)

Serious events: 28 serious events

Other events: 89 other events

Deaths: 68 deaths

Placebo

Serious events: 10 serious events

Other events: 56 other events

Deaths: 52 deaths

Serious adverse events

Measure	Olaparib 300 mg Twice Daily (bd) n=90 participants at risk Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=61 participants at risk Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Infections and infestations Abdominal infection	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Infections and infestations Bartholinitis	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Infections and infestations Pneumonia	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Infections and infestations Urinary tract infection	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Blood and lymphatic system disorders Anaemia	7.8% 7/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Endocrine disorders Hypothyroidism	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Metabolism and nutrition disorders Decreased appetite	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Nervous system disorders Cerebrovascular accident	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Nervous system disorders Embolic stroke	0.00% 0/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Nervous system disorders Transient ischaemic attack	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Cardiac disorders Cardiac failure	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Vascular disorders Vascular stenosis	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Abdominal pain	4.4% 4/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Constipation	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Duodenal perforation	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Gastric varices haemorrhage	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Incarcerated inguinal hernia	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Large intestinal obstruction	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Melaena	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Obstruction gastric	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Pancreatitis	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Vomiting	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	4.9% 3/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Hepatobiliary disorders Bile duct obstruction	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Hepatobiliary disorders Cholangitis	2.2% 2/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Hepatobiliary disorders Cholecystitis	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
General disorders General physical health deterioration	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Investigations Platelet count decreased	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Injury, poisoning and procedural complications Anastomotic haemorrhage	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Product Issues Device occlusion	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Product Issues Stent malfunction	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
General disorders Pyrexia	0.00% 0/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	3.3% 2/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Infections and infestations Bronchiolitis	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Infections and infestations Empyema	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Infections and infestations Pneumonia pneumococcal	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Infections and infestations Influenza	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Nervous system disorders Syncope	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Renal and urinary disorders Renal failure	0.00% 0/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Injury, poisoning and procedural complications Incisional hernia	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Injury, poisoning and procedural complications Infusion related reaction	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Product Issues Device dislocation	1.1% 1/90 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.

Other adverse events

Measure	Olaparib 300 mg Twice Daily (bd) n=90 participants at risk Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.	Placebo n=61 participants at risk Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
Gastrointestinal disorders Nausea	48.9% 44/90 • Number of events 66 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	24.6% 15/61 • Number of events 17 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Diarrhoea	37.8% 34/90 • Number of events 49 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	16.4% 10/61 • Number of events 11 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Abdominal pain	28.9% 26/90 • Number of events 39 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	24.6% 15/61 • Number of events 17 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Constipation	27.8% 25/90 • Number of events 33 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	11.5% 7/61 • Number of events 8 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Vomiting	25.6% 23/90 • Number of events 49 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	14.8% 9/61 • Number of events 12 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Stomatitis	8.9% 8/90 • Number of events 10 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	4.9% 3/61 • Number of events 3 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Abdominal pain upper	10.0% 9/90 • Number of events 11 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	14.8% 9/61 • Number of events 10 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Dry mouth	8.9% 8/90 • Number of events 8 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • Number of events 2 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Dyspepsia	10.0% 9/90 • Number of events 16 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	8.2% 5/61 • Number of events 5 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Abdominal distension	5.6% 5/90 • Number of events 6 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	9.8% 6/61 • Number of events 6 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Flatulence	2.2% 2/90 • Number of events 3 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	6.6% 4/61 • Number of events 4 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
General disorders Fatigue	46.7% 42/90 • Number of events 47 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	26.2% 16/61 • Number of events 19 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
General disorders Asthenia	17.8% 16/90 • Number of events 24 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	9.8% 6/61 • Number of events 6 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
General disorders Pyrexia	18.9% 17/90 • Number of events 28 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	6.6% 4/61 • Number of events 5 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
General disorders Oedema peripheral	8.9% 8/90 • Number of events 11 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	8.2% 5/61 • Number of events 5 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Musculoskeletal and connective tissue disorders Back pain	26.7% 24/90 • Number of events 28 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	21.3% 13/61 • Number of events 13 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Musculoskeletal and connective tissue disorders Arthralgia	21.1% 19/90 • Number of events 25 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	18.0% 11/61 • Number of events 11 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Musculoskeletal and connective tissue disorders Muscle spasms	6.7% 6/90 • Number of events 9 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	3.3% 2/61 • Number of events 2 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Musculoskeletal and connective tissue disorders Pain in extremity	8.9% 8/90 • Number of events 10 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	6.6% 4/61 • Number of events 4 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 6/90 • Number of events 6 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	4.9% 3/61 • Number of events 5 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Musculoskeletal and connective tissue disorders Flank pain	3.3% 3/90 • Number of events 3 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	6.6% 4/61 • Number of events 4 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Nervous system disorders Dysgeusia	6.7% 6/90 • Number of events 6 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	4.9% 3/61 • Number of events 3 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Nervous system disorders Neuropathy peripheral	10.0% 9/90 • Number of events 10 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	11.5% 7/61 • Number of events 7 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Nervous system disorders Dizziness	8.9% 8/90 • Number of events 8 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	4.9% 3/61 • Number of events 4 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Nervous system disorders Headache	8.9% 8/90 • Number of events 10 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	13.1% 8/61 • Number of events 8 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Nervous system disorders Peripheral sensory neuropathy	6.7% 6/90 • Number of events 6 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	3.3% 2/61 • Number of events 2 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Blood and lymphatic system disorders Anaemia	28.9% 26/90 • Number of events 35 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	16.4% 10/61 • Number of events 12 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Blood and lymphatic system disorders Neutropenia	8.9% 8/90 • Number of events 9 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	6.6% 4/61 • Number of events 4 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Blood and lymphatic system disorders Thrombocytopenia	8.9% 8/90 • Number of events 9 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	6.6% 4/61 • Number of events 4 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Metabolism and nutrition disorders Decreased appetite	26.7% 24/90 • Number of events 29 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	6.6% 4/61 • Number of events 5 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Metabolism and nutrition disorders Hyperglycaemia	8.9% 8/90 • Number of events 15 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.7% 1/60 • Number of events 1 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Skin and subcutaneous tissue disorders Rash	13.3% 12/90 • Number of events 15 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	4.9% 3/61 • Number of events 4 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Skin and subcutaneous tissue disorders Pruritus	10.0% 9/90 • Number of events 11 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	6.6% 4/61 • Number of events 4 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Investigations Alanine aminotransferase increased	11.1% 10/90 • Number of events 16 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • Number of events 1 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Investigations Aspartate aminotransferase increased	8.9% 8/90 • Number of events 14 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • Number of events 1 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Investigations Blood creatinine increased	7.8% 7/90 • Number of events 12 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	3.3% 2/61 • Number of events 2 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Investigations Blood alkaline phosphatase increased	6.7% 6/90 • Number of events 7 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	4.9% 3/61 • Number of events 3 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Investigations Platelet count decreased	5.6% 5/90 • Number of events 9 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Psychiatric disorders Insomnia	8.9% 8/90 • Number of events 8 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • Number of events 1 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Psychiatric disorders Anxiety	10.0% 9/90 • Number of events 10 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	3.3% 2/61 • Number of events 2 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Psychiatric disorders Depression	5.6% 5/90 • Number of events 6 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.1% 10/90 • Number of events 11 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	4.9% 3/61 • Number of events 4 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 9/90 • Number of events 13 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	3.3% 2/61 • Number of events 3 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Infections and infestations Nasopharyngitis	13.3% 12/90 • Number of events 21 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	3.3% 2/61 • Number of events 2 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Infections and infestations Influenza	6.7% 6/90 • Number of events 8 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.6% 5/90 • Number of events 5 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	3.3% 2/61 • Number of events 2 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
General disorders Influenza like illness	6.7% 6/90 • Number of events 6 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Nervous system disorders Paraesthesia	2.2% 2/90 • Number of events 3 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	6.6% 4/61 • Number of events 4 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Blood and lymphatic system disorders Lymphopenia	5.6% 5/90 • Number of events 9 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Investigations Weight decreased	7.8% 7/90 • Number of events 7 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	4.9% 3/61 • Number of events 3 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Investigations Gamma-glutamyltransferase increased	6.7% 6/90 • Number of events 9 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	1.6% 1/61 • Number of events 1 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Investigations Neutrophil count decreased	6.7% 6/90 • Number of events 16 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	0.00% 0/61 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.
Vascular disorders Hypertension	5.6% 5/90 • Number of events 12 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.	4.9% 3/61 • Number of events 3 • From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years). Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.

Additional Information

Global Clinical Leader

AstraZeneca AB

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee This submission /document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
• Publication restrictions are in place

Restriction type: OTHER