Trial Outcomes & Findings for Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer (NCT NCT00628251)

Last Updated: 2019-12-05

Results Overview

PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

Results posted on

2019-12-05

Participant Flow

First patient enrolled on 30 July 2008 and last patient on 3 March 2009 at 25 centres in 9 countries

97 of 125 screened women with advanced BRCA 1/2 ovarian cancer who had chemotherapy were randomized

Participant milestones

Participant milestones
Measure	Olaparib 200 mg bd Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Randomised Part STARTED	32	32	33
Randomised Part COMPLETED	32	32	32
Randomised Part NOT COMPLETED	0	0	1
Ongoing Initial Study Treatment at DCO STARTED	32	32	32
Ongoing Initial Study Treatment at DCO Discontinued Initial Study Treatment	22	20	25
Ongoing Initial Study Treatment at DCO Crossover to Olaparib	0	0	14
Ongoing Initial Study Treatment at DCO Ongoing Crossover at DCO	0	0	5
Ongoing Initial Study Treatment at DCO Discontinued Crossover	0	0	9
Ongoing Initial Study Treatment at DCO COMPLETED	10	12	7
Ongoing Initial Study Treatment at DCO NOT COMPLETED	22	20	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Olaparib 200 mg bd Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Randomised Part Withdrawal by Subject	0	0	1
Ongoing Initial Study Treatment at DCO Adverse Event	1	2	3
Ongoing Initial Study Treatment at DCO Condition under investigation worsened	19	15	13
Ongoing Initial Study Treatment at DCO Withdrawal by Subject	1	2	1
Ongoing Initial Study Treatment at DCO Other reason	0	1	6
Ongoing Initial Study Treatment at DCO Other	1	0	2

Baseline Characteristics

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Total n=97 Participants Total of all reporting groups
Age, Continuous	57.2 Years STANDARD_DEVIATION 8.53 • n=93 Participants	53.8 Years STANDARD_DEVIATION 8.77 • n=4 Participants	54.3 Years STANDARD_DEVIATION 9.32 • n=27 Participants	55.5 Years STANDARD_DEVIATION 8.92 • n=483 Participants
Sex: Female, Male Female	32 Participants n=93 Participants	32 Participants n=4 Participants	33 Participants n=27 Participants	97 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race/Ethnicity, Customized African-Caribbean	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Ashkenazi Jewish	8 Participants n=93 Participants	10 Participants n=4 Participants	11 Participants n=27 Participants	29 Participants n=483 Participants
Race/Ethnicity, Customized Sephardic Jewish	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Not applicable	20 Participants n=93 Participants	21 Participants n=4 Participants	19 Participants n=27 Participants	60 Participants n=483 Participants
Race/Ethnicity, Customized Other	4 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants
BRCA status Deleterious BRCA1 mutation	26 Participants n=93 Participants	28 Participants n=4 Participants	27 Participants n=27 Participants	81 Participants n=483 Participants
BRCA status Deleterious BRCA2 mutation	6 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants	16 Participants n=483 Participants

PRIMARY outcome

Timeframe: Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Progression Free Survival (PFS)	19 Participants	20 Participants	20 Participants	—

PRIMARY outcome

Timeframe: Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Progression Free Survival (PFS)	6.5 Months Interval 5.5 to 10.1	8.8 Months Interval 5.4 to 9.2	7.1 Months Interval 3.7 to 10.7	—

SECONDARY outcome

Timeframe: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Objective Response Rate (ORR) Complete response	0 Participants	0 Participants	0 Participants	—
Objective Response Rate (ORR) Number of Partial responders	8 Participants	10 Participants	6 Participants	—

SECONDARY outcome

Timeframe: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) \>4 months, divided by the number of randomised patients

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Disease Control Rate	21 Participants	21 Participants	19 Participants	—

SECONDARY outcome

Timeframe: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Population: Duration of response is analysed for patients experiencing a response.

The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=8 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=10 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=18 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin n=6 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Overall Duration of Response	5.95 Months Interval 3.71 to The upper limit for the 95% CI was not reached.	6.80 Months Interval 5.52 to 7.39	6.24 Months Interval 5.52 to 7.39	5.49 Months Interval 4.67 to 9.13

SECONDARY outcome

Timeframe: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Best Percentage Change in Tumour Size	-15.90 Percent change Interval -75.3 to 31.48	-24.60 Percent change Interval -100.0 to 51.1	-14.3 Percent change Interval -87.5 to 32.4	—

SECONDARY outcome

Timeframe: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Best percentage change in cancer antigen 125 (CA-125) levels

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=30 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=31 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Best Percentage Change From Baseline in CA-125 Levels	-37.42 Percent change Interval -98.77 to 327.76	-71.19 Percent change Interval -96.88 to 70.56	-55.8 Percent change Interval -99.5 to 192.1	—

SECONDARY outcome

Timeframe: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Confirmed RECIST Response and/or CA-125 Response	37.5 Percentage of participants	59.4 Percentage of participants	39.4 Percentage of participants	—

SECONDARY outcome

Timeframe: At the time of the cut-off for the final analysis of overall survival (30 April 2010)

OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Overall Survival (OS)	9 Participants	11 Participants	13 Participants	—

SECONDARY outcome

Timeframe: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Population: Evaluable for TOI at baseline

Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100.

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Best Quality of Life (QoL) Response for Trial Outcome Index (TOI) Improved	7 Participants	5 Participants	3 Participants	—
Best Quality of Life (QoL) Response for Trial Outcome Index (TOI) No change	10 Participants	10 Participants	11 Participants	—
Best Quality of Life (QoL) Response for Trial Outcome Index (TOI) Worsened	3 Participants	7 Participants	6 Participants	—
Best Quality of Life (QoL) Response for Trial Outcome Index (TOI) Non-evaluable	5 Participants	7 Participants	7 Participants	—

SECONDARY outcome

Timeframe: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Population: Evaluable for FACT-O at baseline

Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Improved	3 Participants	6 Participants	1 Participants	—
Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) No Change	14 Participants	11 Participants	11 Participants	—
Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Worsened	3 Participants	5 Participants	7 Participants	—
Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Non-evaluable	5 Participants	7 Participants	8 Participants	—

SECONDARY outcome

Timeframe: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Population: Evaluable for FOSI at baseline

Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3.

Outcome measures

Outcome measures
Measure	Olaparib 200 mg bd n=32 Participants Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 Participants Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=33 Participants Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks	Liposomal Doxorubicin Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Best QoL Response for FACT-O Symptom Index (FOSI) Non-evaluable	5 Participants	7 Participants	7 Participants	—
Best QoL Response for FACT-O Symptom Index (FOSI) Improved	5 Participants	4 Participants	3 Participants	—
Best QoL Response for FACT-O Symptom Index (FOSI) No change	14 Participants	9 Participants	10 Participants	—
Best QoL Response for FACT-O Symptom Index (FOSI) Worsened	1 Participants	9 Participants	7 Participants	—

Adverse Events

Olaparib 200 mg bd

Serious events: 5 serious events

Other events: 32 other events

Deaths: 0 deaths

Olaparib 400 mg bd

Serious events: 6 serious events

Other events: 32 other events

Deaths: 0 deaths

Liposomal Doxorubicin

Serious events: 5 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Paula del Rosario

AstraZeneca

Phone: +44 7884 735492

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No publication of the study results may be made until publication of the results of the multi-centre study or 2 years after study completion, whichever is the sooner
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Olaparib 200 mg bd n=32 participants at risk Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 participants at risk Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=32 participants at risk Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Gastrointestinal disorders Vomiting	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Constipation	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Intestinal Obstruction	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Nausea	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Subileus	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
General disorders Fatigue	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
General disorders Pyrexia	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Hepatobiliary disorders Cholelithiasis	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Infections and infestations Bacteraemia	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Injury, poisoning and procedural complications Overdose	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Injury, poisoning and procedural complications Haemoglobin Decreased	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Nervous system disorders Cerebrovascular Accident	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Nervous system disorders Syncope	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Vascular disorders Deep Vein Thrombosis	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.

Other adverse events
Measure	Olaparib 200 mg bd n=32 participants at risk Olaparib (AZD2281) 200 mg oral capsules twice daily	Olaparib 400 mg bd n=32 participants at risk Olaparib (AZD2281) 400 mg oral capsules twice daily	Liposomal Doxorubicin n=32 participants at risk Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
Infections and infestations Gastroenteritis	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Infections and infestations Intertrigo Candida	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Infections and infestations Rhinitis	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Infections and infestations Tinea Pedis	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Infections and infestations Tonsillitis	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Infections and infestations Viral Infection	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Blood and lymphatic system disorders Anaemia	12.5% 4/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	34.4% 11/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Blood and lymphatic system disorders Neutropenia	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	9.4% 3/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	18.8% 6/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Blood and lymphatic system disorders Leukopenia	15.6% 5/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Blood and lymphatic system disorders Thrombocytopenia	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Cardiac disorders Palpitations	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Eye disorders Dry Eye	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Nausea	59.4% 19/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	78.1% 25/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	56.2% 18/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	59.4% 19/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Vomiting	34.4% 11/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	50.0% 16/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	31.2% 10/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Abdominal Pain	37.5% 12/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	25.0% 8/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	37.5% 12/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Constipation	28.1% 9/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	18.8% 6/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	37.5% 12/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Diarrhoea	25.0% 8/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	37.5% 12/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	31.2% 10/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Dyspepsia	15.6% 5/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	21.9% 7/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	21.9% 7/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Abdominal Distension	9.4% 3/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	9.4% 3/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	15.6% 5/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Dry Mouth	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	12.5% 4/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	9.4% 3/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Flatulence	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	12.5% 4/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	9.4% 3/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Haemorrhoids	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	9.4% 3/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Abdominal Pain Upper	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Ascites	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Gastritis	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Oral Pain	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
Gastrointestinal disorders Salivary Hypersecretion	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
General disorders Fatigue	37.5% 12/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	65.6% 21/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	43.8% 14/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
General disorders Asthenia	18.8% 6/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	34.4% 11/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	12.5% 4/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
General disorders Mucosal Inflammation	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	21.9% 7/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
General disorders Pyrexia	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	12.5% 4/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	12.5% 4/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
General disorders Chills	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	9.4% 3/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
General disorders Oedema Peripheral	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	9.4% 3/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.
General disorders Pain	0.00% 0/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	3.1% 1/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.	6.2% 2/32 AEs reported = all events up to OS data cut-off. After PFS data cut-off, AEs only collected for olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at time of PFS. One patient was recorded as crossing over to olaparib but not receiving cross-over treatment.