Trial Outcomes & Findings for A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU) (NCT NCT03459846)

NCT ID: NCT03459846

Last Updated: 2026-01-30

Results Overview

Progression-free survival based on investigator assessments according to RECIST 1.1

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 154 participants
• Primary outcome timeframe: Assessments performed at baseline and every 8 weeks from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), assessed up to the data cut-off date (15 Oct 2020), up to a max. of 31 months
• Results posted on: 2026-01-30

Participant Flow

Participant milestones

Measure	Durva + Olaparib Patients received a combination of durvalumab 1500mg intravenous (IV) every 4 weeks (q4w) with olaparib 300mg orally (PO) twice daily (BID) adjusted based on patient's creatinine clearance	Durva + Placebo Patients received durvalumab 1500mg IV q4w and placebo PO BID
Overall Study STARTED	78	76
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	78	76

Reasons for withdrawal

Measure	Durva + Olaparib Patients received a combination of durvalumab 1500mg intravenous (IV) every 4 weeks (q4w) with olaparib 300mg orally (PO) twice daily (BID) adjusted based on patient's creatinine clearance	Durva + Placebo Patients received durvalumab 1500mg IV q4w and placebo PO BID
Overall Study Death	52	46
Overall Study Study terminated by sponsor	24	28
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

Baseline characteristics by cohort

Measure	Durva + Olaparib n=78 Participants Patients received a combination of durvalumab 1500mg intravenous (IV) every 4 weeks (q4w) with olaparib 300mg orally (PO) twice daily (BID) adjusted based on patient's creatinine clearance	Durva + Placebo n=76 Participants Patients received durvalumab 1500mg IV q4w and placebo PO BID	Total n=154 Participants Total of all reporting groups
Age, Continuous	73.4 Years STANDARD_DEVIATION 10.8 • n=35 Participants	70.2 Years STANDARD_DEVIATION 10.26 • n=4328 Participants	71.9 Years STANDARD_DEVIATION 10.62 • n=8687 Participants
Sex: Female, Male Female	22 Participants n=35 Participants	21 Participants n=4328 Participants	43 Participants n=8687 Participants
Sex: Female, Male Male	56 Participants n=35 Participants	55 Participants n=4328 Participants	111 Participants n=8687 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=35 Participants	3 Participants n=4328 Participants	6 Participants n=8687 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	75 Participants n=35 Participants	73 Participants n=4328 Participants	148 Participants n=8687 Participants

PRIMARY outcome

Timeframe: Assessments performed at baseline and every 8 weeks from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), assessed up to the data cut-off date (15 Oct 2020), up to a max. of 31 months

Population: Full analysis set

Progression-free survival based on investigator assessments according to RECIST 1.1

Outcome measures

Measure	Durva + Olaparib n=78 Participants Patients received a combination of durvalumab 1500mg intravenous (IV) every 4 weeks (q4w) with olaparib 300mg orally (PO) twice daily (BID) adjusted based on patient's creatinine clearance	Durva + Placebo n=76 Participants Patients received durvalumab 1500mg IV q4w and placebo PO BID
Progression-free Survival (PFS)	4.2 Months Interval 3.6 to 5.6	3.5 Months Interval 1.9 to 5.1

SECONDARY outcome

Timeframe: From the date of randomization until the death due to any cause, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months

Population: Full analysis set

Number of Participants with Overall Survival (OS), where OS was defined as the time from the date of randomization until death due to any cause.

Outcome measures

Measure	Durva + Olaparib n=78 Participants Patients received a combination of durvalumab 1500mg intravenous (IV) every 4 weeks (q4w) with olaparib 300mg orally (PO) twice daily (BID) adjusted based on patient's creatinine clearance	Durva + Placebo n=76 Participants Patients received durvalumab 1500mg IV q4w and placebo PO BID
Overall Survival (OS) Died	52 Participants	46 Participants
Overall Survival (OS) Censored (includes subjects with unknown survival status or subjects who were lost to follow up)	26 Participants	30 Participants

SECONDARY outcome

Timeframe: From the date of randomization to the date of progression or the last evaluable assessment in the absence of progression, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months

Population: Full analysis set

ORR (per RECIST 1.1 using Investigator assessments) is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions; PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters

Outcome measures

Measure	Durva + Olaparib n=78 Participants Patients received a combination of durvalumab 1500mg intravenous (IV) every 4 weeks (q4w) with olaparib 300mg orally (PO) twice daily (BID) adjusted based on patient's creatinine clearance	Durva + Placebo n=76 Participants Patients received durvalumab 1500mg IV q4w and placebo PO BID
Objective Response Rate (ORR) Response	22 Participants	14 Participants
Objective Response Rate (ORR) No Response	56 Participants	62 Participants

SECONDARY outcome

Timeframe: Tumor assessments every 8 weeks after randomization for the first 48 weeks and then every 12 weeks thereafter until the date of objective disease progression. Assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months

Population: Duration of Response (DoR) was calculated for all responders (N=36)

Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression

Outcome measures

Measure	Durva + Olaparib n=22 Participants Patients received a combination of durvalumab 1500mg intravenous (IV) every 4 weeks (q4w) with olaparib 300mg orally (PO) twice daily (BID) adjusted based on patient's creatinine clearance	Durva + Placebo n=14 Participants Patients received durvalumab 1500mg IV q4w and placebo PO BID
Duration of Response (DoR)	8.9 Months Interval 4.7 to 12.1	14.8 Months Interval 7.5 to 17.2

Adverse Events

Durva + Olaparib

Serious events: 37 serious events

Other events: 65 other events

Deaths: 52 deaths

Durva + Placebo

Serious events: 26 serious events

Other events: 63 other events

Deaths: 46 deaths

Serious adverse events

Measure	Durva + Olaparib n=76 participants at risk Patients received a combination of durvalumab 1500mg intravenous (IV) every 4 weeks (q4w) with olaparib 300mg orally (PO) twice daily (BID) adjusted based on patient's creatinine clearance	Durva + Placebo n=76 participants at risk Patients received durvalumab 1500mg IV q4w and placebo PO BID
Infections and infestations Urinary tract infection	7.9% 6/76 • Number of events 7 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	7.9% 6/76 • Number of events 7 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Blood and lymphatic system disorders Anaemia	6.6% 5/76 • Number of events 5 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Renal and urinary disorders Renal failure	5.3% 4/76 • Number of events 4 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Renal and urinary disorders Haematuria	3.9% 3/76 • Number of events 5 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Renal and urinary disorders Hydronephrosis	3.9% 3/76 • Number of events 3 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Pneumonia	3.9% 3/76 • Number of events 3 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	2.6% 2/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Renal and urinary disorders Chronic kidney disease	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Renal and urinary disorders Acute kidney injury	2.6% 2/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	3.9% 3/76 • Number of events 3 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Kidney infection	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Klebsiella infection	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Septic shock	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Peritonitis	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Escherichia bacteraemia	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Oral candidiasis	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Urosepsis	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Candida infection	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Pyelonephritis chronic	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Blood and lymphatic system disorders Neutropenia	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Cardiac disorders Acute coronary syndrome	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Cardiac disorders Atrioventricular block	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Ear and labyrinth disorders Vertigo positional	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Endocrine disorders Hyperthyroidism	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Eye disorders Cataract	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Abdominal pain	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Gastric haemorrhage	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Nausea	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Small intestinal obstruction	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Colitis	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Constipation	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Diarrhoea	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Intestinal obstruction	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
General disorders Fatigue	2.6% 2/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
General disorders Pyrexia	2.6% 2/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
General disorders Asthenia	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Injury, poisoning and procedural complications Hip fracture	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Injury, poisoning and procedural complications Femur fracture	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Investigations Blood creatinine increased	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Investigations Transaminases increased	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Metabolism and nutrition disorders Dehydration	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Metabolism and nutrition disorders Hyponatraemia	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Musculoskeletal and connective tissue disorders Bone pain	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of prostate	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Nervous system disorders Myasthenia gravis	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Renal and urinary disorders Ureteric obstruction	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Renal and urinary disorders Urinary retention	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Reproductive system and breast disorders Genital haemorrhage	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Reproductive system and breast disorders Balanoposthitis	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Respiratory, thoracic and mediastinal disorders Immune-mediated pneumonitis	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Skin and subcutaneous tissue disorders Rash	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76

Other adverse events

Measure	Durva + Olaparib n=76 participants at risk Patients received a combination of durvalumab 1500mg intravenous (IV) every 4 weeks (q4w) with olaparib 300mg orally (PO) twice daily (BID) adjusted based on patient's creatinine clearance	Durva + Placebo n=76 participants at risk Patients received durvalumab 1500mg IV q4w and placebo PO BID
Blood and lymphatic system disorders Anaemia	44.7% 34/76 • Number of events 50 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	27.6% 21/76 • Number of events 22 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Endocrine disorders Hypothyroidism	9.2% 7/76 • Number of events 7 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	5.3% 4/76 • Number of events 5 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Nausea	26.3% 20/76 • Number of events 23 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	7.9% 6/76 • Number of events 6 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Constipation	17.1% 13/76 • Number of events 14 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	15.8% 12/76 • Number of events 15 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Diarrhoea	13.2% 10/76 • Number of events 12 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	6.6% 5/76 • Number of events 7 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Vomiting	9.2% 7/76 • Number of events 8 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	2.6% 2/76 • Number of events 3 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Abdominal pain	7.9% 6/76 • Number of events 6 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	2.6% 2/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Abdominal pain upper	5.3% 4/76 • Number of events 4 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Gastrointestinal disorders Dyspepsia	2.6% 2/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	5.3% 4/76 • Number of events 4 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
General disorders Fatigue	28.9% 22/76 • Number of events 25 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	17.1% 13/76 • Number of events 13 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
General disorders Asthenia	13.2% 10/76 • Number of events 11 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	2.6% 2/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
General disorders Pyrexia	9.2% 7/76 • Number of events 7 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	9.2% 7/76 • Number of events 9 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
General disorders Oedema peripheral	3.9% 3/76 • Number of events 3 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	5.3% 4/76 • Number of events 5 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Infections and infestations Urinary tract infection	11.8% 9/76 • Number of events 11 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	5.3% 4/76 • Number of events 4 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Investigations Blood creatinine increased	10.5% 8/76 • Number of events 9 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	5.3% 4/76 • Number of events 4 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Investigations Amylase increased	5.3% 4/76 • Number of events 5 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	2.6% 2/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Investigations Gamma-glutamyltransferase increased	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	5.3% 4/76 • Number of events 4 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Metabolism and nutrition disorders Decreased appetite	25.0% 19/76 • Number of events 22 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	13.2% 10/76 • Number of events 10 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Metabolism and nutrition disorders Hyperglycaemia	5.3% 4/76 • Number of events 4 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	2.6% 2/76 • Number of events 2 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Metabolism and nutrition disorders Hypokalaemia	3.9% 3/76 • Number of events 4 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	5.3% 4/76 • Number of events 4 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Musculoskeletal and connective tissue disorders Back pain	10.5% 8/76 • Number of events 8 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	9.2% 7/76 • Number of events 7 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Musculoskeletal and connective tissue disorders Arthralgia	6.6% 5/76 • Number of events 7 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	6.6% 5/76 • Number of events 6 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Nervous system disorders Dizziness	9.2% 7/76 • Number of events 7 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	3.9% 3/76 • Number of events 3 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Nervous system disorders Headache	3.9% 3/76 • Number of events 3 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	5.3% 4/76 • Number of events 7 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Psychiatric disorders Insomnia	3.9% 3/76 • Number of events 3 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	5.3% 4/76 • Number of events 4 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Renal and urinary disorders Haematuria	9.2% 7/76 • Number of events 8 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	7.9% 6/76 • Number of events 6 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Reproductive system and breast disorders Pelvic pain	0.00% 0/76 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	5.3% 4/76 • Number of events 5 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.2% 7/76 • Number of events 7 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	3.9% 3/76 • Number of events 3 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Respiratory, thoracic and mediastinal disorders Cough	7.9% 6/76 • Number of events 6 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	7.9% 6/76 • Number of events 6 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Skin and subcutaneous tissue disorders Rash	9.2% 7/76 • Number of events 9 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	7.9% 6/76 • Number of events 6 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Skin and subcutaneous tissue disorders Pruritus	7.9% 6/76 • Number of events 6 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	10.5% 8/76 • Number of events 8 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76
Vascular disorders Hypertension	1.3% 1/76 • Number of events 1 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76	7.9% 6/76 • Number of events 6 • From first administration of study treatment until 90 days after the last dose of study medication, assessed up to the data cut-off date (15 October 2020), to a maximum of 31 months There were 78 subjects randomised to Durva + Olaparib (Full Analysis Set), however 2 of these subjects did not receive treatment (resulting in 76 in the Safety Analysis Set). Hence, for Durva + Olaparib, the Total number at risk for all-cause mortality = 78 while the Total # at Risk by any Serious Adverse Event = 76 and the Total # at Risk by any Other Adverse Event = 76

Additional Information

Global Clinical Lead

AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

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