Trial Outcomes & Findings for Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer. (NCT NCT01924533)

NCT ID: NCT01924533

Last Updated: 2024-03-22

Results Overview

Time from the date of randomization until death due to any cause

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 525 participants
• Primary outcome timeframe: Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years
• Results posted on: 2024-03-22

Participant Flow

The number of participants in the participant flow (525) includes all participants who were eligible and assigiend to each treatment group.

Participant milestones

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 Placebo tablets bd + Paclitaxel 80 mg/m\^2
Overall Study STARTED	263	262
Overall Study COMPLETED	74	57
Overall Study NOT COMPLETED	189	205

Reasons for withdrawal

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 Placebo tablets bd + Paclitaxel 80 mg/m\^2
Overall Study Death	181	200
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	7	3
Overall Study Other Eligibility criteria	1	1

Baseline Characteristics

The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.

Baseline characteristics by cohort

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=263 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=262 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2	Total n=525 Participants Total of all reporting groups
Age, Continuous	57.0 Years STANDARD_DEVIATION 12.08 • n=48 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	60.9 Years STANDARD_DEVIATION 9.90 • n=46 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	58.9 Years STANDARD_DEVIATION 11.18 • n=94 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
Age, Customized >=18 - <50	12 Participants n=48 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	7 Participants n=46 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	19 Participants n=94 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
Age, Customized >=50 - <65	22 Participants n=48 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	24 Participants n=46 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	46 Participants n=94 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
Age, Customized >=65	14 Participants n=48 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	15 Participants n=46 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	29 Participants n=94 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
Sex: Female, Male Female	89 Participants n=263 Participants	77 Participants n=262 Participants	166 Participants n=525 Participants
Sex: Female, Male Male	174 Participants n=263 Participants	185 Participants n=262 Participants	359 Participants n=525 Participants
Race/Ethnicity, Customized Not Hispanic Or Latino	263 Participants n=263 Participants	262 Participants n=262 Participants	525 Participants n=525 Participants
Race/Ethnicity, Customized Asian	48 Participants n=48 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	46 Participants n=46 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	94 Participants n=94 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
Race/Ethnicity, Customized Not Hispanic or Latino	48 Participants n=48 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	46 Participants n=46 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	94 Participants n=94 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
ATM Status Negative	48 Participants n=263 Participants	46 Participants n=262 Participants	94 Participants n=525 Participants
ATM Status Positive	200 Participants n=263 Participants	196 Participants n=262 Participants	396 Participants n=525 Participants
ATM Status Unknown	15 Participants n=263 Participants	20 Participants n=262 Participants	35 Participants n=525 Participants
Gastrectomy Status Full	13 Participants n=48 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	13 Participants n=46 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	26 Participants n=94 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
Gastrectomy Status None	16 Participants n=48 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	21 Participants n=46 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	37 Participants n=94 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
Gastrectomy Status Partial	19 Participants n=48 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	12 Participants n=46 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.	31 Participants n=94 Participants • The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.

PRIMARY outcome

Timeframe: Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years

Population: Full analysis set population

Time from the date of randomization until death due to any cause

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=263 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=262 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Overall Survival	82 participants	62 participants

PRIMARY outcome

Timeframe: Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years

Population: Full analysis set - ATM negative population

Time from the date of randomization until death due to any cause

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=48 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=46 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Overall Survival	19 participants	11 participants

SECONDARY outcome

Timeframe: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years

Population: FAS analysis set population

Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion.

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=263 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=262 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Progression-Free Survival (PFS)	47 participants	29 participants

SECONDARY outcome

Timeframe: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years

Population: FAS analysis set - ATM negative population

Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion.

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=48 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=46 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Progression-Free Survival (PFS)	11 participants	7 participants

SECONDARY outcome

Timeframe: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years

Population: Full analysis set population

Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=263 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=262 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Number of Patients With Objective Response.	44 participants	28 participants

SECONDARY outcome

Timeframe: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years

Population: Full analysis set - ATM negative population

Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=48 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=46 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Number of Patients Objective Response	12 participants	5 participants

SECONDARY outcome

Timeframe: Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years

Population: Patients whose baseline HRQoL score \>=10 in full analysis set population

Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=240 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=249 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale	160 participants	177 participants

SECONDARY outcome

Timeframe: Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years

Population: Patients whose baseline HRQoL score \>=10 in full analysis set ATM negative population

Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=41 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=43 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale	29 participants	33 participants

SECONDARY outcome

Timeframe: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years

Population: Patients with objective response in full analysis set population

Time from randomization to the first onset of a confirmed objective tumour response

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=44 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=28 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Time to Response	57.0 days Interval 54.5 to 64.0	57.0 days Interval 56.0 to 111.5

SECONDARY outcome

Timeframe: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years

Population: Patients with objective response in full analysis set ATM negative population

Time from randomization to the first onset of a confirmed objective tumour response

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=12 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=5 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Time to Response	57.5 days Interval 57.0 to 113.0	57.0 days Interval 55.0 to 58.0

SECONDARY outcome

Timeframe: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years

Population: Patients with objective response in full analysis set population

Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=44 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=28 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Duration of Response	166.0 days Interval 89.0 to 218.0	64.0 days Interval 54.0 to 186.0

SECONDARY outcome

Timeframe: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years

Population: Patients with objective response in full analysis set ATM negative population

Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits

Outcome measures

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=12 Participants Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=5 Participants Placebo tablets bd + Paclitaxel 80 mg/m\^2
Duration of Response	171.0 days Interval 124.0 to 350.0	108.0 days Interval 57.0 to 113.0

Adverse Events

Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2

Serious events: 92 serious events

Other events: 257 other events

Deaths: 181 deaths

Placebo Tablets bd + Paclitaxel 80 mg/m^2

Serious events: 65 serious events

Other events: 253 other events

Deaths: 200 deaths

Serious adverse events

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=262 participants at risk Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=259 participants at risk Placebo tablets bd + Paclitaxel 80 mg/m\^2
Metabolism and nutrition disorders Dehydration	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Anaemia	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Bone marrow disorder	2.3% 6/262 • Number of events 7 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	1.2% 3/259 • Number of events 4 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Febrile neutropenia	1.9% 5/262 • Number of events 5 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.77% 2/259 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Granulocytopenia	1.9% 5/262 • Number of events 6 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.77% 2/259 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Leukopenia	1.9% 5/262 • Number of events 5 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Neutropenia	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.77% 2/259 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Cardiac disorders Cardiac arrest	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Cardiac disorders Cardiac failure	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Ear and labyrinth disorders Hypoacusis	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Abdominal pain	1.5% 4/262 • Number of events 5 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	1.2% 3/259 • Number of events 3 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Ascites	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Diarrhoea	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Dyspepsia	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Dysphagia	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Gastric haemorrhage	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.77% 2/259 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Haematemesis	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Haematochezia	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Ileus	1.5% 4/262 • Number of events 4 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	1.5% 4/259 • Number of events 5 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Intestinal dilatation	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Intestinal obstruction	1.1% 3/262 • Number of events 3 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Melaena	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Nausea	1.1% 3/262 • Number of events 4 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Obstruction gastric	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Oesophageal obstruction	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Vomiting	1.5% 4/262 • Number of events 4 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	1.5% 4/259 • Number of events 4 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
General disorders Asthenia	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.77% 2/259 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
General disorders Chest pain	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
General disorders Death	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
General disorders Fatigue	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
General disorders Multiple organ dysfunction syndrome	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.77% 2/259 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
General disorders Pyrexia	1.5% 4/262 • Number of events 5 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	1.5% 4/259 • Number of events 4 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Hepatobiliary disorders Bile duct stenosis	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Hepatobiliary disorders Bile duct stone	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Hepatobiliary disorders Cholangitis	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Hepatobiliary disorders Cholangitis acute	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Hepatobiliary disorders Cholecystitis	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Hepatobiliary disorders Dilatation intrahepatic duct acquired	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Hepatobiliary disorders Hepatic function abnormal	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Hepatobiliary disorders Jaundice cholestatic	1.1% 3/262 • Number of events 3 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Hepatobiliary disorders Liver injury	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Abdominal infection	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Atypical mycobacterial infection	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Biliary tract infection	0.38% 1/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Bronchiolitis	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Bronchitis	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Device related infection	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Enterocolitis infectious	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Gastroenteritis	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Lung infection	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Pneumonia	2.3% 6/262 • Number of events 6 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	1.5% 4/259 • Number of events 4 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Scrub typhus	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Sepsis	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Upper respiratory tract infection	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Urinary tract infection	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Injury, poisoning and procedural complications Splenic rupture	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 3 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Alanine aminotransferase increased	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Aspartate aminotransferase increased	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Blood bilirubin increased	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Coagulation test abnormal	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Granulocyte count decreased	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Neutrophil count decreased	0.38% 1/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Weight decreased	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations White blood cell count decreased	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Metabolism and nutrition disorders Decreased appetite	0.76% 2/262 • Number of events 3 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Metabolism and nutrition disorders Hypoproteinaemia	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Musculoskeletal and connective tissue disorders Muscular weakness	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Cerebral haemorrhage	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Dizziness	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Epilepsy	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Headache	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Loss of consciousness	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Optic neuritis	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Syncope	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Product Issues Device malfunction	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Product Issues Stent malfunction	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Psychiatric disorders Delirium	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Psychiatric disorders Suicide attempt	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Renal and urinary disorders Acute kidney injury	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Renal and urinary disorders Calculus bladder	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Renal and urinary disorders Haematuria	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Renal and urinary disorders Hydronephrosis	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.77% 2/259 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.38% 1/262 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/262 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.39% 1/259 • Number of events 1 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Vascular disorders Deep vein thrombosis	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Vascular disorders Venous thrombosis	0.76% 2/262 • Number of events 2 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	0.00% 0/259 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.

Other adverse events

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n=262 participants at risk Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m\^2	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n=259 participants at risk Placebo tablets bd + Paclitaxel 80 mg/m\^2
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 17/262 • Number of events 21 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	5.8% 15/259 • Number of events 26 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Anaemia	37.8% 99/262 • Number of events 156 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	23.9% 62/259 • Number of events 101 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Leukopenia	27.1% 71/262 • Number of events 232 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	22.0% 57/259 • Number of events 177 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Neutropenia	46.6% 122/262 • Number of events 373 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	41.7% 108/259 • Number of events 300 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Abdominal distension	7.3% 19/262 • Number of events 22 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	7.3% 19/259 • Number of events 20 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Abdominal pain	8.8% 23/262 • Number of events 26 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	10.8% 28/259 • Number of events 33 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Abdominal pain upper	7.6% 20/262 • Number of events 23 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	5.8% 15/259 • Number of events 17 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Constipation	14.5% 38/262 • Number of events 52 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	19.3% 50/259 • Number of events 63 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Diarrhoea	25.2% 66/262 • Number of events 102 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	19.7% 51/259 • Number of events 65 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Dyspepsia	5.0% 13/262 • Number of events 14 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	5.0% 13/259 • Number of events 16 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Nausea	28.6% 75/262 • Number of events 121 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	24.3% 63/259 • Number of events 93 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Stomatitis	8.0% 21/262 • Number of events 32 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	4.6% 12/259 • Number of events 13 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Gastrointestinal disorders Vomiting	17.2% 45/262 • Number of events 67 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	16.6% 43/259 • Number of events 70 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
General disorders Asthenia	17.2% 45/262 • Number of events 50 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	13.5% 35/259 • Number of events 51 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
General disorders Fatigue	18.3% 48/262 • Number of events 70 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	20.1% 52/259 • Number of events 71 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
General disorders Malaise	5.7% 15/262 • Number of events 41 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	4.6% 12/259 • Number of events 23 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
General disorders Pyrexia	13.0% 34/262 • Number of events 45 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	13.9% 36/259 • Number of events 59 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Nasopharyngitis	6.1% 16/262 • Number of events 20 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	3.5% 9/259 • Number of events 16 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Infections and infestations Upper respiratory tract infection	7.3% 19/262 • Number of events 31 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	5.4% 14/259 • Number of events 16 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Alanine aminotransferase increased	11.8% 31/262 • Number of events 40 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	5.4% 14/259 • Number of events 18 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Aspartate aminotransferase increased	8.8% 23/262 • Number of events 27 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	6.2% 16/259 • Number of events 22 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Blood bilirubin increased	3.8% 10/262 • Number of events 13 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	5.4% 14/259 • Number of events 15 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Haemoglobin decreased	6.9% 18/262 • Number of events 35 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	7.7% 20/259 • Number of events 37 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Neutrophil count decreased	25.6% 67/262 • Number of events 188 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	14.7% 38/259 • Number of events 80 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations Platelet count decreased	7.6% 20/262 • Number of events 28 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	4.6% 12/259 • Number of events 18 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Investigations White blood cell count decreased	22.9% 60/262 • Number of events 165 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	18.5% 48/259 • Number of events 116 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Metabolism and nutrition disorders Decreased appetite	32.8% 86/262 • Number of events 127 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	26.6% 69/259 • Number of events 97 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Metabolism and nutrition disorders Hypoalbuminaemia	5.3% 14/262 • Number of events 16 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	5.0% 13/259 • Number of events 16 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Metabolism and nutrition disorders Hypokalaemia	8.0% 21/262 • Number of events 25 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	6.2% 16/259 • Number of events 22 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Musculoskeletal and connective tissue disorders Back pain	3.1% 8/262 • Number of events 9 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	5.0% 13/259 • Number of events 16 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Musculoskeletal and connective tissue disorders Myalgia	14.1% 37/262 • Number of events 51 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	13.5% 35/259 • Number of events 65 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Dizziness	4.2% 11/262 • Number of events 14 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	5.4% 14/259 • Number of events 14 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Hypoaesthesia	7.6% 20/262 • Number of events 23 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	6.2% 16/259 • Number of events 18 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Neuropathy peripheral	15.6% 41/262 • Number of events 41 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	16.2% 42/259 • Number of events 45 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Nervous system disorders Peripheral sensory neuropathy	15.6% 41/262 • Number of events 45 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	11.2% 29/259 • Number of events 30 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Psychiatric disorders Insomnia	7.6% 20/262 • Number of events 22 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	7.3% 19/259 • Number of events 36 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Respiratory, thoracic and mediastinal disorders Cough	8.4% 22/262 • Number of events 29 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	9.3% 24/259 • Number of events 27 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Skin and subcutaneous tissue disorders Alopecia	42.7% 112/262 • Number of events 112 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	44.8% 116/259 • Number of events 117 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Skin and subcutaneous tissue disorders Pruritus	3.8% 10/262 • Number of events 13 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	6.6% 17/259 • Number of events 18 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
Skin and subcutaneous tissue disorders Rash	13.4% 35/262 • Number of events 44 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.	9.3% 24/259 • Number of events 29 Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.

Additional Information

Gershon Locker Global Clinical Lead (GCL)

AstraZeneca

Email: gershon.locker@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee At least 60 days prior to submission of any material for publication or presentation, Institution and Principal Investigator (PI) shall jointly provide AstraZeneca with such material for review. If requested in writing by AstraZeneca, Institution and PI shall withhold material from submission for publication or presentation for an additional 90 days from the date of AstraZeneca's request to allow for the filing patent application or preserve its proprietary rights in the information.
• Publication restrictions are in place

Restriction type: OTHER