Trial Outcomes & Findings for Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) (NCT NCT04003636)

NCT ID: NCT04003636

Last Updated: 2025-04-23

Results Overview

Overall survival was defined as the time from randomization to death due to any cause.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1069 participants
• Primary outcome timeframe: Up to approximately 38 months
• Results posted on: 2025-04-23

Participant Flow

As of the data cut-off (DCO) (15-DEC-2022) for the final analysis (FA), a total of 1069 participants were randomized to the Intent-to-Treat (ITT) population (533 in the pembrolizumab plus chemotherapy group and 536 in the placebo plus chemotherapy group)

Participant milestones

Measure	Arm A (Pembrolizumab+Gemcitabine+Cisplatin) Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.	Arm B (Placebo+Gemcitabine+Cisplatin) Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Overall Study STARTED	533	536
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	533	536

Reasons for withdrawal

Measure	Arm A (Pembrolizumab+Gemcitabine+Cisplatin) Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.	Arm B (Placebo+Gemcitabine+Cisplatin) Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Overall Study Death	409	443
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	5	2
Overall Study Participant On-going	119	90

Baseline Characteristics

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

Baseline characteristics by cohort

Measure	Arm A (Pembrolizumab+Gemcitabine+Cisplatin) n=533 Participants Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.	Arm B (Placebo+Gemcitabine+Cisplatin) n=536 Participants Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.	Total n=1069 Participants Total of all reporting groups
Age, Continuous	63.3 Years STANDARD_DEVIATION 10.3 • n=5 Participants	61.8 Years STANDARD_DEVIATION 11.0 • n=7 Participants	62.5 Years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	253 Participants n=5 Participants	264 Participants n=7 Participants	517 Participants n=5 Participants
Sex: Female, Male Male	280 Participants n=5 Participants	272 Participants n=7 Participants	552 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	59 Participants n=5 Participants	52 Participants n=7 Participants	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	433 Participants n=5 Participants	449 Participants n=7 Participants	882 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	41 Participants n=5 Participants	35 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	245 Participants n=5 Participants	250 Participants n=7 Participants	495 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	256 Participants n=5 Participants	268 Participants n=7 Participants	524 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Geographic Region Asian	242 Number of Participants n=5 Participants	244 Number of Participants n=7 Participants	486 Number of Participants n=5 Participants
Geographic Region Non-Asian	291 Number of Participants n=5 Participants	292 Number of Participants n=7 Participants	583 Number of Participants n=5 Participants
Disease Status Locally Advanced	60 Participants n=5 Participants	66 Participants n=7 Participants	126 Participants n=5 Participants
Disease Status Metastatic	473 Participants n=5 Participants	470 Participants n=7 Participants	943 Participants n=5 Participants
Site of Origin Gallbladder	115 Participants n=5 Participants	118 Participants n=7 Participants	233 Participants n=5 Participants
Site of Origin Intrahepatic	320 Participants n=5 Participants	313 Participants n=7 Participants	633 Participants n=5 Participants
Site of Origin Extrahepatic	98 Participants n=5 Participants	105 Participants n=7 Participants	203 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 38 months

Population: All randomized participants

Overall survival was defined as the time from randomization to death due to any cause.

Outcome measures

Measure	Arm A (Pembrolizumab+Gemcitabine+Cisplatin) n=533 Participants Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.	Arm B (Placebo+Gemcitabine+Cisplatin) n=536 Participants Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Overall Survival (OS)	12.7 Months Interval 11.5 to 13.6	10.9 Months Interval 9.9 to 11.6

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: All randomized participants

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR, or death due to any cause, whichever occurred first.

Outcome measures

Measure	Arm A (Pembrolizumab+Gemcitabine+Cisplatin) n=533 Participants Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.	Arm B (Placebo+Gemcitabine+Cisplatin) n=536 Participants Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)	6.5 Months Interval 5.7 to 6.9	5.6 Months Interval 5.1 to 6.6

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: All randomized participants

ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters [SOD] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.

Outcome measures

Measure	Arm A (Pembrolizumab+Gemcitabine+Cisplatin) n=533 Participants Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.	Arm B (Placebo+Gemcitabine+Cisplatin) n=536 Participants Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	28.7 Percentage of Participants Interval 24.9 to 32.8	28.5 Percentage of Participants Interval 24.8 to 32.6

SECONDARY outcome

Timeframe: Up to approximately 38 months

Population: All randomized participants with CR or PR

For participants who demonstrate a confirmed CR or PR, DOR was the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first.

Outcome measures

Measure	Arm A (Pembrolizumab+Gemcitabine+Cisplatin) n=153 Participants Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.	Arm B (Placebo+Gemcitabine+Cisplatin) n=153 Participants Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR	9.7 Months Interval 1.2 to 22.7	6.9 Months Interval 0.0 to 19.2

SECONDARY outcome

Timeframe: Up to approximately 38 months

Population: All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention

An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

Outcome measures

Measure	Arm A (Pembrolizumab+Gemcitabine+Cisplatin) n=529 Participants Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.	Arm B (Placebo+Gemcitabine+Cisplatin) n=534 Participants Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Number of Participants Who Experience One or More Adverse Events (AE)	524 Participants	532 Participants

SECONDARY outcome

Timeframe: Up to approximately 38 months

Population: All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention.

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Measure	Arm A (Pembrolizumab+Gemcitabine+Cisplatin) n=529 Participants Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles. Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.	Arm B (Placebo+Gemcitabine+Cisplatin) n=534 Participants Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)	138 Participants	122 Participants

Adverse Events

Pembrolizumab + Chemotherapy

Serious events: 276 serious events

Other events: 512 other events

Deaths: 413 deaths

Placebo + Chemotherapy

Serious events: 263 serious events

Other events: 522 other events

Deaths: 443 deaths

Pembrolizumab Second Course

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Pembrolizumab + Chemotherapy n=529 participants at risk Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.	Placebo + Chemotherapy n=534 participants at risk Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.	Pembrolizumab Second Course n=2 participants at risk Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.
Gastrointestinal disorders Fistula of small intestine	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Gastric stenosis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Gastric ulcer	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Gastritis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.95% 5/529 • Number of events 5 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Gastrointestinal toxicity	0.19% 1/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Anaemia	2.5% 13/529 • Number of events 13 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	1.9% 10/534 • Number of events 10 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Coombs negative haemolytic anaemia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	1.3% 7/529 • Number of events 8 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	1.5% 8/534 • Number of events 8 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Immune thrombocytopenia	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Microangiopathic haemolytic anaemia	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Myelosuppression	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Pancytopenia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Acute coronary syndrome	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Acute myocardial infarction	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Angina pectoris	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Atrial fibrillation	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Cardiac arrest	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Cardiac failure	1.1% 6/529 • Number of events 6 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Cardiac failure congestive	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Cardiomyopathy	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Myocardial infarction	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Myocarditis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Pericardial effusion	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Cardiac disorders Pericarditis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Endocrine disorders Adrenal insufficiency	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Endocrine disorders Hyperthyroidism	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Endocrine disorders Hypophysitis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Endocrine disorders Hypopituitarism	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Endocrine disorders Hypothyroidism	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Eye disorders Retinal detachment	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal pain	1.1% 6/529 • Number of events 7 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	1.3% 7/534 • Number of events 7 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Ascites	1.1% 6/529 • Number of events 7 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	2.4% 13/534 • Number of events 14 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Autoimmune colitis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Colitis	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Colonic fistula	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Constipation	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	1.1% 6/534 • Number of events 6 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Diverticular perforation	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Duodenal obstruction	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Enterocolitis	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Haematemesis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Ileus	0.76% 4/529 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.75% 4/534 • Number of events 6 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Ileus paralytic	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Inguinal hernia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Intestinal ischaemia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Intestinal obstruction	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Intestinal perforation	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Intestinal varices haemorrhage	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Jejunal perforation	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Large intestine perforation	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Malignant gastrointestinal obstruction	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Mechanical ileus	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Melaena	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Nausea	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Obstruction gastric	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Oesophageal stenosis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Oesophagitis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Pancreatitis	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Pancreatolithiasis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Prepyloric stenosis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Small intestinal haemorrhage	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Small intestinal obstruction	0.76% 4/529 • Number of events 5 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Subileus	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Vomiting	1.3% 7/529 • Number of events 7 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.75% 4/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Asthenia	0.38% 2/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Death	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.94% 5/534 • Number of events 5 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Fatigue	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders General physical health deterioration	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Hyperpyrexia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Influenza like illness	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Malaise	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Oedema peripheral	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Pain	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Peripheral swelling	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Puncture site haemorrhage	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Pyrexia	5.7% 30/529 • Number of events 34 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	2.2% 12/534 • Number of events 15 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Systemic inflammatory response syndrome	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Bile duct stone	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Biliary dilatation	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Biliary obstruction	2.3% 12/529 • Number of events 14 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	3.0% 16/534 • Number of events 18 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Biloma	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Cholangitis	5.9% 31/529 • Number of events 39 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	4.5% 24/534 • Number of events 38 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Cholangitis acute	1.3% 7/529 • Number of events 8 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Cholecystitis	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Cholecystitis acute	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Cholestasis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Gallbladder rupture	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Hepatic cirrhosis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Hepatic displacement	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Hepatic function abnormal	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Hepatic haemorrhage	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Hepatic ischaemia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Immune-mediated hepatitis	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.75% 4/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Jaundice cholestatic	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.94% 5/534 • Number of events 6 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Liver injury	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Portal hypertension	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Portal vein thrombosis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Steatohepatitis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Immune system disorders Contrast media allergy	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Immune system disorders Infusion related hypersensitivity reaction	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Abdominal abscess	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Abdominal infection	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Abdominal wall abscess	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Arthritis bacterial	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Bacteraemia	1.5% 8/529 • Number of events 8 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Biliary sepsis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Biliary tract infection	3.2% 17/529 • Number of events 21 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	3.4% 18/534 • Number of events 25 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Bronchiolitis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Burkholderia cepacia complex infection	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations COVID-19	1.3% 7/529 • Number of events 7 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	1.5% 8/534 • Number of events 8 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations COVID-19 pneumonia	1.1% 6/529 • Number of events 6 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Cellulitis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Chlamydial infection	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Cholangitis infective	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Device related infection	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Diarrhoea infectious	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Diverticulitis	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Encephalitis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Enterobacter sepsis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Enterocolitis infectious	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Escherichia bacteraemia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Febrile infection	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Fungal sepsis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Gastroenteritis	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Helicobacter infection	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Hepatic infection	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Herpes zoster	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Infection	0.76% 4/529 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Intervertebral discitis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Klebsiella bacteraemia	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Klebsiella infection	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Liver abscess	0.76% 4/529 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	2.1% 11/534 • Number of events 13 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Lower respiratory tract infection	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Lung abscess	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Mucosal infection	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Neutropenic infection	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Neutropenic sepsis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Peritonitis	0.76% 4/529 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Peritonitis bacterial	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pleural infection	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pneumococcal bacteraemia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pneumococcal sepsis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pneumocystis jirovecii pneumonia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pneumonia	1.5% 8/529 • Number of events 9 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	1.5% 8/534 • Number of events 9 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pneumonia acinetobacter	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pneumonia aspiration	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pneumonia bacterial	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pneumonia viral	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Postoperative abscess	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pseudomembranous colitis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pyelonephritis	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Pyelonephritis acute	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Sepsis	2.5% 13/529 • Number of events 15 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	3.0% 16/534 • Number of events 17 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Septic embolus	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Septic shock	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.75% 4/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Skin infection	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Spontaneous bacterial peritonitis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Systemic candida	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Tuberculosis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Urinary tract infection	1.9% 10/529 • Number of events 10 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	1.1% 6/534 • Number of events 6 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Urosepsis	0.19% 1/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Craniocerebral injury	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Fall	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Post procedural fever	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Postoperative adhesion	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Road traffic accident	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Spinal compression fracture	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Spinal fracture	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Stoma site ulcer	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Ureteric injury	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Alanine aminotransferase increased	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.75% 4/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Aspartate aminotransferase increased	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Blood alkaline phosphatase increased	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Blood bilirubin increased	0.95% 5/529 • Number of events 5 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.75% 4/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Blood creatinine increased	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Gamma-glutamyltransferase increased	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Neutrophil count decreased	2.1% 11/529 • Number of events 13 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Neutrophil count increased	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Platelet count decreased	3.6% 19/529 • Number of events 19 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	1.9% 10/534 • Number of events 12 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Transaminases increased	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Troponin increased	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations White blood cell count decreased	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Alkalosis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Cachexia	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.76% 4/529 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.94% 5/534 • Number of events 5 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Electrolyte imbalance	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Food refusal	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.57% 3/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hypernatraemia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.75% 4/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hypophagia	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Chest wall haematoma	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pathological fracture	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of testis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Altered state of consciousness	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Aphasia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Cerebellar infarction	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Cerebral haemorrhage	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Cerebral infarction	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Cerebral venous sinus thrombosis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Cerebrovascular accident	0.95% 5/529 • Number of events 5 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.75% 4/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Epilepsy	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Haemorrhage intracranial	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Headache	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Hepatic encephalopathy	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Ischaemic stroke	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Lethargy	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Loss of consciousness	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Myasthenia gravis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Radicular pain	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Syncope	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Transient ischaemic attack	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Product Issues Device dislocation	0.38% 2/529 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Product Issues Device malfunction	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Product Issues Device occlusion	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Psychiatric disorders Confusional state	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Psychiatric disorders Delirium	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Psychiatric disorders Depressed mood	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.76% 4/529 • Number of events 5 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	1.9% 10/534 • Number of events 12 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Chronic kidney disease	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Haematuria	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Renal failure	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Renal impairment	0.19% 1/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Renal vein thrombosis	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Ureterolithiasis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Urinary retention	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.75% 4/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.19% 1/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.75% 4/534 • Number of events 4 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.3% 7/529 • Number of events 7 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.56% 3/534 • Number of events 3 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.1% 11/529 • Number of events 11 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	1.5% 8/534 • Number of events 8 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Surgical and medical procedures Euthanasia	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Aortic aneurysm	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Deep vein thrombosis	0.38% 2/529 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Embolism	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Haematoma	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Hypertension	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Hypovolaemic shock	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Inferior vena caval occlusion	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Peripheral artery thrombosis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Shock	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Shock haemorrhagic	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/534 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Thrombosis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Vena cava embolism	0.00% 0/529 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.

Other adverse events

Measure	Pembrolizumab + Chemotherapy n=529 participants at risk Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity plus Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.	Placebo + Chemotherapy n=534 participants at risk Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.	Pembrolizumab Second Course n=2 participants at risk Participants in Arm A who stopped study intervention after achieving stable-disease (SD) or better may have been eligible to receive additional pembrolizumab for up to 17 cycles if they experienced radiographic disease progression while off study intervention, according to the protocol-defined criteria. Gemcitabine may have been continued until progressive disease (PD) or unacceptable toxicity during second course at investigator's discretion.
Metabolism and nutrition disorders Hyperkalaemia	6.6% 35/529 • Number of events 78 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	5.4% 29/534 • Number of events 35 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	7.2% 38/529 • Number of events 52 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	9.2% 49/534 • Number of events 67 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	9.1% 48/529 • Number of events 67 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	12.5% 67/534 • Number of events 92 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	14.9% 79/529 • Number of events 148 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	14.8% 79/534 • Number of events 139 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	9.6% 51/529 • Number of events 86 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	9.2% 49/534 • Number of events 59 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 39/529 • Number of events 45 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	7.7% 41/534 • Number of events 50 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	10.0% 53/529 • Number of events 65 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	13.5% 72/534 • Number of events 77 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Weight decreased	9.6% 51/529 • Number of events 52 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	11.8% 63/534 • Number of events 75 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations White blood cell count decreased	26.7% 141/529 • Number of events 740 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	23.8% 127/534 • Number of events 616 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	26.7% 141/529 • Number of events 185 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	28.3% 151/534 • Number of events 206 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	50.0% 1/2 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	6.8% 36/529 • Number of events 58 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	7.5% 40/534 • Number of events 51 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Anaemia	59.5% 315/529 • Number of events 528 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	57.3% 306/534 • Number of events 486 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Endocrine disorders Hypothyroidism	8.5% 45/529 • Number of events 46 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	2.6% 14/534 • Number of events 14 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal distension	7.0% 37/529 • Number of events 41 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	6.4% 34/534 • Number of events 43 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal pain	16.6% 88/529 • Number of events 122 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	21.9% 117/534 • Number of events 152 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	7.6% 40/529 • Number of events 53 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	10.5% 56/534 • Number of events 72 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Ascites	5.5% 29/529 • Number of events 31 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	6.2% 33/534 • Number of events 34 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Constipation	35.0% 185/529 • Number of events 227 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	35.2% 188/534 • Number of events 233 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	100.0% 2/2 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	19.3% 102/529 • Number of events 149 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	17.4% 93/534 • Number of events 149 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Dyspepsia	6.2% 33/529 • Number of events 36 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	10.3% 55/534 • Number of events 64 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	50.0% 1/2 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Nausea	43.9% 232/529 • Number of events 418 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	45.9% 245/534 • Number of events 421 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Stomatitis	4.9% 26/529 • Number of events 30 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	6.4% 34/534 • Number of events 37 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	50.0% 1/2 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Vomiting	22.7% 120/529 • Number of events 234 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	23.8% 127/534 • Number of events 268 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Asthenia	14.2% 75/529 • Number of events 134 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	17.4% 93/534 • Number of events 165 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Fatigue	35.2% 186/529 • Number of events 281 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	31.8% 170/534 • Number of events 231 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Malaise	6.8% 36/529 • Number of events 65 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	5.8% 31/534 • Number of events 59 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Mucosal inflammation	5.3% 28/529 • Number of events 34 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	4.3% 23/534 • Number of events 31 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Oedema peripheral	13.8% 73/529 • Number of events 87 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	15.9% 85/534 • Number of events 124 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
General disorders Pyrexia	22.3% 118/529 • Number of events 228 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	18.0% 96/534 • Number of events 172 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Infections and infestations Urinary tract infection	5.5% 29/529 • Number of events 37 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	4.3% 23/534 • Number of events 26 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Alanine aminotransferase increased	16.3% 86/529 • Number of events 142 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	20.6% 110/534 • Number of events 169 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Aspartate aminotransferase increased	16.6% 88/529 • Number of events 160 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	18.4% 98/534 • Number of events 187 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Blood alkaline phosphatase increased	7.9% 42/529 • Number of events 59 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	9.7% 52/534 • Number of events 72 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Blood bilirubin increased	8.7% 46/529 • Number of events 69 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	11.4% 61/534 • Number of events 80 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Blood creatinine increased	10.6% 56/529 • Number of events 101 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	10.9% 58/534 • Number of events 103 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Gamma-glutamyltransferase increased	4.3% 23/529 • Number of events 30 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	5.4% 29/534 • Number of events 39 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Lymphocyte count decreased	4.3% 23/529 • Number of events 49 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	5.4% 29/534 • Number of events 48 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Neutrophil count decreased	62.0% 328/529 • Number of events 1386 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	61.2% 327/534 • Number of events 1269 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Investigations Platelet count decreased	39.1% 207/529 • Number of events 571 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	39.5% 211/534 • Number of events 568 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	5.1% 27/529 • Number of events 36 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	5.6% 30/534 • Number of events 33 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	5.3% 28/529 • Number of events 35 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	4.1% 22/534 • Number of events 24 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Dizziness	6.0% 32/529 • Number of events 44 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	9.4% 50/534 • Number of events 55 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	50.0% 1/2 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Dysgeusia	5.9% 31/529 • Number of events 34 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	6.0% 32/534 • Number of events 34 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Headache	10.0% 53/529 • Number of events 79 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	8.4% 45/534 • Number of events 53 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Neuropathy peripheral	4.0% 21/529 • Number of events 23 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	5.4% 29/534 • Number of events 31 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Nervous system disorders Peripheral sensory neuropathy	5.9% 31/529 • Number of events 33 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	5.4% 29/534 • Number of events 30 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Psychiatric disorders Insomnia	7.8% 41/529 • Number of events 46 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	7.7% 41/534 • Number of events 45 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	6.8% 36/529 • Number of events 42 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	6.9% 37/534 • Number of events 43 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.6% 51/529 • Number of events 59 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	9.6% 51/534 • Number of events 56 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	10.4% 55/529 • Number of events 58 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	12.7% 68/534 • Number of events 71 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	14.6% 77/529 • Number of events 106 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	9.6% 51/534 • Number of events 60 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	50.0% 1/2 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	16.6% 88/529 • Number of events 113 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	9.2% 49/534 • Number of events 64 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Vascular disorders Hypertension	6.4% 34/529 • Number of events 40 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	6.9% 37/534 • Number of events 60 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.00% 0/2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Oesophagitis	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.37% 2/534 • Number of events 2 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	50.0% 1/2 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Fluid retention	0.19% 1/529 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	0.19% 1/534 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.	50.0% 1/2 • Number of events 1 • Up to approximately 38 months All-Cause Mortality included all allocated participants. Serious and Other AEs were reported according to treatment course for all participants who received ≥1 dose of study treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
• Publication restrictions are in place

Restriction type: OTHER