Trial Outcomes & Findings for Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (NCT NCT04697628)

NCT ID: NCT04697628

Last Updated: 2025-12-18

Results Overview

Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 502 participants
• Primary outcome timeframe: From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months)
• Results posted on: 2025-12-18

Participant Flow

Participants with recurrent/metastatic cervical cancer (rCC/mCC) who received 1 or 2 prior lines of systemic therapy for their recurrent or metastatic disease were included.

A total of 660 participants were screened of which 158 participants failed screening and 502 participants were enrolled in the study.

Participant milestones

Measure	Tisotumab Vedotin Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
Overall Study STARTED	253	249
Overall Study Treated	250	239
Overall Study COMPLETED	114	131
Overall Study NOT COMPLETED	139	118

Reasons for withdrawal

Measure	Tisotumab Vedotin Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
Overall Study Withdrawal by Subject	17	23
Overall Study Lost to Follow-up	0	4
Overall Study On-going in study	122	91

Baseline Characteristics

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Baseline characteristics by cohort

Measure	Tisotumab Vedotin n=253 Participants Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy n=249 Participants Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.	Total n=502 Participants Total of all reporting groups
Age, Continuous	51.9 Years STANDARD_DEVIATION 11.8 • n=47 Participants	51.0 Years STANDARD_DEVIATION 11.6 • n=41 Participants	51.4 Years STANDARD_DEVIATION 11.7 • n=88 Participants
Sex: Female, Male Female	253 Participants n=47 Participants	249 Participants n=41 Participants	502 Participants n=88 Participants
Sex: Female, Male Male	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants
Race/Ethnicity, Customized Race · White	122 Participants n=47 Participants	122 Participants n=41 Participants	244 Participants n=88 Participants
Race/Ethnicity, Customized Race · Asian	90 Participants n=47 Participants	90 Participants n=41 Participants	180 Participants n=88 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	7 Participants n=47 Participants	7 Participants n=41 Participants	14 Participants n=88 Participants
Race/Ethnicity, Customized Race · Black or African American	4 Participants n=47 Participants	6 Participants n=41 Participants	10 Participants n=88 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=47 Participants	1 Participants n=41 Participants	3 Participants n=88 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	1 Participants n=47 Participants	0 Participants n=41 Participants	1 Participants n=88 Participants
Race/Ethnicity, Customized Race · Not Reported	19 Participants n=47 Participants	17 Participants n=41 Participants	36 Participants n=88 Participants
Race/Ethnicity, Customized Race · Unknown	8 Participants n=47 Participants	6 Participants n=41 Participants	14 Participants n=88 Participants
Race/Ethnicity, Customized Ethinicity · Not of Hispanic or Latino/a, or Spanish Origin	176 Participants n=47 Participants	177 Participants n=41 Participants	353 Participants n=88 Participants
Race/Ethnicity, Customized Ethinicity · Hispanic or Latino/a, or of Spanish Origin	52 Participants n=47 Participants	50 Participants n=41 Participants	102 Participants n=88 Participants
Race/Ethnicity, Customized Ethinicity · Not Reported	19 Participants n=47 Participants	17 Participants n=41 Participants	36 Participants n=88 Participants
Race/Ethnicity, Customized Ethinicity · Unknown	6 Participants n=47 Participants	5 Participants n=41 Participants	11 Participants n=88 Participants

PRIMARY outcome

Timeframe: From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months)

Population: ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.

Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.

Outcome measures

Measure	Tisotumab Vedotin n=253 Participants Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy n=249 Participants Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
Overall Survival	11.5 Months Interval 9.8 to 14.9	9.5 Months Interval 7.9 to 10.7

SECONDARY outcome

Timeframe: From the date of randomization to first documentation of PD or death due to any cause, or censoring date whichever occurred first (maximum up to 25 months)

Population: ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.

PFS per investigator was defined as the time from the date of randomization to the first documentation of disease progression (PD) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, or death due to any cause, whichever occurred earlier. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Participants without evidence of radiographic disease progression or death were censored at the date of last adequate tumor assessment prior to data cut-off date or start of new anti-cancer therapy. Participants with disease progression or death that occurred after 2 or more missed scans were censored at the last adequate tumor assessment prior to missed scans. Participants without post-baseline scan data were censored at the day of randomization.

Outcome measures

Measure	Tisotumab Vedotin n=253 Participants Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy n=249 Participants Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
Progression Free Survival (PFS) as Assessed by Investigator	4.2 Months Interval 4.0 to 4.4	2.9 Months Interval 2.6 to 3.1

SECONDARY outcome

Timeframe: From the date of randomization until date of confirmed CR or PR (maximum up to 25 months)

Population: ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.

Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The minimum criteria for stable disease (SD) duration are defined as ≥ 5 weeks after the date of randomization. For a response to be considered as confirmed, the subsequent response had to be at least 4 weeks after the initial response. Two-sided 95% exact confidence interval (CI) was computed using the Clopper-Pearson method.

Outcome measures

Measure	Tisotumab Vedotin n=253 Participants Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy n=249 Participants Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
Confirmed Objective Response Rate (ORR) as Assessed by Investigator	17.8 Percentage of participants Interval 13.3 to 23.1	5.2 Percentage of participants Interval 2.8 to 8.8

SECONDARY outcome

Timeframe: From the date of randomization to date of date of the first confirmed objective response (maximum up to 25 months)

Population: ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants who achieved a confirmed CR or PR based on investigator assessment were included in the analysis.

TTR was defined as the time from the randomization date to the date of the first confirmed objective response (CR or PR that was subsequently confirmed). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Tisotumab Vedotin n=45 Participants Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy n=13 Participants Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
Time-to-Response (TTR) as Assessed by the Investigator	1.58 Months Interval 1.2 to 4.5	1.74 Months Interval 1.2 to 3.9

SECONDARY outcome

Timeframe: From the date of first documented response of CR or PR to the first documented PD or death from any cause, whichever occurred first (maximum up to 25 months)

Population: ITT analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants who achieved a confirmed CR or PR based on investigator assessment were included in the analysis.

DOR was defined as the time from the date of the first confirmed objective response (CR or PR that was subsequently confirmed) to the date of the first documented PD per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Measure	Tisotumab Vedotin n=45 Participants Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy n=13 Participants Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
Duration of Response (DOR) by Investigator Assessment	5.3 Months Interval 4.2 to 8.3	5.7 Months Interval 2.8 to Upper limit of 95% CI could not be estimated due to insufficient number of participants with event.

SECONDARY outcome

Timeframe: From start of treatment up to 30 days after last dose of study treatment (up to 25 months)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment (tisotumab vedotin or chemotherapy).

An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment and with onset date on or before 30 days after the last dose of study treatment.

Outcome measures

Measure	Tisotumab Vedotin n=250 Participants Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy n=239 Participants Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	246 Participants	237 Participants

SECONDARY outcome

Timeframe: From start of treatment until end of follow-up

The EQ-5D-5L questionnaire is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems). Responses to the 5 items are then converted to a weighted health state index (utility score) based on values derived from general population samples. This health utility score is between 0 and 1, where 0 is death and 1 is perfect health.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment until end of follow-up

EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state) ; higher scores indicate a better health state.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment until end of follow-up

The EORTC-QLQ-C30 questionnaire is composed of 30 questions for which the answers ranges either from 1 (not at all) to 4 (very much) for items 1 to 28, or from 1 (very poor) to 7 (excellent) for items 29 to 30. The EORTC QLQ-C30 scale scores will be calculated using the EORTC QLQ-C30 Scoring Manual. These include 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items (i.e., no item occurs in more than one scale). All of the scales and single-item measures range in score from 0 to 100, with a high scale score representing a higher response level (e.g., a high level of functioning, a high QoL, or a high level of symptomatology/problems)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment until end of follow-up

The EORTC QLQ-CX24 questionnaire is meant for use among cervical cancer participants varying in disease stage and treatment modality. The EORTC-QLQ-CX24 questionnaire is composed of 24 questions for which the answers ranged from 1 (Not at all) to 4 (Very much). Four functional scales and 5 symptom scales will be calculated using the EORTC QLQ-CX24 Scoring Manual. The 9 scores computed from the EORTC-QLQ-CX24 questionnaire will be summarized by treatment arm using descriptive statistics.

Outcome measures

Outcome data not reported

Adverse Events

Tisotumab Vedotin

Serious events: 82 serious events

Other events: 233 other events

Deaths: 123 deaths

Chemotherapy

Serious events: 94 serious events

Other events: 223 other events

Deaths: 140 deaths

Serious adverse events

Measure	Tisotumab Vedotin n=250 participants at risk Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy n=239 participants at risk Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
General disorders Malaise	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Blood and lymphatic system disorders Anaemia	0.80% 2/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	4.2% 10/239 • Number of events 12 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Blood and lymphatic system disorders Febrile neutropenia	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	3.3% 8/239 • Number of events 10 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Blood and lymphatic system disorders Lymph node pain	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Blood and lymphatic system disorders Neutropenia	0.80% 2/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	1.7% 4/239 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	1.7% 4/239 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Cardiac disorders Cardiac tamponade	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Cardiac disorders Palpitations	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Cardiac disorders Pericardial effusion	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Ear and labyrinth disorders Vertigo	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Abdominal distension	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Abdominal pain	2.0% 5/250 • Number of events 6 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Anal incontinence	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Ascites	0.40% 1/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Colitis	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Constipation	1.2% 3/250 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Diarrhoea	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Dysphagia	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Enteritis	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Gastrointestinal toxicity	0.40% 1/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Haematemesis	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Haematochezia	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Ileus	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Ileus paralytic	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Intestinal obstruction	0.80% 2/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Large intestinal obstruction	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Large intestine perforation	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Malignant gastrointestinal obstruction	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Nausea	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	1.3% 3/239 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Pancreatitis acute	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Proctitis	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Rectal prolapse	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Small intestinal obstruction	2.4% 6/250 • Number of events 7 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Small intestinal perforation	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Stomatitis	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Truncus coeliacus thrombosis	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Vomiting	1.6% 4/250 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Fatigue	1.2% 3/250 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	1.7% 4/239 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Gait disturbance	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders General physical health deterioration	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Generalised oedema	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Non-cardiac chest pain	0.80% 2/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Oedema peripheral	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Peripheral swelling	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Pyrexia	1.6% 4/250 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	1.7% 4/239 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Hepatobiliary disorders Biliary obstruction	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Hepatobiliary disorders Cholangitis	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Hepatobiliary disorders Jaundice cholestatic	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Hepatobiliary disorders Liver injury	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations COVID-19	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	1.3% 3/239 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Cellulitis	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Conjunctivitis	0.40% 1/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Conjunctivitis bacterial	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Cystitis	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Device related infection	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Enterocolitis infectious	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Erysipelas	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Pelvic infection	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Pneumonia	0.80% 2/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	1.3% 3/239 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Pyelonephritis	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	1.3% 3/239 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Pyelonephritis acute	0.80% 2/250 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Pyuria	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Sepsis	2.0% 5/250 • Number of events 5 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Septic shock	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Sinusitis	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Skin infection	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Urinary tract infection	4.0% 10/250 • Number of events 12 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	7.1% 17/239 • Number of events 21 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Urinary tract infection bacterial	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Urosepsis	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Vulval abscess	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Injury, poisoning and procedural complications Cystitis radiation	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Injury, poisoning and procedural complications Infusion related reaction	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Injury, poisoning and procedural complications Stoma site discomfort	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Injury, poisoning and procedural complications Urinary tract stoma complication	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Alanine aminotransferase increased	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Aspartate aminotransferase increased	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Blood creatinine increased	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Lymphocyte count decreased	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Neutrophil count decreased	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Platelet count decreased	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations White blood cell count decreased	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Metabolism and nutrition disorders Dehydration	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Metabolism and nutrition disorders Hypercalcaemia	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Metabolism and nutrition disorders Hypokalaemia	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Metabolism and nutrition disorders Hyponatraemia	1.2% 3/250 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Musculoskeletal and connective tissue disorders Back pain	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Musculoskeletal and connective tissue disorders Muscular weakness	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Musculoskeletal and connective tissue disorders Pain in extremity	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Nervous system disorders Headache	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Nervous system disorders Peripheral sensory neuropathy	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Nervous system disorders Seizure	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Nervous system disorders Somnolence	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Nervous system disorders Spinal cord compression	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Product Issues Device occlusion	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Psychiatric disorders Hallucination	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Renal and urinary disorders Acute kidney injury	1.2% 3/250 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	2.1% 5/239 • Number of events 5 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Renal and urinary disorders Bladder perforation	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Renal and urinary disorders Haematuria	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Renal and urinary disorders Hydronephrosis	0.80% 2/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	2.9% 7/239 • Number of events 7 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Renal and urinary disorders Renal failure	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Renal and urinary disorders Renal tubular disorder	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Renal and urinary disorders Urinary tract obstruction	0.80% 2/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Renal and urinary disorders Urogenital fistula	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Renal and urinary disorders Vesical fistula	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Reproductive system and breast disorders Female genital tract fistula	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Reproductive system and breast disorders Ovarian cyst torsion	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Reproductive system and breast disorders Pelvic pain	1.2% 3/250 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Reproductive system and breast disorders Vaginal haemorrhage	1.6% 4/250 • Number of events 5 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	1.3% 3/239 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.80% 2/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.84% 2/239 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Skin and subcutaneous tissue disorders Erythema	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Skin and subcutaneous tissue disorders Rash macular	0.40% 1/250 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.80% 2/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Vascular disorders Hypovolaemic shock	0.80% 2/250 • Number of events 2 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Vascular disorders Shock haemorrhagic	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.

Other adverse events

Measure	Tisotumab Vedotin n=250 participants at risk Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).	Chemotherapy n=239 participants at risk Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
Blood and lymphatic system disorders Anaemia	22.4% 56/250 • Number of events 69 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	49.8% 119/239 • Number of events 160 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Blood and lymphatic system disorders Leukopenia	1.2% 3/250 • Number of events 3 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	6.7% 16/239 • Number of events 24 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Blood and lymphatic system disorders Neutropenia	6.0% 15/250 • Number of events 18 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	21.8% 52/239 • Number of events 119 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Eye disorders Dry eye	13.2% 33/250 • Number of events 41 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Eye disorders Keratitis	15.6% 39/250 • Number of events 53 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.00% 0/239 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Abdominal pain	12.0% 30/250 • Number of events 36 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	8.8% 21/239 • Number of events 25 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Abdominal pain upper	4.0% 10/250 • Number of events 10 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	5.0% 12/239 • Number of events 15 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Constipation	23.6% 59/250 • Number of events 68 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	16.3% 39/239 • Number of events 40 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Diarrhoea	21.2% 53/250 • Number of events 72 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	15.1% 36/239 • Number of events 45 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Nausea	33.2% 83/250 • Number of events 101 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	38.9% 93/239 • Number of events 140 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Gastrointestinal disorders Vomiting	16.8% 42/250 • Number of events 56 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	18.0% 43/239 • Number of events 61 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Asthenia	16.0% 40/250 • Number of events 49 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	15.9% 38/239 • Number of events 52 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Fatigue	11.6% 29/250 • Number of events 37 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	15.1% 36/239 • Number of events 41 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Oedema peripheral	3.6% 9/250 • Number of events 9 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	12.1% 29/239 • Number of events 30 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
General disorders Pyrexia	16.0% 40/250 • Number of events 54 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	19.7% 47/239 • Number of events 76 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations COVID-19	5.2% 13/250 • Number of events 13 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	3.8% 9/239 • Number of events 9 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Conjunctivitis	30.8% 77/250 • Number of events 106 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	0.42% 1/239 • Number of events 1 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Infections and infestations Urinary tract infection	10.4% 26/250 • Number of events 35 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	10.5% 25/239 • Number of events 36 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Alanine aminotransferase increased	6.8% 17/250 • Number of events 23 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	10.9% 26/239 • Number of events 31 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Aspartate aminotransferase increased	6.4% 16/250 • Number of events 18 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	11.3% 27/239 • Number of events 34 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Neutrophil count decreased	1.2% 3/250 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	8.8% 21/239 • Number of events 37 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Platelet count decreased	0.00% 0/250 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	5.4% 13/239 • Number of events 19 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Investigations Weight decreased	9.6% 24/250 • Number of events 26 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	5.0% 12/239 • Number of events 12 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Metabolism and nutrition disorders Decreased appetite	23.6% 59/250 • Number of events 68 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	17.2% 41/239 • Number of events 50 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Metabolism and nutrition disorders Hypokalaemia	5.6% 14/250 • Number of events 17 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	5.4% 13/239 • Number of events 15 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Musculoskeletal and connective tissue disorders Arthralgia	7.2% 18/250 • Number of events 20 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	5.0% 12/239 • Number of events 13 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Musculoskeletal and connective tissue disorders Back pain	6.4% 16/250 • Number of events 19 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	8.4% 20/239 • Number of events 22 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Musculoskeletal and connective tissue disorders Myalgia	5.6% 14/250 • Number of events 14 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	2.9% 7/239 • Number of events 8 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Musculoskeletal and connective tissue disorders Pain in extremity	7.2% 18/250 • Number of events 20 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	3.3% 8/239 • Number of events 8 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Nervous system disorders Headache	4.4% 11/250 • Number of events 11 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	5.4% 13/239 • Number of events 16 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Nervous system disorders Peripheral sensory neuropathy	28.0% 70/250 • Number of events 75 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	2.5% 6/239 • Number of events 7 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Psychiatric disorders Insomnia	7.6% 19/250 • Number of events 21 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	5.0% 12/239 • Number of events 12 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Renal and urinary disorders Haematuria	6.8% 17/250 • Number of events 22 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	1.7% 4/239 • Number of events 4 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Reproductive system and breast disorders Pelvic pain	2.4% 6/250 • Number of events 6 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	5.0% 12/239 • Number of events 12 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Reproductive system and breast disorders Vaginal haemorrhage	8.4% 21/250 • Number of events 21 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	4.2% 10/239 • Number of events 10 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 14/250 • Number of events 14 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	8.8% 21/239 • Number of events 23 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.2% 8/250 • Number of events 9 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	5.9% 14/239 • Number of events 14 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Respiratory, thoracic and mediastinal disorders Epistaxis	26.0% 65/250 • Number of events 79 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	2.5% 6/239 • Number of events 8 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Skin and subcutaneous tissue disorders Alopecia	24.4% 61/250 • Number of events 64 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	2.9% 7/239 • Number of events 7 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.
Skin and subcutaneous tissue disorders Pruritus	10.0% 25/250 • Number of events 39 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.	2.9% 7/239 • Number of events 8 • For All-Cause Mortality: From randomization to date of death due to any cause (up to 25 months); For SAEs and non-SAEs: From start of treatment up to 30 days after last dose of study treatment (approximately up to 25 months) Same event may appear as both other (non-serious adverse event \[non-SAE\]) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for ITT analysis set, data for SAE and non-SAE were collected for safety analysis set.

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