Trial Outcomes & Findings for Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (NCT NCT03298451)

NCT ID: NCT03298451

Last Updated: 2026-01-14

Results Overview

OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This primary outcome measure presents OS analysis of Treme 300mg x1 dose + Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1324 participants
• Primary outcome timeframe: From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).
• Results posted on: 2026-01-14

Participant Flow

The study includes 1324 participants. Participants were screened in 16 countries from Oct2017 to Jun2019. Recruitment in T75+D arm was closed during the study. Results are reported at data cut-off (DCO).

Of 1,950 participants screened in the study, 1,324 were randomized across 4 arms, out of which 1,302 participants received treatment.

Participant milestones

Measure	Durva 1500 mg Durvalumab 1500 mg every 4 weeks (Q4W)	Treme 300 mg x1 Dose + Durva 1500 mg Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg Sorafenib 400 mg twice daily (BID)
Overall Study STARTED	389	393	153	389
Overall Study Received Treatment	386	389	153	374
Overall Study COMPLETED	104	125	30	82
Overall Study NOT COMPLETED	285	268	123	307

Reasons for withdrawal

Measure	Durva 1500 mg Durvalumab 1500 mg every 4 weeks (Q4W)	Treme 300 mg x1 Dose + Durva 1500 mg Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg Sorafenib 400 mg twice daily (BID)
Overall Study Death	275	260	122	280
Overall Study Lost to Follow-up	1	1	0	7
Overall Study Withdrawal by Subject	9	7	1	20

Baseline Characteristics

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Baseline characteristics by cohort

Measure	Durva 1500 mg n=389 Participants Durvalumab 1500 mg every 4 weeks (Q4W)	Treme 300 mg x1 Dose + Durva 1500 mg n=393 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=153 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=389 Participants Sorafenib 400 mg twice daily (BID)	Total n=1324 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 11.47 • n=14 Participants	63.0 years STANDARD_DEVIATION 11.65 • n=10 Participants	63.4 years STANDARD_DEVIATION 12.03 • n=24 Participants	63.5 years STANDARD_DEVIATION 11.12 • n=78 Participants	63.1 years STANDARD_DEVIATION 11.48 • n=713 Participants
Age, Customized <65	203 Participants n=14 Participants	195 Participants n=10 Participants	74 Participants n=24 Participants	195 Participants n=78 Participants	667 Participants n=713 Participants
Age, Customized >=65-<75	130 Participants n=14 Participants	145 Participants n=10 Participants	55 Participants n=24 Participants	137 Participants n=78 Participants	467 Participants n=713 Participants
Age, Customized >=75	56 Participants n=14 Participants	53 Participants n=10 Participants	24 Participants n=24 Participants	57 Participants n=78 Participants	190 Participants n=713 Participants
Sex: Female, Male Female	66 Participants n=14 Participants	66 Participants n=10 Participants	32 Participants n=24 Participants	52 Participants n=78 Participants	216 Participants n=713 Participants
Sex: Female, Male Male	323 Participants n=14 Participants	327 Participants n=10 Participants	121 Participants n=24 Participants	337 Participants n=78 Participants	1108 Participants n=713 Participants
Race/Ethnicity, Customized White	160 Participants n=14 Participants	182 Participants n=10 Participants	70 Participants n=24 Participants	179 Participants n=78 Participants	591 Participants n=713 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=14 Participants	7 Participants n=10 Participants	4 Participants n=24 Participants	10 Participants n=78 Participants	23 Participants n=713 Participants
Race/Ethnicity, Customized Asian	212 Participants n=14 Participants	195 Participants n=10 Participants	75 Participants n=24 Participants	189 Participants n=78 Participants	671 Participants n=713 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=14 Participants	1 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants	1 Participants n=713 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants	0 Participants n=713 Participants
Race/Ethnicity, Customized Other	15 Participants n=14 Participants	7 Participants n=10 Participants	4 Participants n=24 Participants	5 Participants n=78 Participants	31 Participants n=713 Participants
Race/Ethnicity, Customized Missing	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	6 Participants n=78 Participants	6 Participants n=713 Participants
Race/Ethnicity, Customized Hispanic or Latino	13 Participants n=14 Participants	21 Participants n=10 Participants	11 Participants n=24 Participants	21 Participants n=78 Participants	66 Participants n=713 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	376 Participants n=14 Participants	372 Participants n=10 Participants	142 Participants n=24 Participants	362 Participants n=78 Participants	1252 Participants n=713 Participants
Region group Asia (except Japan)	167 Participants n=14 Participants	156 Participants n=10 Participants	60 Participants n=24 Participants	156 Participants n=78 Participants	539 Participants n=713 Participants
Region group Rest of World (includes Japan)	222 Participants n=14 Participants	237 Participants n=10 Participants	93 Participants n=24 Participants	233 Participants n=78 Participants	785 Participants n=713 Participants

PRIMARY outcome

Timeframe: From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).

Population: The FAS included all participants who were randomized. T75+D arm was closed during study.

OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This primary outcome measure presents OS analysis of Treme 300mg x1 dose + Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=393 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=153 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=389 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=389 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg	16.43 months Interval 14.16 to 19.58	16.36 months Interval 12.39 to 19.65	13.77 months Interval 12.25 to 16.13	16.56 months Interval 14.06 to 19.12

SECONDARY outcome

Timeframe: From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).

Population: The FAS included all participants who were randomized. T75+D arm was closed during study.

OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This secondary outcome measure presents OS analysis of Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=389 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=153 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=389 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=389 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg	16.43 months Interval 14.16 to 19.58	16.36 months Interval 12.39 to 19.65	13.77 months Interval 12.25 to 16.13	16.56 months Interval 14.06 to 19.12

SECONDARY outcome

Timeframe: At 18, 24, and 36 months post-randomization. Assessed at the final analysis DCO (27Aug2021).

Population: The FAS included all participants who were randomized. T75+D arm was closed during study.

Percentage of participants who were alive at fixed time points (18, 24, and 36 months) after randomization. The estimated percentage of survival along with the 95% confidence interval were calculated using Kaplan-Meier technique on the full analysis set.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=393 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=153 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=389 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=389 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Overall Survival (OS) at 18, 24, and 36 Months After Randomization Survival rate at 18 months	48.7 percentage of survival Interval 43.6 to 53.5	46.4 percentage of survival Interval 38.4 to 54.1	41.5 percentage of survival Interval 36.5 to 46.4	47.4 percentage of survival Interval 42.4 to 52.3
Overall Survival (OS) at 18, 24, and 36 Months After Randomization Survival rate at 24 months	40.5 percentage of survival Interval 35.6 to 45.3	37.3 percentage of survival Interval 29.6 to 44.9	32.6 percentage of survival Interval 27.9 to 37.4	39.6 percentage of survival Interval 34.8 to 44.5
Overall Survival (OS) at 18, 24, and 36 Months After Randomization Survival rate at 36 months	30.7 percentage of survival Interval 25.8 to 35.7	22.9 percentage of survival Interval 16.6 to 29.8	20.2 percentage of survival Interval 15.8 to 25.1	24.7 percentage of survival Interval 20.0 to 29.8

SECONDARY outcome

Timeframe: Tumor scans performed at baseline, every 8 weeks for the first 48 weeks following randomization, and every 12 weeks thereafter until RECIST 1.1-defined progression. Assessed up to DCO (27Aug2021, to a maximum of approximately 46 months)

Population: The FAS included all participants who were randomized. T75+D arm was closed during study.

PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST 1.1] using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death by any cause in the absence of progression, regardless of whether the patient withdrew from study treatment or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as a at least 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir) - this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm from nadir.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=393 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=153 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=389 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=389 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Progression Free Survival (PFS)	3.78 months Interval 3.68 to 5.32	3.65 months Interval 2.79 to 4.86	4.07 months Interval 3.75 to 5.49	3.65 months Interval 3.19 to 3.75

SECONDARY outcome

Timeframe: From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Population: The FAS included all participants who were randomized. T75+D arm was closed during study.

TTP was defined as the time from randomization until objective tumor progression in the absence of death. If participants died without tumor progression, they were censored at the time of death.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=393 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=153 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=389 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=389 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Time To Progression (TTP)	5.42 months Interval 3.81 to 5.62	3.75 months Interval 3.55 to 5.59	5.55 months Interval 5.13 to 5.75	3.75 months Interval 3.68 to 5.42

SECONDARY outcome

Timeframe: From the date of randomization until objective tumor progression, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Population: The FAS included all participants who were randomized. T75+D arm was closed during study.

ORR (per RECIST 1.1 as assessed by the Investigator) was defined as the number (%) of participants with at least 1 confirmed visit response of CR or PR until progression, or the last evaluable assessment in the absence of progression. Participants who go off treatment without progression, receive a subsequent therapy, and then respond will not be included as responders in the ORR. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=393 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=153 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=389 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=389 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Objective Response Rate (ORR)	79 Participants	26 Participants	20 Participants	66 Participants

SECONDARY outcome

Timeframe: From the date of randomization until objective tumor progression or date of death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Population: The FAS included all participants who were randomized. T75+D arm was closed during study.

Number (%) of participants with a Best Objective Response (BoR) of CR, PR, or SD. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (ie., SD) was defined as neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increase to qualify for progression.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=393 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=153 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=389 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=389 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Disease Control Rate (DCR) Yes	236 Participants	89 Participants	236 Participants	213 Participants
Disease Control Rate (DCR) No	157 Participants	64 Participants	153 Participants	176 Participants

SECONDARY outcome

Timeframe: From the date of first documented response until the first date of documented progression or death, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Population: A subset of FAS subjects who achieve confirmed CR or PR as determined per RECIST 1.1 using Investigator assessment. T75+D arm was closed during study.

Time from the date of first documented confirmed response (complete or partial response) until the first date of documented progression or death in the absence of disease progression. Complete response (ie., CR) was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. Partial response (ie., PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=79 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=26 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=20 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=66 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Duration of Objective Response (DoR) Duration of response from onset of response	22.34 months Interval 8.54 to Not reached	14.75 months Interval 7.46 to 14.75	18.43 months Interval 6.51 to 25.99	16.82 months Interval 7.43 to Not reached
Duration of Objective Response (DoR) Time to onset of response from randomization	2.17 months Interval 1.84 to 3.98	2.02 months Interval 1.87 to 3.71	3.78 months Interval 1.89 to 8.44	2.09 months Interval 1.87 to 3.98

SECONDARY outcome

Timeframe: From the date of randomization until death due to any cause, assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Population: A subset of FAS who had non-missing baseline PD-L1 status. T75+D arm was closed during study.

Overall survival by baseline PD-L1 expression levels (positive vs. negative). PD-L1 expression level is based on the Tumor and Immune Cell Positivity (TIP) score method as: PD-L1 Positive (TIP ≥ 1%) or PD-L1 Negative (TIP < 1%).

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=337 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=144 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=329 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=344 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Overall Survival (OS) by PD-L1 PD-L1 expression negative (TIP<1%)	14.26 months Interval 11.5 to 21.29	14.46 months Interval 8.97 to 17.51	13.93 months Interval 12.39 to 16.69	15.06 months Interval 12.68 to 18.53
Overall Survival (OS) by PD-L1 PD-L1 expression positive (TIP>=1%)	17.00 months Interval 13.11 to 22.31	24.21 months Interval 14.55 to 27.24	15.93 months Interval 10.68 to 21.72	17.22 months Interval 12.29 to 24.38

SECONDARY outcome

Timeframe: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.

Population: A subset of the FAS who had baseline scores of \>=10. T75+D arm was closed during study.

European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire (QLQ-C30), which consists of 30 questions combined to produce a global health status/QoL scale. Higher scores indicate better health. A clinically meaningful deterioration is defined as a decrease in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=302 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=132 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=323 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=319 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
EORTC QLQ-C30 Time to Global Health Status/QoL Deterioration	7.5 months Interval 5.82 to 10.84	7.3 months Interval 5.65 to 9.33	5.7 months Interval 4.8 to 7.39	7.4 months Interval 5.68 to 9.33

SECONDARY outcome

Timeframe: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.

Population: A subset of the FAS who have a baseline symptom score \<= 90. T75+D arm was closed during study.

EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=291 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=127 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=314 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=315 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
EORTC QLQ-HCC18 Time to Symptom (Abdominal Pain) Deterioration	16.8 months Interval 11.17 to Not reached	14.7 months Interval 8.97 to 36.04	8.9 months Interval 7.23 to 11.14	14.1 months Interval 9.46 to 24.41

SECONDARY outcome

Timeframe: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.

Population: A subset of the FAS who have a baseline symptom score \<= 90. T75+D arm was closed during study.

EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=288 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=127 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=309 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=308 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
EORTC QLQ-HCC18 Time to Symptom (Shoulder Pain) Deterioration	12.6 months Interval 9.23 to 19.58	13.8 months Interval 6.47 to 19.19	9.4 months Interval 7.46 to 13.37	16.0 months Interval 9.03 to 22.31

SECONDARY outcome

Timeframe: At baseline and every 8 weeks for the first 48 weeks and then every 12 weeks thereafter until death or the final analysis DCO (27Aug2021), assessed up to approximately 46 months.

Population: A subset of the FAS who have a baseline symptom score \<= 90. T75+D arm was closed during study.

EORTC 18-item hepatocellular cancer health-related quality of life questionnaire (QLQ-HCC18) is an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30, which includes 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. A high score for a symptom scale/item represents a high level of symptomatology/problem. A clinically meaningful deterioration is defined as an increase in the score from baseline of ≥10. Time to deterioration is defined as the time from the date of randomization until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit or death by any cause in the absence of a clinically meaningful deterioration, regardless of whether the patient discontinues study drug(s) or receives another anticancer therapy.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=290 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=125 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=319 Participants Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=314 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
EORTC QLQ-HCC18 Time to Symptom (Abdominal Swelling) Deterioration	20.9 months Interval 12.88 to 36.01	11.3 months Interval 5.78 to 19.19	11.1 months Interval 9.26 to 13.73	16.7 months Interval 9.46 to 24.8

SECONDARY outcome

Timeframe: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of durvalumab. Assessed until the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

Population: The Durvalumab ADA evaluable set includes all participants who received at least 1 dose of Durvalumab and had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results for Durvalumab. T75+D arm was closed during study.

Number of participants with Anti-Drug Antibody (ADA) response to Durvalumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Durvalumab for each indicated category.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=294 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=108 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=282 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Presence of ADA for Durvalumab Treatment-emergent ADA positive (ADA Incidence)	9 Participants	5 Participants	—	8 Participants
Presence of ADA for Durvalumab Treatment-induced ADA (Positive Post-baseline only)	9 Participants	5 Participants	—	7 Participants

SECONDARY outcome

Timeframe: Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of tremelimumab. Assessed up to approximately 46 months after the first randomization.

Population: The Tremelimumab ADA evaluable set includes all participants who received at least 1 dose of Tremelimumab and had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results for Tremelimumab. T75+D arm was closed during study.

Number of participants with Anti-Drug Antibody (ADA) response to Tremelimumab. ADA positive post-baseline only was also referred to as treatment-induced ADA. Treatment-emergent ADA was defined as the sum of treatment-induced ADA and treatment-boosted ADA. Results are reported as number of participants with ADA responses to Tremelimumab for each indicated category.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=182 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=102 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg Sorafenib 400 mg twice daily (BID)	Durva 1500 mg Durvalumab 1500 mg every 4 weeks (Q4W)
Presence of ADA for Tremelimumab Treatment-emergent ADA positive (ADA Incidence)	20 Participants	23 Participants	—	—
Presence of ADA for Tremelimumab Treatment-induced ADA (Positive Post-baseline only)	20 Participants	22 Participants	—	—

SECONDARY outcome

Timeframe: To evaluate the PK of Durvalumab, samples were collected pre-dose at week 4 and week 12 and post-dose at week 12. Assessed at the final analysis DCO (27Aug2021).

Population: PK analysis set includes all participants who received at least 1 dose Durvalumab per the study protocol for whom any PK post-dose data were available (ie, at least 1 non-missing post-dose PK result). T75+D arm was closed during study.

Blood sample were collected at pre-specified timepoints and Durvalumab concentrations in serum (ug/mL) were reported over time.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=388 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=142 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg Sorafenib 400 mg twice daily (BID)	Durva 1500 mg n=357 Participants Durvalumab 1500 mg every 4 weeks (Q4W)
Summary of Durvalumab Concentration Over Time Cycle 4 (Week 12) pre-dose, Geometric mean	77.5 ug/mL Geometric Coefficient of Variation 280.1	92.1 ug/mL Geometric Coefficient of Variation 137.5	—	113.9 ug/mL Geometric Coefficient of Variation 116.2
Summary of Durvalumab Concentration Over Time Cycle 4 (Week 12) post-dose, Geometric mean	539.3 ug/mL Geometric Coefficient of Variation 38.6	528.4 ug/mL Geometric Coefficient of Variation 36.8	—	556.9 ug/mL Geometric Coefficient of Variation 32.7
Summary of Durvalumab Concentration Over Time Cycle 2 (Week 4) pre-dose, Geometric mean	59.9 ug/mL Geometric Coefficient of Variation 101.6	65.1 ug/mL Geometric Coefficient of Variation 68.4	—	74.7 ug/mL Geometric Coefficient of Variation 86.7

SECONDARY outcome

Timeframe: To evaluate the PK of Tremelimumab, samples were collected at week 0 (post-dose), week 4, and week 12. Assessed at the final analysis DCO (27Aug2021).

Population: PK analysis set includes all participants who received at least 1 dose of Tremelimumab per the study protocol for whom any PK post-dose data were available (ie, at least 1 non-missing post-dose PK result). T75+D arm was closed during study.

Blood sample were collected at pre-specified timepoints and Tremelimumab concentrations in serum (ug/mL) were reported over time.

Outcome measures

Measure	Treme 300 mg x1 Dose + Durva 1500 mg n=388 Participants Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=142 Participants Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg Sorafenib 400 mg twice daily (BID)	Durva 1500 mg Durvalumab 1500 mg every 4 weeks (Q4W)
Summary of Tremelimumab Concentration Over Time Cycle 1 (Week 0) post-dose, Geometric mean	78.0 ug/mL Geometric Coefficient of Variation 117.2	—	—	—
Summary of Tremelimumab Concentration Over Time Cycle 2 (Week 4), Geometric mean	10.7 ug/mL Geometric Coefficient of Variation 84.7	3.2 ug/mL Geometric Coefficient of Variation 67.8	—	—
Summary of Tremelimumab Concentration Over Time Cycle 4 (Week 12), Geometric mean	1.3 ug/mL Geometric Coefficient of Variation 156.5	4.3 ug/mL Geometric Coefficient of Variation 85.4	—	—

Adverse Events

Durva 1500 mg

Serious events: 115 serious events

Other events: 299 other events

Deaths: 280 deaths

Treme 300 mg x1 Dose + Durva 1500 mg

Serious events: 157 serious events

Other events: 334 other events

Deaths: 262 deaths

Treme 75 mg x4 Doses + Durva 1500 mg

Serious events: 52 serious events

Other events: 133 other events

Deaths: 123 deaths

Sora 400 mg

Serious events: 111 serious events

Other events: 333 other events

Deaths: 293 deaths

Serious adverse events

Measure	Durva 1500 mg n=388 participants at risk Durvalumab 1500 mg every 4 weeks (Q4W)	Treme 300 mg x1 Dose + Durva 1500 mg n=388 participants at risk Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=152 participants at risk Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=374 participants at risk Sorafenib 400 mg twice daily (BID)
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Device related infection	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Enterocolitis infectious	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Gastroenteritis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Hepatitis c	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Infection	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Lower respiratory tract infection	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Myocarditis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Meningitis listeria	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Necrotising fasciitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Peritonitis	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Pneumocystis jirovecii pneumonia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Pneumonia	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.8% 7/388 • Number of events 7 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.9% 6/152 • Number of events 6 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.1% 8/374 • Number of events 8 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Pneumonia bacterial	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Postoperative wound infection	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Respiratory tract infection	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Respiratory tract infection viral	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Urosepsis	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Viral infection	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Head injury	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Poisoning	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Radius fracture	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Aspartate aminotransferase increased	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Blood bilirubin increased	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Liver function test increased	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Weight decreased	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Cell death	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Gout	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Hyperglycaemia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Hyperkalaemia	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Ventricular tachycardia	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Blood and lymphatic system disorders Anaemia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.3% 5/388 • Number of events 5 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.0% 3/152 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Chest wall haematoma	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Polymyositis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma stage 0	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Endocrine disorders Adrenal insufficiency	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Cerebral haematoma	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Cerebral infarction	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Encephalopathy	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Haemorrhage intracranial	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Hepatic encephalopathy	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.80% 3/374 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Endocrine disorders Glucocorticoid deficiency	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Spinal cord compression	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Syncope	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Psychiatric disorders Completed suicide	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Psychiatric disorders Confusional state	0.26% 1/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Pain	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Psychiatric disorders Restlessness	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Endocrine disorders Hypercalcaemia of malignancy	0.26% 1/388 • Number of events 7 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Proteinuria	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Renal failure	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Ureterolithiasis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Urinary retention	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Drug-induced liver injury	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.1% 4/374 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.3% 2/152 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Endocrine disorders Hypothyroidism	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Eye disorders Diplopia	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Diabetic wound	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Stevens-johnson syndrome	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Bleeding varicose vein	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Abdominal pain	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.3% 2/152 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.6% 6/374 • Number of events 6 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Bacillus bacteraemia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Bacteraemia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Biliary tract infection	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Bone abscess	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Covid-19 pneumonia	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Candida infection	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Cellulitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Clostridium difficile colitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Clostridium difficile infection	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Cytomegalovirus infection	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Diarrhoea infectious	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Anal haemorrhage	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Erysipelas	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Escherichia sepsis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Ascites	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.0% 4/388 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Gastroenteritis bacterial	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Gastroenteritis viral	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Hepatic infection	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Autoimmune enteropathy	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Infectious pleural effusion	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Influenza	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Liver abscess	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Colitis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.5% 6/388 • Number of events 6 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Orchitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Peritonitis bacterial	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Pharyngitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Post procedural infection	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Pulmonary tuberculosis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Salmonella sepsis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Sepsis	1.0% 4/388 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.1% 8/388 • Number of events 8 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.3% 2/152 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Septic shock	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Streptococcal sepsis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Suspected covid-19	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Tuberculosis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Infections and infestations Urinary tract infection	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.1% 4/374 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Fall	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Humerus fracture	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Overdose	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Post embolisation syndrome	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Radiation pneumonitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Rib fracture	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Spinal fracture	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Alanine aminotransferase increased	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Amylase increased	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Hepatic enzyme increased	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations International normalised ratio increased	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Lipase increased	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Liver function test abnormal	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Dehydration	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Diabetes mellitus	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.0% 4/388 • Number of events 7 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Hypoglycaemia	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Hyponatraemia	0.52% 2/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Malnutrition	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Back pain	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Coccydynia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Immobilisation syndrome	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Melaena	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma malignant	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Nausea	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of head and neck	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Oesophageal varices haemorrhage	1.0% 4/388 • Number of events 6 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.0% 3/152 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Cerebral haemorrhage	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Cerebrovascular accident	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Dizziness	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Facial paralysis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Headache	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Hemiparesis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Myasthenia gravis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Nervous system disorder	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Neuritis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Neuropathy peripheral	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Polyneuropathy	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Nervous system disorders Thalamic infarction	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.8% 7/388 • Number of events 9 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.1% 4/374 • Number of events 5 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Psychiatric disorders Psychotic disorder	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Acute kidney injury	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.0% 4/388 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Vomiting	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Autoimmune nephritis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Haematoma	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Chronic kidney disease	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Haematuria	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Immune-mediated nephritis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Renal and urinary disorders Nephrolithiasis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Fatigue	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.0% 4/388 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.0% 3/152 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Rash	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Skin ulcer	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Deep vein thrombosis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Hypertension	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Hypotension	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Hypovolaemic shock	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Internal haemorrhage	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Peripheral ischaemia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Phlebitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Shock haemorrhagic	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Thrombophlebitis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Atrioventricular block	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Jaundice	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Immune system disorders Contrast media allergy	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Death	2.1% 8/388 • Number of events 8 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.0% 4/388 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.3% 5/152 • Number of events 5 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.3% 5/374 • Number of events 5 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Immune system disorders Drug hypersensitivity	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Bradycardia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Cardiac arrest	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Cardiac failure	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Cardio-respiratory arrest	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Cardiomyopathy	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Left ventricular dysfunction	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Myocardial infarction	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Ear and labyrinth disorders Vertigo	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Endocrine disorders Adrenocorticotropic hormone deficiency	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Endocrine disorders Hyperthyroidism	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Eye disorders Retinal detachment	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Abdominal pain upper	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Constipation	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Diarrhoea	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.3% 9/388 • Number of events 9 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.6% 4/152 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.6% 6/374 • Number of events 6 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Dysphagia	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Enterocolitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Gastric ulcer	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Gastric varices haemorrhage	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Gastritis erosive	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Blood and lymphatic system disorders Thrombocytopenia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.3% 5/388 • Number of events 5 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.8% 7/388 • Number of events 8 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.80% 3/374 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Haematemesis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Haematochezia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Inguinal hernia	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Acute myocardial infarction	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Mesenteric vein thrombosis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Pancreatitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Portal hypertensive gastropathy	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Angina pectoris	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Asthenia	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Dehiscence	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Gait disturbance	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Hernia pain	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Mucosal inflammation	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Multiple organ dysfunction syndrome	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Atrial fibrillation	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Oedema	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Oedema peripheral	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Pyrexia	1.5% 6/388 • Number of events 6 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.0% 4/388 • Number of events 5 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Biliary obstruction	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Cholangitis	0.52% 2/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Cholangitis acute	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Cholecystitis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Cardiac disorders Atrial flutter	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Hepatic cirrhosis	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Hepatic failure	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.3% 2/152 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.3% 5/374 • Number of events 5 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Hepatic function abnormal	1.3% 5/388 • Number of events 6 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Hepatic haemorrhage	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Hepatitis	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.6% 4/152 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/374 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/388 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.27% 1/374 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.

Other adverse events

Measure	Durva 1500 mg n=388 participants at risk Durvalumab 1500 mg every 4 weeks (Q4W)	Treme 300 mg x1 Dose + Durva 1500 mg n=388 participants at risk Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W	Treme 75 mg x4 Doses + Durva 1500 mg n=152 participants at risk Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W	Sora 400 mg n=374 participants at risk Sorafenib 400 mg twice daily (BID)
Investigations Alanine aminotransferase increased	10.8% 42/388 • Number of events 49 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	9.0% 35/388 • Number of events 45 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.9% 9/152 • Number of events 9 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.3% 20/374 • Number of events 26 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Amylase increased	2.3% 9/388 • Number of events 11 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.2% 28/388 • Number of events 38 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.9% 6/152 • Number of events 6 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.7% 10/374 • Number of events 17 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Aspartate aminotransferase increased	13.9% 54/388 • Number of events 63 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	11.9% 46/388 • Number of events 53 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	10.5% 16/152 • Number of events 17 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	6.4% 24/374 • Number of events 33 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Blood bilirubin increased	5.9% 23/388 • Number of events 30 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	4.9% 19/388 • Number of events 23 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.6% 4/152 • Number of events 5 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.8% 29/374 • Number of events 32 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Gamma-glutamyltransferase increased	3.1% 12/388 • Number of events 12 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	4.6% 18/388 • Number of events 18 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	4.6% 7/152 • Number of events 7 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.1% 19/374 • Number of events 24 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Lipase increased	5.9% 23/388 • Number of events 27 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	8.2% 32/388 • Number of events 38 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.3% 8/152 • Number of events 10 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	4.0% 15/374 • Number of events 17 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Metabolism and nutrition disorders Decreased appetite	13.7% 53/388 • Number of events 58 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	16.8% 65/388 • Number of events 69 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	15.8% 24/152 • Number of events 24 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	17.9% 67/374 • Number of events 72 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Back pain	8.2% 32/388 • Number of events 35 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.2% 28/388 • Number of events 35 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	6.6% 10/152 • Number of events 11 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.5% 13/374 • Number of events 13 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Blood and lymphatic system disorders Anaemia	7.2% 28/388 • Number of events 29 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	8.2% 32/388 • Number of events 39 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	8.6% 13/152 • Number of events 15 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	8.3% 31/374 • Number of events 32 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Pain in extremity	1.0% 4/388 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.6% 10/388 • Number of events 11 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	6.6% 10/152 • Number of events 12 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.2% 12/374 • Number of events 14 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Psychiatric disorders Insomnia	5.4% 21/388 • Number of events 21 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	10.3% 40/388 • Number of events 44 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	6.6% 10/152 • Number of events 10 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	4.3% 16/374 • Number of events 16 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Endocrine disorders Hyperthyroidism	2.3% 9/388 • Number of events 9 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.7% 30/388 • Number of events 31 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.9% 9/152 • Number of events 10 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.53% 2/374 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Cough	8.0% 31/388 • Number of events 34 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.7% 30/388 • Number of events 31 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	10.5% 16/152 • Number of events 19 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.9% 22/374 • Number of events 22 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.0% 4/388 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	1.3% 2/152 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.0% 26/374 • Number of events 26 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.4% 13/388 • Number of events 14 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.9% 23/388 • Number of events 24 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.9% 6/152 • Number of events 6 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.7% 14/374 • Number of events 15 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Endocrine disorders Hypothyroidism	4.9% 19/388 • Number of events 20 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	12.1% 47/388 • Number of events 47 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	12.5% 19/152 • Number of events 20 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	4.3% 16/374 • Number of events 16 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Alopecia	1.3% 5/388 • Number of events 5 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.52% 2/388 • Number of events 2 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.66% 1/152 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	14.2% 53/374 • Number of events 54 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.26% 1/388 • Number of events 1 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.77% 3/388 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.0% 3/152 • Number of events 3 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	46.3% 173/374 • Number of events 197 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Pruritus	14.4% 56/388 • Number of events 61 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	22.9% 89/388 • Number of events 106 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	17.8% 27/152 • Number of events 34 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	6.4% 24/374 • Number of events 25 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Skin and subcutaneous tissue disorders Rash	10.1% 39/388 • Number of events 51 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	21.6% 84/388 • Number of events 101 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	17.8% 27/152 • Number of events 32 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	13.4% 50/374 • Number of events 54 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Vascular disorders Hypertension	4.4% 17/388 • Number of events 18 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.7% 22/388 • Number of events 26 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.9% 6/152 • Number of events 10 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	18.2% 68/374 • Number of events 79 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Abdominal pain upper	5.4% 21/388 • Number of events 24 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.5% 29/388 • Number of events 35 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.9% 6/152 • Number of events 9 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	4.8% 18/374 • Number of events 18 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Constipation	10.8% 42/388 • Number of events 48 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	9.3% 36/388 • Number of events 45 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.9% 12/152 • Number of events 13 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	9.1% 34/374 • Number of events 36 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Diarrhoea	14.7% 57/388 • Number of events 67 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	25.0% 97/388 • Number of events 125 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	18.4% 28/152 • Number of events 39 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	43.9% 164/374 • Number of events 241 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Dyspepsia	3.9% 15/388 • Number of events 17 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.3% 9/388 • Number of events 9 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.3% 5/152 • Number of events 5 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.3% 20/374 • Number of events 20 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Blood and lymphatic system disorders Thrombocytopenia	3.9% 15/388 • Number of events 18 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	3.9% 15/388 • Number of events 20 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	6.6% 10/152 • Number of events 14 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.9% 22/374 • Number of events 26 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Vomiting	4.6% 18/388 • Number of events 21 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	6.2% 24/388 • Number of events 28 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.3% 8/152 • Number of events 10 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	9.1% 34/374 • Number of events 37 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Asthenia	12.4% 48/388 • Number of events 63 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	10.1% 39/388 • Number of events 46 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	13.2% 20/152 • Number of events 22 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	11.8% 44/374 • Number of events 49 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Fatigue	9.5% 37/388 • Number of events 49 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	16.8% 65/388 • Number of events 71 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	16.4% 25/152 • Number of events 31 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	18.7% 70/374 • Number of events 75 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Oedema peripheral	6.2% 24/388 • Number of events 25 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	8.2% 32/388 • Number of events 34 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	10.5% 16/152 • Number of events 18 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.1% 19/374 • Number of events 21 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
General disorders Pyrexia	8.0% 31/388 • Number of events 38 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	12.4% 48/388 • Number of events 62 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	10.5% 16/152 • Number of events 18 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	8.6% 32/374 • Number of events 34 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Investigations Weight decreased	2.8% 11/388 • Number of events 12 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.2% 28/388 • Number of events 28 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.3% 8/152 • Number of events 8 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	9.6% 36/374 • Number of events 37 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 37/388 • Number of events 46 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	9.0% 35/388 • Number of events 38 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.2% 11/152 • Number of events 12 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.6% 21/374 • Number of events 21 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Abdominal pain	9.0% 35/388 • Number of events 36 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	11.3% 44/388 • Number of events 46 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	15.8% 24/152 • Number of events 26 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	15.8% 59/374 • Number of events 72 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Ascites	6.2% 24/388 • Number of events 26 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.7% 22/388 • Number of events 24 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.3% 8/152 • Number of events 8 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	5.3% 20/374 • Number of events 21 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Nausea	9.5% 37/388 • Number of events 41 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	11.9% 46/388 • Number of events 53 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	8.6% 13/152 • Number of events 13 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	13.9% 52/374 • Number of events 61 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
Gastrointestinal disorders Stomatitis	1.0% 4/388 • Number of events 4 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	2.3% 9/388 • Number of events 11 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	0.00% 0/152 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.	7.8% 29/374 • Number of events 36 • All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months). TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.

Additional Information

Global Clinical Lead

AstraZeneca Clinical Study Information Center

Phone: 1 8772409479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator agrees not to independently publish the results of the Study until first occurrence of one of the following: (i) multi-centre primary Publication is published; (ii) no multi-centre primary publication is submitted within two years after conclusion, abandonment, or termination of the Study at all sites; or (iii) Sponsor confirms in writing there will be no multi-centre primary Publication.
• Publication restrictions are in place

Restriction type: OTHER