Trial Outcomes & Findings for A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer (NCT NCT04209114)

NCT ID: NCT04209114

Last Updated: 2024-06-27

Results Overview

Pathologic Complete Response (pCR) is defined as the percentage of randomized participants with absence of any cancer in pathology specimens after radical cystectomy, based on blinded independent pathology review (BIPR). Participants who do not undertake surgery will be counted as non-pCR.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 114 participants
• Primary outcome timeframe: From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months)
• Results posted on: 2024-06-27

Participant Flow

Per Protocol Amendment 04, participants who are currently receiving bempegaldesleukin plus nivolumab in Arm A are required to discontinue bempegaldesleukin and may continue to receive nivolumab monotherapy.

Participant milestones

Measure	Arm A: Nivolumab + Bempegaldesleukin Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm B: Nivolumab Nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Pre-Treatment Phase STARTED	37	37	40
Pre-Treatment Phase COMPLETED	37	37	32
Pre-Treatment Phase NOT COMPLETED	0	0	8
Treatment Phase STARTED	37	37	32
Treatment Phase COMPLETED	15	13	32
Treatment Phase NOT COMPLETED	22	24	0

Reasons for withdrawal

Measure	Arm A: Nivolumab + Bempegaldesleukin Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm B: Nivolumab Nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Pre-Treatment Phase Completed without radical cystectomy	0	0	5
Pre-Treatment Phase Other reasons	0	0	1
Pre-Treatment Phase Death	0	0	1
Pre-Treatment Phase Participant withdrew consent	0	0	1
Treatment Phase Other reasons	5	3	0
Treatment Phase Lost to Follow-up	1	0	0
Treatment Phase Participant withdrew consent	1	0	0
Treatment Phase Adverse event unrelated to study drug	1	5	0
Treatment Phase Death	4	1	0
Treatment Phase Study drug toxicity	4	6	0
Treatment Phase Disease progression	6	9	0

Baseline Characteristics

A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

Baseline characteristics by cohort

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm B: Nivolumab n=37 Participants Nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=40 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Total n=114 Participants Total of all reporting groups
Age, Continuous	73.0 Years STANDARD_DEVIATION 8.8 • n=5 Participants	72.0 Years STANDARD_DEVIATION 7.5 • n=7 Participants	74.5 Years STANDARD_DEVIATION 8.4 • n=5 Participants	74.0 Years STANDARD_DEVIATION 8.2 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	30 Participants n=7 Participants	31 Participants n=5 Participants	92 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	35 Participants n=7 Participants	36 Participants n=5 Participants	107 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants

PRIMARY outcome

Timeframe: From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months)

Population: All randomized participants in Arms A and C

Pathologic Complete Response (pCR) is defined as the percentage of randomized participants with absence of any cancer in pathology specimens after radical cystectomy, based on blinded independent pathology review (BIPR). Participants who do not undertake surgery will be counted as non-pCR.

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=40 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care	10.8 Percentage of participants Interval 3.0 to 25.4	2.5 Percentage of participants Interval 0.1 to 13.2	—

PRIMARY outcome

Timeframe: From randomization up to first EFS event (up to approximately 30 months)

Population: All randomized participants in Arms A and C

Event Free Survival (EFS) is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence based on blinded independent committee review (BICR) assessments, or death due to any cause.

Participants who did not have an EFS event will be censored on the date of their last evaluable tumor assessment (imaging or biopsy) or at the date of radical surgery whichever occur last. Participants who did not have any baseline tumor assessments (imaging or biopsy) and did not undergo radical cystectomy for other reason than worsening/progression of disease will be censored on their date of randomization. Participants who did not have any on study tumor assessments (imaging or biopsy) and did not die will be censored on their date of radical cystectomy (or randomization date if no radical cystectomy performed).

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=40 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Event Free Survival (EFS) - Nivolumab + Bempegaldesleukin Compared to Standard of Care	22.11 Months Interval 8.21 to Upper limit not calculated due to insufficient number of events.	15.18 Months Interval 11.63 to Upper limit not calculated due to insufficient number of events.	—

SECONDARY outcome

Timeframe: From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months)

Population: All randomized participants in Arms B and C

Pathologic Complete Response (pCR) is defined as the percentage of randomized participants with absence of any cancer in pathology specimens after radical cystectomy, based on blinded independent pathology review (BIPR). Participants who do not undertake surgery will be counted as non-pCR.

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=40 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Pathologic Complete Response (pCR) Rate - Nivolumab Compared to Standard of Care	10.8 Percentage of participants Interval 3.0 to 25.4	2.5 Percentage of participants Interval 0.1 to 13.2	—

SECONDARY outcome

Timeframe: From randomization up to first EFS event (up to approximately 30 months)

Population: All randomized participants in Arms B and C

Event Free Survival (EFS) is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence based on blinded independent committee review (BICR) assessments, or death due to any cause.

Participants who did not have an EFS event will be censored on the date of their last evaluable tumor assessment (imaging or biopsy) or at the date of radical surgery whichever occur last. Participants who did not have any baseline tumor assessments (imaging or biopsy) and did not undergo radical cystectomy for other reason than worsening/progression of disease will be censored on their date of randomization. Participants who did not have any on study tumor assessments (imaging or biopsy) and did not die will be censored on their date of radical cystectomy (or randomization date if no radical cystectomy performed).

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=40 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Event Free Survival (EFS) - Nivolumab Compared to Standard of Care	NA Months Interval 10.84 to Median and upper limit not calculated due to insufficient number of events.	15.18 Months Interval 11.63 to Upper limit not calculated due to insufficient number of events.	—

SECONDARY outcome

Timeframe: From randomization to study completion, up to approximately 40 months

Population: All randomized participants

Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.

OS was not calculated for Arm A and Arm B because the number of events did not meet the threshold due to early study termination. In lieu of OS, time to death is reported as a Post-Hoc endpoint.

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=37 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care n=40 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Overall Survival (OS)	NA Months Median, lower and upper limit not calculated due to insufficient number of events.	NA Months Median, lower and upper limit not calculated due to insufficient number of events.	23.23 Months Interval 14.36 to Upper limit not calculated due to insufficient number of events.

SECONDARY outcome

Timeframe: from first dose to 100 days following last dose (up to approximately 20 months)

Population: All treated participants

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=37 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care n=32 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
The Number of Participants Experiencing Adverse Events (AEs)	34 Participants	36 Participants	19 Participants

SECONDARY outcome

Timeframe: from first dose to 100 days following last dose (up to approximately 20 months)

Population: All treated participants

A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=37 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care n=32 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
The Number of Participants Experiencing Serious Adverse Events (SAEs)	15 Participants	18 Participants	14 Participants

SECONDARY outcome

Timeframe: from first dose to 100 days following last dose (up to approximately 20 months)

Population: All treated participants

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=37 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care n=32 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	8 Participants	8 Participants	0 Participants

SECONDARY outcome

Timeframe: from first dose to 100 days following last dose (up to approximately 20 months)

Population: All treated participants

IMAEs are specific AEs that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis), and other specific events, considered as potential immune-mediated events by investigator that meet the definition summarized below:

• those occurring within 100 days of the last dose,
• regardless of causality,
• treated with immune-modulating medication (of note, endocrine AEs such as adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis are considered IMAEs regardless of immune-modulating medication use, since endocrine drug reactions are often managed without immune-modulating medication).
• with no clear alternate etiology based on investigator assessment, or with an immune-mediated component.

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=37 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care n=32 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
The Number of Participants Experiencing Immune-Mediated Adverse Events (IMAEs)	10 Participants	10 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose to 100 days following last dose (up to approximately 20 months)

Population: All treated participants

Clinical laboratory values by worst CTC grade are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=37 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care n=32 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Worst Grade Clinical Laboratory Values Hypernatremia · Grade 3	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Lymphocytes (Absolute), Local Lab · Grade 1	4 Participants	6 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hemoglobin · Grade 0	5 Participants	5 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hemoglobin · Grade 1	23 Participants	23 Participants	2 Participants
Worst Grade Clinical Laboratory Values Hemoglobin · Grade 2	7 Participants	8 Participants	3 Participants
Worst Grade Clinical Laboratory Values Hemoglobin · Grade 3	1 Participants	1 Participants	1 Participants
Worst Grade Clinical Laboratory Values Hemoglobin · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hemoglobin · Not Reported	1 Participants	0 Participants	26 Participants
Worst Grade Clinical Laboratory Values Platelet Count · Grade 0	35 Participants	34 Participants	5 Participants
Worst Grade Clinical Laboratory Values Platelet Count · Grade 1	1 Participants	3 Participants	1 Participants
Worst Grade Clinical Laboratory Values Platelet Count · Grade 2	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Platelet Count · Grade 3	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Platelet Count · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Platelet Count · Not Reported	1 Participants	0 Participants	26 Participants
Worst Grade Clinical Laboratory Values Leukocytes, Local Lab · Grade 0	33 Participants	35 Participants	6 Participants
Worst Grade Clinical Laboratory Values Leukocytes, Local Lab · Grade 1	2 Participants	2 Participants	0 Participants
Worst Grade Clinical Laboratory Values Leukocytes, Local Lab · Grade 2	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Leukocytes, Local Lab · Grade 3	1 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Leukocytes, Local Lab · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Leukocytes, Local Lab · Not Reported	1 Participants	0 Participants	26 Participants
Worst Grade Clinical Laboratory Values Lymphocytes (Absolute), Local Lab · Grade 0	23 Participants	12 Participants	0 Participants
Worst Grade Clinical Laboratory Values Lymphocytes (Absolute), Local Lab · Grade 2	0 Participants	6 Participants	0 Participants
Worst Grade Clinical Laboratory Values Lymphocytes (Absolute), Local Lab · Grade 3	3 Participants	2 Participants	0 Participants
Worst Grade Clinical Laboratory Values Lymphocytes (Absolute), Local Lab · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Lymphocytes (Absolute), Local Lab · Not Reported	7 Participants	11 Participants	32 Participants
Worst Grade Clinical Laboratory Values Absolute Neutrophil Count · Grade 0	31 Participants	36 Participants	0 Participants
Worst Grade Clinical Laboratory Values Absolute Neutrophil Count · Grade 1	4 Participants	1 Participants	0 Participants
Worst Grade Clinical Laboratory Values Absolute Neutrophil Count · Grade 2	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Absolute Neutrophil Count · Grade 3	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Absolute Neutrophil Count · Grade 4	1 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Absolute Neutrophil Count · Not Reported	1 Participants	0 Participants	32 Participants
Worst Grade Clinical Laboratory Values Alkaline Phosphate, Local Lab · Grade 0	24 Participants	30 Participants	2 Participants
Worst Grade Clinical Laboratory Values Alkaline Phosphate, Local Lab · Grade 1	10 Participants	7 Participants	0 Participants
Worst Grade Clinical Laboratory Values Alkaline Phosphate, Local Lab · Grade 2	2 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Alkaline Phosphate, Local Lab · Grade 3	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Alkaline Phosphate, Local Lab · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Alkaline Phosphate, Local Lab · Not Reported	1 Participants	0 Participants	30 Participants
Worst Grade Clinical Laboratory Values Aspartate Aminotransferase, Local Lab · Grade 0	31 Participants	30 Participants	2 Participants
Worst Grade Clinical Laboratory Values Aspartate Aminotransferase, Local Lab · Grade 1	5 Participants	6 Participants	0 Participants
Worst Grade Clinical Laboratory Values Aspartate Aminotransferase, Local Lab · Grade 2	0 Participants	1 Participants	0 Participants
Worst Grade Clinical Laboratory Values Aspartate Aminotransferase, Local Lab · Grade 3	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Aspartate Aminotransferase, Local Lab · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Aspartate Aminotransferase, Local Lab · Not Reported	1 Participants	0 Participants	30 Participants
Worst Grade Clinical Laboratory Values Alanine Aminotransferase, Local Lab · Grade 0	26 Participants	30 Participants	2 Participants
Worst Grade Clinical Laboratory Values Alanine Aminotransferase, Local Lab · Grade 1	10 Participants	7 Participants	0 Participants
Worst Grade Clinical Laboratory Values Alanine Aminotransferase, Local Lab · Grade 2	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Alanine Aminotransferase, Local Lab · Grade 3	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Alanine Aminotransferase, Local Lab · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Alanine Aminotransferase, Local Lab · Not Reported	1 Participants	0 Participants	30 Participants
Worst Grade Clinical Laboratory Values Total Bilirubin, Local Lab · Grade 0	33 Participants	35 Participants	2 Participants
Worst Grade Clinical Laboratory Values Total Bilirubin, Local Lab · Grade 1	2 Participants	2 Participants	0 Participants
Worst Grade Clinical Laboratory Values Total Bilirubin, Local Lab · Grade 2	1 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Total Bilirubin, Local Lab · Grade 3	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Total Bilirubin, Local Lab · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Total Bilirubin, Local Lab · Not Reported	1 Participants	0 Participants	30 Participants
Worst Grade Clinical Laboratory Values Creatinine, Local Lab · Grade 0	11 Participants	13 Participants	5 Participants
Worst Grade Clinical Laboratory Values Creatinine, Local Lab · Grade 1	10 Participants	14 Participants	1 Participants
Worst Grade Clinical Laboratory Values Creatinine, Local Lab · Grade 2	12 Participants	9 Participants	0 Participants
Worst Grade Clinical Laboratory Values Creatinine, Local Lab · Grade 3	3 Participants	1 Participants	0 Participants
Worst Grade Clinical Laboratory Values Creatinine, Local Lab · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Creatinine, Local Lab · Not Reported	1 Participants	0 Participants	26 Participants
Worst Grade Clinical Laboratory Values Hypernatremia · Grade 0	34 Participants	36 Participants	6 Participants
Worst Grade Clinical Laboratory Values Hypernatremia · Grade 1	2 Participants	1 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypernatremia · Grade 2	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypernatremia · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypernatremia · Not Reported	1 Participants	0 Participants	26 Participants
Worst Grade Clinical Laboratory Values Hyponatremia · Grade 0	24 Participants	29 Participants	5 Participants
Worst Grade Clinical Laboratory Values Hyponatremia · Grade 1	12 Participants	7 Participants	1 Participants
Worst Grade Clinical Laboratory Values Hyponatremia · Grade 2	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hyponatremia · Grade 3	0 Participants	1 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hyponatremia · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hyponatremia · Not Reported	1 Participants	0 Participants	26 Participants
Worst Grade Clinical Laboratory Values Hyperkalemia · Grade 0	24 Participants	25 Participants	6 Participants
Worst Grade Clinical Laboratory Values Hyperkalemia · Grade 1	7 Participants	9 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hyperkalemia · Grade 2	4 Participants	3 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hyperkalemia · Grade 3	1 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hyperkalemia · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hyperkalemia · Not Reported	1 Participants	0 Participants	26 Participants
Worst Grade Clinical Laboratory Values Hypokalemia · Grade 0	24 Participants	25 Participants	6 Participants
Worst Grade Clinical Laboratory Values Hypokalemia · Grade 1	7 Participants	9 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypokalemia · Grade 2	4 Participants	3 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypokalemia · Grade 3	1 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypokalemia · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypokalemia · Not Reported	1 Participants	0 Participants	26 Participants
Worst Grade Clinical Laboratory Values Hypercalcemia · Grade 0	33 Participants	34 Participants	4 Participants
Worst Grade Clinical Laboratory Values Hypercalcemia · Grade 1	3 Participants	3 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypercalcemia · Grade 2	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypercalcemia · Grade 3	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypercalcemia · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypercalcemia · Not Reported	1 Participants	0 Participants	28 Participants
Worst Grade Clinical Laboratory Values Hypocalcemia · Grade 0	29 Participants	28 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypocalcemia · Grade 1	6 Participants	7 Participants	3 Participants
Worst Grade Clinical Laboratory Values Hypocalcemia · Grade 2	1 Participants	1 Participants	1 Participants
Worst Grade Clinical Laboratory Values Hypocalcemia · Grade 3	0 Participants	1 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypocalcemia · Grade 4	0 Participants	0 Participants	0 Participants
Worst Grade Clinical Laboratory Values Hypocalcemia · Not Reported	1 Participants	0 Participants	28 Participants

POST_HOC outcome

Timeframe: From randomization to study completion, up to approximately 40 months

Population: All randomized participants

The amount of time in months from when participants were randomized until death. Survival was reported as time to death instead of overall survival by Kaplan-Meier analysis due to the small number of events at the time of early study completion.

Outcome measures

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 Participants Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=37 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.	Arm C: Standard of Care n=40 Participants Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Time to Death	6.77 Months Interval 3.2 to 18.4	9.43 Months Interval 1.8 to 20.1	8.49 Months Interval 1.6 to 23.2

Adverse Events

Arm A: Nivolumab + Bempegaldesleukin

Serious events: 16 serious events

Other events: 32 other events

Deaths: 8 deaths

Arm B: Nivolumab

Serious events: 22 serious events

Other events: 29 other events

Deaths: 6 deaths

Arm C: Standard of Care

Serious events: 15 serious events

Other events: 18 other events

Deaths: 12 deaths

Serious adverse events

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 participants at risk Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm B: Nivolumab n=37 participants at risk Nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=32 participants at risk Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Blood and lymphatic system disorders Hypereosinophilic syndrome	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Acute myocardial infarction	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Atrial fibrillation	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiac arrest	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiac failure acute	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Endocarditis noninfective	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Myocarditis	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Congenital, familial and genetic disorders Vallecular cyst	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Adrenal insufficiency	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Hernial eventration	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Ileus	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Intestinal barrier dysfunction	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Intestinal fistula	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Rectal perforation	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Umbilical hernia	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Asthenia	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Multiple organ dysfunction syndrome	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Sudden cardiac death	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Bile duct stone	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Cholecystitis	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Appendicitis perforated	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations COVID-19	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Escherichia urinary tract infection	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pelvic abscess	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pyelonephritis	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pyelonephritis acute	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Sepsis	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Septic shock	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urosepsis	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Hip fracture	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Incision site impaired healing	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood creatine increased	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood creatinine increased	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations General physical condition abnormal	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Lipase increased	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Cerebral infarction	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Ischaemic stroke	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Syncope	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Product Issues Device occlusion	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Mental status changes	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Acute kidney injury	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Haematuria	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Hydronephrosis	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Immune-mediated nephritis	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Renal failure	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypertension	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Other adverse events

Measure	Arm A: Nivolumab + Bempegaldesleukin n=37 participants at risk Bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by bempegaldesleukin 0.006 mg/kg once every 3 weeks plus nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm B: Nivolumab n=37 participants at risk Nivolumab 360 mg once every 3 weeks for 3 cycles as neoadjuvant therapy, followed by Radical Cystectomy, followed by nivolumab 360 mg once every 3 weeks up to an additional 12 cycles.	Arm C: Standard of Care n=32 participants at risk Standard of care therapy, with cystectomy alone, without neoadjuvant or adjuvant therapy.
Blood and lymphatic system disorders Anaemia	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.9% 7/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Eosinophilia	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Hyperleukocytosis	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Bradycardia	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hyperthyroidism	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypothyroidism	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.5% 5/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Eye disorders Dry eye	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain upper	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.9% 7/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	21.6% 8/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Oesophagitis	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Asthenia	24.3% 9/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.5% 5/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Chills	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Fatigue	21.6% 8/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.2% 6/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Influenza like illness	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Oedema peripheral	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pain	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Peripheral swelling	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pyrexia	27.0% 10/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Xerosis	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Immune system disorders Hypersensitivity	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations COVID-19	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Cystitis	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	13.5% 5/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.9% 7/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Amylase increased	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood creatinine increased	13.5% 5/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Gamma-glutamyltransferase increased	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Lipase increased	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Weight decreased	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.9% 7/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Weight increased	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Decreased appetite	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Groin pain	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Dizziness	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Headache	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Product Issues Device occlusion	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Anxiety	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Insomnia	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Dysuria	0.00% 0/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Haematuria	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dry skin	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 2/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	35.1% 13/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.2% 6/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypertension	2.7% 1/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.2% 6/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypotension	8.1% 3/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.8% 4/37 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 40 months). Serious adverse events (SAEs) and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 20 months). The number at risk for All-Cause Mortality represents all randomized participants. The number at risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trails@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER