Trial Outcomes & Findings for Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) (NCT NCT04191096)

NCT ID: NCT04191096

Last Updated: 2025-08-29

Results Overview

rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per modified RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1251 participants
• Primary outcome timeframe: Up to approximately 32 months
• Results posted on: 2025-08-29

Participant Flow

Of the 1251 randomized participants1250 participants received treatment. The safety analyses were conducted using all participants as treated population, which included all randomized participants who received at least 1 dose of study intervention.

Participant milestones

Measure	Pembrolizumab + Enzalutamide + ADT Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Overall Study STARTED	626	625
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	626	625

Reasons for withdrawal

Measure	Pembrolizumab + Enzalutamide + ADT Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Overall Study Death	102	89
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	5	5
Overall Study Participants Ongoing	518	530

Baseline Characteristics

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

Baseline characteristics by cohort

Measure	Pembrolizumab + Enzalutamide + ADT n=626 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=625 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.	Total n=1251 Participants Total of all reporting groups
Age, Continuous	67.6 Years STANDARD_DEVIATION 8.3 • n=5 Participants	67.6 Years STANDARD_DEVIATION 8.2 • n=7 Participants	67.6 Years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	626 Participants n=5 Participants	625 Participants n=7 Participants	1251 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	119 Participants n=5 Participants	112 Participants n=7 Participants	231 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	505 Participants n=5 Participants	510 Participants n=7 Participants	1015 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) Asian	99 Participants n=5 Participants	118 Participants n=7 Participants	217 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	447 Participants n=5 Participants	440 Participants n=7 Participants	887 Participants n=5 Participants
Race (NIH/OMB) More than one race	39 Participants n=5 Participants	37 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Prior Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) at Baseline Yes	64 Participants n=5 Participants	61 Participants n=7 Participants	125 Participants n=5 Participants
Prior Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) at Baseline No	562 Participants n=5 Participants	564 Participants n=7 Participants	1126 Participants n=5 Participants
Presence of High-Volume Disease at Baseline Yes	392 Participants n=5 Participants	398 Participants n=7 Participants	790 Participants n=5 Participants
Presence of High-Volume Disease at Baseline No	234 Participants n=5 Participants	227 Participants n=7 Participants	461 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 32 months

Population: All randomized participants

rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per modified RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=626 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=625 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)	NA Months NA = Median, lower limit and upper limit of 95% CI for rPFS cannot be calculated at the time of last disease assessment due to insufficient number of participants with events.	NA Months NA = Median, lower limit and upper limit of 95% CI for rPFS cannot be calculated at the time of last disease assessment due to insufficient number of participants with events.

PRIMARY outcome

Timeframe: Up to approximately 32 months

Population: All randomized participants

OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=626 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=625 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Overall Survival (OS)	NA Months NA = Median, lower limit and upper limit of 95% CI for OS cannot be calculated at the time of last disease assessment due to insufficient number of participants with events.	NA Months NA = Median, lower limit and upper limit of 95% CI for OS cannot be calculated at the time of last disease assessment due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to Approximately 32 months

Population: All randomized participants

TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product limit (Kaplan-Meier) method for censored data. Participants without documented event at time of analysis will be censored at the date of last known time to have not received subsequent new anti-cancer therapy.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=626 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=625 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST)	NA Months Interval 29.0 to NA = Median and upper limit of 95% CI for TFST cannot be calculated at the time of last disease assessment due to insufficient number of participants with events	NA Months NA = Median, lower limit and upper limit of 95% CI for TFST cannot be calculated at the time of last disease assessment due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to Approximately 32 months

Population: All randomized participants

TTSSRE was the time from randomization to the first symptomatic skeletal-related event defined as: use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms, occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral), occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention, whichever occurs first. The TTSSRE was calculated using the Kaplan-Meier method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=626 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=625 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Time to First Symptomatic Skeletal-related Event (TTSSRE)	NA Months NA = Median, lower limit and upper limit of 95% CI for TTSSRE cannot be calculated at the time of last disease assessment due to insufficient number of participants with events.	NA Months NA = Median, lower limit and upper limit of 95% CI for TTSSRE cannot be calculated at the time of last disease assessment due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to Approximately 32 months

Population: All randomized participants

Time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, or 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. Time to PSA was calculated using Kaplan-Meier method for censored data. Participants without PSA progression were censored at the last PSA date.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=626 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=625 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Time to Prostate-specific Antigen (PSA) Progression	NA Months NA = Median, lower limit and upper limit of 95% CI for Time to PSA Progression cannot be calculated at the time of last disease assessment due to insufficient number of participants with events.	NA Months NA = Median, lower limit and upper limit of 95% CI for Time to PSA Progression cannot be calculated at the time of last disease assessment due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to Approximately 32 months

Population: All randomized participants

The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=626 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=625 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of PCWG-Modified RECIST 1.1 as Assessed by BICR	NA Months NA = Median, lower limit and upper limit of 95% CI for time to radiographic soft tissue progression cannot be calculated at the time of last disease assessment due to insufficient number of participants with events	NA Months NA = Median, lower limit and upper limit of 95% CI for time to radiographic soft tissue progression cannot be calculated at the time of last disease assessment due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to Approximately 32 months

Population: All randomized participants who received at least one dose of study treatment, and who had at least 1 BPI-SF assessment

TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF. Pain progression was defined as: 1) For participants asymptomatic at baseline: a >2-point change from baseline in the average BPI-SF item 3 score at 2 consecutive visits or initiation of opioid use for pain 2) For participants symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids; a >2-point change from baseline in the average BPI-SF Item 3 score and the average worst pain score >4 and no decrease in average opioid use. TTPP was calculated using the Kaplan-Meier method for censored data. Participants who had > 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=622 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=622 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item #3 ("Worst Pain in 24 Hours") and Opiate Use	NA Months Interval 25.4 to NA = Median and upper limit of 95% CI for TTPP cannot be calculated at the time of last disease assessment due to insufficient number of participants with events	NA Months NA = Median, lower limit and upper limit of 95% CI for TTPP cannot be calculated at the time of last disease assessment due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to Approximately 32 months

Population: All randomized participants

PFS2 was defined as the time from randomization to disease progression as determined by investigator assessment of radiological or clinical progression after next-line of therapy or death from any cause, whichever occurs first.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=626 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=625 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Time From Randomization to Disease Progression as Determined by Investigator Assessment After Next-line of Therapy or Death From Any Cause, Whichever Occurs First (PFS2)	NA Months Interval 29.0 to NA = Median and upper limit of 95% CI for PFS2 cannot be calculated at the time of last disease assessment due to insufficient number of participants with events	NA Months NA = Median, lower limit and upper limit of 95% CI for PFS2 cannot be calculated at the time of last disease assessment due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to Approximately 32 Months

Population: All randomized participants who had a baseline PSA measurement and had data available for analysis

PSA response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by >50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed >3 weeks from the original response.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=619 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=617 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Prostate-specific Antigen (PSA) Response Rate	90.3 Percentage of participants Interval 87.7 to 92.5	93.0 Percentage of participants Interval 90.7 to 94.9

SECONDARY outcome

Timeframe: Up to Approximately 32 Months

Population: All randomized participants with detectable PSA at baseline and had data available for analysis

PSA undetectable rate was defined as the percentage of participants with detectable PSA (> 0.2 ng/mL) at baseline, which becomes undetectable (< 0.2 ng/mL) during study treatment.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=587 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=585 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Prostate-specific Antigen (PSA) Undetectable	63.4 Percentage of Participants Interval 59.3 to 67.3	64.1 Percentage of Participants Interval 60.1 to 68.0

SECONDARY outcome

Timeframe: Up to Approximately 32 Months

Population: All randomized participants with measurable disease at baseline and had data available for analysis

ORR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on base scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=248 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=245 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Objective Response Rate (ORR) Per PCWG-Modified RECIST 1.1 as Assessed by BICR	65.7 Percentage of Participants Interval 59.5 to 71.6	71.8 Percentage of Participants Interval 65.8 to 77.4

SECONDARY outcome

Timeframe: Up to Approximately 32 Months

Population: All randomized participants who demonstrated a CR or PR, and had data available for analysis

DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of a least 5 mm. PD per PCWG was the appearance of >2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for >6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Measure	Pembrolizumab + Enzalutamide + ADT n=163 Participants Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=176 Participants Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Duration of Response (DOR) Per PCWG- Modified RECIST 1.1 as Assessed by BICR	NA Months Interval 22.2 to NA = Median and upper limit of 95% CI for DOR cannot be calculated at the time of last disease assessment due to insufficient number of participants with response.	NA Months NA = Median, lower limit and upper limit of 95% CI for DOR cannot be calculated at the time of last disease assessment due to insufficient number of participants with response.

SECONDARY outcome

Timeframe: Up to Approximately 59 Months

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Participants who experienced an AE will be reported for each arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Approximately 59 Months

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported for each arm.

Outcome measures

Outcome data not reported

Adverse Events

Pembrolizumab + Enzalutamide + ADT

Serious events: 252 serious events

Other events: 588 other events

Deaths: 105 deaths

Placebo + Enzalutamide + ADT

Serious events: 145 serious events

Other events: 551 other events

Deaths: 93 deaths

Serious adverse events

Measure	Pembrolizumab + Enzalutamide + ADT n=625 participants at risk Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=625 participants at risk Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Blood and lymphatic system disorders Anaemia	0.80% 5/625 • Number of events 5 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Blood and lymphatic system disorders Febrile neutropenia	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Acute coronary syndrome	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Acute myocardial infarction	0.16% 1/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Angina pectoris	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Angina unstable	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Aortic valve stenosis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Arteriosclerosis coronary artery	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Atrial fibrillation	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Atrial flutter	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Bradycardia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Cardiac arrest	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Cardiac failure	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Cardiac failure congestive	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Cardiac ventricular thrombosis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Coronary artery disease	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Immune-mediated myocarditis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Myocardial infarction	1.1% 7/625 • Number of events 7 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	1.1% 7/625 • Number of events 7 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Myocardial ischaemia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Myopericarditis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Cardiac disorders Supraventricular tachyarrhythmia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Endocrine disorders Adrenal insufficiency	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Endocrine disorders Hypophysitis	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Eye disorders Normal tension glaucoma	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Chronic gastritis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Colitis	1.1% 7/625 • Number of events 8 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Constipation	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Diarrhoea	0.80% 5/625 • Number of events 6 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Dysphagia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Enlarged uvula	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Enteritis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Gastric ulcer	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Gastritis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Immune-mediated gastritis	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Inguinal hernia	0.64% 4/625 • Number of events 4 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Intestinal obstruction	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 9 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Large intestine polyp	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Nausea	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Pancreatitis	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Pancreatitis acute	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Vomiting	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Asthenia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Chest pain	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Condition aggravated	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Death	0.96% 6/625 • Number of events 6 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Fatigue	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Injection site reaction	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Peripheral swelling	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Pyrexia	0.80% 5/625 • Number of events 5 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Sudden death	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Autoimmune hepatitis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Bile duct stone	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Cholecystitis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Cholecystitis acute	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Cholelithiasis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Drug-induced liver injury	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Hepatic function abnormal	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Hepatitis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Hepatitis acute	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Hepatotoxicity	0.32% 2/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Hyperplastic cholecystopathy	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Hypertransaminasaemia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Hepatobiliary disorders Immune-mediated hepatitis	0.80% 5/625 • Number of events 5 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Immune system disorders Contrast media reaction	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Immune system disorders Hypersensitivity	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Abdominal abscess	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Abdominal infection	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Appendicitis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Bacterial sepsis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Bone tuberculosis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations COVID-19	0.96% 6/625 • Number of events 6 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.80% 5/625 • Number of events 5 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations COVID-19 pneumonia	0.64% 4/625 • Number of events 4 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.96% 6/625 • Number of events 6 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Cellulitis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Cholecystitis infective	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Clostridium difficile infection	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Cystitis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Device related infection	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Diarrhoea infectious	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Diverticulitis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Enterocolitis infectious	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Erysipelas	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Gastroenteritis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Gastrointestinal infection	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Infection	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Joint tuberculosis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Lower respiratory tract infection	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Nosocomial infection	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Perineal abscess	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Pneumonia	1.4% 9/625 • Number of events 10 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	1.1% 7/625 • Number of events 8 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Pneumonia legionella	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Post procedural infection	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Postoperative wound infection	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Pulmonary sepsis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Pyelonephritis	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Rash pustular	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Sepsis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Septic shock	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Staphylococcal bacteraemia	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Urinary tract infection	1.8% 11/625 • Number of events 16 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	1.1% 7/625 • Number of events 7 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Urosepsis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Wound infection	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Concussion	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Cystitis radiation	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Electric shock	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Femoral neck fracture	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Femur fracture	0.96% 6/625 • Number of events 6 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Foot fracture	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Fracture	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Head injury	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Hip fracture	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Humerus fracture	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Limb injury	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.48% 3/625 • Number of events 4 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Pelvic fracture	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Soft tissue injury	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Spinal compression fracture	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Spinal cord injury	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Subdural haematoma	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Toxicity to various agents	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Alanine aminotransferase increased	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Aspartate aminotransferase increased	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Blood glucose increased	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Neutrophil count decreased	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Oxygen saturation decreased	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Troponin I increased	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Dehydration	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Diabetes mellitus	0.64% 4/625 • Number of events 4 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Hypercalcaemia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Hypoglycaemia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Hyponatraemia	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Type 3 diabetes mellitus	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Vitamin B1 deficiency	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Arthralgia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Autoimmune myositis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Back pain	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Myopathy	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Myositis	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Pain in extremity	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Pathological fracture	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Sarcopenia	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Spinal ligament ossification	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Spinal pain	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glottis carcinoma	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.16% 1/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Basal ganglia infarction	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Brain injury	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Brain oedema	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Carotid artery stenosis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Cauda equina syndrome	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Cerebellar haemorrhage	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Cerebral infarction	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Cerebrovascular accident	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Dementia	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Dizziness	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Encephalopathy	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Facial nerve disorder	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Haemorrhage intracranial	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Headache	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Intracranial pressure increased	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Ischaemic stroke	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Nerve compression	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Neuropathy peripheral	0.16% 1/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Noninfective encephalitis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Polyneuropathy	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Presyncope	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Progressive bulbar palsy	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Radiculopathy	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Sciatica	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Seizure	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Spinal cord compression	0.48% 3/625 • Number of events 4 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.80% 5/625 • Number of events 5 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Syncope	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Toxic encephalopathy	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Transient ischaemic attack	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Product Issues Device dislocation	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Product Issues Device malfunction	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Psychiatric disorders Confusional state	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Psychiatric disorders Depression	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Psychiatric disorders Mania	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Acute kidney injury	0.64% 4/625 • Number of events 4 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Bladder diverticulum	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Calculus bladder	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Calculus urinary	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Dysuria	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Haematuria	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.48% 3/625 • Number of events 4 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Haemorrhage urinary tract	0.16% 1/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Hydronephrosis	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Immunotactoid glomerulonephritis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Nephrolithiasis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Renal failure	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Renal impairment	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Tubulointerstitial nephritis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Ureteric stenosis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Ureterolithiasis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Urethral stenosis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Urinary incontinence	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Urinary retention	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.64% 4/625 • Number of events 4 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Renal and urinary disorders Urinary tract obstruction	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Reproductive system and breast disorders Prostatic obstruction	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Reproductive system and breast disorders Testicular pain	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Hypersensitivity pneumonitis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.64% 4/625 • Number of events 4 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.1% 7/625 • Number of events 7 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.48% 3/625 • Number of events 3 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Dermatitis	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.80% 5/625 • Number of events 5 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Drug eruption	0.80% 5/625 • Number of events 5 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Eczema	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Erythema multiforme	0.80% 5/625 • Number of events 5 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Rash	1.6% 10/625 • Number of events 10 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Rash erythematous	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.6% 10/625 • Number of events 10 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Rash morbilliform	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Urticaria	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Vascular disorders Aortic stenosis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Vascular disorders Deep vein thrombosis	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Vascular disorders Embolism	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Vascular disorders Hypertensive crisis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Vascular disorders Hypotension	0.32% 2/625 • Number of events 2 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Vascular disorders Peripheral arterial occlusive disease	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Vascular disorders Peripheral ischaemia	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Vascular disorders Phlebitis	0.00% 0/625 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	0.16% 1/625 • Number of events 1 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.

Other adverse events

Measure	Pembrolizumab + Enzalutamide + ADT n=625 participants at risk Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met.	Placebo + Enzalutamide + ADT n=625 participants at risk Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met.
Blood and lymphatic system disorders Anaemia	15.5% 97/625 • Number of events 139 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	13.6% 85/625 • Number of events 108 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Endocrine disorders Hypothyroidism	13.1% 82/625 • Number of events 82 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	4.0% 25/625 • Number of events 25 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Abdominal pain	5.1% 32/625 • Number of events 41 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	4.6% 29/625 • Number of events 33 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Constipation	17.3% 108/625 • Number of events 133 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	16.5% 103/625 • Number of events 117 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Diarrhoea	20.3% 127/625 • Number of events 196 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	11.7% 73/625 • Number of events 92 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Nausea	16.8% 105/625 • Number of events 125 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	12.0% 75/625 • Number of events 86 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Gastrointestinal disorders Vomiting	5.6% 35/625 • Number of events 43 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	4.6% 29/625 • Number of events 36 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Asthenia	12.8% 80/625 • Number of events 101 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	8.8% 55/625 • Number of events 66 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Fatigue	31.0% 194/625 • Number of events 236 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	28.5% 178/625 • Number of events 200 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Oedema peripheral	10.7% 67/625 • Number of events 73 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	8.0% 50/625 • Number of events 54 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
General disorders Pyrexia	10.1% 63/625 • Number of events 68 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	4.2% 26/625 • Number of events 31 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations COVID-19	12.0% 75/625 • Number of events 76 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	12.0% 75/625 • Number of events 76 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Infections and infestations Urinary tract infection	5.9% 37/625 • Number of events 43 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	5.0% 31/625 • Number of events 40 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Injury, poisoning and procedural complications Fall	7.0% 44/625 • Number of events 51 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	8.5% 53/625 • Number of events 64 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Alanine aminotransferase increased	11.7% 73/625 • Number of events 89 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	6.1% 38/625 • Number of events 39 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Aspartate aminotransferase increased	11.8% 74/625 • Number of events 93 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	6.2% 39/625 • Number of events 43 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Blood alkaline phosphatase increased	6.4% 40/625 • Number of events 49 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	2.9% 18/625 • Number of events 20 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Blood creatinine increased	5.8% 36/625 • Number of events 58 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	3.2% 20/625 • Number of events 29 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Investigations Weight decreased	9.1% 57/625 • Number of events 62 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	3.2% 20/625 • Number of events 25 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Decreased appetite	14.6% 91/625 • Number of events 107 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	8.3% 52/625 • Number of events 59 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Metabolism and nutrition disorders Hyperglycaemia	9.3% 58/625 • Number of events 90 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	8.2% 51/625 • Number of events 71 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Arthralgia	29.0% 181/625 • Number of events 251 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	25.8% 161/625 • Number of events 208 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Back pain	16.3% 102/625 • Number of events 114 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	18.1% 113/625 • Number of events 125 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Bone pain	6.2% 39/625 • Number of events 40 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	5.3% 33/625 • Number of events 36 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Myalgia	8.6% 54/625 • Number of events 63 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	8.0% 50/625 • Number of events 65 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Neck pain	5.1% 32/625 • Number of events 33 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	3.4% 21/625 • Number of events 23 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Musculoskeletal and connective tissue disorders Pain in extremity	10.4% 65/625 • Number of events 81 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	10.6% 66/625 • Number of events 83 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Dizziness	9.4% 59/625 • Number of events 66 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	7.4% 46/625 • Number of events 53 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Dysgeusia	5.9% 37/625 • Number of events 39 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	3.7% 23/625 • Number of events 24 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Headache	12.6% 79/625 • Number of events 98 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	10.4% 65/625 • Number of events 81 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Nervous system disorders Paraesthesia	3.5% 22/625 • Number of events 28 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	6.6% 41/625 • Number of events 43 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Psychiatric disorders Insomnia	9.9% 62/625 • Number of events 71 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	7.5% 47/625 • Number of events 53 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Cough	8.2% 51/625 • Number of events 54 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	7.0% 44/625 • Number of events 51 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.2% 51/625 • Number of events 60 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	3.8% 24/625 • Number of events 25 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Dry skin	7.8% 49/625 • Number of events 56 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	7.7% 48/625 • Number of events 55 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Pruritus	17.6% 110/625 • Number of events 142 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	8.8% 55/625 • Number of events 73 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Rash	23.7% 148/625 • Number of events 200 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	9.3% 58/625 • Number of events 66 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.0% 56/625 • Number of events 61 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	2.4% 15/625 • Number of events 23 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Vascular disorders Hot flush	17.6% 110/625 • Number of events 119 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	23.0% 144/625 • Number of events 148 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
Vascular disorders Hypertension	17.3% 108/625 • Number of events 130 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.	20.8% 130/625 • Number of events 155 • Up to Approximately 32 months All-cause mortality was reported on all randomized participants and adverse events (serious and non-serious) were reported on all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor will comply with the requirements for publication of study results. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
• Publication restrictions are in place

Restriction type: OTHER