Trial Outcomes & Findings for Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (NCT NCT04736199)

NCT ID: NCT04736199

Last Updated: 2026-02-06

Results Overview

rPFS used conventional imaging method (99mTc-phosphonate bone scan, CT/MRI scan). rPFS was defined as the time from the date of randomization to the date of progressive disease in malignant soft tissue lesions, progressive disease in malignant bone lesions, or death due to any cause, whichever occurs first. Malignant soft tissue lesions were assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and malignant bone lesions were assessed by Prostate Cancer Clinical Trials Working Group (PCWG3) criteria.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 669 participants
• Primary outcome timeframe: From randomization to the date when 222 rPFS events were observed, approximately 36 months
• Results posted on: 2026-02-06

Participant Flow

Study was conducted at 133 centers in Europe/Rest of the world (ROW), Asia, and Latin America between 23-Feb-2021 (first participant first visit) and 07-Jun-2024 (primary completion date). Study is still ongoing.

In total 889 participants were screened in the study and 202 participants were screen failures. An additional 18 participants prematurely discontinued screening. A total of 669 participants were randomized (446 to the darolutamide arm and 223 to the placebo arm).

Participant milestones

Measure	Darolutamide+ADT Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Placebo+ADT Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Overall Study STARTED	446	223
Overall Study Treated	443	223
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	446	223

Reasons for withdrawal

Measure	Darolutamide+ADT Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Placebo+ADT Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Overall Study Adverse Event	28	22
Overall Study Death	9	3
Overall Study Lost to Follow-up	4	1
Overall Study Physician Decision	5	9
Overall Study Withdrawal by Subject	21	9
Overall Study Progressive disease	120	101
Overall Study Subject decision	13	13
Overall Study Required study drug interruption longer than allowed per protocol	2	0
Overall Study Additional primary malignancy	1	0
Overall Study Non-compliance with study drug	0	1
Overall Study Other reason	0	1
Overall Study Ongoing with study drug	240	63
Overall Study Study drug never administered	3	0

Baseline Characteristics

Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

Baseline characteristics by cohort

Measure	Darolutamide+ADT n=446 Participants Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Placebo+ADT n=223 Participants Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Total n=669 Participants Total of all reporting groups
Age, Continuous	69.6 Years STANDARD_DEVIATION 8.8 • n=192 Participants	69.2 Years STANDARD_DEVIATION 8.9 • n=170 Participants	69.5 Years STANDARD_DEVIATION 8.8 • n=185 Participants
Sex: Female, Male Female	0 Participants n=192 Participants	0 Participants n=170 Participants	0 Participants n=185 Participants
Sex: Female, Male Male	446 Participants n=192 Participants	223 Participants n=170 Participants	669 Participants n=185 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	104 Participants n=192 Participants	58 Participants n=170 Participants	162 Participants n=185 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	334 Participants n=192 Participants	157 Participants n=170 Participants	491 Participants n=185 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=192 Participants	8 Participants n=170 Participants	16 Participants n=185 Participants
Race/Ethnicity, Customized White	251 Participants n=192 Participants	125 Participants n=170 Participants	376 Participants n=185 Participants
Race/Ethnicity, Customized Black or African American	41 Participants n=192 Participants	24 Participants n=170 Participants	65 Participants n=185 Participants
Race/Ethnicity, Customized Asian	144 Participants n=192 Participants	65 Participants n=170 Participants	209 Participants n=185 Participants
Race/Ethnicity, Customized Other	10 Participants n=192 Participants	9 Participants n=170 Participants	19 Participants n=185 Participants

PRIMARY outcome

Timeframe: From randomization to the date when 222 rPFS events were observed, approximately 36 months

Population: Full analysis set (FAS)

rPFS used conventional imaging method (99mTc-phosphonate bone scan, CT/MRI scan). rPFS was defined as the time from the date of randomization to the date of progressive disease in malignant soft tissue lesions, progressive disease in malignant bone lesions, or death due to any cause, whichever occurs first. Malignant soft tissue lesions were assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and malignant bone lesions were assessed by Prostate Cancer Clinical Trials Working Group (PCWG3) criteria.

Outcome measures

Measure	Placebo+ADT n=223 Participants Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Darolutamide+ADT n=446 Participants Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Radiological Progression-free Survival (rPFS) Assessed by Central Review	25.0 Months Interval 19.0 to NA signifies that value cannot be estimated due to insufficient number of participants with events.	NA Months NA signifies that value cannot be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From randomization to the date when 222 rPFS events were observed, approximately 36 months

Population: Full Analysis Set (FAS)

Time from the date of randomization to the date of death from any cause.

Outcome measures

Measure	Placebo+ADT n=223 Participants Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Darolutamide+ADT n=446 Participants Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Overall Survival (OS)	NA Months Interval 33.8 to NA signifies that value cannot be estimated due to insufficient number of participants with events.	NA Months NA signifies that value cannot be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From randomization to the date when 222 rPFS events were observed, approximately 36 months

Population: Full Analysis Set (FAS)

Time from the date of randomization to the date of first castration resistant event (radiological progression, Prostate-specific antigen (PSA) progression or symptomatic skeletal events, whichever occurs first).

Outcome measures

Measure	Placebo+ADT n=223 Participants Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Darolutamide+ADT n=446 Participants Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Time to Castration-Resistant Prostate Cancer (CRPC)	13.8 Months Interval 12.0 to 16.8	NA Months NA signifies that value cannot be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From randomization to the date when 222 rPFS events were observed, approximately 36 months

Population: Full Analysis Set (FAS)

Time from the date of randomization to initiation of first subsequent anti-cancer therapy for prostate cancer.

Outcome measures

Measure	Placebo+ADT n=223 Participants Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Darolutamide+ADT n=446 Participants Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Time to Initiation of Subsequent Anti-cancer Therapy	NA Months Interval 27.7 to NA signifies that value cannot be estimated due to insufficient number of participants with events.	NA Months NA signifies that value cannot be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From randomization to the date when 222 rPFS events were observed, approximately 36 months

Population: Full Analysis Set (FAS)

Time from the date of randomization to the date of first prostate-specific antigen (PSA) progression. PSA progression with serum testosterone being at castrate level <0.50 ng/mL, is defined as a ≥25% increase above the nadir (lowest at or after baseline) value and an increase in absolute value of ≥2 ng/mL above nadir, and is at least 12 weeks from randomization date, which is confirmed by a second value 3 or more weeks later. All PSA values between the initial assessment meeting the PSA progression criteria and confirmation assessment must be ≥2 ng/mL and ≥25% increase above nadir, serum testosterone at castrate levels <0.50 ng/mL is requested at initial assessment.

Outcome measures

Measure	Placebo+ADT n=223 Participants Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Darolutamide+ADT n=446 Participants Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Time to PSA Progression	16.8 Months Interval 13.9 to 20.1	NA Months NA signifies that value cannot be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From randomization to the date when 222 rPFS events were observed, approximately 36 months

Population: Participants with detectable PSA values ≥0.2 ng/mL at baseline

Percentage of subjects with detectable PSA values of ≥0.2 ng/mL at baseline which became undetectable with any PSA values <0.2 ng/mL during the period between randomization and 30 days after last dose of study drug or start of new anti-cancer therapy whichever occurred earliest, based on the subjects had detectable PSA value at baseline.

Outcome measures

Measure	Placebo+ADT n=211 Participants Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Darolutamide+ADT n=425 Participants Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
PSA Undetectable Rates (<0.2 ng/mL)	18.5 Percentage of participants Interval 13.5 to 24.4	62.6 Percentage of participants Interval 57.8 to 67.2

SECONDARY outcome

Timeframe: From randomization to the date when 222 rPFS events were observed, approximately 36 months

Population: Full Analysis Set (FAS)

Pain progression was assessed by Question 3 (Q3) of the BPI-SF questionnaire related to the worst pain in the last 24 hours (worst pain subscale [WPS]) taken as an average for post baseline score, or initiation of short or long-acting opioids for malignant disease for ≥7 consecutive days after randomization. Pain progression was defined as: (1) for asymptomatic subjects with WPS=0 at baseline, an increase of 2 or more points in the WPS score from nadir observed at 2 consecutive evaluations ≥4 weeks apart, or initiation of short- or long-acting opioid use for malignant disease for ≥7 consecutive days after randomization; (2) for symptomatic subjects with WPS >0 at baseline, an increase of 2 or more points in the WPS score from nadir observed at 2 consecutive evaluations ≥4 weeks apart and a WPS ≥5, or initiation of short- or long-acting opioid use for malignant disease for ≥7 consecutive days after randomization.

Outcome measures

Measure	Placebo+ADT n=223 Participants Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Darolutamide+ADT n=446 Participants Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Time to Pain Progression	29.9 Months Interval 29.7 to NA signifies that value cannot be estimated due to insufficient number of participants with events.	NA Months NA signifies that value cannot be estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From start of study drug administration until 30 days after the last administration

Population: Safety analysis set (SAF)

An AE is any untoward medical occurrence in a patient or clinical study participant, after providing written IC for participation in the study, may or may not be temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AE (TEAE) is defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug.

Outcome measures

Measure	Placebo+ADT n=221 Participants Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Darolutamide+ADT n=445 Participants Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Number of Participants With Adverse Events as a Measure of Safety Any TEAE	199 Participants	405 Participants
Number of Participants With Adverse Events as a Measure of Safety Any TESAE	52 Participants	105 Participants
Number of Participants With Adverse Events as a Measure of Safety Any study drug-related TEAE	64 Participants	144 Participants

Adverse Events

Darolutamide + ADT

Serious events: 105 serious events

Other events: 321 other events

Deaths: 105 deaths

Placebo + ADT

Serious events: 52 serious events

Other events: 149 other events

Deaths: 61 deaths

Serious adverse events

Measure	Darolutamide + ADT n=445 participants at risk Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Placebo + ADT n=221 participants at risk Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Blood and lymphatic system disorders Anaemia	0.67% 3/445 • Number of events 4 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	1.4% 3/221 • Number of events 3 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Acute myocardial infarction	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Angina pectoris	0.67% 3/445 • Number of events 3 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Angina unstable	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Arrhythmia	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Atrial fibrillation	0.67% 3/445 • Number of events 3 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Atrial flutter	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Atrioventricular block	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Atrioventricular block complete	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Cardiac arrest	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Cardiac failure	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Cardiac failure acute	0.22% 1/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Cardiac failure congestive	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Myocardial infarction	0.67% 3/445 • Number of events 3 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Pericarditis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Acute coronary syndrome	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Cardiac disorders Dilated cardiomyopathy	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Ear and labyrinth disorders Vertigo	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Eye disorders Cataract	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Eye disorders Cataract cortical	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Eye disorders Macular degeneration	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Eye disorders Retinal detachment	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Eye disorders Rhegmatogenous retinal detachment	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Ascites	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Chronic gastritis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Diarrhoea	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Gastrointestinal pain	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Incarcerated inguinal hernia	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Inguinal hernia	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Pancreatitis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Large intestine polyp	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Chest pain	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Death	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Gait disturbance	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Pain	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Pyrexia	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Sudden death	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Performance status decreased	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders General physical health deterioration	0.22% 1/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Systemic inflammatory response syndrome	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Disease progression	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Multiple organ dysfunction syndrome	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Hepatobiliary disorders Hepatic cirrhosis	0.22% 1/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Hepatobiliary disorders Hepatic function abnormal	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Hepatobiliary disorders Portal vein thrombosis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Cellulitis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Dengue fever	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Erysipelas	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Gangrene	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Hepatitis C	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Infection	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Leptospirosis	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Liver abscess	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Lower respiratory tract infection	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Nasopharyngitis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Osteomyelitis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Pneumonia	1.3% 6/445 • Number of events 6 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Pneumonia viral	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Pulmonary tuberculosis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Sepsis	0.67% 3/445 • Number of events 3 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Septic shock	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Urinary tract infection	1.8% 8/445 • Number of events 10 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Urosepsis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Pulmonary sepsis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Respiratory tract infection	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Herpes zoster meningitis	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Pneumonia acinetobacter	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Acinetobacter sepsis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations COVID-19	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations COVID-19 pneumonia	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Back injury	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Fall	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Femoral neck fracture	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Femur fracture	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Gastroenteritis radiation	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Ilium fracture	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Traumatic fracture	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Thermal burn	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Pelvic fracture	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Injury, poisoning and procedural complications Craniocerebral injury	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Investigations Alanine aminotransferase increased	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Investigations Aspartate aminotransferase increased	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Investigations Eastern Cooperative Oncology Group performance status worsened	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Investigations SARS-CoV-2 test positive	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Metabolism and nutrition disorders Hyperglycaemia	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Metabolism and nutrition disorders Hyponatraemia	0.22% 1/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Arthralgia	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Back pain	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Bone pain	0.90% 4/445 • Number of events 5 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Muscular weakness	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Pathological fracture	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complication	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of prostate	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Cerebral infarction	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Cerebrovascular accident	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Diabetic neuropathy	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Dizziness	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Guillain-Barre syndrome	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Haemorrhage intracranial	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Neuralgia	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Paraparesis	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Post herpetic neuralgia	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Sciatica	0.22% 1/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Spinal cord compression	1.1% 5/445 • Number of events 6 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Subarachnoid haemorrhage	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Syncope	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Ischaemic stroke	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Psychiatric disorders Delirium	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Bladder neck obstruction	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Calculus bladder	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Cystitis haemorrhagic	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Haematuria	0.67% 3/445 • Number of events 3 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Hydronephrosis	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 3 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Nephrolithiasis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Renal colic	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Renal failure	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Urinary retention	0.67% 3/445 • Number of events 3 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Urinary tract obstruction	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Urinary tract pain	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Bladder perforation	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Chronic kidney disease	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Renal and urinary disorders Acute kidney injury	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Reproductive system and breast disorders Prostatic haemorrhage	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Deep vein thrombosis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Reproductive system and breast disorders Prostatitis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.45% 2/445 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Respiratory, thoracic and mediastinal disorders Emphysema	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.90% 2/221 • Number of events 2 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Surgical and medical procedures Transurethral bladder resection	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Surgical and medical procedures Skin neoplasm excision	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Surgical and medical procedures Urinary calculus removal	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Surgical and medical procedures Prostate ablation	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Hypotension	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Pelvic venous thrombosis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Peripheral ischaemia	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Thrombosis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Peripheral artery occlusion	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Peripheral embolism	0.00% 0/445 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.45% 1/221 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Diabetic vascular disorder	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Superficial vein thrombosis	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Product Issues Device expulsion	0.22% 1/445 • Number of events 1 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	0.00% 0/221 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).

Other adverse events

Measure	Darolutamide + ADT n=445 participants at risk Participants received darolutamide (BAY1841788) 600 mg (2 tablets of 300 mg) twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.	Placebo + ADT n=221 participants at risk Participants received matching placebo twice daily with food and androgen deprivation therapy (ADT) of investigator's choice as standard therapy.
Blood and lymphatic system disorders Anaemia	20.0% 89/445 • Number of events 101 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	16.7% 37/221 • Number of events 42 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Gastrointestinal disorders Constipation	9.4% 42/445 • Number of events 43 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	7.2% 16/221 • Number of events 17 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
General disorders Fatigue	5.6% 25/445 • Number of events 26 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	8.1% 18/221 • Number of events 19 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations Urinary tract infection	10.8% 48/445 • Number of events 63 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	7.7% 17/221 • Number of events 27 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Infections and infestations COVID-19	7.2% 32/445 • Number of events 35 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	6.3% 14/221 • Number of events 15 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Investigations Alanine aminotransferase increased	8.8% 39/445 • Number of events 45 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	8.1% 18/221 • Number of events 18 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Investigations Aspartate aminotransferase increased	9.4% 42/445 • Number of events 47 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	7.7% 17/221 • Number of events 18 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Investigations Blood creatinine increased	4.7% 21/445 • Number of events 22 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	6.8% 15/221 • Number of events 20 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Investigations Weight increased	7.4% 33/445 • Number of events 39 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	7.7% 17/221 • Number of events 19 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Investigations Blood alkaline phosphatase increased	6.7% 30/445 • Number of events 33 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	5.9% 13/221 • Number of events 14 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Metabolism and nutrition disorders Hyperglycaemia	6.1% 27/445 • Number of events 34 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	3.6% 8/221 • Number of events 8 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Arthralgia	12.4% 55/445 • Number of events 63 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	11.3% 25/221 • Number of events 31 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Back pain	9.4% 42/445 • Number of events 54 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	10.0% 22/221 • Number of events 24 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Bone pain	7.0% 31/445 • Number of events 34 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	11.8% 26/221 • Number of events 29 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Musculoskeletal and connective tissue disorders Pain in extremity	8.5% 38/445 • Number of events 44 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	8.1% 18/221 • Number of events 23 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Nervous system disorders Headache	4.0% 18/445 • Number of events 23 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	6.3% 14/221 • Number of events 15 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Psychiatric disorders Insomnia	6.3% 28/445 • Number of events 30 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	2.7% 6/221 • Number of events 6 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Hypertension	8.5% 38/445 • Number of events 41 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	8.6% 19/221 • Number of events 21 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).
Vascular disorders Hot flush	9.2% 41/445 • Number of events 43 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).	7.2% 16/221 • Number of events 16 • From start of study drug administration until 30 days after the last administration. All-cause mortality death events at any time during the study, up to cut-off date for the primary completion analysis 07 JUN 2024 (approximately 39 months).

Additional Information

Therapeutic Area Head

Bayer AG

Phone: (+) 1-888-8422937

Email: clinical-trials-contact@bayer.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60