Trial Outcomes & Findings for A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder (NCT NCT04919512)

NCT ID: NCT04919512

Last Updated: 2026-03-25

Results Overview

pCR was defined as percentage of participants who achieved complete pathologic response. Complete pathologic response is defined as ypT0N0 (no evidence of disease) as assessed by pathologic evaluation on radical cystectomy (RC) specimen. pCR was determined by central pathologic review.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

163 participants

Primary outcome timeframe

At Week 12

Results posted on

2026-03-25

Participant Flow

Participants with muscle-invasive urothelial carcinoma of the bladder (MIBC) who were scheduled for radical cystectomy (RC) and were ineligible for or refusing cis-platinum based neoadjuvant chemotherapy were enrolled in the study. Results are currently reported up to cut off date that is 09 May 2025. Remaining results will be posted upon study completion.

Participant milestones

Participant milestones
Measure	TAR-200 + Cetrelimab Participants received intravesical TAR-200 along with cetrelimab. TAR-200 was placed intravesically via the urinary placement catheter (UPC) at Weeks 0, 3, 6 and 9. The initial TAR-200 which was placed at Cycle 1, Day 1 of Week 0 was removed via flexible or rigid cystoscopy at Week 3, and then the second TAR-200 was placed via a UPC. This removal/replacement procedure was repeated for a third and fourth dosing cycle at Week 6 and Week 9, respectively. The fourth TAR-200 was removed at Week 12. Cetrelimab 360 milligrams (mg) was administered intravenously starting from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.	Cetrelimab Alone Cetrelimab 360 mg was administered intravenously from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.
Overall Study STARTED	104	59
Overall Study COMPLETED	20	10
Overall Study NOT COMPLETED	84	49

Reasons for withdrawal

Reasons for withdrawal
Measure	TAR-200 + Cetrelimab Participants received intravesical TAR-200 along with cetrelimab. TAR-200 was placed intravesically via the urinary placement catheter (UPC) at Weeks 0, 3, 6 and 9. The initial TAR-200 which was placed at Cycle 1, Day 1 of Week 0 was removed via flexible or rigid cystoscopy at Week 3, and then the second TAR-200 was placed via a UPC. This removal/replacement procedure was repeated for a third and fourth dosing cycle at Week 6 and Week 9, respectively. The fourth TAR-200 was removed at Week 12. Cetrelimab 360 milligrams (mg) was administered intravenously starting from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.	Cetrelimab Alone Cetrelimab 360 mg was administered intravenously from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	5	4
Overall Study Other	2	0
Overall Study Ongoing	76	44

Baseline Characteristics

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAR-200 + Cetrelimab n=104 Participants Participants received intravesical TAR-200 along with cetrelimab. TAR-200 was placed intravesically via the urinary placement catheter (UPC) at Weeks 0, 3, 6 and 9. The initial TAR-200 which was placed at Cycle 1, Day 1 of Week 0 was removed via flexible or rigid cystoscopy at Week 3, and then the second TAR-200 was placed via a UPC. This removal/replacement procedure was repeated for a third and fourth dosing cycle at Week 6 and Week 9, respectively. The fourth TAR-200 was removed at Week 12. Cetrelimab 360 milligrams (mg) was administered intravenously starting from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.	Cetrelimab Alone n=59 Participants Cetrelimab 360 mg was administered intravenously from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.	Total n=163 Participants Total of all reporting groups
Age, Continuous	72.7 years STANDARD_DEVIATION 6.65 • n=138 Participants	67.7 years STANDARD_DEVIATION 8.58 • n=62 Participants	70.9 years STANDARD_DEVIATION 7.76 • n=123 Participants
Sex: Female, Male Female	15 Participants n=138 Participants	12 Participants n=62 Participants	27 Participants n=123 Participants
Sex: Female, Male Male	89 Participants n=138 Participants	47 Participants n=62 Participants	136 Participants n=123 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=138 Participants	10 Participants n=62 Participants	24 Participants n=123 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=138 Participants	48 Participants n=62 Participants	129 Participants n=123 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=138 Participants	1 Participants n=62 Participants	10 Participants n=123 Participants
Age, Categorical Adults (18-64 years)	13 Participants n=138 Participants	15 Participants n=62 Participants	28 Participants n=123 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Asian	18 Participants n=138 Participants	12 Participants n=62 Participants	30 Participants n=123 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Black or African American	1 Participants n=138 Participants	2 Participants n=62 Participants	3 Participants n=123 Participants
Race (NIH/OMB) White	75 Participants n=138 Participants	43 Participants n=62 Participants	118 Participants n=123 Participants
Race (NIH/OMB) More than one race	1 Participants n=138 Participants	0 Participants n=62 Participants	1 Participants n=123 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=138 Participants	2 Participants n=62 Participants	11 Participants n=123 Participants
Region of Enrollment Belgium	14 Participants n=138 Participants	3 Participants n=62 Participants	17 Participants n=123 Participants
Region of Enrollment France	6 Participants n=138 Participants	0 Participants n=62 Participants	6 Participants n=123 Participants
Region of Enrollment Germany	1 Participants n=138 Participants	1 Participants n=62 Participants	2 Participants n=123 Participants
Region of Enrollment Israel	2 Participants n=138 Participants	1 Participants n=62 Participants	3 Participants n=123 Participants
Region of Enrollment Italy	4 Participants n=138 Participants	8 Participants n=62 Participants	12 Participants n=123 Participants
Region of Enrollment Korea, South	18 Participants n=138 Participants	12 Participants n=62 Participants	30 Participants n=123 Participants
Region of Enrollment Spain	15 Participants n=138 Participants	13 Participants n=62 Participants	28 Participants n=123 Participants
Region of Enrollment United Kingdom	2 Participants n=138 Participants	0 Participants n=62 Participants	2 Participants n=123 Participants
Region of Enrollment United States	42 Participants n=138 Participants	21 Participants n=62 Participants	63 Participants n=123 Participants
Age, Categorical From 65 to 74 years	45 Participants n=138 Participants	31 Participants n=62 Participants	76 Participants n=123 Participants
Age, Categorical From 75 to 84 years	44 Participants n=138 Participants	13 Participants n=62 Participants	57 Participants n=123 Participants
Age, Categorical 85 years and over	2 Participants n=138 Participants	0 Participants n=62 Participants	2 Participants n=123 Participants

PRIMARY outcome

Timeframe: At Week 12

Population: Efficacy evaluable analysis set included all participants who had adequate RC results and had centrally evaluable histopathology to determine pCR.

Outcome measures

Outcome measures
Measure	TAR-200 + Cetrelimab n=88 Participants Participants received intravesical TAR-200 along with cetrelimab. TAR-200 was placed intravesically via the urinary placement catheter (UPC) at Weeks 0, 3, 6 and 9. The initial TAR-200 which was placed at Cycle 1, Day 1 of Week 0 was removed via flexible or rigid cystoscopy at Week 3, and then the second TAR-200 was placed via a UPC. This removal/replacement procedure was repeated for a third and fourth dosing cycle at Week 6 and Week 9, respectively. The fourth TAR-200 was removed at Week 12. Cetrelimab 360 milligrams (mg) was administered intravenously starting from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.	Cetrelimab Alone n=46 Participants Cetrelimab 360 mg was administered intravenously from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.
Pathologic Complete Response (pCR) Rate	37.5 Percentage of participants Interval 27.4 to 48.5	28.3 Percentage of participants Interval 16.0 to 43.5

SECONDARY outcome

Timeframe: Cycle Day 1 up to Week 124

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle Day 1 up to Week 124

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle Day 1 up to Week 124

Outcome measures

Outcome data not reported

Adverse Events

TAR-200 + Cetrelimab

Serious events: 60 serious events

Other events: 95 other events

Deaths: 14 deaths

Cetrelimab

Serious events: 26 serious events

Other events: 53 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Director Onc

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	TAR-200 + Cetrelimab n=101 participants at risk Participants received intravesical TAR-200 along with cetrelimab. TAR-200 was placed intravesically via the urinary placement catheter (UPC) at Weeks 0, 3, 6 and 9. The initial TAR-200 which was placed at Cycle 1, Day 1 of Week 0 was removed via flexible or rigid cystoscopy at Week 3, and then the second TAR-200 was placed via a UPC. This removal/replacement procedure was repeated for a third and fourth dosing cycle at Week 6 and Week 9, respectively. The fourth TAR-200 was removed at Week 12. Cetrelimab 360 milligrams (mg) was administered intravenously starting from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.	Cetrelimab n=58 participants at risk Cetrelimab 360 mg was administered intravenously from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.
Blood and lymphatic system disorders Anaemia	2.0% 2/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Blood and lymphatic system disorders Neutropenia	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Cardiac disorders Acute Myocardial Infarction	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Cardiac disorders Atrial Fibrillation	2.0% 2/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Cardiac disorders Bradycardia	0.00% 0/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Cardiac disorders Cardiac Arrest	2.0% 2/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Cardiac disorders Cardiac Failure	3.0% 3/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Cardiac disorders Cardio-Respiratory Arrest	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Endocrine disorders Hypothyroidism	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Abdominal Pain	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	3.4% 2/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Acute Abdomen	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Diarrhoea	2.0% 2/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Enterocolitis	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Enterocutaneous Fistula	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Hernial Eventration	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Ileus	3.0% 3/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Inguinal Hernia	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Intestinal Obstruction	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Nausea	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Rectal Haemorrhage	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Small Intestinal Obstruction	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Volvulus	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
General disorders Asthenia	2.0% 2/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
General disorders Death	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
General disorders Fatigue	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
General disorders Pyrexia	3.0% 3/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Hepatobiliary disorders Hepatic Failure	0.00% 0/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Hepatobiliary disorders Hepatitis Acute	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Abdominal Abscess	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Abdominal Infection	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Actinomyces Bacteraemia	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Bacteraemia	0.00% 0/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Candida Sepsis	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Covid-19	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Pelvic Abscess	0.00% 0/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Peritonitis	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Postoperative Wound Infection	0.00% 0/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Pseudomembranous Colitis	0.00% 0/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Purulence	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Pyelonephritis	5.9% 6/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.

Other adverse events
Measure	TAR-200 + Cetrelimab n=101 participants at risk Participants received intravesical TAR-200 along with cetrelimab. TAR-200 was placed intravesically via the urinary placement catheter (UPC) at Weeks 0, 3, 6 and 9. The initial TAR-200 which was placed at Cycle 1, Day 1 of Week 0 was removed via flexible or rigid cystoscopy at Week 3, and then the second TAR-200 was placed via a UPC. This removal/replacement procedure was repeated for a third and fourth dosing cycle at Week 6 and Week 9, respectively. The fourth TAR-200 was removed at Week 12. Cetrelimab 360 milligrams (mg) was administered intravenously starting from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.	Cetrelimab n=58 participants at risk Cetrelimab 360 mg was administered intravenously from Cycle 1 Day 1 of Weeks 0 up to 4 cycles. Each cycle was of 21 days.
Blood and lymphatic system disorders Anaemia	29.7% 30/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	24.1% 14/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Endocrine disorders Hyperthyroidism	13.9% 14/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	6.9% 4/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Endocrine disorders Hypothyroidism	12.9% 13/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	10.3% 6/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Abdominal Pain	9.9% 10/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	13.8% 8/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Constipation	25.7% 26/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	13.8% 8/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Diarrhoea	22.8% 23/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	15.5% 9/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Dyspepsia	6.9% 7/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	0.00% 0/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Nausea	8.9% 9/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	10.3% 6/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Gastrointestinal disorders Vomiting	5.9% 6/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	6.9% 4/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
General disorders Asthenia	8.9% 9/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	1.7% 1/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
General disorders Chills	4.0% 4/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	6.9% 4/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
General disorders Fatigue	23.8% 24/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	24.1% 14/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
General disorders Oedema Peripheral	7.9% 8/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	3.4% 2/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
General disorders Pyrexia	14.9% 15/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	17.2% 10/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	2.0% 2/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	5.2% 3/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Infections and infestations Urinary Tract Infection	23.8% 24/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	22.4% 13/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	5.2% 3/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Injury, poisoning and procedural complications Procedural Pain	6.9% 7/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	3.4% 2/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Investigations Alanine Aminotransferase Increased	3.0% 3/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	8.6% 5/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Investigations Aspartate Aminotransferase Increased	3.0% 3/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	12.1% 7/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Investigations Blood Creatinine Increased	12.9% 13/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	12.1% 7/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Investigations Blood Lactate Dehydrogenase Increased	4.0% 4/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	5.2% 3/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Investigations C-Reactive Protein Increased	6.9% 7/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	3.4% 2/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Investigations Gamma-Glutamyltransferase Increased	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	8.6% 5/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Investigations Lipase Increased	7.9% 8/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	10.3% 6/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Investigations Weight Decreased	13.9% 14/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	6.9% 4/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Metabolism and nutrition disorders Decreased Appetite	18.8% 19/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	5.2% 3/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Metabolism and nutrition disorders Hyperamylasaemia	6.9% 7/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	13.8% 8/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Metabolism and nutrition disorders Hyperglycaemia	8.9% 9/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	5.2% 3/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Metabolism and nutrition disorders Hyperkalaemia	7.9% 8/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	8.6% 5/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	9.9% 10/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	3.4% 2/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Metabolism and nutrition disorders Hypokalaemia	5.9% 6/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	5.2% 3/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	5.0% 5/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	5.2% 3/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Metabolism and nutrition disorders Hyponatraemia	10.9% 11/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	8.6% 5/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Metabolism and nutrition disorders Hypophosphataemia	5.9% 6/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	3.4% 2/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 3/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	10.3% 6/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Back Pain	4.0% 4/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	10.3% 6/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Musculoskeletal and connective tissue disorders Flank Pain	0.99% 1/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	6.9% 4/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	11.9% 12/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	3.4% 2/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.
Nervous system disorders Headache	7.9% 8/101 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.	3.4% 2/58 • All-cause mortality: Screening (Day -42) up to Week 148; Serious/other AEs: Cycle 1 Day 1 up to Week 148 All-cause mortality: all randomized participants; Serious/other AEs: Safety analysis set included participants who received at least 1 dose of any study treatment.