Trial Outcomes & Findings for A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis (NCT NCT03486899)

NCT ID: NCT03486899

Last Updated: 2022-09-09

Results Overview

The percentage of participants who achieved a ≥1-stage improvement in fibrosis without worsening of NASH or NASH improvement with no worsening of fibrosis at week 24 in liver biopsy. Improvement in fibrosis is defined by the NASH Clinical Research Network (CRN) Fibrosis Score. Improvement in NASH is defined by a ≥2-stage decrease in the nonalcoholic fatty liver disease activity score (NAS). Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by ≥1 point. Worsening of fibrosis is defined as an increase of fibrosis by ≥1 point as determined by the NASH CRN Fibrosis Score. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 197 participants
• Primary outcome timeframe: From first dose to 24 weeks after first dose
• Results posted on: 2022-09-09

Participant Flow

Participant milestones

Measure	BMS-986036 10 mg BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg BMS-986036 40 mg administered subcutaneously once weekly	Placebo Placebo matching BMS-986036 administered subcutaneously once weekly
Overall Study STARTED	49	50	49	49
Overall Study COMPLETED	41	39	41	39
Overall Study NOT COMPLETED	8	11	8	10

Reasons for withdrawal

Measure	BMS-986036 10 mg BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg BMS-986036 40 mg administered subcutaneously once weekly	Placebo Placebo matching BMS-986036 administered subcutaneously once weekly
Overall Study Lost to Follow-up	4	1	4	3
Overall Study Death	1	0	0	1
Overall Study Adverse Event	0	2	0	2
Overall Study Withdrawal by Subject	3	7	4	3
Overall Study Other Reasons	0	1	0	1

Baseline Characteristics

A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

Baseline characteristics by cohort

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly	Total n=197 Participants Total of all reporting groups
Age, Continuous	56.4 Years STANDARD_DEVIATION 9.57 • n=5 Participants	56.3 Years STANDARD_DEVIATION 10.08 • n=7 Participants	57.4 Years STANDARD_DEVIATION 10.50 • n=5 Participants	57.5 Years STANDARD_DEVIATION 8.02 • n=4 Participants	56.9 Years STANDARD_DEVIATION 9.53 • n=21 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	27 Participants n=7 Participants	31 Participants n=5 Participants	29 Participants n=4 Participants	116 Participants n=21 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	23 Participants n=7 Participants	18 Participants n=5 Participants	20 Participants n=4 Participants	81 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	61 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	32 Participants n=7 Participants	34 Participants n=5 Participants	33 Participants n=4 Participants	133 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	42 Participants n=7 Participants	42 Participants n=5 Participants	41 Participants n=4 Participants	168 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants

PRIMARY outcome

Timeframe: From first dose to 24 weeks after first dose

Population: All treated participants

The percentage of participants who achieved a ≥1-stage improvement in fibrosis without worsening of NASH or NASH improvement with no worsening of fibrosis at week 24 in liver biopsy. Improvement in fibrosis is defined by the NASH Clinical Research Network (CRN) Fibrosis Score. Improvement in NASH is defined by a ≥2-stage decrease in the nonalcoholic fatty liver disease activity score (NAS). Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by ≥1 point. Worsening of fibrosis is defined as an increase of fibrosis by ≥1 point as determined by the NASH CRN Fibrosis Score. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Improvement in Fibrosis or Nonalcoholic Steatohepatitis (NASH) at Week 24	30.6 Percentage of Participants Interval 0.88 to 8.52	24.0 Percentage of Participants Interval 0.61 to 6.27	26.5 Percentage of Participants Interval 0.71 to 7.1	14.3 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 24 weeks after first dose

Population: All treated participants

An improvement in fibrosis is defined as a decrease of ≥ 1-stage in the NASH CRN Fibrosis Score at week 24 in liver biopsy. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants Who Achieved an Improvement in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Score at Week 24	16.3 Percentage of Participants	14.0 Percentage of Participants	20.4 Percentage of Participants	8.2 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 24 weeks after first dose

Population: All treated participants

An improvement in Ishak fibrosis is defined as a decrease of fibrosis by ≥ 1-stage in the Ishak fibrosis score at week 24 in liver biopsy. ISHAKs uses a 0-6 scale: 1: centrilobular pericellular fibrosis, 2: centrilobular and periportal fibrosis, 3: bridging fibrosis (few bridges), 4: bridging fibrosis (many bridges), 5: early or incomplete cirrhosis, 6: established or advanced cirrhosis.

Outcome measures

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 24	22.4 Percentage of Participants	16.0 Percentage of Participants	26.5 Percentage of Participants	12.2 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 24 weeks after first dose

Population: All treated participants

An improvement in CPA is defined as any decrease in CPA at week 24 in liver biopsy.

Outcome measures

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 24	42.9 Percentage of Participants	53.5 Percentage of Participants	55.8 Percentage of Participants	65.9 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 24 weeks after first dose

Population: All treated participants

The percentage of participants with NASH resolution without worsening of fibrosis at week 24 in liver biopsy. NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1. Worsening of fibrosis is defined as an increase of fibrosis by ≥ 1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score.

Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade <2). NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis at Week 24	8.2 Percentage Participants	4.0 Percentage Participants	2.0 Percentage Participants	6.1 Percentage Participants

SECONDARY outcome

Timeframe: From first dose to 24 weeks after first dose

Population: All treated participants

NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1 at week 24 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade <2).

Outcome measures

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 24	8.2 Percentage of Participants	4.0 Percentage of Participants	2.0 Percentage of Participants	6.1 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 24 weeks after first dose

Population: All treated participants

The percentage of participants with NASH improvement without worsening of fibrosis at week 24 in liver biopsy. NASH improvement defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by ≥2 points with contribution from >1 NAS component. Worsening of fibrosis is defined as an increase of ≥1-point in the NASH Clinical Research Network (CRN) Fibrosis Score. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement Without Worsening of Fibrosis at Week 24	22.4 Percentage of Participants	14.0 Percentage of Participants	16.3 Percentage of Participants	10.2 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 24 weeks after first dose

Population: All treated participants

An improvement in fibrosis is defined as a decrease of fibrosis by ≥1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score at week 24 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 24	16.3 Percentage of Participants	14.0 Percentage of Participants	16.3 Percentage of Participants	8.2 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 24 weeks after first dose

Population: All treated participants

The percentage of participants with NASH improvement at week 24 in liver biopsy. NASH improvement is defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by ≥ 2 points with contribution from > 1 NAS component. The NASH CRN system assesses liver biopsies for degree of steatosis (0-3), lobular inflammation (0-3), hepatocellular ballooning (0-2), and fibrosis (0-4). The 3 categories are added together in an unweighted fashion to determine the NAS, which ranges from 0 to 8.

Outcome measures

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 24	24.5 Percentage of Participants	18.0 Percentage of Participants	16.3 Percentage of Participants	10.2 Percentage of Participants

SECONDARY outcome

Timeframe: From first dose to 24 weeks after first dose

Population: All treated participants

Progression to cirrhosis is defined by the nonalcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Stage 4 at Week 24 in liver biopsy. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Measure	BMS-986036 10 mg n=49 Participants BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 Participants BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 Participants BMS-986036 40 mg administered subcutaneously once weekly	Placebo n=49 Participants Placebo matching BMS-986036 administered subcutaneously once weekly
The Percentage of Participants With Progression to Cirrhosis at Week 24	30.6 Percentage of Participants	22.0 Percentage of Participants	28.6 Percentage of Participants	20.4 Percentage of Participants

Adverse Events

BMS-986036 10 mg

Serious events: 3 serious events

Other events: 36 other events

Deaths: 1 deaths

BMS-986036 20 mg

Serious events: 7 serious events

Other events: 38 other events

Deaths: 0 deaths

BMS-986036 40 mg

Serious events: 6 serious events

Other events: 39 other events

Deaths: 0 deaths

BMS-986036 Placebo

Serious events: 9 serious events

Other events: 33 other events

Deaths: 1 deaths

Serious adverse events

Measure	BMS-986036 10 mg n=49 participants at risk BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 participants at risk BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 participants at risk BMS-986036 40 mg administered subcutaneously once weekly	BMS-986036 Placebo n=49 participants at risk Placebo matching BMS-986036 administered subcutaneously once weekly
Cardiac disorders Coronary artery disease	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Cardiac disorders Coronary artery occlusion	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Ear and labyrinth disorders Vertigo positional	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Colitis	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Epiploic appendagitis	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Vomiting	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
General disorders Non-cardiac chest pain	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Hepatobiliary disorders Cholecystitis	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations COVID-19 pneumonia	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Campylobacter infection	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Post procedural infection	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Sepsis	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Urosepsis	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Injury, poisoning and procedural complications Road traffic accident	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Investigations Liver function test increased	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma metastatic	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Nervous system disorders Cerebrovascular accident	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Nervous system disorders Dizziness	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Psychiatric disorders Suicidal ideation	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).

Other adverse events

Measure	BMS-986036 10 mg n=49 participants at risk BMS-986036 10 mg administered subcutaneously once weekly	BMS-986036 20 mg n=50 participants at risk BMS-986036 20 mg administered subcutaneously once weekly	BMS-986036 40 mg n=49 participants at risk BMS-986036 40 mg administered subcutaneously once weekly	BMS-986036 Placebo n=49 participants at risk Placebo matching BMS-986036 administered subcutaneously once weekly
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Urinary tract infection	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.0% 2/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	12.2% 6/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Injury, poisoning and procedural complications Procedural pain	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.0% 3/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Metabolism and nutrition disorders Increased appetite	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	10.2% 5/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Metabolism and nutrition disorders Type 2 diabetes mellitus	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Musculoskeletal and connective tissue disorders Arthralgia	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	12.0% 6/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Musculoskeletal and connective tissue disorders Flank pain	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.0% 3/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Musculoskeletal and connective tissue disorders Muscle spasms	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.0% 3/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.0% 3/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Nervous system disorders Dizziness	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.0% 2/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Nervous system disorders Headache	10.2% 5/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.0% 4/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	12.2% 6/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Psychiatric disorders Anxiety	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.0% 3/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.0% 2/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Skin and subcutaneous tissue disorders Pruritus	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.0% 4/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Skin and subcutaneous tissue disorders Rash	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.0% 2/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	12.2% 6/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Vascular disorders Hypertension	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Abdominal distension	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.0% 4/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Abdominal pain	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	10.0% 5/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Abdominal pain upper	12.2% 6/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.0% 2/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Constipation	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.0% 3/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Diarrhoea	22.4% 11/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	20.0% 10/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	22.4% 11/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	12.2% 6/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Frequent bowel movements	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Gastrooesophageal reflux disease	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.0% 2/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Nausea	26.5% 13/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	22.0% 11/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	14.3% 7/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	16.3% 8/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Gastrointestinal disorders Vomiting	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.0% 3/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
General disorders Fatigue	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	14.0% 7/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
General disorders Injection site bruising	10.2% 5/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.0% 2/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
General disorders Injection site erythema	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.0% 3/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	14.3% 7/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
General disorders Injection site pain	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	10.0% 5/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
General disorders Injection site pruritus	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.0% 2/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
General disorders Pain	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.0% 4/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Bronchitis	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.0% 3/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.2% 4/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations COVID-19	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.0% 4/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Ear infection	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	2.0% 1/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	0.00% 0/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Nasopharyngitis	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	8.0% 4/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Sinusitis	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.0% 2/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	6.1% 3/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	4.1% 2/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).
Infections and infestations Upper respiratory tract infection	10.2% 5/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	12.0% 6/50 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	12.2% 6/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).	12.2% 6/49 • All-cause mortality was assessed from first dose to study completion (up to approximately 35 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks).

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email:

Email: Clinical.Trials@bms.com

Results disclosure agreements

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

Restriction type: OTHER